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First, Do No Harm
Joseph Calfee, Ph.D., New York Sun, 10-18-05

On the topic of avian flu, Calfee sounds a welcome note of moderation. He advises policymakers not to panic, but to prepare.

What to do? First, avoid panic. Avian flu viruses seldom jump to humans, having done so only three times in the last century. When a virus does jump, it is usually not especially lethal, as seen in the two more recent pandemic flus, those of 1957 and 1968. ...
But avoiding panic is not the same as doing nothing. This is an excellent time to fix some of the things that are broken in the flu vaccine industry. …Congress should pass legislation insulating flu vaccine manufacturers from liability suits as long as they meet Food and Drug Administration standards of testing and manufacturing. The vaccine industry and the FDA need to phase out a decades-old vaccine manufacturing technology in which individual doses are grown in millions of chicken eggs and replace it with one based on cell culture similar to what is used for many other drugs. ...
In the meantime, two anti-viral drugs used to treat the traditional flu appear to be active against the H5N1 avian flu bug. Roche is ramping up production of Tamiflu, the most promising anti-viral, while Glaxo-Smith-Kline is doing the same with its Relenza. ...
But already, there is talk of compulsory licensing to break Roche's patent and let other firms manufacture Tamiflu for sale to governments around the world, not least from Senator Schumer, who yesterday called for just this action. This extraordinarily dangerous movement should be nipped in the bud. Tamiflu and Relenza are no solutions to the avian flu problem. If they are distributed in a massive and uncontrolled fashion they will quickly generate drug-resistant mutations--some of which have already been detected--leaving us worse off than we are now. Just as seriously, we will suppress incentives to create even better drugs, which we desperately need because the ones we have now are no more than stop-gaps. The pharmaceutical industry has not forgotten the threat of the Secretary of Health and Human Services, Tommy Thompson, against the Cipro patent during the 2001 anthrax crisis. The last thing we need now is a repetition of what everyone hoped was a onetime-only mistake.

Unfortunately, international officials seem more content to break patents in the event of a crisis than actually prepare for one. This is to be expected, given public pressures, but it is extremely unwise, as Calfee explains.

Project FDA.
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