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E-DRUG: WP Editorial and Reuters on US AIDS Plan and Generics
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[copied as fair use; WB]
Washington Post
Editorial Page
March 26, 2004
8,000 Deaths a Day
THE BUSH administration deserves credit for invigorating the fight
against the global AIDS pandemic, which inflicted some 5 million new HIV
infections last year. But its strategy has two defects. Not enough of the
expanded AIDS budget is going through the Global Fund to Fight AIDS,
Tuberculosis and Malaria, which was up and running before the U.S. program
and has a track record of disbursing money quickly. At the same time, the
administration is taking a tortuous approach to AIDS treatment. Rather than
back the use of unpatented "generic" medicines made by foreigners, it
appears keen to find excuses to procure patented drugs from U.S. firms.
Generic AIDS drugs cost perhaps a quarter as much as patented rivals,
even after the latter have been discounted, according to the medical
charity Medecins Sans Frontieres. Using the expensive option, and therefore
treating fewer patients, is perverse, given the scale of the pandemic. Of
the 40 million people living with HIV, some 6 million are considered to be
in urgent need of treatment, but only 400,000 are receiving it. At $500 per
patient per year, which is the low end of the range for patented medicines,
it would cost nearly $3 billion per year to buy drugs for all who need
them, and billions more to deliver the medicine and monitor treatment. And
that's before counting the cost of spreading safe-sex or abstinence
messages, not to mention the cost of caring for AIDS orphans. In his State
of the Union address last year, President Bush promised to boost spending
on international AIDS to $3 billion annually. That's a huge increase, but
not enough to cover drugs that are four times the price of generics.
Generic drugs are also easier to administer. Because they operate outside
U.S. intellectual-property laws, makers of generic drugs can copy the
ingredients of patented AIDS drugs and combine them into a single pill. For
people with HIV, this can mean taking two pills a day instead of a cocktail
of six patented tablets. The simplification makes it easier for patients to
take the pills as they are supposed to, reducing the speed at which drug
resistance develops.
The administration says that it is concerned that generic drugs may not
be safe and that it wants to procure drugs reviewed by a stringent
regulatory agency such as the Food and Drug Administration. Generic
versions of AIDS drugs are barred from the United States by patent law, so
they do not have FDA certification. However, doctors at the World Health
Organization have published a list of generic drug makers that produce the
drugs to acceptable standards, and other donors have sufficient confidence
to buy and distribute their tablets. If the administration does not trust
the WHO, it should dispatch inspectors immediately to generics factories.
But instead, it is sponsoring a conference next week to discuss principles
on which combination pills should be evaluated. This seems like a
digression. Meanwhile AIDS is killing more than 8,000 people a day.
Reuters
Groups Accuse U.S. of Pushing Brand-Name HIV Drugs
Thu Mar 25, 2004 09:42 PM ET
By Maggie Fox, Health and Science Correspondent
WASHINGTON (Reuters) - AIDS activist groups teamed up with the
international relief group Doctors Without Borders on Thursday to accuse
the U.S. government of pushing expensive, brand-name HIV drugs in poor
countries.
The groups accused the United States of supporting the for-profit
pharmaceutical giants that make the drugs, instead of joining the World
Health Organization and other groups in distributing much cheaper and
easier-to-take generics.
The U.S. government has said it is concerned that the generics, which often
mix several drugs in one pill, may not be safe or completely effective in
the long term.
At issue are the drug cocktails that allow patients infected with the AIDS
virus to lead healthy lives, as long as they can juggle the complicated
drug regimens, which often have serious side-effects.
These cocktails, called highly active antiretroviral therapy or HAART, are
very expensive. But the World Health Organization and many groups have
negotiated cheaper prices from some companies that make them. They have
also bought and are distributing cheap copycat versions made by two Indian
companies -- Cipla Ltd., and Ranbaxy Laboratories Ltd.
WHO, U.S. officials, scientists and experts are expected to discuss the
issue at a meeting in Botswana next week.
"The generic drugs opposed by the United States allow people with HIV/AIDS
to take only two pills a day, and they are much cheaper than the equivalent
brand-name drugs," AIDS activist group Human Rights Watch said in a
statement.
The cheapest cocktail costs $140 per year per patient as opposed to the
brand-name equivalent which costs $600 a year, the group said. The groups
say generics are safe and work well.
"WHO has made enormous headway in verifying the quality of generic AIDS
drugs that are the only hope for millions of low-income people with AIDS,"
said Joanne Csete, director of the HIV/AIDS Program at Human Rights Watch.
GENERICS ALREADY WIDELY USED
"But to protect brand-name pharmaceutical interests, the United States may
dash that hope."
Doctors Without Borders, or as it is more commonly known, Medecins Sans
Frontieres, said it was widely distributing the disputed generics.
"MSF is currently providing antiretroviral therapy to more than 11,000
people living with HIV/AIDS in over 20 countries in Africa, Asia, Latin
America, and Eastern Europe, and expects the total number of patients on
(HAART) to reach 25,000 in 25 countries by the end of 2004," the group
wrote in a letter to U.S. Global AIDS Coordinator Randall Tobias and Health
and Human Servoices Secretary Tommy Thompson.
But Tobias, a former chairman of Eli Lilly and Co., has said he is
concerned about the drugs' safety.
"I think it is very, very important that we move rapidly but with certainty
that we're not endangering people's lives," Tobias told a hearing before a
House Appropriations subcommittee last week.
Sharonann Lynch, Director of international policy for Health GAP, another
AIDS activist group, disputed Tobias' intentions. "This is industry
protection and politics masquerading as science," she said in a statement.
The dispute echoes a fight that ended in 2000 when former president Bill
Clinton's administration backed down from a controversial plan to block
generic HIV drugs.
Drug companies had argued that generics violated patent protections and
compromised future research.
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