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On 8 Sep 2005 12:42:05 -0700, "fresh~horses" wrote:
>'New' drugs too often offer little new
>Breakthrough drugs are rare. Most newcomers driving up
>costs are just me-too marketing darlings
The reader might take note of the fact that Canada isn't
what one would call a hotbed of drug development.
Overwhelmingly, Canadians "free ride" on the investments
made by multinational corporations who put their research
funding into national jurisdictions where their intellectual
property rights (including their right to keep their profits, if
they can make 'em) are better preserved. The Canadian
government isn't what one would call morally committed
to the preservation of individual rights. Try to send a
copy of *Unintended Consequences* to a friend living
in Toronto and you'll see what I mean.
Beyond that, however, there is the fact that even in the
markets where the greatest potential profits are to be
made - these United States still being chief among them
- the costs imposed by regulatory exigencies are ex-
tremely high. Anyone familiar with the history of drug
development in the modern era - from Massengill's Elixir
Sulfanilamide (http://www.fda.gov/oc/history/elixir.html)
to the present date - knows that the lurch and shudder
of the political regulators from one crisis to another have
raised the cost of doing business in this economic sector
without really having done much to improve product
safety.
Not surprisingly, the drug manufacturers have found that
"me-too" drug products are easier to get through govern-
ment agencies' sclerotic regulatory processes. Truly inno-
vative ("breakthrough") medications are generally - indeed,
almost by definition - those with novel mechanisms of action
(MoA), and in each such case there is considerable risk
for the developer. Prior to the thalidomide episode that
gave Senator Kefauver the golden opportunity to punish
and extort the pharmaceutical industry back in the '60s,
there was merely the reasonable requirement that a pharma
manufacturer must demonstrate the safety of his/her product.
After Kefauver-Harris was enacted, however - in the trail
of a product *safety* mishap involving thalidomide as a
teratogen in the first trimester of human pregnancy - such
manufacturers were required to prove the *efficacy* of their
new products in specific treatment areas involving specific
patient populations - a much more costly and prolonged
process than the thorough scientific establishment of safety
parameters.
Does that make much sense to you? No? Well, hell.
You're not Senator Kefauver or any of his successors in
the U.S. Congress, are you?
At any rede, it's a helluva lot easier to demonstrate drug
efficacy (as well as safety) when your product is a "me-too"
molecule that merely refines an existing therapeutic approach
to a well-studied and well-understood disease process.
Pharmaceuticals companies being run by ex-Business majors
(you remember? those guys whose drunken bodies used to
litter the floors in the dormitories every Sunday morning
while you were on your way to the college library to study?),
it's natural that they should shy away from truly novel and
innovative approaches to any problem. Only the fact that
you can occasionally catch the Pointy-Haired Boss in a
state of pliable inebriation accounts for the fact that research
guys and clinicians manage to turn Big Pharma investment into
areas other than Elbonian mud refining.
Regrettably, that doesn't happen often.
But "me-too" drugs have their advantages. I've got patients
who are taking Nexium (esomeprazole, AstraZeneca) right
now after having tried every other combination of H2 blocker
and proton pump inhibitor available. Only the S-isomer of
omeprazole - a thorough and abject "me-too" product -
works for these patients. What's the alternative? A good old
reliable Bilroth-II surgical procedure? No, thanks! Nexium
for years and years and years is cheaper - and a helluva lot
less dangerous.
By the same token, amoxicillin is merely a "me-too" for
ampicillin, which is simply a "me-too" for penicillin, which
was - in all justice - considered nothing more than a ho-hum
unnecessary follow-on for sulfanilamide. And who needed
ibuprofen when we had aspirin, for crying out loud? True,
you needed to push the dosing of aspirin to the point at
which the patient complains of an incessant ringing in the
ears (no fooling; that's actually how we used to dose aspirin
for rheumatoid arthritis back in the days before we had
alternative "me-too" drugs to replace it), but aspirin is
just as good an anti-inflammatory as ibuprofen or naproxen
sodium or piroxicam or any of those other fancy non-salicylate
NSAIDs. And don't get me started on the "me-too" salicylates
like choline magnesium trisalicylate, salsalate, etc. So they're
more convenient for the patient, and safer, and easier to dose
and monitor. So what? They're "me-too" drugs.
Well, you get the point, don't you? What unthinking idiots
call "me-too" drugs are commonly therapeutic advances down
previously proven pathways. They tend very strongly to be
lower-risk steps in medical progress (though always bear in
mind the fact that Massengill's Elixir Sulfanilamide was a "me-
too" product as well, compounding an established active prin-
ciple with a ghodawful excipient).
For the ex-Business majors, they're more of a "sure thing" in
a costly process severely strangulated by feeble-minded govern-
ment bureaucrats and politicians.
For the FDA bureaucrats (underfunded, undermanned, and
replete with cement-headed Civil Service types), the "me-too"
drugs offer the comforting thought that most of the risks and
all of the efficacy criteria are well-established before you ever
open the truckload of paperwork the manufacturer is required
to send down to Rockville.
For the practicing physicians, there's the benefit of established
drug MoA with a "me-too" medication, coupled with clinical studies
that - hopefully - show patient-centered benefits such as better
adverse events profiles, less frequent dosing, less bothersome
potential for drug/drug interactions, and so forth. A "me-too"
drug is a helluva lot easier to incorporate in your practice than
a totally novel medication, I assure you.
Snotty critiques of the pharma industry for marketing "me-too"
drugs are borne chiefly of willful stupidity on the part of the
simple sons of bitches who write them. Such dimwits know
nothing of the political regulatory environment that makes such
a profound impact upon the economics of pharmaceutical research
and development, and even less about the practice of medicine.
I'd say that it was perfectly okay to ignore these jackasses if
it weren't so much fun to get them sputtering and screaming and
jumping up and down in impotent rage.
----------------------------
Hygiene is the corruption of medicine by morality. It is
impossible to find a hygienist who does not debase his
theory of the healthful with a theory of the virtuous.
The whole hygienic art, indeed, resolves itself into an
ethical exhortation. This brings it, at the end, into
diametrical conflict with medicine proper. The true aim
of medicine is not to make men virtuous; it is to safeguard
and rescue them from the consequences of their vices. The
physician does not preach repentence; he offers absolution.
-- H.L. Mencken, The Smart Set, May 1919
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