Anthrax vaccine opponents gear up to renew fight
http://www.marinetimes.com/story.php?f=1-292925-2318585.php
By Gayle S. Putrich, Staff writer
As the Pentagon prepares to resume mandatory anthrax shots, vaccines opponents — including lawyers, medical experts and veterans — gathered Saturday in Washington to discuss current cases and potential legal avenues for helping those who say they were harmed by the vaccine.
The day-long seminar was held in the shadow of the Defense Department’s Oct. 16 announcement of its plan to resume mandatory anthrax vaccinations after a nearly two-year, court-ordered hiatus.
But Byron Holcomb, the lawyer who organized the seminar, said the day-long event was not prompted by the Pentagon’s policy change. He said it had been in the works since July with an underlying goal of trying to “see what we can do … to get us yoked together to do the right thing.”
Holcomb, a retired Navy judge advocate general who has been involved with various anthrax-related court cases since 2002, said every victim’s story pains him, and has spurred him to seek ways in which legal, medical and defense officials could cooperate to ensure those harmed by the vaccine get the legal and medical help they need.
“These are young people who are essentially done for in life,” Holcomb said.
The Defense Department’s recent announcement of its decision to restart the mandatory vaccination program made the seminar even more relevant and necessary, Holcomb said.
Part of the reason the Seattle-based lawyer wanted to hold the event in Washington was to make it easier for military lawyers who adjudicate contested findings from military medical and physical evaluations boards and military doctors, especially those from the vaccine health care center at Walter Reed Army Medical Center, to attend.
Holcomb said many were invited — but none came. He said those who had previously indicated they would attend canceled at the last minute, without giving a specific reason.
Although the Pentagon insists the vaccine is safe and effective, with an adverse event rate that is not outside the norm for other vaccines, reported side effects of the anthrax shots range from mild reactions such as rashes and sores to severe, incapacitating, irreversible damage.
For example, retired Air Force Capt. Kelli Donley, a former military lawyer, told seminar attendees she contracted idiopathic spinal cerebellar ataxia, a shrinking of the brain’s cerebellum, which governs motor function, after taking the first three shots of the six-shot anthrax vaccine regimen in 2000.
She said she began to suffer from slurred, slow speech, became clumsy in her movements and experienced numbness in the arm in which she received the shots. After returning to the U.S. from Korea, she underwent tests that showed her cerebellum was shrinking.
“It was a bittersweet relief — I wasn’t imagining this,” she said.
Also attending the seminar were Air Force Reserve Maj. Margaret McFann, a nurse diagnosed with lupus after receiving the vaccine, and former Air Force Reserve Lt. Col. Frank Fisher, a physician who contracted Still’s disease and became disabled after taking the shots. Still’s disease is a rare disorder marked by high, spiky fevers, rashes and joint pain that may lead to chronic arthritis.
Some service members have died after taking the shots, but the Defense Department says the deaths cannot be conclusively linked to the vaccine.
The Food and Drug Administration issued a report on adverse reactions to the anthrax vaccine last December, at about the same time that it made a final ruling on the safety and efficacy of the vaccine.
From July 1990 through March 2005, the government-sponsored Vaccine Adverse Event Reporting System (VAERS) logged 4,279 reports of health problems as a result of anthrax vaccine, 390 of which were classified as “serious.”
But critics of the vaccine have claimed the number of adverse events is actually much higher, and even the FDA acknowledged the voluntary nature of VAERS may lead to underreporting.
Dr. Mark Geier, a Maryland-based physician who previously worked as a researcher at the National Institutes of Health for 10 years and has studied vaccines for more than 30 years, told seminar attendees that his review of available data shows the anthrax vaccine has “a safety profile significantly worse than almost any civilian vaccine.”
Continuing the fight
The U.S District Court for the District of Columbia shut down the military’s mandatory anthrax vaccine program in December 2004 with an injunction.
At that time, Judge Emmet Sullivan ruled that forcing troops to take the vaccine amounted to an illegal order because the FDA had failed to follow its own regulatory procedures in declaring the drug safe and effective against all forms of anthrax, including the inhalation variety that defense officials say poses a threat to U.S. troops.
In the interim, defense officials launched a voluntary vaccination program. About half the troops offered the vaccine have taken it, officials said.
In December 2005, the FDA followed through on the approval process and a federal appeals court dissolved the injunction, clearing the way for the Pentagon to resume mandatory shots.
Mark Zaid, one of the lawyers representing the six anonymous military and civilian plaintiffs in the Doe v. Rumsfeld anthrax lawsuit, said he expects to file a new suit in the coming weeks to challenge the resumption of the mandatory program on the grounds that in addition to being potentially extremely harmful, the vaccine’s effectiveness is questionable at best.
“You can’t show it’s effective in humans from the studies,” said Zaid, who gave a legal history of the vaccine and the fight against the mandatory program at the seminar.
The suit will question the science behind the FDA’s approval of the vaccine, he said, which has been a pillar of the opposition’s strategy all along.
“There will be nothing new in this lawsuit,” Zaid said. “The Defense Department is just exploiting the weakness of the FDA.”
Geier noted that the efficacy of the anthrax vaccine is based on several studies in animals and has never been tested in a double-blind, placebo-controlled human vaccine trial.
The only study of anthrax vaccine use in humans, he said, was published in 1962 of a clinical trial among a little over 1,133 mill workers who handled animal hides.
In addition to being geared specifically toward the skin form of anthrax — not the inhalation variety troops would be expected to encounter on the battlefield — the vaccine in that trial had a different formulation than the current one, Geier said.
As it has from the beginning, the Pentagon maintains that the drug is safe and effective against all forms of anthrax.
“The licensed vaccine is safe, effective and based on sound science,” Dr. William Winkenwerder Jr., the Defense Department’s top health official, said in a statement. “This was determined by eight separate independent reviews, including the National Academy of Sciences’ Institute of Medicine.”
The IOM also states adverse events due to the anthrax vaccine are ‘comparable to those observed with other vaccines administered to adults,’ ” he said.
When the inoculation program resumes in 30 to 60 days, the shots will be mandatory for all service members, defense civilian employees and contractors going for more than 15 days to Korea or anywhere within the U.S. Central Command area of operations, which includes Afghanistan and Iraq.
U.S. personnel in those areas are considered by the Pentagon to be at “high risk” for weaponized anthrax exposure.
“We vaccinate our service members to protect them against deadly diseases — both natural and those potentially spread by terrorists or enemy forces,” Winkenwerder said. “Protection against anthrax is important to the mission, and that’s why we are returning to a mandatory program for those at higher risk.”
By Gayle S. Putrich, Staff writer
As the Pentagon prepares to resume mandatory anthrax shots, vaccines opponents — including lawyers, medical experts and veterans — gathered Saturday in Washington to discuss current cases and potential legal avenues for helping those who say they were harmed by the vaccine.
The day-long seminar was held in the shadow of the Defense Department’s Oct. 16 announcement of its plan to resume mandatory anthrax vaccinations after a nearly two-year, court-ordered hiatus.
But Byron Holcomb, the lawyer who organized the seminar, said the day-long event was not prompted by the Pentagon’s policy change. He said it had been in the works since July with an underlying goal of trying to “see what we can do … to get us yoked together to do the right thing.”
Holcomb, a retired Navy judge advocate general who has been involved with various anthrax-related court cases since 2002, said every victim’s story pains him, and has spurred him to seek ways in which legal, medical and defense officials could cooperate to ensure those harmed by the vaccine get the legal and medical help they need.
“These are young people who are essentially done for in life,” Holcomb said.
The Defense Department’s recent announcement of its decision to restart the mandatory vaccination program made the seminar even more relevant and necessary, Holcomb said.
Part of the reason the Seattle-based lawyer wanted to hold the event in Washington was to make it easier for military lawyers who adjudicate contested findings from military medical and physical evaluations boards and military doctors, especially those from the vaccine health care center at Walter Reed Army Medical Center, to attend.
Holcomb said many were invited — but none came. He said those who had previously indicated they would attend canceled at the last minute, without giving a specific reason.
Although the Pentagon insists the vaccine is safe and effective, with an adverse event rate that is not outside the norm for other vaccines, reported side effects of the anthrax shots range from mild reactions such as rashes and sores to severe, incapacitating, irreversible damage.
For example, retired Air Force Capt. Kelli Donley, a former military lawyer, told seminar attendees she contracted idiopathic spinal cerebellar ataxia, a shrinking of the brain’s cerebellum, which governs motor function, after taking the first three shots of the six-shot anthrax vaccine regimen in 2000.
She said she began to suffer from slurred, slow speech, became clumsy in her movements and experienced numbness in the arm in which she received the shots. After returning to the U.S. from Korea, she underwent tests that showed her cerebellum was shrinking.
“It was a bittersweet relief — I wasn’t imagining this,” she said.
Also attending the seminar were Air Force Reserve Maj. Margaret McFann, a nurse diagnosed with lupus after receiving the vaccine, and former Air Force Reserve Lt. Col. Frank Fisher, a physician who contracted Still’s disease and became disabled after taking the shots. Still’s disease is a rare disorder marked by high, spiky fevers, rashes and joint pain that may lead to chronic arthritis.
Some service members have died after taking the shots, but the Defense Department says the deaths cannot be conclusively linked to the vaccine.
The Food and Drug Administration issued a report on adverse reactions to the anthrax vaccine last December, at about the same time that it made a final ruling on the safety and efficacy of the vaccine.
From July 1990 through March 2005, the government-sponsored Vaccine Adverse Event Reporting System (VAERS) logged 4,279 reports of health problems as a result of anthrax vaccine, 390 of which were classified as “serious.”
But critics of the vaccine have claimed the number of adverse events is actually much higher, and even the FDA acknowledged the voluntary nature of VAERS may lead to underreporting.
Dr. Mark Geier, a Maryland-based physician who previously worked as a researcher at the National Institutes of Health for 10 years and has studied vaccines for more than 30 years, told seminar attendees that his review of available data shows the anthrax vaccine has “a safety profile significantly worse than almost any civilian vaccine.”
Continuing the fight
The U.S District Court for the District of Columbia shut down the military’s mandatory anthrax vaccine program in December 2004 with an injunction.
At that time, Judge Emmet Sullivan ruled that forcing troops to take the vaccine amounted to an illegal order because the FDA had failed to follow its own regulatory procedures in declaring the drug safe and effective against all forms of anthrax, including the inhalation variety that defense officials say poses a threat to U.S. troops.
In the interim, defense officials launched a voluntary vaccination program. About half the troops offered the vaccine have taken it, officials said.
In December 2005, the FDA followed through on the approval process and a federal appeals court dissolved the injunction, clearing the way for the Pentagon to resume mandatory shots.
Mark Zaid, one of the lawyers representing the six anonymous military and civilian plaintiffs in the Doe v. Rumsfeld anthrax lawsuit, said he expects to file a new suit in the coming weeks to challenge the resumption of the mandatory program on the grounds that in addition to being potentially extremely harmful, the vaccine’s effectiveness is questionable at best.
“You can’t show it’s effective in humans from the studies,” said Zaid, who gave a legal history of the vaccine and the fight against the mandatory program at the seminar.
The suit will question the science behind the FDA’s approval of the vaccine, he said, which has been a pillar of the opposition’s strategy all along.
“There will be nothing new in this lawsuit,” Zaid said. “The Defense Department is just exploiting the weakness of the FDA.”
Geier noted that the efficacy of the anthrax vaccine is based on several studies in animals and has never been tested in a double-blind, placebo-controlled human vaccine trial.
The only study of anthrax vaccine use in humans, he said, was published in 1962 of a clinical trial among a little over 1,133 mill workers who handled animal hides.
In addition to being geared specifically toward the skin form of anthrax — not the inhalation variety troops would be expected to encounter on the battlefield — the vaccine in that trial had a different formulation than the current one, Geier said.
As it has from the beginning, the Pentagon maintains that the drug is safe and effective against all forms of anthrax.
“The licensed vaccine is safe, effective and based on sound science,” Dr. William Winkenwerder Jr., the Defense Department’s top health official, said in a statement. “This was determined by eight separate independent reviews, including the National Academy of Sciences’ Institute of Medicine.”
The IOM also states adverse events due to the anthrax vaccine are ‘comparable to those observed with other vaccines administered to adults,’ ” he said.
When the inoculation program resumes in 30 to 60 days, the shots will be mandatory for all service members, defense civilian employees and contractors going for more than 15 days to Korea or anywhere within the U.S. Central Command area of operations, which includes Afghanistan and Iraq.
U.S. personnel in those areas are considered by the Pentagon to be at “high risk” for weaponized anthrax exposure.
“We vaccinate our service members to protect them against deadly diseases — both natural and those potentially spread by terrorists or enemy forces,” Winkenwerder said. “Protection against anthrax is important to the mission, and that’s why we are returning to a mandatory program for those at higher risk.”
