The strategy pursued by drug giant Pfizer for the development of its new anti-HIV product (an inhibiter of the CCR5 receptor) is putting at risk the health of hundreds of treatment-naïve patients with low CD4 count and high viral load [Le TRT-5 and EATG have had similar problems with trial P03802, aiming to evaluate Schering Plough anti-CCR5 compound, SCH 690. The Journal of Health Democracy has published [an article on this issue ]]. TRT5 [[TRT-5 (Traitements et Recherche Thérapeutique) is an inter-collaborative group consisting of Actions Traitements, Act Up-Paris, Aides, Arcat, , Dessine-Moi Un Mouton, Nova Dona, Sida Info Service, Sol En Si, and is also a close collaborator of European Aids Treatment Group (EATG).]], the inter-collaborative group for French HIV treatment advocates, denounces this unethical practice and alerts the various authorities concerned by this trial.
Pfizer is about to start in France several clinical trials with a new entry inhibitor antiretroviral UK-427. By using a new therapeutic target – the CCR5 receptors on CD4 cells – UK-427 could extend the range of treatments available to HIV+ patients.
At this time, the data available to Pfizer about UK-427 comes from in-vitro studies and phase I/IIa human trials where a few dozen HIV+ patients received UK-427 alone for 10 days. Consequently, as yet Pfizer does not know the final dose of UK-427’s, nor its interaction profile with other antiretrovirals that are used in combination therapy.
Results of well-known cohort studies have showed that treatment-naïve patients below 200 in CD4 count and over 100,000 in viral load must imperatively receive a treatment of proven efficacy. Yet, in its phase IIb trials on UK-427, Pfizer is planning to expose hundreds of patients concerned by this medical situation to a combination of UK-427 and zidovudine/lamivudine. Indeed, Pfizer is insisting on very wide enrolment criteria in order to include such patients.
TRT5 denounces the unethical practices of Pfizer and other drug companies developing their products in utter disregard to medical ethics, expert recommendations and the health of HIV+ research participants.
It should be noted that Schering-Plough and GlaxoSmithKline are also developing their own CCR5 inhibitors in treatment-naïve patients. In deciding to enrol as many patients as possible irrespective of whether unproven therapy might be dangerous to them or not, Pfizer may be simply aiming at overtaking its competitors.
TRT5 condemns the conduct of trials which do not offer the required safety guarantees for all the human subjects involved. Treatment-naïve patients have no specific vital need to access UK-427, since there already exist a large range of validated therapies for them. Therefore, nothing can justify exposing such patients to potential harm. Conversely, where drugs which may improve the chances of patients in treatment failure are concerned, it becomes critical to ensure as early an access as possible.
TRT5 calls to Pfizer to conduct genuine phase IIb trials in order to define UK-427’s optimal dose and interaction profile with other antiretrovirals, involving patients with a CD4 count not below 200 and not above 350/mL, and a viral load below 100,000 copies/mL.
Finally, TRT5 is calling on relevant authorities [[TRT-5 has alerted the European Medicines Agency, the French medicinal regulatory agency, the national ethics committees, the Health Ministry and the National Aids Council.]] to settle the issue of whether such trials do or do not fall outside of the laws governing medical research, ethics and patient protection.
