July 2006
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The FDA at 100: Are you that much safer?
A century ago, in an era of snake-oil salesmen, dangerous medicines, and horrifying conditions in the meatpacking industry, Congress created the Food and Drug Administration.
Consumers’ health and safety has improved remarkably since then. Yet problems with our food and drugs today echo the very reasons the FDA was established. Current issues include:
Drugs. Consumers increasingly believe that drugmakers don’t tell all they know about dangerous side effects. The pain medication Vioxx was recently linked to heart attack and stroke risk, and antidepressants such as Paxil were tied to increased risk of suicidal thoughts and behavior in children and adolescents. The FDA was criticized for its delay in making those risks public. A report released in March by the GAO, the government’s investigative arm, concluded that the agency failed to track ongoing safety problems and lacked criteria for taking safety actions.
Congress and some states are considering legislation to require that drug companies make public their clinical trial results. And measures in Congress would empower the FDA to require drugmakers to complete any requested follow-up safety studies once their products are on the market, so patients and doctors know about harmful side effects. But the bills languish, fought by a pharmaceutical industry that flourishes in the status quo.
Supplements. A May 2004 Consumer Reports investigation identified a dozen hazardous dietary supplements that shouldn’t be on the market based on government warnings, adverse-event reports, and medical experts. Some of those products have been linked to cancer, kidney failure, and death; at least five of them are banned in Asia, Europe, or Canada. Two years after our report, 11 of those supplements are still widely available in the U.S. The 12th, androstenedione, was categorized in 2004 as an illegal performance-enhancing drug.
Beef. In 1906, Upton Sinclair’s book “The Jungle” revealed filthy conditions in Chicago’s meatpacking plants. Meat sales dropped by half. The meatpacking industry has improved dramatically over the years, but meat safety in the U.S. faces a new threat: BSE, or mad-cow disease.
The FDA and the USDA oversee beef safety. Under existing FDA rules, cattle can be given feed that includes the blood of mammals, and excrement, feathers, and spilled feed swept from chicken coops. Those practices risk spreading the disease. At a news conference held more than two years ago, an FDA commissioner said that these items would be banned in feed, but to date they have not been.
The FDA reported in a retrospective that when its authorization bill was approved in 1906, business groups “congratulated themselves“ that the bill’s strictures “had not turned out to be tougher than they were.” Now, as then, special interests hamper efforts to improve food and drug safety. So while FDA actions have helped enhance Americans’ health, our food and drugs are still not as safe as they should be.
It is up to Congress and the FDA to approve measures that ensure a substantial increase in safety for consumers over the next 100 years.
