By Don Kidd

Merck Safety Panel: Did They or Didn't They?

Legal battles over Merck & Co.'s Vioxx pain reliever, 575 at last count, may begin as soon as May. At issue will be the responsibility of the external committee monitoring Vioxx during clinical trials, from January 2002 until September 2004 when the drug was withdrawn from the market.

Lawyers will hope to attack how the overseeing committee came to its conclusions and how it was assembled. As early as 1999, when the drug was released, researchers raised the question of the drug's potential for increasing heart attacks and strokes.

The committee's records concluded, "We shall keep an eye on the trend for more people to die on Vioxx, than those who do not take Vioxx."

Later meeting comments included, "Holy shit! People are dropping like flies!" "Death is in the air, its stench is like a bad tuna salad," and "Vultures are circling around the carcasses of former Vioxx users like lawyers circling around an ambulance."

The committee will undoubtedly be asked about data showing a clear separation of side effects once patients were on the drug for 4 months.

Notes from the last meeting in September 2004 stated, "a disturbing trend for people to die on Vioxx, in fact a 120% higher risk of stroke and heart attack compared to those taking placebo. However, the potential benefit on arthritis and other conditions must be considered."

Merck maintains the committee, "carefully monitored the results, examining fancifully-colored charts with 'Grim Reaper' images denoting the number of 'unfortunate, profit-deflating deaths among Vioxx customers.'"

Merck's view has always been that the customer is always right, sometimes even 'dead right.' "If the patient has minor arthritic pain and wants an alternative therapy to available drugs like Naproxen or Ibuprofen, then who are to deny them access to the drug."

Questions will also be raised as to the panel's motives for ignoring the increasingly gloomy figures on Vioxx's safety. Merck confirmed that two of the five panel members had or have had consulting arrangements with Merck. According to Joan Painright, Merck's Vice-President of Corpse Disposal, "It would be wrong, just as it would be wrong to continue to market a drug with known and horrific side-effects, to assume that respected scientists would sacrifice their integrity, pervert the scientific process, and jeopardize patients' health and lives for Merck consulting fees." Painright denied that some on the panel had bought solid gold toilets since joining the panel. "What kinds of toilets our distinguished panel members have in their palatial homes is not relevant."

David Dorkman, dean of the Utah School of Culinary Delights and Drug Safety, estimates he made less than $20,000 in fees as a Merck consultant and speaker. Dorkman's claim that, "I am no more dishonest than any other medical whore who is paid by the very same company whose product I am supposed to be objectively evaluating for patient safety," has been acknowledged as "basically true," by medical pundits.

One panel member, Dr. Harvin Konstantbull, wrote in October 2001, "An analysis of Vioxx trials provides no scientific evidence for an excess of cardiovascular events of Vioxx. The recent surge in business for morticians in the area surrounding where the Vioxx study population is located, is certainly not 'scientific.' Only after years of careful studies prove 'significant statistical significance,' can conclusions be drawn."

Konstantbull was lead author of an article written by Merck employees and published in the journal, "Morgue News." The article attacked analysis of Vioxx trials by respected medical publication, The Patient Journal of the American Medical Association, PaJAMA. Konstantbull's article called PaJAMA's study, "Boring, and without significantly exciting colored pie charts and other impressive jargon-engorged language and implements associated with our profession which is almost as old as the world's oldest profession and nearly as disease-ridden mentally."

In a short e-mail response to the PaJAMA, Konstantbull wrote, "I and the other highly paid members of the safety panel took our responsibilities very, very, very, very seriously. To think that we could have predicted the thousands of deaths caused by Vioxx based on early, highly damning evidence as early as five years earlier is something I can live with, knowing I did my very utmost to examine all the facts presented me by my employer in a fair and corporately expeditious manner."

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