Pharma & Data Transparency

"self portrait" by shawnchin  (2005) CC BY-SA 2.0

self portrait” by shawnchin (2005) CC BY-SA 2.0

I absolutely adore those instances when my job and my degree dovetail, so reading about the pharmaceutical industry’s latest proposal for more transparent data was quite interesting. The interplay between data transparency to validate the effectiveness of clinical trials and protecting the privacy of the patients involved in those trials is certainly proving to be a delicate balance to strike.

The New York Times reports:

Representatives of the world’s biggest pharmaceutical companies pledged … to release detailed data about their drugs to outside researchers, a move that was applauded by some but also seen as an effort to head off more extensive disclosure requirements that are under review in Europe.

Yet, just a few months ago the Pharmaceutical Research and Manufacturers of America (PhRMA) had released a statement in response to Dr. Ben Goldacre’s Bad Pharma, which criticized the recommendations for transparent clinical trial data as “encourag[ing] second-guessing of the regulatory approval process, which would be disastrous for patients,” and could potentially “jeopardize patient privacy and could serve as a deterrent to individuals considering participation in trials.”

The New York Times goes on to point out that “proponents say doctors and patients need independent information — not just that provided by manufacturers — about the risks and benefits of drugs.” Meanwhile, there is already skepticism brewing in the wings. These developments should prove quite fascinating to follow in the months leading up to the proposed January 2014 adoption date.

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