December 19th, 2011 by Michael Kirsch, M.D. in News, Opinion
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The Cleveland Browns have been in the news this week, and not because of newfound success on the gridiron. While sports is not among my highest priorities, I have developed increasing interest over the years since professional sports is religion to so many here in Cleveland and in Ohio. Cleveland sports teams all enjoy great success, provided that success is not defined by victories. It’s not if you win or lose but how…
I watched the Cleveland Browns compete against the Pittsburgh Steelers two Thursdays ago. I cringed as I witnessed our young quarterback, Colt McCoy, take a blow to the head that could have landed the perpetrator a 10 year prison sentence had this act occurred on the street. I wasn’t worried that McCoy would have to miss the rest of the game. I feared that he might have to miss the rest of his life. Violence sells tickets.
If an activity requires a participant to don a helmet and a coat of armor, then clearly it is an unwise activity for a human to engage in.
McCoy was taken off the field and reentered the arena 2 plays later, after an exhaustive evaluation that was completed in about 100 seconds. Since everything in sports and medicine is now measured, we know that McCoy was sidelined for a total of Read more »
*This blog post was originally published at MD Whistleblower*
October 30th, 2011 by GarySchwitzer in News, Research
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Reporter John Fauber has published the latest in his “Side Effects” watchdog series, headlined “Doctors didn’t disclose spine product cancer risk in journal: Spine-product paper omitted key data.” Excerpts:
“Doctors paid millions of dollars by Medtronic failed to identify a significant cancer risk with the company’s spine surgery product in a 2009 paper about results of a large clinical trial.
The surgeons left out important data and claimed there was no significant link between the product and cancer.
The company and doctors had become aware of information on Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
July 5th, 2011 by GarySchwitzer in News, Research
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The Spine Journal has published a special June issue focusing on Medtronic’s INFUSE product, or rhBMP-2, a bone growth product commonly used in spine fusion surgeries. A journal news release states:
A critical review of 13 industry-sponsored studies on a spine surgery product found that the actual risk of adverse events was 10 to 50 times the estimates originally reported. The product in question is recombinant bone morphogenetic protein-2 (rhBMP-2), a controversial synthetic bone growth factor often used as a bone graft substitute in spine fusion surgeries. This eye-opening study, “A critical review of rhBMP-2 trials in spinal surgery: emerging safety concerns and lessons learned” is included in a special BMP-focused issue of The Spine Journal.
The comprehensive review found four main areas of concern among the 13 original industry-sponsored studies:
• Conflicts of interest were either not reported or were unclear in each study. Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
May 14th, 2011 by Mary Knudson in Opinion
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I’ve been working for a couple of months on an in-depth article on personal defibrillators that are implanted beneath the skin of a person’s chest to shock a heart that starts shaking, thereby restoring its normal beating and preventing sudden death. Discussing these defibrillators is extremely complex, which is why I am spending so much time on researching and writing the article intended to help patients and their families make an informed decision by learning the truth about the devices known as implantable cardioverter defibrillators (ICDs) — the good and the bad, your life saved vs nothing happening or the accompanying risks and harm you may receive. So when I heard that a new study would be presented at the annual scientific meeting this week of the Heart Rhythm Society, a professional organization of cardiologists and electrophysiologists who use cardiac devices in their patients, I made sure to get an advance copy of what would be presented and interview the lead author.
Potentially such a study would be of interest to physicians and to patients considering getting an ICD because it looked at all shocks the defibrillators gave the heart in patients who took part in the clinical trial, including those sent for life-threatening rhythms and in error. For several reasons, I felt the study is not ready to report to the public. It is only an abstract. The full study has not yet been written, let alone published in a peer-reviewed journal or even accepted for publication. Patients with defibrillators who received shocks were matched to only one other patient who was not shocked, but the two patients were not matched for what other illnesses or poor quality of health they had. Yet they were matched to see who lived the longest and the study looked at death for all causes, not just heart-related. One critical question the study sought to answer was this: Do the shocks themselves cause a shortened life (even if they temporarily save it) or is a shortened life the result of the types of heart rhythms a person experiences? Read more »
*This blog post was originally published at HeartSense*
April 17th, 2011 by Elaine Schattner, M.D. in Opinion
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Recently Ed Silverman of Pharmalot considers the case of a ghost-written medical text’s mysterious disappearance. The 1999 book, “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” (reviewed in a psychiatry journal here) came under scrutiny last fall when it became evident that the physician “authors” didn’t just receive money from a relevant drug maker, SmithKline Beecham; they received an outline and text for the book from pharmaceutical company-hired writers.
poster for the X-Files
Now the book’s listing is gone from the website of STI (Scientific Therapeutic Information), the company that provided the authorship “help.” I tried to get a copy of the handbook on Amazon.com, where it’s currently out-of-stock. The book is listed in the Library of Congress on-line catalog: #99015420.
I’m reminded of clinical handbooks I used all the time when I was practicing hematology and oncology. At the hospital, I’d get freebie, small-sized chemo regimen primers that conveniently fit into my white coat pocket. In retrospect, perhaps I didn’t adequately check the authors’ credentials on those mini-book sources. It was too easy to take that information and keep it at hand, literally, especially in the times before we had constant Web access. Read more »
*This blog post was originally published at Medical Lessons*
I watched the Cleveland Browns compete against the Pittsburgh Steelers two Thursdays ago. I cringed as I witnessed our young quarterback, Colt McCoy, take a blow to the head that could have landed the perpetrator a 10 year prison sentence had this act occurred on the street. I wasn’t worried that McCoy would have to miss the rest of the game. I feared that he might have to miss the rest of his life. Violence sells tickets.
