Physician Advertising Ethics

Michael said:

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

And Amgen

Quoted message said:

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!!!!!!!!

The answer is that much of it is unethical.

I know what you're talking about---the use of TNF-a
inhibitor Enbrel for back disc problems. It is not totally
out of line scientifically, as anti-inflammatory steroids
are standard treatment, and there is some evidence that TNF-
a does contribute to disease process.

This is a FTC and professional standards issue.