In just a few months, the countervailing powers of academics, researchers, and the British medical profession have mounted the final campaign against the corrupting practices of hiding negative trial results that earned prominent attention recently in The New York Times. Led by Peter Doshi and Ben Goldacre, the campaign includes formal endorsement by the British Medical Association, the Medical Research Council, and the editorial boards of three of the world’s leading medical journals. Thirty years of distorting medical knowledge and clinical guidelines seem to be ending; but imagine the difference if the AMA, the IOM and the NEJM joined them.
While transparency is important in its own right, the real goal is to reduce unnecessary injury and sickness to patients that results from hidden or misleading information about the harm:benefit ratio – the chances of being harmed from toxic side effects compared to the chances of being helped by taking a new drug. Harm to patients is mentioned in passing, but it deserves greater attention as reflecting the root of this and related practices that distort medical knowledge – substantially more sales and profits from selected positive spin than full disclosure would generate. The BMJ has just published my letter making this case.
As rational economic actors, pharmaceutical companies suppress or selectively publish results from clinical trials to make their drugs look less harmful or more effective than they really are so that more doctors will prescribe them and increase profits. That means more patients are exposed to a worse harm:benefit ratio than they are led to believe.
This applies to other Edmond J. Safra research projects on pharmaceutical policy as well. For example, the bottom line for ghost managing and ghost writing articles is more sales but more adverse events and less benefit for patients who are misled to believe drugs are safer and better than they are.
The bottom line for paying experts and clinicians is more sales but more adverse events and less benefit for patients who are misled to believe drugs are safer and better than they are.
The bottom line of off-label marketing that skirts FDA prohibitions is more sales but more adverse events and less benefit for patients who are misled to believe drugs are safer and better than they are.
Evidence of an epidemic of harmful side effects from drugs that usually have few or no advantages to offset their risks is made in an article for the Edmond J. Safra special issue of the Journal of Law, Medicine and Ethics on pharmaceutical policy. Emphasizing that epidemic magnifies the importance of policy research on data transparency, ghost management, payment disclosure, and prescribing for unapproved uses.