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Dear Mr. Lauer:

The scenario you paint has already happened once with Selegiline or
Deprenyl.  After the first release of the interrupted DATATOP study, the
company manufacturing and distributing selegiline marketed this drug as the
first drug to "slow down the progression" of parkinsonism.

For several years every patient with Parkinson's disease was started on
Selegiline, either by the inititative of the neurologist or very often at
the request of the patient.  Never mind that the FDA never approved
Selegiline with the indication of slowing down the the progression of the
disease.

Selegiline can be useful like entacapone, in delaying the metabolism of
dopamine  This allows for greater spacing of the dosing interval in patients
who have trouble with wearing off or end of dose effects.  It was for this
indication that the FDA approved the drug, but the drug companies involved,
(SANDOZ and Somerset) ignored the real indication and the whole marketing
effort was for the off-label indication of slowing down the progression of
the disease.

Of course, the rest is history.  When the five year follow -up studies came
out, it was clear that selegiline did not delay significantly the
progression of PD, but thousands of PD patients used it for several years,
allowing the company to run all the way to the bank with their windfall
profits for an unproven indication..

The selegiline story is not all to blame on the drug companies.  They were,
of course, trying to make a buck.  Their marketing was effective.  But the
PD population participated by asking, (some demanding) to be placed on this
drug almost without fail.  One has to be very careful.  The drug companies
will make every effort to sell their product.  Their marketing begins even
before the product is out - sewing the seed for upcoming and effective
medications.

Research is needed.  Patience is needed.  Certainly, pressure from the
community helps, but it can backfire if theoretically promising but untested
new therapeutic efforts are pushed into the market before they are ready for
prime time.

To suggest that the motivation behind drug manufacture is for the benefit of
the sick is like suggesting that General Motors makes cars with the
motivation of providing transportation.  People need cars, people need
medications.  These companies are set up to sell these products to make a
profit.

Perhaps the FDA decision in shooting this down is for our benefit -
indicating that more research is needed before the drug company has the OK
to market an unproven product.

Despite their constant harping on how much research and development costs,
the drug companies as a group have one of the highest returns in corporate
profits of any industry in America.  These are profits AFTER paying for
research, development, and marketing!!!

The research investment of drug companies is just that - investment.   It is
like drilling for oil.  Some wells will not produce what you hoped for, but
you have to drill wells to find oil, so that expenses of drilling are part
of the investment.  Research is part of the investment drug companies make
to ensure their continuing success and incredible profits.


Jorge A Romero, MD


----- Original Message -----
From: "Paul Lauer" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Sunday, July 29, 2001 6:58 AM
Subject: Re: Shot down again


> Jacob:
> I think your $ motivation theory needs a little more analysis. Let's
assume
> the theory is correct. at the moment, some number of drug companies, I
don't
> know how many, are capitalizing on us PDers by supplying drugs which do
> nothing but ameliorate our
> symptoms. One supplies Sinemet, another Requip, (perhaps) another Permax,
> another Mirapex, another Tasmar, another Comtan (I have little conception
of
> who makes which so I concede that some may be made by the same company,
but
> logic dictates that there are multiple companies involved). Each company
has
> its share of the PD misery pie, luxuriating in the fact that it will go on
> forever and corporate profits on PD drugs will go on forever. Never mind
that
> the Sinemet maker lost a portion of his market to the agonists, one by
one,
> which in turn lost share to the succeeding Agonist and that first Tasmar
and
> then Comtan ate into all the preceding shares and that inexorably, new
things
> come along to replace the old or worse yet from the companies' point of
view,
> the life of its patent runs out and the copycats flood in to further
dilute
> the market. Forget all the foregoing and imagine the first company to find
a
> cure and its capture of the market.  IT WILL CAPTURE THE ENTIRE MARKET FOR
AS
> LONG AS IT IS PRIME. Think about it. One company selling to all of us.
Which
> company in its corporate right mind doesn't want to be that company? Which
> company wouldn't give up an eye tooth or the corporate equivalent to be
the
> first in that position? For these reasons at least, I believe that
> corporations which are not unabashedly eleemosynary institutions would
rush
> to be the first to discover a cure and any of them with the muscle in
their R&
> D budgets to do so, are trying like crazy.
>
> Paul H. Lauer
>

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