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TMJ
News Bites
August
2011
Volume
3, Issue 5 |
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Expanding
TMJ Research to New Horizons
The
TMJ Association's Sixth Scientific meeting held
June 5-7, 2011 in Bethesda, MD was an impressive
event bringing together many distinguished
scientists.
Pat
McCaffrey, Ph.D., Executive Director of Harvard's
Pain
Research Forum, attended our meeting and wrote
the following article for the Pain Research
Forum's website, TMJA Scientific Symposium: The
Puzzle of Comorbid Chronic Pain. We're
pleased that Dr. McCaffrey published this article
which promotes awareness of the complexity of
these comorbid conditions as well as the research
opportunities for the scientific
community.
A Major Idea for Pain
Research
A
Direct Result of The TMJA Scientific
Meeting
The National Institutes of
Health (NIH) Common Fund supports
exceptionally innovative programs that are
inherently high-risk but have the potential for
high-payoff, catalyzes research across NIH and in
the biomedical research community. We have just
learned that among the Common Fund’s list of ideas
submitted to the community for comment, are three
that focus on pain research. They are, 1.
Biomarkers for Chronic Pain Using Functional Brain
Connectivity, 2. Venture Fund for Research and
Development of New Medications to Treat Chronic
Pain and one that directly includes research on
Temporomandibular Disorders – 3. A
Transformative Classification for Stimulating
Research, Improving Diagnosis, and Personalizing
Treatment. This last idea is a direct
result of the Sixth Scientific Meeting of The TMJ
Association. Twelve percent of the US population
suffers from TMJ disorders. That amounts to
approximately 36 million people suffering from
mild TMJ discomfort to severe and unrelenting
pain. The majority also suffer from other pain
conditions. This project would greatly accelerate
scientific progress on TMJ disorders but more
importantly, bring understanding to the condition
and with it, the hope for treatments that work and
don’t cause harm. We
are extremely pleased to see that there are three
ideas for pain research being suggested to the
Common Fund. In light of the recent Institute of
Medicine Report on pain, which found that chronic
pain affects over 116 million U.S. adults and
costs the U.S. economy up to $635 billion dollars
per year, we would be negligent if we did not deem
all three projects worthy of
funding.
Now
Available
We
have just updated our brochure, A Resource
Guide for Temporomandibular Disorders, which
is now available as a downloadable PDF on our website.
You may also request hard copies by
mail. We encourage you to share this
brochure with your friends, health care
professionals and family as it is a great
educational resource for everyone.
Our
thanks to Drs. Daniel Laskin, Sharon Gordon,
William Maixner, Joan Wilentz, and our volunteers
for their contributions to this
brochure.
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Terrie
Cowley, President of the TMJA talks with Dr.
Jeffrey Shuren, Director of the FDA's
CDRH. |
Voicing TMJ Implant Patients'
Concerns
FDA
Townhall
Event
TMJ
Association representatives attended “A
Conversation with FDA’s Center for Devices and
Radiological Health (CDRH)” on June 27, 2011 in
Washington, D.C. This event sponsored by the
National Organization for Rare Disorders provided
an open dialogue for patient advocates with FDA
officials.
The
TMJA welcomed the invitation to participate in
this event. We shared TMJ patient stories
and concerns with Dr. Jeffrey Shuren, Director of
the CDRH and his staff regarding TMJ implant
devices.
At
this event we learned the CDRH is considering
several ways they can interact with patient
advocacy organizations on a routine basis in order
to obtain information pertinent to implant
devices. This is very encouraging news! It
is so important that your voices be heard when it
comes to TMJ implant devices.
TMJ
Implants - 510(k)
Process
Institute
of Medicine
The
Institute of Medicine (IOM) of the National
Academy of Sciences was commissioned by the Food
and Drug Administration’s (FDA) to evaluate the
510(k) clearance process for medical devices and
to make recommendations directed toward improving
regulation of these devices. The IOM is a widely
respected organization that assembles experts to
study a range of health-related issues, often at
the request of government agencies.
The
510(k) process allows manufacturers to market new
devices without clinical testing for safety and
efficacy if they were shown to be "substantially
equivalent" to devices marketed before passage of
the 1976 Medical Devices Amendment Act. The result
was that many TMJ patients had devices made of
synthetic materials, for example, silicone and
Proplast Teflon, which broke down and caused
serious complications.
Last
year The TMJ Association (TMJA) submitted a
written statement to Congress concerning TMJ
implant devices and the FDA’s 510k approval
process. Additionally, Terrie Cowley,
President of The TMJA, attended the April 13,
2011, Senate Congressional Hearing entitled, "A
Delicate Balance: The FDA and the Reform of the
Medical Device Approval Process." We
encourage you to read the TMJA’s written statement and summary and recommendations
submitted and included in the Congressional
Hearing.
The
IOM’s report on medical devices was released on
Friday, July 29, 2011. In the report the IOM
committee concluded that the 510(k) process
lacks the legal basis to be a reliable
premarket screen of the safety and
effectiveness of moderate-risk devices and,
furthermore, that it cannot be transformed into
one. Click here to view a summary of the
IOM’s report.
The
FDA released a statement in response to the
IOM's recommendation to scrap the 510(k) process.
“FDA believes that the 510(k) process should not
be eliminated but we are open to additional
proposals and approaches for continued improvement
of our device review programs,” said Jeffrey
Shuren, M.D., director of the FDA’s Center for
Devices and Radiological Health. FDA is now
seeking public comments through a Federal Register notice. The
TMJA will submit comments on the 510(k) process
concerning TMJ implants and encourages patients to
do so as
well. |
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Katie
"Pain
- My TMJ pain comes in many forms. It starts
with soreness in my jaw, usually one side or the
other, not both at the same time. As it
worsens it feels like tooth pain. Terrible
tooth pain that moves from tooth to tooth so you
can’t tell which it is. When it’s really bad
the entire side of my face is in pain. My
teeth, my cheeks, my jaw, my ear. It can
feel like an earache, or a headache. It can
feel like my teeth are going to fall out of my
head. My neck hurts, my back hurts, my
shoulders hurt. I think that I will die
before the pain goes away.
Beginning
- My
pain started in high school about a year after I
had my braces removed. I had no idea what
was wrong and my dentist said it was TMJ and to
stop chewing gum. He also fit me for a mouth
guard. With Advil, the pain eventually went
away." Click
here to read more of Katie's
story.
Ringing in Your
Ears?
Tinnitus
(ringing in the ears) is one of the less common
symptoms of TMJ disorders. If you are experiencing
tinnitus you might want to read the recently
published article by the National Institutes of
Health. Click here to read the
article.
National Institute of Dental and
Craniofacial Research
A New
Director
Martha
J. Somerman, D.D.S., Ph.D., has been
appointed director of the National Institute
of Dental and Craniofacial Research (NIDCR). She
is currently Dean of the University of Washington
School of Dentistry, Seattle, a position she has
held since 2002. She will begin her duties as
NIDCR director on Aug. 29, 2011. National
Institutes of Health Director Francis S. Collins,
M.D., Ph.D., selected Somerman. Click here to read full
story.
The
TMJA plans to meet with the new Director in the
near future as we continue our advocacy efforts at
NIDCR. |
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TMJ
Survey
As
a TMJ News Bites subscriber, your
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Please take our brief online survey.
Your response will help us serve your
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TMJ
Research Opportunity
On
August 3, 2011 the National Institutes of Health
issued the following grant
opportunity:
NIDCR
Institutional Career Development Award for
Enhancing Research Capacity in Temporomandibular
Joint Disorders and Orofacial Pain
(K12)
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