New Book: Drug makers "blackmail the public"
From: Rita Stanley (rlstanley_at_comcast.net)
Date: 08/22/04
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Date: Sun, 22 Aug 2004 19:23:27 GMT
http://www.businessweek.com/technology/content/aug2004/tc20040818_7567_tc121
.htm
BUSINESS WEEK
AUGUST 18, 2004
Drugmakers "Blackmail the Public"
Author Marica Angell says her research shows their huge influence over
Congress, the FDA, and doctors is harming Americans
After she stepped down in June, 2000, as interim editor-in-chief of the New
England Journal of Medicine (NEJM), Dr. Marcia Angell decided to write a
book about biases in clinical trials. As she was doing her research and
writing, she realized that "all roads led back to drug companies." Angell
decided there was a bigger story to tell -- about the vast influence the
pharmaceutical industry has over how medicine is practiced today.
During her 20-year career at NEJM, Angell had watched drugmakers expand
their sway. They became the main sponsors of clinical testing and physician
education and are also a critical source of funding for the Food & Drug
Administration. "I finally decided just to bite the bullet and write about
[the industry]." The result is The Truth about Drug Companies: How They
Deceive Us and What to Do About It, which arrives in bookstores in late
August.
The book provides a detailed account of the intimate interconnections
between drug companies and every other player in the health field --
including medical journals, doctors, government agencies, Congress,
universities -- and how such relationships harm the public. Dr. Angell
recently spoke with BusinessWeek Online reporter Amy Tsao. Edited excerpts
of their conversation follow:
Q: You give a very troubling account of the drug industry's practices. What,
in your view, are the big truths that it doesn't want the public to
understand?
A: I would say they're threefold. One, they spend relatively little on
R&D -- less than they make in profits and far less than they spend on
marketing and administration. What the industry does is essentially to
blackmail the public. It says: "We're the source of your miracles, of your
innovative drugs, and therefore don't mess with us."
The second truth is that they're not particularly innovative. Their major
product is "me-too" drugs -- and even the innovative drugs that they do
produce are almost always based on research that's been done at taxpayer
expense [and] funded by the NIH [National Institutes of Health].
The third truth is that they have pretty much had their own way because of
their control and influence over the institutions in society that really
ought to be checking them. They have pretty much bought and paid for
Congress. They have a lot of influence over the FDA through user fees they
pay [to have their drugs reviewed by the agency], and they have way too much
influence over doctors and the medical profession generally.
Q: You mentioned that in other countries drug companies can sell medication
for a profit, [but] there are price controls. What's the difference between
the profit margins in the U.S. vs. countries where there are price controls?
A: I don't know the answer to that. That's another way they're very
secretive. We do know that they make a profit in other countries because
they aren't charities. They don't give drugs away. But let's assume that
they did.
Look at the year 2002 , when the profit margin for the 10 [drug] companies
on the Fortune 500 list was 17% of sales, and sales in this country amounted
to about half of their worldwide sales. You can calculate even if they made
no profit whatsoever in the rest of the world, they would still come out
with at least an 8.5% profit margin. And that would be higher than the
median of the other Fortune 500 companies that year, which was 3.1%.
Q: What role should physicians play in curbing some of the industry's
marketing influence?
A: I think my harshest criticism, perhaps, was not for the industry but for
my fellow physicians and the medical profession. After all, the industry is
in business to make money, but that isn't what doctors and medical schools
should be doing. They don't have to be in bed with the drug companies. But
they are.
Drug companies finance most of the continuing medical education of doctors,
as well as meetings of professional societies. They lavish all manner of
gifts on doctors in practice, including dinners in luxurious restaurants and
trips (ostensibly for educational purposes) to exotic resorts. And they
provide speakers and meals for interns and residents in teaching hospitals.
The profession should acknowledge that this is all a form of marketing,
which adds to the prices of prescription drugs. Doctors should take
responsibility for their own education and buy their own meals.
Q: What about medical journals? Are there enough safeguards in place to make
sure that the right research is published?
A: There are two issues in that question. One, is the research valid, and
can we trust it? And I'm concerned that increasingly, we can't -- that the
sponsors introduce all kinds of bias in the designs and analyses of the
study and that some of the more interesting data are suppressed.
The second issue is whether journals are publishing the most medically and
scientifically important research or whether they're publishing studies that
are preferentially favorable to the industry. The answer depends a lot on
the journal.
I don't think the big distinguished journals, the reputable journals, like
the New England Journal of Medicine or the Journal of the American Medical
Assn. are selecting papers to publish because they're favorable to sponsors.
Not at all. [But] I think many journals are publishing papers that are
favorable to the industry because they're totally dependent on the industry
for advertising revenues.
Q: We're seeing many individuals -- even whole states -- buying drugs from
abroad. What will be the impact of this?
A: I think the industry is going to use trade agreements to force other
countries to let their prices rise. This is something that Mark McClellan,
former FDA commissioner, talked about last year. Already, a recent trade
agreement with Australia was designed to do that, and it gives the drug
companies the right to prevent importing drugs from Australia. I think the
intention is for other bilateral trade agreements do the same thing.
The real answer is to regulate prices here in some way, not to require them
to go up [elsewhere].
Q: Is that a possibility?
A: Not as long as the pharmaceutical industry has the largest lobby in
Washington and contributes so generously to political campaigns.
Q: What about legislative solutions?
A: The most important and most doable solution in many ways is to require
that companies, to get FDA approval, have to compare [the new product] with
older drugs already in the market, not just with placebos. The new drug
should be shown to be superior in some way to existing treatments -- more
effective, safer, or substantially more convenient. This would pull the rug
out from the me-too industry.
Q: What about the recent talk of clinical trial registries. Is that a
solution?
A: All clinical trials should be registered in one central place. It should
be a condition of enrolling human subjects. After all, human subjects don't
sign onto clinical trials just for fun. They are hoping that this will yield
knowledge. If that knowledge is suppressed, then they've been used in a
misleading way. Research must be registered, and it should be done so at the
inception of the study. The reason for registering it at the beginning is
that it doesn't allow companies to shift the goal post as the trial goes on.
Q: What can individuals do to fight back?
A: One recommendation is to be aware that this industry speaks through many
voices, and whenever anyone makes a pronouncement about drug prices or
anything else dealing with prescription drugs, people ought to ask
themselves if there is a conflict of interest. Often there is.
Patients have to become much more skeptical about claims that drugs will
cure whatever ails them. There's reason to believe that some new drugs are
not nearly as good as they're claimed to be, that doctors believe the claims
as much as their patients do, and we have to remember that almost any drug
has a risk of side effects. This isn't to say that there aren't important
drugs on the market. They can be very helpful and even life-saving.
I'm not trying to say never take a drug -- but I'm saying that people should
be reluctant to take drugs unless they're pretty sure that they're needed.
Edited by Thane Peterson
BOOK INFORMATION:
The Truth About the Drug Companies : How They Deceive Us and What to Do
About It
Author: MARCIA ANGELL
Release Date: 24 August, 2004
ISBN: 0375508465
Publisher: Random House
Format: Hardcover
Price: Walmart $15.27 Barnes & Noble $19.96
------------------------------
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