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[e-drug] The Truth About the Drug Companies

E-DRUG: The Truth About the Drug Companies: How They Deceive Us and What to Do 
About It
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[Review of Marcia Angell's latest book on big farma in the NEJM [Volume 
351:1580-1581, October 7, 2004], whose editor she was for many years. 
In this "must-read" book she pleads for control of me-too drugs, re-empowerment 
of the FDA, overseeing Big Pharma's clinical research, curbing patent length 
and abuse, keeping Big Pharma out of medical education, making company 
financial statements transparent, and imposing price controls or guidelines.

The NY Review published a chapter which is online at 
http://www.nybooks.com/articles/17244

A critical review from the 'other' side is at 
http://www.techcentralstation.com/090104F.html
WB]
 
By Marcia Angell. 305 pp. New York, Random House, 2004. $24.95. ISBN 
0-375-50846-5.

In this book, her most recent, Marcia Angell explores pharmaceutical research, 
deplores the rapidly expanding involvement (and distortion of truth) of Big 
Pharma, and implores us all (physicians, patients, politicians) to do something 
about it. The dust-jacket blurb asserts that Angell, "during her two decades at 
[the Journal] had a front-row seat on the growing corruption of the 
pharmaceutical industry." Perhaps, but since leaving the Journal, she's gone 
behind the curtains of Big Pharma, Big University, and Big Faculty. Drawing on 
her own work and on her thoughtful analysis of research, company financial 
statements, and investigative reports into drug development and marketing, 
Angell writes with the unambiguous and unyielding style that Journal readers 
came to expect and trust. 

By Angell's account, the current slide toward the commercialization and 
corruption of clinical research coincided with the election of President Ronald 
Reagan in 1980 and the passage of the BayhDole Act, a new set of laws that 
permitted and encouraged universities and small businesses to patent 
discoveries from research sponsored by the National Institutes of Health (NIH). 
Research paid for by the public to serve the public instantly became a private, 
and salable, good, one that is producing drug sales of more than $200 billion a 
year. 

Commercialization had both specific and broad effects. Readers of this journal 
and others are familiar with investigations into the control that research 
sponsors at pharmaceutical companies exert on the design and analysis of 
clinical trials (including the distortion of primary outcome measures in 
trials) and the issue of reporting, nonreporting, and biased reporting of 
results. Angell reminds us of the increasingly cozy relationships between big 
industry and the faculties of universities. Not only are narcissistic donors 
renaming the medical schools; they are buying access to the best minds of their 
faculties. Angell's examples of the large consulting fees paid by industry to 
individual faculty members and to NIH scientists and directors are astounding. 

The broader effects are felt in the commercialization of universities, medical 
faculties, and our profession. In 2000, in a letter written in response to 
Angell's Journal editorial, "Is Academic Medicine for Sale?" a reader supplied 
the answer: "No. The current owner is very happy with it." The increasing 
intrusion of industry into medical education and the almost complete domination 
of continuing medical education (especially regarding drugs) by the marketing 
departments of large pharmaceutical companies are a scandal. 

The same companies also spend heavily to lobby governments. According to 
Angell, Pharmaceutical Research and Manufacturers of America, the 
pharmaceutical industry's U.S. trade association, has "the largest lobby in 
Washington," which in 2002 employed 675 lobbyists (including 26 former members 
of Congress) at a cost of more than $91 million. The result has been 
above-average growth in corporate profits during both Republican and Democratic 
administrations. The most recent and (at least to observers outside the United 
States) perplexing lobbying effort caused Congress explicitly to prohibit 
Medicare from using its huge purchasing power to get lower prices for drugs, 
thus opening up a dollar pipeline, in the form of higher drug prices, directly 
from taxpayers to corporate coffers. These changes, along with the cave-in by 
the Food and Drug Administration (FDA) in 1997 that permitted 
direct-to-consumer advertising to bypass mention in their ads of all but the 
most serious side effects, have further augmented profits. The overall effect 
has been a corruption not only of science but also of the dissemination of 
science. 

Angell documents that, contrary to what they claim, large pharmaceutical 
companies have "paltry output" in innovative research. In fact, as permitted by 
BayhDole, pharmaceutical companies buy discoveries coming out of the 
basic-science enterprises, including universities and publicly funded granting 
agencies. The real costs of research on drugs by pharmaceutical companies are 
much less than the oft-quoted $800 million or so per new drug brought to 
market. Most of their research is on me-too drugs  unoriginal, tax-deductible 
(and thus paid for in lost taxes by the public), and mostly unnecessary, except 
for corporate profits and executive bonuses. The Big Pharma companies are, in 
essence, manufacturing and marketing companies. 

Angell's concluding chapter, the least convincing one in an otherwise 
fascinating and penetrating book, contains the solutions, all of them 
predictable (and probably unattainable): control me-too drugs, re-empower the 
FDA, oversee Big Pharma's clinical research, curb patent length and abuse, keep 
Big Pharma out of medical education, make company financial statements 
transparent (so we can tell what the costs of research really are, as distinct 
from marketing), and impose price controls or guidelines. Granted, the problems 
are so prevalent and the corporate tentacles so entwined with our way of being 
that it is hard to see what else to recommend. 

But perhaps Angell is right. We must change the way we manage research and the 
development and distribution of new drugs. Not only are health and health care 
at risk, but so are the research enterprise and the reputations of universities 
and governments. The integrity of scientific research is too important to be 
left to the invisible hand of the marketplace. 

John Hoey, M.D. 
Canadian Medical Association Journal 
Ottawa, ON K1G 3Y6, Canada 
john.hoey@cma.ca 

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