Drug Recall Lawyer Blog

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 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.”
• FDA Chastises GE: The FDA warns GE that its website for Visipaque is misleading. Visipaque is a drug used with x-rays to provide clearer images, and the FDA reports that there is no data showing it to be safer than other contrast agents. GE is currently facing lawsuits on it’s MRI contrast dye, Gadolinium.
• Meridia: Tom Lamb and the Drug Injury Watch report on a possible Meridia drug recall.
• Glaxo and Merck Disclose (Hide?) Payments to Doctors: The TortsProf Blog cites a story about Glaxo and Merck publicizing the money they give to doctors. The blog reports that the disclosure lists were “difficult to locate.”
• Hormone Therapy: Bloomberg reports that a judge denied Pfizer’s attempts to forcibly remove a YouTube video on hormone therapy, posted by Plaintiffs’ attorneys. The judge did, however, require the attorneys to rename the video and indicate it was not a news segment (which was obvious from watching the video). See the video here.

Happy Tuesday!

The results of a six-year trial on Meridia’s active ingredient, sibutramine, show a statistically significant increase in heart attacks, strokes and death. Meridia, manufactured by Abbott Laboratories, was approved by the FDA in 1997 as a prescription-only weight loss supplement.

The SCOUT study (Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event—we don’t understand the acronym, either) is a post-marketing surveillance study required by the European Medicines Agency as a condition for approval of the drug. 10,000 patients were enrolled in the study, with 5,000 taking a placebo and 5,000 taking sibutramine. It was designed to show that weight loss with sibutramine was more effective in reducing cardiovascular events. The study shows just the opposite, however.

The FDA has indicated that, upon initial review of the study, sibutramine-use is associated with a 1.4% increase in adverse cardiovascular events. This is statistically significant, especially because in the past year there have been 294,000 prescriptions for Meridia (only one version of the drug) in the United States. 1.4% of 294,000 is 4,116 cardiovascular events, which may include death. The FDA’s Adverse Event Reactions (AERS) database indicates that there have been 84 reports of death from cardiovascular causes. Of those 84 deaths, 11 were under the age of 31.

Meridia is contraindicated for patients with pre-existing coronary artery disease, congestive heart failure, peripheral arterial occlusive disease, arrhythmia and cerebrovascular disease. The European Medicines Agency will review the study in January, 2010. Likewise, the FDA indicated in its November 20, 2009 Early Communication that it is reviewing the data and “is conducting an expedited safety review.”

Public Citizen has re-petitioned the FDA for recall of the drug based on the results of the study. It asked for a recall twice before, in 2003 and 2005. The 2005 FDA denial letter specified that

An unbiased, objective assessment of sibutramine’s cardiovascular safety profile, particularly when used in obese patients with known or occult cardiovascular disease, can best be made through analysis of data from a large, randomized, controlled trial. The Sibutramine Cardiovascualr Outcomes, or SCOUT study, is such a trial.

So, now the FDA has everything they need to make a recall. Our bet is that they don’t pull the trigger, however. We hope we’re wrong.