Drug Recall Lawyer Blog

Not drug related, but Happy Anniversary is in order.

Now that you know more about me than you are probably comfortable with (who celebrates that?), let’s get to business with some noteworthy items:

• Reuters discusses the FDAs investigation of using drugs like Seroquel on children.
• Recently expanded indications for Seroquel by children.
• The Chicago Tribune writes about abuses in prescribing psychotropic medications without consent and without a valid medical reason. Note the front-and-center picture of Seroquel.
• The Wall Street Journal discusses a clinical study showing that an experimental once-a-week treatment woks better to treat type-2 diabetes than Januvia.
• Tomorrow (December 8, 2009) the FDA will convene a joint meeting of the Cardiovascular and Renal Drugs Committee and Drug Safety and Risk Management Advisory Committee. They will discuss safety as it pertains to Gadolinium-based contrast agents, which are used before MRI procedures. A copy of the background material (agenda, briefing information and meeting roster) is located here. More information on Gadolinium-based contrast agents can be found at our blog and our website.
• More on Ghostwriting (courtesy Brian Ketterer). I like this excerpt:

If a professional writer is paid by a company to write a piece and a non-author doctor is asked to approve it, the appropriate outcome would be for the professional writer to be listed as the author and for the non-author doctor to be thanked in an acknowledgement for having reviewed the paper. If the non-author doctor makes substantial enough changes to the paper, he or she might be listed as a coauthor. In either case, the funding for the paper should be disclosed.

Happy Monday!

Here are some links to what’s going on the world of drug and device recalls, and pharmaceutical litigation:

• Numerous blog posts featuring inside information on Vytorin and Zetia research studies, including the Arbiter 6 study that we recently posted on (courtesy Schearlings-Got-Plowed).
  
• Twitter hashtag of information on the FDA’s Social Media Meeting (courtesy @skypen).
• FDA celebrates International Internet Week of Action by sending 22 warning letters to operators of websites for illegally selling unapproved or misbranded drugs to U.S. customers.
• Procter & Gamble recalls three lots of Vicks Sinex Nasal Spray, because of bacterial contamination.
• Google Scholar now available to perform legal research—free opinions from U.S. federal and state district, appellate and supreme court opinions.
• Visit the Drug Industry Document Archive (DIDA) for over 1500 drug company documents, many only revealed after litigation. Included are some Wyeth ghostwriting documents (courtesy Tom Lamb).
• Fun new blog on Evidence in Medicine.

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.

Continue reading "Next Step: Punitive Damages" »

Here's a link to a good video on the ghostwriting behind Wyeth's hormone therapy, by CBS in Chicago.

Ghost(writing) Busters (08-06-09)

There’s been a flurry of newspaper and internet articles of late about Wyeth’s ghostwriting troubles. We broke the news here on July 27 with Judge Wilson’s order unsealing ghostwritten documents.

One terrifically written article is by the New York Times, which describes the specifics of the ghostwriting practice. See the article and an excellent chart showing the ghostwriting process.

The plaintiffs lawyers, led by Cleveland Ohio attorney Jim Szaller (the true Ghost(writing) Buster), really worked hard to bring these documents and practices to light. Essentially, ghostwriting is a company’s practice of writing a medical article (either on their own or with the help of an outside company), asking a medical doctor to “author” it after-the-fact, and then publishing it in otherwise reputable journals without disclosing the writing process or the financial interest of the actual writer or “author.” This is simply marketing masquerading as science. It works to the detriment of patients, who are prescribed these drugs because their physicians believe they have been well-vetted in the medical journals. In fact, those journals articles are simply clever advertisements.

In one article highlighted by the court, the physician received a manuscript from a company paid by Wyeth to write the document, and made “one correction.” That’s not authorship by any stretch of the imagination.

On Friday, Judge Wilson of the U.S. District Court for Arkansas ordered the unsealing of Wyeth documents regarding the company’s practice of “ghostwriting.” Wyeth has been the subject of much litigation for many years over hormone therapy drugs (Prempro and Premarin) that were routinely prescribed to post-menopausal women. Innumerable studies have been published showing that the drugs cause breast cancer. Wilson is currently sheparding over 8,000 hormone therapy cases.

Front-and-center in the litigation is the advertising methods that Wyeth used. Ghostwriting is an insidious practice, where a drug company will pay a doctor for the right to use his or her name on a publication that the drug company writes to tout the benefits of their product. The publication is typically written by the marketing department, but disguised to look like science. Then, drug company sales representatives take that publication to other doctors, and say, “Dr. Smith wrote a terrific article about our drug—he likes it and affirms that it is safe, so you should prescribe it to your patients.” Needless to say, it’s never disclosed to the doctors that Dr. Smith didn’t write the article, or that the drug company did.

Plaintiffs’ attorneys used the documents in litigation, but they were marked confidential. Senator Charles Grassley of Iowa obtained copies last year for an investigation by the Senate Finance Committee, evaluating physician influence by drug companies. Prompting the unsealing, the New York Times has requested copies, and the unsealing of these documents will allow the public to see what really goes on behind the closed doors of drug companies. This is a small victory for corporate accountability.