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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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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.

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Profit-02-15-10%29.JPGIn Foster Care Children and Off-Label Drug Use, I discussed the use of drugs, particularly psychotropics, to medicate children. In Who Do The Drug Companies Cater To? I talked about doctors (one in particular) who, by all accounts, clearly overprescribed medications, including Seroquel and clozapine.

Now, an article from the Anchorage Daily News reports that the Law Project for Psychiatric Rights filed a federal lawsuit against over a dozen Alaskan psychiatrists, stating that the doctors “unnecessarily drugged children and committed Medicare fraud.”

The article points out that children on Medicare are four times as likely to be put on antipsychotic medication as children who have private insurance. 90% of children seeing psychiatrists are put on medication, while less than 10% of those medications are FDA approved for children.

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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;
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Instead of doing our usual Monday Drug Blog Round-Up yesterday, we opted for a fuller post on the recent plaintiffs’ pain pump victory in Oregon. For more on that story, see the Oregonian. So, today we’ll bring you the links to the stories we’re following:

  • Direct-to-Consumer Advertising: FiercePharma lists the top ten drugs for a percentage of web-based traffic from DTC ads. YAZ is seventh, even “better” than Viagra.
  • Radiation Therapy Malpractice: Pat Malone reports on the dangers of technology, training, and procedures in radiation therapy: “Scott Jerome-Parks suffered terrible radiation burns to his neck, and lingered for two years in agony before dying, because he received a seven-fold overdose in the radiation that was supposed to treat his tongue cancer, on three separate occasions.”
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It will be a great year. If one of your new year’s resolutions is to follow industry news more closely, here’s some required reading:

  • Hormone Therapy: Bloomberg reports on the latest Plaintiff’s Prempro victory (actually, the drug at issue here was Provera, later combined with Premarin by Wyeth to make Prempro)—a Pennsylvania appeals court ruled that the trial court wrongly granted judgment for defendants, notwithstanding a jury verdict for Plaintiff. We’ll report more on this later in the week.
  • Conflicts of Interest: The New York Times notes that two Harvard Hospitals (Massachusetts General and Brigham and Women’s) have issued new guidelines on outside pay for senior officials. They can now only accept a maximum of $5,000 per day of actual work—and no stock. Importantly, the speaker’s fees from drug companies are prohibited for all employees. The momentum is good—let’s hope these attitudes spread.
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The United States Court of Appeals for the Eighth Circuit yesterday issued its opinion in Scroggin v. Wyeth, et al. The opinion is overwhelmingly positive for women and their families who have been injured by the hormone therapy. Donna Scroggins, like many women who took hormone therapy, suffered from breast cancer in both of her breasts and later had both of them removed.
In the underlying 2008 Arkansas trial, the jury found Defendants liable to the tune of $2.75 million in compensatory damages, and $27 million in punitive damages.

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