You go to the doctor complaining of severe heartburn or depression or another common ailment. Your physician listens as you list your symptoms and then prescribes a medication that he trusts will work—based, in part, on the scientific literature published in peer-reviewed journals that espouses the drug’s safety and efficacy. Hundreds of thousands of Americans are prescribed popular medications in just this manner every day. But what if the evidence doctors rely on to make these decisions isn’t as objective as it appears? What if the results are influenced by who bankrolled the trial?
According to Children’s Hospital Boston researcher Florence Bourgeois, MD, MPH, that’s exactly what’s happening in the United States. In her recent study, she found that drug trials funded by industry are much more likely to have favorable outcomes than those funded by the government. While only half of the federally funded studies reported positive results, a whopping eighty-five percent of industry-backed studies were positive. The research team looked at five popular classes of drugs: cholesterol-lowering drugs, antidepressants, antipsychotics and ulcer and blood pressure medications.
“There’s an inherent conflict of interest when the pharmaceutical company that designs and conducts a trial is also the company that stands to gain financially from study results,” says Bourgeois. “While we can’t say for sure what is causing this association between favorable outcomes and industry funding, there’s concern that it could be due to a bias in the way industry is designing studies and in the way they are reporting their results.”
There are a number of ways data can be manipulated to make a drug look more favorable, says Bourgeois. A drug can be enrolled in a multicenter trial—tested in multiple locations—but results could only include those centers where the drug performed well. “You can ‘cherry-pick’ the data,” she says.
Another method of manipulating data can occur when a new drug is compared to a similar medication already in use. For example, a trial might test a new pain reliever against Advil to see how well the new drug performs. But if you test the comparative drug in ineffective doses—either too high or too low—it can make the drug of interest appear superior by comparison.
Manipulating clinical trial results is not only dishonest—it’s dangerous. “Ultimately, it threatens the integrity of the scientific literature that guides clinicians in making treatment decisions for their patients,” she says.
But according to Bourgeois, the solution is not to exclude industry funding. “There are certainly benefits to some industry relationships. For one thing, due to the high costs of large studies, many organizations depend on industry contributions to conduct trials,” she says Instead, she says that better approaches are needed to ensure that industry doesn’t carry excessive influence on the way studies are designed and the reporting of results generated by clinical trials.
So what can be done? Bourgeois recommends increasing transparency around how drug trials are designed and conducted and results analyzed and reported. She advocates for study protocols and comprehensive trial results—beyond what is reported in publications—to be made publicly available.
“Industry will continue to fund trials, and we benefit from that, but we need an approach that guarantees that the relations between industry and the clinical world are not manipulated to generate results that favor industry’s financial motives as opposed to improving the care we provide to patients.”