Questioning Anthrax Vaccine Program

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"Potential injury from any vaccine alarms The National Vaccine Information Center, a private organization founded in 1982 by parents of children whose injuries or deaths were attributed to vaccinations. Barbara Loe Fisher, president and co-founder of the center, suggested the country should sink its anthrax resources into treating people after an attack."

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At Odds Over Anthrax
The Federal Government Wants To Stockpile Anthrax Vaccines To Protect Americans From A Biological Attack; Critics Question Costs, Wonder If Effort Is Even Necessary
April 10, 2006
By THOMAS D. WILLIAMS, Courant Staff Writer

Weaponized anthrax killed five Americans in 2001, yet the federal government is coming under criticism for its pursuit of vaccines to protect the United States from future attacks.

The government has committed to investing more than $1 billion to develop, buy and stockpile anthrax vaccines - fully one-quarter of a special fund created by President Bush for medical countermeasures against chemical, biological, radiological or nuclear attack on the United States.

Some critics, however, insist that the investment is misguided at best. There is no evidence that foreign terrorists are capable of a large-scale anthrax assault, they say, and there are other biological agents terrorists might find as easy to use. In any case, anthrax disease can be treated successfully with antibiotics. Some suggest the spending has more to do with politics than with actual threats.

Concerns over the military's use of the only currently licensed vaccine led to a halt, at least temporarily, to mandatory inoculations there. And although new vaccines are being commissioned, some people have warned that the government needs to better supervise its entire anthrax program or risk wasting money, making flawed decisions, and possibly putting the public in danger.

The issue is far from academic. In the event of a national emergency, the government has the power to order vaccination of civilians, regardless of whether the medications are licensed or experimental.

BioShield Target: Anthrax

It has been more than four years since Ottilie Lundgren took ill at her home in Oxford, Conn., and later died, the last victim of the nation's 2001 anthrax attacks - the only successful attacks of their kind in this country or any other. The FBI's main theory is that the weaponized anthrax was generated by a domestic, not foreign, source and most likely originated in a military laboratory.

The attacks have so far led to no criminal charges. What they did lead to, and quickly, was a realization that the country was ill prepared to defend itself against just such a nonconventional attack.

Anthrax spores used in 2001 were delivered through the mail, but government officials are worried about the potential for even greater harm if aerosolized spores could be released by a sprayer or some other device over an urban center. That scenario could put the population at risk of inhalation anthrax, the kind that killed Lundgren and the four other victims.

The United States has a vital need for a vaccine to protect the public against all forms of anthrax, said David P. Ropeik, director of risk communication at Harvard University's Center for Risk Analysis. Addressing all of the more than two dozen other biological threats would be daunting for taxpayers, he said, but anthrax and smallpox are two of a half-dozen mandating close government attention.

Annual civilian biodefense spending, $418 million in fiscal 2001, soared to $3.7 billion the following year and appreciably more every year since.

In 2004, Bush signed Project BioShield legislation, which authorizes spending $5.6 billion over 10 years to buy and stockpile vaccines and drugs to fight anthrax, smallpox and other potential agents of bioterror against the civilian population.

Of that, $1.4 billion is earmarked to buy and stockpile anthrax vaccines for use in case of a national emergency.

The U.S. Department of Health and Human Services has already begun awarding contracts to buy doses of the only licensed vaccine, Anthrax Vaccine Adsorbed, called AVA, and to develop and stockpile a next-generation vaccine.

For years, inhalation anthrax has been considered by the military to be the foremost threat in biological warfare.

"The chairman of the [Pentagon's] Joint Chiefs of Staff considers anthrax to be the No. 1 biological threat agent," said Barbara Goodno, a Pentagon spokeswoman. "Other government agencies and civilian authorities agree. The lethal anthrax attacks of fall 2001, including a death in Connecticut, show how easy it is to disperse anthrax spores with deadly effect."

Seven years ago, when former Defense Department Secretary William Cohen first ordered the mandatory anthrax inoculations for all 2.4 million people in the military, he based his decision on international threats, including Iraq's possession of anthrax spores supplied years earlier by a commercial U.S. biological laboratory.

Some weapons experts, however, say threats from abroad have been exaggerated and no evidence has ever been made public that any terrorist group worldwide, including al-Qaida, has ever successfully produced usable pathogenic anthrax spores.

Anthrax spores are effective because large quantities can be distributed through the air, and they last longer than many other biological agents. However, scientists say there are other biological agents as accessible and deployable as anthrax spores - the ricin and botulinum toxins among them. Also, weapons-grade anthrax is not easy to make or use, and variable winds make dispersing anthrax spores over a wide area problematic.

"The question is: Is anybody going to use anthrax as a weapon?" said Dr. Victor W. Sidel, co-author of the 2002 book "Terrorism and Public Health: A Balanced Approach to Strengthening Systems and Protecting People." "And if they do, we don't know what form of anthrax will be used. We don't know how anthrax materials will be modified or how they will be militarized."

He said the country needs to establish which proven diseases to work against, such as malaria, tuberculosis, AIDS, and which to disregard because they are being promoted for "a political reason" - comments echoed by John Richardson, a retired U.S. Air Force colonel who has contributed historical research on the anthrax vaccine to a federal lawsuit that blocked the military from ordering that military personnel be inoculated.

"Politicians only want to be able to say - in the aftermath of a terrorist event - that, `We did all we could do,'" Richardson said. "Defending against hypothetical bioterrorism deaths will bring in votes and contributions. The spending is driven by political expediency, not the threat.

"There is no magic shot that will immunize politicians from political consequences of terrorism," he said.

Licensing, Safety Issues

Under BioShield, the government has contracted with a biopharmaceutical company, VaxGen Inc., to produce 75 million doses of a new type of anthrax vaccine, called rPA102. The Washington Post reported in March that a setback in drug trials will prevent the company from meeting a November deadline to deliver the first 25 million doses into a national stockpile.

The only vaccine currently licensed for use, Anthrax Vaccine Adsorbed, made by BioPort Corp., requires a series of six shots before exposure: three initial doses at two-week intervals, followed by three additional doses at 6, 13 and 18 months. An annual booster is recommended.

The original license was granted for use against exposure to cutaneous anthrax, historically the most common - though still rare - form of the disease. People working with livestock are at risk of getting this type of anthrax through cuts or open sores.

Significant questions remain about the validity of using the vaccine for exposure to aerosolized spores - a scenario envisioned in a terrorist attack or on a battlefield. Critics of forced inoculations in the military argue that the vaccine has not been proved effective conclusively against inhaled spores in human or animal testing.

"To this day ... [the vaccine] has not been properly licensed for wide use against inhaled anthrax because of the pathetic level of evidence of safety, potency and efficacy," Connecticut Attorney General Richard Blumenthal said in a Dec. 30, 2005, court brief against forced inoculations in the military.

The U.S Food and Drug Administration disagrees. In reaffirming its licensing of the existing vaccine, the agency declared in December that "there are sufficient data from adequate, well-controlled clinical studies to assess the safety and effectiveness of AVA as a vaccine against anthrax infection regardless of route of exposure."

Six anonymous military employees mounted a legal challenge to mandatory vaccinations in the military, and a U.S. District judge last spring halted the mandatory inoculations. Voluntary inoculations have been allowed to continue. The Department of Defense has appealed the judge's ruling, but the appeals court sent it back to the trial judge for a reassessment.

BioPort says that contrary to criticism, its vaccine is proven and safe, and it has multiple government agencies to support it. The FDA and the Defense Department back it up, based on animal testing and data from past use on humans. The National Academy of Sciences Institute of Medicine released a report in 2002 that concluded the vaccine was acceptably safe and effective.

"Eighteen studies confirm the safety of BioPort's anthrax vaccine," the company says on its website. "Licensed for more than 30 years by the FDA, the safety profile of the anthrax vaccine is similar to that of the diphtheria and tetanus vaccines we give our children. ...

"Like with other vaccines, BioPort's anthrax vaccine may cause reactions in some individuals. Most of these reactions are limited to redness, itching and minor swelling at the site of injection; these events typically resolve in a matter of days."

The adverse reaction rate, once listed at 0.2 percent, is now listed at 5 percent to 35 percent.

The vaccine's package insert, warning doctors and vaccine users of possible, not proven, side effects, refers to unfavorable incidents reported to a national vaccine safety surveillance program called the Vaccine Adverse Event Reporting System, or VAERS. Though the program seeks to identify safety concerns, a VAERS listing does not prove that the reported malady was caused by the vaccination. Such events could have occurred coincidentally after vaccination.

From 1990 to 2001, more than 2 million doses of the vaccine were administered in the United States, followed by 1,850 reports to VAERS. About 6 percent of the reported events were listed as "serious." Such events include those that result in death, hospitalization, permanent disability or are life-threatening. Reports of fatalities included two sudden cardiac arrests, one myocardial infarction, one aplastic anemia, one suicide and one central nervous system lymphoma.

What About Antibiotics?

Potential injury from any vaccine alarms The National Vaccine Information Center, a private organization founded in 1982 by parents of children whose injuries or deaths were attributed to vaccinations.

Barbara Loe Fisher, president and co-founder of the center, suggested the country should sink its anthrax resources into treating people after an attack.

"Despite the fear and hysteria that has been created by physician health officials inside and outside of the Pentagon, there has not been one shred of evidence presented to the American people that biological weapons, including viable weaponized anthrax supplies, exist and are ready to be unleashed on the U.S.

"The wiser course may be to spend money to develop antidotes to anthrax exposure and have them ready to be dispersed at the first sign that there has been a real attack using weaponized anthrax," she said.

Inhalation of airborne anthrax can be treated after exposure by using antibiotics. The U.S. Department of Health and Human Services says that if there were a sizable anthrax attack on the civilian population now, the medical response would include antibiotics along with doses of the BioPort vaccine now in hand. The department says it has antibiotics to treat 40 million people.

The FDA acknowledges in its December ruling that antibiotic therapies are safe and effective in treating anthrax disease, and in the prevention of anthrax disease after exposure. It cautioned, however, that "long-term use of such therapies in individuals at high risk for anthrax disease, potentially for a period of years, has not been studied."

The FDA said the early stages of inhalation anthrax present flu-like symptoms, and a delay in a definitive diagnosis lessens the success rate for using antibiotics. In 2001, five of the 11 patients with inhalation anthrax died despite aggressive medical care, including antibiotic therapy, the FDA noted. The other six were treated and survived.

Protecting Vaccine Makers

A law passed by Congress in late December offers little comfort to people suspicious of mass vaccinations.

Unless a victim can prove willful misconduct, the law immunizes drug makers from lawsuits by people who become sick after they have been compelled to take a vaccine in a declared national health emergency.

The new law was designed to encourage drug makers to develop vaccines in preparation for a possible bird flu outbreak and other emergency situations, including biological attacks.

Sen. Bill Frist, R-Tenn., a force behind the law, said, "The bill strikes a reasonable balance where those who are harmed will be fairly compensated and life-saving products will be available in ample supply to protect and treat as many Americans as possible."

The law provides for a compensation fund covering serious injury or death, but opponents point out that it does not appropriate money for the fund.

Democratic Sens. Christopher J. Dodd of Connecticut and Edward Kennedy of Massachusetts were among those fighting the measure. In a combined press release, they said, "Without a real compensation program, the liability protection ... provides a Christmas present to the drug industry and bag of coal to everyday Americans."

Keeping An Eye On It All Almost none of the biological warfare vaccine spending has been audited by various federal agency inspectors general or the U.S. Government Accountability Office, the watchdog for Congress, with the exception of an audit six years ago of multimillion-dollar defense spending to modernize the anthrax vaccine manufacturing plant in Lansing, Mich.

Blumenthal, Connecticut's attorney general, noted that government spending in this area has increased tremendously and said the Government Accountability Office ought to be called in.

"I believe there should be a searching GAO investigation, not only as to Department of Defense and BioPort Corp., but of all the costs surrounding [new] vaccine development," he said.

Said Blumenthal: "We also need a new, safer and updated vaccine. I think the government should help invest in a new vaccine, but also exercise control over what the company charges."

The head of BioPort last year urged policy makers to use caution when pursuing so-called next-generation vaccines. In Congressional testimony last July, BioPort President and CEO Robert G. Kramer called for "a multi-disciplined review" to consider vaccine proposals. "The risks of failure are too great and the cost of failure is too large to simply continue to operate in a vacuum," Kramer said.

His comments were echoed in December 2005 by Andrea Meyerhoff, former director of WMD Defense for the Department of Defense and former director of counterterrorism for the FDA.

"We must take steps to avoid the potential for flawed decisions because unproven countermeasures can be a waste of taxpayers' money, and worse, may not be safe and effective," Meyerhoff said. "Without oversight by an independent advisory oversight board, there is a real risk that an experimental, unproven countermeasure may be used in a bioterror attack, potentially resulting in unexpected side effects and failure to protect the public."

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