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Africa: Generic Drugs under Threat
AfricaFocus Bulletin
Mar 25, 2004 (040325)
(Reposted from sources cited below)
Editor's Note
One of the most important battles affecting how many people with
AIDS will receive needed anti-retroviral drugs is to take place in
a so-far little publicized conference in Botswana on March 29 and
30. AIDS activists and generic drug manufacturers fear that
pharmaceutical companies and the Bush administration will succeed
in a behind-the-scenes campaign to discredit the most effective
generic treatment, recommended by the World Health Organization, in
favor of more expensive patented drugs approved by the U.S. Food
and Drug Administration.
This issue of AfricaFocus Bulletin contains an urgent sign-on
letter to U.S. Global AIDS Coordinator Randall Tobias, initiated by
HEALTHGAP. Organizational sign-ons should be sent to
pdavis@healthgap.org by the end of Friday March 26, 2004. Also
included in this issue are excerpts from a message from U.S.
generics manufacturer Bill Haddad, who has played a key role in
supporting the use of generic AIDS drugs worldwide, and a note
from Doctors Without Borders (MSF) on their use of fixed-dose
generic combinations. Additional documents on the Botswana meeting
can be found at
http://lists.essential.org/pipermail/ip-health/2004-March/006079.html.
The MSF factsheet on fixed-dose combinations is available at:
http://www.accessmed-msf.org/documents/factsheetfdc.pdf
Two recent critiques of the Bush administration's AIDS plan are
available at:
http://www.healthgap.org/HGAP_PEPFAR_fact_sheet.pdf
and
http://www.genderhealth.org/pubs/AIDS5-YearStratAnalysisMar-04.pdf
For additional background and related links, see
http://www.africafocus.org/docs04/whr0312.php,
http://www.africafocus.org/docs04/hgap0312.php,
and
http://www.africafocus.org/docs04/hiv0402c.php
++++++++++++++++++++++end editor's note+++++++++++++++++++++++
March 24, 2004
Please send additional organizational signatures for this letter to
Paul Davis <pdavis@healthgap.org>
24 Mar 2004
Dear friends,
The Bush Administration has launched the most insidious assault in
the history of the global AIDS treatment access movement. On Monday
and Tuesday March 29 and 30, the White House is convening a
completely spurious meeting in Botswana to apply the thumbscrews to
impoverished nations everywhere to deny generic medicines to treat
AIDS. The Administration is attempting to create new policy that
would A) discredit internationally recognized standards on drug
quality, B) prohibit the use of affordable and proven-effective
single-pill combinations in all US programs and C) make it all but
impossible for developing countries to use other funding streams or
their own resources for the procurement of generics. THIS MEETING
MUST NOT BE SUCCESSFUL, and we MUST give as much support as
possible to the NGOs and country governments that will resist this
attack from the United States.
In just 48 hours, already 195 NGOs have signed on. PLEASE sign your
ORGANIZATION on to this letter AS SOON AS POSSIBLE -- the letter is
closed by the end of Friday, March 26, 2004. Send *organizational*
endorsements to: pdavis@healthgap.org -- sorry, we are not
collecting individual endorsements right now.
The sign-on letter is below.
Best regards,
Paul Davis Health GAP (Global Access Project)
pdavis@healthgap.org
t: +1 215.833.4102 (mobile) f: +1 215.474.4793
http://www.healthgap.org
26 March 2004
Ambassador Randall Tobias
Global AIDS Coordinator
U.S. Department of State
Washington, D.C.
Dear Ambassador Randall Tobias,
We, the undersigned organizations, are writing to express our
serious concerns about efforts by the Bush administration and by
your office to block the use of affordable generic HIV/AIDS
medicines in U.S.-financed programs in poor countries. In order to
mount a rapid and successful response to the growing AIDS pandemic,
we call upon you to ensure that programs use the most affordable
medicines available, and accept the current drug quality standards
of World Health Organization's drug prequalification program.
We are particularly concerned about the U.S.-initiated "Conference
on Fixed-Dose Combination (FDC) Drug Products: Scientific and
Technical Issues related to Safety, Quality, and Effectiveness,"
29-30 March 2004 in Gaborone, Botswana. This meeting needlessly
casts doubt upon the clinically proven quality of generic AIDS
medicines, and disregards the WHO's internationally recognized Drug
Prequalification Program. The meeting is intended to create a
justification to use only expensive, more complex branded treatment
regimens in international assistance programs, and will be used by
the US to justify its efforts to use bilateral assistance programs
to lock generics out of developing countries. Of particular concern
is your attempts to discredit the use of urgently needed fixed-dose
combinations (FDCs) of antiretroviral AIDS medications.
Single-pill combinations promote adherence, decrease the risk of
resistance, and facilitate stock and procurement management, and
are widely recognized as a core element in efforts to scale up ARV
treatment in developing countries. FDCs are strongly preferred over
blister packs and other multi-pill regimens. In addition to ease of
use and other advantages, FDCs, which are taken in the form of one
pill twice a day, are also by far the least expensive option:
today, triple FDCs from generic manufacturers are available for as
little as $140 per person per year. The same combination from
brand-name companies costs a minimum of $562 per person per year
and must be taken in the form of six pills a day. Forcing people
with HIV/AIDS to accept higher pill burdens, wasting limited
taxpayer resources on brand name products, and, most importantly,
using scarce resources to treat one person when the same amount of
money could treat four is unacceptable.
If the ambitious goals of the Presiden's Emergency Plan for AIDS
Relief (PEPFAR), and the WHO's "3 by 5" initiative are to be met,
triple combination FDCs pre-qualified by WHO must be made widely
available. FDCs are recommended in WHO treatment guidelines, and
several generic FDCs have been certified by WHO as meeting
stringent international standards for drug quality, safety and
efficacy through its Prequalification Project. The WHO's standards
for prequalification are supported by UNICEF, the World Bank, the
Global Fund to Fight AIDS. TB, and Malaria, Columbia University's
MTCT-Plus program, many national governments in developing
countries, international humanitarian organizations such as
Medecins Sans Frontieres (MSF), and other programs with experience
treating people living with HIV. Clinicians in resource poor
settings are already using triple combination generics with tens of
thousands of patients, with efficacy and adherence rates
equal-to-or-better than treatment success and adherence rates in
the United States.
Rather than disregarding the drug procurement policies of
developing nations to creating expensive new barriers that benefit
US drug companies, your office should accept the WHO's
internationally recognized drug quality standards and promote
access to affordable medications. We object to any and all efforts
by the Bush Administration and your office to block the use of WHO
prequalified generic medications, and any efforts to discredit the
standards of WHO's prequalification project that would impose new
barriers to generics entering the global market.
Signed,
[list still in formation until COB Friday 26 March]
over 200 international and U.S. organizations signed-on by March
24, 2004 - for list see
http://lists.essential.org/pipermail/ip-health/2004-March/006124.html
Message from U.S. generic drugs manufacturer Bill Haddad
Delivery of the Generic Triple ARV to Poor Nations Is Seriously
Threatened by Combined Actions of the US Government, Pharma, WHO,
UNICEF, UNAIDS, HHS.
March 16, 2004
Posted on the ip-health list hosted by the Consumer Project on
Technology: see http://www.cptech.org/ip/health/
Excerpts only. For full text see:
http://lists.essential.org/pipermail/ip-health/2004-March/006082.html
For those of you who do not know me, I am a generic drug
manufacturer who volunteered three years ago to help Dr. Yusuf
Hamied and Cipla organize their campaign to reduce the price of
AIDS medicines. At the behest of WHO I organized all of the
companies manufacturing generic AIDS drugs into an association so
we could have a voice at WHO. I am a former Herald Tribune New York
Post investigative reporter/editor; worked with the Kennedys;
helped to set up the Peace Corps and the Poverty program. As CEO of
the generic trade association I initiated and negotiated
Waxman-Hatch, the Drug Price Competition Act, that removed the
barriers to generic competition in the United States.
This memo addresses the efforts by an unusual coalition of forces
to remove from the market and continued financing the triple ARV
pre-approved by WHO. The triple ARV is the medicine most often
sought by poor nations based on its safety, effectiveness, price
and its ease of use. They want the Fixed Dose Combination (FDC)
...one tablet taken twice a day... replaced by brand products in
blisters and a return to a regime of different medicines at various
times. The barrier blocking their effort is the WHO pre-approval
process, the basis for most international funding.
A Short Backgrounder for Those Unfamiliar With Recent Events:
As you know we have been successful in dramatically reducing prices
for the triple ARV, one tablet taken twice a day, from $12,000 to
about $200 and under special circumstances as low as $140 per year
. On AIDS Day WHO announced the approval of the low cost, safe,
effective triple and this drug was as at the heart of their 3 X 5
program. The approval process took two years.
This success can go down the drain if the United States government,
UN agencies, the MNCs and Pharma are successful in their renewed
effort to undermine WHO's pre-approval process and remove triple
ARVs from the market. Having failed twice before to do this, the
United States, I have strong reason to believe, pressured WHO,
UNAIDS and others into a third meeting...scheduled for March 29 and
30 in Botswana, a meeting that excluded the experts that blocked
their efforts earlier.
To date, this has been a virtually secret meeting. It needs to be
exposed to those who are concerned about low cost generics reaching
African and other nations.
Many of you know of the barriers we have crossed to get to Lima and
competitive bidding for AIDS medicines: the South Africa legal
actions from which Pharma withdrew when the media embarrassed them
after Cipla and MSF offered ARVs at less than a dollar a day; the
UN Accelerated Access to Medicines program originated with the UN
... a program that established a monopoly at ten times the generic
price and banned generic participation; the Global Fund's refusal
to consider submissions from poor nations that included generic
drugs (now reversed); you know the rest. In Lima, we finally broke
the back of the Accelerated Program when nine Andean nations and
Mexico held an open bidding with generics winning all but one bid
(Abbott). We set a worldwide price of about $249.00.
Ironically, one of the major steps forward was President Bush's
commitment in last year's State of the Union message, to AIDS
funding...based on the reduction in price from $12,000 to $300 a
year from generic manufacturers.
Bush: "...anti-retroviral drugs can extend life for many years. And
the cost of those drugs has dropped from 12,000 dollars a year to
under 300 dollars a year which places a tremendous possibility
within our grasp...Ladies and gentlemen, seldom has history offered
a greater opportunity to do so much for so many..."
... At the Paris Global Fund meeting, I asked Secretary Thompson
from the floor if the President continued to support the $300
generic. (As a Kennedy Democrat, I had called the Bush statement,
courageous, faith-based and personal.) Thompson grew angry at me
(and later perennially confronted me) but as chairman of the
meeting that included most African Ambassadors, he angrily asked me
what made me think the President would not stand by his word. As
many of you may remember the NGOs had crisscrossed Africa during
Bush's trip to get him to restate the generic price. They failed.
Later the price of the triple continued to decline ...under
specified circumstances and prerequisites to as low $140 a year for
certain countries.
On December First, AIDS Day, WHO approved ... after two years ...
the triple ARV in one tablet taken twice a day developed by Dr.
Yusuf Hamied of Cipla (Triomune) and the Ranbaxy's clone...as the
product that was essential to Dr. Lee's 3 X 5 program [WHO program
to treat 3 million by the end of 2005]. As noted above, we know the
triple is the most requested medicine not only for its medical
impact, but its ease of administration.
The WHO decision set in motion a rather violent political reaction
by the MNCs operating behind closed doors and with direct access to
WHO. The only way to challenge the WHO decision was to undermine
the entire WHO pre-approval process...essential for Global Fund and
other international monies.
It soon became apparent that another goal was an additional level
of western approval to insure that the Bush monies, greatly
reduced, but still a major contribution over the next few years,
would only go to the MNCs. ...
The United States government has now arranged for the same
discussion but before a new audience, western regulatory agencies,
African nations receiving US assistance...a meeting given
authenticity by the sponsorship of FDA, WHO (correct, WHO), UNAIDS
(yes, UNAIDS). India and Brazil, the two major suppliers of generic
ARVs were not invited; the NGOs were not included; neither were the
generic manufacturers making the product. I am not sure how many
MNCs were asked to participate but they were there for the planning
meeting in South Africa in February. We were not officially
informed of this meeting and we were not permitted to attend...we
being those of us concerned about continuing the use of generic
ARVs.
The anti-generic viewpoint was made public policy during the
appearance of Ambassador Tobias before the Hyde Committee last
week. In answer to a direct question, he defended the African
Conference and went on to disparage generic medicines ...
The eye of the dragon is in Secretary Thompson's office where Bill
Steiger is the enforcer. He led the fight within the Global Fund to
deny US monies if the Fund insisted on generic medicines. ...
For those of us who fought the thirty year generic war in the
States, this is politics disguised as science. What you do,
scientifically, if you feel there is a problem, is to bring in
neutral academics (not those on the Pharma payroll), have them
collect and analyze the data, write a peer-reviewed report and
publish. ...
When we won the generic wars in the States, I was asked what
happened in the thirty-first year that had not happened before?
It was an easy answer: we moved the issue from behind the closed
legislative doors of power where money talked to the public that
the legislators needed to get elected. ...
MSF on Fixed-Dose Combinations
From Sean.HEALY@geneva.msf.org
March 23, 2004
Posted on http://www.essentialdrugs.org/edrug and e-3x5 mailing
list http://list.healthnet.org/mailman/listinfo/e-3x5
It should be noted that fixed-dose combinations are *already*
showing their benefits in resource-poor settings.
MSF uses FDCs in most of its ARV projects, and has done so for more
than a year, with excellent results, in terms of both adherence
and clinical outcomes.
Presently MSF has approximately 11,000 patients in around 45
projects in 22 countries. Of these between 70-80% are on FDCs,
mostly the d4T/3TC/NVP from Ranbaxy and/or Cipla.
Nine MSF's 10 largest projects, treating over 6200 patients, use
FDCs. Seven of these projects began treating patients in 2001
and 2002. Collated results in October 2003 showed that
adherence was excellent, at 87.6% (9.9% died, 1.2% were lost to
follow up, 0.8% were stopped due to poor compliance). Clinical,
immunological and where available virological results are
comparable to Western standards, even in severely ill patients.
FDCs have greatly assisted our efforts to rapidly increase the
numbers on ART. The safety, quality and efficacy of these FDCs
has been validated by the WHO pre-qualification system as well
as by our own pharmacists, and their bioequivalence with the
originator formulations has been demonstrated.
Their lower price is an additional, obvious advantage: with prices
at least half that of equivalent brand drugs, governments could
treat 2-3 times more patients with the same outlay, if they
used generic triple FDCs instead of the brand-name equivalents.
This is why the Global Fund and UN Agencies are so supportive
of their use
For more, have a look at a briefing paper we've just prepared on
the topic:
http://www.accessmed-msf.org/documents/factsheetfdc.pdf
Sean Healy
Information Officer, Campaign for Access to Essential Medicines
Medecins Sans Frontieres
Geneva, Switzerland
tel ++41-22-8498 401 fax ++41-22-8498 404
mobile tel ++41-79-239 9271
sean.healy@geneva.msf.org
http://www.accessmed-msf.org
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