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Healthy Skepticism Library item: 12441

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Schuman J.
New Suspicions For Big Pharma
The Wall Street Journal 2008 Jan 17
http://online.wsj.com/article/the_morning_brief.html


Full text:

Just as the pharmaceutical industry seemed on the verge of moving past a series of scandals that battered its reputation earlier in the decade, a skein of new revelations could again taint the drug makers in patients’ eyes and renew pressure for tighter regulation.

In the latest potential hit to the industry, researchers in this week’s New England Journal of Medicine say they were suspicious about the choices being made on which drug studies to publish in peer-review journals and decided to pour through the raw reviews given to the Food and Drug Administration. They found that among 74 trials testing the effectiveness of 12 antidepressant drugs, only 31% were published. And a systematic review of these selections shows a link between the studies’ outcome and whether and where they were published. Nearly all studies with positive outcomes were published, while most with negative or questionable outcomes were either not published or published in a way that conveyed a positive outcome, the researchers say.

“We cannot determine whether the bias observed resulted from a failure to submit manuscripts on the part of authors and sponsors, from decisions by journal editors and reviewers not to publish, or both,” the researchers say.
But Dr. Jeffrey M. Drazen, editor in chief of the New England Journal, explains to the New York Times why the study is so alarming for doctors and patients. “When you prescribe drugs, you want to make sure you’re working with best data possible; you wouldn’t buy a stock if you only knew a third of the truth about it,” he says. Moreover, patients who agree to be guinea pigs “take some risk to be in the trial, and then the drug company hides the data?” he asks. “That kind of thing gets us pretty passionate about this issue.” Lead researcher and psychiatrist Erick Turner points out to The Wall Street Journal that doctors unaware of the unpublished studies can make inappropriate prescribing decisions for their patients.

Antidepressant sales in the U.S. come to about $21 billion a year, the Journal says, citing IMS Health, and the drug makers were quick to defend their blockbuster products. While Wyeth and Pfizer declined to comment on the NEJM study, they expressed a commitment to disclose all trial results — if not necessarily in the medical journals where doctors are looking.
GlaxoSmithKline said it has posted the results of more than 3,000 drug trials on its Web site, and Schering-Plough and Eli Lilly said all their study results are published, though sometimes as part of larger medical articles rather than pieces on an individual drug, the Journal reports.

The NEJM study comes just two months after Merck announced a settlement that potentially includes thousands of plaintiffs who claimed to suffer cardiovascular problems as a result of taking one-time blockbuster painkiller Vioxx — which Merck pulled from the market in 2004 amid a run of disturbing news about drugs that were harming patients despite their FDA approvals. Under pressure from Congress and public opinion, the agency tightened its controls on clinical-trial data before and after approval, and the pharmaceutical firms promised to release more data to the public. The new NEJM study raises new questions about whether profit concerns continue to override patients’, and comes on the heels of yet another finding that renewed doubts about the industry’s publishing veracity.

Congress is now looking into whether Schering-Plough and Merck improperly delayed publishing the results of studies that unfavorably compared cholesterol medications Vytorin and Zetia — Schering’s most profitable drugs, which the two companies jointly sell — to cheaper generic alternatives, as the Journal reports. Moreover, researchers studying the drugs had even considered changing their study’s principal goals in what would have been a violation of scientific protocol. Worry about generic competition — Big Pharma’s perpetual nemesis — is apparently responsible for the industry’s other nascent scandal, which began to unfold yesterday in Europe. European Commission regulators raided the offices of Pfizer, GlaxoSmithKline, AstraZeneca and Sanofi-Aventis, among others, in search of evidence that they conspired to keep generic competition off the market after the patents of their own drugs expired. As the Financial Times notes, European antitrust authorities are focusing on whether the companies abused their patent rights to fight off lower-cost competition, and whether they even made a deal with one manufacturer of generics in a way that excluded others.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909