Study Finds Generic AIDS Drug Effective
Foreign Desk; SECTA
Study Finds Generic AIDS Drug Effective
By DONALD G. McNEIL Jr.
881 words
2 July 2004
The New York Times
Late Edition - Final
5
English
(c) 2004 New York Times Company
The first clinical trial of generic AIDS drugs in a simple 3-in-1 pill has found
that they work as well as brand-name drugs, researchers are reporting today.
Because of patent problems, brand-name drugs for first-line treatment do not
come in 3-in-1 pills, and medicines that are deeply discounted for poor
countries by their makers usually still cost more than generics.
The issue is important because the United States has refused to let the $15
billion that President Bush has committed to fighting AIDS in the third world be
used for generic drugs, arguing that there is not enough proof they are
effective.
Normally, the makers of generics need only prove that their drugs are chemically
identical to brand-name drugs. But because of the skepticism about generics,
Doctors Without Borders, a charity that wants to use the drugs widely in Africa
and Asia, and the University of Montpellier's Research Institute for Development
in France, which does scientific research benefiting poor countries, did the
study to confirm that the drugs worked in the field.
The research was overseen by the French National Agency for Research on AIDS, a
leading European research institution, and was published in the July 3 issue of
the medical journal The Lancet.
The trial followed 60 patients in two hospitals in Cameroon for 24 weeks who
took Triomune, a combination of nevirapine, stavudine and lamivudine made by
Cipla Ltd. of Mumbai, India. The drugs are also known as NVP, d4T and 3TC or
under the brand names Viramune, Zerit and Epivir.
One Triomune pill is taken twice a day, which helps patients take all their
medicine and makes it nearly impossible to sell or give away part of a handful
of pills -- a practice, common in poor countries, that can encourage the virus
to mutate drug-resistant strains and kill patients.
Nearly all the patients in Cameroon were in advanced stages of AIDS. By the end
of the trial, 80 percent had the amount of virus circulating in their blood
driven to very low levels. Most had increases in CD-4 cells, the immune-system
cells that the virus attacks.
Most importantly, said Dr. Michel Kazatchkine, director of France's AIDS
research agency, the levels of the three drugs in the blood was the same as
would be expected from three mainstream drug brands.
A spokesman for the Pharmaceutical Research and Manufacturers of America, the
lobbying group for the brand-name drug industry, said it had no comment on the
study.
Only one patient dropped out because of adverse drug reactions.
Dr. Richard G. A. Feachem, executive director of the Global Fund to Fight Aids,
Tuberculosis and Malaria, called the study ''extremely good news.''
The fund buys generics approved by the World Health Organization, including
Triomune, so ''this gives strong scientific support for the procurement policies
the Global Fund has been pursuing for 18 months,'' he said.
Dr. Kazatchkine said it would also reassure African countries that had been
buying W.H.O.-approved generics because they were the cheapest.
The Bush administration, under the president's emergency plan for AIDS relief,
will not yet buy generic AIDS drugs, a stance that has put it in opposition to
the rest of the world.
But on May 16, the Bush administration announced that companies that make
generic drugs could apply to have their drugs approved by the Food and Drug
Administration and that the usual $500,000 application fee would be waived.
None have applied yet, but several are expected to soon, said Dr. Mark R. Dybul,
the medical adviser to the office of Randall L. Tobias, the administration's
global AIDS coordinator.
Several calls and messages to Ambassador Tobias's office asking for comment on
the Lancet study were not returned.
Cipla was not involved in the Cameroon study, said Amar Lulla, the company's
joint managing director, and he said he had not seen the Lancet article. But
''it is not surprising,'' he said, after reading a copy. An unpublished study of
1,200 patients in India followed for two years ''found that our drugs are
clinically efficacious,'' he said.
Similar pills are made by Ranbaxy Laboratories Ltd., another Indian company.
Companies in South Africa, Brazil and elsewhere are expected to follow suit.
As of last month, Doctors Without Borders was treating 13,000 patients in poor
countries with 3-in-1 pills made by Cipla or Ranbaxy.
''We're getting good results in weight gain, CD-4 rise and viral load,'' said
Daniel Berman, co-director of the medical charity's campaign for access to
inexpensive drugs.
The only brand-name antiretroviral in a 3-in-1 pill is GlaxoSmithKline's
Trizivir, which the company concedes is not an ideal starting regimen because it
consists of three drugs in the same class, instead of a mix of classes.
In the past, brand-name companies said they could not cooperate to combine their
drugs into one pill out of fear of prosecution under antitrust laws. But when
the Bush administration made its May 16 announcement, which also encouraged the
development of 3-in-1 pills, five brand-name companies quickly said they would
discuss collaborating.
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