Judge Bars Military from Forced Anthrax Vaccine – Victory for Infomed Consent Doctrine

Thu, 28 Oct 2004

On October 27, a federal court ruled against the US government for violating the right of military personnel to informed consent.

U.S. District Judge Emmet G. Sullivan ruled that the “involuntary anthrax vaccination program” by the Department of Defense is “illegal.”

Furthermore, the Court ruled that the FDA’s approval of the anthrax vaccine for use on military personnel was invalid inasmuch as the FDA failed to comply with its own safety procedures. The Court found the FDA was in violation of the Administrative Procedures Act: “This Court has an obligation to ensure that FDA follow the law in order to carry out its vital role in protecting the public’s health and safety.” The Court ruling is a permanent injunction that will remain in effect “unless and until the FDA” obeys the law. Until that time, DoD’s “involuntary anthrax vaccination program is rendered illegal.”

The plaintiffs in the case were 6 military servicemembers. The defendants: Secretary of Defense (Donald Rumsfeld), Secretary of Health and Human Services (Tommy Thompson), and Commissioner of the Food and Drug Administration (Mark McClellan).

Justice Sullivan rebuked the government, stating: “Congress has prohibited the administration of investigational drugs to service members without their consent. This Court will not permit the government to circumvent this requirement. The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all – public scrutiny. This is the process the FDA in its expert judgment has outlined, and this is the course this Court shall compel FDA to follow.” See: http://www.dcd.uscourts.gov/03-707c.pdf (p.40).

This decision is a major victory affirming the universal right of informed consent to medical experimentation – including members of the armed forces. The decision is a bitter sweet victory exonerating soldiers who were subjected to disciplinary measures for asserting their right to refuse an experimental vaccine that in their judgment posed unacceptable heath hazards.

The anthrax vaccine decision underscores the need for civilian oversight over the military and the immense importance of trial lawyers who often provide the only means for stopping government officials from abusing their authority. Once again, the FDA has been shown to put its seal of approval to illegal practices that adversely affect the health and safety of citizens – in this instance, military personnel.

The Washington Post recognized the importance of this decision, running the story on the front page.

The New York Times published the wire story and burried it on p. 20.

Another news item:

The Australian Defence Department is also being challenged by soldiers who had been prescribed the controversial malaria drug, Lariam, within the context of research – without their informed consent.

Lariam caused severe psychiatric symptoms “in a number of patients, ranging from anxiety, paranoia and depression to hallucinations and psychotic behaviour”. The US Department of Veterans Affairs has warned US veterans returning from Afghanistan to watch out for possible long-term mental problems and other health effects from the drug.

Contact: Vera Hassner Sharav
212-595-8974

http://www.washingtonpost.com/ac2/wp-dyn/A3691-2004Oct27?language=printer

U.S. Barred From Forcing Troops to Get Anthrax Shots
By Marc Kaufman
Washington Post Staff Writer
Thursday, October 28, 2004; Page A01

The Defense Department must immediately stop inoculating troops with anthrax vaccine, a federal judge ruled yesterday, saying that the Food and Drug Administration acted improperly when it approved the experimental injections for U.S. District Judge Emmet G. Sullivan said the mandatory vaccination program — which has inoculated more than 1.2 million troops since 1998 — is “illegal.” general use.

Concluding that the FDA violated its own rules by approving the vaccine late last year,

Sullivan said that his ban on involuntary vaccination will remain in place until the FDA reviews the anthrax vaccine properly or until President Bush determines that the normal process must be waived because of emergency circumstances.

The Defense Department has required many troops serving in Iraq and Afghanistan to be vaccinated, and it has punished and sometimes court-martialed those who refused. The Pentagon expanded its anthrax and smallpox vaccination programs in July to include troops stationed in South Korea and other areas in Asia and Africa, despite complaints from some service members that the anthrax vaccine made them sick.

In a statement, the Defense Department said it is reviewing the decision and will “pause giving anthrax vaccinations until the legal situation is clarified. . . . DoD remains convinced that the anthrax immunization program complies with all the legal requirements and that the anthrax vaccine is safe and effective.”

In his ruling, Sullivan said that the FDA’s approval was invalid because it did not meet the required review standards and the agency failed to seek the necessary public comment.

“Congress has prohibited the administration of investigational drugs to service members without their consent,” Sullivan said. “This Court will not permit the government to circumvent this requirement.”

“The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all — public scrutiny. This is the process the FDA in its expert judgment has outlined, and this is the course this court shall compel FDA to follow,” Sullivan wrote.

The judge ruled on a suit filed in March 2003 by six service members and civilians who argued that the FDA never properly reviewed the vaccine’s ability to protect against inhalation anthrax. The suit contended that the drug was never shown to be effective, and that some vaccinated troops experienced extreme fatigue, joint pain and temporary memory loss after being vaccinated. The vaccine, made by BioPort Corp. of Lansing, Mich., is given in a series of shots.

Mark Zaid, an attorney for the six who has also defended more than a dozen service members court-martialed for refusing the vaccination, said one of his clients is a breast-feeding mother who does not think the vaccine is safe for her child.

“We will now initiate an effort to ensure the government reverses all punishments that were imposed for refusing an order to take the vaccine,” Zaid said. He said he will also seek compensation for service members who contend they were harmed. “As we’ve seen in Iraq, there wasn’t any actual threat from anthrax, so there was never any real need for the vaccine,” Zaid said.

Sullivan initially ruled in late 2003 that the FDA had never approved the vaccine and ordered that the inoculations be stopped. Eight days later, the FDA approved the vaccine based on an application made 18 years earlier, and the inoculation program was resumed. Yesterday’s ruling concluded that the agency did not follow its own rules in declaring the vaccine safe and effective.

In particular, Sullivan criticized the FDA for not allowing the public to comment on its decision — a prerequisite for any approval. There was some public comment when the approval was first sought in 1986, but the 2003 decision was based on research conducted later and never subjected to public comment.

The FDA argued that comments had been submitted as part of a 2001 citizens’ petition questioning proposals to begin the vaccinations, but Sullivan found them insufficient. “It is clear to this Court that if the status of the anthrax vaccine were open for public comment today, the agency would receive a deluge of comments and analysis that might inform an open-minded agency,” he wrote.

Because the anthrax agent is so deadly, it has been difficult to test a vaccine that might protect against it. The best data have come from a study in the 1950s of workers at a factory that processed animal hides and furs, which can transmit naturally occurring anthrax. That study found that the vaccine now used by the military was effective in reducing the incidence of anthrax spread by contact, but the research involved only a tiny sample of people who might have inhaled the bacteria.

Anthrax vaccine was used in a limited way in the 1991 Persian Gulf War. A more expansive effort began in 1998. Difficulties in manufacturing the vaccine stopped the program in 2000 and 2001, but the vaccination effort was resumed and greatly expanded in 2002.

Staff writer Bradley Graham and researcher Madonna Lebling contributed to this report.

© 2004 The Washington Post Company

Army braces for suit on malaria drug

By Brendan Nicholson
National Security Correspondent
Canberra
October 25, 2004

A Brisbane law firm plans to launch a class action on behalf of Australian soldiers who say they have suffered severe psychotic side effects from a common malaria pill they were issued during service in East Timor.

Simon Harrison, of Quinn and Scattini, said his firm had been contacted by several defence force members who said they were not fully informed of possible side effects of the drug, Lariam or mefloquine.

He said he understood up to 400 soldiers had been given Lariam – and some blamed it for side effects, including deep depression and suicidal thoughts.

Mr Harrison told The Age his firm was planning a class action against the Australian Defence Force on the soldiers’ behalf and it was also considering a product liability claim against the drug’s manufacturer in the United States.

A Defence Force spokeswoman confirmed that five soldiers had suffered “severe adverse events” after using Lariam but they were short-term effects. The spokeswoman rejected claims that there had been widespread side effects among defence personnel.

She said the Army Malaria Institute conducted research on mefloquine to assess its safety and effectiveness against other anti-malarial medications and research reports were being prepared.

The pharmaceutical company Roche, the manufacturer of Lariam, has itself warned that Lariam could cause psychiatric symptoms “in a number of patients, ranging from anxiety, paranoia and depression to hallucinations and psychotic behaviour”.

The company says if those using Lariam suffer acute anxiety, depression, restlessness or confusion that could indicate that a “more serious event” was coming and use of the drug should be discontinued.

The ADF spokeswoman said the ADF gave Lariam to personnel who could not tolerate the antibiotic, doxycycline.

Mefloquine was registered by the Federal Government’s Therapeutic Goods Administration and was the main anti-malarial drug prescribed by civilian travel medicine clinics to those heading for malarial areas.

She said the ADF was aware that side effects could include depression and paranoia.

The US Department of Veterans Affairs has warned US veterans returning from Afghanistan to watch out for possible long-term mental problems and other health effects from the drug.

The ADF’s director-general of defence health services, Air Commodore Tony Austin, told Australian troops through the army newspaper that the ADF was following those reports of adverse effects experienced by US troops in Afghanistan and Iraq.

“The drug is not our preferred choice within the ADF though it is recommended by the World Health Organisation and approved by the Australian Therapeutic Goods Administration and is in fact still the drug of choice by many civilian travellers,” he said.

“The issue coming out of the Middle East and Afghanistan of psychiatric effects with possible links to an increase in violence and suicide is very difficult to determine.”

– with AAP

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