[Ip-health] Gilead´s Tenofovir. Unethical trials, Voluntary licenses to MPP and treatment as prevention.

Francisco Rossi francisco_rossi at hotmail.com
Fri Dec 23 07:09:27 PST 2011


Today, there is a scandal in Colombia due to the unexpected inclusion of
“Truvada” (tenofovir+emtricitabine by Gilead), in the national list of the
Social security system on health. Tenofovir alone or combined with other medicines
was not included. Just the monopolist combination by Gilead.

Gilead is one of the most famous pharmaceuticals, because of its
unconventional marketing procedures. As unconventional as successful. The
global success of “Tamiflu” stock piling against the “inflated” pandemic of
H1N1 is still embarrassing WHO and some ministers of health. 

Is also matter of teaching on unethical trials after the well-known one
conducted in Cameroon with sexual workers testing the efficacy of Tenofovir as
profilactic. This study was suspended by family health international due to
lack of appropriate information and informed consent by participants. 

Last week we were informed that Gilead asked FDA to obtain a license for
the combination tenofovir-emtricitabine as profilactic of HIV. Again; not for
tenofovir (which has more than 10 competitors globally) but for the
monopolistic combination property of Gilead.

I hope all of the people involved in IP and Access to medicines are
aware about the fact that emtricitabine is lamivudine+fluor, and also are aware
that cost of generic versions of tenofovir with or without lamivudine has
dropped dramatically in recent years. Is not the case of Gilead´s tenofovir+emtricitabine

Last year it was announced in Vienna, IAS 2010, that there were proofs
that treatment works as prevention. And Tenofovir was again the “star”.
Nevertheless, when one analyze the report (published in the New England journal
of medicine), this conclusions sounds, at least, reckless.

On the one hand, the trial found a reduction on transmission in serodiscordant
couples by EARLY therapy compared to DELAYED therapy. Is it correct to conclude
a “prophylactic” effect of any ARV?. The magnitude of this reduction must be
revised seriously. From 2,21% to 1,58%. . The most important finding: 82% of
the total transmissions occurred in Africa!!!. (Can you imagine? Now we can says
to Africans that infections non prevented by traditional ways (condoms,
educations, human rights) could be prevented with tenofovir…….

More than 20% of researchers declared conflict of interest with Pharma. 

Tenofovir emerged as the champion of treatment as prevention, despite
the fact that 72% of couples received the conventional AZT+3TC+EFV first line treatment!!!!!

In the past months we faced an intense debate especially between north
and south NGOs on voluntary license to MPP. 
Voluntary license on tenofovir+emtricitabine. It sounds that it was
another step on this unusual, very success marketing initiative from Gilead.
MPP must revise to what extend has been “utilized” in a global marketing

I hope FDA will not grant this “prophylactic” indication for Truvada.
But Gilead obtained an authorization for "Tamiflu" for influenza even before the
pandemic!!!.  Someone suggested that
probably, in the future, we will see “Truvada” as part of some recreational
combination drugs with medicines as  “Viagra”.

Bad prognostics.


Francisco Rossi.


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