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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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 in advance of the new law requiring disclosure beginning in 2013. See Medtronic’s searchable database of payments.
  • Digitek: A request for a class certification was recently denied in the Digitek MDL. The MassTortDefense Blog has an update.
  • PediaCare Recall: over 100,000 bottles of PediaCare, formerly manufactured by Johnson & Johnson (and, still being manufactured in their facility), have been recalled. This is a precautionary recall, based on the known problems with the J&J manufacturing facility.
  • AstraZeneca and Social Media: Here is AstraZeneca’s take on the transparency/social media issue.
  • Generic Drugs: The Supreme Court asks Obama’s administration for an opinion as to whether generic drug manufacturers can be sued for inadequate labeling that matches labeling of brand-name drugs. Here is the Eighth Circuit’s opinion, deciding that generic drug manufacturers can be held liable.
  • Celebrities in the News: Dennis Quaid is bringing public awareness to injuries caused by pharmaceutical companies. He settled with the hospital on the heparin overdose of his children, but now he’s going after the pharmaceutical company, Baxter Healthcare Corp.
  • More on Whistleblowing: Wyeth (through Pfizer) is accused of illegally promoting its kidney transplant drug for other organs and specifically among African-Americans, who have greater risks associated wit the drug.

Happy Wednesday!

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This is something every blog must struggle with. What voice should the blog have? First-person (or the blogger variant–the royal first-person, where everything is about “we” and “us,” though the blog is written by one person), or third-person?

SciFi.jpgCorporations frequently choose a corporate voice, making everything about the corporation. The voice of the blog is often the “voice” of the corporation (corporations are legal entities with rights, of course). But, this can be tough to read sometimes, and still manages to lose the personal flair of a first-person narrative.

So, when my Google Reader blog-feed listed AstraZeneca’s recent post, “Connections for Cardiovascular Health,” I was interested to see that they are gravitating toward a first-person voice. The side panel shows that the main contributor and “voice” is Earl Whipple, the blog editor and senior director in the AZ corporate communications group. The sidebar mentioned that others would contribute (the CEO had a post on March 23), but perusing the posts, it looks like Earl is the only contributor except for occasional guests.

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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:

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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 indicate 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 simply the age-old Hippocratic Oath—that physicians, above all else, must do no harm. The JAMA editor clearly 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.

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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).