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!!!!!!!!