[Ip-health] The Next AIDS: Crisis Why don't the latest AIDS drugs get to dying patients in Africa?

[Judit Rius Sanjuan]

http://www.forbes.com/forbes/2009/1228/health-gilead-glaxosmithkline-hiv-ne=
xt-aids-crisis.html

The Next AIDS Crisis
Why don't the latest AIDS drugs get to dying patients in Africa?
Megha Bahree and Matthew Herper, 12.10.09, 03:00 PM EST
Forbes Magazine
M=E9decins Sans Fronti=E8res' clinics in Khayelitsha, South Africa are
both a success story in the global battle against AIDS and a harbinger
of problems to come. This giant shantytown of corrugated metal shacks
25 miles outside of Cape Town was one of the first poor areas of South
Africa to receive lifesaving AIDS drugs, thanks to a program set up in
2001 by the French aid group to distribute free antiviral medicines.

But of the 13,000 patients that MSF's clinics treat here, 2,000 have
now become resistant to the first-line regimen of antiviral drugs, a
generic combo based on the old drug D4T, says Eric Goemaere, the MSF
doctor who runs the clinics. Sixty of his patients are also resistant
to the only other drug combo available, based on another old generic
drug. One is a 27-year-old woman who got the disease after being raped
by her aunt's boyfriend when she was 13. "I had to tell her there was
no option for her anymore," says Goemaere. He gives her 18 months to
live.

In the U.S. or Europe there would be plenty of other medicines for his
patients to take, including Merck's new Isentress, which is not even
approved in South Africa yet, and Gilead Sciences ( GILD - news -
people )' Truvada. But not in Khayelitsha.

Africa is home to 22 million of the 33 million people worldwide who
are infected with the human immunodeficiency virus. Thanks to aid
efforts, cheap Indian generics and discounted drugs, 2.9 million
people with AIDS in sub-Saharan Africa are on antiviral therapy. But
the latest drugs are just too expensive, even at heavily discounted
prices, Goemaere says. He predicts the number of resistant cases in
Africa is about to explode.

The two drug regimens available to Goemaere are barely used in the
U.S. or Europe because they have serious side effects and must be
taken multiple times a day. But they are cheap, costing under $100 per
patient per year. By contrast, Truvada, the world's bestselling HIV
pill, costs $12,000 annually in the U.S. Gilead sells Truvada to poor
nations for $315 a year, a price at which it makes no profit but which
MSF still cannot afford. Generic-drug makers to which Gilead has
licensed its patent will sell aid workers a similar pill for $120 a
year, still more than Goemaere can afford.

MSF and Unitaid, an international drug-purchasing agency in Geneva,
are pushing a simple solution that could allow African patients to get
Truvada and a third drug for only $86 a year, according to a Boston
University analysis. The concept is to have companies like Merck ( MRK
- news - people ), Abbott Laboratories ( ABT - news - people ) and
GlaxoSmithkline ( GSK - news - people ) put patents for 19 HIV drugs
into a patent pool that could be licensed to select generic-drug
makers. The generic companies would manufacture copycats, pay the
inventors a small royalty and sell them only in agreedupon developing
countries. Competition among the generic companies, who are expert at
producing drugs on the cheap, would cause prices to fall sharply, yet
the inventors would still get some incremental revenue out of Africa.
"The patent holders would get the royalty, and we'd get the drugs,"
says Goemaere.

It sounds straightforward, but the politics are anything but. Three
years after Unitaid broached the idea, it says that so far only Gilead
Sciences, Johnson & Johnson ( JNJ - news - people ) and Merck are
"actively engaged" in negotiating with Unitaid over the patent pool.
Since February Unitaid has been lobbying 9 other drugmakers and 17
generics manufacturers to sit down and discuss the idea. Unitaid met
once with Abbott Laboratories, but it took eight months to schedule a
second meeting. Abbott says it is open to discussions. GlaxoSmithkline
says it has met several times with Unitaid to hear its ideas. Bristol-
Myers Squibb ( BMY - news - people ) says the patent pool could remove
incentives for innovation. But Lisa Haile, a drug patent lawyer at DLA
Piper, says the pool won't hurt earnings. "The good will outweigh the
bad."

Getting many different drugs into the pool is essential, because in
order to control HIV (and keep resistant strains from erupting)
patients must take three medicines at once. The big stumbling block is
how many countries to include. AIDS activists and generic-drug makers
want to include in the drug discount regime as many countries as
possible. But a patent pool that covers China, Brazil or Thailand
could be a deal breaker for branded drug makers. The matter is likely
to come to a head at a mid-December meeting of Unitaid's board.

Patent pools have long been used by technology companies to cross-
license products. James Love, of Knowledge Ecology International, a
think tank, realized that the idea could get more AIDS drugs to Africa
and convinced Unitaid to push the concept when it formed in 2006.

The patent pool got an unlikely boost last year from Gilead Sciences,
the biggest maker of AIDS drugs in the U.S. In 2007 Love filed a
complaint with the Federal Trade Commission contending that Gilead was
violating antitrust laws by licensing its drugs only to select
companies in the developing world. As luck had it, a few months later
he wound up sitting across from Gilead chief counsel Gregg Alton at a
dinner party held by the charity Oxfam. The two men hit it off and
started talking at length about the patent pool idea. "He was not
being a jerk," says Love. "I was struck by the fact that he didn't
take it personally that I filed an antitrust complaint against his
company."

Alton, who is charged with getting Gilead's drugs to the developing
world, realized that the pool had advantages for Gilead. It would mean
less hassle and expense than negotiating licenses for the developing
world with one generics company at a time. In 2008, at an annual
meeting of HIV doctors and drugmakers in Mexico City, Alton spoke up
in favor of the Unitaid patent pool. His argument was so convincing
that representatives from J&J and Merck stood up and expressed general
support for the idea.

Unitaid hopes to get the rest of the companies to the bargaining table
and work out a preliminary agreement within a year. "We're negotiating
with monopolies, and that's not so easy," says Ellen 't Hoen,
Unitaid's senior advisor on intellectual property. Some are skeptical.
"Unitaid has been talking about the patent pool for years, and it
hasn't moved a step forward," says Y.K. Hamied, chairman of the Indian
generic drug company Cipla. Brand companies reflexively delay
generics, he says. Gilead's Alton worries that MSF will push for more
than he can deliver.

Eric Goemaere hopes the patent pool will work out so he doesn't have
to watch his patients in Khayelitsha die. In the U.S. HIV patients
have a 69-year life expectancy. But his patients in Khayelitsha are
running out of options after only 8 years on therapy. "I don't accept
the principle of double standards," he says. "If it's possible to get
69 years of life in the U.S., it should be possible to get something
comparable in South Africa."