The Truth About the Drug Companies

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The Truth About the Drug Companies:

Posted by: greenfloyd

How They Deceive Us and What to Do About It

Granite Bay Press Tribune - CA*

http://www.granitebaypt.com/detail/82417.html

In this book, her most recent, Dr. 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 New England Journal of Medicine had a front-row seat on the

growing corruption of the pharmaceutical industry. "

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.

The current slide toward the commercialization and corruption of

clinical research coincided with the election of President

Reagan in 1980 and the passage of the Bayh-Dole 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 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 Bayh-Dole, 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. The Big Pharma companies are,

in essence, manufacturing and marketing companies.

Angell's concluding chapter, the least convincing in an otherwise

fascinating and penetrating book, contains the solutions, all of

them predictable: 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.

Hoey, M.D.

john.hoey@...