[e-drug] NYT on WHO ARV list

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E-DRUG: NYT on WHO ARV list
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[copied as fair use; WB]

http://www.nytimes.com/2002/03/21/health/21DRUG.html

New York Times
March 21, 2002

New List of Safe AIDS Drugs, Despite Industry Lobby

By DONALD G. McNEIL Jr.

PARIS, March 20 < In a move that could help bring down the price of AIDS
medicines for poor countries, the World Health Organization today released
its first list of manufacturers of safe AIDS drugs, which included a large
Indian producer of generics and three smaller European ones.

The decision represents a setback for the pharmaceutical multinationals who
want only patent-holders to decide what discounts to offer on their most
expensive and profitable products. The medicines on the list are approved
for United Nations purchase, and it will encourage price competition in
poor
nations by telling health officials which of hundreds of generics suppliers
make safe drugs.

"This is a breakthrough," said William F. Haddad, a generics maker who
helped create the cheaper off-brand industry in the United States in the
1980's. He said it was the first time the World Health Organization "has
had
the nerve to challenge the multinationals by listing generic versions of
drugs that are still on patent."

Dr. Peter Piot, director of the United Nations AIDS agency, said he hoped
the list would help patients "gain greater access to affordable H.I.V.
medicines of good quality."

The list includes 41 different formulations of drugs, among them 11
antiretroviral drugs and five drugs for infections that often accompany
AIDS. Of the total, 26 come from major manufacturers: GlaxoSmithKline,
Bristol-Myers Squibb Company, Roche Holding, and Abbott Laboratories.

But 10 were from Cipla Ltd., the generic drug maker based in Bombay, India,
that was the first to try breaking Western patent monopolies in February
2001 by offering AIDS therapy for $350 a year to charities and African
governments.

Before that, AIDS treatment in Africa generally cost the same as it did in
the West, $10,000 or more. Only a handful of countries had negotiated
prices
in the range of $1,000 a year after lengthy negotiations with the
patent-holders, who sometimes required them to keep the lower prices a
secret.

"I am delighted," said Dr. Yusuf K. Hamied, the chairman of Cipla. "This
proves that we adhere to good manufacturing practices on a par with other
companies. It says Cipla is kosher, so now the multinationals can't throw
at
us what they have said: `They're Indian, they're Third World, the quality
might be iffy.' "

Cipla products that the World Health Organization accepted include the
antiretrovirals nevirapine, zidovudine, better known as AZT, and
lamivudine,
better known as 3TC. These three drugs make up one common AIDS cocktail.
The
health organization also accepted Cipla's acyclovir for shingles
infections,
ciprofloxacin for bacterial infections, and vinblastine and vincristine
sulfate for Kaposi's sarcoma, a skin cancer.

India recognizes patents on drug-making processes, not on products, so
Cipla
has a legal right there to make hundreds of chemicals made in the West as
long as it makes them using slightly different steps.

The International Federation of Pharmaceutical Manufacturers in Geneva,
which lobbies on behalf of the multinational drug companies, issued a
statement saying "it would be unfortunate if the current plague of
substandard and counterfeit medicines spread" because generics makers were
on the health organization's list.

Asked if the industry group was questioning the performance of the World
Health Organization inspectors, Eric Noerenberg, the federation's director
of intellectual property, said it was not. But he said he thought approved
factories had been asked only to meet their own countries' standards. When
told that the health organization said it was applying international
standards, Mr. Noerenberg said, "It remains to be seen what will be
supplied. We're interested."

Poor countries and medical charities, like Doctors Without Borders, are
always searching for cheaper drugs, but often lack the money and expertise
to inspect distant foreign factories.

Mr. Haddad said Latin American and African nations often ask him for help.
He said he would write to their ambassadors immediately about the new list.

The health organization began accepting applications for the list a year
ago, and teams of United Nations inspectors spent up to two weeks at each
factory, said Dr. Jonathan D. Quick, the health organization's director of
essential drugs policy.

Dr. Hamied of Cipla said his factories have passed 22 United States Food
and
Drug Administration inspections for generics made for the American market,
so he was not surprised that he passed the United Nations scrutiny.

An Indian competitor, Ranbaxy Laboratories Ltd., did not make the list. It
makes a three-antiretroviral combination that it offers for as little $295
a
year to customers with 5,000 or more AIDS patients.

A spokesman for Ranbaxy, Paresh Chaudhary, said the company is not yet
ready
to export, but hopes its factory in Dewas will pass muster in a World
Health
Organization inspection in April. The Dewas antibiotic production lines
have
already passed inspections by the United States drug agency, he said.

Up to 100 more applications are awaiting approval. The World Health
Organization asked for applications for 16 antiretrovirals that attack the
AIDS virus itself and 24 drugs for other conditions that attack the
weakened
immune systems of AIDS patients.

Dr. Bernard Pecoul, director of a campaign by Doctors Without Borders to
lower drug prices, said he was "totally supportive" of inspections by the
health organization. Of the list he said, "Theoretically, it's excellent
because it creates competition."

But he expressed frustration that some important drugs were missing. There
was not a single approved supplier for fluconazole or other antifungals
that
suppress cryptococcal meningitis, which kills AIDS patients after agonizing
headaches, and thrush, which makes eating so painful that patients can
starve to death.

Several antiretrovirals were missing from the World Health Organization
list, "and for others, there is only one source, the patent manufacturer,"
Dr. Pecoul said. "But, hopefully, W.H.O. will go on."

For other drugs, multiple suppliers are listed. Approved makers of AZT
included GlaxoSmithKline, the world's largest pharmaceutical company, which
holds the patent in most Western countries. Also listed were Cipla and
Combino Pharm, a six-year-old Spanish generics maker that supplies AZT to
Gabon, the Ivory Coast and Tunisia and has a contract with Doctors Without
Borders.

"I won't say we don't mind that. We always defend our patents," a
GlaxoSmithKline spokesman, Adam Chandler, said. "But in this case, the
W.H.O. made the decision and we've got to abide by it. We believe the way
to
do this is to negotiate arrangements with governments and employers in the
developing world, and in poorer countries we've said we will supply at
cost."

For ciprofloxacin, the antibiotic whose patent status and high price became
an issue during last year's anthrax scare, the patent owner, Bayer, is not
on the list as a safe supplier for AIDS-related infections. But Cipla and a
Spanish generics company, Laboratorios Cinfa S.A., are. Dr. Quick of the
health organization declined to say why any particular company was not on
the initial list, but said they might simply not have applied yet.

He said that whether a drug was a patented or generic version was "never a
question." In soliciting applications, the health organization had decided
to inspect "any company that was legally registered in its own country."


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