Bush kills and harms millions for Pharma

From: GMCarter (fiar_at_verizon.net)
Date: 07/14/04 

Date: Wed, 14 Jul 2004 11:47:11 GMT

The Bush approach as it screws the world up and makes life horrible,
spreads suffering and death.

                George M. Carter

**
July 14, 2004
Early Tests for U.S. in Its Global Fight on AIDS
By DEBORAH SONTAG

This article was reported by Deborah Sontag, Sharon LaFraniere and
Michael Wines, and was written by Ms. Sontag.

The Bush administration did not consult with Mozambique last year
before designating the country as a beneficiary of its emergency AIDS
plan. Mozambique was simply informed that it would be one of 12
African nations, and 15 countries overall, awarded substantial
financial assistance.

The pledge of big money was certainly welcome, said Francisco Songane,
the Mozambican health minister; AIDS has lowered life expectancy in
Mozambique to 38. But the approach, perceived by many Mozambicans as
arrogant and neocolonial, was not.

Mozambique, in southeastern Africa, had spent considerable time
developing a national strategy to combat its high rate of H.I.V.
infection. Other international donors had agreed to pool their
contributions and let the Mozambicans control their own health
programs. Thus, Mozambican officials recoiled when the Americans said
earlier this year, "We want to move quickly, and we know that your
government doesn't have the capacity," Mr. Songane said.

The Bush administration wanted the bulk of its funding to go toward
more costly brand-name antiretroviral drugs for treatment programs run
by nongovernmental organizations. But Mozambique had already decided
to treat its people with 3-in-1 generic pills, which were cheaper and
simpler to take. Also, Mozambique did not want an American program
dependent on costly foreign consultants, N.G.O.'s and the largesse of
foreign political leaders, that would run parallel to its own.

There were confrontational meetings in Washington and in Maputo, the
capital of Mozambique. And in the end, to the surprise of many, the
Bush administration agreed to give Mozambique the kind of help it
really wanted, by strengthening its laboratories, blood-transfusion
centers and the Health Ministry itself - albeit indirectly, through a
grant to Columbia University.

"What I witnessed in Mozambique was a disaster averted," said Dr.
Steven Gloyd, an international health specialist at the University of
Washington who works with Mozambique. "So, for countries like
Mozambique, this may turn out to be a positive intervention, even
though it could be a lot more."

Seventeen months after President Bush announced his five-year, $15
billion emergency AIDS initiative, the program is belatedly getting
under way, and surprising some critics of what is seen as its
go-it-alone approach. In some cases, the plan is proving to be more
adaptive and collaborative than had been expected, especially when
countries are strong enough to stand their ground.

The plan is already directing considerable money into health clinics,
laboratories, testing centers and hospices, AIDS treatment, prevention
of H.I.V. and care of orphans.

For every Mozambique, however, where Washington has altered its plans
to meet local objections, there is a Zambia, where local officials are
in the dark. The Zambian health minister, Brian Chituwo, said his
government did not have a formal meeting on the program with the
American ambassador until May, 15 months after Zambia's role was
announced. Further, he said, on everything but blood-transfusion
services, which were negotiated, the Americans' plans for Zambia have
"all come from Washington." The American plan, one senior United
Nations official said, "has created turbulence wherever it has gone."
But another, Michel Sidibe, praised the Americans for making a "major
shift" in May by signing "a declaration of harmonization" in which
they pledged to coordinate their anti-AIDS activities with other
donors.

The president's program, a centerpiece of his compassionate
conservativism, has been a prime topic of conversation at the
International AIDS Conference in Bangkok - and a magnet for some
protests. On Tuesday, President Jacques Chirac of France accused the
United States of blackmailing developing countries into bartering
their right to produce generic H.I.V. drugs for free-trade agreements.
American officials dismissed the charge as groundless.

After decades when the pandemic in Africa spread unchecked, billions
in anti-AIDS money is suddenly pledged to assist the continent, and
questions about how to channel that outpouring have taken center
stage. The administration's AIDS effort is under sharp scrutiny
because it so big, so unabashedly Washington-dominated and tinged by
the administration's political ideology.

Many critics see big pharmaceutical companies behind the Bush
administration's preference for costlier brand-name drugs,
conservative Christians behind its heavy promotion of abstinence, and
hard-line unilateralists behind its decision to bypass the Global Fund
to Fight AIDS, Tuberculosis and Malaria in creating its own plan.

Randall L. Tobias, a former chief executive of the Eli Lilly & Company
drug group and a Republican donor who became the administration's
global AIDS coordinator last October, lamented the politicized
environment and suggested that critics refocus their antagonism. "The
enemy here ought to be apathy, denial and stigma," he said. "I don't
know why people spend so much time fighting each other."

Still, the administration's refusal thus far to use its money to buy
generics is complicating the roll-out of its own emergency plan. Like
the Mozambicans, other African officials have resisted the
distribution of brand name drugs as first-line therapy. As a result,
in a half a dozen or more of the focus countries, the governments
themselves or other donors are picking up most of the cost of
life-saving drugs.

The goal set by President Bush in January 2003 was to treat two
million people in five years. Under the plan, an estimated 6,000 to
10,000 people have started on antiretroviral drugs so far, according
to a Congressional appropriations expert. The global AIDS office could
not give a figure. In the slums of Lusaka, Zambia, American money was
put to use quickly this spring renovating four clinics and training
workers to distribute drugs. American doctors worked in concert with a
local health official to salvage a stockpile of government AIDS drugs
that were about to expire.

In late April, they started handing out drugs that ward off death for
some very ill people, and within two months, they had 700 patients on
antiretroviral therapy.

"There was a patient whose family had sadly sent her off to a hospice"
to die, said Jeffrey Stringer, a doctor from the University of Alabama
who is running the program. Recently, a health worker escorted the
patient back home. "And there was a woman who couldn't crawl who has
now gained weight and is walking around."

Dr. Stringer, who is working in collaboration with the Elizabeth
Glaser Pediatric AIDS Foundation in Los Angeles, noted that he had not
voted for President Bush. But he had to admit, he said, "They ponied
up."

Other American experts are more skeptical.

"Sure, off the bat, you can put 5,000" on antiretroviral drugs, said
Josh Ruxin, an assistant clinical professor of public health at
Columbia and a consultant to Rwanda and Nigeria. "They're easy to ID,
they're terribly sick, they need drugs now, they live in cities, they
have cell phones. So that's the low-hanging fruit. But then what
happens? You quickly reach a point where you can't treat more people
unless you develop the national health systems, and that is not
something I've heard the American government commit to in a big way."

For Bush, a 'Work of Mercy'Mr. Bush presented the President's
Emergency Fund for AIDS Relief in his 2003 State of the Union address,
which also began the countdown to the war in Iraq. He called it a
"work of mercy," offering the soft power of American humanitarianism
to counterbalance the imminent use of military force.

"As our nation moves troops and builds alliances to make our world
safer, we must also remember our calling as a blessed country to make
this world better," he said.

Mr. Bush declared a five-year goal of getting 2 million into
treatment, preventing 7 million infections and providing care to 10
million infected people and AIDS orphans in what he called the most
afflicted countries in Africa and the Caribbean.

The 14 focus countries named were: Botswana, Ethiopia, Guyana, Haiti,
Ivory Coast, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South
Africa, Tanzania, Uganda and Zambia. Vietnam was added last month at
Congress's insistence that there be another nation from a different
region.

The sheer ambition of the proposal stunned advocates for huge
increases in global AIDS funding into applause. Jeffrey Sachs, the
Columbia University economist, called the president's commitment
"historic" and a "breakthrough."

But at a time when American power was being imposed and questioned in
the military arena, the AIDS plan struck some as another kind of
unilateralism. They feared that Mr. Bush's program would undermine the
multilateral Global Fund, which assists eight times as many countries,
including India, China and Russia, whose infection rates are rising
rapidly. And these experts thought it was retrogressive in its
reliance on American universities, faith-based organizations and
nongovernmental organizations, whose ability to pay higher salaries
could drain workers from local public health systems that should be
reinforced instead.

Dr. Paul Zeitz, executive director of the Global AIDS Alliance, said
advocates were baffled. "We thought the international community had
come to a consensus that there needed to be a new way of doing
business where we all worked together and helped strengthen national
capacities," he said.

When he took office, Mr. Bush had inherited a kind of global momentum
toward an international AIDS fund, and a drumbeat for action was
building at home, too. Senators Bill Frist and John Kerry formed a
bipartisan team to fight for greater American involvement. The Rev.
Franklin Graham, who delivered the invocation at Mr. Bush's
inauguration, was catalyzing the evangelical community to get over its
aversion to the disease and confront it as part of its mission.

The push for an international fund was led by, among others, Mr. Sachs
and Secretary General Kofi Annan at the United Nations. But the Bush
administration was a major force in shaping the Global Fund as an
independent, multilateral, public-private partnership, and not a World
Bank or United Nations program.

The Global Fund's approach was conceived as a reaction against years
of inefficient and often ineffective foreign development programs. The
idea was to funnel aid from multiple donors to the affected countries
and let them run their own health programs, thereby eliminating waste,
duplication and burdensome demands on patients.

Yet it took a couple of years for the Global Fund, which is based in
Geneva, to persuade countries to develop plans that could be financed,
and to get the money flowing from government coffers into health care.
The Bush administration was impatient, and concerned that other
countries were not contributing their share. The Global Fund did not
seem the ideal repository for the billions it wanted to pour into the
pandemic.

After the 2003 State of the Union address, Richard Feacham, executive
director of the Global Fund, said: "There was to some degree a mood in
Washington of dichotomy" between the president's plan and the Global
Fund. "People felt the need to make a choice and see a rivalry. We
worked extremely hard to convey the message that the world needs both.
You can't stop the pandemic in 15 countries. The Global Fund is in
130. We also focus on TB and malaria, the greatest killer of African
children."

Right after the State of the Union address, Tommy G. Thompson, the
secretary of health and human services, became the new chairman of the
Global Fund, which made some European donors fear an American
takeover. But Mr. Bush has instead moved to pull back. In his budget
request for 2004, he sought to reduce America's contribution. And in
his 2005 request, he is asking for a 60 percent cut in the
contribution.

Congress, however, refused the Global Fund's allocation for 2004,
instead nearly tripling the administration's request. It also
increased the global financing to $2.4 billion, of which $1.9 billion
goes for H.I.V./AIDS (and the rest for tuberculosis and malaria).
Several members of Congress complained that $2.4 billion was not a lot
of money for a global health emergency, especially compared with more
than $100 billion spent on military operations in Iraq.

The global AIDS coordinator's office, in fact, had only $488 million
in new money this year. It also used old money in new ways, though. By
the end of the 2004 budget year, it will have committed - but not yet
spent - $865 million, one-fifth of which is committed to faith-based
groups. Some $253 million will go toward treatment programs, but the
drug issue has made spending that money more difficult than expected.

Generic Drugs vs. Brand Names"We are using generics here because they
are cheaper," Mr. Songane of Mozambique said. "And apart from being
cheaper, they are prepared in a manner which is simple for our
patients, and even simpler for our staff."

Like Mozambique, many countries prefer generics because they can be
used to treat more people and because, given patent problems, only
generics now come in fixed-dose combinations, which combine three
drugs in one tablet, improving adherence to pill-taking schedules.

Foreign-made 3-in-1 pills have been approved by the World Health
Organization and purchased in bulk by the Global Fund and many
developing countries. But the Bush administration is insisting on
brand-name antiretroviral drugs because the generics have not been
reviewed by the Food and Drug Administration. The F.D.A., Mr. Tobias
said, is the most stringent regulatory authority in the world and
should make the determination whether drugs for an American overseas
program are safe and effective, and of the highest quality.

Mr. Tobias noted that the World Health Organization recently withdrew
two generic antiretroviral drugs made by Cipla of India from its list
of approved treatments. (Its fixed dose tablets remain on the list.)
This, he suggested, cast doubt on the W.H.O.'s screening procedures.

Cipla has said that the problem lay not with the product but with a
contract research laboratory that it no longer uses. Tests are being
repeated in different labs, and the company says it is confident that
the drugs will be back on the approved list soon.

Further, earlier this month, researchers who studied Cipla's Triomune
reported in the Lancet medical journal, that fixed-dose generic AIDS
drugs work as well as brand-name drugs, according to the first
clinical trial. Triomune costs as little as $140 a year per patient,
compared with about $562 for the brand-name versions in the 3-in-1
pill.

In early spring, the Americans discovered that resistance to their
rule on brand-name drugs was coming even from the American
organizations who were getting multicountry, multiyear grants to set
up treatment programs. The American organizations, which are expected
to receive more than $600 million over five years, are the Harvard
School of Public Health; the Glaser foundation; the Joseph L. Mailman
School of Public Health at Columbia University; and a faith-based
consortium led by Catholic Relief Services.

Some expressed their preferences for generics outright. Barry R.
Bloom, the dean of public health at Harvard, said, "The Indian pills
are terrific - you take just two a day." Allan Rosenfield, dean at
Mailman, issued a statement urging the Bush administration to allow
American money to purchase generics.

At an American-initiated conference in Botswana in late March,
Jacqueline Patterson, who manages the program for a Protestant medical
association that is part of the Catholic Relief Services' consortium,
declared that most mission hospitals and clinics in Africa and the
Caribbean were already using fixed-dose combinations and wanted to
continue. She read comments from the field that voiced a collective
anxiety about the imposition of brand-name drugs, resulting in fewer
people in treatment and more skipping doses and sharing pills.

With countries like Mozambique, Namibia and Rwanda holding fast to
their positions that generics would be their first-line drugs,
American officials realized that their assistance in those places
would be limited. They would be able to provide medicine for children,
for whom only brand-name drugs are available, and for those adults,
say, who had developed a resistance to the generics. But essentially,
they would be providing technical support for the drug treatment
program rather than the drugs themselves.

In May, the Bush administration announced that it would set up a new
expedited review for generic antiretrovirals, including the 3-in-1
pills. If approved, the drugs would be eligible for use in the AIDS
plan, it said.

An executive at an American foundation engaged in global AIDS work
said it remained to be seen whether "the F.D.A. process is real, a
stalling tactic, or ultimately a tool for the R-and-D companies." But,
he said, his foundation was encouraging foreign drug companies to
submit dossiers to the agency.

So far, no foreign drug companies have applied for the expedited
review. William F. Haddad, an American representative for Cipla, said
the Indian company was left with unanswered questions about the
accelerated approval process. "When they come back to us with answers,
Cipla will make up its mind about whether to apply," he said. "But the
bottom line is that this is a political act, not a scientific one. Why
is the World Health Organization's stamp of approval O.K. for the
World Bank and the Global Fund and not for the U.S.?"

Abstinence vs. Condoms
With its focus on treatment, Mr. Bush's plan is profoundly changing a
two-decades-long emphasis on H.I.V. prevention as the American
strategy abroad. The prevention efforts are continuing but, on
Congress's mandate, they are being given a new emphasis on abstinence,
with $86 million devoted this year to promoting abstinence.

World Relief International, the humanitarian arm of the National
Association of Evangelicals, is to receive $9.6 million over five
years to promote abstinence. Deborah Dortzbach, international director
for its H.I.V./AIDS programs, said World Relief would use a network of
churches, schools and "Choose Life" clubs in Haiti, Kenya, Rwanda and
Mozambique.

"We teach abstinence as an opportunity," she said, "as a way to delay
the gift of sexuality and its pleasures until they can experience it
with responsibility."

A guide for World Relief instructors includes a detailed chapter on
condom use and how to negotiate the use of a condom with a reluctant
partner. Ms. Dortzbach acknowledged, however, that many pastors were
reluctant to discuss condoms at all with youths and needed some
persuasion to mention them during marriage counseling.

Any discussion of condoms, Ms. Dortzbach said, emphasized that condoms
were not perfectly safe and that "the only guarantee for protection is
abstinence," which is the Bush administration's message.

That message is predicated on the success of the A B C model in
Uganda, which stands for Abstain, Be Faithful, Condomize. Critics say,
however, that the Americans are paying too little attention to "C."

The American government is probably buying more condoms now than at
any time in its history, Mr. Tobias said, but Congress did not want a
broad distribution of condoms to be the primary prevention tool, as it
has been historically. In Africa, too, some experts question the
efficacy of condoms, given that infection rates continue to climb as
many men refuse to use them.

The Bush administration's strategy does suggest condoms for "high
risk" individuals like prostitutes, soldiers, drug users and
"serodiscordant" couples. But critics say everybody in a sub-Saharan
country with a sky-high infection rate is high risk.

"In their approach, they ignore the basic reality that a large share
of unmarried adolescents are already sexually active and so at high
risk," said Jodi L. Jacobson, executive director of the Center for
Health and Gender Equity in Maryland. "They also ignore the fact that
marriage doesn't protect married teens and women from H.I.V., and that
sexual violence and coercion are facts of life."

The Longer Term In Maputo, health officials said that they were struck
by the Americans' obsession with numeric goals.

"To see an increase in numbers of people on antiretrovirals, that was
their only concern," said Mr. Songane, the health minister. "But this
is a complex disease. We can not judge the success of our fight just
by the numbers of people on treatment."

The Mozambicans wanted to move gradually and to strengthen their
health sector at the same time. They did not want to neglect other
health issues, like malaria, childhood diseases and maternal health.
They did not want to use nongovernmental organizations where the
Americans would pay the salaries, buy the drugs and purchase the
vehicles that would travel to the villages to distribute the drugs.

"In one year, two years' time, who is going to follow those people?"
he asked. "When the N.G.O. is gone, who is going to take over?"

Dr. Paul Farmer, an American renowned for his treatment programs in
rural Haiti, said international projects intending to help poor
countries should pay heed, as Mozambique does, to the need to
integrate AIDS treatment with overall health care.

"When you're in a clinic in rural Haiti and someone comes in with a
broken arm or in obstructed labor, you can't say, 'Sorry, we only do
AIDS prevention and care,' " said Dr. Farmer, a Harvard professor.
"The massive loss of life due to H.I.V. disease is only one symptom of
a very sick world in which hundreds of millions are going without any
modern medical care at all. Addressing AIDS properly offers a chance
to set some of this right."

Copyright 2004 The New York Times Company
____________________________________________________