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Anthrax Vaccine and EMS: Beware of Waytes Bearing Gifts

Posted Mar 09 2010 12:00am
Tom Waytes, vice president of Emergent BioSolutions, the manufacturer of anthrax vaccine, spoke at a meeting of Emergency Services Personnel at which he suggested that expiring doses of vaccine should be given to Emergency Services personnel for *free* by DHHS:
"But with unused doses of already purchased anthrax vaccine sitting in the Strategic National Stockpile and reaching their expiry date (the vaccine has a four-year shelf life), Waytes thinks the time is right to take some of these expiring doses and make them available free to EMS personnel."
Why would the manufacturer want a $25/dose product given away??

Anthrax vaccine could be thought of as a modern Trojan Horse (that's where the phrase, 'Beware of Greeks Bearing Gifts' came from). Here's why
  1. HHS is likely to keep expired doses in storage and use them, if needed, in the future. After all, that is what happened until 1998: expired lots were simply given a new expiration date, after being tested for potency using a test that was known to be worthless. (Bruce Ivins got an award around 2007 for helping develop a better test.) So if expiring vaccine gets used up, HHS is more likely to replace it than if it expires and remains in storage, increasing Emergent BioSolutions' profits.
  2. A gift of anthrax vaccine will be the gift that keeps on giving--to Emergent Biosolutions. You see, even after 5 initial shots you still need a yearly booster. So a fireman, for example, would need 23 separate shots during a 20 year career to stay up-to-date on the vaccine.
  3. Anthrax vaccine has made thousands of people sick . Even the vaccine label lists Gulf War Syndrome (using the CDC's definition) as a reported side effect. But Emergent BioSolutions could care less, since they bear no responsibility. On October 1, 2008, Republication DHHS Secretary Michael Leavitt issued an "Emergency" declaration for anthrax vaccine under the Public Readiness and Emergency Responsiveness Act (PREPA), removing essentially all liability from the manufacturer in case of deaths or injuries due to the vaccine . If you suffer a permanent disability or death, the best you can do is hope to collect a little money from the federal government (and the maximum is about $300,000).
  4. Three weeks after Leavitt's declaration, the CDC had its Advisory Committee on Immunization Practices recommend expand anthrax vaccine use to "at risk" civilian first responders. (But who is really at risk? No one knows.) I don't believe the timing was an accident. Emergent wanted to increase sales while continuing to avoid liability for a vaccine that maims and occasionally kills. Soldiers have been barred from suing Emergent in the past, but civilians didn't have the same restriction. So the Bush DHHS obliged with an emergency declaration, followed by a recommendation to expand the vaccine's indications. The Obama administration has failed to remove or amend the PREPA declaration for anthrax, and has failed to remove or amend later declarations for smallpox and multiple influenza pandemic vaccines.
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