Merck’s Initial Conclusions on the Vioxx Withdrawal
On September 30, 2004, Merck announced its decision to withdraw Vioxx. In its report, Merck cited the then-new results of the APPROVe study as the reasoning behind its decision. Merck’s analysis of the APPROVe study showed an increased risk of cardiovascular events in patients who had been taking the drug for 18 months or longer. Merck explained that the results of APPROVe were not complete until this time, and that early results of the study had not demonstrated the same cardiovascular risk that was evidenced by the study results as a whole.
In this statement, Merck also said it would conduct further investigations into its other COX-2 inhibitor, Arcoxia, to determine whether that drug’s prescription information should be amended to include further warnings.
Merck also announced that the value of its stock was expected to fall as a result of the news about Vioxx. In the year preceding the Vioxx withdrawal, Vioxx sales had accounted for just over 10% of Merck’s net earnings.
The Martin Report
In 2005, Merck hired the firm of Debevoise & Plimpton to conduct an investigation of all Vioxx study results and communications by Merck, including internal communications related to Vioxx. The firm was paid $21 million for the report, which was called the Martin Report after Judge John S. Martin, Jr., who headed up the investigation. The report concluded that Merck’s senior management had acted in good faith, and that the source of all the misunderstandings about the clinical safety of Vioxx was the sales team’s overzealousness.
The nearly 200-page Martin Report gave a detailed timeline of events surrounding Vioxx and explained Merck’s honest intentions at every turn. The report specifically addressed 27 different allegations against Merck, including its mishandling of APPROVe and other clinical trial results, its aggressive marketing tactics, and the idea that Merck purposefully withheld information about the risks of Vioxx. In each case, the report found that Merck scientists and officials had handled the data in good faith, and that any errors were the result of oversight, not intentional omission of data. The Martin Report did conclude, however, that Merck’s marketing team had exaggerated the safety of Vioxx and had intentionally used sales tactics in place of thorough information.
Read the entire Martin Report on Merck.com. (The report is a pdf so Adobe Reader is necessary to read.)
Diffusion of Responsibility
In response to the Martin Report, which was published in February of 2006, Merck stated that it was reassured that the findings of the report revealed no negligence on the part of Merck scientists or executives. Merck promised to consider the recommendations contained in the Martin Report, presumably by reconsidering and better supervising its advertising strategies. Whether or not Merck ultimately changed its marketing techniques is unclear, but the total spending for the advertising of drugs in general has not decreased.
Merck had hoped the Martin Report would serve as a definitive explanation of Merck’s position on Vioxx, both in the press and in the courtroom. However, in 2006, Merck announced a correction to its original statistical findings in the APPROVe trial.
Merck scientists reportedly made an error in calculating the cardiovascular risk in relation to the passage of time. In light of the corrected calculations, Merck retracted its claim that the risks of Vioxx were negligible during the first 18 months of treatment. This statement blew a gaping hole in Merck’s legal defense, which supported the 18-month benchmark theory, while also hurting the theory that marketing was entirely to blame for the Vioxx problem.
Throughout the investigations of Merck’s role in the handling of Vioxx, lawsuits have swept through courts across the US, costing Merck billions in settlements. The 2006 announcement only served to invite more lawsuits by destroying the 18-month theory and opening up claims of complications from short-term Vioxx users.
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