Articles Posted in Marketing

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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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Life-and-Times-of-Time.jpgI saw a link the other day to CNBC’s “Pharma’s Market” by Mike Huckman titled The Funny Business of Selling Drugs. Unsure if it was truly funny or more simply “funny” in the sense of “something funny is going on here,” I clicked the link.

Turns out it’s a little of both. It’s a brief article about an HBO Comedy, “The Life and Times of Tim” (which, admittedly, I’ve never seen nor heard of).

According to the article, one episode has the following premise:

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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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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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Interesting developments in online social media and drug companies in the past week. As you know, the FDA has been soliciting requests about how to manage online social media for drug and device manufacturers. This is clearly a lot for drug companies to deal with and here are some things they should wrap their minds around:

  1. Sanofi-Aventis VOICES Facebook Page: This drug company, maker of the cancer drug Taxotere, learned first-hand the downside of having a Facebook site that allows interaction with customers. That downside is that customers interact. One Taxotere-user posted complaints to the FB page about the drug, only to have her post removed. Undeterred, she sent more posts, opened other Facebook accounts, sent more posts, had friends send posts, and just generally assaulted the Sanofi-Aventis stronghold. Finally, Sanofi-Aventis changed its information and stated on the FB page:

    This page is not intended as a forum for discussing sanofi-aventis’ or other companies’ products. As such, Postings that contain product discussions will be removed by sanofi-aventis.