3 years ago today: Probe of Merck "arrangement" with the FDA and data analysisOn 16 October 2004 the Financial Times of London and the Washington Post reported on a probe of the FDA and its relationship with Merck. Vioxx had been withdrawn two weeks previously. The FT discussed a secret deal with US regulators that made Merck privy to government studies on its drugs. An FDA E-mail, suggested regulators discussed a notification agreement with Merck. In a May 14 2002 e-mail, Ann Trontell, FDA deputy drug safety director, warned colleagues that a Merck official had reminded her that "there had been an agreement that Merck would be informed prior to any FDA publication about one of their drug products".
The Washington Post reported that "Merck officials faced a difficult decision about how to handle the catastrophe". "The whole saga, industry experts said, raises unsettling questions about aggressive consumer marketing of drugs before their long-term safety has been proven."
"researchers had been warning about the drug's possible cardiovascular risks since 2000". "Data from a company study found then that users had four times as many heart attacks and strokes". Merck "repeatedly reassured the medical and financial communities that Vioxx was safe". Eric Topol said "Why didn't they stop the DTC [direct to consumer] marketing?". "That's the tragedy here."
"The FDA safety officer in charge of the report, David Graham, concluded that Vioxx posed much greater cardiovascular risk than the other major drug in its class" In an E-mail "a Merck official complained that the FDA had not lived up to a prior agreement to alert the company before releasing any negative information about its products."
Clinical trials include independent safety monitors. "The four monitors, along with a Merck statistician were the only ones with full access to information about the trial, including which patients were getting Vioxx and which were getting the placebo."
(For a glimpse into the way in which data and analyses can get combobulated under such incestuous high-stake conditions a single example will suffice. Therein lies a great deal of the problem.)
Merck is I believe one of the more ethical pharmaceutical companies. Who sets the standards?
Sources: Financial Times, 16 Oct 04, Merck under spotlight for 'deal' with US drug regulators; Washington Post, 16 Oct 04, Painful Withdrawal for Makers of Vioxx