Tells How Merck's Drug Reps Did Their Vioxx "Spin" for Concerned Doctors
In the June 23, 2005 issue of The New England Journal of Medicine (NEJM), is "The Lessons of Vioxx -- Drug Safety and Sales", by Henry A. Waxman. This Congressman from California tells doctors and other readers what he learned recently about how -- during the period from February 2001 up until the September 2004 Vioxx recall -- Merck's sale representatives dealt with the rising level of concern about the increased risk of cardiovascular side effects for patients taking Vioxx.
On May 5, 2005 Congressman Waxman convened the Government Reform Committee of the U.S. House of Representatives for a hearing to seek an answer to a question that has been asked by many doctors and patients, both, since the fall of 2004: How did Vioxx remain such a widely-prescribed drug given the many serious safety issues that were raised during a period of several years before Vioxx was finally withdrawn from the market?
The NEJM article reveals that Congressman Waxman believes the answer, or lesson, has to do with the promotional and sales practices that Merck used in their dealings with prospective prescribing doctors.
Congressman Waxman realizes that the practices used by Merck and its sales representatives are probably similar in kind to those of other drug manufacturers. Accordingly, early on in Waxman's NEJM article, a couple of industry-wide statistics are presented to set the stage:
- The pharmaceutical industry spends more than $5.5 billion to promote drugs to doctors each year.
- Major drug companies employ about 90,000 sales representatives — one for every 4.7 doctors in the United States.
Congressman Waxman points out that, because of the public uproar about the Vioxx debacle, the Government Reform Committee's May 5 hearing focused on Merck, the manufacturer of Vioxx. As a result, Henry Waxman and his fellow Congressmen had an opportunity to learn much about how Merck directed its many Vioxx sales representatives to present doctors who were in a position to prescribe Vioxx with what Waxman calls "a distorted picture of the relevant scientific evidence" concerning the cardiovascular risks of Vioxx.
For example, on February 7, 2001 the FDA's Arthritis Drugs Advisory Committee voted unanimously that doctors should be made aware of the cardiovascular risk information derived from the Vioxx Gastrointestinal Outcomes Research study, more commonly known as the VIGOR study. According to Congressman Waxman in this June 23 NEJM article:
The next day, Merck sent a bulletin to its [Vioxx] sales force of more than 3000 representatives. The bulletin ordered, "DO NOT INITIATE DISCUSSIONS ON THE FDA ARTHRITIS ADVISORY COMMITTEE . . . OR THE RESULTS OF THE . . . VIGOR STUDY." It advised that if a physician inquired about VIGOR, the sales representative should indicate that the study showed a gastrointestinal benefit and then say, "I cannot discuss the study with you."
Merck further instructed its representatives to show those doctors who asked whether [Vioxx] caused myocardial infarction a pamphlet called "The Cardiovascular Card."...
The Cardiovascular Card provided a misleading picture of the evidence on [Vioxx]. The card did not include any data from the VIGOR study. Instead, it presented a pooled analysis of preapproval studies, in most of which low doses of [Vioxx] were used for a short time. None of these studies were designed to assess cardiovascular safety, and none included adjudication of cardiovascular events. In fact, FDA experts had publicly expressed "serious concerns" to the agency's advisory committee about using the preapproval studies as evidence of the drug's cardiovascular safety.
In this NEJM article, Congressman Waxman provides additional 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."
All of the Merck documents discussed by Congressman Waxman in his June 2005 NEJM article, and many other compelling documents, are available on this web site:
This NEJM article concludes by encouraging doctors, medical journal editors, and leaders of medical professional associations to review the various drug company documents obtained by the Government Reform Committee. In giving this encouragement, Congressman Henry Waxman seemingly believes that doctors targeted by the drug company sales representatives must "develop new strategies to keep promotional efforts from distorting clinical care."
This, hopefully, will be the real lesson of Vioxx.
(Posted by: Tom Lamb)