Study: Money Talks in Drug Trials

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Study: Money Talks in Drug Trials

June 5, 2007

 

http://www.intelihealth.com/IH/ihtIH/EMIHC256/333/21291/558296.html?d=dmtICNNews

 

 

SAN FRANCISCO (The New York Times News Service) -- Money talks -- and very

loudly when a drug company is funding a clinical trial involving one of its

products, according to a study released Monday.

 

University of California at San Francisco researchers looked at nearly 200

head-to-head studies of widely prescribed cholesterol-lowering medications, or

statins, and found that results were 20 times more likely to favor the drug

made by the company that sponsored the trial.

 

" We have to be really, really skeptical of these drug-company-sponsored

studies, " said Lisa Bero, the study's author and professor of clinical pharmacy

and

health policy studies at the university.

 

The research, reported in the online editions of PLoS Medicine, a San

Francisco medical journal, focused on studies of six statins -- including Pfizer

Inc.'s Lipitor, Merck & Co.'s Zocor and the generic drug Mevacor -- that had

already been approved by the Food and Drug Administration. The trials typically

involved comparing the effectiveness of a drug to one or two other statins.

 

" If I'm a clinician or funder of health care, I really want to know within a

class of drug which one works better, " Bero said.

 

" What our study shows is that depends on who funds the study. "

 

UCSF researchers also found that a study's conclusions -- not the actual

research results but the trial investigators' impressions -- are more than 35

times more likely to favor the test drug when that trial is sponsored by the

drug's maker.

 

Drug manufacturers, through the industry's trade group, said the federal

government cracks down on biased research.

 

" The new study overlooks the crucial role of the Food and Drug Administration

in reviewing and approving claims that are based on clinical trial results, "

said Ken Johnson, senior vice president of Pharmaceutical Research and

Manufacturers of America, in a statement.

 

" Our industry is dependent upon well-designed clinical trials that will pass

muster with the FDA, " Johnson said.

 

Mark Gibson is deputy director of the Center for Evidence-Based Policy at

Oregon Health & Science University, which reviews existing clinical evidence for

drug effectiveness and safety. He called the UCSF study an " important piece of

work. "

 

" If Americans really want to be able to have sound evidence on which to base

their choice of treatments, they need to think about ways to fund independent

research, " he said.

 

About half of the 192 statin trials examined in the study between 1999 and

2005 were funded by drug companies. Bero said drug companies fund up to 90

percent of drug-to-drug clinical trials for certain classes of medication.

 

About a third of the statin trials did not disclose any funding source.

Trials with no disclosed funding source were less likely to favor the so-called

test drug than those with industry funding, researchers found.

 

The researchers found other factors that could affect trial results. For

example, pharmaceutical companies could choose not to publish results of studies

that fail to favor their drugs, or they could be designed in ways to skew

results.

 

The study found the most important weakness of trials was lack of true

clinical outcome measures. In the case of statins, some trials focused on

less-direct results such as lipid levels but failed to connect the results with

key

outcomes such as heart attacks or mortality.

 

" None of us really care what our cholesterol level is. We care about having a

heart attack, " Gibson said. " For the drug to be worthwhile taking, it has to

be directly related to prevent a heart attack. "

 

The UCSF study was funded by a grant from the California Tobacco Related

Disease Research Program.

 

The study, " Factors Association with Findings of Published Trials of

Drug-Drugs Comparison, " can be found online at www.medicine.plosjournals.org

..

 

Copyright 2007 The New York Times News Service. All rights reserved.