Monday, November 14, 2005

Avian Flu

This a bit about the avian flu and my Uncle's role. He's "Dr. Fedson."

1 Thoughts:

Blogger Demotiki said...

Since access to this site is limited, here's the text of the article. . .

News Focus
AVIAN INFLUENZA:
Preaching Against the Pandemic
Martin Enserink

He's a retired American living in the French countryside. So what makes David Fedson one of the most vocal advocates for pandemic preparedness?
SERGY HAUT, FRANCE--On a clear day, you can see Mont Blanc, Europe's highest mountain, from David Fedson's study. His 320-year-old home, tastefully restored and decorated, is a haven of tranquility in a small French village.
But the relaxed atmosphere is deceptive. Working from his home, Fedson, 67, a former academic and pharma executive, is on a tireless crusade to help ready the world for what he believes could be a global catastrophe: the next influenza pandemic. After a career spent studying adult vaccination, he's convinced that only billions of flu shots, deployed worldwide soon after a pandemic strikes, could avert global mayhem. And the world still isn't moving fast enough to make that possible, he says.

To change that, Fedson is constantly writing papers, talking to scientists, and lobbying policymakers. Colleagues say he's an influential voice in the debate on pandemic preparedness. From 1996 until his retirement in 2002, Fedson was director of medical affairs at Aventis Pasteur MSD (now Sanofi Pasteur MSD) in Lyon. Even then, he was known to speak his mind. Sanofi Pasteur, the world's biggest flu vaccine producer, pays Fedson's expenses to speak about the pandemic danger, but he has no formal ties to this or any other company or organization, which allows him to speak freely, says Harvard epidemiologist Marc Lipsitch: "I'm kind of a fan."

Fedson frequently tries to cajole reporters into covering the subject he worries about. In an e-mail to a New York Times reporter last year, he praised a particular story but said that overall, the paper had "barely scratched the surface," adding, "You have work to do."

Fedson studied medicine at Yale and worked at the University of Chicago before joining the University of Virginia School of Medicine in Charlottesville in 1982, where he became an expert in the clinical effectiveness, cost-effectiveness, and distribution of flu and pneumococcal vaccines. He was a member of the Advisory Committee on Immunization Practices and the National Vaccine Advisory Committee; at Aventis, he founded the Influenza Vaccine Supply International Task Force, an industry group working to prepare for pandemic vaccination. After retiring, he set up a study group to monitor the use of flu vaccines around the world.

Fedson's ideas about pandemic vaccines are based on simple arithmetic. In a pandemic, antiviral drugs like Tamiflu can't be more than a stopgap; only vaccines offer long-term protection. As for supply, for the next 5 years at least, the world is stuck with the nine major flu vaccine companies, which produce just 300 million doses annually using chicken eggs, a process that's difficult to scale up quickly. They could all switch to making pandemic vaccine in an emergency--but they would need to produce billions of doses instead of 300 million.

The only way to increase supply dramatically, Fedson says, is to produce vaccines that use far less antigen, or viral proteins, per dose. For the annual influenza vaccine, which protects against three different strains, manufacturers use 45 micrograms of antigen, 15 for each strain. To vaccinate 3 billion people during a pandemic--and assuming everyone will need two shots--the amount of antigen per shot would have to come down 20-fold, to about 2 micrograms. Studies have suggested that such small doses may be effective when coupled with a so-called adjuvant, such as alum, to rev up the immune system.


Work to do. David Fedson says the world needs a global plan to develop, produce, and distribute pandemic vaccines.
CREDIT: M. ENSERINK/SCIENCE


Trials using such vaccines have been slow to start. Adjuvants aren't needed in annual flu vaccines, and they create regulatory worries about side effects. For these reasons, the first pandemiclike H5N1 vaccine that the United States tested in humans did not contain an adjuvant. The vaccine triggered reasonable levels of antibodies, but only when two doses of 90 micrograms were given (Science, 12 August, p. 996). Rather than stretch global capacity, this approach would dramatically shrink it, says Fedson. Additional trials with dose-sparing strategies, including alum, are now planned in the United States. Still, says Fedson, "they wasted a year. That's unforgivable."
In Europe, adjuvants are widely accepted, but public funding has lagged. Sanofi Pasteur will soon complete one small study, and several more are planned. But in most studies, the lowest dose tested will be 7.5 micrograms of antigen. That's still too high, says Fedson, who recommends testing doses as low as 1.875 micrograms. The hesitation is "absurd," he says: "We know what needs to be done, but it's not being done."

Other hurdles need to be tackled urgently, he adds. To speed new vaccines to the market, Fedson calls for a global licensing protocol, rather than the current patchwork of national regulations. Governments should also shield companies from liability, he argues, because when large numbers of people take a vaccine, some will come down with health problems.

As an alternative strategy, Fedson has urged researchers to study patient databases to see whether statins, cholesterol-lowering drugs that also fight inflammation, might prevent the most severe complications from influenza. If so, he says, generic statins could offer poor countries a cheap alternative to Tamiflu. Two groups recently found encouraging data (Science, 23 September, p. 1976), and top flu teams in the United States have promised to test the idea in H5N1-infected mice and ferrets.

Coordinating a truly global plan for pandemic vaccine development, production, and distribution requires exceptional leadership, which Fedson says the under-funded World Health Organization in nearby Geneva can't provide. He advocates the creation of a new organization like the Global Fund to Fight AIDS, Tuberculosis, and Malaria, led by someone like the blunt and hard-driving General Leslie R. Groves, who built the Pentagon and went on to lead the Manhattan Project.

Meanwhile, Fedson has plenty of advice to give. He hands the reporter a letter urging the World Economic Forum to put the pandemic threat on the agenda of its annual elite gathering in Davos, Switzerland. (They should enlist people such as Bill Clinton, he suggests.) He produces a paper arguing for statin research and another about pandemic vaccine development. More will come by e-mail, he promises. Like General Groves, Fedson knows what needs to be done.

Tuesday, November 15, 2005 11:37:00 AM  

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