E-drug: Stolberg/Gerth on profit agenda and design of clinical trials
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WARNING: LONG MESSAGE [cross posted from pharm-policy. BS, WB]
Another long, thoughtful and interesting article by Stolberg and Gerth
in their Medicine Merchants series in the New York Times. This one
concerns the trials for drugs that lower cholesterol, and how the firm's
profit motives influence the trials that get done, and the trials that
don't get done. Jamie
http://www.nytimes.com/2000/12/23/science/23DRUG.html
December 23, 2000
Single-Page Format
MEDICINE MERCHANTS
Drug Makers Design Studies With Eye to Competitive Edge
By SHERYL GAY STOLBERG and JEFF GERTH
By almost anyone's standards, the cholesterol-lowering pill Pravachol
is a blockbuster. With $1.7 billion in worldwide sales last year -
$1.1
billion in the United States alone - the drug is Bristol- Myers Squibb's
top-selling product. But it is also a medicine with an inferiority
complex.
Pravachol belongs to a class of drugs, statins, that are the most widely
prescribed drugs in the United States. Bristol-Myers Squibb, with its
pioneering research on the drug, helped create the booming statin
market. But a more powerful newcomer, Pfizer's Lipitor, leads the pack
in sales.
Last year, Bristol-Myers executives took a calculated risk, committing
tens of millions of dollars for a comparison of Pravachol to Lipitor.
They gave their study a catchy acronym, Prove It. They also lined up
one of the most famous names in cardiology to oversee it, Dr. Eugene
Braunwald, a Harvard Medical School professor who wrote the leading
textbook on heart disease.
"It's a risk for them," Dr. Braunwald said.
Dr. Christopher Cannon, the study's principal investigator, said,
"Bristol-Myers Squibb is standing up and saying, `We stand behind our
drug and we're going to support this, and if it turns out that the other
guy's drug wins, then we've done a service to cardiology."
But some prominent heart specialists, as well as an expert in clinical
trial design, say Prove It may not be the gamble it appears. They argue
that the design of the study makes it likely to find that, even though
Lipitor brings cholesterol levels lower, the two drugs work equally well
in preventing heart attacks and death. In that case, Bristol-Myers sales
representatives could use the findings to persuade doctors to prescribe
Pravachol.
Both the company and the Harvard investigators say the study is valid.
Yet the debate over Prove It, familiar in cardiology circles, offers
insight into a larger issue in pharmaceutical research: the way that
marketing concerns sometimes shape scientific studies.
[snip]
But while pharmaceutical research can save lives - the early studies on
statins are a case in point - companies also use science to help sell
drugs. Prove It, for instance, grew out of an unsuccessful effort by
Bristol-Myers to win government permission to claim that bringing
cholesterol to ultra-low levels does not necessarily benefit patients.
When the Food and Drug Administration refused, the company, hoping to
bolster its case, initiated the study.
That is hardly unusual, said Dr. Stuart Pocock of the London School of
Hygiene and Tropical Medicine, an expert in clinical trial design.
"Companies put huge amounts of money in trials, which have to be
directed toward what stands a chance of being in their interests," Dr.
Pocock said. "And their interests are, in general, in danger of being in
conflict with what are society's interests."
Most of the industry's research budget is aimed at getting new drugs to
market. About 6 percent is spent on studies, like Prove It, which are
conducted after a therapy is approved, according to the Pharmaceutical
Research and Manufacturers of America, the industry trade group.
[snip]
. . . The role of marketers grows once a therapy is on pharmacy
shelves, Dr. Yale Mitchell, a senior director of clinical research