Thursday, October 25, 2012
Medical device approval process under fire
All parents have heard their kids complain that but for 1 or 2 percentage points, they would have achieved a higher grade.
"This is so unfair! My average is 89.9999 and he is still giving me a B+!"
Every kid should receive an A, of course, since psychologists are now professing that every kid is a prodigy in some new measure of intelligence. Academic intelligence, the conventional and obsolescent notion, has been sidelined to make room for other types of smarts, such as musical intelligence, existential intelligence, interpersonal intelligence, spatial intelligence and many others.
I agree that there's a lot more to being smart than conquering number theory and linear algebra, but I wonder whether this effort to broaden the definition of intelligence is simply so more parents can have smart kids. Personally, I think that the conventional definition of intelligence is too rigid and we should be open to where rigorous research leads.
Fortunately for me, I did not discover that there is a category of navigational intelligence, which would have cost me at least 40 revised IQ points.
In my day, a grade of 94% was a solid A, and we strived to reach this threshold. Were our teachers too lenient? Should a grade of A required that at least 99% of our answers were correct? Where do we draw the lines to separate excellence from acceptable? Who makes the decision?
Last year, a public fight erupted over an Institute of Medicine (IOM) report that had not even been issued that argued for tougher rules for medical device companies. The report had been commissioned by the FDA and was in response to several recalls of medical devices that had malfunctioned and harmed patients. Advocates of medical device companies cried foul, claiming that the 12-member panel was biased. Look for a lot more of this strategy when comparative effectiveness research (CER) goes forward. If a CER panel's conclusion is against your interest, then attack the panel. Lawyers have mastered this technique generations ago. If the facts are on your side, attack the law. If the law is on your side ...
Is the IOM on target or is the aggressive push-back from the industry legitimate? I do know that is an easy task to make medical device companies and pharmaceutical companies appear callous, avaricious and indifferent to human suffering, when this may be entirely false. Can you say demonization?
Of course, we want medical devices and pharmaceuticals to be safe and effective. We expect that artificial hips, pacemakers, defibrillators and stents will perform superbly. Safety and testing policies should be made by experts independent from industry, but I believe that industry is an important voice at the table. Indeed, several constituencies should be represented, including the public. If we strive to eliminate every real and potential conflict of interest, then we will lose many voices of medical experience from the real world.
I'm not suggesting that reform in the device approval process is unnecessary. But, there are truths that must be acknowledged.
--No medical device or drug is 100% safe or effective.
--A percentage of medical devices will fail which may result in injury, reoperation or death.
--A failed medical device is not tantamount to corporate misconduct
What percentage of medical devices should perform as intended? 90%? 95% 98%?
How much testing and clinical trials should medical devices be required to undergo before they can enter the market? If the device is similar to an existing device, or is an existing device that is applying for a new use, should the testing process be the same as for a new product?
A grade of 98% sounds like an A+ to most of us, but this may not be sufficient in the medical device universe. Would we be content on an airplane knowing that we have a 98% chance of landing safely?
If we all agree that the medical device industry needs tougher standards so that their safety and effectiveness levels approach 100%, then we will need to accept higher medical costs and a reduction in innovation. Will this trade off serve the greater good?
I'm sure if the federal highway speed limit were lowered to 50 miles per hour that lives would be saved. No one is hollering for this reform. What should the medical device speed limit be? 
This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.
Labels: guest post, MD Whistleblower, Michael Kirsch, risks and benefits
posted by Michael Kirsch, MD at
11:00 AM
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Albert Fuchs,
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Albert Fuchs, MD, FACP, graduated from the
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And Thus, It Begins
Amanda Xi, ACP Medical
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of Medicine, charter class of 2015, in Rochester, Mich., from which
she which chronicles her journey through medical training from day
1 of medical school.
Zackary Berger
Zackary Berger, MD, ACP Member, is a primary care doctor and
general internist in the Division of General Internal Medicine at
Johns Hopkins. His research interests include doctor-patient
communication, bioethics, and systematic reviews.
Controversies in Hospital
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Run by three ACP
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hands).
db's Medical Rants
Robert M. Centor, MD, FACP, contributes short essays contemplating
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DrDialogue
Juliet K. Mavromatis, MD, FACP, provides a conversation about
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Dr. Mintz' Blog
Matthew Mintz, MD, FACP, has practiced internal medicine for more
than a decade and is an Associate Professor of Medicine at an
academic medical center on the East Coast. His time is split
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Everything
Health
Toni Brayer, MD, FACP, blogs about the rapid changes in science,
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FutureDocs
Vineet Arora, MD, FACP, is Associate Program Director for the
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Discovery at the Pritzker School of Medicine for the University of
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David L. Katz, MD, MPH, FACP, is an internationally renowned
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Richard Just, MD, ACP Member, has 36 years in clinical practice of
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Kevin Pho, MD, ACP Member, offers one of the Web's definitive sites
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MD
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Michael Kirsch, MD, FACP, addresses the joys and challenges of
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relationship, medical ethics and measuring medical quality. When
he's not writing, he's performing colonoscopies.
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Elaine Schattner, MD, FACP, shares her ideas on education, ethics
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Alexander M.
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Rob Lamberts, MD, ACP Member, a med-peds and general practice
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David M. Sack, MD, FACP, practices general gastroenterology at a
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Kimberly Manning, MD, FACP, reflects on the personal side of being
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Paul Sufka,
MD, ACP Member, is a board certified rheumatologist in St. Paul,
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Technology in (Medical)
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Neil Mehta, MBBS, MS, FACP, is interested in use of technology in
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Peter A. Lipson,
MD
Peter A. Lipson, MD, ACP Member, is a practicing internist and
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around in various forms since 2007, offers musings on the
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Why is American Health Care So Expensive?
Janice
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adopting a career in hospital and primary care medicine as a locum
tenens physician. She lives in Idaho when not traveling.
World's Best Site
Daniel Ginsberg, MD,
FACP, is an internal medicine physician who has avidly applied
computers to medicine since 1986, when he first wrote medically
oriented computer programs. He is in practice in Tacoma,
Washington.
Other blogs of note:
American Journal of
Medicine
Also known as the Green Journal, the American Journal of Medicine
publishes original clinical articles of interest to physicians in
internal medicine and its subspecialities, both in academia and
community-based practice.
Clinical
Correlations
A collaborative medical blog started by Neil Shapiro, MD, ACP
Member, associate program director at New York University Medical
Center's internal medicine residency program. Faculty, residents
and students contribute case studies, mystery quizzes, news,
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Interact MD
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he can create an independent, clinician-reviewed space on the
Internet for physicians to report and comment on the medical news
of the day.
PLoS Blog
The Public Library of Science's open access materials include a
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White Coat
Rants
One of the most popular anonymous blogs written by an emergency
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