Merck's General Counsel Frazier Takes Issue With Congressman Henry Waxman's June 2005 NEJM Article
In the September 29, 2005 edition of The New England Journal of Medicine ("NEJM") is a letter to the editor by Kenneth C. Frazier, senior vice president and general counsel of Merck, under the heading "The Lessons of Vioxx". In his letter, Mr. Frazier takes issue with an article by Henry A. Waxman, the U.S. Representative from California, that was published in the June 23, 2005 issue of the NEJM entitled "The Lessons of Vioxx -- Drug Safety and Sales".
As reported earlier, Congressman Waxman was critical of Merck's Vioxx sales tactics in his NEJM article. In particular, Congressman Waxman provided examples of how, as regards Merck and Vioxx during the period 2001 to 2004, there was generally "a broad disparity between the evidence-based perspective provided by scientific journals and expert committees, on the one hand, and the sales pitch used by the company's field staff, on the other."
In retort, Merck's general counsel Frazier seemingly accuses Congressman Waxman of presenting a distorted view of "the facts". Mr. Frazier concludes that "neither Congress nor the American public should be led astray by misleading characterizations of Merck's activities or of the underlying science" -- presumably by Congressman Waxman's article.
The September 2005 Frazier NEJM letter includes the assertion that Merck's sales representatives in the field, i.e., the people who met personally with doctors in an attempt to persuade them to write Vioxx prescriptions, acted properly at all times leading up to the September 2004 Vioxx recall. In support of his position, Merck's general counsel makes the following points:
Until the FDA label change, and consistent with Merck's long-standing policies, Merck instructed its sales force not to initiate discussions about [the Vioxx Gastrointestinal Outcomes Research (VIGOR) study] but to submit physicians' questions about the cardiovascular profile of Vioxx to Merck's Medical Services department.
Our representatives were instructed to present a balanced description of the risks and benefits of Vioxx that were fully consistent with the FDA-approved label and our understanding of the cardiovascular risks associated with Vioxx.
It is largely as a result of Merck's postmarketing studies of Vioxx... that we informed an important scientific discussion regarding the risks and benefits of the entire class of medications. This discussion has led the FDA to conclude that all NSAIDs may present cardiovascular risks. That is the lesson learned from Vioxx.
Essentially, the Frazier attack on Congressman Waxman is reduced to this contention:
Most important, Waxman fails to provide the context of Merck's marketing efforts — Merck's belief in the safety profile of Vioxx and its benefits. Merck's marketing of Vioxx was informed by all available clinical and scientific data.
In the same September 29, 2005 edition of the NEJM, Congressman Waxman replies succinctly to Mr. Frazier's arguments.
First, Congressman Waxman observes that Mr. Frazier does not explain why "Merck's long-standing policies" permitted mention of Vioxx's gastrointestinal benefits in the VIGOR study but not of its cardiovascular risks.
Second, Waxman questions how Frazier can continue to defend Merck's "flawed" cardiovascular analysis of preapproval studies -- which was mailed to thousands of physicians and featured in marketing materials -- as "fully consistent with the FDA-approved label." According to the Waxman NEJM reply:
In fact, the analysis was not mentioned on the label and actually was rejected by the FDA for inclusion in the label.... An FDA official told Congress that Merck's depiction of Vioxx as safer than the alternatives was "scientifically inappropriate" and "ridiculous."
In concluding his reply, Congressman Waxman attempts to bring one's focus back to the real lesson that we should take away from the Vioxx debacle:
Drug advertisements for consumers are receiving increased scrutiny. The lesson of Vioxx is that industry marketing to physicians deserves attention too.
It appears that Mr. Frazier has failed to heed this lesson, still.
(Posted by: Tom Lamb)