Erradicating Forgotten Diseases

When you hear about diseases being fought to eradicate, you think of the big pharmaceutical industries. Those times are a changin', as this NYTimes piece shows.

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.

The first connection, and this is not uncommon, if there appears to be not enough of a profit a drug is not brought to market by the big pharmaceuticals. This is not to say there aren't any "orphan drugs" on the market, because they are. And they are also predominately, high dollar drugs.

The charity has faced, and is continuing to face obsticles, but not the type you would think.

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.
[...]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.

The next obstacle comes from the World Health Organization:

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.

Working with a large for-profit institution is just so much better, not to mention that coninues to keep needy drugs away from the people that need them the most, the poor.

The next challanges come with setting up government buying programs, distribution, administration (recordkeeping of who got the shot). This is a daunting task, to say the least. But, it couldnt' have gotten this far without the help of grants from the Bill and Melinda Gates Foundation and Doctor Without Borders (you can help BWB, by clicking on the And They Cook Too graphic to your left, and get your very own copy of a blogger cookbook, proceeds go to DWB).

What is amazing about this article is not just where the obstructions are coming from in order to develop a vaccine to end a disease that kills a half million people each year, but the lack of movement by pharmaceuticals and the WHO to complete trials on the drug that could have been in use for the past 40 years.

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