FDA fails to halt anthrax anxiety
Insight Mazagine
By Timothy W. Maier
For thousands of Gulf War veterans the holiday season was a roller-coaster ride. Many celebrated when a federal judge ruled in late December the anthrax vaccine was experimental if used to protect against inhaled anthrax instead of anthrax poisoning by skin contact.
The ruling immediately put a halt to the military's anthrax-vaccination program in which more than 1 million troops already have been inoculated since 1998. But eight days later, on Dec. 30, the U.S. Food and Drug Administration dropped a bombshell that in effect reversed the court ruling by declaring the anthrax shot was safe and effective against anthrax delivered by aerosol spray. The adverse-reaction rate of the anthrax vaccine is anywhere from 5 percent to 35 percent.
In 1972, the FDA gained jurisdiction over vaccines and related products from the National Institutes of Health. In 1985 the FDA proposed the anthrax vaccine and some others as safe and effective against bacterial infections but never completely certified those conclusions.
The recent finding, eight days after the court ruling on anthrax vaccination of U.S. troops, was said to be part of a process to certify proposals and findings since the FDA took jurisdiction more than 30 years ago. The official explanation for the timing is that the anthrax attacks of 2001 pushed the FDA to finish the job and issue a final rule based on a review by an expert panel. In any case, the FDA released its final ruling with a prepared statement that clearly indicated a bureaucratic reaction to the decision of the federal court.
"A recent ruling by a United States District Court for the District of Columbia gave the opinion that the anthrax vaccine should be classified as 'investigational' with regard to protecting against inhalation anthrax," the FDA stated. "Today's final rule and order make it clear that FDA does not regard the approved anthrax vaccine as 'investigational' for protection against inhalation anthrax." So that no one missed the point, the FDA also declared this ruling should be noted in any further litigation.
"This will end all lawsuits," claims D. Jacques Smith, an attorney for Michigan-based BioPort Corp., the sole supplier of the anthrax vaccine. "We always believed that the vaccine had a very low risk. The risks are equal to the flu vaccine that I received last month." Except for one slight detail: Coroners do not cite the flu vaccine itself as the cause of death, while the anthrax and smallpox vaccines given to U.S. military troops have been listed as the cause of death for at least a half-dozen veterans, according to civilian medical examiners. Pentagon doctors in turn dispute those conclusions.
The immediate approval of the anthrax vaccine set off a firestorm of criticism among veterans who believe they are being subjected to unnecessary risk. One veteran put it this way: "The ruling is decades overdue and rife with problems, including relying on animal data to fill the legal void created due to the lack of valid human data. A full vetting of the facts is required in order to hold Department of Defense and FDA officials accountable for their abuses of power and discretion."
That full vetting is not likely to happen.
Congress disappeared from the debate shortly after Capitol Hill offices were struck by the anthrax mailings in 2001, and it now appears unlikely that there will be hearings about these problems, especially in light of the recent FDA final ruling. Immediately seizing on the FDA's decision, the Justice Department requested U.S. District Judge Emmet G. Sullivan set aside his preliminary ban and proceed with the class-action lawsuit against the Pentagon by six "John Doe" plaintiffs seeking to stop the vaccination program.
Sullivan, who had ruled that U.S. soldiers should not be used as "guinea pigs" for experimental drugs, since has backpedaled in light of the FDA's finding. While his ban was in line with findings of experimentation by congressional reports from both the House and Senate, the FDA's ruling left him no choice. He lifted the ban Jan. 7, but not before he called the FDA ruling "highly suspicious," following as it did so closely upon the heels of his injunction. "Only after the issuance of an injunction, up pops a federal rule," Sullivan declared with acid sarcasm to Justice Department attorney Shannen Coffin, who is representing the Pentagon in the lawsuit filed by the six John Does. "And you're telling me it's coincidental?" "I'd stand on a stack of Bibles and tell you it's coincidental," Coffin replied to Sullivan. "That's an amazing coincidence," Sullivan shot back.
The FDA claims its final ruling was made prior to Sullivan's holding even though it was not made public until after the ban was implemented. Nonetheless, Sullivan's ban prevented several thousand troops from receiving the inoculation before being sent out to high-risk areas to fight the war on terrorism. Coffin argued that every day the injunction was in place meant that 1,000 additional troops could face harm for being unprotected from anthrax.
Sullivan's ban also prompted an angry response from Assistant Secretary of Defense William Winkenwerder, who called it bad medicine. "It challenges the conclusions of America's best medical experts," he told reporters at his weekly briefing in late December.
Winkenwerder stressed "paramount concern" for the safety of the troops and noted from the evidence of anthrax attacks in the United States that "it doesn't take a Scud missile to kill with anthrax. All it takes is an envelope."
Indeed, said Winkenwerder, "The safety and the effectiveness of the anthrax-immunization program is based upon the best science in the world. In March 2002, the National Academy of Sciences' Institute of Medicine concluded in an exhaustive 250-page report – right here – that the anthrax vaccine is, and I quote from this report, 'an effective vaccine for the protection of humans against anthrax, including inhalation anthrax, caused by all known or plausible engineered strains of bacillus anthracis' – that's the medical term for anthrax. The department fully supports this scientific finding and those of the FDA that the anthrax vaccine is safe and effective against all forms of anthrax." Critics shrugged that FDA bureaucrats had been brought in to rescue the military, to offset claims that U.S. troops were being used as guinea pigs.
While the Pentagon appears to have won the first round, Mark Zaid, who is representing the six anonymous plaintiffs, says he is not about to quit. The scrappy attorney says the ruling "is nothing more than after-the-fact gamesmanship to overrule the court's findings. It appears to be reflective of policy duress rather than independent analysis."
The central issue is whether the anthrax vaccine is licensed for inhalation anthrax, Zaid says. In hindsight, the plaintiff attorney says the Pentagon might have avoided the entire controversy by claiming that the vaccine was to protect troops in case they came into contact with anthrax through the skin, because no one disputes it was licensed for that situation. "If they had taken that posture from day one they could have gotten away with it," Zaid says, although he believes there are legitimate health-risk issues even in that case which have not been fully addressed.
Zaid now plans to argue against the FDA's ruling that the vaccine is safe and will challenge the manner in which the Pentagon may have violated the process by giving the vaccines to some troops out of sequence. The FDA requires that a six-shot regime must be followed in a specific order and completed in a specific time frame for the vaccine to work effectively.
Since 9-11 there no longer are hundreds of veterans publicly speaking out against the vaccine, but there remain pockets of resistance, primarily among reservists who believe adverse reactions to the vaccine may affect their civilian employment. These critics point to Sept. 20, 1996, when the manufacturer submitted a request for an investigational new drug application, IND 6847, to the FDA for new labeling of the vaccine, which would indicate use for inhalation anthrax.
Shortly afterward on Oct. 15, 1996, the Army placed an ad in the Washington Post to recruit subjects for experimental research related to the manufacturer's requested IND. An angry FDA fired back a letter to the chairman of the Army's Human Use Committee at Fort Detrick, Md., objecting to the request and advertisement. Reservists believe the Pentagon's decision to try to change the labeling in 1996 proved one thing.
"The DoD knew its use of the anthrax vaccine was experimental," charges a reservist who asked not to be identified. "The FDA also knew. Both agencies are circling the wagons, protecting themselves, rather than correcting the wrongs inflicted on thousands of soldiers. The dilemma is an ethics case study of failures to self-regulate and act in the best interests of our citizens and soldiers."
While the manufacturer never got its new label, BioPort now can, says FDA spokeswoman Lenore Gelb. However, she says, that may not be necessary because the previous label says the vaccine protects regardless of the route of anthrax exposure. The FDA approved the vaccine in 1970 both for inhalation anthrax and skin contact, she insists. The FDA's position is that the vaccine was never investigational, except when it was used on postal workers.
Gelb explains the vaccine is considered investigational with postal employees because it was used only after they were exposed to anthrax. She also claims that neither the Pentagon nor the White House applied pressure on the FDA to issue its final ruling after the judge dropped the hammer on the Pentagon for using experimental drugs on U.S. troops. "It's something that has been in the process for some time," she says. Critics, meanwhile, point to a jump in adverse reactions to the vaccine that increased from 0.2 percent to somewhere between 5 percent and 35 percent. Col. John Grabenstein, deputy director of the anthrax-immunization program, downplayed those statistics, claiming most of these reactions reflect a change in collection method. The reactions are minor, he says, ranging from headaches to swelling at the injection site.
"If you asked – if you went looking for the side-effect data on flu shots, you'd be getting something in the range of 5 to 35 percent. These are not scary numbers," he insists.
"Tell it to Rachael Lacy!" says a member of the armed forces who asked not to be identified for fear of retaliation. She is the U.S. Army sergeant who died last year because of complications from the vaccine, according to an autopsy report from the Mayo Clinic in Rochester, Minn. Six others also died mysteriously after rolling up their sleeves to receive the anthrax and smallpox shots. But the Pentagon and the FDA dismissed these and related claims, declaring that the vaccine has a 92 percent rate of effectiveness.
Even so, some studies suggest the vaccine does not work against all strains. And while the Pentagon has remained steadfast in its claim of safety, it quietly has told veterans to be careful what they say about the vaccine. The fear of such intimidation has many worried veterans telling Insight that they no longer report what they believe to be vaccine-related illnesses. What also may become alarming is a wave of pneumonia cases that some believe are related to the shots. Already, at least 17 have died as a result of complications from pneumonia.
The recent FDA finding also appears to be a direct shot at the ongoing lawsuit filed by six John Does who argue that the anthrax vaccination was an illegal experiment because, they claim, it was investigational for inhaled anthrax and therefore banned.
In 1991, after many Gulf War I veterans returned home with mysterious illnesses, Congress passed legislation forbidding the Pentagon from using troops as guinea pigs. If the anthrax vaccine was the cause of Gulf War Syndrome it certainly would not be the first time the military served up troops for experiments. The government failed to warn troops in World War II about the potential long-term dangers of mustard gas, and the same was true of atomic radiation during the Cold War and Agent Orange in Vietnam. This experience, combined with the latest outbreak of pneumonia that appears to be related to the anthrax vaccine, has created uneasiness among military personnel.
About 500 active-duty troops have refused to take the vaccine after a series of reports on deaths and illnesses came to light. The Pentagon has court-martialed about 200 of these troops. In addition another 500 pilots and flight-crew members have quit or transferred from the Air National Guard or Reserves, according to plaintiffs' lawyers, troops and base sources.
But Winkenwerder insists the storm has passed. Since 9-11, he boasts, only 10 troops have refused the vaccinations, while 600,000 to 700,000 rolled up their sleeves and did as they were told. "So, contrary to what I think has already appeared in the press about several hundred service members refusing, that was prior to Sept. 11, in the period of 1998 and 1999," Winkenwerder says. "Our experience the last two years is that our service members support the vaccine program and accept it."
Not everyone is accepting Winkenwerder's view.
"The [Department of Defense's]conscious mandate of anthrax vaccine for an unapproved use is just the tip of the proverbial iceberg, an ethical dilemma looming beneath the surface," charges a high-ranking veteran. "Illegal manufacturing changes before the first Gulf War increased the potency up to a hundredfold, adulterating the vaccine. DoD failed to study the vaccine in general or the illegal changes made to the vaccine as a possible cause of Gulf War illness." The FDA does admit it is continuing to study long-term health risks associated with the anthrax shot. The results of that study have yet to be completed.
This alone makes some wonder why the study was not completed prior to troops being subjected to the vaccine. They will have to wait to find out if there are long-term problems. But by then, some worry, it might be too late.
By Timothy W. Maier
For thousands of Gulf War veterans the holiday season was a roller-coaster ride. Many celebrated when a federal judge ruled in late December the anthrax vaccine was experimental if used to protect against inhaled anthrax instead of anthrax poisoning by skin contact.
The ruling immediately put a halt to the military's anthrax-vaccination program in which more than 1 million troops already have been inoculated since 1998. But eight days later, on Dec. 30, the U.S. Food and Drug Administration dropped a bombshell that in effect reversed the court ruling by declaring the anthrax shot was safe and effective against anthrax delivered by aerosol spray. The adverse-reaction rate of the anthrax vaccine is anywhere from 5 percent to 35 percent.
In 1972, the FDA gained jurisdiction over vaccines and related products from the National Institutes of Health. In 1985 the FDA proposed the anthrax vaccine and some others as safe and effective against bacterial infections but never completely certified those conclusions.
The recent finding, eight days after the court ruling on anthrax vaccination of U.S. troops, was said to be part of a process to certify proposals and findings since the FDA took jurisdiction more than 30 years ago. The official explanation for the timing is that the anthrax attacks of 2001 pushed the FDA to finish the job and issue a final rule based on a review by an expert panel. In any case, the FDA released its final ruling with a prepared statement that clearly indicated a bureaucratic reaction to the decision of the federal court.
"A recent ruling by a United States District Court for the District of Columbia gave the opinion that the anthrax vaccine should be classified as 'investigational' with regard to protecting against inhalation anthrax," the FDA stated. "Today's final rule and order make it clear that FDA does not regard the approved anthrax vaccine as 'investigational' for protection against inhalation anthrax." So that no one missed the point, the FDA also declared this ruling should be noted in any further litigation.
"This will end all lawsuits," claims D. Jacques Smith, an attorney for Michigan-based BioPort Corp., the sole supplier of the anthrax vaccine. "We always believed that the vaccine had a very low risk. The risks are equal to the flu vaccine that I received last month." Except for one slight detail: Coroners do not cite the flu vaccine itself as the cause of death, while the anthrax and smallpox vaccines given to U.S. military troops have been listed as the cause of death for at least a half-dozen veterans, according to civilian medical examiners. Pentagon doctors in turn dispute those conclusions.
The immediate approval of the anthrax vaccine set off a firestorm of criticism among veterans who believe they are being subjected to unnecessary risk. One veteran put it this way: "The ruling is decades overdue and rife with problems, including relying on animal data to fill the legal void created due to the lack of valid human data. A full vetting of the facts is required in order to hold Department of Defense and FDA officials accountable for their abuses of power and discretion."
That full vetting is not likely to happen.
Congress disappeared from the debate shortly after Capitol Hill offices were struck by the anthrax mailings in 2001, and it now appears unlikely that there will be hearings about these problems, especially in light of the recent FDA final ruling. Immediately seizing on the FDA's decision, the Justice Department requested U.S. District Judge Emmet G. Sullivan set aside his preliminary ban and proceed with the class-action lawsuit against the Pentagon by six "John Doe" plaintiffs seeking to stop the vaccination program.
Sullivan, who had ruled that U.S. soldiers should not be used as "guinea pigs" for experimental drugs, since has backpedaled in light of the FDA's finding. While his ban was in line with findings of experimentation by congressional reports from both the House and Senate, the FDA's ruling left him no choice. He lifted the ban Jan. 7, but not before he called the FDA ruling "highly suspicious," following as it did so closely upon the heels of his injunction. "Only after the issuance of an injunction, up pops a federal rule," Sullivan declared with acid sarcasm to Justice Department attorney Shannen Coffin, who is representing the Pentagon in the lawsuit filed by the six John Does. "And you're telling me it's coincidental?" "I'd stand on a stack of Bibles and tell you it's coincidental," Coffin replied to Sullivan. "That's an amazing coincidence," Sullivan shot back.
The FDA claims its final ruling was made prior to Sullivan's holding even though it was not made public until after the ban was implemented. Nonetheless, Sullivan's ban prevented several thousand troops from receiving the inoculation before being sent out to high-risk areas to fight the war on terrorism. Coffin argued that every day the injunction was in place meant that 1,000 additional troops could face harm for being unprotected from anthrax.
Sullivan's ban also prompted an angry response from Assistant Secretary of Defense William Winkenwerder, who called it bad medicine. "It challenges the conclusions of America's best medical experts," he told reporters at his weekly briefing in late December.
Winkenwerder stressed "paramount concern" for the safety of the troops and noted from the evidence of anthrax attacks in the United States that "it doesn't take a Scud missile to kill with anthrax. All it takes is an envelope."
Indeed, said Winkenwerder, "The safety and the effectiveness of the anthrax-immunization program is based upon the best science in the world. In March 2002, the National Academy of Sciences' Institute of Medicine concluded in an exhaustive 250-page report – right here – that the anthrax vaccine is, and I quote from this report, 'an effective vaccine for the protection of humans against anthrax, including inhalation anthrax, caused by all known or plausible engineered strains of bacillus anthracis' – that's the medical term for anthrax. The department fully supports this scientific finding and those of the FDA that the anthrax vaccine is safe and effective against all forms of anthrax." Critics shrugged that FDA bureaucrats had been brought in to rescue the military, to offset claims that U.S. troops were being used as guinea pigs.
While the Pentagon appears to have won the first round, Mark Zaid, who is representing the six anonymous plaintiffs, says he is not about to quit. The scrappy attorney says the ruling "is nothing more than after-the-fact gamesmanship to overrule the court's findings. It appears to be reflective of policy duress rather than independent analysis."
The central issue is whether the anthrax vaccine is licensed for inhalation anthrax, Zaid says. In hindsight, the plaintiff attorney says the Pentagon might have avoided the entire controversy by claiming that the vaccine was to protect troops in case they came into contact with anthrax through the skin, because no one disputes it was licensed for that situation. "If they had taken that posture from day one they could have gotten away with it," Zaid says, although he believes there are legitimate health-risk issues even in that case which have not been fully addressed.
Zaid now plans to argue against the FDA's ruling that the vaccine is safe and will challenge the manner in which the Pentagon may have violated the process by giving the vaccines to some troops out of sequence. The FDA requires that a six-shot regime must be followed in a specific order and completed in a specific time frame for the vaccine to work effectively.
Since 9-11 there no longer are hundreds of veterans publicly speaking out against the vaccine, but there remain pockets of resistance, primarily among reservists who believe adverse reactions to the vaccine may affect their civilian employment. These critics point to Sept. 20, 1996, when the manufacturer submitted a request for an investigational new drug application, IND 6847, to the FDA for new labeling of the vaccine, which would indicate use for inhalation anthrax.
Shortly afterward on Oct. 15, 1996, the Army placed an ad in the Washington Post to recruit subjects for experimental research related to the manufacturer's requested IND. An angry FDA fired back a letter to the chairman of the Army's Human Use Committee at Fort Detrick, Md., objecting to the request and advertisement. Reservists believe the Pentagon's decision to try to change the labeling in 1996 proved one thing.
"The DoD knew its use of the anthrax vaccine was experimental," charges a reservist who asked not to be identified. "The FDA also knew. Both agencies are circling the wagons, protecting themselves, rather than correcting the wrongs inflicted on thousands of soldiers. The dilemma is an ethics case study of failures to self-regulate and act in the best interests of our citizens and soldiers."
While the manufacturer never got its new label, BioPort now can, says FDA spokeswoman Lenore Gelb. However, she says, that may not be necessary because the previous label says the vaccine protects regardless of the route of anthrax exposure. The FDA approved the vaccine in 1970 both for inhalation anthrax and skin contact, she insists. The FDA's position is that the vaccine was never investigational, except when it was used on postal workers.
Gelb explains the vaccine is considered investigational with postal employees because it was used only after they were exposed to anthrax. She also claims that neither the Pentagon nor the White House applied pressure on the FDA to issue its final ruling after the judge dropped the hammer on the Pentagon for using experimental drugs on U.S. troops. "It's something that has been in the process for some time," she says. Critics, meanwhile, point to a jump in adverse reactions to the vaccine that increased from 0.2 percent to somewhere between 5 percent and 35 percent. Col. John Grabenstein, deputy director of the anthrax-immunization program, downplayed those statistics, claiming most of these reactions reflect a change in collection method. The reactions are minor, he says, ranging from headaches to swelling at the injection site.
"If you asked – if you went looking for the side-effect data on flu shots, you'd be getting something in the range of 5 to 35 percent. These are not scary numbers," he insists.
"Tell it to Rachael Lacy!" says a member of the armed forces who asked not to be identified for fear of retaliation. She is the U.S. Army sergeant who died last year because of complications from the vaccine, according to an autopsy report from the Mayo Clinic in Rochester, Minn. Six others also died mysteriously after rolling up their sleeves to receive the anthrax and smallpox shots. But the Pentagon and the FDA dismissed these and related claims, declaring that the vaccine has a 92 percent rate of effectiveness.
Even so, some studies suggest the vaccine does not work against all strains. And while the Pentagon has remained steadfast in its claim of safety, it quietly has told veterans to be careful what they say about the vaccine. The fear of such intimidation has many worried veterans telling Insight that they no longer report what they believe to be vaccine-related illnesses. What also may become alarming is a wave of pneumonia cases that some believe are related to the shots. Already, at least 17 have died as a result of complications from pneumonia.
The recent FDA finding also appears to be a direct shot at the ongoing lawsuit filed by six John Does who argue that the anthrax vaccination was an illegal experiment because, they claim, it was investigational for inhaled anthrax and therefore banned.
In 1991, after many Gulf War I veterans returned home with mysterious illnesses, Congress passed legislation forbidding the Pentagon from using troops as guinea pigs. If the anthrax vaccine was the cause of Gulf War Syndrome it certainly would not be the first time the military served up troops for experiments. The government failed to warn troops in World War II about the potential long-term dangers of mustard gas, and the same was true of atomic radiation during the Cold War and Agent Orange in Vietnam. This experience, combined with the latest outbreak of pneumonia that appears to be related to the anthrax vaccine, has created uneasiness among military personnel.
About 500 active-duty troops have refused to take the vaccine after a series of reports on deaths and illnesses came to light. The Pentagon has court-martialed about 200 of these troops. In addition another 500 pilots and flight-crew members have quit or transferred from the Air National Guard or Reserves, according to plaintiffs' lawyers, troops and base sources.
But Winkenwerder insists the storm has passed. Since 9-11, he boasts, only 10 troops have refused the vaccinations, while 600,000 to 700,000 rolled up their sleeves and did as they were told. "So, contrary to what I think has already appeared in the press about several hundred service members refusing, that was prior to Sept. 11, in the period of 1998 and 1999," Winkenwerder says. "Our experience the last two years is that our service members support the vaccine program and accept it."
Not everyone is accepting Winkenwerder's view.
"The [Department of Defense's]conscious mandate of anthrax vaccine for an unapproved use is just the tip of the proverbial iceberg, an ethical dilemma looming beneath the surface," charges a high-ranking veteran. "Illegal manufacturing changes before the first Gulf War increased the potency up to a hundredfold, adulterating the vaccine. DoD failed to study the vaccine in general or the illegal changes made to the vaccine as a possible cause of Gulf War illness." The FDA does admit it is continuing to study long-term health risks associated with the anthrax shot. The results of that study have yet to be completed.
This alone makes some wonder why the study was not completed prior to troops being subjected to the vaccine. They will have to wait to find out if there are long-term problems. But by then, some worry, it might be too late.
