[e-drug] drug companies agree to stop single artemisinine?

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: drug companies agree to stop single artemisinine?
---------------------------------------------------------
[This article, posted on AHILA-NET, crossposted from DRUGINFO, discusses the war of Dr Kochi, the new WHO malaria boss, against malaria and companies selling single artemisinine. Can E-druggers confirm that single products are disappearing from the shelves? WB]

June 27, 2006
Scientist at Work | Dr. Arata Kochi
An Iron Fist Joins the Malaria Wars
By DONALD G. McNEIL Jr.

Correction Appended

In the war on malaria, silver bullets inevitably morph into rubber
ones: the parasite and its mosquitoes develop resistance to every
miracle drug and pesticide that comes along.

Now the war has a new general, with a new tactic.

Instead of simply loading the latest silver cartridge ?
artemisinin, the Chinese anti-malaria drug ? Dr. Arata Kochi, the
new chief of the World Health Organization's global malaria
program, has turned an enfilading fire on the whole field: the
drug-makers, the net-makers, the scientists and even the donors
and the suffering countries they try to help.

"The malaria community hates me," Dr. Kochi said in an interview
in the W.H.O.'s small Manhattan office. "I said, basically, 'You
are stupid.' Their science is very weak. The community is small
and inward-looking and fighting each other."

Dr. Kochi, who in the past ran the agency's Stop TB initiative,
has never been known for his diplomatic skills. A 57-year-old
graduate of Japanese medical schools and the Harvard School of
Public Health, he ruled the Stop TB campaign with an iron fist,
colleagues say, and by his own admission, so alienated the
Rockefeller Foundation and other partners that he was ultimately
forced out of the job.

But even his critics admit that he was a decisive strategist and
that the tuberculosis campaign was one of most effective the
W.H.O. has run.

"His tactic really worked," said Dr. Jacob Kumaresan, a former
chief of the Stop TB Partnership in Geneva and now the president
of the International Trachoma Initiative. "With his staff, he's
pretty strict ? those who don't produce results will be laid off.
But he's very bold, and I think he's on the right track."

The tuberculosis world, Dr. Kochi said, used to be just as
fragmented and hostile as the malaria field is now. Then, in the
early 1990's, an explosion of multidrug-resistant cases everywhere
from New York City to Peru to Siberia forced the advent of a new
paradigm: four-drug cocktails, taken daily for six months, always
under the eye of a nurse or someone else appointed to oversee
treatment, even an imam or a faith-healer.

Under Dr. Kochi's leadership, countries were urged to diagnose and
treat in standard ways (sputum smears instead of chest X-rays, for
example, or four cheap antibiotics instead of exotic drugs and
pulmonary surgery). Drug companies were asked to standardize
products so each patient could be handed a box with six months'
worth of pills. As a result, some partners, like tuberculosis
hospitals and makers of the old BCG vaccine, were very unhappy.

Malaria, he said, will need a similar shift, because everything is
wrong with the efforts to fight it: lax counting of cases, mixed
messages on which medicines to use, counterfeit drugs, expensive
consultants, slothful national governments, weak international
leadership.

The war on malaria - in theory more winnable than the war on AIDS
because a cure exists - is instead being lost, Dr. Kochi says. In
the 1960's, malaria was considered potentially eradicable: DDT and
chloroquine, a synthetic form of quinine, had been invented, and
much of the tropics were under colonial rulers who, whatever their
other faults, were good at killing mosquitoes.

Since then, DDT has been withdrawn because of its environmental
damage, chloroquine and its successor, Fansidar, have become all
but useless and the health systems in most of Africa and parts of
Asia and Latin America have collapsed.

The body count is now at least one million a year, most of them
children and pregnant women. There are 350 million cases of
malaria each year; people may catch it repeatedly in hot seasons
and be too weak to work, so it cripples rural economies.

Dr. Lee Jong Wook, the W.H.O. secretary general who died of a
stroke last month on the eve of the organization's annual
assembly, was about to concede as much.

"Clearly, things are not going well with malaria control," the
draft of the speech he was to give to the world's health ministers
said. "We accept our responsibility for this. Now is not the time
for shyness. W.H.O. will exercise much greater leadership in
malaria control."

Dr. Kochi, who had been appointed by Dr. Lee six months earlier,
was already proving combative.

In January, he attacked the drug industry, naming 18 companies
that were selling artemisinin in single-pill form, and giving them
90 days to stop. Monotherapy encourages resistance, and if
artemisinin was lost, he said, "it will be at least 10 years
before a drug that good is discovered ? basically, we're dead."

If the companies refused to conform, he said, he would disrupt
sales of all their drugs by getting the W.H.O. to refuse to
certify any drug they made for poor countries.

Executives spluttered, saying they would not be blackmailed, that
there was no documented resistance to artemisinin yet and that
they had to supply whatever African governments asked for or their
rivals would. Dr. Kochi promptly compared that to supplying heroin
addicts with whatever they asked for.

"He's a breath of fresh air," said Amir Attaran, a biologist and
lawyer at the University of Ottawa who has accused the W.H.O., the
World Bank and the Global Fund to Fight Aids, TB and Malaria of
squandering millions on old, useless drugs.

"You need to talk tough," he added. "There has been absolute
incoherence on fundamental issues."

Dr. Attaran, a longtime W.H.O. critic, also praised Dr. Kochi for
being one of the first at the agency to realize that AIDS could be
treated in Africa with standard regimens of cheap drugs and simple
blood tests, instead of Western-level care costing tens of
thousands of dollars a year.

In the 90 days before his deadline expired, Dr. Kochi met with
generic drug-makers, many of whom are trying to shift from
duplicating Western drugs to researching new ones. He told them,
he said, that they would face a public relations fiasco if they
made malaria worse.

Caroline Jansen, a member of the family that owns Dafra Pharma, a
Belgian company that supplies about 25 percent of Africa's private
market for malaria drugs, said her company had agreed to stop
selling monotherapy and was developing pills mixing artemisinin
with lumefantrine, amodiaquine and other drugs.

Told that Dr. Kochi called Dafra "bad guys" and that he was
waiting to confirm their compliance because he didn't "trust
them," she expressed surprise, saying: "I understand he had the
same attitude about TB ? he's blunt and not very nice. But using a
strong hand is probably the best way to get this thing done."

When the 90 days were up, Dr. Kochi said all the big companies had
changed their policies. "That war is over," he boasted. "We won."

But he had also learned of the existence of 22 more small
companies and had started warning them: "Don't come in the back
door and try to fill the gap."

Whether he can enforce that remains to be seen. The malaria market
in poor countries is a mess: many tiny shops sell pills without
prescriptions, and counterfeits are common. Chloroquine is still
widely sold because it reduces fevers as aspirin does; patients
briefly feel better, but then die of anemia.

In April, Dr. Kochi targeted the Global Fund, through which rich
countries buy AIDS, malaria and TB drugs for poor ones. He accused
it of ignoring W.H.O. rules forbidding artemisinin monotherapy and
buying from suppliers that fail W.H.O. standards. In May, he
displayed the reply he got, which he dismissed as "excuses ? a lot
of 'but, but, but ' " In June, he announced that the fund had
changed it policies.

Next he wants to change other weapons in the arsenal.

For example, he wants to standardize mosquito nets so that,
instead of a welter of competing styles that must be home-dunked
in pesticide, a few makers of factory-coated nets, which kill
insects for years longer, are left to compete on price. He
dismisses "social marketing," in which nets are branded and sold
cheaply instead of being given away, as with an early Bush
administration policy that flopped. And, despite the objections of
environmentalists, he wants DDT sprayed inside huts to kill
mosquitoes where they rest on walls as they wait for dark.

He is lobbying the governments of poor countries, asking them to
ban monotherapy, and lobbying Congress for more aid.

Senator Tom Coburn, a conservative Oklahoma Republican who took up
malaria as a cause and has demanded that taxpayer dollars be spent
on drugs and nets rather than consultants, said he was "very
impressed" on meeting Dr. Kochi.

"He's not abrasive compared to me," Senator Coburn, who is also a
doctor, said. "A million people are going to die this year. What's
more important ? having a politically correct strategy or a public
health strategy that works?"

Dr. Kochi got his start in public health in 1975 when the Japanese
Health Ministry asked for a volunteer to run a tuberculosis
project in Afghanistan, and later worked in Myanmar. For
interviews, he dresses informally: tie, jeans, no public-relations
assistant. His biggest drawback may be his accent ? he can make an
off-the-cuff impolitic crack in idiomatic English, but then has to
go through the agony of repeating it three times to be
understood.

He did not want the malaria post, he said. He was "semi-retired
and playing a lot of golf" as a W.H.O. adviser in New York, and he
had a good reputation for his tuberculosis work.

"Now, if I fail in malaria," he said, "people only remember
that."

Dr. Lee, he said, gave him two orders: "Fix malaria, and don't
create a Unmalaria." (The second reference was a joking dig at
Unaids, the United Nations agency that is W.H.O.'s partner in
fighting Aids and rival for funds, experts and glory.)

With Dr. Lee's sudden death, Dr. Kochi was asked, can he keep his
job despite his sometimes prickly personality and the usual W.H.O.
infighting?

"We'll see," he said. "It will take till November to choose a new
director. But I don't pick fights I can't win. Maybe if I achieve
results, they'll let me stay. Or let me go back to playing golf."

Correction: June 29, 2006

An article in Science Times on Tuesday, profiling Dr. Arata Kochi,
the new chief of the World Health Organization's campaign against
malaria, referred imprecisely to the pesticide DDT, which can kill
the mosquitoes that spread the disease. Its use has been banned in
many countries for environmental reasons; it has not been
withdrawn entirely.