quinta-feira, março 31, 2005
A entrada infeliz da Pfizer no mercado dos anti-retrovirais
A leading global pharmaceutical company but a novice in HIV treatment, Pfizer prefers to not undertake a trial to evaluate a new antiretroviral in France, Spain, and Germany, rather than conform to the principles of protection of individuals participating in research, TRT-5 says today in a statement released to the press.
The Pfizer laboratory is about to finally announce that it will not undertake trial 1026 in France, Spain, and Germany. This trial was to evaluate the optimal dosage of a new medication against HIV/AIDS (an anti-CCR5) in hundreds of HIV-infected patients not yet having taken antiretrovirals.
In competition with Schering and GSK who in turn are developing their own anti-CCR5, Pfizer, despite its inexperience with HIV treatment, chose to avoid losing time with the ethical concerns of associations and health agencies.
What was the focus of these concerns? The Pfizer trial planned to expose patients with extremely weakened immune defenses, having a known high risk of death, to a treatment including an experimental product whose efficacy and tolerance have not been evaluated for longer than 10 days.
However, these patients must instead receive a “treatment of optimal and validated efficacy” which is today possible due to the antiretrovirals on the market in France. In the absence of preliminary data in patients in less advance immunoviral stages, this trial exposes the very immuno-suppressed patients to an unnecessary risk and is contrary to the international recommendations regarding research ethics.
Based on this report, TRT-5 demanded Afssaps to examine the Pfizer trial protocol. Without waiting for either the position of Afssaps or the opinion of the CNS, Pfizer recently announced that it is withdrawing its trial in France. It did the same in Spain and Germany, where agencies similarly voiced criticism regarding trial 1026.