[Kabar-indonesia] 100 kids go blind in Philippines every week [+NYT in India]

[JoyoNews at aol.com]

also: NYT in India: A Small Charity Takes Lead in Fighting a Disease 

Agence France-Presse
August 1, 2006

100 kids go blind in Philippines every week
 
Every week around 100 Filipino children go blind, mostly due to preventable 
diseases, the health department has said.

"Blindness affects close to half a million people in the country and about a 
hundred Filipino children lose their eyesight every week," Health Secretary 
Francisco Duque said in a statement marking "sight-saving month".

The World Health Organization had recently raised its concern over the 
problem, 
he added.

Duque said that more than 450,000 people in the Philippines are blind, with 
90 percent of them from the poor and 62 percent of these cases due to cataracts.

Among the children, the causes of blindness are poor nutrition, measles and 
premature birth which are all preventable if treated in time.

"With early detection and treatment we know that we could save a lot of 
people 
from losing their sight as well as from disability and poverty," Duque said.

A great majority of Filipinos particularly in the rural areas still have no 
access 
to eye clinics or ophthalmologists due to the high cost of medicines, he 
acknowledged.

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The New York Times
July 31, 2006

A Small Charity Takes Lead in Fighting a Disease 

By STEPHANIE STROM

photo: A boy in Patepur, India, was examined recently by Dr. Syed 
Misbah Hassan for the telltale signs of black fever: a swollen spleen 
and liver. Scott Eells for The New York Times

PATNA, India  -- The drug that could have cured Munia Devi through a series 
of cheap injections was identified decades ago but then died in the research 
pipeline because there was no profit in it. 

So Mrs. Devi lay limp in a hospital bed here recently, her spleen and liver 
bulging from under her rib cage as a bilious yellow liquid dripped into her 
thin arm. The treatment she was receiving can be toxic, and it costs $500. But it 
was her best hope to cure black fever, a disease known locally as kala azar, 
which kills an estimated half-million people worldwide each year, almost all 
of them poor like Mrs. Devi. 

Soon, however, all that may change. A small charity based in San Francisco 
has conducted the medical trials needed to prove that the drug is safe and 
effective. Now it is on the verge of getting final approval from the Indian 
government. A course of treatment with the drug is expected to cost just $10, and 
experts say it could virtually eliminate the disease. 

If approval is granted as expected this fall, it will be the first time a 
charity has succeeded in ushering a drug to market.

This novel way of helping people whose needs have not been met by for-profit 
pharmaceutical companies is gaining traction. Several partnerships are working 
to develop drugs to fight neglected diseases, underwritten by the Bill and 
Melinda Gates Foundation, Doctors Without Borders and other groups. Another 
nonprofit agency, the Aeras Global TB Vaccine Foundation, is searching for a means 
to prevent tuberculosis. 

For its first project, the San Francisco charity, the Institute for OneWorld 
Health, focused on reclaiming the all but abandoned drug, paromomycin, which 
research found promising in the 1960’s. 

That was the easy part. Its hurdles lay elsewhere. The Internal Revenue 
Service at first denied the charity nonprofit status, concerned that it looked too 
much like a for-profit enterprise. The World Health Organization, which 
controlled the drug, was reluctant to hand over the data needed for further 
development. And OneWorld Health had to set up clinical trials matching United States 
and European standards in one of the poorest parts of the world.

photo: Dr. C. P. Thakur, a former Indian health minister, and Dr. Victoria 
Hale, co-founder of OneWorld Health, at a clinic in Patna, India. Scott 
Eells for The New York Times

Nor was it obvious where the money would come from. The idea of a nonprofit 
drug company struck many as folly when Dr. Victoria Hale, a former Genentech 
executive and Food and Drug Administration official, founded OneWorld Health in 
2001. So Dr. Hale and her husband started the project using their own money, 
though they have since won support from the Gates foundation, among others. 

“My colleagues and mentors in the pharmaceuticals industry told me it was a 
wild idea, that it would never work out, that I was jeopardizing my 
reputation,” Dr. Hale said. “I started this organization knowing our first project had to 
be a winner or we wouldn’t survive.”

An Ambitious Goal

Dr. Hale hopes to stamp out black fever eventually, a goal that many doctors 
regard as impossible. “The last disease we truly eradicated was smallpox,” 
she said. “There’s no urgency to eradicating diseases anymore. Why not?”

Black fever is the second-largest parasitic killer in the world after 
malaria. It is spread by sand flies, and Banthu, the squalid village about an hour’s 
drive from here that Mrs. Devi calls home, is an ideal breeding ground for 
them. 

The flies multiply in the cow dung that Mrs. Devi uses as fuel for cooking. 
They relish the sap in the banana groves and bamboo stands, and they thrive in 
the thatch used to make the tiny houses. Flies that have bitten infected 
humans transmit the disease when they bite another person. Smaller than mosquitoes, 
they can pass through most netting. 

Roughly 90 percent of black fever cases worldwide are found here in Bihar 
State in India and in Bangladesh, Nepal, Sudan and northeastern Brazil.

Mrs. Devi’s daughter was the first in the family to contract the disease, and 
she died from it. Then Mrs. Devi’s youngest son, Rajesh, got it, and she 
brought him to the Rajendra Memorial Research Institute of Medical Science here, 
where he was treated and recovered. Now she, too, is receiving treatment. 

It is at the Rajendra Institute, a government research facility, that 
OneWorld Health set up one of the trials needed to make paromomycin widely available.

Many Early Battles

Dr. Hale first set her sights on the drug after she attended a conference in 
Belgium in 1999, where Dr. Shyam Sundar, an expert on black fever, was railing 
against the world’s failure to fight the disease.

“The tragedy, maybe even the crime, is that we have known that this drug is 
an effective treatment for kala azar since the 1960’s,” said Dr. Sundar, whose 
free clinic in Muzaffarpur was also a site for a trial by OneWorld Health. 
“We could do something, but we were choosing not to.” 

After visiting Dr. Sundar’s clinic in 2000, Dr. Hale, who was doing 
consulting work at the time, hired a law firm to help her get the tax exemption 
necessary to create a nonprofit drug company. The I.R.S. turned her down three times 
over 10 months, suspicious that her plan was a scheme by the drug industry to 
shelter profits. The tax agency challenged her to find an example of an 
existing charity that mirrored a for-profit business. 

“It took me five days, and then at dinner, it hit me: N.P.R. and public 
television,” she said. “They look an awful lot like for-profit radio and 
television, but they serve a different audience with programs that their for-profit 
counterparts don’t provide because they can’t profit from them.” 

Two weeks later, OneWorld Health received I.R.S. approval and set out to 
tackle black fever.

The immediate challenge was financing. For a time, OneWorld Health survived 
on the largesse of Dr. Hale and her husband, Dr. Ahvie Herskowitz. They put up 
$100,000, signed a $315,000 promissory note, used the ground floor of their 
house as offices, and worked without pay for two years. 

The Gates foundation, which at the time was primarily underwriting vaccines 
and other preventive strategies, eventually offered a grant of $4.2 million 
that grew to $47.2 million for the development of paromomycin. Dr. Hale also got 
help from others, including the Skoll Foundation, which has provided financing 
to underwrite salaries for new senior executives. 

An Abandoned Drug

An initial, formal test of paromomycin, an antibiotic sold in some countries 
as an oral treatment for diarrhea and as a topical treatment for cutaneous 
leishmaniasis, which causes lesions, was done in the late 1980’s in Africa, two 
decades after it was identified as a simple, cheap, effective cure for black 
fever. 

Through a series of company mergers it was consigned to the corporate shelf 
and forgotten, ending up with the World Health Organization, which lacked the 
money to develop it beyond the Phase II clinical trials.

But negotiations with the World Health Organization to hand over the data 
that would allow OneWorld Health to organize the Phase III clinical trials 
necessary for regulatory approval dragged on for almost two years. At the time, the 
W.H.O was developing another drug for black fever with Zentaris, a large 
pharmaceutical company, and the Indian government. That drug, miltefosine, has the 
advantage of being an oral treatment, while paromomycin is administered by 
injection.

But miltefosine, an anticancer drug, also has drawbacks. In trials, it caused 
gastrointestinal problems in one-third of the patients. And patients must be 
strictly supervised to ensure that they take the full 21-day course of 
treatment and that women of child-bearing age are using birth control. By contrast, 
paromomycin has shown almost no side effects in trials. 

With a price of $100 to $200 a treatment, miltefosine is out of reach for 
most patients and government purchasing programs.

Dr. T. K. Jha, a specialist in black fever who oversaw one of the OneWorld 
Health trials, said the W.H.O. wanted to make sure miltefosine made it onto the 
market before handing over its data on paromomycin. “Commerce got in the 
way,” Dr. Jha said. 

But Dr. Robert G. Ridley, director of the W.H.O.’s special program for 
research and training in tropical diseases, disputed that. Dr. Ridley wrote in an 
e-mail message that the “time lag” had to do with getting financing from the 
Gates foundation and the process of negotiating an agreement with OneWorld 
Health. 

The subject of the commercial aspects of drugs is a difficult one for 
OneWorld Health, which is careful to avoid criticism of its for-profit cousins, as 
well as competition with them. 

“We look a lot like each other,” Dr. Herskowitz said. “But we fill a gap 
pharma companies cannot because they have to make a profit.”

But given the choice of paying more than $100 for Zentaris’s miltefosine or 
$10 for paromomycin, governments and most patients will no doubt choose the 
cheaper drug. 

OneWorld Health does not intend to gain income from the drug. It has given a 
license to Gland Pharma, an Indian drug company that has agreed to manufacture 
the drug and sell it at cost when it is approved. But Dr. Hale can foresee a 
time when, say, a drug OneWorld Health hopes to develop to treat childhood 
diarrhea could be sold to travelers by a for-profit drug maker in exchange for 
royalties that would help sustain her organization’s charitable work. 

Still More Difficulties

Approval of paromomycin will not end OneWorld Health’s challenges. 
Distribution looms as the next hurdle. 

In Patepur, a somewhat more prosperous village than Mrs. Devi’s, Dr. Syed 
Misbah Hassan, a clinical research coordinator for OneWorld Health, diagnosed 
kala azar in one boy after another. 

Dilip Manjhi, who is about 15, lay listless on a string bed as Dr. Hassan 
examined his abdomen for the telltale signs of the disease, a swollen spleen and 
liver. Dilip’s spleen extended eight centimeters below his rib cage and was 
rock hard. His liver protruded three centimeters below his ribs. 

Getting paromomycin to remote villages like Patepur at the end of 
pothole-pocked roads will be difficult. Dr. Hale is trying to enlist a British nonprofit 
group, Riders for Health, to help. The group uses motorcycles to connect poor 
people to medical services. In Zimbabwe, for instance, it has taken pregnant 
women in need of Caesarean sections to hospitals. 

“My thinking,” Dr. Hale said, “is that we could equip a motorcycle with a 
cooler to transport the drug and equip the driver to give the injections and 
maintain records.”

But first, the Bihar State government and India’s central government must 
create a system that encompasses diagnosing the disease, buying and administering 
the drug, keeping records and spraying to reduce the sand fly population.

Some experts wonder whether the government has the will to create such a 
system, when hundreds of thousands of Indian children die each year of measles, 
which can be prevented with a 15-cent vaccine. But Dr. C. P. Thakur, a former 
Indian health minister who oversaw a OneWorld Health trial of paromomycin, noted 
that black fever was one of five insect-borne diseases the Indian government 
had pledged to eliminate. 

India has also signed an agreement with the governments of Nepal and 
Bangladesh to eradicate the disease, and the Bihar State government has shown a 
willingness to work with OneWorld Health. 

“The government will be the biggest challenge,” Dr. Thakur said. “But I 
believe the opportunities to end this disease have never been better, and also 
that the government’s will has never been stronger.”

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Joyo Indonesia News Service
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