Major drugmakers are having a run of bad luck that could make for a sequel to the box-office hit Lemony Snicket’s A Series of Unfortunate Events but for the fact that this is no mock-Gothic story line, and that real-life patients’ health is at risk.
Merck & Co.’s arthritis pain medicine Vioxx is off the market after studies cited an increased risk of heart problems. Pfizer Inc. this week halted advertising for its popular pain-reliever Celebrex on the same grounds.
New warning labels are due for a companion Pfizer drug, Bextra, and even an over-the-counter alternative naproxin, commonly known under the Bayer brand name Aleve is under scrutiny.
It’s clear that these drugmakers failed to learn early enough all the dangerous side-effects from these supposed wonder drugs. In the case of Vioxx, officials at Merck had suspected it was risky for several years prior to the Sept. 30 recall.
While their drugs helped millions of people cope with pain, the companies now must answer regulators’ questions and conduct their own internal reviews as to how the danger of heath problems for some patients slipped notice for so long.
Each of these medications won federal regulatory approval. With drugs so heavily marketed with direct-to-consumer advertising, though, any second-guessing on safety by drugmakers may be deterred by the profitability of these products. Who wants to kill the golden goose, right?
Well, if profit motives do come into play, the recent disclosures prove it’s a case of pay now or pay later. The firms are facing a fearsome incentive to make sure their products are safe: from both Wall Street and the courts.
Investors, for instance, punished Pfizer in recent days by driving down its stock price in heavy trading. That’s how the system is supposed to work on behalf of stockholders, and it benefits consumers as well.
The other incentive for these firms is to avoid the likely huge legal costs stemming from lawsuits by patients who believe they were harmed by medications. Merck faces hundreds of such Vioxx claims already, with legal costs estimated to run into the billions.
The potential for these legal claims to change corporate behavior is why it’s so important to preserve citizens’ access to the courts. That flies in the face of the constant drumbeat from the Bush administration and U.S. Chamber of Commerce about the need for Congress to rein in supposedly “frivolous” lawsuits. Access to the courts is all the more important with drug approvals including some of the painkillers now under a cloud subject to fast-track consideration by regulators.
Those regulators, meanwhile, are taking their deserved share of criticism. The troubling back story to the Vioxx, Celebrex and now Aleve announcements is that the U.S. Food and Drug Administration has provided inadequate scrutiny of drugs it approved as safe for consumers. That has to change, and improve.
Consumers have more right than ever to demand better oversight. They cannot be reassured, though, by recent reviews of the FDA, including a broadside from the influential Journal of the American Medical Association. JAMA in late November faulted the agency’s system of permitting drugmakers to self-report dangerous side-effects of approved drugs, describing it as “the fox in charge of the henhouse.”
Without radical changes at the FDA, the JAMA editors contend, the United States will be “far short of having an effective, vigilant, and trustworthy” drug safety system.
While the White House defends the FDA’s performance, the agency has announced steps to improve safety reviews and heed more dissenting views from drug reviewers. Its first order of business should be to change a culture in which one in five of the FDA’s scientists says they have felt pressured to approve new drugs despite qualms about safety, quality, or effectiveness.
It’s encouraging to see bipartisan congressional support for a thorough review of the agency, as well as House and Senate scrutiny of drugmakers’ actions in bringing these medications to market.