[e-drug] Demand for 2 originator ARVs could soon exceed supply

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: Demand for 2 originator ARVs could soon exceed supply
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[From Wall Street Journal, copied as fair use. WB]

http://online.wsj.com/search#SB110990011415170306

Demand for Two AIDS Treatments Could Soon Exceed Supply

By PAUL DAVIES
Staff Reporter of THE WALL STREET JOURNAL
March 4, 2005; Page B1

A rapid increase in purchases by two big AIDS-relief programs is
stretching supplies of two treatments and will likely lead to shortages
of the drugs for patients in developing countries, relief officials say.

Bristol-Myers Squibb Co., which makes both drugs, and Merck & Co., which
markets one of them in developing countries, acknowledge the likely
shortages and say the problem stems largely from the acceleration of a
five-year, $15 billion emergency relief effort launched by President
Bush to get more drugs to combat AIDS in developing countries,
especially in sub-Saharan Africa.

The short supply is attributed to increased orders from the President's
Emergency Program for AIDS Relief (Pepfar), on top of rising demand from
the Global Fund to Fight AIDS, Tuberculosis and Malaria, a multinational
financing agency, as well as several other organizations.

The most severe shortage is expected to occur with Bristol-Myers's
stavudine , sold under the brand name Zerit, the company says. Stavudine
is one of the most broadly used first-line treatments for patients
infected with HIV. Paul Lalvani, the procurement manager for the Global
Fund in Geneva, says, "Some [developing] countries have indicated when
they placed orders for stavudine  that they have not been able to access
the product."

In addition to increased orders, supplies in developing countries are
low because of the recent withdrawal of generic versions made by two
Indian companies, after the World Health Organization withdrew its
approval of the drugs.

In 2002, about 10% of the stavudine produced by Bristol-Myers went to
developing countries. This year, the company expects one-third to
one-half of its stavudine will be sent to poor countries.

The other drug in short supply is efavirenz, which Bristol-Myers makes
and markets in the U.S. and Merck markets in developing countries under
the brand name Stockrin. Merck says demand for efavirenz has tripled in
some areas.

Bristol-Myers, based in New York, and Merck, of Whitehouse Station,
N.J., hope to work out the supply issues but say shortages could result
as demand heats up.

The companies say it is difficult to predict how long the problem will
persist because demand continues to increase. But a Merck spokesman says
that any shortages of efavirenz should be only "temporary and sporadic."
Some generic companies in India and Africa have been approved to make
efavirenz as well, easing any shortage.

The first priority, both companies say, is to ensure patients using the
drugs continue to get them. But some new patients may have to wait or
seek alternative treatments.

Both companies say shortages could occur in developed countries,
including the U.S. But some observers doubt that will happen, noting
that the drugs are sold at a profit in developed countries; in
sub-Saharan Africa and other developing regions, the AIDS drugs are sold
at cost, according to the companies.

Bristol-Myers says it won't favor one country over another. It says the
company is committed to doing all it can to help HIV/AIDS patients
everywhere.

"We will continue to supply HIV medicines at no profit in the developing
world," spokesman Brian Henry says.

Bristol-Myers says it produced 1.4 metric tons of stavudine last year
and planned to boost output to 2.5 metric tons this year based on
projected orders. As more orders came in, the company ramped up
production and now expects to make four metric tons in 2005. (One metric
ton equals 20 million to 25 million capsules, depending on the dose.)

"Our goal is to maintain uninterrupted supply for current patients,
while accelerating production to meet the forecasted increase in demand
from new patients," Merck said in a statement.

The short supply raises the issue of whether the U.S. government will
approve more generic AIDS drugs for international use. The U.S. requires
that all medications supplied through Pepfar be approved by the Food and
Drug Administration. Those that violate U.S. patent laws can get a
special approval for use in other countries.

Advocacy groups and the foreign generics industry are especially anxious
to see FDA approval for Indian-made products that combine three
medicines in one pill. The products violate U.S. patent laws but are
used in other countries. In January, the U.S. approved a South African
generic product that co-packages three drugs with the permission of the
brand companies.

Approval of more generics would ease shortages, advocates say. "The
generics have this stuff in a warehouse," says Bill Haddad, an advocate
and chief executive officer of biotech research company Biogenerics Inc.

U.S. Global AIDS Coordinator Randall Tobias told a congressional
committee Wednesday that he expected more approvals of generic AIDS
drugs. Mark Dybul, deputy chief of Pepfar, says, "People are very
cognizant of the issue and are working to resolve the problems." He says
the organization is seeking bids from companies to manage supply-chain
issues to avoid future shortages.

Dr. Dybul says he has had no indication the drug makers would use a
shortage to raise prices.

The current short supply shows the need for better forecasting, as well
as more generics approvals, says Kevin Frost, vice president of clinical
research and prevention programs at the American Foundation for AIDS
Research.

To be sure, the vast majority of people sick with AIDS in the developing
world don't have access to life-saving treatments. More than 45 million
people world-wide are infected with HIV, and 95% live in developing
countries, according to the Global Fund.

About three million people died of AIDS in 2003 and an additional five
million became infected, according to the Global Fund. Three quarters of
those who died were in sub-Saharan Africa.

A U.N. study to be released today projected that more than 80 million
Africans may die from AIDS by 2025, and infections could soar to 90
million, or more than 10% of the population.

The number of people in developing countries receiving treatment last
year was only 700,000. Still, that number was an increase of 75% from
the year before, according to the World Health Organization. In
sub-Saharan Africa, the number of people receiving treatment more than
doubled, to 310,000.

"The good news is we're scaling up treatment," said Anil Soni, executive
director of the Friends of the Global Fund, which advocates on behalf of
the Global Fund in the U.S.

But those who treat patients in developing countries say the short
supply is creating fear.

"This is psychological torture to get patients worried that there will
not be enough drugs," says Peter Mugyenyi, the director of the Joint
Clinical Research Centre in Kampala, Uganda. He says the relief
organizations and the drug makers should have done a better job of
coordinating requests and supply.

"AIDS is not an overnight disease," Dr. Mugyenyi says. "The numbers
didn't just materialize. It's not acceptable to run short of the drug
when huge numbers of people are dying."

-- Sarah Lueck and Marilyn Chase contributed to this article.