Indicting Big Pharma

From: Zee (zwalanga_at_yahoo.com)
Date: 12/10/04 

Date: 10 Dec 2004 13:07:33 -0800

http://tinyurl.com/5c3xq

http://www.americanscientist.org/ <snip.....very long>

Indicting Big Pharma
Arthur L. Caplan

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
percent—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") uses—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 doctors—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 effective—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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