Gardasil studies stopped due to sucess

March 2, 2007

I just found out about this – rest assured I’ll post more about it when details surface:

LONDON, Feb 27 (Reuters) – Clinical trials of Gardasil, the recently launched cervical cancer vaccine marketed by Merck & Co Inc and Sanofi-Aventis SA, are to be halted because of the success of the product.

Sanofi Pasteur MSD, a joint venture of the two companies, said on Tuesday the independent Data and Safety Monitoring Board for two trials had recommended they be terminated on ethical grounds, so that young women on placebo could receive Gardasil.

Gardasil was approved last year as the first vaccine to prevent human papillomavirus (HPV), which causes cervical cancer. GlaxoSmithKline Plc has a rival product called Cervarix in development.

People without scientific or epidemiological training may be confused about this result. For the uninitiated here are some explanations.

People are somewhat familiar with clinical trials, in which the drug is given randomly to one group and a placebo to the other. It is unethical to not give a patient a treatment that we know that works, so in the case of clinical trials we give one group the experimental drug and the other group the established standard treatment – again, it is unethical to not treat patients.

Specifically, these are parallel track phase III studies, one previously completed in females, the other ongoing in older females and in adolescent males, which had not been completed at the time of original licensure.