U.S. study sees bias in company-funded statin trials
WASHINGTON |
WASHINGTON (Reuters) - Clinical trials comparing cholesterol-lowering drugs to one another are far more likely to yield results favoring the one whose maker paid for the research, scientists said on Monday in the latest work showing bias in company-sponsored studies.
Researchers led by Lisa Bero of the University of California-San Francisco analyzed the results of 192 trials assessing how well various cholesterol-lowering statin drugs work compared to other ones or non-statin drugs.
Studies that produced favorable results toward a given statin were more than 20 times as likely to have been funded by that drug's manufacturer rather than the company that made the drug to which it was being compared, Bero's team found.
In addition, trials in which the investigators included favorable subjective conclusions or interpretations of statistical results were nearly 35 times more likely to have been funded by the drug's manufacturer, Bero's team added.
The researchers cited design flaws in many company-funded trials like not ensuring that investigators conducting them were unaware of which patients were getting which drugs until the end of the trial.
"It's not like they're all poorly designed," Bero said in a telephone interview. "But, on the other hand, a lot of them are designed in ways that can make the sponsor's drug look better."
Bero said the findings raise suspicions that some drug companies may be manipulating the design and interpretation of trials to get results that can boost sales of a product.
"We can't answer why we're seeing that bias. But it definitely makes me more skeptical," Bero added.
Bero said the bias may stem from actions such as not publishing studies with unfavorable results, or comparing a high dose of a test drug against a low dose of a comparison drug to make the test drug look more effective.
INDUSTRY DEFENDS INTEGRITY
The industry defended the integrity of the clinical trials.
"Our whole business is dependent on well designed, well conducted clinical trials that will pass regulatory muster, whether it's here with the FDA (Food and Drug Administration) or abroad with other foreign regulatory agencies," said Alan Goldhammer, deputy vice president for regulatory affairs for the Pharmaceutical Research and Manufacturers of America.
Goldhammer said drug makers cannot use information from these trials unless it is reviewed and approved by the FDA. "It's an insult to the integrity of the Food and Drug Administration to imply that they're casting a blind eye on industry-sponsored clinical trials."
The study was the latest to find that clinical trials backed by pharmaceutical companies tend to yield more positive assessments of drugs they make than trials conducted without company backing.
Some previous analyses of this issue had focused on company-sponsored studies comparing the effectiveness of their drugs against placebos. This one looked at head-to-head comparison of similar drugs.
A growing number of studies on safety and efficacy of drugs are funded by pharmaceutical companies rather than, for example, the U.S. government. Of these 192 clinical trials, 95 were funded by industry.
Bero said that if results of such trials are heavily influenced by who funds them, then whether one drug is better than another one may remain unknown.
The study appears in the Public Library of Science journal PLos Medicine. It can be read here
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