| Reports of adverse drug events increase, but the risk can be reduced |
Author: Jon Merz
Date: 02-25-10 18:30
Source: Washington Post
URL: http://www.washingtonpost.com/wp-dyn/content/article/2010/02/12/AR2010021204117.html
Date published: February 16th 2010
Reports of adverse drug events increase, but the risk can be reduced
Tuesday, February 16, 2010; HE02
More than half of all prescription drugs cause adverse effects -- some of them serious or fatal -- that aren't detected until after the Food and Drug Administration has approved them, sometimes many years later.
Such delayed detection contributes to the high number of drug-related injuries in the United States. In 2008 alone, the FDA received more than 100,000 reports of serious injuries related to adverse drug events, an increase of about 25 percent over the previous year, according to the Institute for Safe Medication Practices.
Some of the delay is inevitable: It's simply not practical to detect every risk before doctors start prescribing a drug. Doing so would require clinical trials that would be prohibitively large, long and costly. The 2007 FDA Amendments Act promised many changes in the drug-safety system, but whether they will be sufficient remains to be seen. Here's a closer look at why you face these unexpected dangers, and what you can do to protect yourself.
Holes in trials process
Clinical trials involving drugs that have not yet been approved by the FDA have several limitations, some of them unavoidable. They can't adequately assess safety because they're:
-- Too small. They typically involve only about 500 to 3,000 volunteers, enough to spot only the more common adverse effects. Rarer ones may emerge only after millions of people take the drug.
-- Too short. The trials may last for just a few months, but some adverse effects develop only after patients take a drug for many years.
-- Too unrealistic. Most trials are conducted under scrupulously controlled conditions, with carefully selected patients in order to demonstrate that the drug actually works. Adverse events are not the focus of the studies and therefore may not be detected.
In addition, the FDA may approve some new drugs more quickly than others. The time devoted to preapproval review, particularly for drugs deemed "priority," has dropped substantially since 1992. Congress passed a law designed to speed up the FDA approval process for some drugs to get them to the market faster. But doing so may have come at a significant cost. A 2003 survey of FDA reviewers indicated that they generally felt rushed and, in some cases, pressured by their supervisors to approve medications.
Bigger holes after approval
Because not all hazards can be reliably detected before approval, some are discovered afterward. The system for detecting risks has been the weakest link in the safety system, for several reasons:
-- Incidents aren't reported. Patients, physicians and other health professionals are encouraged to inform the FDA and drug manufacturers about any new adverse drug effects. But it's a voluntary effort, and estimates suggest that only a small fraction of such incidents -- about 1 percent to 10 percent -- are actually reported.
-- Post-approval studies aren't done. Clinical trials published after a drug's approval can reveal previously unknown hazards, but drugmakers are generally not required to conduct such testing and they're not eager to do so voluntarily.
-- Studies aren't published. Drug companies sponsor many studies that are never published in medical journals, often because of unfavorable results.
-- Surveillance isn't adequate. Drug hazards may be detected by searching large databases of patient records or insurance claims, from Medicare or the Veterans Administration, for example. But the United States has no coordinated, computerized system for regularly scanning and analyzing such data.
-- The FDA hasn't been effective. The Institute of Medicine, a private group that advises the government, issued a report in 2007 that sharply criticized the FDA's drug-safety efforts. Indeed, the agency's safety division was just one-tenth the size of the approval division. The bigger group, less focused on safety, dominated the final decisions about warnings and restrictions even after a drug's approval. The 2007 law mandated an increase in the safety group's size and status, as well as improvements in the cooperation between the divisions. It's too soon to determine the results of that effort.
What you can do
Even if the FDA reforms are fully implemented, taking prescription drugs, especially new ones, still requires caution. To protect yourself, take these steps:
-- Don't overreact. In general, if you hear that a drug you're taking may have a newly discovered risk, don't stop abruptly. Ask your doctor whether the benefits outweigh the risks.
-- Consider older options. If you're thinking about taking a drug that's been around for only a few years, ask your doctor whether there's an older, equally effective one. (It will probably be less expensive, too.)
-- Resist the ads. Don't let direct-to-consumer advertising move you to pressure your doctor to prescribe a drug unless other options haven't helped and there's strong evidence that you need it.
-- Watch for alerts. Check the Consumer Reports Web site for reports about newly discovered drug risks. Check the FDA site as well: http://www.fda.gov/Safety/MedWatch/default.htm.
-- Do your part. Report any serious drug reactions to your doctor. In addition, you or your doctor can report them to the FDA by telephone (800-FDA-1088) or by completing a form on the agency's Web site, at http://www.fda.gov/medwatch/report/consumer/consumer.htm.
Copyright 2009. Consumers Union of United States Inc.
For further guidance, go to ConsumerReportsHealth.org. More-detailed information -- including CR's ratings of prescription drugs, conditions, treatments, doctors, hospitals and healthy-living products -- is available to subscribers to that site.
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Reports of adverse drug events increase, but the risk can be reduced new |
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Jon Merz |
02-25-10 18:30 |
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