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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+++++++++++++++++++++++

HEALTHGAP Sign-On Letter
http://www.healthgap.org

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


AfricaFocus Bulletin is an independent electronic publication providing reposted commentary and analysis on African issues, with a particular focus on U.S. and international policies. AfricaFocus Bulletin is edited by William Minter.

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