[Ip-health] Re: Responses to some of Amir's comments

[amir_attaran@harvard.edu]

Dear Jamie,

I agree with most of the below, with one exception.

Which drugs are part of the "cheapest and best HAART regime for Africa", as
you put it, is emphatically NOT to be settled on the basis of patent status
or cost.  Africans do not deserve the cheapest.  They deserve the best.

I say this because the core value of medical ethics, in Harare as in
Houston, is that a patient is entitled to the most efficacious, safest
standard of care.   Now, if that is so, there are two important issues that
demand our attention when discussion turns to the cheapest regimens of
AZT+d4T+NEV offered by various Indian manufacturers right now.

   1. These products are not yet bioequivalency tested, which is an
   important consideration in qualifying them as safe and effective.
   Perhaps one day these trials will be done, and hopefully that day is
   soon, but at the moment one is still waiting for the bioequivalency data
   (Brazil, for instance is doing this testing now).  I do not think I am
   saying anything outrageous in suggesting that activists who care about
   access to these generics can and should help accelerate that testing
   process, as ACT-UP Paris apparently is doing.  Perhaps someone from that
   group can answer what it has done to help, but just approaching this
   problem a priori, it seems to me that there's an important role for
   activists to raise funds and organize research networks for
   bioequivalency trials.

   2. To the best of my knowledge, the combination of 3TC+d4T+NEV has
   little published clinical experience behind it.  That is NOT to say it
   is an unsafe or ineffective regimen (the INCAS trials show that using
   brand-name products, 3TC+d4T+NEV works quite nicely), but merely that we
   know less about than we do other regimens.  For this reason, it is not
   the most highly recommended regimen at the moment, and it seems to me
   premature to peg a great deal of hope on it before more extensive trials
   are done.  This is especially true given the hepatotoxicity of
   nevirapine, and the mixed evidence in the biomedical literature that
   nevirapine may not work against HIV-2, which is a viral subtype that's
   very common in Africa but seldom found elsewhere (see for instance Y.
   Isaka et al, Arch Virol 2001;146(4):743-55, or A. Bardsley-Elliot et al,
   Paediatr Drugs 2000 Sep-Oct;2(5):373-407)

None of this is to say "don't use generics", or "don't use cheap
cocktails".   It is, however, to say that given the current state of
product testing and clinical knowledge, benchmarking every other regimen
against generic 3TC+d4T+NEV just because it is cheap is premature.  The
objective of therapy and medicine for Africans ought never to be the
cheapest that we can find.  It ought, simply, to be the best that science
and medicine can provide.

Dr. Amir Attaran