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Kevin
Gilleland of Raleigh, NC, asks:
Will the FDA need to be involved to regulate the effort for approved
drugs and alternative medicine to coexist within treatment regimens?
Dr.
George Lundberg responds:
I believe that the FDA will have to become increasingly involved in
regulating products that are used for the treatment or prevention of
disease. Our government has officially allowed the mass production and
marketing of all manner of substances as "nutritional supplements" with
little or no evidence of efficacy, effectiveness, or the absence of
harm. Even the concentration and purity of many of these substances
are uncertain when purchased. The fact that the manufacturers make no
formal health claim on a label allows such freedom by current law. It
is probably too much freedom and needs new restraints.
Dr.
Marcia Angell responds:
The FDA by law requires that before manufacturers can sell new drugs
or devices, they fund rigorous scientific studies to show the drugs
are reasonably safe and effective. This protects the public from, say,
heart pills that cause death more often than they prevent it, or artificial
heart valves that are likely to become leaky. In 1938, Congress exempted
homeopathic remedies from this requirement, and in 1994, it exempted
products labeled as "dietary supplements." After the 1994, many more
of these "supplements" flooded the market, since they didn't have to
be shown safe or effective. The FDA can take action only if they are
found to be dangerous after they are on the market. Doctors can prescribe
FDA approved drugs for any use they believe is medically indicated,
and, of course, patients can choose to take alternative remedies either
alone or in conjunction with FDA-approved drugs.
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