Question Is it ethical for a pharmaceutical company to keep the results of a negative clinical trial secret? Patients participate in clinical trials of an investigational drug for many reasons. One of these reasons may be the desire to benefit society. If a pharmaceutical company keeps clinical trial results secret, society will not benefit. (Companies keep negative results secret because they want to avoid benefiting a competitor or simply because there is a cost to releasing the information.) There are many adverse consequences of the failure to make negative data public. For example, other companies may unwittingly conduct clinical trials on drugs that work by the same biological mechanism subjecting many people to risks without the possibility of benefit. In addition, the negative results represent important scientific information that may guide researchers to the development of drug strategies that do provide a positive benefit for patients. When pharmaceutical companies enroll patients in a clinical trial, is an implicit inducement the patient's belief that participation will benefit society even if there is no personal benefit? If this is the case, is the company acting in an unethical manner if it does not permit society to benefit?

Accepted:
June 9, 2011

Comments

I can see some justification for wishing to nuance negative results, by claiming that they might be contradicted by future more positive results and so on, but on the whole it is important that negative results are made available generally. This has nothing to do with the wishes of the participants in the experiments, it seems to me, but their general public duty to help people avoid harm. There are two pragmatic aspects to this which are significant. The public ought to realize that results go in a variety of directions and should try to be sophisticated in working out what those results mean. Secondly, companies that are frank about negative results will gain more respect than if they do not, and so might themselves benefit anyway.