When Big Pharma Controls Clinical Drug Trials, Can Patient Safety Be Assured?

companies_control_drug_trialsFinancial relationships between industry and health care have driven significant controversy. Critics of the practice say that these relationships create conflicts of interest that could unduly impact research findings and prescribing practices. This can lead to situations in which patients are no longer the primary focus in health care decisions.

A recently published article, reported Forbes, discusses the issues when drug makers sponsor their own clinical trials writing:  “It’s clear from the start that there is a deep conflict of interest in pharmaceutical companies sponsoring trials on their own drugs. Industry sponsors 90 percent of published clinical trials. A worrying statistic given that, as Goldacre shows, industry-sponsored trials are four times as likely to produce positive results than independently run experiments.” Ben Goldacre is author of the book, Bad Pharma.

Dr. John Abramson, a critic of the pharmaceutical industry agreed saying, “About 85 percent of clinical trials are now funded by the drug industry. They own that data. The docs don’t understand that they are getting a selected, filtered version of what the information is,” Forbes reported.

Although the risk of funding the studies is of concern, so, too is the issue of checks and balances, noted Forbes. Yet, Big Pharma conducting its own studies has been known to backfire. Consider the issues surrounding Medtronic’s Infuse bone graft product.

Infuse was, essentially, positioned as a solution that meant the end of the need to harvest bone from patients’ hips in vertebrae fusions, according to a prior report by Healthworks Collective. But two independent studies, overseen by Yale University, revealed important key findings regarding Medtronic’s Inhuse product—namely, that there is little, if any, difference in the efficacy of Infuse over traditional bone graft. Infuse, a protein-based bone growth stimulator known as rhBMP-2, has been tied to dangerous side effects, including (to name just a few) retrograde ejaculation, cancer, pain, and extraneous bone growth.

Medtronic approached Yale University researchers after a June 2011 study published in The Spine Journal disclosed that Medtronic-paid researchers failed to report serious potential complications associated with Infuse in spinal surgery. The accusations, wrote BMJ, included that Medtronic minimized Infuse’s adverse responses. The Yale-commissioned studies, known as YODA (Yale university Open Data Access) reviewed the clinical trials that compared rhBMP-2 with traditional iliac crest bone grafting, according to BMJ.

The YODA reviews concluded that Infuse was no better than traditional bone graft in efficacy outcomes, for instance, with pain or function, a surprising finding, noted BMJ, given that Infuse was touted in literature as being superior to traditional bone grafting. In fact, in a press release, Medtronic stated, “these [YODA systematic review] findings are consistent with those in the original clinical studies.” Both review teams also discovered a number of issues with the published literature on Infuse concerning the “substantial evidence of reporting bias.” The researchers also found that among the published trials, only 56-88 percent of known efficacy outcomes were reported and six of 17 of Medtronic’s clinical trials—three of which were randomized, control trials—were never published, according to BMJ. Just 23 percent of the known adverse events recorded in the Infuse trial data were ever discussed in the journal publications.

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