Global AIDS Coordinator Tobias* Defends U.S. Policy Not To Use Generic Fixed-Dose Combination Antiretroviral Drugs

April 29, 2004

U.S. Global AIDS Coordinator Randall Tobias in South Africa on Wednesday as part of a three-country, eight-day trip to Africa defended the U.S. policy not to use generic fixed-dose combination antiretroviral drugs in the President's Emergency Plan for AIDS Relief because of quality concerns, the AP/Las Vegas Sun reports (Zavis, AP/Las Vegas Sun, 4/28). Generic FDC antiretroviral drugs, including Cipla's Triomune and Ranbaxy Laboratories' Triviro, combine three different medicines into one pill that is taken twice a day and costs as little as $140 per person per year. A regimen of the same three drugs purchased separately from the companies that hold the patents would require about six pills a day and cost about $562 per patient per year. The drugs have been approved by a World Health Organization prequalification system, but U.S. officials want to ensure that the drugs will not contribute to the development of drug-resistant HIV strains through widespread or improper distribution and use and are proposing guidelines for reviewing FDCs (Kaiser Daily HIV/AIDS Report, 4/9). Tobias said, "Patients ... in Africa deserve to have assurances about the safety and effectiveness of drugs in the same way that people in the United States do," adding, "It is [the U.S.] policy to buy the least expensive drugs that we can find without regard to who manufactures them or where they come from, as long as we can be satisfied as to their safety and effectiveness." He also said that the United States wants a "more transparent and stringent" review process, but he added that the process does not necessarily have to be overseen by FDA, according to the AP/Sun.

Safety, Efficacy
Tobias said, "Maybe [FDC] drugs are safe and effective. Maybe these drugs are, in fact, exact duplicates of the research-based drugs [sold in the United States]. Maybe they aren't. Nobody really knows." He added that the United States does not want to contribute to an increase in antiretroviral drug resistance because of "widespread or inappropriate" use of the treatments, the AP/Sun reports. Tobias said, "With the money that we are putting into this process, it is a whole new ball game. We are massively gearing up the provision of treatment in the world. ... The risks associated with doing something that ends up resulting in increasing drug resistance is quite significant." Tobias began his trip on Sunday in South Africa, visiting projects funded by the United States, and on Wednesday signed an agreement to provide $10 million over three years to the South African group Right to Care, which provides antiretroviral treatment to more than 1,000 people living with HIV, the AP/Sun reports. Tobias also met with officials and community leaders in Ethiopia and underwent a public HIV test to help combat HIV/AIDS stigma. Tobias on Wednesday traveled to Mozambique, where he will conclude his trip, according to the AP/Sun (AP/Las Vegas Sun, 4/28).

'Speedy' Process?
Some senior officials have said that the Bush administration is working to establish a "speedy" approval process for FDCs that could be used in developing countries in an effort to "calm a controversy" over the issue, the Wall Street Journal reports. Under the proposed process, generic FDC drug makers and brand-name drug makers would be able to go through an expedited FDA review process, which could take one to two months. According to the Journal, a senior FDA official speaking on the condition of anonymity said, "The Indian companies can apply to the FDA for approval for their new HIV drugs, and if the data they submit shows that these drugs are safe and effective, FDA could approve them," adding, "As a practical matter, the Indian companies would probably be free to market these drugs in Africa, since the innovator companies have already said they would not enforce their patents in that continent." Bush administration officials said that the faster approval process is "one option" they are examining while determining what drugs PEPFAR grant recipients can purchase, according to the Journal. The administration also is working with WHO to collect more data on the drugs, the Journal reports (Lueck, Wall Street Journal, 4/29).

* Global AIDS Coordinator Tobias is the same American lame-assed bureaucrat who said the week before in Germany on his way to Africa, that "statistics show that condoms really have not been very effective."   more



Generic drugs for fighting AIDS
Friday, April 2, 2004

Since the release of President George W. Bush's Emergency Plan for AIDS Relief, the
U.S. global AIDS coordinator and former CEO of Eli Lilly, Randall Tobias, and other
Bush administration officials have made public remarks that question the quality of
generic antiretroviral drugs and undermine international quality standards set by the
World Health Organization.

Médecins Sans Frontières is deeply concerned that the Bush administration will stand
in the way of countries and programs wishing to use funds provided by the Bush plan to
purchase affordable quality medicines in general, and triple "fixed-dose combinations"
in particular, despite the fact that they are generally three to five times less
expensive than the brand name versions. These generic drugs have been certified by the
WHO by meeting stringent international standards for quality, safety, and efficacy,
and are manufactured by the same pharmaceutical labs that produce hundreds of generic
medicines used by Americans every day.

Fixed-dose combinations of antiretroviral drugs are widely recognized as a key element
to efforts to scale up AIDS treatment in developing countries. Based on Médecins Sans
Frontières's experience delivering antiretroviral therapy in resource-poor settings,
we have become strong advocates of triple fixed-dose combinations. Our clinical
results thus far are encouraging.

WHO-recommended triple fixed-dose combinations are available only from generic
producers because the patents of the three individual compounds are held by three
different companies.

Despite mounting evidence, the Bush administration appears to be ignoring the fact
that these newly adapted tools in the fight against AIDS exist today and are being
widely used in treatment programs that are saving lives.

There is no medical or scientific basis for the Bush administration's attacks against
WHO prequalified medicines, and the United States is isolated in its view that
WHO-prequalification standards are not sufficient. We call upon the United States to
join the international consensus by allowing its grantees to procure quality generics,
including fixed-dose combinations, and by supporting the WHO prequalification project.
We cannot stress enough how disruptive it will be if the United States fails to do so.

The only possible explanation we can imagine for the Bush administration's current
position on procurement of quality-assured generic medicines is that it is more
interested in protecting the interests of the pharmaceutical industry than it is in
expanding antiretroviral treatment to the largest possible number of people.

We would like to be proven wrong.

Ellen 't Hoen, Geneva Interim director, Campaign for Access to Essential Medicines,
Médecins Sans Frontières
http://www.iht.com/articles/512972.html



White House Attempts to Block Generic AIDS Drugs in Africa Stalled; Botswana Meeting & Clinton Foundation Announcement Increase Pressure on Bush Administration

PRESS RELEASE   Africa Action (Washington, DC)

April 6, 2004   Washington, DC

Yesterday, the Clinton Foundation, the Global Fund to Fight AIDS, TB, and malaria, and UNICEF announced plans to drastically reduce the costs of HIV/AIDS drugs, a step which could make treatment more widely accessible to people living with HIV/AIDS in the developing world. The announcement comes on the heels of the Bush administration’s failed attempt to discredit generic HIV/AIDS drugs at a meeting in Botswana last week. The meeting was convened by the White House, at the behest of their patrons in the U.S. pharmaceutical industry, to call into question the safety and efficacy of generic fixed-dose combinations (FDCs) of anti-retroviral drugs.

"Last week’s conference in Botswana demonstrated that there are no limits to the Bush administration’s crusade to protect the profits of the U.S. pharmaceutical industry," said Salih Booker, Executive Director of Africa Action. "Yesterday’s announcement by the Clinton Foundation reflects the strong international consensus on the critical role these drugs play in saving millions of African lives. The Bush administration needs to meet its responsibilities and get in step with the rest of the international community."

Despite the White House’s patent protection agenda, conference participants reasserted the importance, safety, and efficacy of generic FDCs. These drugs are widely acknowledged as essential to expanding treatment in Africa and other developing regions. At the two-day meeting, public health experts and service providers, many of whom receive funding from the U.S. government for HIV/AIDS programs, stood together in support for the use of generic FDCs under the existing WHO approval process. Others, such as the European Agency for the Evaluation of Medicinal Products (EMEA), the largest drug regulatory authority in the European Union, demonstrated their support of these essential medicines by refusing to attend the Botswana conference altogether.

"The Bush Administration should return to the international community and immediately express unequivocal commitment to using Fixed-Dose Combinations and generic drugs," said Njogu Morgan, International Coordinator for TAC and spokesperson for PATAM, the Pan-African Treatment Access Movement. "Simple and affordable drug regimens will enable African countries to rapidly scale up treatment of HIV/AIDS and save thousands more lives."

The threat to the legitimacy of generic FDCs generated outrage and protest among public health experts, medical professionals, lawmakers, and people living with HIV/AIDS last week.

* 381 international organizations signed on to a letter to Randall Tobias, the new US Global AIDS Coordinator, urging him to accept the standards of the WHO's prequalification program and to support the procurement of generic medicines by grantees of the President's Emergency Plan for AIDS Relief (PEPFAR).

* Eight AIDS activists were arrested in Washington, DC on Monday, the first day of the conference, for blocking traffic in front of the offices of PhRMA, the U.S. drug company lobby. They were protesting the White House’s attempt to use the Botswana meeting to discredit generic FDCs.

* U.S. Republican and Democratic lawmakers also sent letters to the Administration calling on the President to permit U.S. funds to be used to buy WHO pre-qualified medicines, including generic FDCs.

Despite the victory achieved, advocates recognize that this is only a first step in the larger struggle to secure generic FDCs through the President’s Emergency Plan for AIDS Relief (PEPFAR) and other funding programs.

"Although the Bush administration is clearly on the defensive, the struggle to place African lives before U.S. drug company profits is by no means over," said Booker. "People Living with HIV/AIDS, health professionals and activists the world over need to keep the pressure on to ensure that PEPFAR treats as many people as possible by buying the most affordable and easy-to-use drug regimens possible."



ACT UP PRESS RELEASE

PhRMA's Washington DC HQ Locked Down in Protest of Bush Assault on Generic
AIDS Medicines, Activists arrested.

2pm Monday 29 March, 1100 15th St. NW, Washington DC

CONTACT: Jen Cohn, 215.668.1646 / Paul Davis, 215.833.4102 / Chadwick Bovee,
646.641.3068

Note to Editors: http://www.healthgap.org/HGAP_PEPFAR_EDITORS_NOTE.doc

(Washington DC) Today a dozen AIDS activists chained themselves to the headquarters of the Pharmaceutical Manufacturers of America, in protest of this weeks Bush Administration's moves this week to ban the use of generic medications from world wide assistance programs such as the Global Fund to fight AIDS, Tuberculosis and Malaria, and the President's own bilateral AIDS relief program.

The activists took action today to oppose the Bush Administration's maneuvers to restrict access to generic AIDS medications in developing nations during a US-convened a meeting this week (29-30 March) in Botswana. This two-day meeting, the "Conference on Fixed-Dose Combination (FDC) Drug Products" will be used to dispute the quality of clinically proven medications already used widely worldwide. White House Global AIDS Coordinator Randall Tobias has repeatedly provided misleading testimony over the last month before Congressional Committees, casting doubt on the quality of WHO approved generics.

"Under the cover of an ostensibly humanitarian program, Bush is using his AIDS plan to ensure big pharma's market dominance and destroy the access to generics," reported Health GAP's Jen Cohn. "Bush campaigns on AIDS and compassion, but his program is merely a slush-fund to reward drug company campaign donors."

The State Department is insisting the U.S. FDA or similar wealthy country drug regulatory authority perform new assessments of the safety and efficacy of generic medicines, rejecting the WHO's internationally supported pre-qualification program which assures the quality and safety of medications. The protocol of the WHO program mimic FDA standards, however, patent barriers prohibit the approval of generic AIDS drugs by the agencies deemed acceptable to Bush officials -- an intentional Catch-22. The WHO has approved dozens of generic AIDS medications for use by numerous national governments, UNICEF, the World Bank, the Global Fund to Fight AIDS, TB, and Malaria, and groups such as Médecins Sans Frontières (MSF).

Unwelcome media coverage and a slew of letters from US Members of Congress last week led to countries including the European Union withdrawing from the meeting. In a letter to President Bush, Senators McCain and Kennedy warn, "We should wait no longer to provide safe and effective low-cost medications to the developing world, and again, urge you to reconsider the Administration's actions. Make no mistake, delays will cost lives." Representatives Brown, Waxman and Lee expressed similar concerns. A letter protesting the meeting and the President's push to restrict generics was endorsed by more than 360 NGOs from 67 countries.

White House officials are particularly opposed to the use of fixed-dose combinations (FDCs) of antiretroviral medications, which combine drugs from multiple originators into single pills. FDCs promote adherence, decrease the risk of resistance and facilitate stock and procurement management. WHO recommended FDCs now available are one pill, taken twice daily. FDCs are the least expensive option: a generic triple combination costs less than $140 per person per year. In the developing world, 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.

"President Bush is a drug company puppet," said Asia Russell from Health GAP. "He plans to force millions of people with HIV/AIDS to accept higher pill burdens and waste tax money to create a slush fund for big pharma. If Bush would use the WHO's quality-assured generics, we could treat four times as many people in need."

By denying quality assured generics under PEPFAR, and requiring poor countries to establish parallel systems for affordable generics, the White House is attempting to lock developing countries into to using only branded drugs.



Study says Generic anti-HIV drugs meet US standards

Thursday, April 22, 2004   
THE ADVOCATE    download (pdf) full report

A study in the May 1 edition of the journal Clinical Infectious Disease
shows that generic antiretroviral drugs distributed in four developing
countries meet United States Pharmacopeia standards, undermining the
reasoning offered for the Bush administration's reluctance to buy the drugs.
USP, a nongovernmental agency made up of representatives from the
pharmaceutical industry, consumer organizations, and the federal government,
as well as pharmacy, medical, and other health care professions, works
closely with the Food and Drug Administration to ensure the quality of
medicines for human and veterinary use.

Bush administration officials oppose using funds from the five-year, $15
billion international AIDS initiative for generic antiretroviral drugs
because they say the drugs have not been evaluated to ensure that they meet
U.S. safety and efficacy standards. The World Health Organization has
already approved the use of the drugs.

The new study, conducted by researchers at the National Institutes of Health
and the University of Alabama, evaluated six different types of anti-HIV
drugs using the Uniformity of Dosage Units test. All of the drugs, which
were obtained from doctors in Lithuania, South Africa, Jamaica, and Zambia,
fell within the USP-approved efficacy range when stored according to
manufacturer specifications. Researchers next plan to study the drugs for
bioequivalency, which tests how much of the drugs are absorbed into the
bloodstream.         
download (pdf) full report



Coalition Expands AIDS Drug Plan Over 100 Nations May Get Discounts

By Shankar Vedantam
Washington Post Staff Writer
Tuesday, April 6, 2004; Page A01

A year-old deal that offers AIDS drugs at a steep discount to 16 countries has been expanded to all the world's poor nations, a key step toward making treatment available to millions of vulnerable patients

Broadening the program to more than 100 countries could dramatically increase the number of AIDS patients being treated and offers hope that the World Health Organization (WHO) might achieve its goal of getting 3 million poor people on antiretroviral therapy by 2005, advocates said.

The groups that negotiated the agreement -- the World Bank, the Global Fund, UNICEF and the Clinton Foundation -- combine for the first time some of the largest funding agencies with those that have the best public health expertise, including WHO.

Missing, however, was one prominent funder: the U.S. government, which has its own plan to help AIDS patients in poor countries. The $15 billion U.S. plan seeks to buy medicines involving multiple combinations of pills from Western pharmaceutical companies that hold patents on the drugs, while yesterday's deal will rely on fixed-dose medicines made in India and South Africa, which combine three drugs in one pill.

Despite the agreement, the participants said, the ambitious "3 by 5" target set by WHO faces daunting challenges, mostly because of a lack of public health infrastructure to deliver the medicines in the poorest countries. But quality drugs at affordable prices are an essential first step.

The cheapest test-and-drug combination will cost about $200 per patient per year under the new agreement.

"It's not a good excuse to say, 'I won't give lower-priced drugs because they don't have infrastructure,' " said Ira Magaziner, chairman of the Clinton Foundation's AIDS initiative, referring to the historical resistance by some U.S. and European pharmaceutical companies to efforts to provide steeply discounted generic medicines to the world's poorest AIDS patients.

Of about 6 million people with AIDS in poor countries, only 200,000 currently receive the treatment that can save their lives. The manufacturers who are to supply the generic medicines will make them available at about one-third to one-half the cost of the cheapest prices being offered by companies in wealthy countries.

Countries that want to get medicines under the agreement will have to build up health systems to deliver them to patients and prevent diversion of the drugs to rich countries, where they could be resold at sizable profits.

"The program could fall apart if black marketeers get in and start diverting medicines," Magaziner said.

Some poor countries already have the public health infrastructure to sign on to the new program immediately, while others may take months or even years before they have a system that can test patients and deliver the medicines correctly, he said.

The new agreement takes advantage of the complementary strengths of the four organizations that worked it out.

"For us, it is not a problem with money, it is a problem of using the money appropriately and being able to implement the project," said Yolanda Taylor, senior specialist for procurement/health at the World Bank. She said the bank had committed $1.6 billion for AIDS, and about 75 percent of that money remains to be spent.

The Global Fund is a public-private partnership that raises money to fight AIDS, tuberculosis and malaria. UNICEF has expertise in procuring drugs, assessing demand and creating distribution networks. By banding together, the groups expect to guarantee generic manufacturers large sales, along with longer contracts and bigger upfront payments -- all of which lower the risk for manufacturers and the cost for participating countries.

"We need low prices, we want the lowest prices possible," said Liza Barrie, a spokeswoman for UNICEF. "And the Clinton Foundation needs volume. So it's a question of marrying different priorities. We can get them volume that they need to get the prices that we want."

Anil Soni, adviser to the executive director of the Global Fund, said the groups would welcome the U.S. government into the agreement if it were willing to sign off on using fixed-dose combinations of AIDS medicines. The signatories to yesterday's agreement stressed that they were abiding by international intellectual property laws, which now allow countries to import generic drugs to fight fatal illnesses such as AIDS. The groups are also open to buying medicines from Western pharmaceutical companies if the firms can match the price being offered by generic manufacturers, they said.

The suppliers of the generic medicines under the agreement are South Africa's Aspen Pharmacare Holdings and four companies from India: Cipla; Hetero Drugs; Ranbaxy Laboratories; and Matrix Laboratories. The AIDS tests will come from Western manufacturers: Beckman Coulter Inc.; Becton, Dickinson and Company; Bayer Diagnostics; bioMerieux; and Roche Diagnostics.



http://www.ipsnews.net/interna.asp?idnews=23080

HEALTH: AIDS Groups Protest U.S. Efforts to Block Generics

Jim Lobe

WASHINGTON, Mar 29 (IPS) - U.S. Africa and AIDS activists are increasing
pressure on the administration of President George W. Bush to abandon its apparent
efforts to block the use of U.S. aid to purchase life-preserving, generic
anti-AIDS drugs for needy Africans, about 6,000 of whom die every day from the
disease.

On Monday, nine AIDS activists were arrested by police here after chaining
themselves together and blocking traffic in front of the downtown headquarters
of the main lobbying association for the U.S. pharmaceutical companies that are
behind the administration's efforts.

The Pharmaceutical Manufacturers of America (PhRMA) has been pressing the
administration to oppose the use of generic drugs by the U.S. Agency for
International Development (USAID) and other international donors in favour of
brand-name drugs that are generally more expensive.

The demonstrators were trying to draw attention to a U.S.-backed meeting this
week in Botswana at which Washington is trying to gain an ''international
consensus'' from United Nations agencies and African countries on what criteria
should be applied to determine the safety and quality of anti-retroviral drugs
that are bought by USAID and other donor agencies.

''The U.S. initiated the Botswana conference at the behest of the
pharmaceutical companies, and its agenda is to protect their profits by blocking the
procurement of generic AIDS drugs'', said Salih Booker, head of Africa Action, one
of the co-sponsors of Monday's protest.

''If the U.S. succeeds, millions of people living with HIV/AIDS will be left
without the medicines they need to survive.''

The Botswana meeting, which runs Monday and Tuesday, comes amid growing
concern over the fate of the global anti-AIDS fight, which appears to have stalled
in recent months due to the failure of major donors to commit more money to
the effort and because of continuing wrangles over the use of patented or
generic drugs.

Activists had hoped that a proposal made by Bush himself 14 months ago to
allocate 15 billion dollars over five years to fighting AIDS in Africa and the
Caribbean would inject major momentum to global anti-AIDS efforts.

But the Bush administration's opposition to the use of generic drugs and its
insistence on providing the vast majority of the money through bilateral
channels rather than through the multilateral Global Fund to Fight AIDS,
Tuberculosis and Malaria, have contributed to the sense that the international response
to the worst epidemic in recorded history is falling far short of what is
required.

Indeed, the lead article in Sunday's 'New York Times', the U.S.' most
influential newspaper, was headlined 'Plan to Battle AIDS Worldwide is Falling
Short'. The feature article noted prominently that only about 300,000 people in the
world's poorest nations are currently getting live-preserving anti-retroviral
drugs, out of the approximately six million who need them.

Late last year, the World Health Organisation (WHO) launched its ''3 by 5
initiative'' to have three million people receiving the drugs by 2005. But earl
ier this month, Stephen Lewis, the special U.N. envoy for AIDS in Africa, the
worst-affected region, admitted that the paucity of donor contributions to date
would make it impossible to reach that goal.

In that respect, the battle over generics versus brand-name drugs is
critical. Even though major western manufacturers have slashed the prices they charge
for these drugs in the world's poorest countries, they remain more expensive
than generics.

U.S. officials are particularly opposed to the use of fixed-dose combinations
(FDCs) of anti-retroviral drugs, which combine drugs from multiple sources
into single pills that are taken twice daily and that are currently recommended
for use by the WHO.

The generic versions of these drugs cost as little as 140 dollars per person
per year, while the same combination from brand-name companies is priced at at
least 560 dollars per year and must be taken in the form of six pills a day.

According to the activists, Washington hopes to persuade participants at the
Botswana meeting to reject FDCs on the grounds that they do not meet adequate
safety and quality standards. U.S. officials deny that is the purpose of the
meeting and stress that they have never ruled out using generics, even for the
administration's own President's Emergency Plan for AIDS Relief (PEPFAR),
Bush's five-year programme.

But the activists say Washington's denial is disingenuous, particularly in
light of the WHO's pre-existing approval of FDCs.

''The moves by the U.S. to call into question the safety and efficacy of
generic AIDS drugs represent a callous attempt to undermine the WHO's existing
rigorous international standards'', said Booker. ''The administration is now
essentially attacking the WHO's '3 by 5' initiative because it knows that generic
FDCs are indispensable to achieving that goal.

''President Bush is a drug company puppet'', said Asia Russell of Health
Global Access Project (Health GAP). ''He plans to force millions of people with
HIV/AIDS to accept higher pill burdens and waste tax money to create a slush
fund for Big Pharma. If Bush would use the WHO's quality-assured generics, we
could treat four times as many people in need''.

The activists are not without powerful allies.

Last week, opposition Democratic Senator Edward Kennedy and his Republican
colleague, John McCain, sent a letter to the White House asking that Bush accept
WHO-approved generics.

''We should wait no longer to provide safe and effective low-cost medications
to the developing world, and again, urge you to reconsider the
administration's actions'', they wrote. ''Make no mistake, delays will cost lives''.

Moreover, the European Union's (EU) drug regulatory authority pulled out of
the Botswana meeting, which could make the ''international consensus'' sought
by Washington much more difficult to achieve.

Fuelling the fire is the fact that Bush's new global AIDS tsar, Randall
Tobias, is himself a former chief executive officer at the U.S. drug company, Eli
Lilly. While he has repeatedly insisted that Washington will support any drug
deemed safe and effective at the lowest possible price, he has also raised
questions about the reliability of generics.

Tobias's past ties to the pharmaceutical companies, which were big donors to
Bush's 2000 election campaign, have only heightened suspicions about their
influence on U.S. policy. Tobias is leading the U.S. delegation in Gaberone.

The WHO strongly favours FDCs and insists that its own standards are based on
the same as those applied by the U.S. Federal Drug Administration (FDA).

Lembit Rago, a senior WHO official, told the Times that as soon as his
assessments office approved Indian-made generic drugs for international anti-AIDS
efforts, ''a very cold wind began to blow from the U.S. It is no secret that
Pharma is lobbying against us in a big way''. (END/2004)



http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2004/03/30/EDGK65S9TU1.DTL

Tuesday, March 30, 2004 (SF Chronicle)
AIDS relief threatened

THE DRIVE TO PROVIDE anti-retroviral drugs to an estimated 6 million poor
people suffering from AIDS worldwide is falling far short of expectations.
The World Health Organization's "3 by 5" plan aims to provide anti-
retroviral drugs to 3 million people by 2005. Yet so far, only 300,000
people are receiving them. Many of the rest face imminent death.
The plan should be getting a huge boost as a result of President Bush's
promise in his 2002 State of the Union address to spend $15 billion over
five years to fight AIDS in Africa and the Caribbean. He set up the
President's Emergency Plan for AIDS Relief, but so far has only requested
from Congress a fraction of what he originally promised.
Now the administration is throwing up another stumbling block that is
further slowing the distribution of effective medication. The United
States is requiring that cheaper generic drugs manufactured in India and
elsewhere meet standards set by the Food and Drug Administration before
the United States will pay for them.
As a result, the United States won't pay for what are called "fixed dose
combination" anti-retroviral drugs manufactured in India, Brazil and
elsewhere. These drugs have already been screened by the World Health
Organization in a process called "prequalification." A year's supply of
one combination of three drugs costs between $136 and $263 -- considerably
less than brand-name versions manufactured by large pharmaceutical
companies.
U.S., African and U.N. representatives are now meeting in Botswana to
examine whether the WHO's screening process is rigorous enough. All
parties should move quickly to resolve this unnecessary fight. Millions of
lives are at stake.



From Saturday's Wpost:

Bush's AIDS Program Balks at Foreign Generics
U.S. Insistence on More Tests Complicates Rollout

By David Brown
Washington Post Staff Writer
Saturday, March 27, 2004; Page A03

http://www.washingtonpost.com/wp-dyn/articles/A28213-2004Mar26.html

The Bush administration is requiring that foreign-made generic AIDS
drugs undergo further evaluation before they are used in its $15
billion global AIDS program, even though the same pills have passed
muster by the World Health Organization and other international
health groups.

Announced three weeks ago to the first organizations to get money
through the Bush program, the decision is already complicating the
rollout of the enormously ambitious President's Emergency Plan for
AIDS Relief. That plan, which goes by the acronym PEPFAR, aims to put
2 million people in 14 African and Caribbean countries on life-saving
antiretroviral therapy over the next five years.

The decision to spend U.S. funds only on brand-name drugs until
foreign generics are studied further has angered AIDS activists. They
see it as an effort to protect the U.S. pharmaceutical industry and
undercut, at least symbolically, the burgeoning offshore generic drug
industry.

"They are trying to hand the U.S. global AIDS plan over to Big
Pharma," said Sharonann Lynch of the group Health GAP. "Look at the
leg up that brand-name drugs are getting, courtesy of George Bush."

PEPFAR officials say they are only showing an abundance of caution as
the United States government commences paying for lifelong medical
treatment for millions of noncitizens, most of them in Africa.

"If in two or three years we have drug resistance as a result of a
therapy that we introduce, we will have lost the continent in terms
of our ability to treat," said Mark R. Dybul, an AIDS researcher from
the National Institutes of Health now assigned to the Office of the
U.S. Global AIDS Coordinator, at the State Department.

" 'Good drugs' isn't good enough. Because of the risk of resistance,
we need the highest possible quality drugs to avert a disaster on the
continent," he added.

Several experts believe the policy could have two possible effects.

It could delay initiating antiretroviral therapy in some AIDS
patients in the developing world. Alternatively, it might require
some of them to start taking more expensive brand-name pills and then
switch to generic equivalents in six months to a year.

Even at the deep discounts offered by their makers, brand-name drugs
in most cases are about three times the price of generics. And even
if the period in which more expensive drugs are used is short, the
policy could sow confusion in the minds of newly treated AIDS
patients and complicate the operation of newly established AIDS
clinics.

This is especially true in countries getting money not only from
PEPFAR but also from sources such as the Global Fund for AIDS,
Tuberculosis and Malaria, which endorses the pills that PEPFAR now
prohibits.

"It is hard to simplify [an AIDS treatment system] when the Americans
say: Let's do it with different drugs and a separate procurement
system," Stephen Gloyd, a physician at the University of Washington,
said. "It has a potential negative effect on the ground. It's not
just an issue of buying more expensive drugs."

Through an organization called Health Alliance International, Gloyd
is helping set up treatment programs in Mozambique with about $3
million from PEPFAR.

Practically speaking, the main drug that PEPFAR recipients will not
be able to use immediately is a "fixed-dose combination" of three
antiretroviral drugs -- stavudine, lamivudine and nevirapine -- made
by several companies in India.

Sold as Triomune, Triviro and other names, it comes in a single pill
and is taken twice a day. A year's supply can cost from $136 to $263.
Taken as separate pills bought at a discount, this combination costs
$559 a year.

The combination is one of four that World Health Organization experts
recommend in the guidelines for the "3 by 5" program -- WHO's
separate effort to help put 3 million people in poor countries on
antiretrovirals by the end of 2005. In practice, about 90 percent of
people who have never taken AIDS drugs are expected to start with it.

PEPFAR's prohibition against using this unusually handy pill arises
from the requirement that AIDS drugs bought through the U.S. program
must be "approved by a stringent regulatory authority or otherwise
demonstrate quality, safety and efficacy at the lowest possible
cost," according to guidelines issued in December. In practical
terms, that means drugs approved by the Food and Drug Administration
(FDA) -- this country's "stringent regulatory authority" -- or
through other mechanisms the PEPFAR may set up.

Several years ago, WHO set up a system to help countries shop wisely
for drugs used to treat the three big infections of poverty -- AIDS,
tuberculosis and malaria. The system is called "prequalification."

Drug companies -- both those making patented brand-name drugs as well
as those making unpatented generics -- are invited to submit their
products for WHO evaluation. The drugs (or, in the case of
combinations, their components) have been tested and licensed
elsewhere. WHO examines them for purity, safety and efficacy.
Employing three-person teams of regulatory experts, it also inspects
the factories where they are made.

If the drug is deemed safe and potent, and the manufacturing
procedures good, it is published on a list. Periodically, samples of
these "prequalified" drugs are tested to make sure they are still up
to standard, and are being made where they are supposed to be made.

The system is voluntary. Because it has no legal standing and is
simply a service for WHO's 192 member states (especially ones that do
not have an equivalent of the FDA), "prequalification" does not
meet PEPFAR's legal requirements.

Generic drug manufacturers in India, Brazil and elsewhere could
submit their products to the FDA for approval, but most do not
because they would then have to honor U.S. patent law. Consequently,
Triomune and similar products are not licensed for use in the United
States.

Dybul said the data WHO collects may contain all the information
PEPFAR needs to reassure itself that Indian generics are good
enough. However, WHO collected the data with the understanding it
would be confidential.

"All we are saying is: We need to see the data ourselves," Dybul
said. He added that if anything bad happened because the Bush program
used substandard drugs, "you would crucify us for not having the due
diligence of looking at the data ourselves -- and rightly so."

However, because the data cannot be turned over to PEPFAR, U.S.
officials are proposing that countries and organizations agree on a
set of principles by which fixed-dose combination drugs -- not only
for AIDS but also for other diseases -- can be evaluated. Each group
could adopt the principles as its own, and drug companies would know
what documentation to submit.

A meeting to work on a statement of principles is scheduled to take
place Monday and Tuesday in Gaborone, Botswana. Even if adopted
quickly, it could be fall before offshore AIDS generics get PEPFAR's
approval under this mechanism.

Many experts do not think such a parallel system is necessary, given
the existence of WHO's prequalification program.

"We are basically doing all the same functions" that the FDA does
when it reviews generic combinations composed of medications that
have long been taken together as separate pills, said Lembit Rago,
WHO's coordinator for quality assurance and safety of medicines.

A clinical pharmacologist who once headed Estonia's counterpart to
the FDA, Rago said in practical terms it is irrelevant that
"prequalification" is not "legal licensure."

"It doesn't matter which color is the cat. It has to catch the mice," he said.



US Official Defends Controversial AIDS Drug Policy
Wed Mar 31, 2004 06:09 PM ET

By Maggie Fox, Health and Science Correspondent

WASHINGTON (Reuters) - A U.S. official on Wednesday denied charges that the
United States supports pharmaceutical giants in a dispute over whether the
government should help provide cheaper generic AIDS drugs.

"What we are looking to do is not to avoid buying generics but to assure the
quality, safety and efficacy of them," said John Lange, deputy to U.S.
Global AIDS Coordinator Randall Tobias.

Lange said the United States was mainly concerned that much cheaper versions
of the drugs made by two Indian companies may end up doing more harm than
good if they are widely distributed.

AIDS activist groups, the international relief group Doctors Without Borders
and some members of Congress have accused the U.S. government of reacting to
pressure from companies that make expensive, brand-name HIV drugs.

Lange told a meeting organized by the Global Business Coalition on HIV/AIDS
and the Council on Foreign Relations in Washington that he expected the
dispute to be resolved soon.

"This is a big issue and it could undermine all the good work we are doing,"
said Richard Holbrooke, chief executive officer of the business coalition.
"Fairly or not, it is going to become a symbol that the United States is
protecting" pharmaceutical companies.

At issue are the drug cocktails that allow patients infected with the AIDS
virus to lead healthy lives.

The World Health Organization and Doctors Without Borders, more commonly
known as Medecins Sans Frontieres, are distributing less expensive versions
made by two Indian companies -- Cipla Ltd. and Ranbaxy Laboratories Ltd. --
that combine the cocktails into single pills.

The United States organized a meeting in Botswana this week to discuss
whether U.S. AIDS programs should also distribute them.

Lange said the meeting reached no conclusions and said it may be difficult
to assess whether the less expensive combinations controlled the AIDS virus
without allowing it to evolve at low levels and eventually develop
resistance to the drugs.

"If we were to purchase antiretroviral drugs that do not meet quality
standards, they could build up resistance and do more harm than good," Lange
told the conference.

He said the U.S. government would commit to the lowest-cost drugs available
that met standards of quality.

"We don't have the data. We are going as fast as we can," Lange said.

"Normally one looks to stringent regulatory authority," he added. But in
this case the U.S. Food and Drug Administration had no jurisdiction, and he
said the WHO was not a regulatory body.



http://www.boston.com/dailyglobe2/091/editorials/Unkept_promise_on_AIDSP.shtml

GLOBE EDITORIAL
Unkept promise on AIDS

3/31/2004

THE GLOBAL effort to combat the three deadliest infectious diseases --
AIDS, tuberculosis, and malaria -- had a rare celebration 14 months ago
when President Bush pledged in his 2003 State of the Union speech to donate
$15 billion to fight AIDS over three years. Since then, US outlays have
been a fraction of the promised amount. And the United States is refusing
to fund AIDS programs that use generic drugs, which cost far less than
brand-name drugs.

A generation from now, history is likely to judge world leaders as much on
what they have done to keep these diseases in check as on their efforts
against terrorism, as destructive as that scourge is. Leaders of
governments and nongovernmental organizations in the developing countries
most afflicted by these diseases must do their part to improve the health
infrastructure needed to reduce the toll. AIDS kills 3 million a year; TB,
2 million; and malaria, 1.2 million.

Stephen Lewis, the United Nations envoy for AIDS in Africa, sounded the
alarm at a press conference early this month. If the UN's Global Fund to
Fight AIDS, TB, and Malaria does not meet its goal for supplying
antiretrovirals to AIDS patients, he said, "there are no excuses left, no
rationalizations to hide behind, no murky slanders to justify indifference
-- there will only be the mass graves of the betrayed." The goal of the
three-year-old fund has been to have 3 million people treated with AIDS
drugs by 2005. Only 300,000 people in the world's poorest countries are
getting them now.

In many countries, infection by both TB and AIDS is making both diseases
more deadly. When a person with latent TB is infected with HIV, that
weakens his immune system and his TB becomes active, which makes him more
likely to infect others. The fight to control TB is also complicated by the
increased mobility of populations, especially the poor, and by the
emergence of TB strains that are resistant to several drugs.

US officials say their concern over development of drug-resistant AIDS
strains is one factor in their opposition to funding programs that use
generic drugs. But critics of the US position say the Bush administration
is simply doing the bidding of the big pharmaceutical companies. The World
Health Organization has approved the generic regimens, which require fewer
daily pills than the brand drugs.

The United States should relent in its opposition to the generics and
fulfill Bush's $15 billion pledge. This, combined with a new resolve to
fight these diseases by governments in Africa -- South Africa has just
initiated its biggest AIDS treatment plan in hospitals in and around
Johannesburg -- could open a more hopeful chapter in mankind's halting war
against infectious disease.

This story ran on page A18 of the Boston Globe on 3/31/2004.



International Herald Tribune – 3-31-04

Role of generic AIDS drugs debated

Sharon LaFraniere NYT

White House doubts safety, effectiveness

JOHANNESBURG Medical authorities from around the world met in Botswana this
week to chart a path through new territory: how best to judge the safety
and effectiveness of relatively cheap, mostly generic drugs that could
vastly expand AIDS treatment in poor countries.

But some participants said they hope the meeting, which ended Tuesday, has
a more direct result: to persuade the Bush administration to pay for
generic drugs for people with HIV, rather than insisting that American
assistance be spent on more expensive patented drugs.

The Bush administration has pledged $15 billion over the next five years -
far more than its predecessors - to fight AIDS in 14 African countries and
the Caribbean. At least initially, the administration says it wants this
money to be spent on patented drugs approved by federal regulators to
ensure that the medicines are safe and effective.

But AIDS activists argue that the administration is protecting the American
pharmaceutical industry.

The two-day conference, held in Botswana's capital, Gaborone, drew dozens
of regulators, aid workers, health officials and pharmaceutical executives.
They drafted principles to help regulators and drug companies evaluate the
cheaper drug combinations to treat AIDS, malaria and tuberculosis.

"The U.S. said it was important to have an agreed set of principles on
these drugs, and I think this meeting has shown that agreement exists,"
said Ellen 't Hoen, of Doctors Without Borders, the French human rights
group. "What we are calling for now is for the U.S. to allow its grantees
to buy these medicines.

"It is hard to come up with an argument as to why you would not want to
fund these drugs, other than that you want the money to go to your own
industry."

The World Health Organization has certified four anti-AIDS drugs as safe
and effective. Three are generic drugs produced by Indian companies.

Not only are the generic compounds cheaper than brand-name pills, medical
experts said, but they are easier for patients to take.

Instead of taking six brand-name pills a day, a patient need take only two
generic tablets.

Dr. Lembit Rago, the coordinator for quality assurance and safety of
medicines for the WHO, said the UN agency has evaluated the drugs in much
the same way as the U.S. Food and Drug Administration certifies the
brand-name drugs.

American officials, however, say the UN agency's review is insufficient to
ensure that the medications will not lead to a drug-resistant strain of
AIDS.

One American health official who attended the meeting said the Bush
administration is seeking an international consensus on how to evaluate the
cheaper generic drugs.

"We want to put as many people as possible in treatment," said that
official, who spoke on condition of anonymity. "We just have to make sure
the treatment is safe and effective."

The New York Times



Dear Colleagues,

Please find below a letter delivered to Ambassador Randall Tobias,
the Global AIDS Coordinator, signed by 381 NGOs, spanning 70
countries. The letter calls on Tobias to accept the standards of the
WHO's prequalification program and to support the procurement of
generic medicines by grantees of the President's Emergency Plan for AIDS
Relief (PEPFAR).

Today was the end of the controversial meeting in Gabarone, Botswana, the
"Conference on Fixed-Dose Combination (FDC) Drug Products: Scientific and
Technical Issues related to Safety, Quality, and Effectiveness." On
Wednesday, March 31, Ambassador Tobias will appear at 2:30 PM
before the Foreign Operations Subcommittee of Senate Appropriations,
where hopefully this issue will continue to have prominence.

There has been much activity regarding U.S. policy on generic HIV
medicines in the last four days. A few highlights include:

* Monday March 29: Carrying a banner reading "Bush and Pharma block
generic AIDS drugs while millions die," eight AIDS activists are
arrested for blocking traffic in front of the offices of PhRMA, the
U.S. drug company lobby. The demonstrators were demanding President Bush
permit the procurement of generics pre-qualified by WHO in the PEPFAR.
Activists, wearing Bush masks, delivered 50 "money bags" to the entrance of
PhRMA before their arrest. (View press release:
http://www.healthgap.org/press_releases/04/032904_HGAP_PR_PEPFAR_demo.html)

* Friday March 26 and Monday March 29: U.S. Republican and Democratic
lawmakers send letters to President Bush calling on the
Administration to permit PEPFAR grantees to buy WHO pre-qualified
medicines, including generic FDCs. (View letters:
http://www.healthgap.org/camp/pepfar.html)

* Friday March 26: the European Agency for the Evaluation of
Medicinal Products (EMEA), the largest drug regulatory authority in
the European Union, decides not to send any representative to the
Botswana meeting on FDCs, despite previous involvement in planning.

There will be important opportunities to increase pressure on the
U.S. over the issue of access to low-cost quality assured generics. For
upcoming events, follow up from the Botswana meeting, suggestions for
action, and to browse press clippings see:
http://www.healthgap.org/camp/pepfar.html


Best

Asia Russell

--
Asia Russell
Health GAP (Global Access Project)
asia@healthgap.org
+1 267 475 2645 mobile
+1 215 474 9329 office
http://www.healthgap.org


--begin NGO sign on letter--

29 March 2004

Ambassador Randall Tobias
Global AIDS Coordinator
U.S. Department of State
SA-29, 2nd Floor
2201 C Street, NW
Washington, DC 20522-2920

Re: Generic medicines and U.S.-initiated conference on Fixed-Dose
Combinations

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 justify the use of expensive, more complex branded treatment
regimens, and will be used by the US as the minimum basis to justify its
efforts to use bilateral assistance programs to lock generics out of
developing countries. Of particular concern is your attempt 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 less than $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 President’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 Médecins Sans Frontières (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 create 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,


International organizations
International Association of Physicians in AIDS Care (IAPAC), Int’l

Partners In Health, Int’l

Oxfam International

International Council of AIDS Service Organizations (ICASO), Int’l

International Planned Parenthood Federation, Western Hemisphere Region,
Int’l

CAFOD International – Catholic Agency for Overseas Development, Int’l

AIDSETI - AIDS empowerment & Treatment International, Int’l

Ecumenical HIV Initiative in Africa, World Council of Churches, Int’l

European AIDS Treatment Group (EATG), Int’l

Health Action International, Int’l

Health Alliance International, Int’l

ILGA - International Lesbian and Gay Association, Int’l

International Community of Women (ICW) living with HIV/AIDS, Int’l

People's Health Movement Global Secretariat, Int’l

Red Centroamericana de Personas que Viven con VIH/SIDA (REDCA+), Int’l

Third World Network, Int’l - Malaysia

African Jesuit AIDS Network, Int’l

Artists for a New South Africa, Int’l/USA-CA

Asociación para la Salud Integral y Ciudadanía de América Latina (ASICAL),
Int’l

COLEGA, La Federación Española COLEGAS de Lesbianas, Gays, Bisexuales y
Transexuales, Int’l

Comite Latinoamericano y del Caribe para Defensa de los Derechos de la Mujer
(CLADEM), Int’l

International Health and Development Associates, Int’l

International Peoples Health Council, Int’l

INTERSECT Worldwide, Int’l

JACANA Real World Development, Int’l

Joint Mongolian-German Reproductive Health Project, Deutsche Gesellschaft
für Technische Zusammenarbeit (GTZ), Int’l

Kenya AIDS Intervention Prevention Project Group (KAIPPG) Int’l

Latin American and Caribbean Women’s Health Network, (LACWHN), Int’l

Movimiento Latinoamericano y del Caribe de Mujeres Positivas (MLCM+), Int’l

Pastoral de la Esperanza Iglesia Catolica CentroAmericana, Int’l

People’s Health Movement East Africa, Int’l

Red de Salud de las Mujeres Latinoamericanas y del Caribe (RSMLAC), Int’l

The River Fund, Int’l

Ukimwi Orphans Assistance, Int’l

Voluntary Services Overseas (VSO), Int’l

WE-ACT - Women's Equity in Access to Care & Treatment, Int’l


US National Organizations
Episcopal Church USA

Presbyterian Church, USA

Unitarian Universalist Association of Congregations, USA

Amnesty International, USA

American Foundation for AIDS Research (AmFAR), USA

National Gay and Lesbian Task Force, USA

ActionAid International USA

Africa Action, USA

AIDS Treatment News, USA

AIDS Vaccine Advocacy Coalition (AVAC), USA

American Jewish World Service, USA

American Medical Students Association (AMSA), USA

Center for Health and Gender Equity (CHANGE), USA

CHAMP, USA

Church Women United, USA

Commission on Social Action of Reform Judaism, USA

Consumer Project on Technology, USA

Essential Action, USA

Gay Men's Health Crisis (GMHC), USA

Global AIDS Alliance, USA

Global Exchange, USA

Health GAP (Global Access Project), USA

Jubilee USA Network, USA

Maryknoll Office for Global Concerns, USA

National Minority AIDS Council (NMAC), USA

Our Bodies Ourselves, USA

Physicians for Human Rights, USA

POZ Magazine, USA

Project INFORM, USA

Reformed Church in America Mission Services program in Africa, USA

Student Global AIDS Campaign, USA

TII CANN - Title II Community AIDS National Network, USA

Treatment Action Group, USA

Washington Office on Africa, USA

Women's International League for Peace and Freedom, United States Section

50 Years Is Enough: U.S. Network for Global Economic Justice, USA

Adrian Dominican Sisters, USA

Africa Faith and Justice Network, USA

AIDS Treatment Data Network, USA

The Praxis Project, USA

AIDS.ORG, USA

Corporate Responsibility Program, Province of St. Joseph of the Capuchin
Order, USA

Health Professional Student AIDS Advocacy Network, USA

Institute for Agriculture and Trade Policy, USA

Keep A Child Alive, USA

Maryknoll AIDS Task Force, USA

Medical Mission Sisters' Alliance for Justice, USA

Missionary Oblates, Justice/Peace & Integrity of Creation, USA

National Association for Victims of Transfusion-Acquired AIDS (NAVTA), USA

Operation USA

Share International USA

South Africa Development Fund, USA

Universities Allied for Essential Medicines, USA

Foreign Country Organizations
Act Up-Paris, France

Agua Buena Human Rights Association, Costa Rica

AIDES, France

Bread for the World, Germany

Deutsche AIDS-Hilfe, Germany

Grupo de Incentivo à Vida, Brazil

Médecins Sans Frontières, Project of Access to ARV therapy, Kenya

Médecins Sans Frontières, Spain

Médecins Sans Frontières, Benin

Royal Tropical Institute, Holland

Treatment Action Movement, Nigeria

Action for Southern Africa (ACTSA), UK

Advancement of Rural People And Nature (ARPAN), India

African Research Institute, LaTrobe University, Australia

African Services Committee, Ethiopia

Agency for Cooperation and Research in Development (ACORD), UK

AGIHAS PLWHA Support group, Latvia

AIDS ACCESS Foundation, Thailand

AIDS Access Foundation, Thailand

AIDS Council of New South Wales (ACON), Australia

AIDS Law Unit, Legal Assistance Centre, Namibia

AIDS Task Force (HIV/AIDS Division of Africa Japan Forum), Japan

AKINA MAMA, Sweden

Alnæmissamtökin á Íslandi, The AIDS Organization of Iceland, Iceland

AMAS/AFAS, Mali

APPRENDE, Peru

Asian-Pacific Resource & Research Centre for Women (ARROW), Malaysia

Asoc. Gente Positiva (GP), Guatemala

Asociación ACCRAD, Argentina

Association is sid'accueil 14, France

Asociacion Amigos de Ayacucho, Spain

Asociación Atlacatl Vivo Positivo, El Salvador

Asociacion Comunitaria Anti SIDA, Spain

Asociación Coordinadora de Sectores de Lucha Contra el SIDA (ACSLCS),
Guatemala

Asociación Costarricense De Personas Viviendo Con VIH/SIDA, Costa Rica

Asociación de Mujeres Contra la Violencia Intrafamiliar, México

Asociación por la Vida (ASOVIDA), Venezuela

Associação Brasileira Interdisciplinar de AIDS (ABIA), Brazil

Associação de apoio a pessoas com VIH/SIDA (ABRAÇO), Portugal

Associação Justiça, Paz e Democracia (AJPD), Angola

Association Bondeko, France

Association de Lutte Contre le SIDA (ACLS), Morocco

Association Kénédougou Solidarité, Mali

ATTAC Japan, Japan

Australasian Society for HIV Medicine, Int’l/Australia

Australian Federation of AIDS Organisations, Australia

Australian People for Health, Education and Development Abroad
(international humanitarian agency of the Australian Council of Trade
Unions), Australia

Australian Red Cross, (Lao PDR Office), Australia

AVERT - Averting HIV and AIDS Worldwide, UK

Begin (learning & living with HIV), UK

BolivaGAY.com, Bolivia

British Columbia Persons With AIDS Society (BCPWA), Canada

Campagne pour les Droits de l'Homme au Congo (CDHC), Congo

Campaign for Improved Access to Treatment for AIDS in resource poor
countries (ImpAcTAIDS), Scotland

Canadian African Partnership on AIDS (CAP-AIDS), Canada

Canadian HIV/AIDS Legal Network, Canada

Canadian Union of Public Employees (CUPE), Canada

CARE Raks Thai Foundation, Thailand

Casa del Paso del Peregrino, Argentina

CASI - Comité d'Action Sociale et Internationale of the Université de
Montréal, Canada

Catholics for AIDS Prevention & Support (CAPS), UK

Center for Health and Gender Equity (CHANGE), Peru

Center for Information and Advisory Services in Health, Nicaragua

Centers of Excellence- Substance Abuse & HIV/AIDS, India

Centre for International Health (CIH) of the Macfarlane Burnet institute for
Medical Research and Public Health, Australia

Centro Regional de Farmacovigilancia, Argentina

Cheshire Homes, South Africa

ChildrenFIRST, South Africa

Children's Rights Centre, South Africa

Christian Health Association of Nigeria (CHAN), Nigeria

Christian Medical Association of India

CICOP Argentina

CIIEMAD/ National Poytechnic Institute, Mexico

Citizen’s Health Initiative, Malaysia

Coalicion ONGSIDA y de la Licda, Dominican Republic

Comité Ciudadano Anti-Sida de Castilla-La Mancha, Spain

Comité Ciudadano Anti-Sida de Burgos (CCASB), Spain

Comite Dominicano de los Derechos Humanos CDH, Dominican Republic

Comité Orgullo México

Committee of Arab and African Families United to Survive AIDS, France

Community Health Cell, India

Consultants for Health and Development, The Netherlands

Consumer Education Trust (CONSENT), Uganda

Coordinadora de Animación Socio Cultural (CASCO), Dominican Republic

COPROMOR, Burundi

Dame Una Mano, Chile

Departamento Acceso a Tratamiento Via Medidas Cautelares (DATVMC), Dominican
Republic

Department of Pharmacology, School of Medicine, National University of La
Plata, Argentina

Difaem - German Institute for Medical Mission. Germany

Discipline of Clinical Pharmacology, Faculty of Health, University of
Newcastle, Australia

d'Unis-Cité, France

Ecumenical Pharmaceutical Network, Kenya

EDU-PRO Foundation, Albania

Egyptian Initiative for Personal Rights, Egypt

Family Aids Caring Trust, Zimbabwe

Farmacéuticos Mundi (ONL), Spain

Farmacia Siglo XXI Foundation, Spain

Farmamundi Extremadura, Spain

Five Loaves of Bread Christian Community for Homosexuals, Hungary

Foundation For Social Concerns Inc., West Indies

Foundation for Studies and Research on Women (FEIM), Argentina

Freedom Foundation, India

Fundación CIPRESS (Centro de Investigación y Promoción de la Salud y la
Sexualidad), Chile

Fundación Henry Ardila, Colombia

Fundación Nimehuatzin, Nicaragua

Fundación para el Desarrollo Humano y Social de la Región del Pueblo Mam
(FUNDAMAM), Guatemala

Fundacion para la Prevencion del VIH/SIDA (PRESIDA), Nicaragua

Fundacion PRESIDA, Nicaragua

Fundación Proyecto Gente, Columbia

Fundacion Schorer, The Netherlands

Génesis Panama+

Ghana AIDS Treatment Access Group (GATAG), Ghana

Gram Bharati Samiti, India

Green Scenery, Sierra Leone

Groupe de Recherche sur les Femmes et les Lois, Senegal

Grupo Argentino Uso Racional de Medicamentos (GAPURMED), Argentina

Grupo de apoyo de personas viviendo con VIH-SIDA (FUNDASIDA), El Salvador

Grupo De Mujeres De La Argentina

Grupo Desde el pié, Argentina

Grupo Desida Por La Vida, Argentina

Grupo Português de Activistas sobre Tratamentos de VIH/SIDA (GAT), Portugal

GTP+ grupo de Trabalhos em Prevenção Posithivo, Brazil

Health Education and Research Association (HERA), Macedonia.

Health Issues Centre, Australia

Helpless Rehabilitation Society (HRS), Nepal

HIV i-Base, UK

Human Genome Analysis, Wellcome Trust Sanger Institute, UK

Imbiza Intersect Coalition, South Africa

Interact Worldwide, Int’l – UK

Interchurch Organisation for Development Cooperation (ICCO), The Netherlands

International Cooperation Area, Foundation Institut Catala de Farmacologia,
Spain

International Family Health, UK

International Gender Equality Network (IGEN), Hungary

Ipas Mexico A.C., Mexico

Irish Missionary Union, Ireland

Jamaica-Japan Network, Japan

Jana Arogya Andolana (PHM - Karnataka), India

Kenya AIDS Intervention Prevention Project Group (KAIPPG), Kenya

Kenya Treatment Access Movement, Kenya

KwaZulu Natal Intersect Coalition, South Africa

l'Association des Femmes Avocates au Congo ( AFEAC), Congo

LGBT Organization of Venezuela

Liga Colombiana De Lucha Contra el SIDA, Columbia

Living Hope Organization, Nigeria

LOCOST (Low Cost Standard Therapeutics), India

Massive Effort Campaign, Switzerland

McGill International Health Initiative, Canada

MCS-Consult, Utrecht, The Netherlands

MICHOACANOS POR LA SALUD Y CONTRA EL SIDA, Mexico

Misiones Diocesanas Vascas, Spain

Mulher e Saúde - Centro de Referência de Educação em Saúde da Mulher, Brazil

Myanmar Buddhist Association of South Africa (MBASA), South Africa

National Association of People Living With HIV/AIDS (NAPWA), Australia

National Forum of People Living with HIV/AIDS Networks and Organisations,
Uganda

Nazareth Hospital-Holy Family Center, Kenya

Network Earth Village Japan, Japan

Network of People Living with HIV/AIDS in Nigeria (NEPWHAN), Nigeria

Network of Sex Work Projects, Int’l - Brazil

Organización de Apoyo a una Sexualidad Integral frente al SIDA (OASIS),
Guatemala

Organization for Social Development of Unemployed, Bangladesh

Pan-African Organisation in Sweden

People Living With HIV/AIDS New South Wales, Australia

People and Planet, UK

People's Health Coalition for Equitable Society, South Korea

Point of View, India

Positive Life Association of Nigeria (PLAN), Nigeria

Positive Living, Malaysia

Positive Movement, Belarus

Positive Women Victoria, inc., Australia

Prodemur significa Promoción de la Mujer Rural, Argentina

Programa de Prevención y Atención a las personas afectadas por ell VIH-SIDA
en Asturias (PAVSA), Spain

Programa de Soporte a la Autoayuda de Personas Viviendo con VIH ( PROSA),
Peru

Progressive Organization of Gays in the Philippines (PROGAY), Philippines

Proyecto de Vacunaciòn y Desarrollo Comunal de Nicaragua (PROVADENIC),
Nicaragua

Public Personalities Against Aids Trust, Zimbabwe

Radio Rhino International Africa, Germany

Reach Out Mbuya HIV/AIDS Initiative, Uganda

Red Argentina de Género, Ciencia y Tecnología (RAGCyT), Argentina

Red Colombiana de Mujeres por los Derechos Sexualers y Reproductivos,
Colombia

Red Hispana de Derechos Humanos en vih - sida y minorías sexuales, Columbia

Red Nacional de Educación Salud Sexual y Desarollo para Jóvenes, Peru

REDBOL, Bolivia

REDVIHDA, Bolivia

Regional AIDS Initiative of Southern Africa (RAISA) initiative of VSO,
Zimbabwe

Regional Committee for the Promotion of Community Health, Nicaragua

Reproductive Health Matters, UK

Reseau des associations des PVVIH, Togo

Réseau du Burundi des PVVIH (RBP+), Burundi

RESULTS, Canada

RNP+ Núcleo RJ, Brazil

Salud Integral para la Mujer, A.C. (SIPAM), Mexico

SAPES Trust, Zimbabwe

Sección Sindical de la Confederación General del Trabajo del Ministerio de
Fomento, Spain

Sida Info Service, France

SIDACTION - Ensemble Contre le SIDA, France

Social Welfare Association for Men (SWAM), India

Sociedad Wills Wilde, Venezuela

Society for Women and AIDS in Africa - Cameroun (SWAA), Cameroon

Solidarité Sida, France

Southern African AIDS Information Dissemination (SAfAIDS), Zimbabwe

Spanish National Community Advisory Board (CACSIDA), Spain

Spiritia Foundation (Indonesian Peer Support Network for PLHAs), Indonesia

St. Joseph's Matale Youth Organization, Uganda

Synthesis, Greece

Tanzania Network Of Organization Of People Living With HIV/AIDS (TANOPHA),
Tanzania

Targeted AIDS Interventions, South Africa

Tertulia Feminist Magazine, Guatemala

Thandanani Childrens Foundation, South Africa

The Ark Foundation, Ghana

TREE, Training & Resources in Early Education, South Africa

Trócaire, Ireland

Tuyakula Group, Namibia

Uganda Coalition for Access to Essential Medicines, Uganda

UK Coalition of People Living with HIV and AIDS (UKC), UK

Unión Afirmativa de Venezuela

United Nations Association Of Uganda

University of Manitoba Medical Students' AIDS Outreach, Canada

University of Toronto International Health Program, Canada

Vanguardia Mexicana de Personas Afectadas por el VIH/SIDA (VANMPAVIH),
Mexico

Vida Positiva Quilpue, Chile

VIH/SIDA de la Iglesia Catolica de Honduras

Waverley Care Trust, Scotland

Wemos Foundation, The Netherlands

Western Cape Intersect Coalition, South Africa

Wits Pediatric HIV Working Group, South Africa

Women on Waves, The Netherlands

Women's Dignity Project, Tanzania

WTO Watch Qld, Australia

Xtending Hope Partnership, St. Francis Xavier University, Canada

Youth (OSDUY), Bangladesh

YWCA of Albania



US Local and Regional Organizations:

ACT UP Cleveland, OH

ACT UP East Bay, CA

ACT UP New York, NY

ACT UP Philadelphia, PA

ActionAIDS Philadelphia, PA

Africa Bridge, OR

African Services Committee, NY

AIDS Action Baltimore, MD

AIDS Foundation of Chicago, IL

AIDS Policy Project, PA

AIDS Survival Project, GA

Balm in Gilead, NY

Blood:Water Mission, TN

Brown University Center for AIDS Research, RI

Catholic Mission Office, Diocese of St. Cloud, MN

Citizens for Consumer Justice, PA

COLOURS Organization, PA

Concerned Medical and Health Care Professionals, MD

Drexel University (Public Health Interest Group) PHIG, PA

George Washington University Student Global AIDS Campaign. DC

God’s Love We Deliver, NY

HIV Law Project, Inc, NY

Housing Works, NY

International AIDS Empowerment, TX

Liberty Research Group, NY

Loyola AIDS Awareness Coalition, MD

Lutheran Campus Ministry at the University of Arizona, AZ

Migration & Refugee Services, Diocese of Trenton, NJ

NCATA (NW Coalition for AIDS Treatment in Africa), WA

New Mexico POZ Coalition, NM

New York AIDS Coalition, NY

Office of Religion, Catholic Diocese of Scranton, PA

PA Civil Rights Initiative, PA

Pacientes de SIDA pro Politica Sana, PR

Pediatric HIV/AIDS program at The Children's Hospital of Philadelphia, PA

Pennsylvania Lesbian and Gay Task Force (PLGTF), PA

Philadelphia College of Medicine Public Health Club, PA

Philadelphia International Action Center, PA

Philadelphia NORML, PA

Planet Poz, NM

Positive Health Clinic, PA

Prevention Point Philadelphia, PA

Princeton Student Global AIDS Campaign, NJ

Priority Africa Network (PAN), CA

Queers For Racial & Economic Justice, NY

Rescue Childhood, PA

RESULTS Seattle, WA

Rochester Area Task Force on AIDS, NY

Rochester Global AIDS Project, NY

Sisters Mobilized for AIDS Research and Treatment (SMART University), NY

Sisters of St. Joseph of Carondelet, St. Louis Province, MO

Starfish Project, New York Presbyterian Hospital, NY

Survive AIDS, CA

The Washington State Africa Network, WA

Universities Allied for Essential Medicines, University of Minnesota, MN

Village Care of New York AIDS Day Treatment Program, NY

Vukani Mawethu Choir, CA

Washington Biotechnology Action Council, WA

Women's Environment and Development Organization (WEDO),NY

Yale AIDS Network, CT

Youth-Health Empowerment Project (Y-HEP), PA



 

 

 


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