[Ip-health] Attaran & Gillespie-White -- JAMA paper is now published
amir_attaran@harvard.edu
amir_attaran@harvard.edu
Wed, 17 Oct 2001 20:56:39 -0400
Dear Richard,
In reply to your note below.
1. The HAART regimens in table 2 are not selected to mislead, and you are
utterly, ABSOLUTELY wrong to write that they are selected to be "the
regimens with the least patent coverage in Africa." Yes, our selection
includes the best case regimen from the patent perspective (d4T+ddI+EFV),
but you failed to notice that it also includes the worst case regimen too
(AZT+3TC+NEL). We restricted the choice of regimen to those which are DHHS
approved, giving preference of course to those regimens which garner a
rating of "Highly Recommended" by DHHS. Note that the $350 regimen offered
by several generic makers (3TC+d4T+NEV) is both not "Highly Recommended",
and also lacks the gold standard of clinical trial evidence, being a
multi-arm clinical trial. That suggests it ought not to be considered as a
first-line regimen, at least for now, because at this writing there are
more highly rated regimens available, for which there exists evidence from
a multi-arm clinical trial.
2. Space constraints limited us publishing in this paper a full comparison
of prices, although I agree with you that would have been helpful. I would
refer you to the thorough MSF comparison which was done two weeks ago, in
which it is shown that while generics are often cheaper than the brand name
product, it is also not unheard of for the brand name product to be cheaper
than the generic. Those are MSF's data, not mine, so I will let them speak
to this. (The MSF data can be found at:
http://www.accessmed-msf.org/upload/ReportsandPublications/51020011422293/Final%20WEB%2005-10-01.pdf)
3. You are correct that footnote 44 does not mention the existence of
Boehringer's donation program for nevirapine, but that it refers to the
cost-effectiveness of nevirapine in blocking mother to child transmission
of HIV. The program was announced last year, and covered in many
newspapers at the time, and is well known to most readers of this list.
This is the nevirapine donation program which, I am told (but I don't know
if I was told correctly), South Africa's government refused because of
misguided concerns that nevirapine should not be given to pregnant women.
4. The source of the statement that only 25,000 Africans are receiving
antiretroviral therapy is the WHO report cited in our paper (footnote 25),
and it is NOT an "invented 'consensus'" as you write. To clarify this
figure, I personally asked the WHO-based authors of that report if this
figure referred to 25,000 people on HAART, or 25,000 people receiving 1 or
more antiretroviral (including HAART), and I was informed that the latter
interpretation is correct. I should note that the WHO report in question,
which you call an "invented consensus", is actually the report of an
international consultative meeting that WHO held in May of this year, and
at which many activists were present and contributing data! The 25,000
figure therefore ought to be familiar to activists as something other than
my invention.
5. I agree with you that the progress which has been made on price drops
for antiretrovirals is dramatic and "represents a success undreamt of just
three years ago" -- you will have ZERO argument from me on this point.
However, acknowledging this "success", on which we agree, should also raise
the question of whether perhaps it is not time to declare victory, and move
on to other issues such as international aid finance and registration of
generics with the drug regulatory authorities in Africa as the top
priorities. At some point, every "success" must lead to a transition in
strategy. The leading point of our paper is that this time has come.
Sincerely,
Amir Attaran
rjefferys@hotmail.com
Sent by: To: ip-health@venice.essential.org, healthgap@critpath.org
ip-health-admin@venice.ess cc:
ential.org Subject: Re: [Ip-health] Attaran & Gillespie-White -- JAMA paper is
now published
10/17/2001 01:23 AM
There are several flagrantly misleading elements to this soberly written
paper. To start with table 2 on page 1890, it is shameful that JAMA would
allow the inclusion of this list of "selected" HAART regimens without the
proper clarification that the basis for selection is that these are the
regimens with the least patent coverage in Africa. Regimens strongly
recommended by the DHHS that include zidovudine (AZT) and lamivudine (3TC)
are almost totally absent from the table, despite the fact that 3TC is the
most widely utilized antiretroviral drug. The closest thing to an
explanation is the following disingenuous paragraph:
"While patents do limit the use of some highly active antiretroviral
therapy regimens on a "no patent" basis (especially those using zidovudine,
lamivudine, or both), the US Department of Health and Human Services (DHHS)
clinical guidelines list several "strongly recommended" regimens for which
there are encouraging clinical trials and which are unpatented in up to 52
of 53 African countries. In addition, other regimens are available on a "1
patent" basis, where that patented drug may be available at discounted
prices. Examples of regimens recommended by the DHHS and their patent
statuses are provided in TABLE 2."
Furthermore, the rationale for this notion of a "1 patent" basis is not
explained, nor are the countries listed where these drugs *may* be
available at "discounted prices," nor are these discounted prices compared
to those that might otherwise be available from generic manufacturers.
Secondly, as others have pointed out, the role of patent monopolies, where
they exist, in explaining the "high cost" of antiretrovirals (or making
these drugs "relatively costly" to use a second and somewhat contradictory
quote from the same paper) is not explored, despite the fact that steep
drug discount and donation offers bloomed only after the seeding of CIPLA's
$350 per year combination offer.
Thirdly, the following statement regarding drugs for the prevention of
mother to child transmission: "(1 such drug, nevirapine, is donated by
Boehringer Ingelheim but is rarely used in Africa).44" Includes a cite that
only refers to nevirapine's efficacy, but sheds no light on whether
nevirapine has in fact been donated by Boehringer Ingelheim or if there may
be problems with this supposed donation program other than an inability of
people in Africa to use the drug due to lack of infrastructure, which is
the point the authors appear to be trying to make.
Lastly, and most importantly, the fact that many more people are receiving
combination therapy in Africa due to the forcing down of ARV prices over
the past few years is totally ignored. The paper only makes reference to a
"consensus" view that 25,000 people "receive 1 antiretroviral drug," giving
the entirely false impression that no-one in Africa is using combination
ARVs, apparently based on a report that the WHO website says is still "in
development" (a seemingly common fate for their HIV/AIDS-related treatment
publications - see below). In the last draft of this report that I managed
to steal a look at, a Ugandan doctor put the number of people in his
country receiving combination ARV's at 13,000, and noted that the cost of
these drugs had dropped from some $515 per patient per month to $70 per
patient per month over the six months prior to May 2001, with a concomitant
and ongoing increase in the number of people able to access therapy. I
didn't make a note but there was a similar precipitous decline in Senegal
and I recently heard an MSF doctor report that both generics and discounted
brand-name drugs are becoming more available in that country, also leading
to a concomitant and ongoing increase in the number of people able to
access therapy. Considering the total number of African countries and the
increasing number of people able to afford drugs, the 25,000 figure becomes
rather dubious (it was not sourced in the copy of the WHO report I saw, I
remember looking for the cite), and the reference to receipt of just "1
antiretroviral drug" appears entirely made up. The authors justify this
reliance on an invented "consensus" by saying that data on antiretroviral
drug consumption in Africa do not exist - whether it might productively be
looked for, or even collected where currently absent, they do not say.
I don't think anyone disagrees with the point that additional international
funding is desperately needed to extend these successes to the majority of
infected people, but neither African countries, nor the incomes of
HIV-positive people living in them, are as homogenous as averages are so
often used to imply. Each reduction in cost and the associated enhanced
efforts at distribution has allowed more people to afford ARV treatment,
notwithstanding the fact that the brand-name pharmaceutical industry has
been shameless in their attempts to block such initiatives with their "take
or leave it" discount approach. To me, each one of these individuals
represents a success undreamt of just three years ago. This, perhaps, is
the most persuasive and potent rejoinder to the argument that debates about
patents are pointless and irrelevant to the issue of access to treatment.
Richard Jefferys
Status of WHO Documents:
http://www.who.int/HIV_AIDS/first.html
Report of the WHO consultative meeting on ARV use in resource limited
settings, May 2001 (pending)
Interim guidelines for ARV use in resource poor settings (in development)
Guidelines for prophylaxis of HIV related opportunistics infections for
resource poor settings (in development)
WHO guidelines on clinical management of HIV disease for resource poor
settings (in development)
Training manual for clinical management of HIV disease for resource poor
settings (in development)
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