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Articles Posted in Conflicts of Interest

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St%20Jude%20Logo-06-22-10%29.gifThe California Watch wrote about questionable ties between a cardiologist, Dr. Michael Burnam, and a medical device company, St. Jude Medical, Inc.

The allegations are that Dr. Burnam convinced St. Jude to give his son a $200,000 a year job in exchange for a lot of new business. St. Jude manufactures defibrillators, and one patient is accusing Burnam of arranging for a completely unnecessary defibrillator implant surgery. That surgery almost cost a patient his life, when the implanting surgeon accidentally stabbed the patient’s heart with the implant.

This kind of quid pro quo is intolerable, particularly to the extent that patients have no idea of the relationship between their physicians and medical device manufacturers. Part of the problem, in this case, is that, as alleged by the patient, the cardiologist deliberately misinformed the implanting surgeon about the patient’s medical history. Had he been properly informed, the surgeon would have realized that the surgery was unnecessary.

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Here are this week’s stories:

  • Vioxx: See Shearlings Got Plowed for a quick summary of the Australian Vioxx trial. Good news.
  • Defibrillator Battery Recall: 5,418 battery packs used in Lifeline AED and ReceiveR external defibrillators are recalled. See the FDA’s notice.
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Here are this week’s stories:

  • Medtronic: Medtronic reported that it paid $15.7 million to U.S. doctors in the first 3 months of 2010. Payments were for consulting fees and royalties. This report comes well before the new law requiring disclosure beginning in 2013. See Medtronic’s searchable database of payments.
  • Digitek: A request for class certification was recently denied in the Digitek MDL. The MassTortDefense Blog has an update.
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The medical journal The Lancet is chiming in on the Avandia debacle. Back in 2009, The Lancet published a paper about the RECORD study (funded by Avandia manufacturer GlaxoSmithKline) which was widely criticized. The major complaint is that the article did not include the drop-out rate—without knowing which patients went off the drug, it is impossible to calculate the risk of Avandia-caused heart attacks. Now, The Lancet issued an editorial titled “Strengthening the credibility of clinical research.” It describes briefly the Avandia situation, likening the recent Senate Committee on Finance report to a John Grisham novel: “GlaxoSmithKline (GSK), intimidated researchers and manipulated the scientific process for commercial advantage.”

Here are some “talking points” from the editorial:

  • At a time when some pharmaceutical firms have received record fines for misconduct, the saga of rosiglitazone [Avandia] tests the limits of tolerance
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Here are the stories we’re following this week:

  • Pfizer: CNN reports on why Pharmaceia, Pfizer’s shell company, “took the fall” for Pfizer’s illegal marketing practices
  • Crestor: will the marketing campaign persuade people to take it when they don’t need it? (HT: Patient Safety Blog).
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The Avandia debacle heats up, this time in the medical journal community. The editor of the premier medical journal, The Journal of the American Medical Association (JAMA) has taken other journals to task for their methods of publishing articles. Using the Avandia RECORD study as the example of the conflicts of interest rampant in the medical publishing community, the editor explains “concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.” For the past ten years, JAMA has required:

…at least 1 author must show that she or he “had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Additionally, that author cannot be funded by any commercial funding source. The source for this criterion is the age-old Hippocratic Oath—that physicians, above all else, must do no harm. The JAMA editor understands that when industry pressures are brought to bear, physicians may be (and have been) influenced to in a manner inconsistent with good science. And the result is that people rely on bad studies, and patients take bad drugs with incomplete and faulty information. The editor further recommends that drug study data be freely available to academic researchers.

Not only will the editor’s suggestions (if enacted by other journals) provide a means to double-check data to ensure its quality, but it will provide an extra reason for scientists and researchers to do the right thing from the beginning, and to stay true to the scientific method.

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Drug Recall Lawyer Blog Round-Up (03-22-10)

Here are this week’s stories:

  • Avandia: The MayoClinic investigated who authored articles supporting Avandia in medical journals, and discovered that 90% had ties to the manufacturer, GlaxoSmithKline (HT: FiercePharma).
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Here are this week’s stories:

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Here are the stories we’re following:

  • Levaquin: NJ.com reports that Levaquin manufacturer Johnson & Johnson may have paid millions in kickbacks to a large pharmacy for prescriptions to nursing home patients. The complaint was filed by the U.S. Attorney in Boston.
  • Acetaminophen: An article published in the medical journal Thorax ScienceDaily reports that there may be a direct link between use of acetaminophen during pregnancy and child asthma.
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The FDA’s Center for Devices and Radiological Health (CDRH—you can follow them on Twitter) will hold a free public meeting to address concerns and discuss strengthening of the 510(k) process. The agenda includes:

  • Issues related to predicate devices;
  • Issues related to new technologies and scientific evidence;