by Dr. Robert E. Marx
Did you guess the FDA? You’re not alone, but it’s not the FDA. Okay, one more guess…
In a 2014 editorial published in the International Journal of Oral and Maxillofacial Implants (JOMI), I pointed out that almost all randomized prospective, double-blinded clinical trials (RCTs) are sponsored, designed, managed, and published by the pharmaceutical companies seeking FDA approval for new drugs and other treatments. Drug companies reimburse universities and research agencies handsomely with salary support for the principal investigator and assistants, along with equipment and monies to their institutions, referred to as indirect costs. Over the past 20 years, such drug company-sponsored research has increased as cuts in Medicaid, Medicare, and insurance reimbursements have plummeted, causing universities to seek these non-clinical revenues.
The problems presented by drug company sponsorship of trials are many, and the reason for them is one: greed. Yearly profits are in the $70 billion range. What effect, then, from numbers like this: 9.5% was the fracture risk found in a non-sponsored study of alendronate (Fosamax) conducted by the International Conference on Advances in Radiation Oncology (ICARO), while the trials by the pharmaceutical companies reported a fracture risk of only 2.7%. Examples like this one are terribly common.
Historically, the chronically under-funded FDA, too, has benefitted from drug companies taking the lead in trials. The sponsorship system enables their approval of new drugs based on their reviews of published trials rather than reviews of original data from trials the agency itself would otherwise need to conduct. Some, including employees of the department, say the ultimate costs of this system are too high. In 2008, nine FDA scientists wrote to Barack Obama, before he was even sworn in as President, disclosing pressures from management, experienced during the previous decade, to manipulate data, including in relation to the review process for medical devices. Characterized as “corrupted and distorted by current FDA managers, thereby placing the American people at risk,” the questionable data was the topic of a 2009 article in the Wall Street Journal.
Though several governmental and non-governmental organizations are tasked with monitoring the FDA’s powers and decisions, its sheer size (directly employing more than 14,000 people) makes the slightest directional change excruciatingly slow. The non-profit, non-governmental Institute of Medicine looked at pharmaceutical regulation in the U.S. and filed a report detailing major deficiencies in the FDA’s “system for ensuring the safety of drugs consumed in America.” (One might consider that particular responsibility rather essential.) Overall, as the Boston Globe reported, the Institute of Medicine called for an increase in FDA independence, funding, and regulatory powers.
To call the situation a “conflict of interest” would be a gross understatement. Pharmaceutical companies funding and manipulating the trials that the FDA will eventually rely upon in determining safety for approval is deeply troubling–and not only on paper. I have directly observed many real-world, real-people deformities and disabilities associated with this unfortunate-for-us, fortunate-for-Big-Pharma status quo. Certainly, the time has come for major changes. The American public deserves to know what “FDA Approved” really means, and toward that goal I will continue to diligently work.