Holes in U.S. Drug Safety Net
Consumer Reports: Drug Approval, Follow-Up 'Flawed'
Institute of Medicine to the Rescue
Lipman, Gardner, and Trewhitt all praise one thing about the FDA. The agency
already has asked for help. Last year, it turned to the independent Institute
of Medicine (IOM) for advice. An IOM committee has since been holding hearings.
Its recommendations are expected in July 2006.
"The FDA has asked the IOM to thoroughly investigate the drug safety
system," Trewhitt says. "It would behoove us to wait to see the
Lipman says it's already time for Congress to act.
"We are getting to where this is a problem for our government," he
says. "There have to be some bills written that would address some of these
problems and that would create a better workforce for the FDA, and that would
give them more monetary resources so they don't have to rely on pharmaceutical
company fees to process new drugs. Basically the buck passes back to our
Gardner says the problem goes far beyond the FDA. The real issue, he says,
is health care in America.
"Our health care system is in real trouble," Gardner says. "This
is an example of a real problem where we don't have the politics yet to create
Drug List From Consumer Reports
The Consumer Reports article lists drugs as examples of
"These drugs are just examples," Lipman says. "There are bound
to be others. Even a perfect safety system could never detect every problem of
The drugs include:
- Estrogen, either alone (Premarin and others) or with progestin (Prempro and
- SSRI antidepressants and other antidepressants
- Topical immunosuppressants such as Elidel and Protopic
Do not stop taking these drugs if you're using them, Consumer
Reports warns. The drugs are helpful for people for whom the benefits
outweigh the risks.
"These are important drugs. They are very useful drugs," Lipman
says. "But in many cases they are not the only drug for the condition. And
the patient should know that by taking one of these drugs there is a certain
inherent risk, and the patient should be aware of this risk."
Lipman advises patients using these drugs to talk with their doctors about
whether there is another drug that can be used with less risk. And all patients
taking any drug should be aware of possible side effects and should tell their
doctors about any ill effects -- even those not listed on the label.