Ethics as borderline to science

The reason for this was that within its design there was no guarantee of safety for the most immune suppressed patients, which makes the trial unethical. (see page 17 for the complete release)

This is not light accusation. Before coming to this point, EATG and the national Community Advisory Boards exhausted all the possible lines of communication the company offered. This was weeks and weeks of internal debate, meetings and teleconferences with Pfizer representatives, long conversations with investigators and communication with the regulatory agencies. Yet, after this great effort an agreement still could not be made, and in the end the multinational continued on with its plans.

EATG believed that it was their obligation to express to the entire HIV community and the general public their point of view against the design of this study, and ask to either change it or cancel it.

It has to be said that, with reason, the entire network of European HIV treatment activists were and are in agreement with the steps taken and the motives for these steps. It is true that some U.S. activists have expressed their disagreement, but others understand and support the reasoning of the European side.

The German, French and Spanish regulatory agencies have also been receptive to our arguments. However it is the opposite with the British and Italian agencies, and surely the FDA of the United States.

This situation has again brought out the weaknesses in the EMEA’s authority, which has no capacity to place a final judgment on the design of clinical studies, but only on the final data that is presented: the recommendations that are currently being discussed, in a rough draft stage, could help solve this problem, although they will not have any obligatory authority.

The investigators generally understood, being that they have contrasting interests, our point of view.

However they insisted on us doing all that was possible to save the study. And we did: we asked Pfizer uncountable times to change their criteria in order to avoid endangering the health of people with low CD4 counts. Yet they did not listen to us.

True: ethics are subjective, but this cannot be a reason to ignore them. EATG consciously acted, after deep analysis of the pros and cons, in the defense of the interest of the trial’s participants. If we did not do this, what else would we be here for?

Joan Tallada

EATN - European AIDS Treatment News, Volume 13, I – Spring 2005

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