Pharmaceutical companies have altered medical research statistics and concealed negative trial results to make their products seem more effective or safer.

A survey of 823 medical specialists in Australia revealed many who had worked on trials funded by drug companies were concerned about the quality of the research.

“We found a lot of potentially negative outcomes of those research relationships such as failure to publish key findings, editing of reports and even concealment of negative findings,” said University of Newcastle professor of clinical pharmacology David Henry, who led the study.

His research, published today in The Medical Journal of Australia, uncovered 374 reports of “potentially negative research outcomes”.

Complaints included premature termination of a study by a drug company, failure to publish key findings, concealment of relevant findings and alteration of patient data.

“Clearly there is substantial under-reporting and that non-reporting tends to be of studies that do not make the drug look so good,” Professor Henry said. He said drug companies were increasingly collaborating with researchers and medical staff in the private sector, who might not be as closely monitored as academic staff.

“In the past the industry has tended to use academic medical centers to do its research; however, we found that a lot of people involved in sponsored research in the past 12 months, about 41per cent, were mostly in private practice … Private practitioners do not always work within a setting with close supervision with easy access to research ethics committees.”

Professor Henry said the recent decision by medical journals to demand trials be registered would make it more difficult for drug companies to conceal negative studies.

The International Committee of Medical Journal Editors, which includes The Medical Journal of Australia, The Lancet and The New England Journal of Medicine, announced that from July 1 they would not publish results of any trials not included on an authorized register. When registering a trial companies must include information such as who is funding the trial, primary and secondary sponsors, details of the research contact person, anticipated trial start dates, target sample size and the purpose of the trial.

The study follows the $25,000 fine imposed on Pfizer Australia for misleading doctors over the safety of its arthritis drug Celebrex. When rival drug Vioxx was withdrawn from the market in September, Pfizer sent doctors a letter claiming “the cardiovascular safety profile of Celebrex has been extensively studied” and “the data do not indicate significant cardiovascular safety concerns with Celebrex”.

But in December the US Food and Drug Administration announced that preliminary results from a long-term study showed there might be an increased risk of cardiovascular disease in people taking high doses of Celebrex.



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