Drug Safety In The United States. It has been a tough three years for the Food and Drug Administration, which until recently was credited with providing the United States with the safest drug supply in the world.
In September, Merck withdrew Vioxx from the market after a study showed that the drug significantly increases the incidence of strokes and heart attacks in patients who use it for more than 18 months.
Three years ago Bayer withdrew Baycol, a cholesterol-lowering drug that causes a rare muscle disease that was responsible for about 30 deaths and thousands of serious injuries.
Fortunately, several lessons can be learned from recent drug tragedies:
• Not all drugs are equal. The standards that are appropriate for breakthrough drugs that significantly advance medical care are not appropriate for drugs that have no measurable advantage over products already on the market.
Before the FDA approved Vioxx, there were numerous other drugs on the market for the treatment of arthritis and other inflammatory diseases, including one that had the claimed advantage of Vioxx (lower risk of stomach complications). Even though anti-inflammatory drugs often are prescribed for many years, Vioxx was tested in a study that lasted less than two years.
Why the rush? A short-term study that would be appropriate for the first drug approved to treat a serious disease is not justified for drugs such as Vioxx, which simply add an option to the arsenal of available drugs.
• The FDA should be given the legal authority and resources to monitor drugs after they enter the marketplace. Typically, new drugs are studied in a population of about 3,000 people. Such a study can detect drug-related injuries that occur at a rate of between one in 500 and one in 1,000.
Yet, if the drug is used by 200,000 people (Vioxx was used by 2 million people in the United States), a serious adverse event appearing in as few as one in 10,000 people is very significant, since it would occur 20 times. These rare reactions can be identified only after a drug has been widely used.
The FDA’s legal authority under federal law to require companies to conduct post-market studies
The FDA’s legal authority under federal law to require companies to conduct post-market studies of approved drugs is unclear. Moreover, the agency has never been given resources that would be necessary to keep careful track of adverse reactions that are reported for drugs. With clear legal authority and additional resources, the FDA could identify drugs causing unexpected adverse reactions sooner.
• The FDA should actively intervene when physicians misuse drugs. It is almost gospel at the FDA that the agency doesn’t interfere with the “practice of medicine.” This means that once a drug is approved for a single use, physicians are free under federal law to prescribe it for any use.
Sometimes these unapproved uses can become widespread and dangerous. In the high-profile case of fen-phen, the diet drug combination that damaged the heart valves of thousands of consumers, the FDA had never approved the drug therapy for long-term weight loss.
In other cases, physicians are ignoring FDA directions and risking the health of their patients. For example, the FDA has approved the drug Accutane only for treating severe acne. Accutane is very effective, but it causes deformities in 25 percent of children born to women who take it during pregnancy, and strong warnings have not been enough to discourage physicians from limiting its use.
The FDA should be given the legal authority to require drug companies to study popular, unapproved uses and to limit physicians’ use of drugs when deviations from FDA-approved uses can lead to severe injuries.
• The FDA should separate the monitoring of drugs after they have been approved from the drug review function. To some extent, the job of the post-market reviewer is to second-guess the decisions of the officials who approved the drug in the first place. Yet today the FDA drug review divisions have primary responsibility for deciding whether drugs should be withdrawn or their recommended uses limited. The post-market function should be separated from the drug review function.
• Leadership and resources matter. The combination of resources from Congress (in the form of user fees paid by the drug companies) and strong FDA leadership cut the review time of new drugs in half and eliminated the “drug lag.” Now is the time for the FDA to turn its attention to drug safety.
If its leaders exert the same energy improving the safety of the drug supply as they exerted in eliminating the drug lag, and if Congress gives them adequate legal authority and monetary resources, once again the United States can indisputably have the safest drug supply in the world.
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