Suppose a doctor has an idea to use an already FDA approved drug for a
novel off-label use based on a few rat studies. Without any human
studies at all, he obtains a "single use patent" through the US patent
office for say, all cardiac diseases for a drug which is FDA approved
for treating rheumatoid arthritis. He injects the drug near the
sternum as a gimick, and trademarks the procedure as "Heartcure". Then
he begins to heavily advertise this procedure on radio, magazines, on
the internet, and gives interviews to newspapers calling it a "magic
bullet" and a "miracle cure". People flock to him by the thousands and
after 2 years he has made nearly $5,000,000 on this procedures, still
without human proof. During the two year interval, two small studies
were published, one a chart review of 20 of his patients who got
better, and another overseas study of 10 patients, neither with
placebo controls or any other controls, and without standard measures
of cardiac function being performed (subjective only).
Questions:
1. Is it generally considered ethical to embark on a
treatment without any clinical trials of efficacy or
safety when using a drug for a new purpose?
2. Is it fraudulant advertising to use "Heartcure"
prominently in advertising when there is no clinical
evidence it cures anything?
3. Is it considered to be charlatanism when a doctor
advertises a scientifically unproven untested
treatment to the masses with advertising reaching over
4 million people?
4. Is it a scam for a doctor to continue charging $2,000-
3,000 per treatment for a drug which costs him $150 and
for which there are no controlled studies?
5. Is there an issue with the doctor repeatedly calling for
more research into this area when the research will
benefit only him financially due to the exclusive patent,
and when has has made millions of dollars already without
any scientific study of the procedure? This is a
hypothetical case. Please answer yes or no to the
questions if possible please. Thanks!!!!!!!!
General fitness, health and nutrition · Public discussion
Poll on Physician Advertising Ethics
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- Original section
- General fitness, health and nutrition
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- 7 June 2004
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- Michael
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