Sunday, February 28, 2010

For the latest news concerning TMJ disorders and The TMJ Association, visit our new sister site: www.tmjassociation.org.

Wednesday, February 17, 2010

Development of Temporomandibular Disorders is Associated

with Greater Bodily Pain Experience

This is a 3–year prospective study of 266 females aged 18 to 34 years initially free of temporomandibular disorders (TMD) pain. All patients completed the Symptom Report Questionnaire (SRQ) at baseline and yearly intervals, and at the time they developed TMD (if applicable)...The development of TMD was accompanied by increases in headaches, muscle soreness or pain, and other pains that were not observed in the Participants who did not develop TMD. Participants who developed TMD also report higher experience of joint, back, chest, and menstrual pain at baseline. Click here to read the abstract.

Friday, January 29, 2010

Wednesday, December 30, 2009

Tuesday, December 08, 2009

NIH: Under New Management

The new Director for the National Institutes of Health, Francis Collins, is no stranger to NIH. He was the Director of the National Human Genome Institute and led the international consortium that mapped and sequenced the entire human genome earlier in the decade. Not surprisingly, he is enthusiastic about genetic research and upbeat about the promise of “personalized medicine,” the subject of a new book he has written coming out in January. What Collins says is that if you know your family history and your own genome you should be able to identify your risk for a range of diseases (at least those diseases so far discovered to be associated with particular gene variants). You may then be able to make lifestyle changes that could lower your risk. 

Pharmacogenetics. Knowing your own genome should also help to personalize disease treatments, since prescribing the right drug for you at the right dose depends in part on knowing how your genes specify how the compounds are metabolized. This new field of research is called pharmacogenetics. Collins is sure that the commercial cost of getting individual genomes sequenced will come down appreciably in the coming decade (it now costs up to a few thousand dollars) and the data could be built into your own electronic health record. Moreover, research is continuing to find the genetic links to more and more diseases, making individual genome sequences even more informative.

TMJD patients already have had some experience with genetic linkages. Pioneering research by investigators at the Universities of Michigan and North Carolina at Chapel Hill have shown that TMJD patients, more than healthy controls, are more likely to carry a variant of the COMT gene that makes them more sensitive to pain.

Stem cells. Under new management, and a new administration, NIH-supported research on stem cells, which could serve as the source for replacements for diseased or damaged tissues, is expected to grow. Investigators are also having some success in developing ways to re-program adult stem cells to become more like embryonic stem cells, which have the potential to develop into any specific cell type in the body, thus avoiding the issues that have clouded stem cell studies over the decade.  

Money issues. There are hurdles ahead; however, Collins worries. The depressed economy will make it hard for NIH to grow the research enterprise. After years of essentially flat budgets, NIH got a boost from the President’s stimulus package, but this is only short-term. The issue concerns what will happen in the regular budget negotiating process in the years ahead as the nation comes to grips with a huge deficit, high unemployment, a fragile economy and competing demands at home and abroad. One thing is clear: the new man at the helm is a brilliant scientist who sees the big picture.  His NIH will not only celebrate basic science but will urge scientists to consider how their work translates to new therapies. “We’re not the National Institutes of Basic Science,” he says, “We’re the National Institutes of Health.”

Friday, December 04, 2009

Norpramin (desipramine hydrochloride) - Dear Healthcare Professional Letter

Audience: Psychiatric healthcare professionals

Sanofi-Aventis and FDA notified healthcare professionals of changes to the Warnings and Overdosage sections of the Prescribing Information for Norpramin (desipramine hydrochloride), indicated for the treatment of depression. The new safety information states that extreme caution should be used when this drug is given to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances; and that seizures precede cardiac dysrhythmias and death in some patients.

Read the complete MedWatch 2009 Safety summary, including a link to the Dear Healthcare Professional letter, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm

Wednesday, December 02, 2009

The Agency for Healthcare Research and Quality recommends asking the following questions before taking medications.

1. What are the brand name and generic name of this medicine?
2. Can I take a generic version of this medicine?
3. What am I taking this medicine for?
4. Does this new prescription mean I should stop taking any other medicines I'm taking now?
5. How do I take the medicine and how often do I take it? If I need to take it three times a day, does that mean to take it at breakfast, lunch, and dinner, or to take it every 8 hours?
6. Do I need to take it all, or should I stop when I feel better?
7. How long will I be taking it? Can I get a refill? How often can I get a refill?
8. Are there any tests I need to take while I'm on this medicine?
9. When should I expect the medicine to start working? How can I tell if it's working?
10. When should I tell the doctor about a problem or side effect?
11. Are there foods, drinks (including alcoholic beverages), other medicines, or activities to avoid while I'm taking this medicine?
12. What are the side effects that can happen with this medicine?
13. What should I do if I have a side effect?
14. What happens if I miss a dose?
15. What printed information can you give me about this medicine?

Source: http://www.ahrq.gov/consumer/safemeds/safeques.htm

Wednesday, November 25, 2009

Orthognathic treatment and temporomandibular disorders: A systematic review. Part 1. A new quality-assessment technique and analysis of study characteristics and classifications
American Journal of Orthodontics and Dentofacial Orthopedics, 11/10/09

Orthognathic treatment and temporomandibular disorders: A systematic review. Part 2. Signs and symptoms and meta-analyses
American Journal of Orthodontics and Dentofacial Orthopedics, Volume 136, Issue 5, November 2009, Pages 626.e1-626.e16
Salma Al-Riyami, Susan J. Cunningham, David R. Moles

Friday, November 20, 2009

Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis

Audience: Orthopedic and Anesthesia healthcare professionals, hospital risk managers

FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain. The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).

Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.

This notice provides further management considerations for healthcare professionals, information for patients, a data summary of the 35 reports, and references.

Read the complete MedWatch 2009 Safety summary, including a link to the Information for Healthcare Professionals sheet, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190496.htm

Friday, November 20, 2009

Our latest e-newsletter, TMJ News Bites is now available on-line at: http://app2.e2ma.net/campaign/33027.9d25535d5d023c1cbe11909746de7860

Friday, November 20, 2009

Thursday, October 29, 2009

Wednesday, October 21, 2009

Arthrocentesis and lavage for treating temporomandibular joint disorders

When the joint between the lower jaw and the base of the skull is not working well, the signs and symptoms such as movement problems, noises (clicking or grating), muscle spasms or pain could take place. It is so-called temporomandibular joint disorders. A range of treatment options for treating temporomandibular joint disorders are available such as arthrocentesis and arthroscopy. The review found that there is no enough evidence to judge whether arthrocentesis is more helpful for people with temporomandibular joint disorders than arthroscopy. Reported side effects were mild and transient.

Read full abstract on the Cochrane Review

Wednesday, October 07, 2009

Research Grant Opportunities

NIH Blueprint for Neuroscience Research Competitive Revisions for Studies Focused on Neuropathic Pain or Neural Plasticity to Promote Collaborative Pain Research (R01) Deadline: November 23, 2009 The NIH Blueprint for Neuroscience Research has announced a funding opportunity that will support partnerships between scientists from the pain and neuroplasticity fields. These partnerships are expected to lead to insights into the neuroplastic changes that occur during the transition from acute to chronic pain. In the next two years, this Blueprint initiative will be expanded to promote larger collaborative projects on the transition from acute to chronic pain, and to train new investigators in state-of-the-art methods for studying pain.

Solicitation of Assays for High Throughput Screening (HTS) in the Molecular Libraries Probe Production Centers Network (MLPCN) (R03) Released Date: March 12, 2009 http://grants.nih.gov/grants/guide/pa-files/PAR-09-129.html. The NIH Molecular Libraries Roadmap Initiative wishes to encourage HTS assay applications from investigators who have the interest and capability to work with the Molecular Libraries Probe Production Centers Network (MLPCN) for chemical probe development. This Funding Opportunity Announcement (FOA) promotes discovery and development of new chemical probes as research tools for use by scientists in both the public and private sectors to advance the understanding of biological functions and disease mechanisms. This initiative is one of the integrated components of the NIH Molecular Libraries Roadmap initiative that offers biomedical researchers access to large-scale automated high throughput screening (HTS) centers in the MLPCN, diverse compound libraries in the Small Molecule Repository (MLSMR) and information on biological activities of small molecules in the PubChem BioAssay public database.

NIAMS Building Interdisciplinary Research Team (BIRT) Revision Awards - RFA) Number: RFA-AR-08-001 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Released Date: November 2, 2007 Expiration Date: January 5, 2012 http://grants2.nih.gov/grants/guide/rfa-files/RFA-AR-08-001.html. To promote interdisciplinary research, the NIAMS plans to provide up to 1 year of research revision support (formerly referred to as “supplement” – see page 1-21 section 2.8 of the SF424 (R&R) Application and Electronic Submission Instructions Version 2) to active NIAMS R01s (parent grants) to establish collaborations among groups of investigators with expertise in the specific areas listed below. The institute intends to supplement interdisciplinary collaboration with high innovation and potentially high impact in the specific NIAMS mission–relevant areas solicited in this FOA. It is understood that such an application may entail high risk. Teams developed under this award are expected to make significant advances beyond the progress expected from the individual researchers alone. Collaborations between scientific areas listed below are selected to pilot the NIAMS BIRT awards and specifically solicited in this FOA. Autoimmunity – Gender and sex factors Autoimmunity or Developmental biology – Systems biology Soft tissue biology – Imaging technologies Tissue engineering – Immunology or Developmental biology

The Biomarkers Consortium The Biomarkers Consortium, a research partnership managed by the Foundation for the National Institutes of Health, is soliciting concepts for biomarker projects. Researchers are encouraged to submit project concepts online at http://www.biomarkersconsortium.org. If a concept is approved for development by the consortium, the Foundation for NIH will seek funds to support the project. The consortium is a large-scale, public-private research partnership formed in 2006 to identify and qualify biomarkers. It encourages participation by academia, government, industry, patient advocacy groups and other non-profit organizations. In addition to the Foundation for NIH, founding members of the consortium include the NIH, the Food and Drug Administration and the Pharmaceutical Research and Manufacturers of America. Information about the Foundation for NIH is available at http://www.fnih.org.

Tuesday, October 06, 2009

Breakthrough: Bone Graft Grown in Exact Shape of Complex Skull-Jaw Joint

By Charles Q. Choi
Technique could be a preferred substitute for replacing missing or damaged bones with titanium, donated bones or those harvested from elsewhere in a patient's body

http://www.scientificamerican.com/article.cfm?id=bone-graft-tmj&SID=mail&sc=emailfriend

Monday, September 28, 2009

What to do if your jaw locks

Although it is not the most common of TMJ problems, closed lock is very frightening for those who have it. In its most acute stage, the mouth is almost impossible to open because of both a physical block by a displaced disk and great pain. Because of this, surgery has long been the treatment of choice, since it was assumed that this was the only way to get the disk back in place. However, it was also known that symptoms can improve with simple symptom management, or a combination of symptom management and physical therapy. This prompted a group at the University of Minnesota to carry out a randomized clinical trial of four treatments for Closed Lock.   Click here to read about this study.

Monday, September 28, 2009

Antidepressants in Pregnancy Up Heart Defect Risk

Reuters

If you take antidepressants such as fluoxetine (marketed as Prozac) early in your pregnancy, you may be doubling the risk that your newborn will be born with a heart defect.

http://www.reuters.com/article/healthNews/idUSTRE58O39F20090925

Monday, September 28, 2009

Young women with autoimmune condition need to be warned about the dangers of smoking and use of oral contraceptives

Medical News Today

An article published Online First and in the November edition of The Lancet Neurology reports that women with a particular subtype of antibody called lupus anticoagulant (LA) have a more than 40-fold increased risk of stroke. Moreover, they have a 5-fold increased risk of heart attack compared with the general population of young women.

http://www.medicalnewstoday.com/articles/165330.php

Monday, September 28, 2009

Monday, September 28, 2009

 Workplace Fundraising Campaigns

Federal Employees...We Need You!

Monday, September 28, 2009

 Now is the Time....Become a TMJA Advisor

The TMJA needs volunteers willing to serve in an advisory capacity with the goal of increasing overall awareness of temporomandibular joint and muscle disorders (TMJD) and promoting scientific research.  You, as a patient or someone close to a patient, have full understanding of how devastating these conditions can be and the impact they have on the lives of TMJ patients and their loved ones. Your experience and understanding of TMJD will make you a valuable asset in helping the organization move forward.  Please review the position descriptions.  If you or someone you know can help, contact us.  Think of how much more your Association will be able to accomplish with your help.

Monday, September 28, 2009

Cyclobenzaprine (Flexeril) for the Treatment of Myfascial Pain in Adults

Friday, August 21, 2009

Ibuprofen (Unapproved) topical drug products

FDA informed consumers and healthcare professionals of its intent to take action against eight companies that market unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.  The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen.  However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products. 

The names of the products and manufacturers that received warning letters are: 
Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)

Read the complete MedWatch 2009 Safety summary including a link to the FDA press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm179925.htm

Wednesday, August 19, 2009

Wednesday, July 22, 2009

TMJ Treatments Raise Ethical Issues about TMJD Trial Conduct & Clinical Care

High on the national agenda to reform health care in America is to conduct studies to find out what treatments really work and thus eliminate often costly but ineffective and possibly harmful alternatives. In that light it is sad to report that a recent analysis of over 200 systematic reviews comparing surgical and non-surgical interventions for temporomandibular joint and muscle disorders (TMJDs) concluded that the poor quality of most studies precluded making any recommendations whatsoever.  Indeed, the authors of the article,* found only two systematic review articles out of 211 published over the last 40 years that met the authors’ inclusion criteria for further analysis.

“Systematic reviews” have become popular in recent years as a means of validating clinical practice. The reviewers amass the published reports in the medical literature of clinical trials of a procedure – a diagnostic method or means of prevention or treatment --over a period of time, using standard databases like Medline. They then judge whether a particular trial design is of sufficient quality to merit inclusion in their review and analyze the group of trials selected to see if some definitive pattern of results emerges. In some cases the data from a number of published trials can be combined into one big “meta-analysis,” which adds weight to the statistical analysis.

In the case of the systematic reviews of TMJD surgical and non-surgical treatments, the authors could find only two systematic reviews that met their inclusion criteria. (They excluded reviews of in vitro or animal studies, reviews of non-surgical treatments only, editorials, simple narratives, letters to the editor, and articles published outside a selected set of languages). Worse, only a few subsets of studies included in each of the reviews the authors selected met high-quality criteria and these studies represented only a small percentage of all the patients involved in the studies.  While both reviews found no statistically significant differences in outcomes for surgical vs. non-surgical interventions, the conclusions were based on combining results for all the studies in the reviews–whether high, low, or of middling quality.   As a further caveat, the BMC authors independently evaluated the methodology employed by the authors of the two reviews themselves, using three different sets of established methodology criteria.  On a scale of 0-100% one review met only 23.5% plus or minus 6.0% (mean and standard deviation) and the other, 77.5% plus or minus 12.8% of the methodology quality criteria.

To their credit, the authors of the two systematic reviews discussed the flaws in the studies in their reviews: few trials tailored specific treatments to specific sub-groups of TMJD patients so judgments of relative efficacy could not be made.  Also, trials varied in how they defined the success or improvements following treatment.

Such criticisms are not new:  the lack of standardized diagnostic criteria and outcome measures for TMJDs has plagued TMJD studies for years, along with such issues as sample size and patient follow-up. The BMC authors advise that “clinical scientists need to be designing, implementing, and reporting clinical trials and systematic reviews that meet international standards.”  For TMJD studies in particular, trials should incorporate international standards assessing chronic pain pre- and 3-months post-therapy, measures which would include the number and percentage of patients with 50% pain relief for both the experimental and control group.

Ethical Concerns

The authors conclude, “The most troubling aspect of our findings involves the ethics of trials that do not meet international standards of conduct, and the care of patients that is not based on high levels of evidence.”  They cite a Supreme Court ruling in which the Federal Rules of Evidence for causality of harm were applied, based on the highest level of evidence.  But it should not take the threat of litigation to alter clinical trial design or practice. As the authors observe, “having clinical scientists register their trials, select and implement interventions and comparisons in a standard, randomized, blinded fashion, and completely report these results …would substantially improve the evidence base, reduce the variation in care and improve knowledge of patient outcomes.”

Wednesday, July 22, 2009

Leigh's Thoughts on Being a Mom with a TMJD

I am a Mom suffering with TMJD. To be honest, I have only had a few big flare-ups since having my son 4 1/2 years ago. But my jaw feels tired on most days. I don’t have any cartilage left in my joints so a lot of talking - especially on the phone or when reading aloud - just makes me sore. I find that my condition keeps me from singing or reading to my son. It's just uncomfortable to me so I find any excuse to not do these things. Just last night I let him stay up 30 minutes longer with the understanding that there would be no bedtime stories. I feel bad that he has to miss out on these things and just doesn’t realize that it's due to my TMJD.

Leigh

North Carolina

Wednesday, July 22, 2009

"It’s a Rotten Way to be Wounded"

Tuesday, July 21, 2009

Research Grant Opportunity

Building Interdisciplinary Research Careers in Womens Health (K12)
(RFA-OD-09-006)
National Institutes of Health
National Cancer Institute
National Institute on Aging
National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institute on Drug Abuse
Office of Dietary Supplements
Office of Research on Women's Health
Application Receipt Date(s): September 18, 2009
http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-09-006.html

Thursday, July 16, 2009

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Brookstone Pharmaceuticals Issues a Voluntary Recall of All Lots of Brookstone Pharmaceuticals' Concentrated Acetaminophen Drops

FOR IMMEDIATE RELEASE – July 13, 2009 – Brookstone Pharmaceuticals, LLC, Alpharetta, GA has initiated a nationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers.  This 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations. This aspect of the product coupled with the absence of an integrated dosage delivery device is a contributing factor to possible dosing errors, especially inadvertent overdosing. Brookstone has distributed 344 bottles nationally and has donated 5301 bottles to charity for international distribution.

Over dosage of acetaminophen may result in liver toxicity, kidney damage, and blood disorders. FDA is aware of several medication error reports that document life-threatening or fatal adverse events in children less than three years of age, due to confusion associated with the concentrated versus regular strength acetaminophen liquid. Also, in a recent FDA advisory panel, it was recommended that one of the two strengths of acetaminophen should be removed from the market due to possible confusion which could result in overdosing.

Brookstone’s concentrated acetaminophen contains acetaminophen 80 mg/0.8 mL.  Regular strength acetaminophen elixir contains 160 mg/5 ml.  The firm is recalling its product to the consumer level as a cautionary measure to minimize any confusion and potential risk to patients from dosing errors.

Brookstone Pharmaceuticals has notified customers that it has voluntarily stopped manufacturing and shipping Concentrated Acetaminophen Drops in bulk containers and has also advised customers (wholesalers and hospitals) to quarantine and hold the product for return to Brookstone Pharmaceuticals for a full refund.  Customers with questions about the recall may contact Brookstone Pharmaceuticals, LLC at 1-800-541-4802, option 2.  Brookstone has not received any adverse events associated with this product but due to recent advisory panel concerns, Brookstone has taken voluntary action.

The recalled drops were manufactured by Pharmaceutical Associates, Inc.  This recall is being conducted with the knowledge of the Food and Drug Administration.

Customers who have this product in their possession should stop using it immediately.  Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

Tuesday, July 14, 2009

On July 7, 2009, the Food and Drug Administration (FDA) announced actions it was taking to reduce the risk of overdose in people who use pain medications, such as Darvon and Darvocet. These medications contain the drug propoxyphene, which is linked to death from overdoses.

FDA finds there is evidence that propoxyphene can effectively treat pain at recommended doses. But because of the drug’s potential risks, the agency is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain treatment.

FDA Actions

• FDA is requiring manufacturers of propoxyphene-containing products to strengthen the label’s boxed warning to emphasize the risk for overdose when using these products.
• FDA is requiring manufacturers to provide a medication guide (FDA-approved information that must be given to patients with each prescription or refill) to stress the importance of using the pain drugs only as directed.
• FDA is requiring a new safety study to find out more about the effects of propoxyphene on the heart at higher than recommended doses.
• FDA is planning to work with other federal agencies, such as the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs, to conduct additional studies on the safety of products that contain propoxyphene as compared to other commonly used pain medications.
• FDA has denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene.
• FDA will further evaluate the safety of propoxyphene and take additional regulatory action, if necessary.

FDA Takes Action on Darvon and Other Pain Medications

About Propoxyphene

• Propoxyphene has been on the market since 1957.
• It is a widely prescribed medication in a group of drugs known as opioids, and is used to treat mild to moderate pain.
• The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting.

Advice for Consumers

• Be aware of all the risks associated with pain medication, including propoxyphene, when making decisions on how to treat pain. All pain medicines have side effects.
• Talk to your health care professional to decide on the appropriate pain treatment for you if you need relief from pain.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: July 14, 2009

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Thursday, July 09, 2009

The Food and Drug Administration has ordered stronger warnings for Davron and Darvocet.  Click here to read the article.

Thursday, July 09, 2009

The following article does a nice job addressing concerns and questions people may have about the use of acetaminophen.

Thursday, July 09, 2009

Arthroscopic Shavers: Ongoing Safety Review

Audience: Orthopedic healthcare professionals, hospital risk managers, surgical services supervisors

FDA informed healthcare professionals of instances in which pieces of tissue have remained within arthroscopic shavers, a device used in orthopedic surgical procedures, even after the cleaning process was believed to have been completed according to the manufacturer’s instructions. Since retained tissue in these devices can compromise the entire sterilization process, FDA is actively working with the manufacturers of these devices to gather more data about this situation and to understand its potential public health impact. FDA encourages facilities that use any of these types of devices to evaluate the adequacy of their cleaning procedures and has provided recommendations for minimizing the potential risk to patients. 

FDA asks that surgical facilities that discover retained tissue in arthroscopic shavers after following the manufacturer-recommended cleaning procedures file a voluntary report with MedWatch, the FDA Safety Information and Adverse Event Reporting program online. These voluntary reports will help FDA gather additional information related to this problem and assess its public health impact.

Read the complete MedWatch 2009 Safety summary, including a link to the FDA communication about the ongoing safety review, at:

www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170730.htm

Wednesday, June 24, 2009

On June 29 and 30, 2009, FDA will hold an advisory committee meeting in Adelphi, Md., about how to address the problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription products. For more information about the meeting, visit the Advisory Committee Web page.

Acetaminophen is the generic name of a drug found in many common brand name OTC products such as Tylenol, as well as prescription products such as Vicodin and Percocet. Acetaminophen is an important drug, and its effectiveness in relieving pain and fever is widely known. This drug is generally considered safe when used according to the directions on its labeling. But taking more than the recommended amount can cause liver damage, ranging from abnormalities in liver function blood tests, to acute liver failure, and even death.

Q: What is acetaminophen?

A: Acetaminophen (pronounced: a∙seet·aminofen), is an active ingredient found in many OTC and prescription medicines to help relieve pain and reduce fever.

It is also found in combination with other active ingredients, called combination medicines, which treat conditions such as:

• symptoms of colds and flu
• allergy
• sleeplessness

Medicines containing acetaminophen are available in many forms, including drops, syrups, capsules, and pills.

Many people call OTC acetaminophen by a brand name, Tylenol. Others may know Percocet or Vicodin, which are prescription brand names that contain acetaminophen and other active ingredients to help relieve pain.

You might see acetaminophen abbreviated as “APAP” on prescription medicines.

In other countries, acetaminophen may have a different name. For example, acetaminophen is known as paracetamol in the United Kingdom.

Q. Are there risks from taking too much acetaminophen?

A: Yes, acetaminophen can cause serious liver damage if you take too much. It is very important to follow your doctor’s directions and the directions on the medicine label.

You may not notice the signs and symptoms of liver damage right away because they take time to appear. Or, you may mistake early symptoms of liver damage (for example, loss of appetite, nausea, and vomiting) for something else, like the flu. Liver damage can develop into liver failure or death over several days.

Acetaminophen is generally safe when taken as directed. To lower your risk of liver damage make sure you do the following:

• Follow dosing directions and never take more than directed; even a small amount more than directed can cause liver damage.
• Don’t take acetaminophen for more days than directed.
• Don’t take more than one medicine that contains acetaminophen at a time. For example, your risk of liver damage goes up if you take a medicine that contains acetaminophen to treat a headache, and while that medicine is still working in your body, you take another medicine that contains acetaminophen to treat a cold.

Q: How can I tell which medicines contain acetaminophen?

A: Medicines have ingredients listed on their labels. On OTC medicines, check the “Drug Facts” label under the section called Active Ingredients. If your medicine contains acetaminophen, it will be listed in this section. On prescription medicine containers, the label will say “acetaminophen” or “APAP.”

Q: When should I talk to a doctor before taking acetaminophen?

A: Talk to your doctor before taking acetaminophen if you

• drink alcohol (three or more drinks every day)
• have liver disease

Under these conditions, taking acetaminophen puts you at greater risk of getting liver damage, even when taking acetaminophen at the recommended dose.

If you take the blood thinner warfarin, you should also talk to your doctor before taking acetaminophen because taking warfarin and acetaminophen together may raise your risk of bleeding.

Q: How can I safely take acetaminophen?

A: Follow this advice to take acetaminophen safely:

• Read all the information given to you by your doctor and follow directions.
• Read the information on the OTC “Drug Facts” label or on the prescription label and follow directions.
• Be sure you understand the following:
  - the dose, which is how much acetaminophen you can take at one time
  - how many hours you must wait before taking another dose of acetaminophen
  - how many doses of acetaminophen you can take safely each day
  - when to stop taking acetaminophen and ask a doctor for help
• Never take more than directed, even if your pain or fever isn’t any better. Taking more acetaminophen than directed can put you at risk for liver damage.
• Never take more than one medicine that contains acetaminophen. Check the active ingredients of all your medicines to make sure you are taking no more than one medicine containing acetaminophen at a time.

Q: How can I safely give acetaminophen to my child?

A: You can safely give acetaminophen to infants, children, and teenagers if you

• Check the active ingredients in the other medicines that your child is taking (or that your child may take) to make sure they don’t contain the active ingredient acetaminophen. Your child should never be taking more than one medicine containing acetaminophen at a time.
• Read all the information given by your child’s doctor and follow directions.
• Read the information on the OTC “Drug Facts” label or on the prescription label and follow directions.
• Choose the right medicine based on your child’s weight and age. On OTC medicines, the Directions section of the “Drug Facts” label tells you:
  - if the medicine is right for your child
  - how much medicine to give
  - how many hours you must wait before giving another dose
  - when to stop giving acetaminophen and ask a doctor for help

If a dose for your child’s weight or age is not listed on the label, or you can’t tell how much to give, ask your pharmacist or doctor what to do.

• Use the measuring tool that comes with the medicine. It will give the exact dose. If you don’t have the right measuring tool, ask a pharmacist.
• Don’t use a spoon that’s meant to be used for cooking or eating. A spoon should not be used to measure medicine because it may give the wrong amount.
• Never give more than one medicine that contains acetaminophen. If you give more, it could harm your child.

Prevent medicine accidents:

• Keep a record of the medicines you give your child. Write down the dose and time when you give the medicine. This will help everyone who cares for your child know how much medicine your child has had. This will help everyone avoid giving an extra dose by mistake.
• Keep medicine where it can’t be seen or reached by children and pets; a locked box, cabinet, or closet is best.

Q: What should I do if the pain or fever doesn’t get better after taking acetaminophen as directed?

A: Take the medicine only as directed. Don’t take more. If the medicine doesn’t help you feel better, talk to your doctor, nurse, or pharmacist.

Q: What should I do if I took too much acetaminophen? What should I do if I gave too much acetaminophen to my child?

A: Don’t wait! Call 9-1-1 or Poison Control at 1-800-222-1222 right away to find out what to do. The signs or symptoms of liver damage may not be noticeable for hours or even days after taking acetaminophen. By the time you notice changes, the liver damage may be severe and could lead to death.

Q: Where can I get more information on acetaminophen?

A:

• Talk to a doctor, nurse, or pharmacist.
• Visit FDA’s consumer Web pages:

Don’t Overdo It with Acetaminophen

Safe Use of Over-the-Counter Pain Relievers and Fever Reducers

A Guide to Safe Use of Pain Medicine

• Contact the FDA at 1-888-INFO-FDA.
• Or, e-mail questions to FDA at druginfo@fda.hhs.gov

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Wednesday, June 03, 2009

Discovery that botulinum toxin when injected at selected sites in the face could temporarily eliminate wrinkles and other signs of aging has led to the commercial success of cosmetic “Botox” type products.  But the toxin, produced by the bacterium Clostridium botulinum is a powerful neurotoxin used medically to treat muscle spasticity in children and adults and also as an alternative to surgery in treating a relatively rare condition called masseter muscle hypertrophy.  In that condition one or both masseter muscles, which are used in chewing, swells in the area near the angle of the lower jaw, the mandible.  The swelling may be disfiguring and also cause pain.  Injection of the neurotoxin into the muscle inhibits the action of neurotransmitters causing selective paralysis and subsequent atrophy of the muscle. 

The Cochrane Collaboration, an international and highly regarded agency conducting scientific reviews of clinical interventions of products used in the diagnosis, prevention or treatment of diseases, has recently completed a study of the use of botulinum toxin type A in masseter muscle hypertrophy.  The reviewers concluded that there simply were not enough high quality studies to properly evaluate the toxin’s effectiveness nor its potential harms, and called for future research sufficient to provide evidence for people to make informed decisions about its use.

In parallel with the cautions raised by the Cochrane Collaboration, the Food and Drug Administration has raised the bar in advertising botulinum products.  The agency, after an ongoing safety review begun in February 2008 is now requiring that manufacturers of licensed botulinum toxin products strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events should the toxin leak beyond the site where it is injected.  FDA will also require manufacturers to develop and implement a Risk Evaluation and Mitigation Strategy.  This “REMS” would include:

§         a communication plan to provide consumers with more information about the risks of toxin spreading beyond the injection site;

§         an explanation why various toxin products cannot be interchanged; and

§         a medication guide explaining the risks to patients, their families, and caregivers.

 FDA is also requiring manufacturers to submit safety data after multiple administrations of toxin products in a specific number of children and adults with spasticity. For further information check the FDA Medwatch safety summary, including the link to the Communication about Botox, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164255.htm

Wednesday, June 03, 2009

Overlapping Medical Conditions Meeting in Milwaukee, WI

The TMJ Association (TMJA) and the International Foundation for Functional Gastrointestinal Disorders (IFFGD) a meeting on Overlapping Medical Conditions at the Crowne Plaza Milwaukee-Wauwatosa (WI) Hotel on April 28^th.  The meeting drew a large crowd eager to hear three guest speakers talk about the relationship among a number of medical conditions, any one of which can co-occur with one or more of the other in the same individual.  Highlighted were; Chronic Fatigue Syndrome, Endometriosis, Fibromyalgia, Interstitial Cystitis, Irritable Bowel Syndrome, Temporomandibular Joint and Muscle Disorders and Vulvodynia.

Welcoming remarks were offered by IFFGD President, Nancy J. Norton, and Terrie Cowley, President of The TMJA.

The first speaker, John W. Kusiak, PhD., is a neurobiologist and a Program Director at the National Institute of Dental and Craniofacial Research of the National Institutes of Health in Bethesda, MD. His talk, Advancing the Pain Research Agenda at the National Institutes of Health, addressed federal support of pain research. He stated that the new administration’s stimulus package has allowed 10.4 billion dollars for biomedical research at the NIH, some of which will be used for NIH-wide pain initiatives. Of particular importance will be studies of the transition from acute to chronic pain.

As a follow-up, Ms. Cowley urged members of the audience to contact their government representatives to let them know the severity of their conditions.  Elected officials need to hear that research is essential in order to find safe and effective treatments and medication options. She noted that the NIH is funded by taxpayers’ dollars and, as such, serves the public.

The second speaker, William Maixner, Ph.D., D.D.S., Professor, Director, Center for Neurosensory Disorders at the University of North Carolina School of Dentistry, Chapel Hill, NC, spoke on the topic of Complex Persistent Pain Conditions: Unique and Shared Pathways of Vulnerability. He began by defining pain and spoke of its negative impact on daily life: how it influences the sense of self and affects how we feel and interact with others. Pain and our perception of pain, he explained, are determined by multiple influences, including environmental and genetic factors and an individual’s life history. Speaking specifically of TMJDs, Dr. Maixner pointed out that 3 to 15 percent of the Western world population will suffer from TMJDs with a female/male ratio of two to one. Referring to overlapping medical conditions, he stated that a patient with one of the conditions has an 80 percent chance of having another one.

Dr. Maixner is the Research Director of a large study titled, Orofacial Pain: Prospective Evaluation and Risk Assessment (OPPERA), which will follow more than 3,200 volunteers over a seven-year span, collecting baseline data and assessing them every three months. The study group will be made up of men and women who do not have a temporomandibular joint and muscle disorder, and is designed to see who will develop a TMJD over time. Among other risk factors, the OPPERA Study hopes to identify which specific genetic variants contribute to an individual’s susceptibility, and may also help researchers identify new treatments for TMJD.

The third speaker, Dr. Lin Chang, M.D., Professor of Medicine, Division of Digestive Diseases, Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, CA, had words of advice on How to Talk to Your Doctor—You are Not Alone.  Dr. Chang remarked that patients are looking for acknowledgment of their illnesses as well as satisfactory treatment for their symptoms. Finding the right doctor is especially important for those suffering from chronic conditions. She suggested learning a provider’s level of expertise, general approach, and type of practice (specialty and experience) and also the degree to which he or she is well-versed on your condition and the various treatment options. In preparing for a clinic visit, she suggested bringing along a symptom diary and noting which symptoms are the most bothersome. Additionally, patients should bring with them any diagnostic studies (test results and scans), medical records, and lists of medications used. She also advises bringing in writing any questions so that none are forgotten, and not being afraid to ask for clarification if necessary.  For your convenience, a more detailed list of Dr. Chang’s advice is included as a separate article.

A question and answer session followed the formal presentations and the program closed with an ice cream social.

Wednesday, June 03, 2009

How to Talk to Your Doctor

Dr. Lin Chang, a Professor of Medicine at UCLA, spoke at the Overlapping Medical Conditions Meeting in Milwaukee on April 28^th, 2009 on the topic: How to talk to Your Doctor—You Are Not Alone.  Her suggestions would be helpful to any patient, but especially one with chronic conditions like TMJDs, which require an ongoing relationship with a physician. Here are the highlights from her excellent talk:

How to Prepare for a Clinic Visit

Educate Yourself Prior to Your Visit

• Obtain information about your condition or symptoms
• Familiarize yourself with the “lingo” or medical terms used with regard to your condition
• Learn about how the diagnosis is made
• Learn about the different treatments and management approaches
• Learn about your provider and his or her  expertise, approaches, and type of practice 

Provide Your Physician with Information about Your Symptoms (What to bring to the appointment)

• Keep a symptom diary

1. Key information would include the duration and frequency of symptoms, as well as what is most bothersome
2. Note what makes your symptoms better or worse

• Bring diagnostic studies—any past test results or scans 
• Bring a list of the types of treatments you’ve received, and your response to the treatment
• Bring all medical records and a list of your current medications.  You might ask if your doctor would like you to bring the medication containers. 

How to Talk to Your Doctor

• Communicate your needs and objectives to your physician
• State the primary reason for your visit early
• List concerns and bring prepared questions
• Ask for clarification if need be
• Ask about other types of diagnoses and tests
• Ask about different treatment options
• Obtain a management plan—if one course of action isn’t effective, what will the next step be?
• Give feedback—let your physician know if you are in agreement with the plan
• Help to guide the focus of the visit to meet your concerns and needs
• It’s important to discuss both positive and negative experiences with medical care (past and present) if relevant, in a diplomatic way
• Communicate preferences for studies, treatment, and referral providers
• Be honest, diplomatic and respectful

Monday, May 18, 2009

Tuesday, April 14, 2009

 Let Your Voice Be Heard

National Pain Care Policy Act of 2009

Tuesday, April 07, 2009

Over the years, increased evidence reveals that temporomandibular joint and muscle disorders (TMJDs) tend to overlap with several other medical conditions, including tension-type (TT) and Migraine headaches. Recent studies show that acupuncture, a therapy of Chinese origin, in which thin needles are inserted into the skin at defined points, may benefit patients who suffer from these types of headaches. Two articles recently published by The Cochrane Collaboration, a reliable source of evidence-based health care, detail these studies. The Abstract found at the top of the linked pages will be of special interest to those in scientific fields. Scroll down to find the Plain Language summary, which covers the principal points in lay person’s terms.

• Acupuncture for migraine prophylaxis
• Acupuncture for tension-type headache

Tuesday, April 07, 2009

http://www.fda.gov/medwatch/safety/2009/mar09_quickview.htm

WARNINGS AND PRECAUTIONS

• Discontinuation of Treatment with Cymbalta

ADVERSE REACTIONS

• Other Adverse Reactions observed during the premarketing and postmarketing clinical trial evaluation of Duloxetine
  • Ear and Labyrinth Disorders
    • ... and tinnitus
  • General Disorders and Administration Site Conditions
    • ... gait disturbance
  • Nervous System Disorders
    • ...and poor quality sleep
  • Renal and Urinary Disorders
    • polyuria
  • Reproductive System and Breast Disorders
    • ...and sexual dysfunction
  • Skin and Subcutaneous Tissue Disorders
    • dermatitis contact
• Postmarketing Spontaneous Reports
  • aggression and anger (particularly early in treatment or after treatment discontinuation)
  • gynecological bleeding
  • muscle spasm
  • restless legs syndrome, seizures upon treatment
    discontinuation
  • tinnitus (upon treatment discontinuation)

Wednesday, April 01, 2009

If one or more of these conditions affects your life - Chronic Fatigue Syndrome, Endometriosis, Fibromyalgia, Interstitial Cystitis (IC), Irritable Bowel Syndrome (IBS), Temporomandibular Joint and Muscle (TMJ) Disorders or Vulvodynia -  join us for a special presentation to learn more about Overlapping Medical Conditions.
 
When:Tuesday, April 28, 2009 at 6:00pm - 9:00pm
Where: Crowne Plaza Milwaukee-Wauwatosa Hotel, 10499 Innovation Drive, Wauwatosa, WI
Cost: No cost to attend. Reservations recommended.
Register: Call Toll Free: 1-888-964-2001 or email: overlappingconditions@iffgd.org

A flyer for the meeting may be found at http://www.iffgd.org/pdfs/OverlappingConditions.pdf.

We would appreciate you posting the flyer or emailing it to anyone you know who may be interested in joining us for this event. 

Please feel free to contact us at the phone number or email above with questions. 
 
We look forward to seeing you there!
 
Sponsored by: International Foundation for Functional Gastrointestinal Disorders (IFFGD) and The TMJ Association

Wednesday, April 01, 2009

In February, we asked for your thoughts and experiences regarding your TMJ disorder diagnosis. On March 30^th, the president of The TMJA, Terrie Cowley, incorporated your feedback into her speech, What Do Patients Want from a Diagnosis?, presented at the International Consensus Workshop: Convergence on an Orofacial Pain Taxonomy in Miami, FL. She was pleased to have the opportunity to advocate on behalf of TMJD patients. We’d like to thank everyone who responded to our request for a patient’s perspective on the diagnostics of TMJ disorders. Your time and efforts were appreciated. Terrie’s speech can be seen here:  http://www.tmj.org/RDC.pdf.

Monday, March 30, 2009

TMJA Joins Forces with Five Non-Profits to Help Millions of Patients Suffering from Chronic Medical Conditions

In an effort to help millions of Americans suffering from multiple chronic medical conditions, six independent nonprofit organizations have come together to form the Overlapping Conditions Alliance. The new Alliance will promote research into the underlying connection(s) between coexisting conditions. As part of this effort, the Alliance has launched an informational web site - www.OverlappingConditions.org.

Millions of Americans suffer from one or more of these chronic disorders: chronic fatigue syndrome, endometriosis, interstitial cystitis (painful bladder syndrome), irritable bowel syndrome (IBS), temporomandibular joint and muscle disorders (TMJ) and vulvodynia. Health care providers receive limited training on these conditions, leading to frequent misdiagnosis and inappropriate treatment for millions of patients.

Studies indicate these conditions often 'overlap'. Much more research is needed to understand the connection(s) and develop more effective treatments. All of these conditions cause enormous physical and emotional distress for sufferers and their families. In addition, they cost the US billions of dollars each year in medical costs and lost productivity.

The mission of the Overlapping Conditions Alliance is to change this situation by advancing the scientific, medical, and policy needs of individuals afflicted with multiple chronic conditions. The Alliance is composed of six independent nonprofit patient advocacy organizations: the Chronic Fatigue and Immune Dysfunction Syndrome Association of America, Endometriosis Association, Interstitial Cystitis Association, International Foundation for Functional Gastrointestinal Disorders, National Vulvodynia Association, and The TMJ Association.

Wednesday, March 25, 2009

A recent study conducted by researchers at University College in London, found that women who use antidepressants appear to have an increased risk for sudden cardiac death. This finding is especially notable because the study group consisted of women with no prior history of heart disease, signifying the importance of further research in the area of heart health in connection with antidepressants.  This article may be of interest to TMJD patients as many are prescribed antidepressants.  The article can be seen in its entirety here: http://health.usnews.com/articles/health/healthday/2009/03/10/antidepressant-use-tied-to-cardiac-death-in-women.html

Wednesday, March 25, 2009

The National Institutes of Health (NIH) recently announced an extraordinary opportunity for research money supported by funds made available through the American Recovery and Reinvestment Act of 2009.  We’re hoping this favorable happenstance could lead to money for TMJD research.

 NIH Challenge Grants in Health and Science Research

(http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-09-003.html) requests applications on topic areas that address specific challenges in biomedical and behavioral research that would benefit from significant 2-year jumpstart funds.  NIH defined 15 broad challenge areas, and the NIH Institutes, Centers and Offices identified specific topics within those areas that address their missions and TMJDs are included in this listing.

Click here for a list of the priority topics, as identified by the National Institute of Dental and Craniofacial Research.

The due date for Challenge Grant applications is April 27, 2009. Researchers are encouraged to consider submitting a grant application with TMJDs as their focus.

Together we’re changing the face of TMJ!

Friday, March 06, 2009

Almost every TMJ patient suffers pain. The TMJ Association, along with 120 other organizations, has joined forces with the American Pain Foundation, in a commitment to provide better pain care. To further this goal we have signed a consensus statement and continue to urge the passing of the re-introduced National Pain Care Policy Act of 2009. 

We encourage you to contact your state and local elected officials and let them know your difficulty in getting pain treatment and the need for policy reform. Our goal is to increase professional education on pain management, public awareness of the importance of getting pain treated, and improvements in access to timely, appropriate pain care in your community.

Wednesday, March 04, 2009

Changing The Face of TMJ…One Wristband at a Time

Visitors to our Web site see a bright red wristband on the home page with the slogan “Changing the face of TMJ.” More than a thank-you for a donation, the wristband signals support for all those suffering from temporomandibular joint and muscle disorders (TMJDs).

 

The TMJ Association is the voice of TMJD patients and their loved ones, advocating for understanding, awareness and the research that can generate truly effective means of diagnosis, treatment and prevention. The wristband is one way to raise awareness and show your commitment to those goals.   Here’s what some of you have already told us:

 

Judy B., a TMJD patient in New Jersey thanked us for our work and to let us know she wears her wristband to all her doctor’s appointments.

 

 Kristyn H., a young woman in Arkansas awaiting surgery, said she wanted bracelets for her “…wonderful support group of friends, family and church family… I would love to provide each of them a wristband for them to wear as I go through this—for they are going through it with me.” Her aim, was to remind the wearers “…to pray for my doctors and nurses as well as other TMJD sufferers, and spread the word and knowledge of TMJ. I know they will. Because they care.”

 

We love to hear these stories, because they show that band-wearers are willing to get the message out, to explain to whomever asks what TMJDs are all about and why we need to end the pain and suffering of millions of Americans.  Tell us your experiences – we’d love to hear them!

 

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Wednesday, March 04, 2009

The TMJ Association participates in the following social network communities.  We invite you to visit and join us on-line!

• TMJA forum
• Change.org
• Facebook
• MySpace
• Twitter
• Firstgiving

Friday, February 27, 2009

I have been invited to present the patients' perspectives on diagnostics of TMJ disorders at a meeting on April 1st. As I like to do in these situations is to ask you for your thoughts on the topic.

I thought the following questions would stimulate some ideas to share with me.

• Did you have a difficult time getting a diagnosis?
• Who diagnosed your TMJ disorder - a dentist? A medical doctor?
• Did you have any diagnostic testing with instruments? How much did these tests cost? Do you feel they were worth the expense?
• Did you have diagnostic testing with the provider only pressing in places on your face and listening to your joints with a stethoscope?
• Did your provider give you a complete diagnosis, such as, "you have disc displacement" "you have osteoarthritis of the right joint"?
• Did your provider simply tell you that "you have TMJ."
• Did you have symptoms of a TMJ disorder which led you to seek a diagnosis?
• Were you diagnosed with TMJ disorders by a health care professional without you having any symptoms?
• From your perspective, could someone have diagnosed your TMJ disorder by you telling them your history and explanation of your pain and/or dysfunction?
• Did you Diagnose your TMJ problem by researching your symptoms via the Internet?
• Do you have suggestions about how one should/could obtain an accurate diagnosis?
• Do you find it difficult to discuss diagnosis without discussing treatment?

I would greatly appreciate receiving your opinions, experiences and suggestions on this topic. Please respond by e-mail to info@tmj.org and thank you in advance.

Terrie Cowley, President

Thursday, February 05, 2009

As you may know, almost all research into temporomandibular joint and muscle disorders (TMJDs) is funded by the National Institutes of Health (NIH). In the past five years their budget has been severely curtailed. 

 

We now have an opportunity to encourage our elected officials to contribute 6.5 billion dollars to NIH, as part of the Economic Stimulus package being voted on this week.

 

Increasing the NIH budget will lead to more available funds for medical research, which may translate into increased funding for TMJ research.

 

Dollars spent by the NIH not only benefit medical research, they also help the economy. Recent reports have shown NIH is a significant economic contributor, creating more than 350,000 jobs nationwide and returning $2.21 million in new business activity for every $1 million invested. 

 

By giving a few moments of your time you can make a difference. Please email your elected officials and respectfully urge them to support NIH funding.

 

Use the links below to contact your elected officials about this important issue:

  

http://www.house.gov/house/MemberWWW_by_State.shtml

 

http://www.senate.gov/general/contact_information/senators_cfm.cfm

 

Thursday, February 05, 2009

January 15, 2009

 

 

Dear Colleague,

 

Patient Advocate Foundation’s Co-Pay Relief Program (CPR) is pleased to announce the launch of a pain fund to serve patients suffering with chronic pain, beginning on February 1, 2009.  As with the Program’s existing disease silos, breast, lung, kidney, colon, pancreatic, head and neck and/or prostate cancers, malignant brain tumor, lymphoma, multiple myeloma, myelodsyplastic syndrome, osteoporosis, sarcoma, diabetes, autoimmune disorders and chemo induced anemia and neutropenia, patients must financially and medically qualify to access co-payment assistance. 

 

Patients and providers can contact the Co-Pay Relief Program toll-free at 1-866-512-3861 to initiate a request for assistance.  In addition CPR also offers providers the opportunity to enroll patients into the program through a secure web based application service.  Interested patients and providers should visit the program’s website at www.copays.org to register.

 

Patients who contact CPR for assistance work directly with a call counselor throughout the application process to complete a pre-populated application for review and signature by the patient. The call counselor works with the patient as well as with the provider of care to obtain necessary medical, insurance and income verification in an expeditious manner.  The ability to efficiently move patients through the application process to approval affords the patient the ability to utilize their healthcare coverage and obtain the therapy benefit in a timely manner for the management of their disease.  Once deemed medically and financially eligible for assistance, funds can be provided directly to the insured patients’ medical and/or pharmaceutical providers.  In special cases, patients may receive the funds directly.

 

Additionally, since office practice managers and billing coordinators continually work with patients to interpret and confirm insurance coverage levels and co-payment amounts, they can be helpful in recognizing those patients most in need of financial assistance and refer them to our program.

 

Thank you in advance for helping us promote this program and informing patients about this available assistance. Please do not hesitate to contact us if you would like further information about the PAF Co-Pay Relief Program, or visit us at www.copays.org  or www.patientadvocate.org. 

 

We look forward to working with you to provide assistance to your patients in need! 

 

Best Regards,

 

Pamela Cleck

Operations Director, Co-Pay Relief Program

 

 

 

 

 

 

 

 

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Tuesday, February 03, 2009

A recent article in The New York Times, Best Treatment for TMJ May Be Nothing (February 2, 2009), by health writer Jane Brody gives an overview of the disorder and emphasizes the NIH approach that “Less is often best.” Well worth reading, the article in its entirety can be seen here: http://www.nytimes.com/2009/02/03/health/03brod.html?_r=1&ref=science

 

The TMJ Association would like to thank Marina, a TMJ patient who took time to send e-mail letters to the editor of The New York Times and the Science Times conerning Ms. Brody's article.  Marina gave us permission to share these letters with our readers.  

 

To the Editor of The New York Times:

 

Re "Best Treatment for TMJ May Be Nothing," (Personal Health, Feb. 3): My thanks to Jane Brody for addressing the pitfalls in seeking treatment for TMJ disorders. I speak from bitter personal experience, having had my bite destroyed by an alleged TMJ

specialist. I would encourage anyone experiencing TMJ pain to visit www.tmj.org, an online resource for evidence-based information and support, before they seek medical or dental care. Knowledge really is power.

 

MARINA

 

 *******************************************

 

To the Science Times Editor:

 

(Note: this letter isn't intended for publication.)

 

I'm writing regarding Jane Brody's article, "Best Treatment for TMJ May Be Nothing," (Personal Health, Feb. 3).

 

In her article, Ms Brody wrote, "But too often, experts say, patients fail to have the problem examined in a comprehensive way and undergo costly and sometimes irreversible therapies that may do little or nothing to relieve their symptoms." The experts err in blaming patients:

the costly and irreversible therapies aren't the patients' collective failure.

 

The failure is on the part of the medical and dental professions.

Doctors routinely send TMJ patients to dentists (as my doctor did). Many dentists (as mine did) routinely offer patients irreversible and often deeply harmful jaw repositioning treatments (also known as malocclusion therapy), even though such treatments have been widely discredited since 1996 ("Management of Temporomandibular Disorders," published by the N.I.H.). This failure is nothing less than health care fraud on a massive scale, ripe for investigation.

 

www.tmj.org is the single best online source of evidenced-based information. I request that Ms Brody reference tmj.org in a future brief update to her article, and link to it online. Patient education--beyond what Ms Brody's helpful column can provide on its own--is essential.

 

Sincerely,

Marina

 

 

 

 

Thursday, January 22, 2009

The TMJ Association made a commitment to you that in 2009 we would improve our communication capabilities. One way that we are planning to do that is to make our Web site more user friendly and patient focused. However, we need your help to do that.

The TMJ Association is about "changing the face of TMJ" and TMJ is about faces - your face!

As part of our ongoing "Changing the Face of TMJ" campaign we ask you to contribute your stories, pictures, and testimonials to be featured throughout our website. We'd like to have a photo of YOU- a real TMJ patient. Send one that you are comfortable being seen on our Web site. No need to send glamour shot, just one living a real life - with your pet, gardening, cooking, relaxing, etc. For your stories we'd like it to be short, just a few sentences on how TMJ has affected your life (both in positive and negative ways). Your testimonials would also be very much appreciated. If you would like to say something about how the TMJ Association has helped you, we would love to feature that on our website.

Would you please send the photos, stories and testimonials via e-mail to info@tmj.org? We would like to have these by February 15th, if possible. I hope all of you will take the time to write your story and share your photos. This is just one of the ways we will " change the face of TMJ " in 2009 - by giving a face to the disorder so that people understand that this is real, and affects millions of people, just like you.

Monday, January 19, 2009

FDA Public Health Advisory
Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions

 

FDA is issuing this advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from medical tests and conditions.  In February 2007, FDA issued a Public Health Advisory- Life-Threatening Side Effects with the use of Skin Products Containing Numbing Ingredients for Cosmetic Procedures -that described the deaths of two young women who used topical anesthetics prior to laser hair removal [http://www.fda.gov/cder/drug/advisory/topical_anesthetics.htm].  Now, FDA is aware that lidocaine, a type of topical anesthetic, was studied to see if it may reduce discomfort during breast mammography¹.

During the study, the topical product was spread over a wide area and covered with plastic wrap. Although no serious side-effects were reported in this study, it was not large enough to evaluate whether uncommon but serious reactions could occur with this use. FDA remains concerned about the potential for topical anesthetics to cause serious and life-threatening adverse effects when applied to a large area of skin or when the area of application is covered.
 
Topical anesthetics work by blocking pain sensation in the skin.  Some of the medication in a topical anesthetic can pass through the skin into the blood stream.  More of the medication will pass into the blood stream if the topical anesthetic is applied over a large area of the skin, if a large amount is applied, if it is applied to irritated or broken skin, or if the skin temperature increases.  Skin temperature can increase during exercise, by covering the skin with a wrap, or with use of a heating pad.  Under these circumstances, the amount of anesthetic medication that reaches the blood stream is unpredictable and may be high enough to cause life-threatening adverse effects such as irregular heartbeat, seizures, breathing difficulties, coma and even death.

There are several topical anesthetics available by prescription and over-the-counter.  When used appropriately, these products may provide safe and effective pain relief.  Before recommending a topical anesthetic for any purpose, doctors should determine if the desired amount of pain relief can be achieved safely with a topical anesthetic, or if a different treatment would be more appropriate.  If a topical anesthetic is determined to be the best choice, the lowest needed amount should be prescribed. Patients should speak with their doctor if they are considering using a topical anesthetic before a mammogram.  If a topical anesthetic is recommended then patients should:

• use a topical anesthetic that contains the lowest amount possible of medication that will relieve the pain; 
• apply the topical anesthetic sparingly and only to the area where pain exists or is expected to occur;
• not apply the topical anesthetic to broken or irritated skin.
• ask their doctor what side effects are possible and how to lower their chance of having life-threatening side effects from anesthetic drugs.
• be aware that if wrapping or covering the skin with any type of material or dressing is recommended or considered, this can increase the chance of serious side effects, as can applying heat to the treated area while the medication is still present.

FDA is working with healthcare professional organizations and other media that distribute healthcare information to spread the message about the potential hazards and safe use of topical anesthetics.

¹Lambertz CK et al.  Premedication to Reduce Discomfort during Screening Mammography.  Radiology 2008; 248 (3):  765-72.

Stakeholder Letter(PDF)

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Date created: January 16, 2009

Monday, January 19, 2009

Some Medications and Driving Don't Mix

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On this page:

• Products That Require Caution
• If You Have To Drive
• Alternatives to Driving Yourself

If you are taking a medication, is it OK to drive?

Most likely, yes. But the Food and Drug Administration (FDA) advises that it's best to be absolutely sure before you get behind the wheel.

While most medications don't affect driving ability, some prescription and over-the-counter (OTC) medicines can cause reactions that may make it unsafe to drive.

These reactions may include

• sleepiness/drowsiness
• blurred vision
• dizziness
• slowed movement
• fainting
• inability to focus or pay attention
• nausea
• excitability

Driving while on medications can also be a legal issue. State laws differ, but being found driving under the influence of certain medications (prescription and OTC products) could get you in the same kind of trouble as people caught driving under the influence of alcohol.

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Products That Require Caution

Knowing how your medications—or any combination of them—affect your ability to drive is clearly a safety measure involving you, your passengers, and others on the road.

Products that could make it dangerous to drive include

• prescription drugs for anxiety
• some antidepressants
• products containing codeine
• some cold remedies and allergy products
• tranquilizers
• sleeping pills
• pain relievers
• diet pills, "stay awake" drugs, and other medications with stimulants (e.g. caffeine, ephedrine, pseudoephedrine)

Products that contain stimulants may cause excitability or drowsiness. Also, never combine medication and alcohol while driving.

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If You Have To Drive

Let's say that you must take medications that could affect your driving. But you also have to get to work, pick up the kids from school or sports practice, or run errands. Here are some tips for what to do:

Don't stop using your medicine unless your doctor tells you to. Take medications at prescribed levels and dosages.

Talk to your health care professionals about side effects. Doctors and pharmacists can tell you about known side effects of medications, including those that interfere with driving. Request printed information about the side effects of any new medicine.

Inform health care professionals about all of the products you are taking, including prescription, OTC, and herbal products. Also, let them know about any reactions you may experience.

Health care professionals may be able to

• adjust the dose
• adjust the timing of doses or when you use the medicine
• add an exercise or nutrition program to lessen the need for medicine
• change the medicine to one that causes less drowsiness

Monitor yourself. Learn to know how your body reacts to the medicine and supplements. Keep track of how you feel, and when the effects occur.

Carry a medication list. In case of an emergency, carry a list of all medications you are taking, including product names and dosages.

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Alternatives to Driving Yourself

Planning ahead will help get you to the places you want to go. Consider the following alternatives to driving yourself:

• rides with family and friends
• taxi cabs
• shuttle buses or vans
• public buses, trains, and subways
• walking

Also, senior centers and religious and other local service groups often offer transportation services for older adults in the community.

• Seniors can call the ElderCare Locator at 1-800-677-1116 and ask for the phone number of the local Office on Aging, or go to the Web site at www.eldercare.gov.
• Regional transit authorities can provide information on which bus or train to take.
• Easter Seals Project ACTION (Accessible Community Transportation In Our Nation) can direct you to transportation resources near you. Call 1-800-659-6428 or visit www.projectaction.org.
  

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

For More Information

Brochure: Driving When You Are Taking Medications
www.fda.gov/cder/consumerinfo/driving_taking_meds.htm

FDA's Center for Drug Evaluation and Research
www.fda.gov/cder

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Date Posted: December 11, 2008

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Friday, January 09, 2009

On this page:

• Diagnosing the Disease
• Types of Antidepressants
• Selecting Antidepressants
• Effectiveness of Antidepressants
• Managing Side Effects
• Serious Risks

Depression affects about 121 million people worldwide and is a leading cause of disability, according to the World Health Organization (WHO).

"In my experience as a practicing psychiatrist, I've seen that many people with depression don't realize that they have the condition or that it's treatable," says Mitchell Mathis, M.D., deputy director of the Division of Psychiatry Products at the Food and Drug Administration (FDA).

Some who suffer from depression don't recognize the symptoms, or they attribute them to lack of sleep or a poor diet. Others realize they are depressed, but they feel too fatigued or ashamed to seek help.

Not all depression requires treatment with medication.

"Studies have shown that the best way to treat a patient with the more severe form of major depressive disorder is through both therapy and prescribed antidepressant medication," Mathis says. "They work best in combination with one another."

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Diagnosing the Disease

Medical professionals generally base a diagnosis of major depressive disorder on the presence of certain symptoms listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Diagnosis depends on the number, severity, and duration of these symptoms:

• depressed mood
• loss of interest or pleasure in almost all activities
• changes in appetite or weight
• disturbed sleep
• slowed or restless movements
• fatigue, loss of energy
• feelings of worthlessness or excessive guilt
• trouble in thinking, concentrating, or making decisions
• recurring thoughts of death or suicide

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Types of Antidepressants

Antidepressants work to normalize naturally occurring brain chemicals called neurotransmitters—primarily serotonin, norepinephrine, and dopamine. Scientists have found that these particular chemicals are involved in regulating a person's mood.

There are several different classifications of antidepressants:

• Selective Serotonin Reuptake Inhibitors (SSRIs): Examples are Prozac (fluoxetine), Celexa (citalopram), and Paxil (paroxetine).
• Serotonin and Norepinephrine Reuptake Inhibitors (SSNIs): Examples are Effexor (venlafaxine) and Cymbalta (duloxetine).
• Tricyclic antidepressants (TCAs): Examples are Elavil (amitriptyline), Tofranil (imipramine), and Pamelor (nortriptyline).
• Monoamine Oxidase Inhibitors (MAOIs): Examples are Nardil (phenelzine) and Parnate (tranylcypromine).

There are other antidepressants that don't fall into any of these classifications and are considered unique, such as:

• Remeron (mirtazapine)
• Wellbutrin (bupropion)

The antidepressant medications in each classification affect different neurotransmitters in particular ways. For example, SSRIs increase the production of serotonin in the brain. MAOIs block monoamine oxidase, an enzyme that breaks down neurotransmitters. Blocking their breakdown means that neurotransmitters remain active in the brain. Research is ongoing to determine antidepressants' exact mechanism of action on a person's brain.

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Selecting Antidepressants

So how does a physician determine which antidepressant to prescribe? Doctors typically use a patient history and a mental status exam. With this information, the doctor can evaluate symptoms, rule out medical causes of depression, and decide if the criteria are met for major depressive disorder.

"In my opinion, it's best when antidepressant medications are personalized," says Mathis. "For example, some depressed people have difficulty sleeping. So they would benefit from a more sedating antidepressant at night. Other people with depression sleep too much and would benefit from a more activating antidepressant in the morning."

It's important to communicate how you are feeling so that your physician can evaluate the medication's effectiveness.

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Effectiveness of Antidepressants

Approximately 60 to 70 percent of patients respond to the first antidepressant that is prescribed or to an increased dosage of that drug, according to Mathis.

But patients must take regular doses of a prescribed antidepressant for at least 3 to 4 weeks before they are likely to experience the full therapeutic effect. And if patients start to feel better, they should not stop taking the antidepressant.

"Even if you start to feel better, you may be in between episodes," says Mathis. "Depression tends to be chronic and requires everyday treatment just like high blood pressure."

If you get used to an antidepressant and just quit it, you may experience some withdrawal symptoms such as anxiety and irritability. Worst of all, depression may recur.

Patients should continue taking an antidepressant for 6 to 12 months, or in some cases longer, according to the National Institute of Mental Health (NIMH). This gives medication time to be effective and can help prevent a relapse of the depression. Patients should carefully follow their doctor's instructions.

Mathis estimates that about 10 percent of depressions are treatment resistant and won't respond to prescribed antidepressants.

That means that 20 to 30 percent of patients may not respond to the first antidepressant that is prescribed for them. NIMH-funded research has shown that patients who did not get well after taking a first medication increased their chances of becoming symptom-free after they switched to a different medication or added another medication to their existing one.

With appropriate treatment, many people with depression experience improvement of their symptoms and return to living normal and productive lives.

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Managing Side Effects

All antidepressants come with Medication Guides. These guides provide FDA-approved information for patients, families, and caregivers that could help improve monitoring of a drug's effects. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

Many people who take antidepressants have at least one side effect. Side effects can include:

• Headache
• Night sweats
• Nausea
• Agitation
• Sexual problems
• Dry mouth
• Constipation

Side effects are the most common reason people stop taking antidepressants. It's recommended that you don't stop taking your antidepressants or reduce the dosage without talking to your doctor or mental health professional first.

And there are coping strategies for the most common side effects of antidepressants. For a more complete list of side effects and suggested coping strategies, visit www.nimh.nih.gov/health/publications/medications/antidepressant-medications.shtml

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Serious Risks

Suicidal Thinking: In October 2004, FDA directed manufacturers to add a boxed warning to the labeling of all antidepressant medications to alert the public about the increased risk of suicidal thinking or suicide attempts by children and adolescents taking antidepressants.

A boxed warning is the most serious type of warning used on prescription drug labeling. In May 2007, FDA directed that the warning should be extended to include young adults up through age 24.

More detailed analysis by FDA of antidepressant clinical trials showed an increased risk of suicidality—suicidal thoughts or behavior. "There weren't more actual suicides, but more people under 24 were thinking or talking about it," explains Mathis. "This occurs most often within the first 30 days of an adolescent or young adult starting on an antidepressant."

Mania: When people are in a manic "high," they may be overactive, overly talkative, have a great deal of energy, and need less sleep than normal.

There are two different types of mood disorders, both of which are cyclical. One is unipolar disorder, in which the cycle is that a person feels normal and then feels depressed. The other type is bipolar disorder, in which the person's mood cycles from depressed to normal to manic.

"The doctor needs to screen patients for a bipolar history," said Mathis. If an antidepressant is prescribed to a person with bipolar disorder, it can cause mania. And the person can even become psychotic if the mania is severe.

Birth Defects: In December 2005, FDA changed Paxil (paroxetine) from a pregnancy risk category of C to D. With a Category C drug, fetal risk can't be ruled out. With a Category D drug, positive evidence of fetal risk exists. FDA chooses a medicine's letter category based on what is known about the medicine when used in pregnant women and animals.

High Blood Pressure: It can be much more difficult for patients to take one of the MAOIs for depression because of the many dietary and medicinal restrictions that must be followed. People taking MAOIs must avoid certain foods that contain high levels of the chemical tyramine, which is found in many cheeses, wines and pickles, and some medications including decongestants. MAOIs interact with tyramine in such a way that may cause a sharp increase in blood pressure, which could lead to a stroke or other complications.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

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For More Information

Antidepressant Use in Children, Adolescents, and Adults
www.fda.gov/cder/drug/antidepressants/default.htm

National Institute of Mental Health (NIMH)
www.nimh.nih.gov/

Date Posted: January 9, 2009

Tuesday, December 30, 2008

Audience: Pharmacists, consumers, primary care healthcare professionals
ETHEX and FDA notified heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets. Hydromorphone is a drug used for pain management. If someone were to take a higher than expected dose of Hydromorphone, the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation. The recalled tablets are a blue, round tablet with a script "E" on one side and a "2" on the other side.

The parent company of ETHEX Corporation, KV Pharmaceutical has advised FDA that it is voluntarily suspending shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to address manufacturing issues that have come to management’s attention.

Read the complete MedWatch 2008 Safety summary, including links to the Ethex and KV press releases and a list of KV products affected by the suspension, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Hydromorphone

Friday, December 26, 2008

Stryker Custom Cranial Implant Kits

Audience: Maxillofacial surgeons, hospital risk managers Stryker Leibinger USA and FDA notified healthcare professionals of a Class 1 recall of all sizes of the cranial implant kit distributed from November 5, 2007 through October 23, 2008. The company is recalling these products because sterility cannot be assured. Custom cranial implants are designed individually for each patient to correct trauma and/or defects in the lower jaw, upper jaw and face or the cranium and the face. Implanting surgeons were notified individually of the problem in a October 24, 2008 recall letter. The letter advised them of the risk for serious infections, and instructed them to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits. Read the complete MedWatch 2008 Safety summary, including a link to the Class 1 recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Stryker

Tuesday, December 23, 2008

A new area of clinical research, called pharmacogenomics research, is emerging.  This kind of research looks at how a person’s genetic makeup might predict which drug is the safest, most effective, drug for that person.

Recently a new law, called the Genetic Information Nondiscrimination Act, was signed into law. This law will prohibit employers and health insurance companies from discriminating against individuals based on their genetic information. This law will go into effect in 2009.

We’d like to ask you a few questions about GINA and pharmacogenomic research. Your response will be anonymous.

Please click this link – there are only a few questions so this should only take a few minutes --

http://www.zoomerang.com/Survey/?p=WEB228N3YU85FS

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Thursday, December 18, 2008

Intended or Unintended, the Unforgivable Injury

We have been listening to TMJ patients since 1986. Our conversations and letters have run the gamut from simple questions to in-depth descriptions of what this disorder has done to our lives. Even for those whose short bout with TMJ ended in "life back to normal," the episode has left them questioning this disease that put them into a period of pain and dysfunction, thankful to be better, and somewhat apprehensive regarding recurrence.

We hope this article, based on thousands of phone calls and letters, will shed some light on how TMJ has affected the lives of those afflicted. We share with you the concerns, events, and life decisions that people face in their TMJ battles. Some will recognize themselves in the paragraphs that follow; others will feel fortunate to have had few of these experiences. The importance of this article is that The TMJ Association has listened and learned and is compelled to share this information with you.

TMJ disorders can drastically alter the life patterns of the patients, their families and loved ones. As with any major chronic illness, or the loss of a loved one, everyone experiences the grieving process. In a matter of months or overnight, the patient becomes a totally different person, experiencing unexpected and unfamiliar physical limitations and accompanying fear. The patient is forced to give up not only part of oneself, but also the idealizations and hopes one has had. If these losses are not replaced with hope through understanding and acceptance, everything seems hopeless. Unfortunately, for TMJ patients there are few answers and little that makes sense, which makes understanding, and therefore acceptance, difficult.

Family relationships change in countless ways. Frequently, people are forced to give up jobs and promising careers. Some have abandoned the idea of having children. Patients tell us how much it hurts to see their children gradually depending on the other parent to fulfill needs they previously met. The well spouse is forced to assume household and child-rearing responsibilities, and often has the added pressure of working longer hours or holding down several jobs to replace the lost income needed to pay the mounting medical expenses. Many families have had to develop "second careers," battling insurance companies and creditors. Unfortunately, many marriages are unable to survive all of the stress and adjustments.

We sometimes hear from parents of adult TMJ patients who have become caretakers again. Some have depleted their life savings. A mother told us she and her husband spent their pension fund of $300,000 on their daughter's multiple surgery bills. They are now bankrupt and caring for their 30-year-old daughter in their home.

Tragically, the children of a parent with TMJ sometimes find themselves "parenting" at a time when they themselves need nurturing. Daily, they watch the pain and effects this illness wreaks on the sick parent. They see the changed face and emotions of the parent, and they do not understand what is happening. And some face the unimaginable fear of losing their mother or father. A woman told us her five-year old son didn't want to go to school for gifted children because he wouldn't be able to go home during lunch "to check on Mommy."

Unpredictability is the mainstay of TMJ patients. They are unable to plan simple outings, such as going to a movie, let alone a vacation or other more demanding family activity. With a disorder that can wax and wane within hours, plans with family and friends frequently have to be altered or canceled on short notice. Most TMJ patients live with guilt over disrupting the entire family because of their illness. They also dread the inevitable days of recovery they will face if they participate in family activities. And it is virtually impossible for family members and friends not to respond to these limitations with anger, as well as guilt of their own.

An inherent problem experienced by people with TMJ pain and dysfunction is the effect the illness has on the sex lives of the patient and partner. The once pleasurable sensations of being touched, hugged, kissed, having one's face stroked, and all the things that are an integral part of lovemaking and affection sharing, are now for many excruciatingly painful. Spouses frequently say they are hesitant to make sexual overtures for fear of physically hurting the sick partner or appearing insensitive to his or her pain.

TMJ patients must deal with dramatic changes in their appearance resulting from the disorder, treatment, and nutritional problems. Facial deformities can occur, causing diminished self-esteem and feelings of shame and revulsion. Some describe the shock of looking in the mirror and seeing someone they no longer recognize. And there is the ultimate shame of being stared at in public. For some people, along with the facial deformity, the body image is also distorted. For example, those taking prescribed medications, such as anti-depressants, experience weight increase over a fairly short period of time. One woman told us she gained so much weight she could no longer wear any of her clothes, couldn't afford to buy new ones, and now lives in her husband's pajamas. Another, facing the twelfth operation, began eating uncontrollably, gained 30 pounds in two weeks, and sobbingly told us she felt certain she would never eat again after the next surgery. On the flip side of the coin, many patients have such severe difficulty chewing and swallowing that they live on liquids, blended food or baby food for years. Some are even surviving on feeding tubes. They experience digestive problems and fight a constant battle to keep weight on and obtain minimal nutrition. Finally, there are those patients fortunate enough not to have experienced either facial deformities or weight loss or gain. These people are stigmatized because they look perfectly normal and therefore no one believes they are experiencing a disabling disorder.

To further add to the isolation already imposed on their lives, many TMJ sufferers are denied dining out - contemporary society's way of interacting in a social or business manner. Some are physically unable to go out and eat in a restaurant. Others who might feel like going out suffer the embarrassment imposed by their masticatory inadequacy, such as having food fall out of their mouths or choking. Many of these people have lost valuable friendships and are unable to participate in daily experiences and pleasures normal people take for granted.

An incredibly damaging component of this disorder is that most people believe it is psychogenic. Many TMJ patients suffer through years of being told that their medical problems should have been resolved, and because they haven't, their illness is psychosomatic, or imagined. They are made to feel like hypochondriacs and/or are perceived as hypochondriacs. Additionally, professional authors generally relate TMJ pain to stress and frequently treat it as though the sufferer is simply stressed and depressed (depression is secondary to the problem in nearly all cases and, like anger, inevitable after a period of time). Some doctors make trite suggestions to their patients - that they change jobs, change spouses, or take a vacation. They offer hope from a limited number of suggestions as the life of the afflicted person crumbles. Whether resented or believed, patients who are desperate will often succumb to the recommendations of their doctors, even though these professionals seem oblivious to the fact that their patients are living in a state of chronic pain and masticatory dysfunction. They are being treated in a system where no one professional takes responsibility for the patient - a system of an unbelievable number of referrals with unscientific, unproven treatments (and hope) sold to the patient by each referring physician. In many cases, patients end up worse and more and more destitute, yet they grasp for hope with each referral until some become gun-shy, resisting all treatment. In fact, some even refuse medical treatment in life-threatening situations.

One patient wrote, "All these years, he told me my pain was psychosomatic ... so, I continued with his treatments - counseling, physical therapy, biofeedback, TENS, hypnosis, 13 surgeries, etc ... I cannot believe I've been deceived all these years. The only way I learned about my condition was out of a magazine."

As evidenced by this woman's statement, many people have not only lost hope, they feel betrayed. Betrayed by doctors who took an oath to "do no harm," yet ignore the harm that was done, and continue to utilize treatments with little scientific validity of safety and efficacy - treatments that can exacerbate or initiate a TMJ problem. Many professionals assume no responsibility for their patients, but rather blame them for the treatment failure, and/or abandon them, leaving them in some cases with no care whatsoever. According to Beverly Flanigan, author of Forgiving the Unforgivable (New York: Macmillan, 1992), "It is a painful situation for a person to depend upon a protector who is at the same time a harmer. If you reject the harmer, you lose the protector." (p. 39) One patient succinctly put it when she said that although she knows its an "unrealistic desire," she wishes that "just one of the doctors who harmed me would say 'My God, what have I done to you and what can I do now to make it better?'" (Marilyn Sadler, "Jaws," Memphis, Dec. 1992, pp.26+)

Standard operating procedure for TMJ treatment is the inclusion of a psychological evaluation and/or counseling. Yet many people tell us the psychologists don't seem to understand their concerns and feelings. Patients talk about jaw pain, and the psychologist believes they were sexually abused. Or they talk about how this disorder is destroying the family, and the psychologist believes marital stress is the cause of the disorder. Many patients say they just can't win. If they walk into the doctor's office for an appointment looking respectfully dressed and well groomed, their pain is doubted. If they walk in looking how they feel, their pain is still doubted and they are accused of being depressed. The present system feels compelled to find flaws in the individual to blame for the disorder, totally oblivious to the real problems. The medical quagmire the patient gets caught in introduces a new set of psychological factors not yet addressed in this area of medicine - how to treat the psychological trauma resulting from failed medical treatment, harmful treatment, or shotgun treatment which leads people on the medical merry-go-round and ends in chaos and destroyed lives. Many patients tell us they feel like trapped animals with nowhere to turn for help and no one who understands the psychological support they really need.

The danger of this type of approach has been driven home to us tragically and all too often. For example, a multi-surgical implant patient visited her doctor with her husband. The oral surgeon impressed upon them that her problem was strictly psychological, not a result of the surgeries or implants. When they returned home, the husband told his wife, "He is the authority. Who should I believe - you or him?" The wife walked into the bedroom and shot herself.

Another patient told us he was kept in a mental health facility for three weeks because they thought he was having a panic attack. He said: "Of course, I was panicked because I was having this incredible pain, they wouldn't believe me, and they kept telling me it was psychological." A wife of a TMJ implant patient told us she did not believe her husband could possibly be experiencing the amount of pain he said he had. After all, no professional would validate his pain. So she returned to graduate school, fully intending to divorce her husband upon graduation. She didn't, but over the last ten years, she has had two major nervous breakdowns and she and her husband "have lost everything." They eventually learned the dangers of implants through the media and, armed with the truth of what happened, are trying to sort out their lives. What we are hearing from TMJ patients is that they are desperately trying to make someone understand the essence of their problems. Yet what they say is continuously distorted by professionals who have pre-conceived ideas and do not even begin to comprehend what their patients are feeling.

Not only have TMJ patients been betrayed by their doctors, they feel betrayed by professional dental organizations. The American Dental Association has shirked its responsibility by failing to make TMJ a specialty and to provide uniform guidelines based on scientific criteria, not "state-of-the-art/anecdotal information." This lack of standards creates more controversy, havoc, and ultimately, more harm to the patient. In the case of the implant patients, the behavior of the American Association of Oral and Maxillofacial Surgeons (AAOMS) has been described by many as shameful. Even Congress, in a letter dated December 14, 1994, was compelled to demand explanations from AAOMS concerning such issues as the lack of research, the use of illegal and/or experimental devices, failure to contact patients with implants, abandonment, and the absence of financial assistance for TMJ patients, particularly those who need to have implants removed.

Perhaps one of the hardest betrayals for many TMJ patients to accept is that by our government - a government that established the FDA to protect consumers, and the National Institutes of Health to conduct research that would ultimately lead to safe, effective treatments for all TMJ sufferers. Obviously, both of these agencies have failed to do their jobs. Additionally, device manufacturers appear to have done no animal, biomechanical, or immunological experimentation (let alone human studies). Insurance systems have further contributed to the problem through haphazard coverage of treatment.

"An unforgivable injury is a profound and irreversible assault on the fundamental belief system of the person who has been injured (Flanigan, p. 26). ... The loss of the belief in trust itself is like the loss of beliefs suffered in other unforgivable injuries. It goes to the core of a person and how he thereafter views his world" (p. 51). Ms. Flanigan goes on to say, "By definition, unforgivable injuries destroy beliefs about oneself, other people, and the world in general" (p. 52). Her sentiments sum up the emotions expressed by many TMJ patients.

Clearly, TMJ touches the lives of patients and those around them in innumerable ways. This article barely scratches the surface. For example, we have not done justice to the subject of pain. Many patients live in such excruciating agony that every day is a battle against suicide. They exist in a world where every minute seems like hours, and they can only count the time until the next pain pill. And they live in a constant state of terror, wondering how much worse it can get and how much more they can take. Some go from doctor to doctor, feeling as though they are "groveling" for medication from professionals who do not believe their pain is real or severe enough to warrant drugs and who, in many cases, refuse to prescribe much-needed painkillers. Some patients say they are reduced to looking for relief through street drugs. This is not only demeaning, but dangerous and uncalled for.

After writing this article, we asked several people to read it. Most reacted with, "This is so depressing - can I sign my name to this article? This is me." The state-of-the-art of science and treatment of this disorder are depressing. That TMJ is in a rather horrible state of affairs cannot be denied. And there is no way we can lie about what we are hearing or legitimately keep this information secret. Our fight has been to expose the truth about TMJ disorders as we the patients experience it. The truth is not pretty, but perhaps articles such as the ones we have been writing are stripping away, bit by bit, the falsehoods and cover-up that we all have experienced in our lives with TMJ. And maybe if friends, family, and treating professionals read this article, they will gain insight into who we are and what we are going through.

This article is probably the first written about how we really feel and how we are treated. The importance of this is that TMJ is coming out of the closet. If we all support each other and begin speaking these truths with one voice, it won't be long before we stop hearing, "Nobody really understands," or "I can't tell anybody I have TMJ. I'm too embarrassed."

As with many issues people in the world face today, we have hope that the campaign we have embarked upon is making a difference. All across the country, people are joining support groups to be heard as one voice, to support each other, and to demand good science and humane treatment. There is strength in numbers. This is our hope for the future. The hope is in our hands to help turn this tragedy around and make it into something positive.

We would like to thank Dr. Harry Prosen, Professor and Chairman of the Department of Psychiatry and Mental Health Sciences at the Medical College of Wisconsin, and member of The TMJ Association's Advisory Board, for his help with this article.

Tuesday, December 09, 2008

Many TMJ patients have had imaging procedures which show that they have displaced discs or degenerative joint disease. They then have a surgical procedure to repair what is shown to be wrong. Rather than being pain free after the surgery, many aren't. In fact, many experience more pain than they had before the procedure and develop abnormal bone growth around the joint or other adverse events. These articles let us know that pain can can be referred - pain in another part of the body other than it originates.

Health / Research

Nerves Tangle, and Back Pain Becomes a Toothache

By KATE MURPHY

Published: September 16, 2008

Referred pain can make diagnoses difficult, but it also opens a research window for neuroscientists.

http://www.nytimes.com/2008/09/16/health/research/16pain.html?partner=permalink&exprod=permalink

 

The Evidence Gap

The Pain May Be Real, but the Scan Is Deceiving

By GINA KOLATA

Published: December 9, 2008

Scans are increasingly finding abnormalities that may not be the cause of the problem for which they are blamed.

http://www.nytimes.com/2008/12/09/health/09scan.html?partner=permalink&exprod=permalink

Thursday, November 20, 2008

The Combined Federal Campaign (CFC) fund drive has begun.  If you are a federal employee, your designation of The TMJ Association on your donor form will be invaluable.  Simply select #12102 on the donor registration card. 

 

If you're not a federal employee, please share this information with those who are—we all know at least one federal worker, our postal carrier.  Also, you may have family members or friends serving in the military who would be willing to support our cause! 

 

SECC:

State employees can contribute through the State Employee Contribution Campaign (SECC). Each state has its own eligibility requirements and the TMJA currently qualifies and participates in the following states: 

•      Arizona   

•      California

•      Connecticut

•      Florida

•      Maryland

•      Massachusetts

•      New Jersey

•      New York

•      Ohio

•      Rhode Island

•      Washington

•      Wisconsin

 

Thursday, November 20, 2008

You can help the TMJA this holiday season by shopping online for your holiday gifts.  When you shop at any of over 700 participating online stores through iGive, a portion of each purchase comes back to us in the form of a donation check.

It's free for you, free for us, and you pay the same (or less!) than you would by going directly to the store. Shopping online means no wasted gas and no more standing in long lines at the mall. And to all you smart shoppers: don't miss iGive's treasure-trove of coupons, sales, and free shipping. 

Save money, save time, and send gifts that give twice.  What could be better than that?

See for yourself at: www.iGive.com/TMJA

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Thursday, November 13, 2008

The Acting Director of the National Institutes of Health, Dr. Raynard Kington, announced on Wednesday the appointment of Lawrence Tabak, D.D.S., Ph.D., as Principal Acting Deputy Director for the NIH, effective November 13, 2008. Dr. Tabak has been the Director of the National Institute of Dental and Craniofacial Research since September 2000.

Prior to joining the NIH, Dr. Tabak was the Senior Associate Dean for Research and professor of dentistry and of biochemistry and biophysics in the School of Medicine and Dentistry at the University of Rochester. Dr. Kington said that while Acting as NIH Principal Deputy Director, Dr. Tabak will also continue his role as the NIDCR Director.

Tuesday, November 11, 2008

The NIH Web site is currently highlighting the NIDCR’s “Less Is Often Best” awareness initiative for TMJDs. The site is: http://www.nih.gov/

Friday, November 07, 2008

The National Family Caregivers Association, a member of the National Health Council has extended the following opportunity to our constituents who are family caregivers. It is hosting a Free TeleClass to improve caregivers' skills so they can be more effective and better advocates for their loved one and their selves.

Although this TeleClass is designed especially for caregivers, as patients, we found it informative and useful. Dr. Crystal Dea Moore and Ms Suzanne Mintz (President of the NFCA) offered many helpful tips on ways to approach healthcare professionals. Dr.Moore gave many examples of ways to build a cooperative team of caregivers, patients and doctors to work towards the desired result in a non-adversarial manner. Other valuable insights were given regarding how to identify all the stakeholders involved in one's healthcare in addition the patient and physicians -- such as pharmacists, physical therapists, insurance case workers, medical office personnel, etc., and how important it is to know who to contact for specific information. The second part of the series will take place on Thursday, November 13th. You may register online at: http://www.thefamilycaregiver.org/national_family_caregiver_month/teleclass.cfm.

The first part of this series will be archived on the Website of the National Family Caregivers Association Web site in the near future.

Communicating Effectively with Healthcare Professionals

A two-part Series - Thursday, November 6 & 13, 2008

 

2 PM to 3 PM Eastern

To Register Go to:

www.thefamilycaregiver.org

For More Information Call: 1/800-896-3650

Thursday, October 30, 2008

The TMJ Association participates in the following social network communities.  We invite you to visit and join us on-line!

• TMJA forum
• Change.org
• Facebook
• MySpace
• Twitter
• Firstgiving

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Wednesday, October 29, 2008

FDA Warns Bayer About Two Unapproved Aspirin Products
Questions and Answers for Consumers

What action is FDA announcing?

On Oct. 28, 2008, the Food and Drug Administration (FDA) sent warning letters to Bayer HealthCare regarding two over-the-counter (OTC) products that combine aspirin with a dietary supplement into a single pill. The products are not approved by FDA.

Which products are affected?

• Bayer Aspirin with Heart Advantage (Bayer Heart Advantage)–aspirin combined with phytosterols (a plant-based supplement also known as plant sterols)
• Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's)–aspirin combined with calcium

Why is FDA issuing these warning letters?

In addition to marketing these products as pain relievers, Bayer is also marketing them for reducing the risks of heart disease. The labeling for Bayer Women's also claims that the product helps "fight" osteoporosis.

• The products are unapproved new drugs. Because these products combine aspirin with a dietary supplement into one pill, FDA considers them to be new drugs that must undergo FDA review before they can be marketed. Their safety and effectiveness for their marketed uses have not been reviewed by the agency.
  
  Under the OTC Drug Review–a process that lays out ingredients and uses that are allowed in OTC products–FDA allows some drugs to be marketed without first obtaining formal agency approval. But Bayer Heart Advantage and Bayer Women's are not covered by FDA's OTC Drug Review, nor are they otherwise approved by the agency.

• Bayer is marketing the products over-the-counter, but their use requires a physician's supervision. Products that are being marketed for preventing heart attacks, for preventing and/or treating heart disease, and/or for treating osteoporosis require the supervision of a physician to ensure safe use.
• The products have inadequate and misleading directions and warnings. Both products lack adequate directions and warnings for their safe use by consumers. For example, these products are labeled with directions and warnings that are inconsistent and contradictory.
  
  The "Drug Facts" panels on the labeling for these products specify that consumers should stop use and ask a doctor if pain gets worse or lasts more than 10 days. But the "Supplement Facts" panels on the labeling for these products include directions for daily use, without mentioning any limitations on duration of use.

Have there been adverse events related to these products?

FDA is not aware of significant adverse events related to these products. But the agency is concerned because Bayer Heart Advantage and Bayer Women's have not been proven safe and effective for their labeled uses.

What is FDA's advice for consumers who may have been taking these products?

FDA has not approved these products. The agency recommends that consumers talk with their health care providers about alternatives to taking an unapproved drug. Consumers who are taking any aspirin products for cardiovascular health should only do so under the supervision of a physician.  

Why is it important to use aspirin products under the supervision of a physician?

Studies have shown that aspirin can help prevent the recurrence of heart attacks and stroke, but aspirin use has also been associated with adverse events. These include gastrointestinal side effects, such as stomach pain, heartburn, nausea, vomiting, and bleeding. Also, using aspirin for cardiovascular health may not be necessary or appropriate for some people.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

For More Information

FDA Press Release: FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
www.fda.gov/bbs/topics/NEWS/2008/NEW01907.html

Is It Really FDA Approved?
www.fda.gov/consumer/updates/approvals093008.html

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Date Posted: October 28, 2008

Wednesday, October 29, 2008

The National Family Caregivers Association, a member of the National Health Council, and has extended the following opportunity our constituents who are family caregivers. They are hosting a Free TeleClass to improve caregivers skills so they can be more effective members of their loved one's team and also better advocates for their loved one and themselves.

Communicating Effectively with Healthcare Professionals

A two-part Series - Thursday, November 6 & 13, 2008

 

2 PM to 3 PM Eastern

To Register Go to:

www.thefamilycaregiver.org

For More Information Call: 1/800-896-3650

Wednesday, October 22, 2008

The following is an article from Integrity in Science Watch e-newsletter from October 14, 2008. We are posting this information because TMJ patients are often prescribed Neurontin.

Lawsuit: Pfizer Hid Negative Neurontin Studies

Pfizer, maker of the anti-seizure drug Neurontin, suppressed studies showing negative results for its off-label use in neurological and psychiatric conditions, a class action lawsuit filed in U.S. District Court in Boston charged. Health insurers and consumers who are seeking refunds alleged that "Pfizer's marketers influenced the drug's scientific record to boost sales at least until 2003 by declining to release or altering the conclusions of studies that found no beneficial effect from Neurontin for various off-label conditions," the Wall Street Journal reported. In 2004, Pfizer's Warner-Lambert unit pleaded guilty to felony charges that it promoted Neurontin for uses not approved by FDA, including bipolar disorder and chronic nerve pain. The company settled the charges by paying $430 million.

The alleged suppression of research results drew fire from public health scientists. Kay Dickersin, a professor of epidemiology at Johns Hopkins University in Baltimore, wrote in a brief supporting the suit that patients who agree to participate in clinical trials are short-changed when companies refuse to release data from negative trials. "Patients are told they are contributing to human knowledge," she said. "Ethically, one is compelled to publish results." Dickersin's fee for writing the brief will be donated to Johns Hopkins to house Pfizer's documents and make them publicly available.

Monday, October 20, 2008

Summary: Non-expert - TMJ

Category: Healthcare

Name: Hallie Potocki

Email: hpotocki@aol.com

Title: Health writer

Media Outlet/Publication: First for Women

Anonymous? No

Specific Geographic Region? No

Region: National

Deadline: 1:00 PM EASTERN - October 25

Query:

"I'm seeking everyday women (non-experts), who have experienced TMJ and who for years were beset with misdiagnosis and fatigue.

If you or someone you know fits the bill, please respond with your name, city and state, a brief summary of your story and an electronic photo, so we can put a face with the story.

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Thursday, October 02, 2008

TMJ implant patients may be interested in the outcome of the lawsuits filed against the Canadian government by thousands of breast implant patients as well as another class action lawsuit by Vitek TMJ implant patients. A lower court decision eliminated recipients of siliastic and other TMJ implants allowing only the Vitek to proceed. The Canadian government claimed that the manufacturers - not government officials -were the ones responsible for the safety and reliability of both the breast and TMJ implants.  To read this article, click here.

Wednesday, October 01, 2008

The TMJ Association Introduces an Online Support Community

 

Milwaukee, WI, October 1, 2008--The TMJ Association (TMJA) has introduced an online forum where those affected by Temporomandibular joint and muscle disorders (TMJDs) and their loved ones can exchange information, share experiences and find mutual support. The forum, available at http://forum.tmj.org, extends the TMJA's outreach to raise awareness about the realities of TMJDs and advance our mission to support TMJ patients and their loved ones.   Providing patients with support and reliable and comprehensive information has been a goal of The TMJA since it's founding. The forum will be a powerful addition to the TMJA Web site, www.tmj.org, in addressing that goal.

 

TMJA President and Co-Founder Terrie Cowley, says "Patients need to understand that TMJDs remain medical mysteries. We don't understand all the causes and there are no scientifically based treatments guaranteed to work, so patients need to be wary. Patients also need to realize that they are not alone. There are many other TMJD sufferers and the forum is a way of bringing them together."

This online community is a part of a larger effort by the organization to reach out to its constituents and potential members on the internet.

The TMJA is a 501(c)3 non-profit organization based in Milwaukee, Wisconsin, whose mission is to improve the quality of healthcare and lives of everyone affected by TMJDs.  The forum, with TMJD patient Stacy Stone as the TMJA’s Online Communications Coordinator to guide operations, adds to the TMJA’s presence on the internet.  The Association’s web site, www.tmj.org, has already been recognized as the leading source of reliable information on TMJDs by scientists and health information experts.

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Contact:

The TMJ Association
www.tmj.org

info@tmj.org

262.432.0350

 

Wednesday, September 24, 2008

Dear Friends and Colleagues:                                                    
 
Today, with mixed feelings, I wrote to inform NIH scientists, administrators, staff, contractors, and trainees that at the end of October, I will be leaving NIH to explore new opportunities and to devote my attention to several writing projects.   

I wanted to also thank and recognize the commitment and tireless efforts of the non profit organizations like yours that help NIH accomplish the great work that it does.  For over six years, I have enjoyed and benefitted from your thoughtfulness, dedication, and devotion to our shared mission: to make a difference in the nation’s health through the discovery of new knowledge.  Together, we have faced great challenges posed by the unique times in which we live and where there are profound changes and shifts in the scientific environment, Government, and the world. 

Each one of you is among the most extraordinary, committed group of individuals with which I have ever interacted.  Whenever NIH asks for your ideas, input, suggestions, and, participation, you answer the call, regardless of the nature and the complexity of the question, concern, or issue under discussion.  You have every right to share credit for the agency’s achievements as you form a unique and essential component of our success.  It is also because of you that NIH is one of the true “wonders of the world” and takes such a prominent place in rankings of Federal agencies.  

NIH is the “Nation’s Medical Research Agency,” and with your continued guidance, support, and volunteerism, the agency will remain on the leading edge of health, medical, and scientific advancement.  Our continued success depends on nothing less.  I want to sincerely thank you for your kind support during my tenure.

Please feel free to distribute this message to your officers, advisors, and members.

Elias A. Zerhouni, M.D.

Wednesday, September 24, 2008

Bethesda, Md, September 24, 2008 -- Elias A. Zerhouni, M.D., the director of the National Institutes of Health, today announced his plans to step down at the end of October 2008 to pursue writing projects and explore other professional opportunities.

Dr. Zerhouni, a physician scientist and world-renowned leader in radiology research, has served as NIH director since May 2002. He led the agency through a challenging period that required innovative solutions to transform basic and clinical research into tangible benefits for patients and their families. One of the hallmarks of his tenure is the NIH Roadmap for Medical Research, launched in 2003, after extensive consultations with the scientific community. The NIH Roadmap brought together all of the NIH 27 Institutes and Centers to fund compelling research initiatives that could have a major impact on science, but that no single institute could tackle alone. Additional information about the NIH Roadmap can be found at <www.nihroadmap.nih.gov>.

Dr. Zerhouni also launched new programs to encourage high-risk innovative research, such as the Director's Pioneer Awards and New Innovator Awards, and focused especially on the need to support new investigators and foster their independence. During his tenure, Zerhouni worked to lower barriers between disciplines of science and encourage trans-NIH collaborations. For example, he inspired significant interdisciplinary efforts such as the NIH Strategic Plan for Obesity Research and the Neuroscience Blueprint.

Zerhouni also led a major reform of the translational and clinical research system in the United States. He also worked to improve public access to scientific information. These efforts, along with his continual advocacy for the public's investment in the NIH, greatly contributed to Congress passing the NIH Reform Act of 2006, which was a sign of renewed confidence in the NIH. (For more detailed information, see a listing of key accomplishments attached to this release.)

"I have had the privilege of leading one of the greatest institutions in the world for six and a half years," Dr. Zerhouni said. "NIH's strength comes from the extraordinary commitment and excellence of its people in serving a noble mission. It also comes from the nation's scientific community, whose discoveries alleviate the suffering of patients throughout the world. Over the past six years, we experienced a revolution in the biomedical sciences and I feel fortunate to have been part of it. I will miss the NIH and all my colleagues, not only for their friendship and support through 'thick and thin,' but also for their essential role in the progress we made in advancing innovative research, fostering scientific collaboration, supporting young scientists, and enhancing basic, translational, and clinical research, despite great challenges."

"Elias has been a powerful voice for the medical research community as head of the NIH. His tenure has been marked by the spirit of collaboration, good management and transformation. The Roadmap for Medical Research that he developed and implemented will benefit the health of this nation for many years to come," said Secretary of Health and Human Services Michael O. Leavitt. "His many achievements include promotion of genetic research, support for advances of biodefense research and helping raise awareness of women's heart disease. I want to thank Elias for his leadership and wish him the best of luck as he begins this new chapter."

NIH is part of the U.S. Department of Health and Human Services (HHS), and is the nation's premiere biomedical research agency. The agency has more than 18,000 employees and a fiscal year 2008 budget of $29.5 billion. It supports more than 325,000 researcher personnel at more than 3,100 institutions throughout the United States, and around the world.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers.

This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at <http://www.nih.gov/icd/od/>.

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit <www.nih.gov>.

---------------------

KEY ACCOMPLISHMENTS OF ELIAS A. ZERHOUNI, M.D.

As NIH Director, Dr. Zerhouni significantly advanced the NIH mission:

(1) to pursue fundamental knowledge about the nature and behavior of living systems, and (2) to apply that knowledge to the extension of healthy life and the reduction of the burdens of illness and disability.

Zerhouni forged new connections between basic and clinical research, integrating the component parts of NIH's mission to unprecedented degrees. He also led the agency to be better prepared to meet the public health and science needs, challenges, and opportunities of the 21st century.

THE NIH ROADMAP

As NIH director, Dr. Zerhouni launched a number of far-reaching initiatives to address the explosion of new knowledge in the biomedical sciences and the growing challenges in public health. In September 2003, he with the Institute and Center leadership initiated the NIH Roadmap for Medical Research, a vision that helped chart the course for the future of NIH. The NIH Roadmap focused on a short list of compelling initiatives for the NIH to pursue that would make a profound, measurable difference in biomedical research. The NIH Roadmap efforts stimulated new pathways to discovery, building research teams for the future, and re-engineering the clinical research enterprise. The NIH Roadmap is a continuing programmatic priority at NIH and is managed by a newly-established Office of Portfolio Analysis and Strategic Initiatives (OPASI). The ongoing goal of the NIH Roadmap is to ensure that NIH is nimble, dynamic, and responsive to emerging scientific opportunities and public health needs.

TRANS-NIH COLLABORATIONS

Drawing from a "common fund" of money, NIH's 27 Institutes and Centers collaborate on initiatives that are essential to the advancement of biomedicine, initiatives that no single Institute or Center are able to undertake alone. The NIH Office of Portfolio Analysis and Strategic Initiatives is organized around three themes: "New Pathways to

Discovery": "Re-engineering the Clinical Research Enterprise," and "Research Teams of the Future." Today, initiatives within each of these themes are making significant contributions to the science and practice of medicine. In 2006, Congress passed the NIH Reform Act. Only the third omnibus reauthorization in NIH's history, the Reform Act gives the NIH Roadmap, and the Common Fund, legislative weight and continued support.

 

TRANS-NIH INITIATIVES TO ADDRESS MAJOR PUBLIC HEALTH NEEDS Dr. Zerhouni also established NIH-wide research initiatives to address major public health problems, including obesity research and neuroscience research. Shortly after Dr. Zerhouni's arrival in 2002, he established the NIH Obesity Research Task Force to address one the nation's most costly and debilitating health challenges. The task force drew representatives from 7 NIH Institutes, Centers, and Offices and developed a strategic plan that combined new research opportunities with the coordination of resources across the NIH. The plan called for interdisciplinary research teams to bridge the study of environmental and behavioral causes with the study of genetic and biologic causes.

Dr. Zerhouni also spearheaded the NIH Neuroscience Blueprint to (1) leverage the resources of 17 NIH Institutes and Centers, (2) tackle common scientific problems and (3) train the future generation of neuroscientists, all in an effort to address mental illness, neurological disorders, and a range of behavioral disorders that together affect millions of individuals at a yearly cost to the U.S. of more than $500 billion.

CLINICAL AND TRANSLATIONAL SCIENCE AWARDS In October 2006, Dr. Zerhouni launched a national consortium designed to transform clinical and translational research. Called the Clinical and Translational Science Awards (CTSAs), the program represented the first systematic change in the agency's approach to clinical research in 50 years. The consortium got underway in with 12 sites; more were added each year with the plan of supporting 60 such institutions by 2012. NIH began to see the transformative effects of the program as changes occurred and new partnerships at institutions were forged. The CTSA initiative grew out of the NIH commitment to re-engineer the clinical research enterprise, one of the key objectives of the NIH Roadmap for Medical Research.

MOLECULAR LIBRARIES

The NIH Roadmap identified one key "new pathway": the need for molecular libraries. The Molecular Libraries initiative resulted in development of a nationwide consortium of 10 small molecule screening centers; including NIH; a database, PubChem; and new tools and technologies to better serve investigative needs. PubChem provides free access to discoveries about the chemical structures and biological activities of small molecules. The program was designed to provide investigators with a comprehensive set of small molecule modulators of a majority of the genes and functions of humans and other organisms. The Molecular Libraries initiative is also aimed at producing innovative chemical tools for use in biological research and drug development. The Molecular Small Molecule Repository currently contains over 300,000 small molecules, and the network of centers has entered the second phase of its research agenda, focusing on small molecule probes.

SUPPORT FOR HIGH RISK/HIGH IMPACT RESEARCH During his tenure, Dr. Zerhouni also addressed the agency's continued support of high risk/high impact research, innovation in research, and funding for early-career investigators.

 

NIH DIRECTOR'S PIONEER AWARDS

Dr. Zerhouni launched the NIH Director's Pioneer Award Program in 2004 as a high-risk research initiative. The awards are designed to support individual scientists of exceptional creativity who propose pioneering-and possibly transforming approaches-to major challenges in biomedical and behavioral research. "Pioneering" refers to highly innovative approaches with the potential of producing an unusually high impact on a broad area of biomedical or behavioral research. Awards may include grants for conducting research as opposed to recognizing past achievement.

PATHWAY TO INDEPENDENCE AWARDS

In January 2006, Dr. Zerhouni announced the NIH Pathway to Independence Award program, which targeted promising postdoctoral scientists for receipt of mentored and independent research support, both from the same award. The program is among several initiated by Dr. Zerhouni to support scientists at the early part of their careers while maintaining the agency's "pipeline" of future-generation researchers.

With the program's debut, Dr. Zerhouni said, "Encouraging independent inquiry by promising new investigators is a major goal for NIH. We must invest in the future of our new scientists today if we expect to meet the nation's health challenges of tomorrow. New investigators who successfully cross the bridge from research dependence to research independence bring fresh ideas and innovative perspectives to the research enterprise."

NIH NEW INNOVATOR AWARDS

In March 2007, Dr. Zerhouni announced the New Innovator Awards Program, designed to cultivate new investigators, support innovative ideas, and encourage and reward creativity. Under the program, New Innovator Awardees propose bold and highly innovative research approaches that have the potential to produce solutions for broad, important problems in biomedical and behavioral research. The program complements other NIH efforts to fund new investigators through R01 grants, the original and historically oldest grant mechanism used by NIH, and the one that continues to be the major source of NIH support for new investigators.

In 2007, thirty new investigators were provided New Innovator Awards under the NIH Roadmap to initiate their own new five-year research programs. The awards provide brilliant emerging scientists with the resources, time, and freedom to pursue creative ideas.

TRANSFORMATIVE R01 PROGRAM

Dr. Zerhouni launched the Transformative R01 (TR01) program in September

2008 to provide support for individual scientists or collaborative investigative teams who propose transformative approaches to major contemporary challenges. The primary objective of the T-R01 initiative is to create a program that is specifically designed to support exceptionally innovative, high risk, original and/or unconventional research with the potential to create new or challenge existing scientific paradigms. The program is a High Risk/High Reward Demonstration Project with support from the NIH Common Fund.

HUMAN MICROBIOME PROJECT

In December 2007, NIH launched the Human Microbiome Project under Dr.

Zerhouni. The human microbiome is the collective genomes of all the microorganisms in or on the human body and is largely unexplored. The project has the potential to transform scientific understanding of human health and to prevent, diagnose, and treat a wide range of conditions.

The project is part of the NIH Roadmap for Medical Research and was chosen by NIH leadership as a major research opportunity that no single Institute or Center could address alone.

EPIGENOMICS PROJECT

In January 2008, NIH announced a 5-year, $190 million investment for the study of epigenomics: the analysis of epigenetic changes across many genes in a cell or an entire organism. Epigenetics focuses on the processes that regulate how and when certain genes are turned on and turned off. "Epigenomics will build upon our new knowledge of the human genome and help us better understand the role of the environment in regulating genes that protect our health or make us susceptible to disease," said Dr. Zerhouni at the announcement of the program's start.

STRUCTURAL BIOLOGY ROADMAP

The Structural Biology Roadmap is a strategic effort to create a comprehensive gallery of three-dimensional shapes of proteins in the body. The program seeks to develop methods or producing protein samples for use by scientists in determining the three-dimensional structure or shape of a protein. During the first phase of the Structural Biology Roadmap (FY2004-2008), the NIH funded two Centers for Innovation in Membrane Protein Production that enabled interdisciplinary groups of scientists to develop innovative methods for producing large quantities of membrane proteins. The NIH program is designed to catalyze what is currently a hit-or-miss process into an organized, coordinated, systematic, and streamlined routine, helping researchers clarify the role of protein shape in health and disease. A number of small exploratory and regular research grants were also awarded to individual investigators to broaden the base of innovative ideas under development.

 

 

ORGANIZATIONAL REFORMS

During his tenure, Dr. Zerhouni embarked on a wide array of efforts to make NIH more responsive to changes and challenges in the scientific landscape and more nimble as an organization. Under Dr. Zerhouni's leadership, NIH initiated a number of important and unprecedented programs to improve how science is conducted and to ensure that the agency takes full advantage of the progress made to date in improving people's health.

NIH GOVERNANCE IMPROVEMENT-STEERING COMMITTEE In July 2003, Dr. Zerhouni announced the formation of the NIH Steering Committee, with a rotating membership of ten directors derived from the

27 Institutes and Centers to provide a more strategic direction to the agency and streamline its decision-making process. The committee is chaired by the NIH director. As the agency had grown in size and complexity in recent years, there had been an increased need for a more efficient trans-NIH coordination. The Steering Committee transformed NIH's ability to manage and address the complex issues facing the agency.

SCIENCE MANAGEMENT REVIEW BOARD

In September 2008, Dr. Zerhouni announced formation of the NIH Scientific Management Review Board (SMRB) as an outgrowth of the NIH Reform Act of 2006. The SMRB brings together NIH leaders with outside experts to examine NIH's organizational structure and make recommendations for greater agency flexibility and responsiveness.

EFFORTS TO ENHANCE THE NIH PEER REVIEW SYSTEM In June 2008, Dr. Zerhouni announced major changes to improve and enhance the NIH peer review system, marking the end of a year-long effort to determine ways to further enrich the traditional NIH peer review system. NIH is now implementing the programmatic results of Dr.

Zerhouni's original charge, "to fund the best science, by the best scientists, with the least administrative burden." The formal review process involved consultation with and comment from internal staff, patient groups, and the broad scientific community, as well as analysis of thousands of comments, feedback, and opinions about the current NIH peer review system.

PUBLIC ACCESS TO NIH-FUNDED PUBLISHED RESEARCH In February 2005, Dr. Zerhouni announced an unprecedented policy designed to expand and accelerate public access to published articles resulting from NIH-funded research. The policy was the first of its kind and called on scientists to release manuscripts from research supported by NIH as soon as possible, and within 12 months of publication. Publications are made available in a web-based archive managed by the National Library of Medicine. At a time when demand for such information is on a steady rise, the online archive increases the public's access to health-related publications.

ENHANCED TRANSPARENCY

NIH's responded to a call by Congress and the public for enhanced transparency and accessibility regarding disease funding by creating the Research, Condition, and Disease Categorization (RCDC) system. RCDC utilizes a computer-based tool that applies a uniform process of accounting for NIH funding for diseases and conditions. The process produces a fully transparent list of grants underlying and supporting the dollar amounts for each reporting area. NIH will unveil the first RCDC reports as part of the release of the President's 2010 budget request.

SWEEPING REFORM OF NIH ETHICS

In February 2005, Dr. Zerhouni announced a set of ethics regulations to address outside consulting between some NIH employees and representatives of the pharmaceutical and biotechnology sectors. Dr.

Zerhouni launched the revised rules to help NIH (1) preserve its historic role as the primary source of unbiased scientific health information for the country and (2) maintain the highest ethical standards, both while sustaining the agency's ability to support and conduct the best medical research in the world.

PUBLIC TRUST INITIATIVE

In October 2007, Dr. Zerhouni announced release of a new Request for Applications (RFA) for the Partners in Research Program, which supports studies of innovative ways to increase science literacy, improve public understanding of health research, and engage the public through community-based organizations. The program is one of several programs initiated by NIH to maintain and enhance public trust in medical research.

REACHING OUT TO THE PUBLIC

Under Dr. Zerhouni's leadership, NIH reached to the public in an unprecedented way with the communication of science-based health information and scientific results. He led efforts to make the incomparable resources of the NIH and its grantees, resources accessible to the public. Key to these efforts are the health education programs across the agency. With more than 2 million visits a day to the NIH websites, including the NIH's NLM vast collection materials available through comprehensive clearinghouses and #800, use of new resources of podcasting, vodcasting, Research Matters, NIH: News in Health, YouTube, and radio resources to reach audiences who depend upon radio more than the web, materials for people who have challenges of literacy, language or access were also developed. He worked closely with the Council of Public Representatives in encouraging these efforts. In two important messages to NIH and the public, Dr. Zerhouni encouraged open discourse about science noting: "Timely and accurate research results and science-based health communications are an integral part of the NIH mission."

##

This NIH News Release is available online at:

<http://www.nih.gov/news/health/sep2008/od-24.htm>.

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Wednesday, September 10, 2008

Research Grant Opportunities

Roadmap Transformative R01 Program (R01) RFA-RM-08-029 http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-029.html Letters of Intent Receipt Date(s): December 29, 2008 Application Due Date(s): January 29, 2009 One area of highlighted need in the RFA is: “Transitions from Acute to Chronic Pain” More than 30 million Americans suffer from unrelieved chronic pain. Management strategies often fail, in part because an individual’s susceptibility to chronic pain is highly variable, the identification of those destined to transition from acute to chronic pain is difficult, and, once pain has become chronic, changes may have occurred that cannot be easily reversed. The lack of well defined phenotypes that reflect the cellular, molecular, genetic, psychological, cognitive, and behavioral changes that occur as individuals transition to chronic pain has been a major barrier to development of personalized approaches to pain intervention. For these reasons, T-R01 proposals are sought that will transform how we view the pain state of individuals and that will revolutionize the current empirically-based analgesic treatment approaches to ones based upon objective and predictive measures of an individual’s pain phenotype. It is anticipated that responsive studies will involve formation of innovative partnerships including interdisciplinary and multidisciplinary teams to adequately address the topic and experimental aims.

Harnessing Inflammation for Reconstruction of Oral and Craniofacial Tissues (R01)(RFA-DE-09-002) http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-09-001.html Harnessing Inflammation for Reconstruction of Oral and Craniofacial Tissues (R21)(RFA-DE-09-002) http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-09-002.html Application Receipt Date(s): October 31, 2008

Probes and Instrumentation for Monitoring and Manipulating Nervous System Plasticity (R01)(RFA-MH-09-030) Release/Posted Date: March 19, 2008 Opening Date: August 16, 2008 (Earliest date an application may be submitted to Grants.gov) Letters of Intent Receipt Date(s): August 16, 2008 Expiration Date: September 17, 2008 http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-09-030.html. This Funding Opportunity Announcement (FOA) is issued as an initiative of the NIH Blueprint for Neuroscience Research. The Neuroscience Blueprint is a collaborative framework through which 16 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/). Applications are solicited for support of projects that will develop probes, instrumentation, and other tools for understanding, monitoring, and manipulating nervous system plasticity. This FOA will focus on the development of tools or techniques that will significantly advance the current state of the art in neuroplasticity research. Although applications will not be restricted to a particular type of technology, we are especially interested in applications that seek to harness the ability to assess and manipulate activity with exquisite subcellular resolution, and in cells specified by their circuit connectivity and/or transmitter phenotype.

NIAMS Building Interdisciplinary Research Team (BIRT) Revision Awards - RFA) Number: RFA-AR-08-001 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Released Date: November 2, 2007 http://grants2.nih.gov/grants/guide/rfa-files/RFA-AR-08-001.html. To promote interdisciplinary research, the NIAMS plans to provide up to 1 year of research revision support (formerly referred to as “supplement” – see page 1-21 section 2.8 of the SF424 (R&R) Application and Electronic Submission Instructions Version 2) to active NIAMS R01s (parent grants) to establish collaborations among groups of investigators with expertise in the specific areas listed below. The institute intends to supplement interdisciplinary collaboration with high innovation and potentially high impact in the specific NIAMS mission–relevant areas solicited in this FOA. It is understood that such an application may entail high risk. Teams developed under this award are expected to make significant advances beyond the progress expected from the individual researchers alone. Collaborations between scientific areas listed below are selected to pilot the NIAMS BIRT awards and specifically solicited in this FOA. Autoimmunity – Gender and sex factors Autoimmunity or Developmental biology – Systems biology Soft tissue biology – Imaging technologies Tissue engineering – Immunology or Developmental biology

Translational Application of Gene Silencing Strategies to Oral and Craniofacial Disorders (R21) National Institute of Dental and Craniofacial Research Release/Posted Date: September 13, 2007 Opening Date: October 26, 2007 (Earliest date an application may be submitted to Grants.gov) Letters of Intent Receipt Date(s): November 1, 2007; November 1, 2008 Expiration Date: November 27, 2008 http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-08-005.html. The primary objective of this FOA is to enhance translational research within the mission areas of the NIDCR by harnessing oligonucleotide-based approaches such as RNA interference (RNAi) to modify the expression of genes associated with oral, dental, and craniofacial diseases and disorders. These diseases are complex conditions involving multiple genes and gene-environmental interactions. The ability to selectively silence or modify gene expression is fundamental to understanding complex disease processes and to developing possible therapeutics and prevention strategies. Research proposing to apply RNAi and other oligonucleotide-based strategies can provide rapid and efficient methods for developing new therapeutics for the prevention and treatment of many oral and craniofacial disorders. Applicants should demonstrate that the proposed oligonucleotide-based approaches directly influence molecular, biochemical, electrophysiological or other functional changes in a condition that falls within the NIDCR mission area. These areas include tooth and bone disorders, oral cancer, chronic inflammatory conditions, viral infections, autoimmune disorders, craniofacial birth defects, acute and chronic pain conditions, salivary gland dysfunction, as well as other oral, dental and craniofacial disorders (see http://www.nidcr.nih.gov). Eligible applications may include a component proposing technological innovations to improve the efficiency of delivery, specificity, processing or stability of the oligonucleotide-based strategy, but the proposal must be focused on an oral, dental, or craniofacial health problem. Applications must include a detailed discussion of strategies to assess and minimize nonspecific and off-target effects such as the silencing or induction of unintended targets, as well as potential immune responses triggered by the intervention. Studies that use human samples, animal models, or tissue culture cells are considered appropriate in response to this FOA.

The Biomarkers Consortium The Biomarkers Consortium, a research partnership managed by the Foundation for the National Institutes of Health, is soliciting concepts for biomarker projects. Researchers are encouraged to submit project concepts online at http://www.biomarkersconsortium.org. If a concept is approved for development by the consortium, the Foundation for NIH will seek funds to support the project. The consortium is a large-scale, public-private research partnership formed in 2006 to identify and qualify biomarkers. It encourages participation by academia, government, industry, patient advocacy groups and other non-profit organizations. In addition to the Foundation for NIH, founding members of the consortium include the NIH, the Food and Drug Administration and the Pharmaceutical Research and Manufacturers of America. Information about the Foundation for NIH is available at http://www.fnih.org. A news release about the consortium’s call for biomarker project concepts is available at: http://www.fnih.org/news/biomarkers_web_site.shtml

US-JAPAN Brain Research Cooperative Program - US Component, NOT-NS-07-009 National Institute of Dental and Craniofacial Research Released Date: May 3, 2007 Receipt Dates: September 15, 2007, 2008, 2009 Earliest Anticipated Start Date: February 1, 2008 http://grants1.nih.gov/grants/guide/notice-files/NOT-NS-07-009.html. This Notice is to inform potential applicants that the NIH is once again accepting applications for the U.S. component of the U.S. – Japan Brain Research Cooperative Program (BRCP). The purpose of the BRCP is to promote scientist exchange, training, and research collaborations between neuroscientists from the U.S. and Japan. The U.S. component of the BRCP supports the following activities: 1) Visit of U.S. scientists to conduct collaborative research and/or to acquire advanced research skills in Japanese institutions, 2) Joint workshops to exchange scientific information and to foster collaborations. Areas of research interests of the participating NIH Institutes The NIDCR supports research on molecular mechanisms regulating normal craniofacial development; genetic and environmental influences on abnormal craniofacial disorders; and the etiology and pathophysiology of chronic pain in orofacial tissues with a focus on the temporomandibular joint.

Monday, September 08, 2008

National Invisible Chronic Illness Awareness Week (Sept 8-14)

http://www.restministries.org/invisibleillness/invisibleillnesshome.htm

Listen to 20 free on-line seminars this week at www.invisibleillnessconference.com.

 

Wednesday, July 23, 2008

TMJ patients continue to enjoy the strong support of the U.S. Senate Appropriations Subcommittee on Labor, Health, and Human Services headed by Senators Tom Harkin and Arlen Specter.  This committee is responsible for funding the National Institutes of Health (NIH).

This is the 14th year that the United States Senate has advised the NIH to improve scientific research on TMJDs. We invite you to read the Report of the Commitee on Appropriations U.S. Senate.  The TMJA has continuously advocated for such research because only through studying the entire patient will we begin to understand the "TMJ patient."

We encourage you to write and thank Senators Kohl, Harkin and Specter for their continued support.  Please go to our TMJA grassroots page for details.

Friday, June 27, 2008

The TMJ Association is now on Facebook! Please join us at www.facebook.com

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Wednesday, June 18, 2008

Your Guide to Reporting Problems to FDA

Wednesday, June 18, 2008

ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.

Read the MedWatch 2008 safety summary, including a link to the firm's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Morphine

Tuesday, March 11, 2008

Class II Recall: Chattem, Inc. Icy Hot Heat Therapy Products

Date Recall Initiated	February 12, 2008
Product:	All lots and sizes of the following Icy Hot Heat Therapy Products Icy Hot Heat Therapy Air Activated Heat-Back Icy Hot Heat Therapy Air Activated Heat- Arm, Neck, and Leg Icy Hot Heat Therapy Air Activated Heat-Arm, Neck, and Leg single consumer use “samples” included on a limited promotional basis in cartons of 3oz. Aspercreme Pain Relieving Crème No other Icy Hot Heat Therapy products are affected by this recall. The company manufactured these products from October 1, 2006 through July 31, 2007 and distributed them from December 4, 2006 through February 4, 2008.
Use:	These products are used for the temporary relief of muscular and joint pain associated with arthritis. They are for external use only.
Recalling Firm:	Chattem, Inc. 1715 W 38 th Street Chattanooga, Tennessee 37409-1248
Reason for Recall:	The company recalled these products because of consumer reports of first, second, and third degree burns, skin irritation, and skin removal.
Public Contact:	Consumers with questions or concerns may call Chattem’s Consumer Affairs Department at 1-888-442-4464 (Monday through Friday) 8 am to 4 pm Eastern Standard Time.
FDA District:	New Orleans
FDA Comments:	The company began its recall on February 8, 2008, by issuing a press release warning the public of the hazard and directing them to stop using the product and either return or discard the products. Four days later, the company instructed its sales force to notify all Chattem wholesalers and retailers with instructions for consumers to stop using the product, discard them, or return them to Chattem, Inc. This product may be returned for a full refund (average retail price) by calling Chattem’s Consumer Affairs Department at 1-877-742-6275 (Monday through Friday) from 8 am to 4 pm Eastern Standard Time or by visiting their website at www.Chattem.com. To read FDA’s Questions and Answers about Chattem Inc. Icy Hot Heat Therapy products, please go to: http://www.fda.gov/cdrh/safety/icyhot-qa.html For more information about this recall, please see the company’s press release at: http://www.fda.gov/oc/po/firmrecalls/chattem02_08.html Healthcare professionals and consumers may report any problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX. Online:www.fda.gov/MedWatch/report.htm Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 FAX: 1-800-FDA-0178

Friday, March 07, 2008

Sponsorship Opportunity

Our science meeting budget shows that The TMJ Association needs approximately $50,000 beyond the NIH funding to cover the costs of the meeting and we need your help. Please consider supporting and participating in this important scientific meeting with a contribution. We will honor your wish to fund a specific expense if that is your choice. Otherwise, your contribution will be applied to one or more of the items below:

• Printing the meeting agenda and handouts
• Printing the meeting proceedings and recommendations booklet
• Travel awards for young investigators to attend the meeting
• Awards for scientific research at the meeting
• Science writer who will summarize the meeting proceedings and recommendations
• Meeting of patient advocates on Sunday, June 1, prior to science meeting
• Audiovisual equipment and labor
• Meeting banquet services
• Gift bags for attendees

Your contribution will be acknowledged from the podium and listed in meeting and published materials and signage.

We appreciate your consideration of this request and will be most grateful for your support. The TMJ Association is committed to working to ease the pain and suffering of TMJD patients through improved diagnosis and treatment. Click here to download our science meeting sponsorship form. Please contact us at (262) 432-0350 with any questions you may have.

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Wednesday, February 20, 2008

Actavis Recalls Certain Fentanyl Patches in the US as Precaution

Media Contact:
Actavis Inc.
Sarita Thapar, PharmD
908-659-2471

FOR IMMEDIATE RELEASE -- Morristown, NJ -- February 17, 2008 -- Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that 14 lots of Fentanyl transdermal system CII patches sold in the United States by Actavis' subsidiary Actavis South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies as a precaution.

The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC.

Fentanyl patches sold by Actavis in Europe are not affected by this recall.

The 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Although unaware of any injuries resulting from this issue Actavis, as a precaution, is recalling these lots. As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.

The lots covered by this recall are: 27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr.

Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:

Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18.

Anyone who has fentanyl patches labelled with an Abrika or Actavis label should check them for these lot numbers.

Affected patches should not be handled directly.

Anyone with Actavis Fentanyl transdermal system patches with the above listed lot numbers should call 1 877 422 7452.

Patients using fentanyl patches who have medical questions should contact their health-care providers.

This recall is being conducted with the knowledge of the Food and Drug Administration.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Fentanyl transdermal system is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

http://www.fda.gov/oc/po/firmrecalls/actavis02_08.html

Friday, February 15, 2008

Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches

Audience: Pain management specialists, other healthcare professionals, patients
[Posted 02/15/2008] PriCara and Sandoz Inc. announced a nationwide recall of all lots of 25 mcg/hr Duragesic Patches sold in the United States. The product is being recalled because the patches may have a cut along one side of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl is a potent Schedule II opioid medication and exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose, that may be fatal. Patches with a cut edge should not be used. These recalled patches have expiration dates on or before December 2009 and are all manufactured by ALZA Corporation.

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Duragesic

[February 12, 2008 - Press Release - PriCara]

Friday, February 08, 2008

FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA's "Early Communication about an Ongoing Safety Review" for Agency recommendations and additional information for healthcare professionals.

Read the complete 2008 MedWatch Safety Summary including a link to the FDA's Early Communication about an Ongoing Safety Review regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#botox

Tuesday, February 05, 2008

FDA has issued a Public Health Advisory cautioning practitioners about avoiding overdoses when they are prescribing methadone or managing patients taking this drug. Since the 1970s, methadone has been primarily used in treating drug abuse, but now it’s also being used increasingly for the treatment of pain.

FDA issued the Advisory because of reports of life-threatening adverse events and death in patients receiving methadone for pain control. Part of the reason is that physicians prescribing methadone for pain relief may not fully understand the drug’s pharmacology and potential adverse effects. For example, methadone, like other opioids, causes respiratory depression. But in addition, it can also have effects on cardiac conduction, leading to prolonged QT intervals and serious arrhythmias. Methadone also interacts with many other drugs, some of which can slow methadone’s elimination from the body and thus increase the likelihood of overdose and adverse effects related to either respiratory depression or cardiac arrhythmias.

Overdoses can also occur because methadone remains in the body much longer than the drug's analgesic effect lasts. So if a patient takes more methadone to extend the duration of pain relief, he or she may be at serious risk of respiratory depression.

The Advisory lists several recommendations for health care professionals, including closely monitoring patients on this drug, especially when starting treatment or adjusting the dose. This should be done even for patients who are opioid-tolerant.

Because many patients will be taking the methadone at home without medical supervision, much of the responsibility for avoiding overdoses rests with patients and caregivers. Because of this, FDA is working on a Medication Guide for patients, to be distributed when prescriptions for methadone are dispensed.

In the meantime, health care professionals should refer patients to the Patient Package Insert for advice on how to use the drug safely. Here’s what patients should know if they take methadone for pain relief:

• First, don’t take more of the drug than prescribed. If pain isn’t relieved at the prescribed dose, call your doctor.

• Be aware that pain relief may take a few days after you start the drug.

• Get medical attention right away if you experience palpitations, dizziness, lightheadedness or fainting.

• And be sure to tell your doctor about other medications you’re taking because they may interact with the methadone.

Additional Information:

FDA MedWatch Safety Alert. Dolophine (methadone hydrochloride). November 27, 2006.
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Methadone

FDA Center for Drug Evaluation and Research. Information for Healthcare Professionals, Methadone Hydrochloride. July 2007.
http://www.fda.gov/cder/drug/InfoSheets/HCP/methadoneHCP.htm

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Thursday, January 31, 2008

The following medications are frequently prescribed to TMJ patients.  We wanted to share this FDA MedWatch alert with our readers.

FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.

Read the complete 2008 MedWatch Safety Summary including a link to the Healthcare Professional Sheet regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic

Tuesday, January 29, 2008

Popular Osteoporosis Drugs Triple Risk of Bone Necrosis A University of British Columbia and Vancouver Coastal Health Research Institute study has found that a popular class of osteoporosis drugs nearly triples the risk of developing bone necrosis, a condition that can lead to disfigurement and incapacitating pain. Read more...

http://www.womenshealthresearch.org/site/R?i=JKCuH2Q19OLQomUw_2L8hA..

Friday, January 25, 2008

TMJD patients often experience tinnitus – ringing in the ears.  Research today indicates tinnitus could be caused by the brain.  We thought the following articles by ScienceDaily would be of interest to our site visitors.

 

Searching For The Brain Center Responsible For Tinnitus http://www.sciencedaily.com/releases/2007/10/071005185125.htm

 

Researchers Find Sites In Brain Responsible For Tinnitus; Work Raises Possibility Of Treatments, Cure http://www.sciencedaily.com/releases/1998/01/980123071732.htm

 

Monday, January 14, 2008

Final Report of the TMJD Working Group

In September 2007 the National Institute of Dental and Craniofacial Research convened a group of thought leaders to determine the best approaches for future basic and clinical research on TMJD within an integrated systems approach and various options to advance this goal.  The recommendations from this workshop are now available at: http://www.nidcr.nih.gov/AboutNIDCR/CouncilAndCommittees/NADCRC/FinalReportTMJDWorkingGroup.htm

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Monday, December 24, 2007

Second Safety Warning on Fentanyl Skin Patch

FDA issued its second safety warning on Dec. 21, 2007, about the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin. In July 2005, FDA issued a similar warning to the public and to health care providers emphasizing that the directions on the product label and on the patient package insert should be followed exactly in order to avoid overdose.

FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or after people incorrectly used it.

The agency is also asking manufacturers of all fentanyl patches to update their product information and to develop a medication guide for patients. The patch is marketed as Duragesic by Johnson and Johnson, and generic versions are sold by other manufacturers. 

The fentanyl skin patch contains the opioid fentanyl, a potent narcotic. The patch was approved by FDA in 1990 for use in people with persistent, moderate-to-severe pain who have become opioid-tolerant—meaning that they have been using another strong opioid narcotic pain medicine around-the-clock for a week or longer. The skin patch is most commonly prescribed for people with cancer.

Recent reports to FDA describe deaths and life-threatening side effects after health care professionals inappropriately prescribed the patch or after people used the patch incorrectly.

Advice for Consumers

• Fentanyl patches are only for people who are opioid-tolerant and have chronic pain that is not well controlled with other pain medicines. The patches are not to be used to treat sudden, occasional, or mild pain, or pain after surgery. 
• Be aware of the signs of fentanyl overdose: trouble breathing, or slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, get medical attention right away.
• If you are prescribed the fentanyl patch, tell your doctor, pharmacist, and other health care professionals about all the medicines you take. Some medicines may interact with fentanyl, causing dangerously high fentanyl levels in the blood.
• Read the instructions on how to use the fentanyl patch in the patient information that comes with the patch (www.fda.gov/cder/drug/infopage/fentanyl/DuragesicPPI.pdf).
• Do not use heat sources such as heating pads, electric blankets, saunas, or heated waterbeds, or take hot baths or sunbathe while wearing a patch. If your temperature is higher than 102 degrees while wearing a patch, call the doctor right away.

For More Information

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentanyl

(We have heard from TMJ patients who have been prescribed Fentora for their pain and therefore we are posting this FDA alert notice)

Wednesday, November 21, 2007

Dear Supporter,

 

Remember the phrase, “A penny saved is a penny earned”?

 

Since we discovered the iGive.com community, that phrase has come to mean something very special to The TMJ Association. And it will to you, too. Because when you become a member of iGive.com, up to 26% of every purchase you make at the Mall at iGive.com will go to The TMJ Association at a penny-saving, no cost to you!

 

With the over 600 national merchants at your fingertips, the Mall at iGive.com has everything you need –– from books and CD’s to clothing, flowers, toys, office supplies and software.

 

Along with the gas money you’ll save by shopping online, you’ll also get free membership … super savings and deals every day …guaranteed privacy … and of course, free donations to The TMJ Association every time you shop!

 

Join www.iGive.com/TMJA.  Be a philanthropist every time you shop online for everyday items. Start saving your pennies so we can earn them. Get clicking now!

 

Sincerely,

 

The TMJ Association

 

Tuesday, November 13, 2007

Research Grant Opportunities

NIAMS Building Interdisciplinary Research Team (BIRT) Revision Awards - RFA) Number: RFA-AR-08-001 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Released Date: November 2, 2007 http://grants2.nih.gov/grants/guide/rfa-files/RFA-AR-08-001.html. To promote interdisciplinary research, the NIAMS plans to provide up to 1 year of research revision support (formerly referred to as “supplement” – see page 1-21 section 2.8 of the SF424 (R&R) Application and Electronic Submission Instructions Version 2) to active NIAMS R01s (parent grants) to establish collaborations among groups of investigators with expertise in the specific areas listed below. The institute intends to supplement interdisciplinary collaboration with high innovation and potentially high impact in the specific NIAMS mission–relevant areas solicited in this FOA. It is understood that such an application may entail high risk. Teams developed under this award are expected to make significant advances beyond the progress expected from the individual researchers alone. Collaborations between scientific areas listed below are selected to pilot the NIAMS BIRT awards and specifically solicited in this FOA. Autoimmunity – Gender and sex factors Autoimmunity or Developmental biology – Systems biology Soft tissue biology – Imaging technologies Tissue engineering – Immunology or Developmental biology

Translational Application of Gene Silencing Strategies to Oral and Craniofacial Disorders (R21) National Institute of Dental and Craniofacial Research Release/Posted Date: September 13, 2007 Opening Date: October 26, 2007 (Earliest date an application may be submitted to Grants.gov) Letters of Intent Receipt Date(s): November 1, 2007; November 1, 2008 Expiration Date: November 27, 2008 http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-08-005.html. The primary objective of this FOA is to enhance translational research within the mission areas of the NIDCR by harnessing oligonucleotide-based approaches such as RNA interference (RNAi) to modify the expression of genes associated with oral, dental, and craniofacial diseases and disorders. These diseases are complex conditions involving multiple genes and gene-environmental interactions. The ability to selectively silence or modify gene expression is fundamental to understanding complex disease processes and to developing possible therapeutics and prevention strategies. Research proposing to apply RNAi and other oligonucleotide-based strategies can provide rapid and efficient methods for developing new therapeutics for the prevention and treatment of many oral and craniofacial disorders. Applicants should demonstrate that the proposed oligonucleotide-based approaches directly influence molecular, biochemical, electrophysiological or other functional changes in a condition that falls within the NIDCR mission area. These areas include tooth and bone disorders, oral cancer, chronic inflammatory conditions, viral infections, autoimmune disorders, craniofacial birth defects, acute and chronic pain conditions, salivary gland dysfunction, as well as other oral, dental and craniofacial disorders (see http://www.nidcr.nih.gov). Eligible applications may include a component proposing technological innovations to improve the efficiency of delivery, specificity, processing or stability of the oligonucleotide-based strategy, but the proposal must be focused on an oral, dental, or craniofacial health problem. Applications must include a detailed discussion of strategies to assess and minimize nonspecific and off-target effects such as the silencing or induction of unintended targets, as well as potential immune responses triggered by the intervention. Studies that use human samples, animal models, or tissue culture cells are considered appropriate in response to this FOA.

Collaborative Research on Tinnitus (R01) National Institute on Deafness and Other Communication Disorders Office on Dietary Supplements National Institute of Dental and Craniofacial Research Released Date: This is a reissue of RFA-DC-07-004 which was previously released July 10, 2006 http://grants.nih.gov/grants/guide/rfa-files/RFA-DC-08-002.html. The purpose of this FOA is to support collaborative research teams to investigate tinnitus. Tinnitus is the perception of sound in the absence of an environmental acoustic stimulus. Though tinnitus is a symptom often associated with many forms of hearing loss, it may occur in the absence of hearing loss. Tinnitus can also be a symptom of other health problems. Though tinnitus is often referred to as “ringing in the ears,” some people hear hissing, roaring, whistling, chirping or clicking. It can be intermittent or constant and its perceived volume can range from barely perceptible to shattering. The NIDCR is interested in collaborative research proposals on tinnitus and the central mechanisms that may underlie this disorder. Tinnitus is a condition that may be comorbid with temporomandibular joint disorder (TMJD). TMJD is a chronic orofacial pain disorder that affects tissues surrounding the joint, including the ear. Ear ache, loss of hearing, and tinnitus are symptoms that have been associated with TMJD. The mechanisms responsible for these comorbidities are unknown, but recent research results suggest that central nervous system defects may play a role. The NIDCR is interested in applications from interdisciplinary teams of researchers exploring the biological mechanisms that are responsible for the association of tinnitus with TMJD.

The Biomarkers Consortium The Biomarkers Consortium, a research partnership managed by the Foundation for the National Institutes of Health, is soliciting concepts for biomarker projects. Researchers are encouraged to submit project concepts online at http://www.biomarkersconsortium.org. If a concept is approved for development by the consortium, the Foundation for NIH will seek funds to support the project. The consortium is a large-scale, public-private research partnership formed in 2006 to identify and qualify biomarkers. It encourages participation by academia, government, industry, patient advocacy groups and other non-profit organizations. In addition to the Foundation for NIH, founding members of the consortium include the NIH, the Food and Drug Administration and the Pharmaceutical Research and Manufacturers of America. Information about the Foundation for NIH is available at http://www.fnih.org. A news release about the consortium’s call for biomarker project concepts is available at:

US-JAPAN Brain Research Cooperative Program - US Component, NOT-NS-07-009 National Institute of Dental and Craniofacial Research Released Date: May 3, 2007 Receipt Dates: September 15, 2007, 2008, 2009 Earliest Anticipated Start Date: February 1, 2008 http://grants1.nih.gov/grants/guide/notice-files/NOT-NS-07-009.html. This Notice is to inform potential applicants that the NIH is once again accepting applications for the U.S. component of the U.S. – Japan Brain Research Cooperative Program (BRCP). The purpose of the BRCP is to promote scientist exchange, training, and research collaborations between neuroscientists from the U.S. and Japan. The U.S. component of the BRCP supports the following activities: 1) Visit of U.S. scientists to conduct collaborative research and/or to acquire advanced research skills in Japanese institutions, 2) Joint workshops to exchange scientific information and to foster collaborations. Areas of research interests of the participating NIH Institutes The NIDCR supports research on molecular mechanisms regulating normal craniofacial development; genetic and environmental influences on abnormal craniofacial disorders; and the etiology and pathophysiology of chronic pain in orofacial tissues with a focus on the temporomandibular joint.

Osteoimmunology- Crosstalk between Immune System and Bone (R01) National Institute of Dental and Craniofacial Research Opening Date: December 14, 2007 Closing Date: January 15, 2008 http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-08-006.html. The goal of this initiative is to solicit novel research projects designed to provide a fundamental understanding of the intersystem crosstalk between alveolar bone and the immune system, and how osteoimmunology operates in normal and pathologic conditions. It will contribute to our understanding of how both systems are physiologically regulated, at the molecular and cellular levels and at the level of organ systems. Specifically this initiative solicits research that will identify the influence of the immune system on oral bone biology; the extent to which normal immune responses affect oral bone homeostasis; the consequences of oral bone metabolism on adaptive immune responses; the interplay between the immune system and age-related oral bone changes; and the changes in the host immune system that impact oral bone loss. The emerging field of osteoimmunology is important for formulating intervention strategies for periodontitis as well as for basic and clinical studies in related fields.

Osteoimmunology- Crosstalk between Immune System and Bone (R21) National Institute of Dental and Craniofacial Research Opening Date: December 14, 2007 Closing Date: January 15, 2008 http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-08-007.html. The goal of this initiative is to solicit novel research projects designed to provide a fundamental understanding of the intersystem crosstalk between alveolar bone and the immune system, and how osteoimmunology operates in normal and pathologic conditions. It will contribute to our understanding of how both systems are regulated physiologically, at the molecular and cellular levels and at the level of organ systems. Specifically the initiative solicits research that will identify the influence of the immune system on oral bone biology; the extent to which normal immune responses affect oral bone homeostasis; the consequences of oral bone metabolism on adaptive immune responses; the interplay between the immune system and age-related oral bone changes; and the changes in the host immune system that impact oral bone loss. The emerging field of osteoimmunology is important for formulating intervention strategies for periodontitis as well as for basic and clinical studies in related fields.

Joint Degeneration: Mouse Models (R21) PA-06-450 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Aging National Institute of Dental and Craniofacial Research Opening Date: June 9, 2006 Closing Date: November 2, 2007 http://grants.nih.gov/grants/guide/pa-files/PA-06-450.html. This program will support research with the potential to reveal the biological mechanisms underlying non-inflammatory joint degeneration in mouse models. Research supported by this initiative will identify specific genes, proteins, and biochemical pathways that contribute to joint degeneration. Information to be gained will include the timing and anatomical location of events that lead to joint degeneration, the functional characterization of proteins identified as causal factors, and the definition of pathways by which particular gene products contribute to joint degeneration. Objectives include: the characterization of new models; the development and testing of hypotheses that arise from the properties of new and existing models; and the definition of functional roles for specific molecular entities identified as contributing to joint degeneration. The NIDCR is interested in supporting meritorious research targeting new animal models of osteoarthritis that have relevance to the temporomandibular joint (TMJ). Applications describing animal models that elucidate molecular mechanisms of TMJ degeneration and aid in the diagnosis and treatment of TMJ disorders are particularly encouraged. Applications addressing unique features of the TMJ including the presence of fibrocartilage on its articulating surfaces and the distinctive anatomy and mechanical loading of this joint also are of interest to the NIDCR.

Temporomandibular Joint and Muscle Disorders: Pathophysiological Mechanisms Linking Comorbid Conditions (R01)(PA-06-188) National Institute of Dental and Craniofacial Research National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Deafness and Other Communication Disorders National Institute of Neurological Disorders and Stroke Office of Research on Women's Health Application Receipt/Submission Date(s): Multiple dates, see announcement http://grants.nih.gov/grants/guide/pa-files/PA-06-188.html. The purpose of this program announcement is to stimulate research on discovering etiological and pathophysiological mechanisms underlying a set of chronic, comorbid conditions associated with temporomandibular joint and muscle disorders (TMJMDs). TMJMDs are a complex collection of diseases involving one or more tissues of the TMJ and facial musculature. Primary symptoms include chronic pain in facial muscles and limited and painful movement of the jaw. In addition, these and other symptoms of TMJMD can occur together with other chronic illnesses such as fibromyalgia, atypical face pain, trigeminal neuralgia, chronic fatigue syndrome, multiple chemical sensitivity, irritable bowel syndrome, complex regional pain syndrome, migraine headache, speech hearing, swallowing, balance, smell, and taste disorders, and certain cardiovascular diseases. This program announcement seeks research applications that use state-of-the-art, multidisciplinary and interdisciplinary approaches to discover molecular, physiological, and behavioral mechanisms responsible for the overlapping symptoms manifested in the set of disorders that may co-exist with TMJMD. These applications may have as their research focus the chronic, comorbid conditions themselves or TMJMDs, provided that the aims and goals of the project are to discover biological mechanisms linking the comorbidities. While the overarching goal of this announcement is to arrive at a better understanding of potential mechanisms underlying TMJMDs as related to the variety of comorbidities associated with them, it is expected that no single research project will be able to accomplish this. Applicants are, therefore, encouraged to focus their attention on a particular pathway and a specific disease that is comorbid with TMJMD.

Drug Delivery Systems for Orofacial Disease (SBIR [R43/R44]) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Release/Posted Date: December 13, 2005 Opening Date: February 1, 2006 Expiration Date: April 2, 2008 http://grants.nih.gov/grants/guide/pa-files/PA-06-085.html. This Funding Opportunity Announcement (FOA) from the National Institute of Dental and Craniofacial Research (NIDCR) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) solicits Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose the design and development of novel delivery systems for rapid and/or sustained, on-demand release of therapeutic agents (e.g., antimicrobial, anti-inflammatory, antibodies, peptides, nucleotides, small molecule receptor agonists/antagonists) in the oral cavity. The expected outcomes are the delivery of agents with more precise localization and appropriate half-lives to treat oral diseases such as caries and periodontal disease, oral mucositis and temporomandibular joint and muscle disorders and chronic pain.

Drug Delivery Systems for Orofacial Disease (SBIR [R41/R42]) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Release/Posted Date: December 13, 2005 Opening Date: February 1, 2006 Expiration Date: April 2, 2008 http://grants1.nih.gov/grants/guide/pa-files/PA-06-084.html. This Funding Opportunity Announcement (FOA) from the National Institute of Dental and Craniofacial Research (NIDCR) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) solicits Small Business Technology Transfer (STTR) grant applications from small business concerns (SBCs) that propose the design and development of novel delivery systems for rapid and/or sustained, on-demand release of therapeutic agents (e.g., antimicrobial, anti-inflammatory, antibodies, peptides, nucleotides, small molecule receptor agonists/antagonists) in the oral cavity. The expected outcomes are the delivery of agents with more precise localization and appropriate half-lives to treat oral diseases such as caries and periodontal disease, oral mucositis, and temporomandibular joint and muscle disorders and chronic pain.

 

Wednesday, October 31, 2007

The TMJ Association is redesigning its Web site to make it more user-friendly so we can better inform, advocate and support the needs of TMJD patients. We want the new site to be about you, your needs, your experiences, and your health. So as we redesign our Web site, we hope that you will want to be a part of it as you are the reason this organization exists! The TMJ Association is collecting pictures from patients for use on our new Web site. Please submit a photo (face picture preferred) and a quote/comment to info@tmj.org. There is nothing better than matching a face to a story!

The TMJ Association will use submitted photos and comments solely on www.tmj.org. In order to protect the privacy of our patients, photos and comments will be kept anonymous.

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Tuesday, October 23, 2007

Occlusal splints for treating sleep bruxism (tooth grinding)

Macedo CR, Silva AB, Machado MA, Saconato H, Prado GF

There is insufficient evidence to either support or refute the use of occlusal splints for treating patients with tooth grinding or clenching during sleep (sleep bruxism)

Sleep bruxism is characterised by several signs and symptoms. Among them abnormal tooth wear, fractured teeth, joint pain or tenderness, jaw muscle discomfort, and headaches. Treatments include odontological devices such as occlusal splints, pharmacotherapy, and psychotherapy. An occlusal splint is a removable appliance worn in the upper jaw (maxilla) or the lower jaw (mandible), with coverage of the dental surfaces. They are usually used to prevent tooth wear.
There is not enough evidence in the literature to show that occlusal splints can reduce sleep bruxism.

Click here to read the complete review by the Cocrane Database of Systematic Reviews 2007.

(The Cochrane Collaboration is an international organization that aims to help people make well-informed decisions about health care by preparing, maintaining and promoting the accessibility of systematic reviews of the effects of healthcare interventions. The main work of the Collaboration is done by approximately fifty Collaborative Review Groups, within which Cochrane Systematic Reviews are prepared and maintained. The Cochrane Oral Health Group aims to produce systematic reviews which primarily include all randomized control trials (RCTs) of oral health. Oral health is broadly conceived to include the prevention, treatment and rehabilitation of oral, dental and craniofacial diseases and disorders.)

Friday, October 19, 2007

TMJ Implant GAO Investigation

The Government Accountability Office (GAO) recently conducted an investigation looking at the FDA's approval of four TMJ implant devices.   The GAO investigation report is available on-line at: http://www.gao.gov/cgi-bin/getrpt?GAO-07-996.    A summary of the report is also available at: http://www.gao.gov/highlights/d07996high.pdf. 

Tuesday, September 25, 2007

Cartilage engineered with human embryonic stem cells

9/13/2007

By Eugene J. Koay, Gwen M.B. Hoben, Kyriacos A. Athanasiou

 

Rice University researchers have engineered musculoskeletal cartilages with human embryonic stem cells (hESCs), with the hope of eventually using the hESC-derived neotissue for the replacement of damaged or diseased cartilages, such as the temporomandibular joint (TMJ) disc, in humans.

 

The need for cartilage replacements results from the inability of human musculoskeletal cartilages to effectively heal.  This can lead to functionally deficient tissue and can result in the clinical syndrome known as arthritis, a major clinical problem with significant social and economic burdens.

 

Though important progress has been made in recent years toward engineering replacement cartilages in the laboratory, there are still many challenges to address, including the identification of a useful source of cells that can generate the new cartilage.  Cartilage tissue engineering requires many cells to produce a piece of tissue that has clinically relevant dimensions, and this requirement far exceeds our current capability to obtain cartilage cells from an individual patient.

 

Stem cells, from both embryonic and adult sources, may address this particular hurdle, though a great deal of work still needs to be performed.  Human embryonic stem cells (hESCs), in particular, have been scarcely studied to date for cartilage applications.

 

Toward understanding the use of hESCs for generating cartilage, two questions need to be addressed.  First, how can the cells be “differentiated” or coaxed into cartilage-producing cells?  Second, how can the cells be used for tissue engineering of cartilage?

 

In a recent study published in the journal Stem Cells, the Rice University researchers, including myself, Ms. Gwen M.B. Hoben, and Professor Kyriacos A. Athanasiou, used National Institutes of Health (NIH)-approved hESCs which were differentiated in conditions with distinct regimens of biochemical agents (growth factors) that are known to have cartilage-inducing properties.  The resulting cells were then used in a tissue engineering strategy called self-assembly, which deviates from traditional engineering approaches in that self-assembly does not require any scaffold material to direct the formation of tissue.

 

This self-assembly approach with the hESC-derived cartilage cells resulted in uniform pieces of cartilage with cellular, biochemical, and biomechanical properties most similar to the TMJ disc and the knee meniscus, which are both fibrocartilages.  Interestingly, the cartilages from each distinct biochemical regimen had a unique set of characteristics, suggesting that different types of cartilage can be generated with a single cell source in hESCs.

 

This study was the first demonstration of the ability of cartilage-differentiated hESCs to “self-assemble” and produce such robust cartilage, though there is still room for improvement.  Additionally, the concept of producing multiple types of cartilage with this single cell source is new for the field, as the different cartilages of interest have diverse structures and biomechanical functions.

 

This initial study sets the ground for new research that seeks to enhance the properties of the hESC-derived cartilage, direct their differentiation for specific cartilage applications, and determine the clinical applicability of these cells, including their safety.  This work was funded by an unrestricted fund from Rice University.

 

Friday, September 14, 2007

Fentora FDA Medwatch Alert

We have heard from TMJ patients who have been prescribed Fentora for their pain and therefore we are posting this FDA alert notice:

 

Fentora (fentanyl buccal tablet)

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora

Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora. Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Serious adverse events, including deaths, have occurred in patients treated with Fentora. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution. The healthcare professional letters provide key points regarding appropriate patient selection and proper dosing and administration of Fentora to reduce the risk of respiratory depression.

[September 10. 2007 - Dear Doctor Letter - Cephalon]
[September 10, 2007 - Dear Healthcare Professional Letter - Cephalon]
[March 2007 - Label with Medication Guide - Cephalon]

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Wednesday, September 12, 2007

Jaw-implant class action given the go-ahead

An Ontario Superior Court judge allowed a class-action lawsuit to go-ahead against the Canadian federal government over jaw implants. The lawsuit specifically alleges the Health Canada employees negligently approved the Vitek TMJ Implants under the Food and Drugs Act, and that they failed to warn doctors and patients of the potential risks. The class action was certified by the Kathryn Taylor case.

To read the story on-line go to: http://www.theglobeandmail.com/servlet/story/LAC.20070911.IMPLANT11/TPStory/TPNational/Ontario/

Wednesday, August 15, 2007

How We Put Your Contributions to Use

Regular visitors to our web site know that The TMJ Association (TMJA) asks for financial contributions to fund our activities and services. We would like to let you know how much we typically raise each year and how the money is used.

In 2006, The TMJ Association raised approx. $147,000-almost all in small sums by individuals. The TMJ Association received a grant from the National Institutes of Health for $31,000, which was used to help offset half of the expenses associated with our Fourth Scientific meeting in September 2006. Day-to-day operating expenses total more than $80,000 per year. Expenses include office rent, telephone, mail, office equipment expenses, liability insurance, a year-end financial audit, web site maintenance, and salary for our two part-time employees. The TMJ Association relies heavily upon its volunteers who provide bookkeeping, fundraising, technical and scientific support, and assistance with writing, editing, and communication.

In part related to the complexities of TMJ diseases and disorders, The Association has generally been unsuccessful in obtaining financial support from corporate sponsors and foundations. There are currently no pharmaceutical studies being conducted on TMJ diseases and disorders. Because of the lack of scientific research underlying any TMJ treatments, The TMJA will not endorse any TMJ products, services, or devices. As a result of these circumstances, raising corporate and foundation dollars has been extremely challenging. There is still no standard of care and effective treatment for TMJ diseases and disorders in the medical profession. This is why we desperately count on contributions from individuals like you!

WE NEED YOUR HELP! Your contributions, regardless of size, will have a direct, immediate, and positive effect on our efforts to Change the Face of TMJ. Please consider helping with a donation today!

OUR GOALS AND SPECIAL PROJECTS FOR 2007-2009:

1. TMJ Brochures

• Purpose: Educational material that is distributed to better inform TMJ patients and other interested parties about TMJ diseases and disorders. We would like to develop new brochures and update existing ones.
• Costs: Approx. $5,000 to develop each new brochure.

2. TMJ Newsletters: "The TMJ Communiqué"

• Purpose: Educational material that provides up-to-date information, support, and comfort to TMJ patients.
• Costs: Approx. $5,000 per issue to produce and mail out. This does not include staff and volunteer time.

3. TMJ Patient Support

• Purpose: We would like to expand our current patient support network by adding features to our web site such as a patient blog and an online chat with a guest knowledgeable about TMJ diseases and disorders.
• Costs: Range from $5,000-$10,000.

4. TMJ Patient Survey

• Purpose: Conduct regular patient surveys relating to TMJ patients' experiences and perspectives.
• Costs: $5,000+ per year.

5. TMJ Public Awareness Campaign "The TMJ Association - Giving TMJ Patients a Voice"

• Purpose: Educate the public about the complexities and severity of TMJ diseases and disorders.
• Costs: Range from $2,500 for a 100-word article circulated nationwide for a year to $200,000+ full PR/marketing campaign.

6. TMJ Research

• Purpose: Offer our own research grant that will provide funding to a scientist or young investigator interested in expanding the knowledge base of TMJ.
• Costs: Range from $15,000-$30,000.

7. TMJ Science Journal

• Purpose: Scientific journal, with monographs accessible to laypeople and general readers, which relays the results of our scientific meetings to the public, including health professionals, government agencies, scientists, educational institutions, and TMJ patients and their loved ones.
• Costs: $10,000-$15,000 per journal (includes publication and dissemination costs)

8. TMJ Science Meetings

• Purpose: Increase knowledge and understanding of TMJ diseases and disorders among research scientists, including but not limited to credible treatment options, current research findings, emerging research and suggestions for future research, and feedback and findings from TMJ patient surveys. Encourage young and emerging scientists to pursue research in the TMJ field; recognize contributions by pioneering researchers.
• Costs: Approx. $60,000-$100,000 per meeting.

9. TMJ Web Site Redesign

• Purpose: Update our existing web site in terms of design, structure, and information mapping, including the addition of better usability and search features
• Costs: Approx. $5,000-$20,000+ (depending on the type of services).

Wednesday, August 15, 2007

You Are the Face of TMJ!

 

The TMJ Association is redesigning its web site to make it more user-friendly, so we can better inform, advocate and support the needs of TMJD patients.  We want the new site to be about you, your needs, your experiences, and your health.  So as we redesign our web site, we hope that you will want to be a part of it as you are the reason this organization exists!  The TMJ Association is collecting pictures from patients for use on our new web site. Please submit a photo (face picture preferred) and a quote/comment to info@tmj.org.  There is nothing better than matching a face to a similar story to let TMJ patients know that they are not alone!

 

The TMJ Association will use submitted photos and comments solely on www.tmj.org. In order to protect the privacy of our patients, photos and comments will be kept anonymous. 

Friday, August 03, 2007

The TMJ Association has recently listed items for auction on eBay! 100% of auction proceeds benefit the TMJA. The following items are available - click on the corresponding link to view the eBay auction page.

- Riviera Hotel and Casino Las Vegas Comedy Show Gift Certificate (Admit 2)

http://cgi.ebay.com/Riviera-Hotel-Casino-Las-Vegas-Comedy-Club-Admit-2_W0QQitemZ140144580713QQihZ004QQcategoryZ31411QQssPageNameZWDVWQQrdZ1QQcmdZViewItem

- ComedySportz Milwaukee Gift Certificate (Admit 1)

http://cgi.ebay.com/Comedy-Sportz-Admit-One-Milwaukee-Proceeds-Donated_W0QQitemZ140144582076QQihZ004QQcategoryZ31411QQssPageNameZWDVWQQrdZ1QQcmdZViewItem

- Pizzeria Piccola Milwaukee $10 Gift Certificate

http://cgi.ebay.com/Pizzeria-Piccola-10-Gift-Certificate-Charity-Auction_W0QQitemZ140144584794QQihZ004QQcategoryZ31411QQssPageNameZWDVWQQrdZ1QQcmdZViewItem

 

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Friday, July 20, 2007

Over a decade ago, in August 1996, Terrie invited Dr. Stephen B. (Chuck) Milam, D.D.S., Ph.D., of the University of Texas Health Science Center at San Antonio to join the Scientific Advisory Board of the TMJA. Dr. Milam was Professor and Chairman of the Department of Oral and Maxillofacial Surgery. He was one of the country’s leading TMJD researchers and a clinician who treated TMJD patients. Terrie invited him because of his impeccable credentials as a scientist and his compassion for his patients. His work always embodied the high ethical and intellectual standards that science and clinical care demand. In the course of serving on the Scientific Advisory Board, Dr. Milam contributed his time and talents to providing valuable advice and helping to plan and present papers at the TMJA’s scientific meetings.

On Wednesday, July 18, 2007, Dr. Milam passed away due to a Glioblastoma Multiforme brain tumor. The tumor was inoperable and malignant. His family has established a Web site, www.caringbridge.org/visit/chuckmilam, to enable persons to send messages of comfort and healing as his loved ones make their way through this difficult journey. We at the TMJA are grateful for all of Chuck’s contributions over the years and for his loyal support of our mission. On behalf of everyone at The TMJ Association, we extend our deepest sympathies to the Milam family at this most difficult time.

Tuesday, July 17, 2007

Advice for Patients: Possible Burns or Fires from Heating Pads Manufactured by HoMedics, Inc.

Issued: July 11, 2007

Background

On February 9, 2007, HoMedics, Inc. recalled their TheraP model heating pads after receiving complaints from users that these products had caused fires and burns. For a complete list of the recalled pads, see below.

The source of the problem may be a loose connection in the heating pad which could cause a short circuit. This may pose a risk of burns, fire, and damage to materials in close contact to the heating pad, such as bedding, furniture, or clothing.

The voluntary recall includes approximately 292,108 heating pads produced in 2001 and shipped to retailers in 2001 and 2002. These heating pads were sold in the U.S. to Walgreens and other retail drug and department stores.

Advice for Patients

• Check the models below to see if you have one of the affected heating pads:
  • Walgreen’s by Homedics® Model 802857 Standard Size Moist/Dry Heating Pad
  • HoMedics® Thera-P® Model HP-100 Standard Size Dry Heating Pad
  • HoMedics® Thera-P® Model HP-150 Standard Size Moist/Dry Heating Pad
  • HoMedics® Thera-P® Model HP-200 Standard Size Moist/Dry Heating Pad with Auto Shut-off
  • HoMedics® Thera-P® Model HP-300 King Size Moist/Dry Heating Pad
  • HoMedics® Thera-P® Model HP-500 King Size Moist/Dry Heating Pad with Auto Shut-off

Each HoMedics® heating pad is marked with a unique 4-digit date code located both on the back of the hand control as well as on the bottom panel of the packaging. ONLY 4-DIGIT DATE CODES ENDING IN "01" ARE SUBJECT TO THIS VOLUNTARY RECALL.

• If you have one of the recalled pads, stop using it immediately and return it to the retailer for a full refund.
   
• Report to the FDA's MedWatch Adverse Event Reporting program (see below).

For More Information about the Homedics Heating Pad recall, check:

• the FDA Recall Notice at:
  http://www.fda.gov/cdrh/recalls/recall-020907.html

• Homedics press release at: http://www.homedics.com/MediaCenter/PressRelease.aspx?id=90&cat=prp for more information about this recall,

For more about general heating pad safety, check:

• The FDA/CPSC Public Health Advisory: Hazards Associated with the Use of Electric Heating Pads at http://www.fda.gov/cdrh/heatpad.pdf. Although this Advisory was released in 1995, the recommendations are still valid.

Consumers with questions may contact:

• HoMedics, Inc . at 1-800-466-3342, John Wettlaufer at 1-249-863-3000 ext. 1168, or email cservice@homedics.com.

MedWatch Reporting

Consumers who have experienced adverse reactions or quality problems with the use of this product are also encouraged to report to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
• By phone: 1-800-FDA-1088
• Regular Mail: use postage-paid FDA form 3500 available at:
  www.fda.gov/MedWatch/getforms.htm.
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178  

Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration

Updated July 12, 2007

Tuesday, July 17, 2007

Sponsorships help defray the cost of the golf outing and are a great way to show additional support! There are several sponsorships available for the 2007 Golf Outing, to be held September 20, 2007.  All sponsorships include recognition in the player program, national newsletter, and Web site, as well as additional perks listed below.

 

Event Sponsor – $2,500

Includes 2 complimentary golfer packages and sponsor signage.

 

Hole-in-One Sponsor – $1,000

Includes sponsor signage.

 

Lunch Sponsor – $500

Includes sponsor signage during lunch.

Hole Sponsor – $250

Includes sponsor signage at hole.

 

Invoices are available upon request.

Click here to download our golf sponsorship registration form. For more information, please contact Lisa at info@tmj.org.

Friday, June 29, 2007

A New Vision for Medical Research

On June 22 Dr. Lawrence Tabak, Director of the National Institute of Dental and Craniofacial Research, testified before the Senate Appropriations Subcommittee on Labor, HHS, and Education as part of the fifth NIH theme hearing on the FY 08 Budget for the National Institutes of Health: A New Vision for Medical Research (Part 1). 

The following was reported by Dr. Tabak concerning TMJDs.

TEMPOROMANDIBULAR MUSCLE AND JOINT DISORDERS

Integrative approaches are proving productive in our ongoing efforts to understand temporomandibular muscle and joint disorders, or TMJDs.  Previously, NIDCR-supported scientists found that different sets of common sequence variations in the COMT gene correlate with low, moderate, and high susceptibility to chronic pain.  This finding makes good biological sense.  The COMT gene encodes an enzyme that helps to inactivate nerve signaling compounds and stop the transmission of an unpleasant sensation.  The scientists recently showed that each of these sets of sequence variations changes the resulting structure of the corresponding messenger RNA.  When a gene is expressed, it is copied into messenger RNA which, like an order form, contains the information to produce a specific protein.  The scientists determined that the genetic variations that correlate with high sensitivity to pain produce messenger RNA with long, rigid loops in their structure, which reduces the rate of COMT protein synthesis and thus slows the nerve’s ability to turn off an unpleasant sensory signal.  The likely result: those with the “sensitive” variations will personally experience the sensation of pain longer and possibly more intensely.
  
Such findings are particularly exciting because these studies could not have been conducted just a generation ago.  Not enough was known about the basic mechanisms of pain.  But as more of the biochemical pieces to the puzzle are found in the years ahead, great progress in controlling pain will be possible, and the NIDCR will help in leading the way for all those battling chronic pain conditions, including TMJDs, to find relief through a more accurate diagnosis and more personalized care.

Dr. Tabak’s entire statement can be viewed on-line at:
http://www.nidcr.nih.gov/AboutNIDCR/Director/Congressional/ANewVisionforMedicalResearch.htm.

 

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Friday, May 11, 2007

The TMJA's President, Terrie Cowley, was recently interviewed by Rachel Moeller Gorman with Proto - Massachusetts General Hospital Dispatches from the Frontiers of Medicine.  The article "The Body In Pain" appears in the Spring 2007 issue of Proto. 

Wednesday, March 28, 2007

Dr. Wesley Shankland, author of “TMJ:Its Many Faces” and “Face The Pain”, has been investigated by the Ohio State Board and has been placed on five years probation for inappropriate treatment.  To read the outcome of the investigation click here.

Wednesday, March 14, 2007

The TMJ Association - Giving TMJ Patients A Voice

 

We are proud to announce our new campaign, The TMJ Association - Giving TMJ Patients A Voice.  Our goal is to empower you to share your story with your family, friends, and colleagues and, by doing so, raise much-needed public awareness of TMJD.

 

Through this campaign, and with your help, we hope to raise funds that will support our scientific meetings and enable us to fund the quality science this disorder so desperately needs.

 

Through this partnership you will be able to use the Internet to:

·        Create your own web page

·        Share your story with your family, friends, colleagues, and

·        Raise awareness of and funding for TMJ scientific meetings and research

 

Visit firstgiving.com/tmja to see our page.

 

Here are additional occasions for which you can raise funds for The TMJA:

·        Marathons, swims, golf outings, and bike rides

·        Birthdays, weddings, and anniversaries

·        Memorial or tribute to a loved one

·        A simple request from others to help a cause you care about

·        Challenges and other events

 

GETTING STARTED IS EASY 1-2-3 AND IT’S FREE…

1.      Follow this link to firstgiving.com/tmja

2.      It only takes a few minutes to create your own online personal fundraising web page.

3.      Write your own story and add a personal photo or graphic.

4.      Send the link out to your family, friends, and colleagues.

 

Thursday, March 01, 2007

The TMJ Association is now on MySpace.com. It is still a work-in-progress, but thusfar we have information about The TMJA as well as patient blogs. Please visit our page at:

http://www.myspace.com/tmja

 

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Wednesday, February 28, 2007

We received an update from the Closson family informing us that Art’s surgery went well, however,he still has a difficult recovery ahead of him.  The Closson family would like to thank everyone who sent their support.  You may continue to send letters of encouragement to Art by writing to: gumpa@optonline.net.

***

Art Closson, a TMJ Vitek implant patient and long-time TMJ Association supporter, told us that he will be undergoing heart bypass surgery on Tuesday, February 27^th.  Art wrote “I’m pretty scared and any e-mails would be greatly appreciated.”  Art promised to answer all e-mails.  His address is gumpa@optonline.net.  Art has our wishes for a successful and speedy recovery.

Friday, February 23, 2007

Tuesday, February 20, 2007

The TMJA's recent on-line poll results are as follows.  We greatly appreciate the input from all those who participated in our brief survey.                                  

I Visit WWW.TMJ.ORG For… 

311      Information      

164      News/Updates

128      Support

127      Scientific Research       

57        Publications     

30        Other Reasons 

What Type Of Patient Support Are You Looking For?      

102      Treatment Advice & Scientific Research           

47        Emotional        

45        Doctor Referrals

18        Financial

8          Awareness

What Type Of Information Are You Looking For? 

173      Treatment Options

20        Co-Morbid Conditions

14        Surgery Options

11        Doctor Referrals

5          Patient Stories

4          Advocacy

Have You Contributed To The TMJA?

249      No

27        Yes

Should The TMJA Have A Membership Fee?       

222      No

28        Yes

28        Maybe Or It Depends…

What Should The TMJA's Focus Be For 2007?        

110      Scientific Research

86        Public Awareness

81        Patient Support

57        Other

20        Interactive Site

Wednesday, January 17, 2007

The FDA issued a warning letter to TMJ Implants, Inc. concerning the promotion of hemi and full mandibles without premarket clearance or approval from the FDA.  http://www.fda.gov/foi/warning_letters/g6181d.pdf.   TMJ Implants, Inc.'s response to the warning letter is posted on the FDA's site at: http://www.fda.gov/foi/warning_letters/w0079r.pdf.

Additional information on this and other TMJ devices can be found on our site at: http://www.tmj.org/implants5.asp#TMJIMPLANTS

Friday, January 12, 2007

Dr. Wesley Shankland, author of “TMJ:Its Many Faces” and “Face The Pain”, is being investigated by the Ohio State Board for inappropriate treatment.  Click here to read the full story on The Columbus Dispatch. 

Friday, December 29, 2006

New eBay items below!

Buy and sell on eBay Giving Works to support The TMJ Association. As a seller, you can opt for a portion of your sale to be donated to The TMJ Association. As a buyer, you can look for items that support our great cause! Click the following link to shop or sell on eBay to support The TMJ Association http://pages.ebay.com/givingworks/index.html

Please visit our eBay Charity Works page to view current auctions, with 100% of the proceeds benefiting The TMJ Association:

http://www.missionfish.org/NPMMF/nphomepage.jsp?NP_ID=3290

Auction items - Check back soon for new items!

The TMJA welcomes donations of gift certificates for our ongoing auction to support research and patient services.

Please mail to:

P.O. Box 26770

Milwaukee, WI  53226

All donations are tax-deductible to the fullest extent of the law.

http://www.missionfish.org/NPMMF/nphomepage.jsp?NP_ID=3290

Tuesday, December 26, 2006

NEWS SERVICES  210 Pittsboro Street Campus Box 6210 Chapel Hill, NC 27599-6210

T 919-962-2091 F 919-962-2279 www.unc.edu/news/  news@unc.edu

News Release

For immediate use

Dec. 22, 2006 -- No. 614

Genetic mechanism helps
explain chronic pain disorders

CHAPEL HILL - Researchers at the University of North Carolina at Chapel Hill have discovered that commonly occurring variations of a gene trigger a domino effect in chronic pain disorders. The finding might lead to more effective treatments for temporomandibular joint disorder (TMJD) and other chronic pain conditions.

Catechol-O-methyltransferase (COMT), an enzyme that metabolizes neurotransmitters such as epinephrine, norepinephrine and dopamine and that has been implicated in the modulation of persistent pain, as well as cognition and mood, is regulated by a gene, also called COMT. Previous UNC-led research showed that common genetic variants of this gene are associated with increased pain sensitivity and the likelihood of developing TMJD.

Now, the researchers have discovered that specific variants of the COMT gene can dramatically affect the secondary structure of corresponding messenger RNA - which, in turn, leads to alterations in the amount of enzyme crucial for regulating pain processing. The discovery is published in the Dec. 22 issue of Science.

"TMJD is a complex pain condition that is frequently associated with other pain conditions such as fibromyalgia syndrome, chronic headaches and irritable bowel syndrome," said Dr. William Maixner, director of the Center for Neurosensory Disorders in UNC's School of Dentistry and a study co-author.

"This study has identified a new genetic mechanism that influences an individual's susceptibility to develop chronic pain conditions such as TMJD," Maixner said.

The study was conducted to understand the mechanism by which the identified genetic variants influence enzymatic activity and, ultimately, biological functions such as pain transmission. The researchers found that three major variants of COMT show significant differences in how they code for the secondary structure of messenger RNA, or mRNA. The differences lead to dramatic alterations in protein expression, which substantially influences pain sensitivity in humans.

These findings are clinically important because pain conditions resulting from low COMT activity or elevated catecholamine levels are likely to be susceptible to treatment with pharmacological agents that block beta 2- and beta 3-adrenergic receptors, which mediate COMT-dependent pain signaling, or that control mRNA secondary structure.

"Elucidating the genetic mechanisms that mediate pain perception will provide new insights into how chronic pain develops and will ultimately contribute to the identification of unique markers for diagnosing clinical pain conditions, as well as provide novel targets for the development of effective individualized therapeutics for TMJD and related conditions," said Dr. Andrea Nackley Neely, a research assistant professor in the Center for Neurosensory Disorders and the study's lead author.

"These data have broad medical and evolutionary implications regarding the analysis of variants common in the human population," Nackley Neely said. "It is believed that variants leading to altered protein structure have the strongest impact on gene function. However, this study demonstrates that combinations of common genetic variants that influence mRNA secondary structure may have even stronger effects and, thus, represent another key factor responsible for disease onset and progression."

"This study provides additional evidence of a genetic, molecular and physiological basis for pain perception and human pain conditions and should help to remove the stigma associated with conditions such as TMJD and fibromyalgia," said Dr. Luda Diatchenko, an associate professor in the center and the study's chief investigator.

Other researchers were Dr. Inna Tchivileva, a postdoctoral research associate within the Center for Neurosensory Disorders; Kathryn Satterfield, a former research assistant within the center; Dr. Olex Korchynskyi, a former postdoctoral research associate within the UNC-Chapel Hill School of Medicine's Thurston Arthritis Research Center; Dr. Sergei S. Makarov, a former associate professor at the Center for Neurosensory Disorders and the Thurston center and now president and chief executive officer of Attagene Inc.; and Dr. Svetlana A. Shabalina, a staff scientist with the National Center for Biotechnology Information.

Funding was provided by the National Institute of Dental and Craniofacial Research, National Institute of Child Health and Human Development and National Institute of Neurological Disorders and Stroke, all components of the National Institutes of Health. Additional support came from the Intramural Research Program of the National Center for Biotechnology Information.

Other Center for Neurosensory Disorders research initiatives are currently under way that further explore the genetic basis of pain: One seven-study, a $19-million National Institute of Dental and Craniofacial Research-funded agreement involving multiple institutions and based at the center, will follow 3,200 health individuals and 200 who have facial pain. Titled OPPERA (Orofacial Pain: Prospective Evaluation and Risk Assessment), the study is designed to identify both environmental and genetic factors that increase an individual's susceptibility to TMJD and other chronic pain conditions.

Related link on OPPERA study: http://www.unc.edu/news/archives/dec05/maixst120505.htm

Note: Contact Dr. Nackley Neely at (919) 452-6588 (cell) and Dr. Diatchenko at (919) 672-4542 (cell)

News Services contact: Clinton Colmenares, (919) 843-1991 (office), (919) 218-7833 (cell) or clinton_colmenares@unc.edu

Friday, December 22, 2006

The TMJ Association was recently granted public foundation status by the Internal Revenue Service. Please check with your company's Human Resources department to see if your company has a matching gift/grant program. If so, this is a great way to double your donation!

Below is a list of major corporations with a matching gift program. Please check with your HR department to see if your company has a matching gift program!

AIG

Abbott

Accenture

Aetna

Alliant Energy

American Express

Anheuser-Busch, Inc.

AOL Time Warner, Inc.

AON

Assurant

AT & T

Avon

Bank of America

Bank One

Baxter

Bayer

BF Goodrich

BlueCross

BP

CarMax Auto Superstore, Inc.

Century 21 Real Estate LLC

Chicago Tribune Company

Chiquita Brands International, Inc.

Citibank

Coca-Cola Company

Colgate-Palmolive Company

Commonwealth Edison Company

ConAgra

DaimlerChrysler Corporation

Dana Corporation

eBay

Equifax Card Services, Inc.

Exelon Corporation

Exxon Mobil Corporation

Fannie Mae

Farmers Insurance

Fifth Third Bancorp

Frito-Lay

Gap, Inc.

GE

GlaxoSmithKline

GM

Great-West Healthcare

Hammermill Papers

Harley-Davidson Motor Company USA

Harrah’s

Harris Bank

Hershey Foods Corporation

Holiday Inn Hotels & Resorts

Honda of America

HP Hewlett-Packard Company

HSBC - North America, Inc.

Humana, Inc.

IKON

J.P. Morgan Chase

Jimmy Dean Foods

John Hancock Financial Services

Johnson & Johnson - Merck

Kaplan Test Prep & Admissions

Kellogg Company

Key Bank

Kraft Foods, Inc.

L’Oreal USA

Lincoln Financial Group

Loews Corporation

Macy’s

Marathon Oil Company

May Department Stores Company, The

Maytag Corporation

McDonald’s Corporation

McKinsey & Company, Inc.

Merrill Lynch & Company, Inc.

Microsoft Corporation

Morgan Stanley

Motorola Inc.

Nabisco Brands

NBC Universal Television

Nestle USA, Inc.

Old Navy

Ore-Ida Foods

PepsiAmericas

Pfizer

PG&E Pacific Gas & Electric

Procter & Gamble

Quaker Oats

RadioShack Corporation

Rockwell Automation, Inc.

Sara Lee Bakery

SBC Communications Inc.

Sensient Technologies Corporation

Shell Oil Company

Sony Corporation of America

Spaulding

Square D

Starbucks Corporation

State Farm Companies

SYSCO Corporation

TCF Bank

Texaco Chemical Company

Ticketmaster

U.S. Bank

Union Pacific Railroad Company

Universal Studios, Inc.

UPS United Parcel Service of America, Inc.

Verizon Communications

Walt Disney Company, The

Wells Fargo

Wisconsin Energy Corporation

Xerox Corporation

Yahoo, Inc.

Friday, December 22, 2006

Click here to take a brief survey.

Tuesday, December 19, 2006

TMJ DISEASES AND DISORDERS MAY INDICATE OTHER CONDITIONS

Fourth Science Meeting of the TMJ Association calls for
more study of potentially related conditions

The Fourth Scientific Meeting of The TMJ Association, A Systems Approach to the Understanding of TMJ as a Complex Disease, set as a top priority the goal of finding and studying the poorly understood relationship between TMJ and other medical conditions. The meeting took place in September in Bethesda, Md., at the Federation of American Societies for Experimental Biology.

Temporomandibular joint diseases and disorders, commonly called TMJ, are a collection of conditions characterized by jaw and facial pain and limitations in jaw movements. Injury and conditions that routinely affect other joints in the body, such as arthritis, may affect the temporomandibular joint.

The National Institute of Dental and Craniofacial Research of the National Institutes of Health estimates that more than 10 million people in the United States suffer from TMJ problems at any given time. While both men and women experience TMJ problems, 90 percent of the most severely affected are women in their childbearing years.

People diagnosed with TMJ may be experiencing other symptoms and medical conditions as part of broader multi-systems illnesses that go unrecognized. Patients with TMJ are most often diagnosed and treated primarily by dentists or oral surgeons, while another medical professional may be treating them for other conditions, such as allergies, headaches, fibromyalgia, cardiac arrhythmias, sleep disorders, movement disorders, tinnitus and irritable bowel syndrome, each treating one of the constellation of conditions without considering the body as a collection of interrelated systems.

"Patients often face bewildering, expensive and unproven treatments that may not help them because the connection between the conditions is not realized," says Terrie Cowley, president and co-founder of the TMJ Association, based in Milwaukee, Wis. "Making the connection between TMJ and these other illnesses could bring better understanding and, as a result, the hope for safer, more effective treatments."

Presenters at The Fourth Scientific Meeting of the TMJ Association included medical and dental clinicians, as well as basic scientists from many disciplines. The top recommendation from the September meeting was to direct the National Institutes of Health to create regional research centers for the study of TMJ disorders and other health conditions by focusing more closely on patients' full set of symptoms, including the "co-morbid conditions" so many TMJ patients exhibit.

The centers should work closely with universities and other agencies to develop basic research projects, while advancing clinical practices for better patient care along with stronger community medical and dental programs and education. Research should include many diverse fields such as endocrinology, neurology, immunology, rheumatology, epidemiology, bioinformatics, genetics and others.

This approach signals a paradigm shift in how TMJ diseases and disorders are studied and treated. Temporomandibular diseases and disorders are complex conditions that may be related to larger health issues that are influenced by genes, gender, environmental triggers, such as trauma, and behavior, the conference concluded.

"It is more important than ever that we understand the full scope of these disorders," said Dr. Allen W. Cowley, Jr., Chair and Professor of Physiology at the Medical College of Wisconsin, Chairman of the Scientific Meeting Planning Committee and husband of Ms. Cowley, the association's president and co-founder.

"For years we have heard many patients say their problems are not well understood and the treatments are not working." Ms. Cowley says. "People who are suffering need help and that's not always possible if their illness is not completely understood." "This conference brings us closer to better understanding why, so we can establish a standard of care for people who are experiencing what we currently call TMJ."

National Institutes of Health Co-Sponsors of The Fourth Scientific Meeting

• Office of Research on Women's Health
• National Institutes of Dental and Craniofacial Research
• National Institute of Arthritis and Musculoskeletal and Skin Diseases
• National Institute on Deafness and Other Communication Disorders
• National Institute on Drug Abuse
• National Institute of Neurological Disorders and Stroke

About the TMJ Association

The TMJA is a national non-profit organization whose mission is to improve the diagnosis, care and treatment of everyone affected by TMJ diseases and disorders through fostering research, education and other activities with the ultimate goal of preventing TMJ problems.

The TMJ Association's scientific meetings and continuous advocacy for multidisciplinary research have resulted in initiatives from the member agencies of the National Institutes of Health that will lead to multi-disciplinary research specifically focused on TMJ diseases and disorders.

Monday, November 06, 2006

TMJ Disorders Publication Now Available from NIDCR

The National Institute of Dental and Craniofacial Research (NIDCR), one of the Federal National Institutes of Health (NIH), has just released an updated patient education brochure on temporomandibular joint and muscle disorders.  TMJ Disorders focuses on current knowledge of the causes, signs and symptoms, diagnosis, and treatment of this group of painful conditions.  The brochure also cautions about treatments that may not be necessary, as well as some that may be harmful.  The publication concludes with a brief description of trans-NIH research under way on TMJD.  TMJ Disorders is produced and distributed by NIDCR in partnership with the NIH Office of Research on Women’s Health.  Copies can be ordered online from the National Oral Health Information Clearinghouse at https://www.nidcr.nih.gov/OrderPublications or by contacting:

National Institute of Dental and Craniofacial Research

National Oral Heath Information Clearinghouse

1 NOHIC Way

Bethesda, MD 20892-3500

301-402-7364

Wednesday, November 01, 2006

OHSU School of Dentistry team discovers potential new target for treating craniofacial pain problems

A new study, published in the Journal of Neurochemistry, identifies a key interaction between head and neck nerve cell proteins that may help shed light on migraines and temporomandibular joint disorders

PORTLAND, Ore. - Researchers at Oregon Health & Science University's School of Dentistry (www.ohsu.edu/sod) have uncovered an interaction between two proteins in the nerve cells that carry pain information from the head and neck to the brain. The finding could play a significant role in the development of therapies to cure migraines and other craniofacial pain conditions like TMJ (temporomandibular joint) disorder. According to the National Institutes of Health (NIH), approximately 10 percent of Americans suffer from chronic pain conditions and a significant portion of them have chronic craniofacial pain.

The new discovery was published online (http://www.blackwell-synergy.com/doi/full/10.1111/j.1471-4159.2006.04161.x) Oct. 25, 2006, in the Journal of Neurochemistry, one of the leading peer-reviewed neuroscience journals. The study also is expected to be published in the print version of the Journal of Neurochemistry within the next two weeks.

"Our discovery reveals the complexities of pain signaling mechanisms from the head and neck to the brain," said Agnieszka Balkowiec, M.D., Ph.D., principal investigator, OHSU School of Dentistry assistant professor of integrative biosciences and OHSU School of Medicine adjunct assistant professor of physiology and pharmacology.

Head pain is signaled to the brain by what's known as the trigeminal nerve. The trigeminal nerve also conveys other types of sensation, such as touch and temperature, from numerous structures of the face, including skin, ears, cornea, temporomandibular joints and teeth. Studies suggest that the trigeminal nerve provides the signaling pathway for pain associated with migraines, TMJ disorder, periodontal pain, dental surgical pain, trigeminal neuralgia, head and neck cancer pain, and other neuropathic and inflammatory pain conditions.

The OHSU study focused on two trigeminal nerve cell proteins: Calcitonin Gene-Related Peptide (CGRP), and Brain-Derived Neurotrophic Factor (BDNF). Previous studies found that during a migraine attack, the stimulation of trigeminal nerve cells releases CGRP at the peripheral end of the cells, widening blood vessels in the brain coverings called meninges. Widening the blood vessels increases the flow of blood through the meninges and initiates an inflammatory process that likely contributes to the pain experience. Recent clinical studies show that blocking CGRP helps alleviate migraine pain.

The discovery by Balkowiec and her team points to BDNF being a likely culprit behind head pain - a previously unknown finding. The OHSU team found that the stimulation of trigeminal nerve cells, as experienced during a migraine attack, leads to release of not only CGRP, but also BDNF. The study also found that BDNF is released by CGRP when trigeminal nerve cells are not stimulated. In fact, said Balkowiec, CGRP's role at the central end of the trigeminal nerve cells is likely to be the facilitation of BDNF release. BDNF has previously been shown to play an important role in pain signaling from other parts of the body, but this is the first time it has been considered to be a factor in head pain.

"What we now need to better understand is how the interaction between CGRP and BDNF affects pain signaling to the brain in various disorders," said Balkowiec.

Balkowiec's team included School of Medicine doctoral student Ilya Buldyrev; School of Dentistry dental students Nathan Tanner and Loi Nguyen; School of Dentistry research assistant Hui-ya Hsieh; and Oberlin College senior Emily Dodd.

The research at OHSU was funded by grants from the National Institutes of Health, Medical Research Foundation of Oregon, American Association for Dental Research and the OHSU School of Dentistry.

http://www.eurekalert.org/pub_releases/2006-10/ohs-oso103006.php

Monday, October 30, 2006

http://www.fda.gov/medwatch/safety/2006/safety06.htm#Effexor

Monday, August 07, 2006

It does not get much easier than this to raise money for The TMJ Association!

Use GoodSearch like any other search engine (see sidebar at right). But here's the difference...every time you use GoodSearch, money is generated for The TMJ Association  — each completed search raises approximately $0.01 for us! And since GoodSearch is powered by Yahoo, you will get proven, high-quality search results. For example, if 1,000 TMJ Association supporters searched twice a day, we would receive an estimated $7,300 per year to help fund our mission. If 20,000 of our supporters and volunteers used it twice a day, we ’d earn approximately $400 a day! You can keep track of our estimated earnings by clicking on “Amount Raised” once you designate The TMJ Association as your organization of choice. The more people who use the site, the more money we’ll earn, so please spread the word! Start using GoodSearch today for all of your internet searches, and help raise much needed funds for The TMJ Association! Background GoodSearch is an Internet search engine with a simple concept and unique social mission. GoodSearch enables you to help fund any of hundreds of thousands of charities or schools (including The TMJ Association!) through the simple act of searching the Internet. The company was founded by a brother and sister team who lost their mom to cancer and wanted to find an easy way for people to support their favorite causes. It's simple. You use GoodSearch.com like any other search engine (they've partnered with a leading search engine, Yahoo, to ensure the best results), but each time you do, money is generated for your favorite cause. Last year search engines generated close to $6 billion in revenue from advertisers. Think about what your favorite cause could do with even a fraction of that money! The company's goal is to direct as much money to the organizations as possible, so they ’re not spending a lot on advertising. That’s why they need your help in spreading the word! It's hoped that not only will you use GoodSearch as your main search engine from here on out, but will also pass this message on to your friends and family. The more people who use this site, the more money will go to your favorite cause. How To Use GoodSearch 1.  Go to www.goodsearch.com 2.  Type "TMJ Association" in the I'm Supporting box 3.  Click "Verify" 4.  Search Note: Your selection of The TMJ Association will be saved. For future searches, go right to GoodSeach and search! GoodSearch Every Search! Use the GoodSearch Toolbar to easily search from the top of your browser. Goodsearch Toolbar for IE Netscape/Firefox: Use link near the bottom of GoodSearch's homepage Tell Others! The more who use GoodSearch, the more money Heal the Bay will earn, so please spread the word!

Wednesday, July 26, 2006

Professor gets grant to study TMJ

Chronic and acute pain in the jaw joint and muscles characterize the disorders.

News-Leader Staff - Published July 24, 2006

Paul Durham, associate professor of biology at Missouri State University and the director of the university's new Center for Biomedical and Life Sciences, was recently awarded a $1.2 million grant from the National Institutes of Health to study temporomandibular joint disorders, more commonly known as TMJ.

It is estimated that more than 10 million American adults suffer from TMJ disorders, which are often characterized by chronic and acute pain in the jaw joint and accompanying muscles.

The grant will give Durham $243,567 each year for five years for research.

Durham said that when nerves are inflamed, or active, the brain is aware that something is wrong and the result is pain.

With TMJ disorders, Durham suspects that facial pain is the product of the glial cells releasing inflammatory molecules that, in turn, activate the nerve.

Durham's study could ultimately help those who suffer from migraines, chronic allergies and periodontal diseases as well as TMJ disorders.

Durham heads up the Center for Biomedical and Life Sciences, which is designed to support Missouri-based life sciences and biomedical industries. The center will also participate in business-oriented projects and services to promote education.

The center will provide engineering and technical support and conduct cutting-edge research and development.

http://www.news-leader.com/apps/pbcs.dll/article?AID=/20060724/NEWS01/607240349

Wednesday, July 12, 2006

Call For Entries eMotion Pictures: An Exhibition of Orthopaedics in Art

eMotion Pictures: An Exhibition of Orthopaedics in Art is open to both orthopaedic patients (of all ages) and orthopaedic surgeons, and is a component of the American Academy of Orthopaedic Surgeon’s (AAOS) 75^th Anniversary Celebration.

Information about the 75^th Anniversary Celebration
Key historical and anecdotal information for the 75^th Anniversary is being gathered through a content collection Web site (www.aaos.org/75years). With content collected from patients, physicians, specialty and state societies, orthopaedic nurses and orthopaedic industry, the AAOS will share the story of orthopaedics through a series of coordinated, multimedia projects including a film, historical coffee table book, historical reference book, Web site, art show, video modules, Digital Timelines and permanent and traveling exhibits.

The completed project will be unveiled at the 2008 Annual Meeting in San Francisco.

Information about eMotion Pictures
This online entry form must be submitted by artists (orthopaedic patients (of all ages) and orthopaedic surgeons) who wish to participate in eMotion Pictures: An Exhibition of Orthopaedics in Art. Your artwork may be featured in our 75^th Anniversary Celebration Traveling Exhibit, Film, Coffee Table Book, Web site, Online Museum and/or be on display at our 75^th Anniversary Celebration in San Francisco, March 2008.

Important Information for your entry

• Eligibility and Theme
• Entry Instructions
• Agreement
• Notification
• Liability, Insurance and Shipping
• Sales

Note: Internet Explorer for the Macintosh cannot upload files. You may send your files via email . The file name cannot contain spaces. The file name must have the appropriate three character extension for the file type selected; Example: an image file will have an extension of jpg.

If you have any questions, please contact:

Sandra R. Gordon Director, Public Education & Media Rel American Academy of Orthopaedic Surgeons 6300 North River Road Rosemont, Illinois 60018-4262 P: 847-384-4030 F: 847-823-7268 E: gordon@aaos.org

Addy M. Kujawa Manager, Public Relations American Academy of Orthopaedic Surgeons 6300 North River Road Rosemont, Illinois 60018-4262 P: 847-384-4033 F: 847-823-7268 E: kujawa@aaos.org

Sponsored in part by a grant from Kyphon, Inc.

Friday, July 07, 2006

Research Grant Opportunities

Joint Degeneration: Mouse Models (R21) PA-06-450 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Aging National Institute of Dental and Craniofacial Research Opening Date: June 9, 2006 Closing Date: November 2, 2007 http://grants.nih.gov/grants/guide/pa-files/PA-06-450.html. This program will support research with the potential to reveal the biological mechanisms underlying non-inflammatory joint degeneration in mouse models. Research supported by this initiative will identify specific genes, proteins, and biochemical pathways that contribute to joint degeneration. Information to be gained will include the timing and anatomical location of events that lead to joint degeneration, the functional characterization of proteins identified as causal factors, and the definition of pathways by which particular gene products contribute to joint degeneration. Objectives include: the characterization of new models; the development and testing of hypotheses that arise from the properties of new and existing models; and the definition of functional roles for specific molecular entities identified as contributing to joint degeneration. The NIDCR is interested in supporting meritorious research targeting new animal models of osteoarthritis that have relevance to the temporomandibular joint (TMJ). Applications describing animal models that elucidate molecular mechanisms of TMJ degeneration and aid in the diagnosis and treatment of TMJ disorders are particularly encouraged. Applications addressing unique features of the TMJ including the presence of fibrocartilage on its articulating surfaces and the distinctive anatomy and mechanical loading of this joint also are of interest to the NIDCR.

Temporomandibular Joint and Muscle Disorders: Pathophysiological Mechanisms Linking Comorbid Conditions (R01)(PA-06-188) National Institute of Dental and Craniofacial Research National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Deafness and Other Communication Disorders National Institute of Neurological Disorders and Stroke Office of Research on Women's Health Application Receipt/Submission Date(s): Multiple dates, see announcement http://grants.nih.gov/grants/guide/pa-files/PA-06-188.html. The purpose of this program announcement is to stimulate research on discovering etiological and pathophysiological mechanisms underlying a set of chronic, comorbid conditions associated with temporomandibular joint and muscle disorders (TMJMDs). TMJMDs are a complex collection of diseases involving one or more tissues of the TMJ and facial musculature. Primary symptoms include chronic pain in facial muscles and limited and painful movement of the jaw. In addition, these and other symptoms of TMJMD can occur together with other chronic illnesses such as fibromyalgia, atypical face pain, trigeminal neuralgia, chronic fatigue syndrome, multiple chemical sensitivity, irritable bowel syndrome, complex regional pain syndrome, migraine headache, speech hearing, swallowing, balance, smell, and taste disorders, and certain cardiovascular diseases. This program announcement seeks research applications that use state-of-the-art, multidisciplinary and interdisciplinary approaches to discover molecular, physiological, and behavioral mechanisms responsible for the overlapping symptoms manifested in the set of disorders that may co-exist with TMJMD. These applications may have as their research focus the chronic, comorbid conditions themselves or TMJMDs, provided that the aims and goals of the project are to discover biological mechanisms linking the comorbidities. While the overarching goal of this announcement is to arrive at a better understanding of potential mechanisms underlying TMJMDs as related to the variety of comorbidities associated with them, it is expected that no single research project will be able to accomplish this. Applicants are, therefore, encouraged to focus their attention on a particular pathway and a specific disease that is comorbid with TMJMD.

Drug Delivery Systems for Orofacial Disease (SBIR [R43/R44]) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Release/Posted Date: December 13, 2005 Opening Date: February 1, 2006 Expiration Date: April 2, 2008 http://grants.nih.gov/grants/guide/pa-files/PA-06-085.html. This Funding Opportunity Announcement (FOA) from the National Institute of Dental and Craniofacial Research (NIDCR) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) solicits Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose the design and development of novel delivery systems for rapid and/or sustained, on-demand release of therapeutic agents (e.g., antimicrobial, anti-inflammatory, antibodies, peptides, nucleotides, small molecule receptor agonists/antagonists) in the oral cavity. The expected outcomes are the delivery of agents with more precise localization and appropriate half-lives to treat oral diseases such as caries and periodontal disease, oral mucositis and temporomandibular joint and muscle disorders and chronic pain.

Drug Delivery Systems for Orofacial Disease (SBIR [R41/R42]) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Release/Posted Date: December 13, 2005 Opening Date: February 1, 2006 Expiration Date: April 2, 2008 http://grants1.nih.gov/grants/guide/pa-files/PA-06-084.html. This Funding Opportunity Announcement (FOA) from the National Institute of Dental and Craniofacial Research (NIDCR) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) solicits Small Business Technology Transfer (STTR) grant applications from small business concerns (SBCs) that propose the design and development of novel delivery systems for rapid and/or sustained, on-demand release of therapeutic agents (e.g., antimicrobial, anti-inflammatory, antibodies, peptides, nucleotides, small molecule receptor agonists/antagonists) in the oral cavity. The expected outcomes are the delivery of agents with more precise localization and appropriate half-lives to treat oral diseases such as caries and periodontal disease, oral mucositis, and temporomandibular joint and muscle disorders and chronic pain.

Tuesday, June 27, 2006

Temporomandibular joint diseases and disorders, commonly called TMJ, are a collection of poorly understood conditions characterized by pain in the jaw and surrounding tissues and limitations in jaw movements. The scientific goal of the meeting is to define the diverse set of health problems experienced by TMJ patients and to develop cross-disciplinary strategies and an integrated approach to research efforts. Translational research approaches will be emphasized and experts from diverse clinical specialties will share information on integrative systems approaches currently used to advance the understanding and treatment of other complex clinical conditions.

• To convene expert clinical and basic scientists to characterize the multiple symptoms and co-morbid conditions found in TMJD patients (and exemplified by reports of patients attending the meeting) in order to develop research strategies based on an integrated and cross-disciplinary platform. The aim would be to combine resources from diverse fields to examine the etiology, diagnosis, pathogenesis, and treatment of patients with TMJDs from a new perspective.
• To promote the participation of students and young clinical investigators through a Travel Award Program and encourage their involvement in discussions that reflect the challenges of pursuing the interdisciplinary studies necessary to advance understanding of TMJDs as a complex disease.
• To develop a compelling set of recommendations for research initiatives in TMJDs that would synergize the work of multiple Institutes and Centers of the National Institutes of Health and that of academic health centers.

With the diverse set of co-morbid conditions reported by TMJD patients (a range that includes fibromyalgia, tinnitus, interstitial cystitis, mitral valve prolapse, and irritable bowel syndrome), it is evident that the disorders are multifaceted and that diagnostic and therapeutic procedures must involve interdisciplinary approaches. Physicians, dentists, geneticists, epidemiologists, federal agency officials, basic and clinical scientists, TMJ patients, and all who are interested in TMJ diseases and disorders and related co-morbid conditions are encouraged to attend

TMJDs as a Model of a Complex Disease Influenced by Environmental and Iatrogenic Risk Factors
• Terrie Cowley, The TMJ Association, Milwaukee, WI
• Jane M. Kotchen, M.D. M.P.H., Medical College of Wisconsin, Milwaukee, WI
• Christian S. Stohler, D.M.D., Dr. Med. Dent., University of Maryland Dental School, Baltimore, MD
• Robert D. Foreman Ph.D., University of Oklahoma Health Sciences Center, Oklahoma City, OK
• Jay P. Shah, M.D., Clinical Research Center, National Institutes of Health, Bethesda, MD

Chronic Pain as a Model of Clinical Complexity
• Ronald Dubner, D.D.S., Ph.D., University of Maryland Dental School, Baltimore, MD
• Wilfrid Janig, M.D., Christian-Albrechts-Universaitat, Kiel, Germany
• Jon D. Levine, M.D., Ph.D., University of California, San Francisco, CA

Diverse Approaches Used to Study Other Complex Diseases
• Allen W. Cowley, Jr., Ph.D., Medical College of Wisconsin, Milwaukee, WI
• Judith L. Turgeon, Ph.D., University of California-Davis School of Medicine, Davis, CA
• Howard J. Jacob, Ph.D., Medical College of Wisconsin, Milwaukee, WI

How to Create A Workforce Within our Academic Healthcare Centers to Match the Science Required?
• Sharon M. Gordon, D.D.S., M.P.H., Ph.D., University of Maryland, Baltimore, MD
• Theodore A. Kotchen, M.D., Medical College of Wisconsin, Milwaukee, WI and National Center for Scientific Review, National Institutes of Health, Bethesda, MD

• Allen W. Cowley, Jr. Ph.D., Medical College of Wisconsin, Milwaukee, WI (Chair)
• Ronald Dubner, D.D.S., Ph.D., University of Maryland Dental School, Baltimore, MD
• Julie Glowacki, Ph.D., Harvard Medical School, Harvard Dental School of Dental Medicine, Boston, MA
• Stephen L. Gordon, Ph.D., Cognate Therapeutics, Bethesda, MD
• Stephen B. Milam, D.D.S., Ph.D., University of Texas Health Science Center, San Antonio, TX
• Christian S. Stohler, D.M.D., Dr. Med. Dent., University of Maryland Dental School, Baltimore, MD
• John Watson, Ph.D., University of California, San Diego, La Jolla, CA
  

Co-Sponsored by
National Institutes of Dental and Craniofacial Research
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute on Deafness and Other Communication Disorders
National Institute on Drug Abuse
National Institute of Neurological Disorders and Stroke
Office of Research on Women's Health

NIH Grant Number: 1 R13 DE017854-01

The Anspach Effort, Inc.
Procter & Gamble
TMJ Concepts
Anonymous
Ms. Janet Anderson
Mr. John D. Benjamin
Mr. and Mrs. Charles E. Boyette ~ In Honor of Michele Kroll
Mrs. Mary Butterfield
Mr. and Mrs. Christopher Chard
Mary F. Coughlin
Mrs. Sara M. Cox ~ In Memory of John Michael
Mrs. Christa Deutsch
Ms. Linda Dittamo
Ms. Anna R. Estep
Mr. James J. Farina III
Mrs. Alice D. Graves
Ms. Dorothy Hall
Mr. and Mrs. Dan Illes
Mrs. and Mrs. Ed Karadunis
Mr. Darin Kellett
Ms. Paula Miller
Ms. Audrey Norman
Mr. Larry Reingold
Mrs. Kaye H. Shive

Tuesday, June 27, 2006

National TMJ Patient Gathering

Tuesday, June 13, 2006

Terrie Cowley, President of The TMJ Association, was invited to give a key note presentation at the TMJ Bioengineering Conference, May 25-27, 2006 in Boulder Colorado.  Click here to view Ms. Cowley's presentation.   The meeting program and abstracts can be purchased for $50 by contacting Dr. Michael Detamore at The University of Kansas at detamore@ku.edu. 

Wednesday, June 07, 2006

NEWS FROM THE FORSYTH INSTITUTE        

140 The Fenway Boston, MA 02115·617-262-5200·www.forsyth.org

Contact:  Jennifer Kelly 617-892-8602 jkelly@forsyth.org

For Immediate Release                                                                                          June 6, 2006

FORSYTH TO TAKE LEADERSHIP ROLE IN TMJ/TMJD RESEARCH

Scientist Appointed as the Milton & Renée Glass Family Fellow in Jaw Joints & Allied Musculo-Skeletal Research

Boston ¾   The Forsyth Institute has announced the appointment of Lin Xu, MD, PhD, as the Milton & Renée Glass Family Fellow in Jaw Joints & Allied Musculo-Skeletal Research.  Dr. Dominick DePaola, President and Chief Executive of Forsyth said, “I am delighted with the appointment and with the entry into this exciting new field of research for Forsyth. It represents a breakthrough in the application of basic science into a craniofacial disorder affecting millions of Americans.” Dr. Xu’s current research focuses on the underlying causes including genetic factors, of osteoarthritis in the jaw joints.  Arthritis is widely considered a co-morbid condition of temporomandibular muscle (jaw) joint disorders/disease (TMJ/TMJD) the same painful and disabling condition that affects other joints in the body.  

Dr. Xu’s experience and breadth of scientific inquiry fits well within the fellowship mission to explore growth and development of healthy jaw joints in children as they develop pre- and post- natally. Subsequently, the investigation will explore the disorders/diseases of the temporomandibular joints and overlapping or co-morbid health disorders, through genetic and molecular science.

 “This is a landmark appointment for Forsyth,” said Dr. Richard Pharo, Vice President of Operations for Forsyth and Chairman of the Fellowship Mission and Procedures Committee. “Dr. Xu’s fellowship under the tutelage of Forsyth’s scientists, and with mentorship by Dr. Susan Rittling, PhD, in her genetics laboratory, will enable a new paradigm in TMJD research. Together we can work to gain a new understanding of the genetic makeup of these disorders.”

Dr. Lin Xu joins Forsyth from the Harvard School of Dental Medicine, where she worked as a Research Associate in the Department of Developmental Biology. During the past three years, Dr. Xu’s research examined the pathogenetic mechanisms of non-inflammatory degenerative disorders, with a specific focus on the jaw joints.  Although she is relatively early in her research career, Dr. Xu already has been recognized as one of the most promising of investigators in the field of TMJD research.  She has published 15 scientific papers on her TMJD research.  Thus, she brings important background experience to Forsyth in this fellowship.  Dr. Xu obtained her medical degree from Beijing Capital Medical School in China and her doctorate degree in molecular biology from Brigham Young University.

The Milton & Renée Glass Family Fellowship supports the research efforts of postdoctoral fellows at The Forsyth Institute for the study of temporomandibular joints disease and related musculo-skeletal disorders with the goal of understanding the disease, preventing it, and identifying effective therapies for its treatment. The TMJ research program at Forsyth also will provide a unique opportunity to promote awareness of TMJD with special emphasis on TMJD in children.

This Fellowship honors Milton L. Glass, who has served as a member of the Board of Directors and Board of Trustees of the Institute since 1986.  The fellowship also recognizes and honors his wife, Renée Glass, for her dedication to Forsyth and to the issue of Temporomandibular Joint and Muscle Diseases and Disorders.

“In our work in awareness and prevention of TMJD we stress the fact that healthy Jaw Joints are critical to whole body health.  TMJD has long been the “stepchild of the healing arts.”  We hope to re-join the jaw joints to all other joints in the body and in the process engage the medical community along side the dental community in resolving this devastating disorder/disease,” said Renée Glass.

“By bringing basic scientific research into the TMJD paradigm and co-joining medical and dental science at Forsyth, this is a giant step forward of historic proportions for the multitudes suffering from jaw-joint diseases/disorders.  It offers hope where misconceptions, misdiagnosis, stigmatism and mistreatment of TMJ sufferers have been the rule. It breaks a logjam,” said Milton.

The Glasses founded the Jaw Joints & Allied Musculo-Skeletal Disorders Foundation (JJAMD), a 501(c)(3) organization, in 1982. JJAMD is the nation’s pioneer TMJD patient advocacy organization.  Their passion and dedication have increased public awareness of the debilitating medical and oral health disorder. JJAMD’s work with NIH/NIDCR has earned them membership on the NIHTMJD Interagency Working Group, where they participate in planning and discussions involved with a number of governmental agencies either actively involved or potentially participants in TMJD research.  Through close collaboration with Forsyth, JJAMD is addressing an NIH initiative involving advocacy organizations in research. Further information can be obtained by accessing JJAMD’s web site www.tmjoints.org.

The Forsyth Institute is the world’s leading independent nonprofit research organization focused on oral, craniofacial, and related biomedical science.  Established in 1910, Forsyth’s mission is to lead the discovery, communication, and application of breakthroughs in oral health and disease prevention that will significantly improve the health and well-being of the nation and the world. For more information about Forsyth visit its web site at www.forsyth.org.

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Monday, May 15, 2006

FDA MedWatch - Paxil/Paxil CR (paroxetine HCl) and recent meta-analysis of paroxetine showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo

GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the WARNINGS section in the prescribing Information for Paxil and Paxil CR.

These labeling changes relate to adult patients, particularly those who are younger adults.

A recent meta-analysis conducted of suicidal behavior and ideation in placebo-controlled clinical trials of paroxetine in adult patients with psychiatric disorders including Major Depressive Disorder (MDD), other depression and non-depression disorders. Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo. Further, in the analysis of adults with MDD (all ages), the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo. This difference was statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution. All of the reported events of suicidal behavior in the adult patients with MDD were non-fatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30. These MDD data suggest that the higher frequency observed in the younger adult population across psychiatric disorders may extend beyond the age of 24.

It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated.

Read the complete MedWatch 2006 Safety Summary, including links to the Dear Healthcare Professional Letter and the revised approved product labeling at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#paxil

Wednesday, May 10, 2006

TMJ Bioengineering Conference

The temporomandibular joint is one of the most complex joints in the body. Despite the tremendous patient population and the significant morbidity related to a plethora of TMJ disorders, the TMJ has been poorly studied in comparison to joints of interest to the orthopaedic community. Unlike the orthopaedic community, there is no organized continuity between engineers, scientists and clinicians in the TMJ research community. In response to this striking lack of coordinated open communication, a TMJ Bioengineering Conference will be held on May 25–27, 2006 in Boulder, CO.

This meeting will be the first of its kind, bringing patients and surgeons together to deliver specific directives to bioengineers. The overall meeting objective is to provide a unique forum for bioengineers to exchange ideas and perspectives with clinicians and patients, in an effort to identify contemporary challenges with treating TMJ disorders and to devise strategies to address these challenges with bioengineering. This objective will be addressed by the following specific aims: 1) To obtain bioengineering directives from the clinical community, 2) To incorporate into these bioengineering directives needs as identified by representatives of the patient population, and 3) To set a benchmark for current state-of-the-art treatments and scientific knowledge. We have selected the premiere groups of surgeons and patients to issue the directives of aims 1 and 2—the president of the American Society of TMJ Surgeons will deliver a keynote address based on a consensus of priority issues formulated at their annual meeting, and the president of the TMJ Association patient organization will deliver a keynote address based on previous meetings and decades of experience and interaction with TMJ patients. A benchmark for contemporary knowledge of the TMJ will be assessed by 38 speakers in sessions on tissue engineering, biomechanics, biology and clinical treatment. Dissemination of these directives and a summary of salient discussions will be featured in an article that will go to the Annals of Biomedical Engineering, the official journal of the main bioengineering professional society, the Biomedical Engineering Society.

There is a compelling need for this conference, which will set the stage not only for future TMJ-specific bioengineering meetings, but will also serve as a milestone expansion in TMJ research by developing continuity, fostering collaborations, and drawing more talent to the field.

Speakers and Keynote Presenters:

Keynote Speakers:

Terrie Cowley, TMJ Association, Keynote Speaker

William Kirk, D.D.S., American Society of TMJ Surgeons, Keynote Speaker

Presenters:

· Kyriacos Athanasiou, Ph.D., Rice University

· Mark Beatty, D.D.S., M.S., University of Nebraska

· Barry Berkovitz, F.D.S., Ph.D., Guy’s, King’s and St. Thomas’ School of Biomedical Sciences

· Robert Christensen, D.D.S., TMJ Implants

· Michael Detamore, Ph.D., University of Kansas

· Ken Fischer, Ph.D., University of Kansas

· Jim Fricton, D.D.S., M.S., University of Minnesota

· Luigi Gallo, Ph.D., University of Zurich

· Alan Glaros, Ph.D., Kansas City University of Medicine & Biosciences

· Julie Glowacki, Ph.D., Harvard University

· Edward Guo, Ph.D., Columbia University

· Sue Herring, Ph.D., University of Washington

· Scott Hollister, Ph.D., University of Michigan

· Ching-Chang Ko, D.D.S., Ph.D., University of Minnesota

· Regina Landesberg, D.M.D., Ph.D., Columbia University

· Richard LeBaron, Ph.D., University of Texas-San Antonio

· Michael Liebschner, Ph.D., Rice University

· Helen Lu, Ph.D., Columbia University,

· Jeremy Mao, D.D.S., Ph.D., Columbia University

· Lou Mercuri, D.D.S., M.S.,