New research shows a 43% increase in clinical trials funded by drug companies during 2006-2014. Can you say “conflict of interest?”
Concerns have been expressed over the past few years about the independence of clinical trials, due to the funding of some trials by corporations with vested interests. New data from Johns Hopkins University suggests that this is now the norm rather than the exception. The clinical trials that allow a drug to go to market are most often funded by the pharmaceutical industry.
The U.S. Food and Drug Administration (FDA) mandates clinical trials of safety and efficacy for all drugs intended for sale to Americans. Current regulations require that trials start with testing on laboratory animals and culminate with tests on human subjects.
The problem is that – with millions and sometimes billions of dollars at stake – there’s no requirement for these tests to be done by a third party. The drug industry is basically ‘policing itself.’
Clinical trials funded directly by the U.S. National Institutes of Health (NIH) are considered independent. However, a large proportion of trials done by the NIH are now funded by major pharmaceutical corporations. The Johns Hopkins report indicates that the number of independent NIH trials has fallen and the number of pharma-funded NIH trials has risen each year since 2006.
The number of NIH-funded trials fell by 24% from 2006 to 2014, from 1,376 trials to 1,048 trials. During the same period, pharma-funded NIH trials increased by 43%, from 4,585 in 2006 to 6,550 in 2015. These data are from ClinicalTrials.gov, a U.S. government repository with information on various human clinical trials performed since 2005.
Big Pharma companies aren’t required to register clinical trial data with ClinicalTrials.gov. However, most academic journals accept and publish such data only from studies that are held by the U.S. government.
This ‘preference’ of the journals has led Big Pharma to register more studies, and also has allowed an interesting look into just how conflicted the industry is. Fewer independent trials means that drug corporations are not acting with impartiality, nor is the FDA.
One scientist responsible for this new research, Stephan Ehrhardt, noted:
“. . . given that the industry has a vested interest in the outcome of those trials, we don’t get good data to inform the health of the public.”
Ehrhardt also explained that NIH-funded trials look at wider health impacts than pharma-funded trials do. NIH’s budget doesn’t depend on FDA’s approval of a drug. In contrast, the pharmaceutical corporations stand to profit immensely, so they have a narrower focus. They just want the data that will get them the FDA’s approval.
It’s also noteworthy that NIH has less money for running independent studies because Congress has cut its funding. Big Pharma is willing to fund the clinical trials, however, and is not held accountable for transparency in drug testing.
This research has been published in the Journal of the American Medical Association (JAMA) as “Trends in National Institutes of Health Funding for Clinical Trials Registered in ClinicalTrials.gov.”