RE:RE:RE:RE:RE:RE:The delayed newsletterA re-post of a book review on pharma companies..
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.
Editor's Note
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 (https://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.