Rapid Responses to:

NEWS: Andrew Osborn Three Russian doctors face trial for vaccine tests BMJ 2007; 334: 817 [Full text]

Rapid Responses: Submit a response to this article

Rapid Responses published:

The exception is that case was open

Vasiliy Vlassov   (1 May 2007)

The exception is that case was open 1 May 2007
Vasiliy Vlassov, Director Russian Branch of the Nordic Cochrane Centre Send response to journal: Re: The exception is that case was open	Earlier this year the court stopped this trial for defense of interests of citizens and because of number of wrongdoings in the trial. The story was presented in detail in the Russian press (1). It is true that xenophobia is blossoming in Russia fed by the national leadership. But it would be incorrect to say that there was nothing wrong with the mentioned trial. The "independent" hospital is the railroad hospital which has nothing to do with children vaccination programs. The informed consent form was 14 pages long in heavy text translated from English. Parents insist that they did not receive the information about the experimental character of vaccination. The local health care authorities learned about the trial only after checking the complaints. The local review committee, who reviewed the Protocol disappeared and are yet to be found. The Moscow committee approved the protocol with the name of leading researcher who refused to participate in the trial because felt that safety is not assured. Number of wrongdoings were opened in almost every step of approval and proceeding of the trial. Sponsor may successfully disprove some of the accusations, but de-facto sponsor approved them firing the person responsible for the management of this trial. Obviously sponsor of this trial is not the worst creature, and this trial is not the worst one. It is just an example of how miserable the quality of trials is in Russia and developing countries especially. From the bribery in the top echelons of power to the mistreatment of patients. 1. Mezhdunarodnii Zhurnal Meditsinskoi Praktiki [in Russian] 2006 #3:13-4 and 2007#2:75-9. Available at http://www.mediasphera.ru/journals/practik/171/2440/ Competing interests: None declared