Drug Companies Cook Books, Misleading Doctors

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The difference between what drug companies tell the government and doctors suggests that they're cooking the books, which could mislead doctors making prescriptions.

Of 33 new drugs approved by the Food and Drug Administration in 2001 and 2002, one-fifth of supporting clinical trials were not published in medical journals, according to a new study. And those results that were published were often more positive than what companies presented to the FDA in their applications. As a result, potentially unreliable data is being used to promote drugs on which billions of dollars and thousands of lives may ride.

"Some studies aren't published at all. Then, when they are, there are little changes that make the papers look more favorable towards the product," said review co-author Lisa Bero, a University of California, San Francisco health policy expert.

If new — and typically more expensive — drugs are only slightly better than existing drugs, but otherwise are comparable, this is largely an ethical and financial problem. But if the drugs later prove harmful, the damage can be profound.

In 2004, Merck's blockbuster anti-inflammatory drug Vioxx was pulled from the market after killing an FDA-estimated 27,000 people. The drug doubled heart attack risk — a side effect that critics say was glossed over in the company's studies, which in retrospect were partly marketing propaganda. Another Merck blockbuster, the cholesterol-lowering drug Vytorin, has proven ineffective. GlaxoSmithKline's best-selling diabetes drug Avandia was allowed to remain on the market, but only with a label stating its apparent cardiovascular risks.

The difference between what drug companies tell the government and doctors suggests that they're cooking the books, which could mislead doctors making prescriptions.

Of 33 new drugs approved by the Food and Drug Administration in 2001 and 2002, one-fifth of supporting clinical trials were not published in medical journals, according to a new study. And those results that were published were often more positive than what companies presented to the FDA in their applications. As a result, potentially unreliable data is being used to promote drugs on which billions of dollars and thousands of lives may ride.

"Some studies aren't published at all. Then, when they are, there are little changes that make the papers look more favorable towards the product," said review co-author Lisa Bero, a University of California, San Francisco health policy expert.

If new — and typically more expensive — drugs are only slightly better than existing drugs, but otherwise are comparable, this is largely an ethical and financial problem. But if the drugs later prove harmful, the damage can be profound.

In 2004, Merck's blockbuster anti-inflammatory drug Vioxx was pulled from the market after killing an FDA-estimated 27,000 people. The drug doubled heart attack risk — a side effect that critics say was glossed over in the company's studies, which in retrospect were partly marketing propaganda. Another Merck blockbuster, the cholesterol-lowering drug Vytorin, has proven ineffective. GlaxoSmithKline's best-selling diabetes drug Avandia was allowed to remain on the market, but only with a label stating its apparent cardiovascular risks.

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http://blog.wired.com/wiredscience/2008/11/drug-companies.html

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