Drug companies too can kill

From The Statesman



Drug companies too can kill

ND Batra



Drug companies might have killed more people than all the terrorists put together. But who is counting? Raymond V Gilmartin, CEO of the pharmaceutical giant, Merck & Co., said in an open letter the company “is continuing to offer to refund patients for their unused Vioxx.” But Gilmartin didn’t say what kind of refund would Merck give to children whose mothers have been killed by Vioxx, an arthritis painkiller.

After a study established that patients taking the arthritis drug Vioxx for 18 months had twice the risk of heart attacks and strokes than those placed on a placebo, Merck pulled the drug off the market in September. Memos and e-mails leaked from the company to the media indicate that Merck had some knowledge about the side effects of the drug long before it was taken off the shelf. Did the company use its corporate power to choke the bad news? That would be for the lawyers to prove when they pursue class action suits, which might cost the company billions of dollars in settlement.

The US Drug and Food Administration, which approved the drug in 1999, now reports that Vioxx might have been responsible for causing an additional 27,785 heart attacks or deaths from 1999 through 2003. How much is the FDA culpable for not supervising the drug properly? Dr David J Graham, the researcher who led the Vioxx study for the FDA told the Senate Finance Committee Vioxx is a “national disaster” and that the FDA embodies “a profound regulatory failure” and is “incapable of protecting America against another Vioxx.” The drug, Dr Graham said, should have been removed from the market four years ago, alleging some people in the company knew the drug was not very safe but kept quiet. This is nothing but reckless disregard of the truth, what one might call as actual malice against the public, if the whistleblower scientist is proven correct.

But can any drug be totally safe? What are FDA’s safety standards? Sandra L Kweder, the FDA’s deputy director in the Office of New Drugs said, “Unless a new drug’s demonstrated benefits outweighs its known risks for an intended population, FDA will not approve the drug. However, we cannot anticipate all possible effects of a drug during clinical trials that precede approval.” But Dr Graham in his testimony before the Senate Finance Committee compared FDA drug warnings with weather forecasting. He told the Committee that if a weather forecaster said that there’s 80 per cent chance of rain, naturally a person would take an umbrella to his office. But the FDA believes that an umbrella won’t be necessary unless there is a 95 per cent probability of rain.

The analogical criticism of the FDA, however interesting, does not answer the question of acceptable risk for a drug. If a drug kills five patients but saves or makes the lives of a million livable, should that drug be put on the market? Should the FDA obligate the pharmaceutical company that manufactures the drug to put a label, such as: Five in a million users of the drug will die or develop some other serious problems?

Many people wonder whether the FDA has become a promotional arm of the pharmaceutical industry or is intrinsically incapable of doing its work properly. Dr Jerry Avorn, an associate professor of medicine at Harvard Medical School, has authored a new book, Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs. Talking with Ray Suarez of PBS NewsHour whether the FDA was doing a good job of protecting the public, Dr Avorn said, “I think it’s fair to say in light of both the Vioxx experience and also the experience we’ve had with other drugs in the recent past that, no, the system is not working well at all. There’s an enormous focus within the FDA about approving drugs quickly and getting them on to the market. And that’s okay if it’s done well. But then the attention of the FDA really drops off. And the vigilance disappears when it comes to requiring and analysing the data that we need to be able to learn about the safety of the drugs once they’re in widespread use.”

It is difficult to say whether the FDA suffers from a short attention span or is intimidated by corporate power, but Congress and the media can’t ignore the problem of drug safety any longer. In the meantime, Merck has begun its public diplomacy to win the hearts and minds of its shareholders if not the American public. Apparently the three full-page ads in major newspapers were not meant to assure the millions of people who have used Vioxx. Like the rest of corporate USA, Merck is interested in the bottom line; and that’s what Gilmartin said, “Our business prospects are strong and we are well prepared to address the challenges posed by the withdrawal of Vioxx.”

There is nothing wrong in Merck’s interest in delivering “returns to shareholders,” provided it also includes the welfare of the American patient. Now that Merck stands on trial in the court of public opinion and before Congress and faces class action suits, it would be its burden to prove what the ad claims: “Our ethical standards are the foundation of our company. Merck has consistently been recognised as one of the world’s ethical companies.” Who has conferred such a high distinction upon Merck? Where did the company executives learn their ethics? Are they confusing ethics with technical standards and profit making?