Fighting a Third World Menace 

Big Pharma's greed didn't stop Children's Hospital's Dan Granoff from creating a meningitis vaccine for Africa's poor.

In 1999, three years after the worst epidemic of meningitis in history swept across sub-Saharan Africa and left 25,000 people dead, Dr. Dan Granoff decided it was time to try and combat the disease he'd spent his career studying and developing vaccines against. That very year, in fact, another outbreak of the bacteria that cause meningitis -- a dangerous swelling of the tissue around the brain and spinal cord -- had ravaged the Sudan.

Granoff, a medical researcher at the Children's Hospital Oakland Research Institute, wasn't interested in taking up the cause himself. He simply wanted to prod the World Health Organization in Switzerland to address the situation in Africa, where meningitis outbreaks every few years kill or severely impair thousands of children, leaving many of the survivors with permanent disabilities such as hearing loss, retardation, or missing limbs.

Researchers and pharmaceutical companies are familiar with the bacterial strain that has most ravaged the African continent. Since the 1980s, in fact, scientists have known how to create a vaccine for children living in the "meningitis belt," which stretches from the Senegambia in the west to Ethiopia in the east. Although a few drug companies had tinkered with vaccine development in collaboration with the WHO, nothing had ever come of it. So Granoff fired off an e-mail plea to WHO officials. The 59-year-old pediatrician and infectious disease specialist pointed out that little was being done to create a vaccine for Africa, even though it was absolutely within reach to do so.

It turned out the health officials were just as frustrated as the Oakland physician, and after their failed collaborations with the industry, they were uncertain how to proceed.

Granoff's idea was to create a nonprofit that would contract with other companies to develop the vaccine. Intrigued, WHO leaders gave him a grant to look into just how such a project might work. The physician, who'd simply intended to light a fire under some public health bureaucrats, ended up spending much of his own time over the next few years immersed in the endeavor. "What made the project interesting," says the soft-spoken researcher, "is that the scientific know-how to make the vaccine had been in place for at least a decade. The obstacle was not technical. We did not need a scientific breakthrough."

What the effort needed was someone like Granoff, a scientist who understood meningitis and who had spent years working for one of the world's leading vaccine makers, the Emeryville-based Chiron Corporation. Now, five years since his initial e-mail, a meningitis vaccine is in the works with clinical trials set for next year. But the obstacles Granoff encountered along the way would leave him frustrated and cynical about the possibilities of curing the Third World of other microbial scourges.

With the grant money in hand, the doctor consulted with academics, industry people, and African health ministers, and over time developed a solid business proposal. Now he needed cash to develop the vaccine program.

A plea to the Bill & Melinda Gates Foundation in the form of a grant application proved quite persuasive. In 2001 the foundation, which has a $26 billion endowment dedicated to equity in global health and education, announced it would give $70 million to Granoff's vaccine project.

Armed with the big bucks, Granoff then approached vaccine makers to see which companies would be interested. It seemed an easy sell. The research to create the vaccine was done, and the Gates grant would cover much of the initial startup investment. By Granoff's calculations, the pharmaceutical companies would still make a profit of about 25 cents per dose of vaccine, which would translate to about $10 million to $15 million per year for the next decade. The doctor assumed it would be an enticing mix. He was wrong. Big Pharma simply wasn't interested. "I thought if [we're] paying for everything and you don't have any risk, someone might be willing to do it," Granoff says.

What he heard, again and again, was that the opportunity cost of developing such a vaccine was simply too great. The companies followed a kind of roulette business model: Keep four or five high-risk but potentially lucrative research projects in the works with the expectation that one of them will be wildly successful. Success in the world of vaccine makers, Granoff explains, is $1 billion a year. To focus on a meningitis vaccine would take away a high-profit firm's "opportunity" to develop the next Viagra or vaccine for the developed world, so his project made little sense to the industry, he says.

"From a business point of view, they're right," he concedes. "Profit is the goal of the company, and as long as that's the system it's hard to get these companies interested in vaccines or drugs that are going to prevent far more disease but are far less profitable because the people who get these diseases simply cannot afford to buy them."

Granoff and others on the vaccine project decided to forge ahead without the help of Big Pharma. They established a home base in France and created partnerships with smaller companies around the globe to do contract manufacturing.

Dr. Regina Rabinovich, director of the infectious disease program at the Gates Foundation, says Granoff's role has been essential to the project's success. "He was really there at the inception making the case for this project and how it would really make a difference in Africa," she says. "He made the case of what could be done."

Rabinovich predicts that the vaccine, when ready, will make a huge difference. "When these epidemics come in Africa, they are devastating," she says. "We have such low rates of disease here that when we have three to five cases of something, people get into a panic. It's such a different situation in Africa. When an epidemic hits, it affects thousands and thousands of people."

While Granoff is pleased with what has become of his vaccine program, he is also discouraged. The experience has left him with the sense that there's little hope for new drugs and vaccines for the developing world.

"We have this incredible disparity now, and we're working on things here that aren't even diseases," he says. "Things like how do you put hair on people's heads, how do you give people erections, while people are dying from terrible diseases. Companies can make billions of dollars on products and have very little effect on public health."

Somehow, the doctor says, the developed world needs to provide sufficient funding for companies to take on projects like this. It's not charity, he insists: "More and more, we realize our own security depends on improving the lot of people in poor countries."

With clinical trials set to begin next year, Granoff says he believes his story demonstrates one thing: "The power of e-mail," he jokes. But seriously, "I'm really very optimistic," he says. "The vaccine is unbelievable in mice, so if it's a tenth as good in humans, we'll have a good vaccine."

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