Sunday, December 17, 2006

Anthrax: America’s most conveniently unsolved crime

* Henley getting his freak on:
"When historians recollect the first decade of the 21st Century in tranquility, they will find it impossible to overstate the political impact of America’s most conveniently unsolved crime. The September 11, 2001 massacres were bad, but it was the anthrax attacks the following month that ramped up the “madness” Atrios recollected the other day. 9/11 was a shock. The anthrax attacks made terrorism feel like a siege. I think it’s possible that, absent the anthrax attacks, the Bush Administration might have failed to gin up the entirely equivocal support for the Iraq War that it managed."

* meanwhile, this from the The Connecticut Law Tribune:
Two years after an earlier lawsuit temporarily halted mandatory anthrax vaccinations for all 2.4 million U.S. military service members and some military contractors, another group of military service members and Pentagon civilian contractors are going to federal court to block the vaccine's forced use.

Six complainants, remaining unidentified to protect them from retaliatory military discipline, filed suit against federal military and health officials Dec. 13 in U.S. District Court for the District of Columbia. They're asking a judge once again to declare the controversial vaccine an unapproved drug and unlawful for use without informed consent.

Connecticut's U.S. Rep. Christopher Shays, R-Stamford, state Attorney General Richard Blumenthal and two well-known Connecticut U.S. Air Force officers, Thomas Rempfer and Russ Dingle, were leading opponents of the inoculation program when it began in 1997. For seven years, in vain, they pressured Congress, two presidents and high-ranking Pentagon officials to halt the program. Lt. Col. Dingle, of East Hartford, died in September 2005.

A federal court order in late 2004 halted mandatory vaccinations based on a finding that the Food and Drug Administration failed to follow licensing regulations. But soon after the FDA issued a final order approving the vaccine's safety and effectiveness in December 2005, the Department of Defense announced it was reinstituting the mandatory inoculation program for those serving in Korea and the Middle East.

Critics charge the FDA failed to provide evidence the vaccine was effective against inhalation (weaponized) anthrax, and failed to address reports of adverse health consequences from the vaccine.


Adverse Reactions

The U.S. Government Accountability Office reported that the vaccine's systemic adverse reaction rate was 100 times higher than the 0.2 percent rate reported on the product's label. Adverse vaccine reactions were said by users to include immune disorders, muscle and joint pains, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to use of the vaccine, but they have not been definitively proven as linked.

Chicago attorney John J. Michels Jr., co-counsel in the litigation with D.C. attorney Mark S. Zaid, charged, "FDA's certification of the vaccine … is based on slipshod statistical analysis, and an improper use of testing data. [That], as well as the defense department's alteration of the vaccine dosing schedule, renders [it] a drug unapproved for its applied use under current federal law."

* meanwhile, here's ken:
"The Bush Administration's $5.6 billion “Project BioShield,” launched after 9/11 to counter the threat of bioterrorism attacks, has turned into a massive yet largely unnoticed boondoggle. Exhibit A: a sole-supplier contract, worth up to $877.5 million, that the Department of Health and Human Services (HHS) awarded to California-based VaxGen Inc. for the development of an anthrax vaccine. The fate of the contract, which VaxGen has made a mess of, will be determined next Monday when HHS decides whether to cancel the deal or to give the firm an early, taxpayer-financed Christmas present.

VaxGen received the anthrax-vaccine contract two years ago, in spite of the fact that the decade-old firm had produced no marketable products, had demonstrated disturbing ethical failures in the area of human-subject drug testing, and had been delisted by Nasdaq because of accounting irregularities. An earlier, similarly hyped-up effort to develop an AIDS vaccine—for which the company received millions from the National Institutes for Health—ended in total failure and led to a number of lawsuits by investors who charged that VaxGen had fraudulently hyped the vaccine's prospects for success.

VaxGen's competitors suspected that the firm, in winning the anthrax contract, may have received a helping hand from Dr. Phil Russell, formerly a top contracting official at HHS who was involved in the BioShield project. Forbes describes Russell as a “long time acquaintance” of VaxGen CEO Lance Gordon; Russell, for his part, has denied that he helped out VaxGen.

Whatever the reasons for picking VaxGen, the choice has proved a disaster. VaxGen pledged to produce 75 million doses of the vaccine, with deliveries slated to begin early in 2006. But late last year, the company announced that unforseen “product refinements” would force it to postpone delivery of its vaccine until late 2006. Further problems ensued, and now the earliest delivery date would be late 2008 or 2009.
With roughly $1 billion at stake, there's sure to be plenty of lobbying and arm-twisting during the next seven days. Based on VaxGen's string of failures, giving the firm another stay of execution might not just be wasteful, but criminally negligent as well."

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