Letters

Vioxx: Setting the record straight

I was disappointed to read your characterization of Merck and our actions surrounding the withdrawal of Vioxx in your editorial "Outlook for Pharmaceuticals" (C&EN, Dec. 6, 2004, page 3). Your assertion that Merck ignored a safety signal for Vioxx is false. Amid all of the media coverage about Vioxx, much of it inaccurate and incomplete, it is important to directly address the concerns raised in your editorial and set the record straight.

The safety of Vioxx was reviewed publicly at Food & Drug Administration advisory committee meetings in April 1999 and February 2001. The committee did not conclude that there was a clear safety signal for Vioxx, nor did FDA in its labeling for Vioxx. After the public reviews, Merck continued to update the cardiovascular clinical data for Vioxx, and these were provided to regulatory agencies and were published [Circulation, 104, 2280 (2001); Am. Heart J., 146, 591 (2003)]. Our assessments were based on the largest safety database ever developed for any NSAID (nonsteroidal anti-inflammatory drug) or COX-2 inhibitor except aspirin: more than 32,000 patients representing over 19,000 patient-years on rofecoxib or comparator agents.

Throughout this entire period, Merck continued to study and monitor Vioxx. We also disclosed results as they became available in a prompt manner. I encourage you, and all readers of C&EN, to review the extensive information on Vioxx, including the scientific processes that we used, on our public website (http://merck.com).

Merck withdrew Vioxx in response to new data from the three-year-long APPROVe study. These new data were unlike any previously available--the risk of thrombotic cardiovascular events with Vioxx in APPROVe began to increase relative to placebo only after 18 months of continuous treatment with Vioxx, and they did not become statistically significant until after approximately 30 months. Given the questions raised by the data and the availability of alternative therapies, Merck acted in the best interests of its patients and voluntarily withdrew Vioxx from the market.

As a scientist, I am intensely proud of Merck's record. It is only because of Merck's commitment to continue to study and monitor its drugs that we are now having this discussion. Our rigorous adherence to the highest standards of scientific investigation, openness, and integrity has enabled us to bring extraordinary new medicines to the people who need them and will continue to serve patients' interests well into the future.

Peter S. Kim
President, Merck Research Laboratories
West Point, Pa.

I am deeply troubled by your personal, biased comments regarding the circumstances of Merck's withdrawal of Vioxx. Your statements are particularly disturbing in view of the fact that the comments are embedded within an editorial that repeatedly references data and perspectives from the cover story by Selena Class, "Health Care in Focus" (C&EN, Dec. 6, 2004, page 18). When reading the editorial, it is easy for the reader to interpret your perspectives as those articulated in Class's cover story.

In fact, Class's comments regarding Merck and Vioxx are strikingly different from yours. For example, before Merck's own clinical trial data were released on Sept. 30, 2004, Class refers to any "evidence" that Vioxx was linked to an increased risk of cardiovascular events as "speculation." Class is apparently aware that there is ongoing scientific debate as to the degree of Naproxen's cardio-protectiveness. Similar scientific debate also surrounds the idea as to whether or not it is scientifically valid to pool placebo response rates from different clinical trials and apply those results to yet another different clinical trial. In Class's cover story, there are no opinions offered concerning Merck's public accounting for how it has handled the Vioxx situation.

Yet you take the time to compare Merck's Vioxx situation to the 1984 Bhopal disaster, then later to the Three Mile Island accident. One of your statements can only be quoted in its entirety, as it is so riddled with personal bias: "Merck's callous approach to defending its profitable drug in the face of clear evidence of the dangers the drug posed is a public relations disaster that will tarnish the entire industry's reputation for years to come."

Your flagrant disregard for the scientific debates at the core of this issue, as well as the manner in which they are presented in the context of describing the cover story, are stunning. While I would expect this sort of populist journalism from the New York Times or the Wall Street Journal, seeing this sort of thing in C&EN is truly remarkable.

Paul Harmon
Audubon, Pa.

Disappointing turnout

I read with interest the acs election results (C&EN, Nov. 22, 2004, page 16). My congratulations to E. Ann Nalley. It is disturbing, however, that only some 22,000 people, out of nearly 160,000 members, chose to participate in the important privilege of choosing the person to lead ACS. Unless you can gain a larger interest and participation from members, the organization will ultimately pay a price for the lack of interest.

Carlyle B. Storm
West Kingston, R.I.