[lit-ideas] Re: Fw: Re: Autographs (was Re: US exports)
- From: Eternitytime1@xxxxxxx
- To: lit-ideas@xxxxxxxxxxxxx
- Date: Tue, 11 Jan 2005 02:02:28 EST
In a message dated 1/9/2005 6:24:28 PM Central Standard Time,
aamago@xxxxxxxxxxxxx writes:
I think my point, which will never be understood, God bless big pharma, is
that if the FDA was doing its job, people would not need to die before a drug
is pulled off the market. If the FDA were doing its job, bad drugs would
never get on the market.
Hi, Andy,
My point was only that there IS a lot of good that the pharmeucetical
industry workers are trying to do. Not that they didn't need reform.
Sometimes it
was seeming that you wanted to get rid of all pharmeucetical
companies/medicines that they produce as well as the FDA.
I just wanted to point out that there have been some discoveries made (my
son's stuff is fairly new, btw) and that not *everyone* in the industry is bad
and evil--and that there are plenty of people trying very hard to do what they
can to make it better or to provide for alternatives to what currently
exists as a 'whole'.
Although I have too many books that I am reading right now to go read the
one you have suggested (and do wish you would have posted relevant parts --
even
if meant you had to type them in -- instead of simply telling me/us to go
get the book...), I did look up some reviews of it. Here is one which also
discussed the book you have been mentioning--and I thought the comments on the
FDA were (particularly) relevant as it is not so much (it sounds) as though
the FDA is *doing its job*, as much as it is that it does not have the freedom
to do its job.
Thought also that it was intriguing that the reviewer states that "Nor is t
here a lot of sentiment in Washington to take on Big Pharma. In the recent
election the American people made it clear that they do not want or trust the
federal government to regulate much of anything."
I do find it intriguing that the distrust of government is so strong that we
do not understand or recognize the need for oversight...
Anyway, there are a couple of other books discussed here, too!
Better living with (regulated) chemistry,
Marlena in Missouri
Indicting Big Pharma
_Arthur L. Caplan_
(http://www.americanscientist.org/template/AuthorDetail/authorid/1421;jsessionid=baaad7_CO-2fo-)
The Truth about the Drug Companies: How They Deceive Us and What To Do about
It. Marcia Angell. xx + 305 pp. Random House, 2004. $24.95.
On the Take: How Medicine's Complicity with Big Business Can Endanger Your
Health. Jerome P. Kassirer. xx + 251 pp. Oxford University Press, 2005. $28.
Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs.
Jerry Avorn. viii + 448 pp. Alfred A. Knopf, 2004. $27.50.
Is the pharmaceutical industry a dangerous and crooked business that federal
and state authorities need to bring to heel? Should those who develop, market
or prescribe drugs hang their heads in shame when faced with the stark
reality of what they do to earn a living? Is Big Pharma in fact the moral
equivalent of the tobacco industry? One could well come away from Marcia
Angell's The
Truth about the Drug Companies or Jerome Kassirer's On the Take thinking
so. In both books, the sort of moral opprobrium once directed against Big
Tobacco is aimed squarely at the pharmaceutical industry, along with its
legions
of lobbyists, the politicians awash in its campaign contributions and the
doctors it has bought, free meal by free meal, junket by junket, free sample by
free sample and trinket by trinket.
Kassirer and Angell, who are physicians at Tufts and Harvard, respectively,
and who are both former editors of the New England Journal of Medicine, are
not the only authors currently taking a critical look at industry excesses.
Harvard physician and pharmacoepidemiologist Jerry Avorn also has a new book
examining some of the problems with the way prescription drugs are brought to
market, the thoughtful and incisive Powerful Medicines.
It's not hard to see why demonization of the pharmaceutical industry has
become such a popular sport. As Avorn points out, drug companies are now so
obsessed with profits that they are no longer willing to pay for the innovative
research that they claim justifies the high cost of their products. He and
Angell each demonstrate that the numbers do not support the contention that
without high prices there would be no money for the next generation of miracle
drugs. Avorn notes that data from financial reports submitted to the Securities
and Exchange Commission by nine of the largest U.S.-based pharmaceutical
companies show the hollowness of this rationale for exorbitant prices. He cites
a 2002 report by Families, USA, which indicated that these companies spent the
greatest proportion of their revenues (27 percent) on marketing, advertising
and administration. Next came profits at 18 percentâ??a rate of return that
almost no other industry expects or can match. Money spent on research and
development ran a distant third, at 11 percent of revenues. No matter how hard
drug companies spin these numbers, they reveal priorities that serve neither
patients nor the general public.
Other data in these three books strengthen the moral case against the
industry. In the United States, patented, brand-name drugs sell on average for
80
percent more than in Canada and 100 percent more than in France and Italy.
Efforts to redress price inequities by allowing the importation of drugs to the
United States from Canada have met with fierce resistance from Big Pharma,
which has waged a bizarre and deceitful campaign to impugn the safety of
Canadian drugs. The campaign would be laughable had it not been so effective
in
keeping Canadian drugs in Canada.
The sins do not end with high prices, huge budgets for marketing and
advertising, and efforts to restrain free markets. Drug companies, Angell and
Kassirer remind us, have connived to do everything they can think of to capture
the
attention, allegiance and gratitude of physicians. And they have been able
to think of quite a lot.
Dip anywhere at random into The Truth about the Drug Companies or On the
Take and you will find disturbing passages such as this one (from Angell's
book):
Suppose you are a big pharmaceutical company. You make a drug that is
approved for a very limited use. . . . How could you turn it into a
blockbuster? .
. .
. . . You could simply market the drug for unapproved ("off-label") usesâ??
despite the fact that doing so is illegal. You do that by carrying out
"research" that falls way below the standard required for FDA approval, then
"educating" doctors about any favorable results. That way, you could
circumvent the
law. You could say you were not marketing for unapproved uses; you were merely
disseminating the results of research to doctorsâ??who can legally prescribe a
drug for any use. But it would be bogus education about bogus research. It
would really be marketing.
Angell goes on to show that this is exactly what many pharmaceutical
companies have done. In the name of "research," they have subtly encouraged
doctors
to use drugs for unapproved purposes, or for groups of patients (children,
for example) in whom the agent's effectiveness has never been studied. The
industry has also encouraged "innovative" prescription practices on the part
of
doctors who are not equipped to safely monitor and to learn from what they are
doing. Outrage about this sort of conduct infuses every page of her powerful
book.
Kassirer, like Angell, is no slouch at condemning ethical shenanigans:
Big business and physicians alike are involved in a massive charade.
Representatives of the drug companies claim repeatedly that marketing serves
an
essential function in the health-care delivery system by helping to educate
doctors so they can prescribe drugs more appropriately. At the same time, they
press their drug salesmen to push the newest (and usually the most expensive)
products, and their surrogate intermediaries, the medical education companies,
are advertising their services as "persuasive" education.
Kassirer does not write with the same overt anger as Angell, but his quiet
fury is palpable as he watches his beloved medical profession being corrupted
by businesses willing to do whatever it takes to get their drugs prescribed.
It turns out to be relatively easy to make the case against bloated profits,
the herd mentality of companies looking for blockbusters, dishonesty in
marketing and crass schemes to pay off doctors, politicians and the media. No
one
can read these books and not believe that something needs to be done to
reform the way drugs are discovered, patented, sold and used in the United
States
and around the world. But these books are far less satisfying when it comes
to providing solutions.
Despite all the corruption documented by Angell, Kassirer and Avorn, the
pharmaceutical industry is not the tobacco industry. Its products may sometimes
be sold at bloated prices and marketed using techniques more commonly
associated with used car dealers and Internet mortgage brokers. And some of
those
products may even turn out to be dangerous or ineffective. But Big Pharma,
unlike Big Tobacco, is not selling inherently evil products. Many Americans
have
benefited from pharmaceuticals, and more do so every year, which is as much a
cause of higher total expenditures for the nation as are increases in the
prices of individual drugs. So medicine has no real choice but to deal with
Big
Pharma; nobody wants it just to go away. But clearly the drug industry must
be better regulated.
Angell and Kassirer take a fairly straightforward route in their
prescriptions for reform: Get the pharmaceutical industry away from the medical
profession. Prohibit the drug companies from underwriting continuing medical
education, get their sales representatives ("detail" people) out of hospitals
and
doctors' offices, and shut off the junket pipeline. And stop the industry from
flooding the airwaves with ridiculously deceptive direct-to-consumer
advertising.
Easy enough to say, but these are deeply ingrained practices that will prove
next to impossible to eradicate. If you take the detail men and women out of
doctors' offices, they will quickly reappear in the homes, country clubs,
civic organizations and vacation spots of physicians. Companies are willing to
invest heavily in these activities, which means that control (rather than
eradication) is probably the most realistic goal.
Nor is there a lot of sentiment in Washington to take on Big Pharma. In the
recent election the American people made it clear that they do not want or
trust the federal government to regulate much of anything.
What Angell and Kassirer, for all the power of their books, fail to convey is
that the activities they rightly condemn are all symptoms of deeper, more
serious problems in the pharmaceutical industry. As Avorn correctly notes, it
is a lack of science as much as venality that is responsible for the conflicts
of interest and inefficiencies that are rife in medicine's relationships
with the drug business.
Americans think that the U. S. Food and Drug Administration provides tight
oversight ensuring the safety and efficacy of drugs. But the FDA lacks the
authority and resources to do this job well. The FDA and its European
counterparts can demand that pharmaceutical companies provide them with data to
show
that drugs are efficacious. But they have no mandate to show that drugs are
effectiveâ??that they will work not only in closely monitored clinical trials
but
also in the real world under a variety of conditions. Nor is there any
systematic, independent source of evidence about the comparative value of drugs
and
medical technologies. Head-to-head trials comparing a drug with a rival
company's similar product or generic version are almost nonexistent. There are
no
databases that report the results of all trials in a standardized way,
describing adverse events and efficacy in various subpopulations. "The initial
FDA
approval of a drug should be seen as the beginning of an intensive period of
assessment, not the end," Avorn says. But that's not the case. And into this
data vacuum rush the detail men and women bearing gifts.
Doctors, patients, policy makers and regulators are all blind as bats when it
comes to having the data needed to rein in the huge excesses of the
pharmaceutical industry. If no one can really say which drugs are the most
effective
for whom and which will get the job done most cheaply, then marketing based
on trinkets, junkets and hype will continue to flourish. If no one challenges
the industry to live up to its stated ethical goal of using science to
benefit patients, then simply telling the industry's detail men and women to
keep
out of the lecture halls at medical schools will do little to weaken their
influence.
Not only is there insufficient science guiding the pharmaceutical business,
the financial incentives it has are pointing in the wrong direction. Big
Pharma still looks to make its breakthroughs and find its blockbusters by
creating
pills that lots of us can take every day for most of our lives. This means
that the supply of birth control pills, remedies for toenail fungus,
cholesterol blockers and antidepressants is ample, whereas vaccines are
scarce. Big
Pharma and its university partners pay little attention to public health and
the ailments of the poor because there is little money to be made from them.
To have drugs, we must have a pharmaceutical industry. The key to reforming
it in the short run is, as these books show, going after its worst excesses
and tamping them down. In the long run, more serious measures are needed. With
its self-proclaimed ethical mission in mind, the industry must be
restructured. It needs to be firmly grounded in science and properly motivated
to
provide us with the drugs that will do us all the most good. Accomplishing
that is
a matter of dialogue and redirection, not demonization.
Reviewer Information
Arthur L. Caplan is Emmanuel and Robert Hart Professor and chair of the
Department of Medical Ethics at the University of Pennsylvania School of
Medicine
in Philadelphia. He is the author or editor of many books; recent volumes he
has coedited include The Human Cloning Debate (Berkeley Hills Books, 2004),
Health, Disease and Illness: Concepts in Medicine (Georgetown University
Press, 2004) and Who Owns Life? (Prometheus Books, 2002).
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