The researchers found that when pharmaceutical firms or other industry players pay for a drug trial, that drug shows positive results 85 percent of the time. That’s compared to 72 percent for trials funded by non-profits or non-federal organizations, and 50 percent for government-funded trials.
The study’s lead author, Florence Bourgeois, said that disparity could be occurring because whoever funds a drug trial frequently helps design it, and it’s possible to manipulate the design.
“There are a number of things that investigators designing trials can do that can then subsequently add up to factors that result in more favorable results,” said Bourgeois, an emergency medicine physician at Children’s Hospital and an instructor of pediatrics at Harvard Medical School.
Bourgeois said those manipulative techniques may include:
Asking selective questions and omitting other questions
Focusing only on certain aspects of a drug’s performance and ignoring others
Cherry-picking which patients are included in the study and excluding those who might react poorly to a drug
Deciding how long a study population is followed, which could enable researchers to end a study before troubling side effects begin to surface
“I wouldn’t say these things are necessarily deliberate,” she added. “Our findings simply raise concerns about whether there is an inherent conflict of interest if you have pharmaceutical companies designing and conducting trials to validate drugs they are also seeking to market, and standing to gain quite a bit from good results.”
Biased drug trials can compromise the integrity of medical research and potentially put harmful medications on the market.
Yet preventing pharmaceutical firms from funding drug research is an impractical solution, Bourgeois noted, because industry pays for the lion’s share of most clinical trials since the for-profit sector generally has deeper pockets than government and nonprofit funders.
Federal regulators have attempted to make drug trials more transparent by more closely tracking their existence and their clinical outcomes. Still, funding sources tend to get limited scrutiny. So even more oversight and disclosure are needed to ensure truly objective drug trials and guarantee unbiased results, Bourgeois said.
by : Kenneth Mandl.