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Recently, many popular drugs have been taken off the market for killing
or injuring Americans. However, the Food and Drug Administration (FDA)
claims that many of these deaths and injuries are occurring because doctors
are ignoring safety warnings and prescribing them to the wrong patients.
Are Any New Drugs Safe?
A report on ABCNews.com bring up an interesting
point. They state "the problems raise a bigger question: Should
a savvy patient ever swallow a new medicine until it's been sold for a
year? After all, that first year
of sales often is when bad side effects are spotted."
"I sure wouldn't," says Dr. Raymond Woosley,
a leading drug-safety expert and cardiologist at Georgetown University,
according to the report. "I don't personally, and I don't usually
prescribe it unless I have to."
Even the FDA commissioner Dr. Jane Henney urges
consumers to be cautious and to question when your doctor wants to switch
you to a brand-new drug. If the only reason for switching is "to
give it a try", then that is not a good enough reason according to
Dr. Henney.
Is the FDA approving new drugs too quickly? Recently,
under pressure from various sources, the FDA has sped up the review process:
Average review time for new drugs was 14.6 months in fiscal 2000, down
from 34.3 months in 1993. Drugs deemed breakthroughs, and drugs whose
makers pay special fees to FDA, can get a speedier six-month review.
Ignored Warnings
However, few of the recently banned drugs got this
"fast-track" approval. Instead, some FDA scientists say the
main problem was that doctors ignored or never read warning labels that
could have prevented deaths.
If that doesn't change, "additional effective
drugs are likely to be withdrawn, and some drugs may never become available
in the first place," warned FDA drug chief Dr. Janet Woodcock in
an unusual letter to doctors in the Journal of the American Medical Association
(JAMA).
One of the additional problems is that new drugs
are tested on only a few hundred to a few thousand patients, so no one
knows just how many side effects will turn up when they're given to millions.
However, the FDA has just 82 workers tracking side
effects once drugs are on the market. The US Congress has repeatedly refused
additional funds to upgrade the program, which depends on doctors voluntarily
reporting their patients' side effects, which is something that few of
them are doing.
Once it spots a potential problem, the FDA often
tries issuing warnings. However, they maintain the warnings only work
if doctors pay attention to them and heed the warnings.
Some examples:
- Propulsid
- For two years, FDA warned that prescribing it to people with kidney
or heart disease, or those who take certain antibiotics or other pills,
could cause lethal irregular heartbeats. Yet 80 deaths occurred.
- Rezulin
- FDA's own scientists complained for months that patients didn't get
tested for liver damage as warning labels required.
Dr. Sidney Wolfe of the consumer advocacy group
Public Citizen says the cases show
FDA should ban drugs faster because warnings don't work.
Why Aren't Doctors Paying
Attention
There are several reasons proposed as to why doctors
are not getting the message:
- Doctors claim they lack time to read the pages
of fine print
- They claim they can't remember all the warnings
- Most doctors learn about new drugs from pharmaceutical
reps, unlikely to stress the risks of the products they are selling
Although some computer systems can flag risky drugs or combination, even
these systems can sometimes make errors, according to Dr. Woosley. Shortly
before Propulsid's ban, he tested a highly touted pharmacists' system and
found it allowed prescription of a deadly Propulsid-antibiotic mix.
Nor do those flyers
many pharmacies hand out with prescriptions list all the side effects.
The FDA is currently discussing tougher measures,
such as limiting early sales of new drugs or even restricting which drugs
can be prescribed by which doctors.
ABCNews.com December
12, 2000
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