
Study Shows Funding of Antidepressant Clinical Trials by Pharmaceutical Companies Skews Efficiency Results
Robert Carter/October 19, 2024
This month the University of Chicago Press published the results of an Ohio State University study that shows that the source of funding for a clinical trial influences the reported efficacy of the drug being tested. Those trials funded by antidepressant and antipsychotic pharmaceutical manufacturers show their own product on an average to be 49 percent more effective than identically conducted studies funded by independent entities.
“The funding interests of a given drug can explain almost half of the relative efficacy of that drug,” Tamar Oostrom, the author of the study, writes.
Pharmaceutical company sponsored trials for their own products show their drugs are 43 percent more likely to produce statistically significant improvements in the well being of their trial participants, compared to identically run trials sponsored by a research facility other than the manufacturer or its marketing agent.
A full 73 percent of these pharmaceutical manufacturer sponsored trials also show that their drug is more efficient than any competitor’s comparable product. Of course, that then results in greater sales.
How can this occur? It boils down to two main variables in the conduct of the trials. First, a company sponsored trial is one that is much more likely to be published. Therefore, its effect on the market is greater than those unpublished trials that show less beneficial outcomes to trials of the antidepressant’s manufacturer. Those “other” outcomes then remain hidden from the medical industry and from the public in their unpublished obscurity.
In other words, the published trials take on a greater validity merely because they are the ones that are most prominently displayed to the medical and the general public through their appearance in respectable medical journals.
Second, the clinical trial designs for company sponsored and independently sponsored tests can be different, although each is supposedly scientifically based. The length of the trial, the drug’s dosage, and the demographics of the tested population (that is, age, gender, severity of diagnosis, etc.) can be different from sponsored to unsponsored trials and still be scientifically “valid.”
However, the manipulation of those parameters allows sufficient wiggle room for potentially quite different trial outcomes. Oostrom calls his findings the “sponsorship effect.” Per his study, that effect “consistently represents approximately half of the average difference in efficacy between trial arms.”
Oostrom concludes that if that “sponsorship effect” bias were eliminated from clinical trials, only the more effective medicines would be approved by the FDA, and that would translate into fewer psychiatric drug approvals and therefore fewer psychiatric drug prescriptions written.
He notes that would benefit the welfare of consumers because they would then be subject to more effective drugs or – better yet, from this reporter’s perspective – to seeking alternative treatments. Oostrom reports that 70 percent of clinical trials are funded by the pharmaceutical industry at an average cost of $35 million per trial. He also notes that the pharmaceutical market in America is valued at $480 billion.
This is not then a bad return on the pharmaceutical companies’ initial $35 million investment.
Oostrom also points out that the results of these company sponsored trials influence regulatory, prescribing, and medical treatment decisions for decades afterward. Worse, These skewed results also have direct consequences on the health and well-being of American consumers.
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