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.
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.
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.