Papers Spin Scuffle over Study Data into Knockout for Merck Opponents
Published: 12/9/2005 2:00 PM ET
Stacking the deck against Merck and Co., Inc., reporters for The New
York Times and USA Today presented an allegation that the
prescription drug maker tampered with results in its own study. The
company was accused of withholding information on non-fatal heart
attacks, but it had actually disclosed the information five years
ago.
The heart attacks in question, suffered by participants in a study of the painkiller Vioxx, actually occurred after the study had ended. The Times and USA Today featured Merck opponents proclaiming a newfound edge in their Vioxx lawsuits, even though Merck was unable to comment on the substance of the case due to a judges gag order.
The heart of the controversy is an editorial published on December 8 by Dr. Gregory Curfman, executive editor of the New England Journal of Medicine. Curfman called for Merck to submit a correction to its November 2000 study on the effectiveness of Vioxx, approved in 1999 by the FDA for patients with rheumatoid arthritis.
But Curfman and his staff had known for four years about the three heart attacks that had not been added to the 17 tabulated among Vioxx users in the 2000 study. Three myocardial infarctions, all in the rofecoxib group, were not included in the data submitted to the Journal, noted Curfman, adding that the editors first became aware of the additional myocardial infarctions in 2001 when updated data were made public by the Food and Drug Administration.
In response Merck issued a press release the same day noting that its peer-reviewed study fairly and accurately described the results of the study as of the pre-specified cutoff for analysis for the articles publication. Merck also noted the three heart attacks not included in the November 2000 article were disclosed to the FDA in 2000, presented publicly at the FDA's Advisory Committee in February 2001, included in numerous press releases subsequently issued by Merck, disclosed to physicians given a copy of the article by Merck and detailed in the updated prescribing information for VIOXX.
Merck eventually pulled Vioxx from the market in September 2004 over concerns that long-term use elevated risk of heart attacks and strokes, but this was not at issue in the 2000 study in the Journal of Medicine. Quite simply, the dispute with the Journal of Medicine is a narrow issue over data included in a medical journal, not necessarily a sign of a grave cover-up, defense attorney John Brenner cautioned Reuters. My initial impression is, in terms of the litigation, here may be a little less there than immediately meets the eye, said Brenner, who previously has represented drug companies. Brenner added, What I'm waiting to see is what are the authors (of the study) going to say in response. That is critical.
Critical perhaps to a veteran defense attorney, but not to the media. On the front page of the December 9 New York Times, Alex Berenson represented Mercks side of the story in just two sentences. He merely said that Merck said in its statement that it had acted properly and promptly disclosed the results of the study. And while he noted that a judge in a Vioxx case in Houston has forbidden both sides of the case to talk with the media, Berenson found room for attorneys Christopher Seeger and W. Mark Lanier to predict trouble for Vioxx in court.
A December 9 USA Today article also skewed coverage against the Vioxx producer. Mercks position was summarized in one paragraph, without explaining that the heart attacks excluded from the study report didnt occur during the study period. Unlike the Times Berenson, USA Today did not explain why Vioxx had no further comment, but did quote FDA researcher and Merck critic David Graham as saying that Mercks defense was a mere fig leaf to hide behind after quoting Daniel Becnel, a Vioxx plaintiffs attorney, saying that the Journal of Medicine incident changes the whole ballgame.
The slant against Vioxx in the media is not a new phenomenon. The Business & Media Institute (BMI) reported in August 2005 on media coverage of Vioxx litigation. Analysts for BMI found 94 percent of stories aired on evening broadcast network news cited sources on the plaintiffs side, while only 56 percent aired Mercks point of view.
The heart attacks in question, suffered by participants in a study of the painkiller Vioxx, actually occurred after the study had ended. The Times and USA Today featured Merck opponents proclaiming a newfound edge in their Vioxx lawsuits, even though Merck was unable to comment on the substance of the case due to a judges gag order.
The heart of the controversy is an editorial published on December 8 by Dr. Gregory Curfman, executive editor of the New England Journal of Medicine. Curfman called for Merck to submit a correction to its November 2000 study on the effectiveness of Vioxx, approved in 1999 by the FDA for patients with rheumatoid arthritis.
But Curfman and his staff had known for four years about the three heart attacks that had not been added to the 17 tabulated among Vioxx users in the 2000 study. Three myocardial infarctions, all in the rofecoxib group, were not included in the data submitted to the Journal, noted Curfman, adding that the editors first became aware of the additional myocardial infarctions in 2001 when updated data were made public by the Food and Drug Administration.
In response Merck issued a press release the same day noting that its peer-reviewed study fairly and accurately described the results of the study as of the pre-specified cutoff for analysis for the articles publication. Merck also noted the three heart attacks not included in the November 2000 article were disclosed to the FDA in 2000, presented publicly at the FDA's Advisory Committee in February 2001, included in numerous press releases subsequently issued by Merck, disclosed to physicians given a copy of the article by Merck and detailed in the updated prescribing information for VIOXX.
Merck eventually pulled Vioxx from the market in September 2004 over concerns that long-term use elevated risk of heart attacks and strokes, but this was not at issue in the 2000 study in the Journal of Medicine. Quite simply, the dispute with the Journal of Medicine is a narrow issue over data included in a medical journal, not necessarily a sign of a grave cover-up, defense attorney John Brenner cautioned Reuters. My initial impression is, in terms of the litigation, here may be a little less there than immediately meets the eye, said Brenner, who previously has represented drug companies. Brenner added, What I'm waiting to see is what are the authors (of the study) going to say in response. That is critical.
Critical perhaps to a veteran defense attorney, but not to the media. On the front page of the December 9 New York Times, Alex Berenson represented Mercks side of the story in just two sentences. He merely said that Merck said in its statement that it had acted properly and promptly disclosed the results of the study. And while he noted that a judge in a Vioxx case in Houston has forbidden both sides of the case to talk with the media, Berenson found room for attorneys Christopher Seeger and W. Mark Lanier to predict trouble for Vioxx in court.
A December 9 USA Today article also skewed coverage against the Vioxx producer. Mercks position was summarized in one paragraph, without explaining that the heart attacks excluded from the study report didnt occur during the study period. Unlike the Times Berenson, USA Today did not explain why Vioxx had no further comment, but did quote FDA researcher and Merck critic David Graham as saying that Mercks defense was a mere fig leaf to hide behind after quoting Daniel Becnel, a Vioxx plaintiffs attorney, saying that the Journal of Medicine incident changes the whole ballgame.
The slant against Vioxx in the media is not a new phenomenon. The Business & Media Institute (BMI) reported in August 2005 on media coverage of Vioxx litigation. Analysts for BMI found 94 percent of stories aired on evening broadcast network news cited sources on the plaintiffs side, while only 56 percent aired Mercks point of view.
