“A very distorted perspective on the ethics”

Dr. Roy M. Poses, M.D. has written another thought-provoking article at Health Care Renewal examining how data from clinical trials is suppressed and never published when the results don’t favor the sponsor’s financial or political interests.

After sharing a revealing debate between Dr. Robert Califf and Dr. Steven Nissen, he summed it up, saying:

· People participating in clinical experimental research are told that their participation will benefit science and patient care.

· This benefit could only occur if the results of the research are made public, even if they go against the commercial (or ideological) interests of the people who paid to have the research done.

· For the financial supporters of research to keep data they do not like secret violates the trust of the research subjects.

· However, if hiding data has no negative consequences, commercial sponsors will continue to hide data unfavorable to their interests.

· Government regulation would be one way to impose negative consequences for hiding data.

· Preventing the suppression of data from clinical research ultimately will favor the products that are actually best for patients, which would be good for patients, and, incidentally, good for companies that make the better products.

As Dr. Califf said: “The fiduciary responsibility of the corporate board is to not do things that damage the profitability of the company, and that leads, I think, to a very distorted perspective on the ethics that are involved.”

The nonpublishing of data unfavorable to whatever the sponsor is selling - and publishing the favorable stuff - also contributes to “publication bias,” which is another reason we can’t just tally the number of studies supporting something, but have to closely examine the studies themselves.

But there is a larger issue than just the nonpublishing of inconvenient data: It is the publication of clinical trials with obvious flaws in how the studies were designed and/or how the results were spun to give the appearance of positive results that favor the sponsor, when they don’t. With the publishing of the recent bariatric surgery trial results, for example, few pointed out its manipulated nonrandomization of the intervention and control groups, careful interpretation of data, and that it was still unable to show statistically significant results. Peer-reviewed journals regularly fail to critically examine studies today, nor are journalists and many medical professionals willing to take a critical eye to studies, especially if it means possibly losing popularity or favor with funding sources.

The universal lack of interest in exposing problematic studies is proof that financial and political interests regularly trump scientific integrity. The losers are people who need and deserve honest health information and treatments that offer real benefits that outweigh the risks.

These problems have reached such extremes, Dr. Poses proposes a hard-hitting solution to consider: “ban research on humans done or supported by those who have financial interests in the products or services tested by such research.” His entire article can be read here.