March 30, 2005

Anthrax Vaccinations Expected to Resume

By David Ruppe
Global Security Newswire

WASHINGTON — The U.S. Defense Department could soon resume anthrax vaccinations of U.S. military personnel pending a court decision expected this week or following a Food and Drug Administration decision sometime later, according to a lawyer for soldiers who sued to stop mandatory anthrax vaccinations (see GSN, Feb. 25).

A federal judge suspended the required shots last October, after finding that the FDA had not properly reviewed the vaccine before declaring it safe and effective against inhalation anthrax.

U.S. District Judge Emmet Sullivan, however, is expected to rule this week that his injunction does not bar vaccination using the unlicensed drug voluntarily, if authorized under a declared state of emergency.

Following a request from Deputy Defense Secretary Paul Wolfowitz, then-Health and Human Services Secretary Tommy Thompson declared such an emergency in January and issued an “emergency use authorization” for the voluntary vaccinations.

Although the vaccinations would be voluntary, soldiers could still be pressured into taking vaccine, which is believed to have some rare but severe side effects, said attorney Mark Zaid, representing military and civilian personnel in a lawsuit that pushed for the suspension. Without the emergency authorization, the law requires service-members to be informed about an unlicensed drug’s possible side effects and to consent to be vaccinated, unless that requirement is waived by the president.

Zaid said he expects Sullivan to allow the vaccinations to take place under the emergency authorization. The Defense Department has said it would provide vaccine recipients with a tri-fold brochure providing information on the vaccine and on options to accept or refuse the vaccine.

Zaid said, though, that several nongovernmental organizations in an “amicus curiae” brief are pressing Sullivan to require the Pentagon to offer potential recipients more information than the brochure now offers about the vaccine’s risks, to give that information prior to vaccination, and to have recipients sign a form indicating their consent to the vaccination.

“All I want is for them to be able to make an informed choice,” he said.

The government has argued that consideration of the brief is outside the court’s jurisdiction regarding the case.

FDA Ruling Pending

In addition, a 90-day comment period preceding a FDA determination on whether to license the vaccine for inhalation anthrax — a type anticipated in warfare or from terrorism — ended yesterday.

FDA licensing of the vaccine would allow the resumption of mandatory vaccinations without informed consent.

An FDA spokeswoman said yesterday there is no set date for the decision and that it would follow a review of the public comments.

Zaid expects the FDA to license the vaccine. It previously attempted to do so without full public comment in December 2003 after determining the vaccine is effective against skin and inhalation anthrax.

The plaintiffs contend there is insufficient research showing the drug is effective against inhalation anthrax, and so the drug should remain investigational and be administered either with the informed consent of the vaccine recipient or following a presidential order.

“You need to have an expert panel consider all of the evidence and make a recommendation to the FDA,” Zaid said.

March 21, 2005

Next Generation Smallpox Vaccine In Trials


BALTIMORE, March 21 -- Interim data from a phase I/II U.S. clinical trial of a next-generation vaccine for smallpox suggest the vaccine provides immunity without adverse events.

LC16m8 is a live attenuated smallpox vaccine that is produced in cell culture from vaccinia virus that has been attenuated, or modified, so that it can initiate an immune response without causing serious adverse effects. It has been licensed in Japan since 1980.

"The preliminary study results are consistent with the far larger Japanese experience", Dr. Richard Greenberg of the Kentucky School of Medicine, told the 2005 American Society for Microbiology Biodefense Research Meeting. "LC16m8, an attenuated smallpox vaccine, has had a 100 percent take rate and has been well tolerated -- intensive monitoring for myopericarditis has not uncovered any cardiac toxicity in the first 66 volunteers."

"Take rate" is a measure of a smallpox vaccine's effectiveness in producing an immune response.

The only smallpox vaccine licensed for use in the United States is made from unattenuated vaccinia virus and it has been associated with potentially fatal encephalitis and heart inflammation.

March 17, 2005

Soldiers Fear the NeedleThe Pentagon still fights for its anthrax vaccine

by Kareem Fahim, Village Voice

March 22nd, 2005 12:22 PMJesse Kearns says the anthrax vaccine caused his ongoing health woes, including heart attacks, blood clots, and a stroke.
Original link:

Jesse Kearns blames the anthrax vaccines, pumped into his right arm over 14 months while he served in the navy, for leaving him saddled with the medical woes of a man three times his age.Just 25, Kearns has suffered two heart attacks, including one he didn't notice, and a second that was nearly fatal; a stroke that left him disabled, with a slight limp; and blood clots, over the past few years, that have swollen his arms and legs.

His regular regimen of medicine, displayed on a shelf in his mother's Long Island kitchen, includes shots of a blood thinner called Lovenox, which he injects into his abdomen four times a day, leaving a painful trail of black and blue ringing his midriff.

Kearns said he thought nothing of taking the vaccines when doctors aboard his minesweeper in the Persian Gulf told the crew they were required. "I was 20 years old-I didn't know anything about it," he said, and added that refusing the vaccine would have put him at quick odds with his superiors and earned him nothing but derision from fellow sailors.Back in the U.S, concerns over the safety and effectiveness of the anthrax vaccine, which has been mandatory since March 1998 for service members, started to slowly churn in the military. Precise numbers aren't available, but hundreds of soldiers are thought to have left for fear of side effects from the vaccine. At least a hundred more were court-martialed for refusing.

A lore grew up around the shots, and critics claimed the anthrax vaccine, manufactured by a Michigan company called BioPort, might be responsible for ailments ranging from the still mysterious Gulf War Syndrome to death.Today, those protests have grown strong enough to halt the DOD program that administers the anthrax vaccine. In October, a Washington, D.C., district court judge, responding to a lawsuit brought by six John Doe soldiers, issued an injunction against the Anthrax Vaccine Immunization Program (AVIP), saying the process that allowed the shots to be licensed in the first place had been flawed."Congress has prohibited the administration of investigational drugs to service members without their consent," wrote Judge Emmet G. Sullivan. "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." The soldiers' lawyers contended that, among other things, since the Food and Drug Administration had not allowed a sufficient public comment period before licensing the vaccine as effective against a certain type of anthrax exposure-so-called "inhalation anthrax"-the required shots were unlawful.

In December, the Pentagon struck back and obtained emergency authorization to resume the program for military personnel on a voluntary basis. That move has also been controversial, and marks the first time a provision from the Project BioShield Act, a law passed three years after the 9-11 attacks intended to help federal agencies respond to terrorist emergencies, has been invoked.

The FDA has opened a public comment period on the vaccine, which is set to expire at the end of this month. Pentagon lawyers are then expected to argue that the injunction against the vaccine should be lifted, and again make it required of all soldiers.

A Pentagon spokesperson, responding to questions by e-mail, elaborated the reasons his agency thinks the vaccine should be mandatory. "The Department of Defense recognizes that military teams depend on each other to survive on the battlefield. That is why all vaccinations have traditionally been mandatory. The mutual dependence of each team member means each needs to be protected against preventable infections."

If the Defense Department prevails in court-and many observers think this is likely -it could mean a new round of defections, at a time when the U.S. military finds itself stretched between overseas engagements and is missing recruitment goals. Young people like Nick Lilienstern and Skip Muller-sailors who struggled to find honorable ways out of their service rather than receive the shots-could be the new victims of a vaccine that nobody seems to know too much about.

Muller and Lilienstern, who met when they served together briefly on a navy destroyer, found different ways to avoid taking the shots when they became required. Lilienstern refused outright, and immediately received a nonjudicial punishment. He was restricted to his ship for 45 days and received half-pay for two months. During that time, he said, the number of friends he had on his ship began to dwindle. When the captain threatened him with further sanctions-the same punishment for each of the six anthrax shots soldiers take in an 18-month series-his mother contacted their local congressman, and Lilienstern was discharged from the navy.

Skip Muller's superiors told him that refusing the vaccine would mean a court-martial, and possibly a dishonorable discharge. So he took some advice from a sympathetic senior officer and wrote a letter to the ship's captain explaining that he is gay. Within months, he received an honorable discharge.

The activists working against the anthrax vaccination program are a zealous bunch and include doctors, soldiers, lawyers, and former journalists. Their attack on the vaccine proceeds today more or less on two fronts. They argue, first, that there is not yet solid proof that the vaccine works against inhalation anthrax, the aerosol form of the agent that would likely be used to attack U.S. troops, and second, that side effects from the vaccine-which might include death-mean the shots should be voluntary and offered with a brochure that describes the risks. Or better, given that there has never been an anthrax attack directed against the U.S. military, that anthrax treatment shift to post-exposure antibiotics instead.Mark Zaid, one of the lawyers who brought the latest suit against DOD, has been fighting the anthrax vaccine program since it was introduced during the Clinton administration. He said the first service members who dealt with the vaccine dilemma were sailors, like Lilienstern, Muller, and Jesse Kearns-people who served on aircraft carriers and destroyers that were in, or getting ready to sail to, the Persian Gulf.

Zaid said the sailors, thousands of miles from home, were able to connect with the growing network of activists starting to raise concerns about the program. "These kids had Internet access. So they'd e-mail their moms, and their moms would do the research," he said. Many of these moms found the work of Meryl Nass, a doctor based in Maine who specializes in anthrax and bio-terrorism.

"Most people don't get sick," Nass told the Voice, "but a significant minority do." Nass said soldiers started contacting her about the vaccine in 1998, after many of them found a short article she had posted to an Internet mailing list. In the article, she noted there was still no answer to the question of what causes Gulf War Syndrome; and that the anthrax vaccine had not been subjected to a clinical trial.

The DOD maintains that the vaccine has an "extensive" safety record, noting that more than 1.3 million people have received the vaccine, and a million of those people are still on active duty. "The rate of adverse events is similar to other vaccines," wrote a Pentagon spokesperson in an e-mail, adding that the AVIP program is currently "paused." In fact, the program is not paused, legally, but stopped.

"There still exists no reliable clinical data from which to glean the types of adverse reactions, their rates, or severity," said Nass. While there have been extensive tests on animals, she noted that no one has been able to extrapolate that data to humans.

By the time Jesse Kearns's aunt started to suspect the anthrax vaccine was what had made her nephew sick, and started combing the Web for information on it, his illness was well advanced. In 2001, his arm inexplicably ballooned after he lifted a new macerator motor on his ship. Navy doctors told him he had deep-vein thrombosis, and that it would "take care of itself," he recalled. He returned to the U.S. on leave a few months later, and his arm swelled again. Doctors told him he had antiphospholipid syndrome, an autoimmune disease that causes blood clots, and prescribed Coumadin, an anticoagulant. Within eight months, he developed another blood clot in his right leg. His navy service ended in January 2003, and he started a job in a building-supply yard. He had trained on fire crews in the navy, but his condition meant he wouldn't be able to pass a fire department physical at home in New York. This is what Kearns regrets most about his illness, apart from the looming threat to his life: A troubled kid before joining the navy, Kearns had found his confidence working to put out fires on the ship, as well as a plan for his future. Kearns and his family are not sure the anthrax vaccine has anything to do with his ailments; as with many of those who receive the shots and then come down with unexplained illnesses, the rumors surrounding the anthrax shots-and the continuing sense of mystery-provides a possible answer. Dr. Nass said that studies linking vaccinations to Gulf War Syndrome call the anthrax vaccine a "separate risk factor.

"Whatever caused his illness, Kearns's struggle now is with the military bureaucracy. He has applied for disabled-veteran benefits, and today only receives $300 a month. He is in the midst of talks with the Department of Veterans Affairs to get more, so he can move out of his mother's house and start his life. "The suffering of this patient and his struggles to gain support for his medical care highlight how difficult it can be for service members to navigate the health care and disability systems," wrote Dr. Renata Engler, director of the Vaccine Healthcare Centers Network at Walter Reed Medical Center, who did an extensive write-up on the Kearns case. "The fact that he is administratively struggling for recognition of the seriousness of his illness and approached [us] because he felt he had to prove that his illness was service connected saddens this military physician with almost thirty years service."