Indicting Big Pharma
The Truth about the Drug Companies: How They Deceive Us and What
To Do about It. Marcia Angell. xx + 305 pp. Random House,
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
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
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
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.
Arthur L. Caplan and the
University of Pennsylvania's Center for Bioethics post the sources
of funding for their research on the Center's Web site (http://www.bioethics.upenn.edu/Resources). The
list of corporations from which they have received support includes
pharmaceutical companies, a fact that was not noted in the print
magazine when the review was published. A link to some
correspondence on this topic can be found here.