Greetings,

Those of you who have followed the progress of the President's
AIDS Initiative (PEPFAR) may be interested in this article from this
morning's Washington Post. It addresses the Bush administration's
insistence on the purchase of US-brand drugs rather then generics by
groups funded by the US for AIDS treatment. Note comments by Dr. Steve
Gloyd of the University of Washington.

Mary Anne


Bush's AIDS Program Balks at Foreign Generics

By David Brown

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.




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