Friday, January 16, 2009

Litigants Argue U.S. Regulators Lacked Basis to OK Anthrax Vaccine

Global Security Newswire article
National Journal Group

Friday, Jan. 16, 2009
By Elaine M. Grossman

WASHINGTON -- The Food and Drug Administration violated its own regulations three years ago in approving the anthrax vaccine to prevent infection by a "weaponized" form of the disease, attorneys for eight Defense Department employees alleged in a brief filed last week at the U.S. Court of Appeals (see GSN, March 3, 2008).

(Jan. 16) - The anthrax vaccine received approval in late 2005 as a protective measure against inhaled anthrax (Emergent BioSolutions photo).

The Pentagon began a vaccination program for more than 1 million service personnel in 1998, during the Clinton administration, and continued the effort under President George W. Bush. However, compulsory shots were suspended from late 2003 through early 2007, after a federal judge found the Pentagon lacked the legal authority to compel inoculations for an unapproved use of the vaccine.

Critics have voiced concern that it is unclear how useful anthrax vaccine is in preventing the highly lethal disease from being contracted through inhalation, and have called attention to the possible risks associated with giving the inoculations to a large population.

The U.S. government recently moved to shield itself from liability in distributing the vaccine in the event of a bio-warfare attack, just as a key advisory panel to the Centers for Disease Control and Prevention approved extending the shots to emergency first-responders nationwide (see GSN, Oct. 17, 2008, and Oct. 23, 2008).

A December 2005 FDA ruling allowed a vaccine previously labeled for use solely in inhibiting anthrax contracted through the skin or the digestive system to also be administered to prevent acquiring the disease via the lungs.

The decision paved the way for the Defense Department to resume mandatory inoculations for service members whose assignments are believed to put them at increased risk of exposure to anthrax during a potential biological attack (see GSN, Sept. 5, 2007).

However, two attorneys who succeeded in temporarily shutting down the mandatory shots program in 2003 remain dissatisfied. They alleged in a second lawsuit, filed in December 2006, that the Food and Drug Administration had not followed its own standards for reviewing a vaccine for approval in issuing its 2005 go-ahead.

The result, they are alleging, is that the vaccine has not been shown to be safe and effective for preventing inhaled anthrax.

U.S. District Judge Rosemary Collyer last year ruled against the plaintiffs, saying the court "will not substitute its own judgment when the FDA made no clear error of judgment."

Plaintiff attorneys Mark Zaid and John Michels took their case to federal appeals court, and the 73-page brief filed last week constitutes their written argument.

"There are ... internal inconsistencies in the [FDA-reviewed] record showing that nobody believed this vaccine was adequate for preventing inhalation anthrax until the DOD decided they were going to conduct this mass inoculation," Michels said in an interview yesterday. "The FDA's failure [in its 2005 action] to explain all of these contradictory statements [in] their own documents is a violation of the Administrative Procedures Act."

The 1946 federal law controls how government agencies draft and issue regulations.

A Defense Department spokesman praised the federal judge's decision.

"We owe it to our service members to give them every possible protection," Bryan Whitman said last year. "Force protection is the No. 1 priority in the Defense Department and the anthrax inoculation program is an important force-protection measure."

In their Jan. 7 brief to the U.S. Court of Appeals, though, Michels and Zaid took issue with the notion that the vaccine has been proven to protect humans from contracting inhaled anthrax.

If the court invalidates the FDA authorization for this use, the Defense Department could be required to obtain informed consent from any personnel receiving the five-shot series (see GSN, Dec. 22, 2008).

In the case, called Rempfer vs. von Eschenbach, the two lawyers are representing Thomas Rempfer and seven other Defense Department personnel ordered to take the vaccines. Defendants are led by FDA Commissioner Andrew von Eschenbach and include the health and human services and defense secretaries.

"The regulatory history of the [anthrax vaccine] was nothing if not convoluted and contradictory," according to the plaintiffs' new court submission. "The main basis" for Collyer's decision to dismiss the case "was the FDA's reliance on a single human test of [the anthrax vaccine] that occurred more than 50 years ago, using an admittedly different vaccine," the complainants stated.

The district court judge's Feb. 29, 2008, decision "ignored the significant disparities" in vaccine testing as well as plaintiff allegations that "undercut" the key medical study's "validity and scientific basis," the brief reads.

"We are alleging," Michels told Global Security Newswire, "the FDA has not done its job."

Agency records show a "significant failure by FDA to follow its own procedures with regard to licensing of the current version of the vaccine using data from a vaccine that was manufactured using different standards, a different anthrax strain, and different methodology," according to the brief. "The District Court's simple acceptance of the representations made by the government was improper and factually unsupportable."

An FDA spokeswoman today declined to offer comment on the court case.

Pending a possible extension in due date, the government has 30 days to issue its own written brief for the appeals court. After that, the plaintiffs will have an opportunity to submit their response. The appeals panel may then request to hear oral arguments on the case before issuing its decision.

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