Consumer Reports: Are prescription drugs safe? Not necessarily
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Are prescription drugs safe? Not necessarily
Last reviewed: November 2009
The Food and Drug Administration approved them, your doctor prescribes
them, and you see them advertised on TV-so your medications must be
safe, right? Then why is Consumers Union bothering to publish alerts
about drug hazards?
More than half of all prescription drugs cause adverse effects—some
serious or fatal—that aren't detected until after the FDA approves
them, sometimes many years later. Such delayed detection contributes
to the high number of drug-related injuries in the U.S. 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 possible to detect
every risk before doctors start prescribing a drug. Doing so would
require clinical trials that would be prohibitively large, long, and
costly.
In addition, the U.S. system for identifying drug risks before
approval is flawed—and the one for spotting them afterward is even
worse. The 2007 FDA Amendments Act promised many changes in the drug-
safety system, but whether they will be sufficient, even if the agency
uses its new powers effectively, 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 the preapproval process
Clinical trials submitted to the Food and Drug Administration before
approval 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 3000
volunteers, enough to spot only the more-common adverse effects. Rarer
ones may emerge only after millions of people have taken 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. Indeed, randomly-controlled
trials are the gold-standard for doing this. Yet adverse events are
not the focus of the studies and therefore may not be detected.
In the real world, patients may receive lax care that exposes them to
greater risks; moreover, doctors are allowed to prescribe approved
drugs for unapproved purposes, sometimes for patients at considerably
higher risk than the trial volunteers. The trials also tend to include
few women and minority-group members.
And they often use clinical lab results—for example blood cholesterol
levels—to determine how well a drug works rather that measuring how
often it helps a person avoid having a heart attack or if it helps
them to actually live longer. Such measures may represent a misleading
picture of a drug's risks and benefits.
In addition, the FDA may approve some new drugs more quickly that
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. Some studies—though not all—have
found that the faster the review, the greater the chance of hazards
emerging after a drug's approval.
Bigger holes after approval
Because all hazards can't be reliably detected before approval, some
are discovered afterward. Unfortunately, the system for detecting
risks after approval has been the weakest link in the drug-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 voluntary effort, and
estimates suggest that only a small fraction of such incidents—about 1
percent to 10 percent—are actually reported.
* Studies after approval aren't done. Clinical trials published
after a drug's approval can reveal previously unknown hazards. The FDA
sometimes requests such studies, but companies have usually delayed or
avoided them. For the first time, the 2007 law allowed the FDA to
require, rather than merely request, safety trials after a drug's
approval and to impose penalties for delays, but whether that is
sufficient is not yet clear.
* Studies aren't published. Drug companies sponsor many studies
that are never published in medical journals, often because of
unfavorable results. One notorious example: Published trials sponsored
by Merck, maker of rofecoxib (Vioxx), concluded that the drug was
"well tolerated." But the company's internal analyses of the data,
which wasn't given to the FDA or made public until much later, showed
a significant increase in the risk of heart attacks and death for
people who took rofecoxib.
* Surveillance isn't adequate. Drug hazards can be detected by
searching large databases of patient records or insurance claims, from
Medicare or the Veterans Administration, for example. But the U.S.
currently has no coordinated, computerized system for regularly
scanning and analyzing such data. The 2007 law called for the creation
of such a system, but it's not scheduled to be completed until 2012.
* FDA hasn't been effective. The Institute of Medicine, a private
group that advises the government, issued a report in 2007 that
sharply criticized 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 an improvement in the cooperation between the
divisions. It's too soon to determine the results from that effort.
Misleading drug ads
Despite all those problems, pharmaceutical companies typically start
advertising a drug within a year of approval, long before anyone knows
whether its benefits outweigh its risks. And the companies may
minimize the known risks, often by running distracting or reassuring
images while mentioning adverse effects.
The FDA has lacked the resources and authority to regulate drug ads
effectively. Months can go by before it catches up with
misrepresentations, exaggerated claims, or inaccuracies. While the
2007 law authorized more FDA staffing to scrutinize ads and more power
to regulate them, companies still don't need the agency's go-ahead
before running their promotions in most cases, though some do so
voluntarily.
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 for you and whether
other options can achieve adequate results.
* 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). Consult a nonbiased source, such as this Web site
from Consumer Reports Health or the National Library of Medicine's
Medline Plus, to learn more about the safety and effectiveness of the
various options.
* 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 this site for reports about newly
discovered drug risks. They're created by Consumers Union and an
independent academic group, Research on Adverse Drug Events and
Reports (RADAR), devoted to detecting hazards of approved medications.
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 (1-800-FDA-1088) or by completing a form on the agency's Web
site, at http://www.fda.gov/medwatch/report/consumer/consumer.htm.
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Luke