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  The Axis of Good: A Woman's Fight to Save the Poor from Black Fever

The Axis of Good A Woman's Fight to Save the Poor from Black Fever

By Uwe Buse

Part 3: Bill Gates starts the funding

She wanted to establish an aid organization that operates like a pharmaceutical company or, to be more precise, like a non-profit pharmaceutical company. The desire to help, and not to earn profits, would be the company's driving force. Hale wanted to build a company that would do what she believed the industry ought to be doing.

As her first project she envisioned pushing paromomycine through the complicated approval process. She would plan, conduct and analyze the tests and clinical trials, produce the drug and find a company willing to manufacture it at cost. Hale's company would be funded by charitable contributions.

Her friends called it an "interesting idea," implying that there were easier ways to throw away one's money.

Hale sat in her living room, thinking about the men and women in their executive offices, high up in the palaces of globalization, people who she was convinced would be willing to spend a lot of money on building monuments to themselves -- not as corporate executives but as friends of humanity.

She offered her future backers a unique project -- the rare opportunity to save hundreds of thousands of people. It would also be a chance to prove that the system can work, and that the globalized economy is capable of producing the tools to correct its own deficiencies. There were few arguments against her idea.

Hale called her non-profit organization the Institute for OneWorld Health, dubbing it the "first non-profit pharmaceutical company in the United States." She developed a business plan and sent it to potential donors. One of her letters ended up on the desk of Bill Gates, the co-founder of Microsoft, a multi-billionaire and the world's biggest philanthropist. Gates liked the idea and sent Hale a check for $4.7 million as a first installment. That was the beginning. Once the man who spends almost as much of his own money on fighting poverty as the World Health Organization had expressed his confidence in Victoria Hale, others followed, including the Chiron Foundation, the investment bank Lehman Brothers, the Skoll Foundation and many others.

Hale established her company, began searching for office space and hiring employees, first 10, then 20 and finally 50. She needed them to ensure that the approval procedure for paromomycine satisfied international standards. It was a bureaucratic nightmare, and to tackle the task Hale enlisted the help of the World Health Organization (WHO).

Red tape

She flew to WHO headquarters in Geneva and walked into a four-story concrete, glass and metal building, to a corner office on the top floor to meet the man instructed by the world community to rescue the poor from diseases and epidemics. Robert Ridley is the director of the Special Program for Research and Training in Tropical Diseases (TDR) at WHO. His desk is littered with files and documents to be read and signed. His job often consists of little more than delegating responsibility.

TDR was established in 1975, just as biotechnology and genetic manipulation were beginning to revolutionize the pharmaceutical industry. It was set up to find ways in which the new technologies could be used to help the poor. But there was one problem: the program was to be operated on a shoestring budget.

To this day, Ridley's department has no fixed budget and is almost completely dependent on charitable spending. As a result, Ridley must make do on about $30 million a year, $30 million to coordinate the global fight against the 10 biggest killers of the modern age. It isn't much, and it certainly isn't enough to achieve progress. Indeed, much of Ridley's job consists in finding ways to economize.

Hale's reason for visiting TDR was that the organization's researchers had attempted to introduce paromomycine into the Indian market themselves in the early 1990s. But the process dragged on, the budget shrank, cuts had to be made and, in the end, the approval process for paromomycine was suspended. Hale had come to Geneva because she needed the results of the TDR's first two clinical trials, results that could save her years of work.

Today Ridley says that there was a "resource bottleneck" at the time, a phrase he uses to explain why Hale had to wait so long for the data.

At the time, as Hale was requesting the data on paromomycine, TDR was interested in another drug that seemed promising in the fight against black fever. Ridley believed that the drug would offer a better cost-benefit ratio than paromomycine. The drug, known as impavido, is manufactured by a German company whose CEO, Jürgen Engel, has the luxury of producing a drug that doesn't make economic sense.

Rival drug

"We had actually developed impavido as an oral cancer drug, but it couldn't be used for that purpose," says Engel. The side effects were intolerable. But, according to the professional literature, the drug's active ingredient, miltefosine, could be used to treat black fever. Although it has serious side effects that can weaken an already weak patient even further, including nausea and vomiting, impavido is effective.

Like Hale, Engel turned to TDR for assistance, but the man in charge of the research department at the time lacked the funding to support paromomycine and impavido at the same time. He chose impavido, mainly because of its cost-benefit ratio. Impavido comes in tablet form, whereas paromomycine is administered by intramuscular injection. This complicates distribution, and complications cost money. Besides, Engel's company, Zentaris, was a conventional business, and TDR is accustomed to working with conventional companies. Hale, on the other hand, was the head of an oddball, hard-to-comprehend entity that threatened to change the system.

Hale was kept waiting for two years before she got her data. To make matters worse, she had a competitor. It was the last thing she had expected.

When she finally received the data from the TDR, Hale went straight to work. She sent employees to villages in Bihar to document the numbers of the sick. Five hundred patients received paromomycine injections. They were monitored for a year, during which they received regular checkups and potential side effects were addressed.

Samples were sent to laboratories and Hale's employees traveled back and forth between San Francisco and Bihar. Her company's annual expenditures climbed to $30 million. In the end, it was clear that paromomycine is effective in 95 percent of cases, without causing serious side effects. Hale celebrated and continued her work.

She found a company that was willing to produce paromomycine and sell it at a price of $10 for a full course of treatment. The company, Gland Pharma, is based in the Indian city of Hyderabad. Its price calculations were partly influenced by a sense of patriotism and PR considerations.

Ten dollars, which Gland Pharma says is the cost of producing the drug, is affordable for the poor in Bihar. A treatment with Engel's drug, impavido, costs $100 in Bihar.

The approval process ended a few weeks ago when the Indian government approved paromomycine. Impavido was also approved. Hale and Engel are now competing on a level playing field. Both are at equal distances from the finish line, and they will likely cross it together.

A large-scale program to attack black fever is scheduled to begin next year. The Indian government, which is coordinating the attack, has publicly announced its goal of eradicating the disease in India by 2010. The target date for eradication in neighboring Bangladesh and Nepal is 2015.

In a multi-pronged approach, an insecticide will be used to control the sandflies, local doctors will distribute the medication and the three countries' governments will subsidize prices. The treatment will likely consist in a combination therapy that will include both paromomycine and impavido.

This time it seems as though there will be no losers, only winners who will be forced to share the spotlight. For once, here's a story that looks set to have a happy ending.

Translated from the German by Christopher Sultan