Officials Explain Internal Documents Related to Vioxx

posted on:
November 15, 2004

author:
Staff

Merck has begun "offering explanations" for internal documents that allegedly indicated the company was aware of the safety risks of the CQX-2 inhibitor Vioxx years before the voluntary withdrawal of the medication in late September, the Wall Street Journal reports (Martinez, Wall Street Journal, 11/15). In a previous article, the Journal described a 16page internal instructional marketing document called "Dodge Ball Vioxx," which presented Merck sales representatives with sample physician questions about the safety concerns related to Vioxx and listed the correct responses as: "DODGE!" (American Health Line, 11/1). On Friday, Kenneth Frazier, general counsel for Merck, said that the title of the document referred to a sales-training game that encourages sales representatives to answer physician questions with language approved by FDA.

The game includes two teams that question each other on Vioxx, and if one team selects a card that reads "dodge," that team can pass on a question, he said. Frazier also "provided context" for an internal e-mail sent by Merck research chief Edward Scolnick in which he referred to the safety risks of Vioxx (Wall Street Journal, 11/15). In the e-mail, Scolnick

wrote that Vioxx research indicated cardiovascular events "are clearly there" and that the problem is "mechanism based," or related to the effect that the medication has on the body (American Health Line, 11/1). According to Frazier, Scolnick made the comments on the same day that the results of the clinical trial on which he based his conclusions

became available to Merck, and "as such it represented the initial impressions on the data." Frazier added that Merck subsequently "unblinded" two placebo-controlled Vioxx trials on Alzheimer’s patients and found no increased risk for cardiovascular events (Wall Street Journal, 11/15).

Removal of Member From FDA Advisory Committee Examined

The New York Times and Washington Post on Saturday examined the removal of Curt Furberg, a professor at Wake Forest University, from an FDA advisory committee scheduled to review the safety of COX-2 inhibitors next year, after he publicly questioned the safety of Bextra, a COX-2 inhibitor manufactured by Pfizer. Preliminary results of a University of Pennsylvania study presented last week at the American Heart Association annual conference in New Orleans indicated that Bextra doubles patient risk for heart attack and stroke. Furberg said FDA informed him that he would no longer participate on the committee after he said publicly that the results of the study indicate that Bextra appeared to have similar risks to Vioxx and that Pfizer attempted to conceal the information (American Health Line, 11/12). According to Victoria Kao, a spokesperson for FDA, Furberg is "not barred_forever from the panel" but was

asked not to participate because of an "intellectual conflict of interest," the Times reports. Furberg, who said that he did not expect FDA to remove him from the committee, might present his data and opinions in a public comment period at the meeting (Kolata, New York Times, 11/13). "I think they’re trying to control criticism at the committee meeting,"

Furberg said, adding, "The fact that I’ve commented on the issue should be irrelevant." Sandra Kweder, deputy director ofthe FDA Office ofNew Drugs, said that the agency often removes advisory committee members who have financial or intellectual conflicts of interest. She added that FDA could reconsider the decision (Kaufman, Washington Post, 11/13).

NYT Examines Merck Decision To Withdraw Vioxx

The New York Times on Sunday examined events that began in 2000 that led to the withdrawal ofVioxx (Berenson et aI., New York Times, 11/14). Merck voluntarily withdrew Vioxx based on a study that indicated the medication doubled patient risk for heart attack and stroke. Last week, Senate Finance Committee Chair Chuck Grassley (R-Iowa) called on Merck CEO Raymond Gilmartin and FDA acting Commissioner Lester Crawford to testify at a Nov. 18 congressional hearing on actions that the company and the agency took to inform the public about the cardiovascular risks associated with Vioxx (American Health Line, 11/11). In documents filed with the Securities and Exchange

Commission last week, Merck reported that the Department of Justice has launched a criminal investigation into company actions related-to Vioxx that likely will examine whether Merck misled investors, regulators and public health insurance programs about the safety of Vioxx. SEC also has begun an informal inquiry that likely will focus on issues of disclosure, such as whether Merck fully informed investors about the information that emerged from research about Vioxx’s risk (American Health Line, 11/9). According to the Times, Merck officials in May 2000 declined to pursue a study of Vioxx focused on its cardiovascular risks because scientists questioned the feasibility of such a study and company marketers "apparently feared it could send the wrong signal about the company’s confidence in Vioxx." Merck’s "recurring theme" between 2000 and 2004 was that "Vioxx was safe unless proved otherwise," the Times reports. During that time, critics said Merck downplayed Vioxx’s possible risks, including dismissals of studies in

March 2000,2001, October 2002 and April 2004 that showed Vioxx increased patients’ risk of heart attack and stroke. Merck withdrew Vioxx after an FDA study was released in August that showed a heightened cardiovascular risk for Vioxx. In interviews last week, Merck officials said the March 2000 study — which found that five times as many

patients taking Vioxx had heart attacks as those taking naproxen, an older pain reliever — was the first to suggest that Vioxx posed a cardiovascular risk. Company officials said Merck researchers have been ‘.’chasing the question of why the rate of heart problems was so high" since that study was released, according to the Times (New York Times,

11/14).

Lawsuits Related to Vioxx Examined

The Raleigh News & Observer on Saturday examined the "army of lawyers nationwide who are preparing lawsuits against Merck" in response to the withdrawal ofVioxx. According to Merck officials, the company to date faces about 300 lawsuits related to Vioxx. "Hundreds more are expected," and some analysts predict that the litigation could cost Merck as much as $18 billion in liabilities, the News & Observer reports (Rives, Raleigh News & Observer, 11/13).

Broadcast Coverage

NPR’s "All Things Considered" on Friday reported on the increase in lawsuits related to Vioxx. The segment includes comments from attorney Vance Andrus; Andy Birchfield, an attorney in Montgomery, Ala.; Carlene Rhodes-Lewis, an attorney in Houston; and Thomas Moore, a defense attorney (Horsley, "All Things Considered," NPR, 11/12). The

complete segment is available online in RealPlayer. In addition, "Nightly Business Report" on Friday reported on criticism of FDA actions related to Vioxx and other medications safety issues. The segment includes comments from Crawford; Henry McKinnell, chair and CEO of Pfizer; and Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen (Woods, "Nightly Business Report," PBS, 11/12). The complete transcript is available online.

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