Re: The Bull*** Parade

From: Zee (zwalanga_at_yahoo.com)
Date: 07/16/04 

Date: 15 Jul 2004 20:34:57 -0700

"Gregory Poon" <mk.poon@utoronto.ca> wrote in message news:<I0wuM0.5BF@campus-news-reading.utoronto.ca>...
> > N Engl J Med. 2000 Jun 22;342(25):1902-4
> > <URL:http://content.nejm.org/cgi/content/full/342/25/1902> (free for
> > subscribers)
> > <URL:http://www.mercola.com/2000/jun/24/pharmaceutical_industry.htm>
> (free)
> > <URL:http://www.karlloren.com/Diabetes/p17.htm> (free)
> >
> > from the most prestigious medical journal in U.S. don't seem to agree with
> > you. An excerpt:
>
>
> I'm glad I've drawn the ire of the NEJM. Yes most of the basic and
> preclinical research is done with public money, but my contention is that to
> make the fruits of this research available to the general public, industrial
> involvement is indispensable, for reasons that we've already talked about.

I know academics working at your own university who would disgree with
you on this. Take just this example here, the insulin. It went
something like this: when pork insulin wasn't making any money for
anyone, "human" insulin was developed. It was pushed by pharma (Eli
Lilly controlled by the Bush and Quayle families) to exclusion of the
pork insulin and the regret of a sizable and increasingly vocal
diabetic population who are sick, literally, of trying to control
their illness on what isn't working for them. But they can't get the
old pork insulin (or must go to great lengths to do so): it is
virtually unavailable. It is not being produced, doctors don't know
their patients would do better on it, and why? The pharma won't
produce because it is not making anyone any money. This might all be
fine, if you believe wholly in a capitalist system, but the fact is,
new is second best, but apparently killing people. I am not myself
diabetic, and I did not hear this from a couple, but from, as I
mentioned health policy advocates at your own university.

Zee

Yes, Banting and Best (and Collip) came up with insulin at the U of T
on
> public money, but few people with diabetes would benefit from this if Lilly
> did not take the development over and produce it at a scale and quality that
> was viable for general use. Likewise Fleming could not bring penicillin to
> the public; industry did.
>
> Nobel prizes are awarded for research that was deemed truly innovative and
> transformative *in retrospect*, at a time when industry and private
> enterprises have made the research valuable at the population level. Let's
> take what is probably the biggest Nobel prize in recent history: Kary
> Mullis' "invention" of PCR in 1983 (I say biggest because nobody has won a
> Nobel prize, in 1993, so soon after assimilation of their work). Not
> withstanding the fact the Mullis was working in industry when he came up
> with PCR (for Cetus Corp. in CA), PCR would be little more than some
> molecular biologist's toy (and Mullis would certainly not have been awarded
> the Nobel prize) if it weren't for the tremendous commercialization of the
> technology (by, for example, Perkin Elmer, which still owns the patent for
> PCR) into the diagnostic, pharmaceutical, biotech arenas. Last year's Nobel
> for medicine went to two biophysicists who studied MRI; in the "real world"
> MRI would be inaccessible (and therefore useless) to anyone if there are not
> companies out there making these multi-million dollar machines.
>
> There are always going to be "me-too"s out there that are not innovative.
> We have a dozen brands of ultra-luxury SUVs on the road, all do basically
> the same things, but then people think it's a good thing and call it
> competition.
>
> Don't feel patronized by a journal editorial, even if it's the NEJM.
>
>
> "Matti Narkia" <mnng1_REMOVE_THIS@despammed.com> wrote in message
> news:1htcf09bhlskde8bre0j5rbeucp6j9bmps@4ax.com...
> > Wed, 14 Jul 2004 23:48:29 GMT in article
> > <I0v8An.KHp@campus-news-reading.utoronto.ca> "Gregory Poon"
> > <mk.poon@utoronto.ca> wrote:
> >
> > >> Practically all drugs are _manufactured_ by big pharma, that was not an
> > >> issue. The question is where were they invented, who made the
> innovation
> and
> > >> basic research? Most of the major inventions originate from publicly
> funded
> > >> research or small bio-tech companies. Big pharma then buys
> patents/licences
> > >> and starts manufacturing and marketing.
> > >
> > >
> > >There seems to be widespread impression that big pharma does not do
> "real"
> > >drug research. Most of work required to bring a drug substance to the
> > >public is in fact done or funded by the manufacturer -- toxicology,
> > >pharmaceutics, pharmcokinetics, clinical trials, pharmacoeconomics, etc.
> > >Publiclly funded research in these aspects actually plays only a minor
> role,
> > >if only because the amount of money and organization required just don't
> > >exist in university research labs. So if academic research were to
> > >transcend to clinical applications, partnership (or whichever you choose
> to
> > >call it) with the pharmaceutical industry is essential. Insulin is
> probably
> > >the only notable example to date where the development of the drug can be
> > >attributed primarily to publiclly funded research (at the University of
> > >Toronto in the 1920's). And no, I don't work for a pharmaceutical
> company,
> > >but I do work at the U of T, so my plugging for insulin may be
> > >understandable.
> > >
> > Well, the editorial article
> >
> > Angell M.
> > The pharmaceutical industry--to whom is it accountable?
> >
> > "What about the picture of the drug industry as an exemplar of
> > the free market? That image is very far from the truth. On the
> > contrary, the pharmaceutical industry enjoys extraordinary
> > government protections and subsidies. Much of the early basic
> > research that may lead to drug development is funded by the
> > National Institutes of Health. (12) It is usually only later,
> > when the research shows practical promise, that the drug
> > companies become involved. The industry also enjoys great tax
> > advantages. Not only are its research and development costs
> > deductible, but so are its massive marketing expenses. The
> > average tax rate of major U.S. industries from 1993 to 1996 was
> > 27.3 percent of revenues. During the same period the
> > pharmaceutical industry was reportedly taxed at a rate of only
> > 16.2 percent. (13) Most important, the drug companies enjoy 17-
> > year government-granted monopolies on their new drugs -- that
> > is, patent protection. Once a drug is patented, no one else may
> > sell it, and the drug company is free to charge whatever the
> > traffic will bear.
> >
> > Is it correct that the U.S. pharmaceutical industry is highly
> > innovative? Only partly. Some recently launched drugs do indeed
> > fill important, previously unmet medical needs. But it is hard
> > to escape the conclusion that many other new drugs add little
> > to the therapeutic armamentarium except expense and confusion.
> > Consider the welter of very similar drugs to lower cholesterol
> > levels. Developing genuinely innovative drugs is difficult and
> > chancy. It is easier to make "me-too" drugs or minor variants
> > of established products. To be profitable, the variation need
> > only be sufficient to secure a new patent, and the rest is
> > marketing. Critics believe drug companies are doing far too
> > much of that sort of thing. They also charge that many
> > industry-sponsored clinical trials are designed more to find
> > small advantages that can be highlighted in promotional
> > campaigns than to find clinically meaningful effects. (14)
> >
> > The industry has certainly been ingenious in finding ways to
> > extend patents on its bestselling drugs. For example, a recent
> > Wall Street Journal article describes a complicated business
> > deal between Merck and Schering-Plough for the marketing of two
> > new drug combinations, one to lower serum lipid levels and the
> > other to relieve allergies. Each combination will pair one
> > company's "blockbuster" drug, whose patent as a single product
> > will soon expire, with a drug with supplementary action owned
> > by the other company. The combination drugs will have new
> > patents, and their profits will be shared by both companies.
> > (15) This may be good business, but the medical soundness of
> > fixed drug combinations as opposed to flexible combinations of
> > separate drugs is debatable.
> >
> > The marketing budgets of the drug industry are enormous -- much
> > larger than the research and development costs -- although
> > exact figures are difficult to come by, in part because
> > marketing and administrative expenses are often folded together
> > and in part because some of the research and development budget
> > is for marketing research. According to its annual report,
> > Pfizer spent 39.2 percent of its revenues on marketing and
> > administration in 1999 (16); Pharmacia & Upjohn is reported to
> > have spent about the same. (12) The industry depicts these huge
> > expenditures as serving an educational function. It contends
> > that doctors and the public learn about new and useful drugs in
> > this way. Unfortunately, many doctors do indeed rely on drug-
> > company representatives and promotional materials to learn
> > about new drugs, and much of the public learns from direct-to-
> > consumer advertising. (17) But to rely on the drug companies
> > for unbiased evaluations of their products makes about as much
> > sense as relying on beer companies to teach us about
> > alcoholism. The conflict of interest is obvious. The fact is
> > that marketing is meant to sell drugs, and the less important
> > the drug, the more marketing it takes to sell it. Important new
> > drugs do not need much promotion. Me-too drugs do."
> >
> >
> > If you work at the University of Toronto you naturally are familiar with
> the
> > fact that research leading to the discovery of insulin was conducted
> there.
> > What amazes me is that you don't seem to be aware that most major medical
> > breakthroughs originate from publicly funded research. How many percent of
> > the Nobel Prize winners in Physiology or Medicine have worked for the big
> > pharma at the time they have done the work which earned them the prize?
> > And how it is possible that you fail to remember that the research effort
> > which started the rise of modern medicine, the invention of the first
> > antibiotic, penicillin, was totally publicly funded? Sir Alexander
> Fleming,
> > who first discovered penicillin, worked at the St. Mary's Medical School,
> > London University, and Sir Howard Florey and Ernst Boris Chain from Oxford
> > University, were the scientists who developed penicillin further and were
> > chiefly responsible for the research which led to its success as a drug.
> See
> > for example
> >
> > <URL:http://www.nobel.se/medicine/laureates/1945/fleming-bio.html>
> > <URL:http://www.nobel.se/medicine/laureates/1945/>
> > <URL:http://www.time.com/time/time100/scientist/profile/fleming.html>
> > <URL:http://www2.sjsu.edu/depts/Museum/flemin.html>
> >
> <URL:http://www.bbc.co.uk/history/historic_figures/fleming_alexander.shtml>
> >
> > Finally, during the World War II an obscure outpost of a U.S. government
> > agency, the Department of Agriculture's laboratory in Peoria, Illinois,
> > figured out how to mass-produce penicillin, took out a patent on the
> method,
> > and then made all of its patents available to any producer without charge.
> > R. Moss gives some details about this process in the book "The Cancer
> > Industry" (ISBN 1-55778-439-6):
> >
> > It was only with the approach of World War II, when huge
> > casualties loomed and the Allies faced the loss of German sulfa
> > drugs, that some British scientists began campaign to develop
> > penicillin commercially [1]. Two British scientists were brought
> > to United States in 1941, under the auspices of the Office of
> > Scientific Research and development (OSRD), to try to get private
> > pharmaceutical companies interested in working on the projects.
> > "They had almost no luck," Richard Harris wrote in _The Real
> > Voice_, summarizing the results of an investigation by Senator
> > Estes Kefauver's staff [2].
> >
> > A few weeks after the Japanese attacked Pearl Harbor, Dr.
> > Vannevar Bush, director of OSRD, personally brought a number of
> > drug companies into the research effort. A year and a half later
> > he wrote:
> >
> > "Now the pharmaceutical companies have cooperated in this
> > affair after a fashion. They have not made their experimental
> > and their development of manufacturing processess generally
> > available, however [2]."
> >
> > The problem, Harris remarked, "was that most firms were too busy
> > trying to corner patents on various processes in the production
> > of penicillin to produce much of it ..." [2]. On January 19,
> > 1944, the coordinator of the penicillin program of the War
> > Production Board wrote that he could not "with a clear conscience
> > assume the responsibility for coordinating this program" because
> > of the refusal of the drug companies to exchange information, a
> > refusal that was costing thousands of lives on the battlefield.
> >
> > The deadlock was broken only when an obscure outpost of a
> > government agency, the Department of Agriculture's laboratory in
> > Peoria, Illinois, figured out how to mass-produce penicillin,
> > took out a patent on the method, and then made "all of its
> > patents ... available to any producer without charge" [2].
> >
> > Even so, drug companies never showed much enthusiasm for penicillin.
> > "The synthesis of penicillin brought laurels to the scientists," wrote
> > _Fortune_ (March 1976), "but precious little else." For this reason,
> > John McKeen, the president of Pfizer, said in 1950, "If you want to
> > lose your shirt in a hurry, start making penicillin and streptomycin"
> > [3]. Economics professor Alek A. Rozental commented further:
> >
> > "Pfizer announced that it would henceforth concentrate on
> > the development of new and exclusive antibiotic specialties.
> > Other firms had the same idea. Today the few that control
> > production of the broad-spectrum antibiotics (Achromycin,
> > Terramycin, Aureomycin, and tetracyclines) have managed to avoid
> > repetition of the "unhappy" penicillin experience [3].""
> >
> >
> > References:
> >
> > [1] Bäumler, Ernst. A Century of Chemistry. Translated by David Goodman.
> > Dusseldorf: Econ Verlag, 1968.
> >
> > [2] Harris, Richard. The Real Voice. New York: Macmillan Publishing
> > Company, 1964.
> >
> > [3] Rozental, Alek A. "The Strange Ethics of Ethical Drug Industry."
> > In Crisis in American Medicine, edited by Marion K. Sanders. New
> > York: Harper & Row, 1961
> >
> >
> > --
> > Matti Narkia

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