Are Clinical Trials Biased By Industry Sponsorship?
    By News Staff | December 12th 2012 04:30 AM | 1 comment | Print | E-mail | Track Comments

    Clinical trials are obviously important.  The results influence what drugs are approved by regulatory bodies, which can have a billion-dollar impact on companies.

    Clinical trials have always been sponsored by industry - there has never been a meaningful  government-controlled research effort toward drug creation - but they have increasingly come under fire, due to claims that an industry sponsor can influence results and how they are reported to present their company and products in a better light.

    In a culture where increased government regulation has caused venture capital to abandon early-stage pharmaceutical, further criticism would seem to be unnecessary. Like the American automobile industry in the 1960s, healthy current results mask a weak research infrastructure that legacy academic research can't match.  Studies show that industry sponsored drug trials produce more favorable results, but that is the nature for most research.  No one gets funding with the claim that their project will fail. 

    A new Cochrane systematic review has added to the criticism. The researchers call for a rethink of the way that industry bias is handled in medical guidelines and reviews based on a systematic review of 48 studies on drugs and medical devices. The drugs and devices being studied were prescribed for a wide range of different diseases and conditions, from heart disease to psychiatric conditions, and were compared to placebos or other treatments.

    Studies sponsored by industry reported greater benefits and fewer harmful side effects compared to studies that were not sponsored by industry. Papers describing industry sponsored studies presented more favorable overall conclusions, and results and conclusions sections in these papers were less likely to agree. There is no reason a drug company would bother to report on a poorly-performing product, they simply abandon it.  You won't find a lot of null results published for government-controlled scientists either.

    "Our results suggest that industry sponsored drug and medical device studies are more often favourable to the sponsor's products than non-industry sponsored studies," said lead researcher Andreas Lundh of the Nordic Cochrane Centre, Rigshospitalet in Copenhagen, Denmark. "These findings resonate with current calls for better access to information about how trials are carried out, and raw data."

    The possible influence of study sponsorship is not always taken into account in medical guidelines and assessments of the efficacy of drugs and medical devices. The researchers suggest that guidelines and reviews could improve transparency by disclosing sponsorship when results from industry sponsored studies are reported and by regarding industry sponsorship as a factor that increases the risk of bias. In other words, some researchers are to be assumed less ethical than others, they contend.

    "Industry sponsorship should be reported in original published studies, but it must also be taken into account when results are reported on elsewhere," said senior author Lisa Bero of the Department of Clinical Pharmacy and Institute for Health Policy Studies at the University of California San Francisco in San Francisco, US. "If we agree that industry sponsorship is an important source of bias then we need to think about developing better methods for reporting, assessing and handling industry bias in systematic reviews that evaluate the effects of drugs and devices."

    Industry sponsorship is also an important source of science, and forcing industry to adhere to a different standard than academia means drug development will only be done by the government. 


    Gerhard Adam
    In other words, some researchers are to be assumed less ethical than others, they contend.
    Is that actually what was said, or is that simply spin?  It might actually make a difference if the point was whether individuals actually lied or committed fraud.  To argue that someone depending on a paycheck from an organization with a vested interest in results is going to be completely independent and un-influenced by it is wishful thinking.  One doesn't have to be dishonest or unethical to have that occur.

    However, what strikes me as an erroneous conclusion is in assuming that this is an ethical issue.  Humans will be biased based on their own beliefs and objectives.  It would be hard to imagine that somehow scientists are exempt from life's concerns, especially regarding their careers and livelihood to the extent that they would do anything to jeopardize their current positions.

    As a result, even without the issue of ethics, there is little doubt that scientists [like all humans] will tend to act in their own best interest, and that will introduce bias.  Even if one eliminated money altogether, there is enough evidence to suggest that personal political beliefs would still exert an influence.

    So with that as a backdrop, why would anyone question whether industrial funding could influence results.  Of course it could, which is precisely why every other sector of human endeavor recognizes conflicts of interest, so why should science be exempt?
    Mundus vult decipi