- The Washington Times - Wednesday, February 16, 2005

The Food and Drug Administration is the most ubiquitous U.S. regulatory agency. It oversees products that account for 25 cents of every consumer dollar, with a value of more than $1 trillion annually. The agency is also a perennial favorite target of critics, who variously accuse regulators of being too cozy with the drug industry or of excessive risk-aversion and delay of approvals. Former FDA Commissioner Frank E. Young once characterized his agency as “a slow-moving target that bleeds profusely when hit.”

Recent events have plunged the beleaguered FDA into turmoil. First, there were claims the labeling of certain antidepressants failed to warn doctors that the drugs triggered suicidal impulses in some adolescents. Then the agency was blind-sided by Chiron Corp.’s inability to provide flu vaccine this season due to contamination at its manufacturing facility, depriving Americans of half the usual supply. Thereafter came questions about side effects from several widely prescribed anti-inflammatory analgesic drugs.

These events have precipitated a frenzy of attacks on the FDA. In November testimony before the Senate Finance Committee, an FDA medical officer accused his own colleagues of discounting recommendations from FDA safety researchers and of being consistently in denial when data indicate safety problems from an approved drug.

Sen. Ted Kennedy of Massachusetts, ranking Democrat on the Senate FDA oversight committee, called the agency’s drug-safety record “a catastrophic failure.” These blanket condemnations misrepresent the reality and ignore the subtleties of drug testing, evaluation, approval and monitoring.

Shepherding a candidate drug from discovery in the lab to the marketplace typically requires 12-15 years and more than $800 million in direct and indirect costs. On average, it involves more than 60 clinical trials with more than 4,000 patients, but even this extensive testing often does not elicit all possible side effects from a new drug, especially if they occur in a vulnerable sub-population. Like death and taxes, drugs’ side effects are inevitable. Their exact frequency depends partly on how hard one searches for them and how they are defined, but they are extremely common. In the United Kingdom, about 5 percent of hospital admissions are in some way due to an adverse effect of medicine; and between 5 and 10 percent of hospitalized patients are estimated to suffer an adverse drug experience (ADE). In one American study, 6.7 percent of patients had serious side effects during their hospital stay.

Regulators make decisions about marketing approval on the basis of data that are always, in a sense, incomplete: Infrequent ADEs might not show up until hundreds of thousands, or even millions, of patients are exposed to the drug in normal use. Drug companies must report to FDA adverse events and injuries caused by their products, but they depend on practicing physicians to provide these data. Because doctors are unlikely to notice side effects in a small percentage of their patients and have no legal obligation to communicate adverse events, under-reporting is rampant.

The “safety” of a drug is relative. Safety and efficacy, the two criteria required for marketing approval of a drug, are inextricably linked. Regulators’ judgments require a global, and often difficult, calculation of risk and benefit. Regulators and doctors tolerate greater uncertainty and more severe side effects for a potential cure for pancreatic cancer or AIDS, for example, than for treating age spots or indigestion.

When FDA grants marketing approval, the drug is deemed safe and effective for the conditions on the label. The company and FDA painstakingly discuss the labeling, to specify uses, dosage, warnings and side effects. And at the end of the day, if FDA isn’t completely satisfied, there’s no label ” and no approval.

FDA is not the only gatekeeper restricting consumer access to prescription drugs: Physicians must prescribe them and, for many Americans whose drugs are paid for by an HMO plan, the health insurance formularies must include them.

Visiting a doctor is not like going to the supermarket, where you put in your cart whatever you want: Physicians are (or should be) accustomed to saying no to patients who demand specific therapies. Many doctors now firmly ” and correctly ” deny patients unneeded and ineffective antibiotics for virus-induced colds, and routinely do the same for other drugs.

The efficient detection of ADEs is essential, and the United States needs improved pharmacovigilance ” monitoring the safety of approved drugs. This should be done not by creating a new, independent agency, but by fixing the FDA. However, it is questionable if the newly announced FDA Drug Safety Oversight Board, which will monitor approved medicines’ safety, is the answer.

We need better data rather than more bureaucrats. In any case, public health is more imperiled by lack of drugs in the development pipeline ” a legacy of decades of FDA over-regulation ” than by side effects from approved drugs).

To improve pharmacoviligance, we need to encourage physicians to report side effects, perhaps by rewarding them with the Continuing Medical Education credits needed to retain licensure; to contract with organizations that treat large patient populations to monitor and report adverse events; and to share data with foreign regulators. We might also consider some variation of the U.K.’s “yellow card” system, in which doctors, dentists and pharmacists report ADEs to federal regulators (on a small, simple yellow card, of course).

Our drug development and regulation system needs reform. But we must make sure the cure isn’t worse than the disease.

Henry I. Miller, a physician and fellow at the Hoover Institution and Competitive Enterprise Institute, was a Food and Drug Administration official from 1979 to 1994. His latest book, “The Frankenfood Myth” was selected by Barron’s as one of the 25 Best Reads of 2004.

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