Pfizer : French AIDS patients demonstrate against unethical research

Research ethics watchdogs from the three European governments have requested the pharmaceutical industry to only test its new class of AIDS treatments so-called CCR5 inhibitors on the more healthy AIDS patients, and not perform the tests on the more advanced ones. While GlaxoSmithKline and Schering-Plough have abided by the request, Pfizer has chosen instead to retaliate by hurting the patients : Pfizer is altogether pulling out its investigational medicine from France, Spain and Germany, thus punishing healthier AIDS patients for the ethics authorities¹ protectiveness of the weaker patients.

« Pfizer’s unofficial excuse for its deadly conduct is that it is under pressure from stockholders to beat GSK and Schering-Plough in the race to take CCR5 inhibitors to market. So now it’s up to major Pfizer holders, such as Barclays or Fidelity, to let Pfizer know that it can’t just go around trampling ethics like this » said Act Up-Paris Treatment Advocacy Officer Fabrice Pilorgé. « With the ungoing scandal over deadly Pfizer painkillers Bextra and Celebrex, you would think CEO Hank McKinnel would try to clean up his act, but it seems to only make him even more bent on cutting corners » Pilorgé added.

The core reason raised by French, Spanish and German ethics authorities for their decision to limit CCR5 inhibitor tests to the more healthy AIDS patients is that, so far, Pfizer has failed to demonstrate safety and efficacy of the candidate drug beyond a mere 10 days of treatment. Only the healthier patients should therefore take the risk of taking the untried medicine, since over 15 other treatments of proven safety and efficacy are available.

CCR5 inhibitors present the advantage of blocking the AIDS virus before it even enters human cells. If successful, CCR5 inhibitors should have fewer toxic side effects than conventional treatments and offer hope to patients whose virus has developed resistance to older drug classes. Pharmaceutical industry analysts have estimated that a successful CCR5 drug should make Pfizer around $700 million a year.

Because CCR5 inhibitors may be valuable for people with AIDS, Pfizer must immediately resume making its investigational product available to healthier AIDS patients in France, Spain and Germany.

Act Up-Paris calls on Pfizer stock holders [1] to let Pfizer know that its profits must not come at the expense of the health of trial participants during the shareholders Board meeting of next Thursday April 28th in new York. Act Up-Paris further requests the resignation of Hank McKinnel on grounds of his complete disregard for medical research ethics.

Additionnal information, in english and french

– Act Up-Paris, Protocoles n°34 (octobre 2004), Schering plough ou le mépris ;
– Hugues Fischer, Act Up-Paris, sida, la course aux molécules ;
– Corinne Taéron, How is Schering-Plough messing-up? (in french Schering-Plough : le gâchis) ;
– Groupe interassociatif TRT-5, PWH&A addresses Pfizer and likes: “new molecules are needed - but not at any cost” (in french Les séropos s’adressent à Pfizer et consorts : « oui aux nouvelles molécules mais pas à n’importe quel prix ») ;
– Groupe interassociatif TRT-5, First antiretroviral, first European outcry for Pfizer (in french Premier antirétroviral, premier tollé européen pour Pfizer ;
– European Treatmen Group, European activists require regulatory agencies to halt unethical trial (document pdf) ;
– Groupe interassociatif TRT-5, Audition du TRT-5 au Conseil National du Sida (document pdf) ;
– Groupe TRT-5, The safety of clinical trial participants takes precedence over the private interests of pharmaceutical companies (in french La sécurité des personnes incluses dans la recherche prime les intérêts particuliers des firmes) ;

– Conseil national du sida, Opinion on Participation in Clinical Trial Protocols On New Treatments for HIV-Infected Patients Never Having Taken Antiretroviral Medication (in french) ;

– Companies contact : GSK / Shering Plough / Pfizer : les contacts ;
– Major Pfizer holders des actionnaires de Pfizer ;