The U.S. Food and Drug Administration (FDA) is charged with ensuring that only safe and effective drugs are marketed. Such a task is highly complex and fraught with difficulties. Consumers, the ostensible beneficiaries, should examine and question the incentive structure that FDA officials face.
Some drugs are highly beneficial to certain patients but pose an unacceptable risk to others. Vioxx along with Celebrex are in a class of non-steroidal anti-inflammatory drugs (NSAID) known as COX-2 inhibitors. Salicylates, such as aspirin, are a subset of such drugs. COX-2 inhibitors are sometimes prescribed to adult patients for management of acute pain associated with osteoarthritis. Vioxx, since removed from the market, was very beneficial to patients who suffered from stomach bleeding and ulcers when they took other NSAIDs. For other adults, Vioxx presented an increased risk of a stroke or a life-threatening cardiovascular event.
So if you're an FDA official, what are your incentives in terms of whether to approve or disapprove the marketing of a drug that has a tremendous benefit to some patients and poses a health threat to others? Former FDA Commissioner Alexander Schmidt hinted at the answer when he said, "In all our FDA history, we are unable to find a single instance where a Congressional committee investigated the failure of FDA to approve a new drug. But the times when hearings have been held to criticize our approval of a new drug have been so frequent that we have not been able to count them. The message to FDA staff could not be clearer."
There's little or no cost to the FDA for not approving a drug that might be safe, effective and clinically superior to other drugs for some patients but pose a risk for others. My question to FDA officials is: Should a drug be disapproved whenever it poses a health risk to some people but a benefit to others? To do so would eliminate most drugs, including aspirin, because all drugs pose a health risk to some people.
According to the May 17th edition of The Wall Street Journal, in an editorial, "Our Lawless FDA," by Hoover Institution scholars Drs. David Henderson and Charles Hooper, the FDA recently rejected Arcoxia, a new COX-2 inhibitor from Merck. In explaining the FDA's disapproval, Robert Meyer, director of the agency's Office of Drug Evaluation, told reporters that "simply having another drug on the market" wasn't "sufficient reason to approve the product unless there was a unique role defined."