Thursday, March 10, 2011

Where politics and science meet

For thousands of years the malaria parasite has adapted to resist every attempt to combat it, and today infects a staggering 300-500 million people a year, mostly in Africa and Asia. There has never been a vaccine to prevent it. The reasons are both scientific and political. The parasite is complex and evolutionarily evasive. But malaria is also a classic case of a problem affecting people so economically marginalized and voiceless that there are no market incentives or political incentives for solving it. Now, with almost a million children a year dying from the disease, the person who may be closest to ridding the world of malaria is the one most experts had once not only dismissed but even ridicule.

A decade ago Dr. Steve Hoffman left the security of a distinguished 21 year career in the Navy, where he helped coordinate malaria vaccine development, and turned instead to the high risk, high reward uncertainties of his own bio-tech start-up.

His entire enterprise is built on a slender but tantalizing experiment to test the 1967 research of a New York University doctor named Ruth Nussenzweig, by convincing 14 volunteers to allow themselves to be bitten by irradiated mosquitoes about 1000 times to simulate a natural immunity.

When later challenged by being exposed to and bitten by regularly infected mosquitoes, 13 of the 14 were protected from malaria infection. From this Hoffman parleyed his passion and power of persuasion into millions of dollars of grants and ultimately FDA approval for clinical trials using weakened parasites as a vaccine.
The problem is that it has always been considered clinically and logistically impractical to immunize large numbers of people with a vaccine comprised of irradiated parasites extracted by hand from the salivary gland of a mosquito and preserved for intravenous injection. Other experts scoffed at such a cumbersome approach. But Hoffman saw an opening between impractical and impossible, and drove a truck through it. He saw the challenge not as scientific discovery but biotech engineering to scale something proven to work. His lab invented the necessary techniques.

Today Hoffman is up against the giant pharmaceutical Glaxo Smith Kline (GSK) which has its own malaria vaccine candidate, effective only about half the time, now in the third phase of clinical trials. Many observers believe GSK’s vaccine will be first, but that in the long-run Hoffman’s will be best.

Hoffman’s personal qualities can be summarized in three words: imagination, entrepreneurship, and leadership. His hard earned technical successes transformed the perception of his vaccine from preposterous to miraculous. More important, he had the imagination and vision to see each scientific and technological breakthrough not as an end in itself but as a means to a larger end. The time he devoted to science was more than matched by the time he spent coaxing the scientific community up and over Mount Improbable, that Everest-like mountain of skepticism that had prevented them from seeing a solution lying long dormant, but nevertheless in front of them all along. He demonstrated persistence bordering on stubbornness, confidence bordering on arrogance, and a boxer’s willingness to take a punch and come up off the canvas, affirming George Bernard Shaw’s observation that all progress depends on the unreasonable man.

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