Clinical drug trials provide important data that help the Food and Drug Administration (FDA) determine if a drug is safe and effective enough to be marketed in the United States for a particular indication. But a new study has found that sometimes drug companies crunch numbers in a way to make a drug look better than it actually is.
Researchers at Princess Margaret Cancer Centre reached that conclusion after reviewing data from 164 breast cancer trials. They found that a large number of the studies that reported no real benefit of a particular treatment were spun so that they focused on less important outcomes in order to shed a more positive light on the data.
“It’s like politicians. Trying to make things look better than they are,” said Dr. Ian Tannock, who led the study.
More troubling is that many of these studies were featured in reputable medical publications including the Journal of Clinical Oncology, Lancet Oncology, and the New England Journal of Medicine. All trials either tested a new drug or compared a new drug to an existing medication.
Researchers also found that there was bias in the way adverse effects to the treatment were reported, with the most serious side effects being the most poorly reported – especially in trials with treatments that showed significant benefit. For example, some treatments showed improved survival or slowed progression of the cancer but there was substantial increase in toxicity, which the studies failed to point out.
“If a drug improves survival but with a major increase in toxicity, I would say that was a very questionable advance,” Tannock said. This incomplete data can be dangerous for the patient. “Some physicians may be persuaded to use a new or different treatment than the standard because they have read papers that suggest that this is a better treatment when it may not really be a better treatment.”