USA:
Report slates drug companies over tests

A scathing new report in The New England Journal of Medicine says 
that US pharmaceutical companies that pay researchers to design and 
interpret trials of new drugs sometimes spin or suppress unfavourable 
findings. The report, Uneasy Alliance — Clinical Investigators and the 
Pharmaceutical Industry, was written by Dr Thomas Bodenheimer of the 
University of California at San Francisco (UCSF) School of Medicine.

Dr Bodenheimer's interviews with people involved in the drug trial process 
highlight tactics used to mask negative results and warn that the profit 
motive of commercial research outfits threatens to further corrupt the 
high-stakes process of translating science into marketable drugs.

An accompanying editorial by Dr Marcia Angell, the Journal's editor, 
picks apart the cozy relationship that has developed between clinical 
researchers and industry.

"Academic institutions and their clinical faculty members must take care 
not to be open to the charge that they are for sale", she writes.

The articles come a week after the peer-reviewed Journal's 
publisher, the Massachusetts Medical Society, announced that it had named 
Dr Jeffrey M Drazen, a prominent asthma researcher with strong ties to the 
drug industry, as its new editor. He replaces Dr Angell, who will be 
retiring.

Jeffrey Trewhitt, a spokesperson for the drug industry's lobbying group, 
the Pharmaceutical Research and Manufacturers of America, told Reuters that 
"the articles overlook many safeguards in the system, including the fact 
that the US Food and Drug Administration (FDA) reviews all the study data".

But six investigators interviewed by Dr Bodenheimer cited cases in which a 
sponsor actually halted publication or altered a report's content. In one 
instance, Dr Steven Cummings, Professor of Medicine and Epidemiology at 
University of California, San Francisco, said that a company held up the 
prepublication review process for more than six months, secretly penning a 
competing article that favoured the company's point of view.

Another investigator who found adverse reactions while studying a drug was 
told by the sponsor that it would never fund his research again. It 
published a competing article that barely mentioned the adverse reactions.

Critics have long questioned the integrity of drug research funded by the 
pharmaceutical industry. But Dr Bodenheimer warns of a deepening conflict 
as more and more of those studies are farmed out to commercial research 
outfits.

When academia conducts drug studies, there is at least the potential that 
researchers' scientific goals will offset the pharmaceutical industry's 
commercial interests, he notes.

"In contrast, trials conducted in the commercial sector are heavily tipped 
toward industry interests, since for-profit CROs (contract-research 
organisations) and SMOs (site-management organisations), contracting with 
industry in a competitive market, will fail if they offend their funding 
sources", he argues.

Dr Bodenheimer's article recalls the time Dr Curt Furberg, a professor of 
public health sciences at Wake Forest University School of Medicine, 
refused to place his name on published results of a study because the 
sponsor was "attempting to wield undue influence on the nature of the 
paper".

Dr Furberg describes the effort as "so oppressive that we felt it inhibited 
academic freedom". Dr Furberg noted, "Companies can play hardball, and many 
investigators can't play hardball back.

"You send the paper to the company for comments and that's the danger. Can 
you handle the changes the company wants? Will you give in a little, a 
little more, then capitulate? It's tricky for those who need money for more 
studies."

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People's Weekly World, paper of Communist Party, USA