W.H.O. MOVES TO MAKE AIDS DRUGS MORE ACCESSIBLE TO POOR WORLDWIDE
By Donald McNeil Jr.
New York Times 23 April 2002
Paris -- Helping clear the way for Western-style
AIDS treatment to reach even rural Africa, the World Health
Organization released new guidelines today describing the
drug cocktails that work best and the simplest acceptable
laboratory tests for patients.
The guidelines are meant to show doctors in poor areas how
to prescribe powerful "triple-therapy cocktails" safely.
In addition, the W.H.O. today added 12 antiretroviral drugs
to its essential drugs list to encourage price competition
between patent-based and generic companies and prod the
latter to make more three-drugs-in-one-pill dosages.
The two moves are "vital steps in the battle against the
AIDS pandemic and should encourage both industrialized and
developing country governments to make H.I.V. treatment
more widely available," said Dr. Gro Harlem Brundtland, the
director-general of the health organization.
Carmen Perez, pharmaceutical director for the Doctors
Without Borders campaign to make drugs cheaper, called
today's W.H.O. decision a "very good victory."
The moves "show that treatment can be done," she said. "It
will be difficult, but what can we do about that? There are
40 million infected people out there. There are no excuses.
We're already late."
The health organization's announcement is also meant to
silence several sets of critics: drug industry executives
who have argued that triple therapy is too complex and
dangerous for poor, illiterate patients; AIDS skeptics like
President Thabo Mbeki of South Africa who argue that the
drugs don't work or are toxic; and experts who confuse
public health doctors in poor countries by overwhelming
them with competing drug combinations.
Of the 40 million H.I.V.-positive people in the world,
about 6 million are sick enough to need antiretrovirals
now, the health organization estimates. Less than 5 percent
get them because of the drugs' cost and the costly tests
used in the West to monitor them. Some tests like CD-4 cell
and viral load counts cost up to $1,000 and require
equipment unheard of in rural clinics. The health
organization hopes that, by 2005, if African and Asian
health systems can stand the strain, up to three million
people will be getting treatment.
It recently convened 100 AIDS doctors from 30 countries to
come up with four tiers of minimally acceptable tests, said
Dr. Basil Vareldzis, who helped write the new guidelines.
The "absolute minimum" tier was an H.I.V. test and a
hematocrit, which measures the percentage of red cells in
blood. "If your lab can't do those, you shouldn't be giving
out antiretrovirals," Dr. Vareldzis said. Since AZT, a
common antiretroviral, can cause anemia, "you could run the
risk of killing somebody."
The next "basic" level includes blood tests that require
equipment widely available in most district hospitals, even
those in Africa. The equipment tests white blood cell
counts and does simple liver tests.
The white cell count is a proxy for a CD4 test, which
measures "helper T-cells" that set off immune responses. In
the West, a CD4 count below 200 per cubic millimeter
usually prods a doctor to prescribe antiretrovirals. But
white cell counts move roughly up and down with CD4 levels,
so white blood cell counts below 1,200, plus clinical signs
of AIDS are enough, under the new guidelines, to justify
starting the therapy.
"If someone has night sweats and weight loss and is
definitely H.I.V. positive, you can't ethically deny them
drugs just because you can't do a CD4 test," Dr. Vareldzis
Antiretrovirals can poison the liver, but simple liver
tests plus eyes yellowed by jaundice or tender abdomens
could be proxies for expensive toxicity tests in deciding
whether to change drugs.
The health organization is also listing which drug
cocktails it thinks should be tried first. Essentially, it
suggests a mix of AZT, which is also called zidovudine,
plus 3TC, which is also called lamivudine, plus a third
drug like nevirapine or efavirenz or abacavir, depending on
factors that include whether a patient is pregnant or
hypersensitive to abacavir.
Making this an official recommendation "is a way to avoid
all the waste and confusion and tendency to create
resistance that exists in all the weird combinations that
people came up with before," said Dr. Jonathan Quick, the
health organization's director of essential medicines.
Listing the best drugs encourages makers of generic drugs
to put three drugs in one pill, making it much easier for
patients to take their medicine correctly, he added.
Three-in-one pills aren't made by the pharmaceutical giants
because they would have to share their drug patents, which
might violate antitrust laws.
The additions to the essential drugs list are abacavir,
didanosine, efavirenz, indinavir, lamivudine, lopinavir,
nelfinavir, ritonavir low-dose, saquinavir and stavudine.
Ziduvodine and nevirapine were already on it for
mother-child transmission, but can now be given to adults.
The introduction of triple-therapy in the United States in
1996 led to a 70 percent decline in AIDS deaths.
Dr. Harvey E. Bale Jr., director of the International
Federation of Pharmaceutical Manufacturers Associations,
which represents the major pharmaceutical companies in
talks with the health organization, did not oppose putting
patented drugs on the essential drugs list.
The industry, he said, has recognized the need to get AIDS
drugs to the world's poor quickly and has lowered its
prices until its AIDS drugs are competing with their
generic counterparts. He cautioned that safe three-in-one
pills were difficult to develop and must be thoroughly
tested, and he complained that the health organization had
rushed the guidelines through without its normal period for
On March 20, the organization released its first list of
manufacturers of AIDS drugs whose factories it had
inspected and ruled safe.
In a surprise to advocates for the poor who have called the
organization overcautious and beholden to big drug
companies and the United States, the list included generic
makers from India and elsewhere.
"Countries now have the three bits of information they need
- the names of the drugs, the quality assurance and the
treatment guidelines," Ms. Perez said.