Intended for healthcare professionals

Rapid response to:

News

Leading German doctors criticise rising use of post-marketing observational studies by drug companies

BMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b4199 (Published 13 October 2009) Cite this as: BMJ 2009;339:b4199

Rapid Response:

Ethical objections are the way to kill these trials

The "observational studies" are sham studies which are generally
referred to as "seeding" trials. The "actual" research are marketing
studies which overlay the "observational studies" and evaluate the return
on investment related to participation in the sham study.

The physician "investigators" are the real subjects of these studies.
No patient would ever agree to participate as a subject of a trial
designed to determine how physician participation as an "investigator"
could be used to increase drug sales. No IRB would ever approve such a
trial.

Unfortunately side effects the results from these sham trials are
real.

Pharmaceutical companies are systematically misleading patients and
doctors in these seeding trials.

Competing interests:
Testify at the request of patients injured by drugs and devices in law suits.

Competing interests: No competing interests

20 October 2009
david egilman md, mph
clinical associate prof Brown University
usa 02703