In Mill Bay, British Columbia, there’s an elementary school named in honor of Dr. Francis Kelsey. She was inducted into the National Women’s Hall of Fame and given the President’s Award for Distinguished Federal Civilian Service by President Kennedy (interesting historical note—there was a time when Presidential Awards meant you had done something right.) Dr. Kelsey had a distinguished career with the US Food and Drug Administration, but her most memorable achievement was her refusal to approve thalidomide for marketing in the United States. Thanks to Dr. Kelsey, the US was spared the tragedy of the badly deformed newborn infants that resulted from administering thalidomide to pregnant women.
But almost as soon as the tumult and the shouting had died and the captains and kings moved on to the next event, there was a backlash. Magazines were suddenly filled with articles about important drugs that were available in Europe, but hadn’t been approved for use in the US—the way technology publications talk about our lag in cellular telephones.
The pharmaceutical companies may or may not have been behind this grass roots outcry for faster drug approvals, but they certainly profited from it—or thought they did.
It costs a lot to develop a drug and bring it to market, and the pharmaceutical companies are looking for a return on their investment. According to a Tufts University report, the cost of developing a new prescription drug has risen to $802 million, up from $231 million in 1987.
The study was attacked by several consumer groups. Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, was quoted as calling the study as “just a thinly disguised advertisement for the pharmaceutical industry to justify continued price-gouging.” Public Citizen then released an estimate reporting the cost of developing a new drug at $110 million. Even at that price, developing a new drug isn’t exactly chopped liver. Somewhere, a drug company chief financial officer is comparing the price of developing a new drug with the rate of return on mortgage backed securities—sorry, bad example—but if you invest $110 million, you expect to get some return.
Which may be why things have been blowing up so often. Merck marketed Vioxx, which was supposed to be a safer pain reliever. The non-steroidal anti-inflammatory drugs, a group that includes Motrin and Naprosyn, do a good job of relieving pain, but in the high doses and long-term use needed to treat rheumatoid arthritis and other diseases, these drugs cause serious ulcers. Vioxx and Celebrex were expected to reduce the most serious side effects while still relieving pain. The rate of gastric ulcers went down, but more people had cardiovascular problems after taking the drug. Eventually, Merck agreed to pay $4.8 billion to settle the claims from people who had heart attacks after taking Vioxx. More recently, Merck, with its partner Schering-Plough, is stuck with a report that their co-marketed anti-cholesterol drugs Zetia and Vytorin don’t offer any real benefit when compared with a generic statin for cholesterol lowering. This isn’t as bad as finding that the drug did real harm, but it’s a kick in the head for anybody who has been paying $105.99/month for Vytorin 10/40 when 40 milligrams of simvastatin would have been $50.59 (prices from CVS.com).
It’s a legitimate problem, because the unfavorable information on both ezetimibe and rofecoxib didn’t turn up until the companies had done long-term studies. It seems fair to ask how long it’s reasonable to wait before approving a drug. The preliminary information on ezetimibe (Zetia and part of Vytorin) actually looked good—it just didn’t work.
There won’t be an easy answer, but transparency might help a lot. In both cases Merck was accused in some way of hiding the bad news. With rofecoxib, the company kept funding short-term studies, even though the drug had long-term uses. In the case of eztimibe, Dr. John J. P. Kastelein, the lead investigator on the study that questioned the value of the drug, has said that Merck and Schering-Plough sat on the results for two years. If these drugs had worked the way it was originally believed, they might have saved lives. Perhaps, if the FDA could give revocable approvals, and mandate long term studies, and if the ongoing results of these studies were freely available to qualified interested parties so that everybody knew the risks and benefits, there might be some way to balance the need to make new drugs available while still providing the cautious oversight that Dr. Kelsey demonstrated. It would mean a major increase in FDA funding, but at $4.8 billion per mistake, the money might turn up somewhere.
Sam Uretsky is a writer and pharmacist living on Long Island, N.Y.
From The Progressive Populist, May 15, 2008
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