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Poll on Physician Advertising Ethics Poll on Physician Advertising Ethics -- Posted by Michael on 06-06-04 15:22
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!!!!!!!!
Re: Poll on Physician Advertising Ethics -- Posted by Harvey R. Stone on 06-07-04 07:46
"Michael" wrote in message
news:8b36f94b.0406061422.8ca8752@posting.google.com... > 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.
You forgot to do it didn't you or you forgot which wall you wrote on that
said you can not advertise here. But it is OK to waste your time
here because it is letting some other newsgroup rest a little.
Harv
Re: Poll on Physician Advertising Ethics -- Posted by Paul T. Holland on 06-07-04 12:57
hmmm....can't really find a handle on this one...michael is:
Michael L. Whitworth, M.D.
Pain Center
Columbus Regional Hospital
2400 E. 17th St.
Columbus, IN 47201
phone: 812-375-3417
email: algosdoc@yahoo.com
so, is he building a case for, or against???
Michael wrote:
> 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".
so far, the issue appears to be 'off label use' which is, of course, in
and of itself, long standing practice in medicine;
then michael throws in the word 'gimmick'...not exactly clear writing on
his part as to his point...
> >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".
magic - miracle - cure...all the buzzwords of the shyster
> >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.
now, now, leaving out the unshown proof of the hype, making money in and
of itself is not a crime or even unethical
> >During the two year interval, two small studies
> were published,
studies conducted by whom? published where? why no citations?
> >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).
more unsupported statements only, why no actual links or references?
>
> 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?
as an md, you certainly know the normal and customary path to off label
use. the way in which you have worded most of the above leaves too much
unsaid to provide valid and objective judgment.
>
> 2. Is it fraudulant advertising to use "Heartcure" prominently in
> advertising when there is no clinical evidence it cures anything?
while that is actually up to the ftc and fda, once again you are not being
specific: is this the 'packaging' name, i.e. registered trademark, or just
a 'slogan'? without much more info, and based only upon the above, the
former is allowable, the latter is not.
>
> 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?
you continue in the same vein without providing the actual parameters. it
is - of course - clear that you do not approve; but exactly what you are
withholding approbation 'of' you have not really written, only outlined.
why no references or citations?
>
> 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?
oh my! how you do go on! so, the raw material costs 150; what about
overhead, labor, insurance, etc., etc.? this is just plain silly of you at
this point...if you are not going to provide realistic estimates, why
should anyone here take your questions seriously?
>
> 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?
yes there is an issue - by doing so, the actual knowledge would be gained
and proofs (or not) established...
to juxtapose these points with the issue of making some money would - if
followed to a logical conclusion - mean that every pharmco is unethical
because they hold patents and make a profit...
what you are really saying is that you object to this person already
making money?
>
> This is a hypothetical case. Please answer yes or no to the questions
> if possible please. Thanks!!!!!!!!
i strongly doubt that this is really hypothetical
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