[Ip-health] Combined Pills

[rjefferys@hotmail.com]

amir_attaran@harvard.edu wrote:

>You write that:
>
>   "Trizivir...was approved in the US without submission of any trial data
>   from the combined pill whatsoever."
>
>That is false.  The clinical trials I were speaking of, in case you were
>unable to gather from the context, were bioequivalence trials.  It was the
>lack of bioequivalence trials that I was concerned about, and also which
>Mr. Zackie Achmat of TAC was concerned about.  If you check my message of
>earlier, the word "bioequivalence" cropped up several times, so I would
>have thought that was clear.

Well, it might have been if you hadn't written:

"There is no study of the safety and efficacy of those single-pill
fomulations in the biomedical literature, and they are therefore unproven."

- leading me to think that you were suggesting that there had been "safety
and efficacy" studies of Trizivir. Silly me. I was not intending for one
second to suggest that the FDA would approve a drug without bioequivalence
studies, I thought that would be obvious. Even for people for whom it might
not be, including the link hopefully made it clear.

>Therefore my propositions remain true as before:
>
>   1. The generic antiretrovirals have not been through bioequivalence
>   testing, while the brand name ones (including Trizivir) have.

Well, you did also say "safety and efficacy." It's my understanding that
bioequivalence studies have been done with many generic antiretrovirals,
but correct me if I'm wrong.

>   2. There is a serious ethical question in activists urging that Africans
>   use generic antiretrovirals which have not undergone bioequivalence
>   testing, when we would NEVER use these in the United States or Europe.

If you could quote some activists that are "urging that Africans use
generic antiretrovirals which have not undergone bioequivalence testing,"
that would help clarify that such activists exist. Although you chose not
to include it in your reply, my original response to your points about
bioequivalence was:

"The bioequivalence issue for generics can surely be rationally
addressed (ACT-UP Paris have recently taken a look at some of CIPLA's
products, for example)."

>   4. EVERYONE agrees that  bioequvalence studies need to be done urgently.
>   But until that's done successfully, it seems to me that activists need a
>   self-imposed moratorium on promoting generic antiretrovirals to poor
>   countries, for obvious ethical reasons.  If it were more widely known
>   that activists were promoting products that short-circuit this important
>   testing for safety and efficacy, it could in the long-run trigger a
>   backlash that makes poor countries LESS willing to use generics,
>   INCLUDING the ones which are bioequivalence tested, and that would be
>   counter-productive to say the least.  This backlash is already
>   happening, and it is notable that most of the countries in Africa which
>   have bought antiretrovirals have bought them from brand name companies,
>   not generics, in part because of safety concerns.

You have some nerve, I give you that. What makes you think activists bear
the sole responsibility for bioequivalence studies? How do you see the role
of manufacturers and in-county regulatory processes?  What exactly do you
consider "promotion" - encouraging people to use their rights under TRIPS?

As someone who greatly admired your Washington Post editorial regarding
Andrew Natsios, I fear you've wandered into some strange and nonsensical
territory here Dr. Attaran.

Richard Jefferys