Tuesday, March 9, 2010

Anthrax Vaccine and EMS: Beware of Waytes Bearing Gifts

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.


Anonymous said...

If we impair all of our health care workers, and emergency first responders, there will not be many around to help out in emergency. What a way to cripple America. Cripple us Financially, Medically, our personal health, we are already crippled judicially...what next ? Only a matter of time before a takeover.

Anonymous said...

It is pretty bizarre but in the U.S. the only time this vaccine has provided anyone any protection to date is when they have worked in research connected to the anthrax vaccine.

Also bizarre is that the only anthrax that U.S. civilians have needed protection from is anthrax produced by the U.S. to test the vaccine since we started manufacturing the vaccine for a profit.

With the thousands of people who have already been sicken by the vaccine it seems clear that our Emergency Services Personnel would be better protected by ending the for profit research on the vaccine instead of giving them life threatening vaccinations

Anonymous said...

GAO reported in 2008 that it is costing the US HHS over $100 million a year to properly dispose of expired human anthrax vaccine doses in the Strategic National Stockpile, because it is formulated with two known carcinogens and EPA hazardous material destruction regulations apply.

The "gift" of human anthrax vaccine is at best a facetious comment, and at worst, the failure of current US vaccine liability law to fix responsibility on vaccine manufacturers, instead of the US government's Vaccine Injury Compensation Program.

Please ask your congressmen to support passage of H.R. Bill 1478 to give military personnel access to the VICP for all vaccine injury claims as a result of direct orders to receive vaccines. The right to seek compensation for military medical malpractice, received under orders, was denied in the 1950s by the Supreme Court ruling in Feres vs. US.