Saturday, March 15, 2008

Judge Keeps Anthrax Suit Alive

WASHINGTON (AP) — A federal judge Friday kept alive a lawsuit in which two Connecticut Air National Guard pilots said they were forced to resign nine years ago for refusing to be vaccinated against anthrax.

An Air Force panel must spell out the reasons for denying the two compensation for back pay and lost promotions, U.S. District Judge James Robertson ruled.

One of the pilots, Russell Dingle, died in 2005 and he is represented in the lawsuit by the executor of his estate. The other Connecticut Air National Guard pilot is Thomas Rempfer.

A federal court blocked the Pentagon's anthrax vaccination program in 2003, ruling that the vaccine had not been licensed or approved for use against inhalation anthrax. Other courts have ruled differently, affirming the legality of involuntary anthrax vaccination.

Robertson relied on the ruling that halted the vaccination program, saying that at the time the two pilots were refusing an order by their superiors, "it was a violation of federal law for military personnel to be subjected" to involuntary inoculation against anthrax.

The Food and Drug Administration has made changes in the vaccine that resulted in another court ruling two weeks ago by another federal court. That decision concluded the Pentagon can require its troops to be vaccinated against anthrax.

In the lawsuit of Rempfer and Dingle, they were assigned to a unit whose job it was to investigate the Pentagon's anthrax vaccination program in the late 1990s.

Rempfer and Dingle raised questions about the effectiveness and safety of the vaccine, but they said there was no satisfactory response from those higher in the chain of command.

Faced with what they considered an illegal order to be vaccinated or face discipline, both sought reassignment to the U.S. Air Force Reserves and were honorably discharged.

Reports prepared by superiors never mentioned their duties or their objections to the anthrax program.

The Air Force Board for Correction of Military Records must explain its conclusions about the claims by Rempfer and Dingle's family and about their demands for compensation, the judge ruled.

Tuesday, March 11, 2008

Here is a summary of the presentation I gave to the Maine Commission to Protect the Lives and Health of National Guard Members

Problems with Military Vaccines

Meryl Nass, MD

Although biological warfare is considered a military threat, achieving mass casualties is extremely difficult. Historically, the target has been civilians, not troops. Nonetheless, the Defense Department has undertaken to vaccinate all deploying soldiers to Central Command with anthrax and smallpox vaccines: approximately 1.8 million soldiers have received each in the past ten years.

In retrospect, the current administration used the threat of chemical and biological warfare to buttress a preemptive strike on Iraq in 2003. Initiating smallpox vaccinations for soldiers and civilians may have had more to do with public relations than public health. The civilian program stopped after 40,000 inoculations, due to cardiac complications.

Despite this, the mandatory military smallpox vaccination program has never slowed down. According to the CDC Advisory Committee for Immunization Practices, such vaccination programs require a risk-benefit analysis, which was never performed. The Institute of Medicine’s analysis of the smallpox program noted, “The combination of known vaccine-related problems and an immeasurable disease threat was deeply problematic.”

The smallpox vaccine caused myocarditis in one of every 145 people who received it in a clinical trial, leading to a black box warning in the label. However, the warning fell on deaf ears, since the vaccine remained a requirement for deployment.

Recently, a newer smallpox vaccine, derived from the old vaccine, was licensed. The government announced that stocks of the old vaccine would be destroyed, and the new vaccine would be given to soldiers. But is there really a difference? The new vaccine is said to cause myocarditis in one in 175 recipients.

The anthrax vaccine story is similar: the General Accounting Office reported to Congress in both 1999 and 2006 that the long-term safety of the vaccine is unknown. Crucial data and research remain buried.

Although civilians injured by smallpox vaccine can seek compensation from a government fund, soldiers are barred by the Feres Doctrine from compensation, and their only recourse in the event of illness is the healthcare system of the military and Veterans Administration. Unfortunately, vaccine-induced illnesses generally respond poorly to treatment.

In the absence of both demonstrable threat and effectiveness against biological weapons, these pork barrel vaccine programs exact much too high a price from our service-members and our treasury. It is time to end the politicization of military public health.

Thursday, March 6, 2008

Anthrax Vaccine Lawsuit Dismissed: What Does That Mean?

Federal Judge Collyer last week dismissed a lawsuit challenging Biothrax's license on the basis that efficacy has not been demonstrated. The suit contended that anthrax vaccine had never been approved for its current intended use, inhalation anthrax.

The judge ruled that FDA is, in essence, the arbiter of the science and can interpret the data as FDA sees fit.

However, many articles in the medical literature and popular press over the past several years provide ample evidence that FDA makes judgments about products that are unsupported by scientific evidence. Congressman Jim McDermott, MD's Subcommittee will examine the use of psychotropic medicine on children in foster care next week (March 12)--a drug scandal FDA has chosen to ignore. The state of Alaska is suing the manufacturer of Zyprexa, seeking damages to pay for the care of those the drug made diabetic. Another drug scandal to which FDA turned a blind eye.

Time will tell whether "our" federal agencies will ever be brought to account. If federal agencies choose not to perform the tasks legally required of them, the value the federal government has to its citizens wanes. If we cannot "buy" quality public health, cannot obtain the oversight to ensure our drugs, foods and medical devices are reasonably safe and effective, and their review free of bias, why pay taxes to fund the FDA, CDC, and other public health agencies?

The "Hannah" autism case, in which a number of vaccines were judged by a Vaccine Court Special Master to have lead to a child developing autism, is the latest nail in the coffin of a totally politicized and unreliable federal public health enterprise.