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Saturday, Jul 11, 2009
The pharmaceutical giant knew there were heart risks associated with its painkiller -- but its own studies were designed to avoid finding out how serious they were.
Mar 31, 2005 | The same week that drug manufacturer Merck pulled its highly profitable painkiller, Vioxx, from the market last September, acknowledging that it was linked to heart attacks and strokes, a Las Vegas legend dropped into our local poker game. Ray is one of poker's few long-term success stories. A math wiz, highly praised author of several authoritative books on game theory and high-limit poker, and a practicing Buddhist, Ray was reminiscing about his early days in Las Vegas.
"Cheating was rampant," he said. "Stripped decks, wired hands, coolers, seconds, holdouts and marked cards. You name it, they did it -- the dealers and the players."
Ray had been able to make a great living in poker because he assumed the games might be rigged and acted accordingly. He studied the players and dealers, even watched videos of how card dealers dealt off the bottom of the deck or from the middle. He always expected the worst and was prepared.
"You weren't bothered playing with a bunch of crooks?" I asked.
Ray laughed. "You got to play with someone. We all have cheat in us, given the right circumstances." He smiled slyly. "But even cheats don't cheat all the time. The trick is to know when and how."
With its spectacular medical advances, Big Pharma is the only game in town. We cannot walk away; we must play. But unlike Ray, we are reluctant to assume that drug companies are rigging the outcome. Without this requisite skepticism, we are at their mercy -- in this case, with fatal consequences. The U.S. Food and Drug Administration has linked Vioxx, since it was released in 1999, to more than 27,000 acute heart attacks and sudden cardiac deaths. What the agency didn't report was its own culpability in the debacle.
Even the disclosure of tragic deaths, though, won't stop the same malfeasance from happening again. In order to protect ourselves as patients, we need to know how the game might be fixed. Dissecting the way that Merck developed Vioxx gives us a perfect opportunity.
I was initially reluctant to write another piece on the Vioxx scandal. The mainstream press has more than adequately pointed the finger of blame at Merck for knowing the cardiovascular risks of Vioxx and yet minimizing them to reap huge economic rewards. The medical literature has been equally damning. Two months after Vioxx was recalled, Dr. Richard Horton, editor in chief of the British medical journal Lancet, wrote: "With Vioxx, Merck and the F.D.A. acted out of ruthless, short-sighted, and irresponsible self-interest."
But the medical literature related to Vioxx suggests an even more onerous possibility, which is that Merck intentionally designed its studies to avoid discovering the truth about the potential C.V. risks of Vioxx. I have not been privy to the company's private staff meetings and internal documents. But it has been my experience that undertaking any major research study involves extensive consultation between experts in all pertinent fields, including pharmacologists, epidemiologists, statisticians and business managers. Given the enormous intellectual investment in the design of a drug like Vioxx, it is reasonable to presume that all potential outcomes were seriously entertained. I must presume that Merck would factor in what might happen to Vioxx sales with each study result. And so it's hard to escape the sadly cynical conclusion that the company consciously crafted its tests to avoid exposing the risks of Vioxx to the public.
After all, the stakes of new drug development are enormous. Only a fraction of new drugs submitted to the FDA for approval make it to market; the average cost per approved drug is over $800 million. Any drug that makes it into the marketplace is a potential bonanza to be coddled, cherished and protected. A drug patent lasts 17 years, and then the drug is thrown to the generic manufacturers. The FDA approved Vioxx for sale in May 1999. By 2004, 20 million Americans had taken the painkiller and its annual sales exceeded $2.5 billion. Is it any wonder that Merck sought to present Vioxx to the public in the best possible light?
