Merck and the FDA ... Vioxxx
January 14, 2005 10:14

On September 17, 2001, the FDA issued an 8-page WARNING LETTER to Merck concerning its false and misleading promotional campaign. The FDA found:

"You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator non-steroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen)."

The FDA demanded that Merck discontinue promoting Vioxx to doctors for unofficial uses and found after a review of several of Merck's promotional conference calls and sales pitches that the promotions by Merck "are false, lacking in fair balance, or otherwise misleading in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations." The FDA also required Merck to send letters about the deception to the medical community.

The letter dealt with so many improper and deceptive practices that it is difficult to imagine Merck, a leader in the field of prescription pharmaceuticals, had not formulated a plan to intentionally deceive the public, prescribing physicians, and the FDA itself as to the dangers posed by Vioxx. The FDA found:

• False advertising in misrepresenting the safety profile for Vioxx;
• Minimization of the potentially serious cardiovascular findings found in a prior study;
• Failure to disclose the fact that Merck?s explanation for the cardiovascular incident discrepancy in a prior study was only "hypothetical" and not "demonstrated by substantial evidence;"
• Failure to disclose that another explanation for the increased cardiovascular incident rate in the Vioxx group was that Vioxx "may have pro-thrombotic properties;"
• Improper minimization of the Vioxx/Coumadin (warfarin) drug interaction;
• The omission of "important risk information;"
• Unsubstantiated superiority claims against other NSAIDs;
• Promotion of Vioxx for unapproved uses;
• Promotion of an unapproved dosing regimen; and
• Misrepresenting Vioxx?s safety profile by "minimizing the potentially serious risk of significant bleeding that can result from using Vioxx and warfarin concomitantly."

kind of miss seeing Dorothy Hamill glide across the surface of those Vioxx commercials on her silver blades. The Olympic gold medalist reminded me of the old joke about the man who asks his surgeon if he'll be able to play the piano after the operation. When the doctor says yes, the man says, "That's funny, I couldn't play it before."

I began to have a fantasy that if I popped a couple of Vioxx I could finally do a triple Lutz before I got on Medicare.

http://pubs.acs.org/cen/news/83/i02/8302vioxx.html Oxidation to a maleic anhydride derivative may be a factor in the long-term toxicity of rofecoxib (Vioxx), a new report suggests. This previously unknown reactivity is not shared by other cyclooxygenase-2 (COX-2) inhibitors, such as celecoxib (Celebrex), valdecoxib (Bextra), and lumiracoxib (Prexige). The hypothesis, if proven true, runs counter to the assumption that other COX-2 inhibitors pose the same risk to humans as Vioxx. Vioxx was withdrawn from the market last September by its manufacturer, Merck, after a clinical trial indicated that it poses an increased risk of cardiovascular events.

January 11, 2005 09:15 AM US Eastern Timezone Hundreds of Lawyers Gather at LexisNexis-Sponsored Symposium On Vioxx to Discuss Recent Developments in the Legal Drive Against Merck for January 20-21 (Thursday-Friday) --(BUSINESS WIRE)--Members... (Read this Vioxx Article)

The European Medicines Agency probe mirrors a parallel investigation by the U.S. Food and Drug Administration next month into the safety of the drug class, following the withdrawal of Merck's Vioxx and concerns over Pfizer's Celebrex.

Both drugs -- widely used by arthritis sufferers around the world -- have been linked to an increased risk of heart attack.