And the FDA was either extraordinarily lax or frankly complicit. In April 2002, the federal agency did state that Merck must affix a new label to Vioxx, advising doctors to use caution when prescribing it to patients with heart disease. But it didn't rule that the drug be withdrawn from the shelves.

Based upon their review of available data about Vioxx, a team of medical scientists from the University of Berne, Switzerland, published this summary in a December 2004 issue of Lancet: "Our findings indicate that Vioxx should have been withdrawn several years earlier. The reasons why manufacturer and drug licensing authorities did not continuously monitor and summarize the accumulating evidence need to be clarified."

This situation is not likely to change. On at least three occasions, Congress has voted to approve partial FDA funding by pharmaceutical companies. Beginning in 1992 with the passage of PDUFA -- the Prescription Drug User Fee Act -- pharmaceutical companies have been paying up to $500,000 for each new drug application. Currently, greater than 50 percent of drug reviewers at the FDA are funded by the pharmaceutical industry.

According to the Center for Science in the Public Interest, 10 of the 32 FDA advisory board members who, in 2005, recommended the continued sale of coxibs, had previously consulted for Merck, Pfizer or Novartis. (Pfizer and Novartis have not withdrawn their coxibs, Celebrex and Prexige, respectively, from the market.) To be fair, this isn't entirely damning, as many top researchers have ties with pharmaceutical companies yet maintain unbiased positions. Dr. FitzGerald, one of Merck's harshest critics, has received research funding from Merck.

When Merck withdrew Vioxx, the FDA responded: "The risk that an individual patient taking Vioxx will suffer a heart attack or stroke related to the drug is very small." This is both true and profoundly misleading.

A truly independent agency for the evaluation of new drugs is essential. But the unfortunate truth for the foreseeable future is that we are dependent upon the pharmaceutical industry and its hired security guards -- the FDA -- to police itself.

We are not helpless. We do have one ace in the hole -- the simplest and most difficult of questions. Do I need this medication? Or, as Ray would say, is this the only game in town and do I need to play?

If you have rheumatoid arthritis and can barely dress and feed yourself, a doubled chance of a heart attack on Vioxx might be an acceptable trade-off for increased mobility. A disabling stroke, no matter how unlikely, doesn't seem like a reasonable risk for a twinge of tennis elbow.

The decision to take any medication is highly personal, a reflection of everything from genetic predispositions to cultural values to the loftiest of metaphysics. It cannot depend exclusively upon statistics. An honest and thorough medical system can provide the information, but the old saw, know thyself, is essential to such choices.

So is know thy playing partner.

And the key to making the right personal decision is that we need transparency of data. We need to get our hands on the deck and look for ourselves. There are plenty of smart and independent folks who could sift through the information and give us an informed opinion. We must demand that study data be made publicly available to those without a vested interest.

The best place to start is with your own family doctor. If you and your physician had adopted Ray's approach to medication, you would have known in August 2001 that leading cardiologists such as Dr. Topol had major concerns about possible Vioxx C.V. effects. And you would have carefully discussed the labeling change ordered by the FDA in 2002. Unless you are an Internet health letter, medical journal junkie, only your doctor would have received this news in a timely fashion.

However, the problem of post-approval drug side effects will not go away. After 30 years on the market, it is still unclear as to the C.V. effects of the allegedly "safe" NSAIDs such as Aleve. We have to anticipate the unknown, accept certain knowledge limitations, and trust someone to be our advocate in an ever more confusing medical landscape. And we need to balance a well-deserved skepticism with an equal appreciation of what modern medicine has accomplished.

In the big picture, Merck has had an outstanding reputation. It offers a variety of formidable drugs that both improve and save lives. As a niche drug, prescribed to those unresponsive to the older NSAIDs, or to those with unacceptable G.I. complaints or at high risk for ulcers or bleeding, Vioxx would have been a good alternative. If the properly designed studies had been carried out, and we had been given full and prompt access to the data, we could have made our own smart choices. It's a tragedy that Vioxx led to fatal heart attacks and strokes. And it's a sad irony that those who were clearly benefiting from the drug no longer find it available to them.

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