Thursday, October 12, 2006

Anthrax Vaccine for Servicemembers, legal status

In October 2004, federal district court judge Sullivan ruled that the anthrax vaccine had not undergone proper procedures for licensure, and made a previously temporary injunction prohibiting forced vaccinations, permanent. This effectively removed the vaccine's license.

In early 2005 DOD asked FDA and HHS for permission (an “Emergency Use” authorization—though DOD attorneys had informed Judge Sullivan there was no emergency) to continue to use the vaccine, although unlicensed, based on new legislation passed for bioterrorism emergencies or potential emergencies. Permission was granted, but the judge required that vaccinations be voluntary and not mandatory, as they had been, and that a copy of his ruling be placed in every clinic administering anthrax vaccine.

Subsequently, only about 10% of those persons asked to take the vaccine have done so voluntarily, and only a fraction of these complete the full course of inoculations. Similar data regarding acceptance rates for anthrax vaccinations in British troops, where vaccination has always been voluntary, has been published in two articles.

In December 2005, FDA issued a new “Final Rule” for anthrax vaccine, following a required comment period. FDA glossed over many of the scientific and legal concerns that were raised in the hundreds of comments received, claiming the vaccine was safe and effective.

On Sept. 7, 2006, after an appeals court had remanded the case back to Judge Sullivan, he refused to vacate his original order. This means that the vaccine was improperly licensed until FDA issued its Final Rule in December 2005. Vaccinations have remained voluntary. Those who were punished for refusing the vaccine may now seek to get their record reversed and might be able to be reinstated.

Evaluating and Treating the Illnesses Following Vaccinations

Thousands of vaccine recipients are still sick, and the military Vaccine Healthcare Centers have processed over 1200 persons who were seriously injured (putatively) by anthrax vaccine. The military has tried to remove funding for these centers over the past two funding cycles, but Congress has stepped in and guaranteed funding, so far. These centers were created by Congress to care for those with vaccine injuries, and they have developed considerable expertise in the evaluation of injured soldiers. Cures, however, remain a long way away, and little if any research is being done in this area. The Vaccine Healthcare Centers (at Walter Reed Army Medical Center in Washington, D.C.; Lackland Air Force Base in Texas; Portsmouth Naval Base, Virginia; and Fort Bragg, North Carolina) have yet to publish descriptions of the illnesses they are treating, and research they have performed. Because there are so few physicians who are knowledgeable about these illnesses, reservists, veterans and Merchant Mariners are all eligible for treatment at a military Vaccine Healthcare Center.

Disability Settlements

One case of a Merchant Marine who became disabled immediately following anthrax and smallpox vaccinations was settled early this year for about $2 million. I believe this is the only anthrax vaccine injury case to have been resolved. Only Merchant Mariners have the potential to sue over injuries (they can sue the shipping company that required the vaccinations under Maritime law), because the Feres Doctrine prevents soldiers from suing the U.S. government for injuries received "incident to military service."

“Licensed” Smallpox Vaccinations Still Mandatory

Although the smallpox vaccine program for civilians died, due to adverse reactions, after only 40,000 people were vaccinated, the vaccine is still mandatory in the military. Because no major legal effort has been undertaken to fight this vaccine, as was done for anthrax vaccine, it continues to be given to all U.S. soldiers deployed to Iraq, Afghanistan and possibly Korea. The military reports that over 1 million soldiers have been inoculated for smallpox since December 2002. There have been a number of cases of myo-pericarditis (inflammation of the heart) as a result. Some of these cases have gone on to develop heart failure. It is possible that some of the “mystery (noninfectious) pneumonia” cases that have occurred in Iraq and Afghanistan, and some of the non-combat deaths in soldiers deployed overseas are due to this vaccine complication.

Yet the military is using over twenty year-old, expired smallpox vaccine for its soldiers. Although FDA gave this expired product a license, FDA regulations say that expired product cannot be used, as it is considered adulterated. Were the smallpox vaccine license to be challenged in court, it would almost certainly be judged to have been licensed improperly, as happened for anthrax vaccine.

Mandatory Vaccinations for Civilians?

What should concern ordinary Americans is the purchase, by the Department of Health and Human Services, of 10 million doses of the military’s anthrax vaccine for the civilian stockpile, at a cost of $243 million. DHHS has additionally contracted to purchase 75 million doses of a similar vaccine for $877 million. Legislation proposed by Senator Richard Burr (R-NC) would create a new federal agency to oversee the development of new remedies for bioterrorism, but under a veil of secrecy greater than that granted the CIA.

Thus, very little may be known about the drugs and vaccines produced until an emergency arose. The products do not even have to be licensed by FDA to be stockpiled for use. Yet millions of Americans could be forced (under other recently passed bioterrorism legislation) to take such products.

Burr’s bill would give drug and vaccine manufacturers complete immunity from liability for injuries caused by the drugs and vaccines produced for the new agency. This would speed up drug and vaccine development, and decrease costs, since the manufacturers would not require liability insurance. However, it would result in a situation in which stockpiled drugs and vaccines may have undergone only very limited testing in humans, with unknown safety profiles and questionable effectiveness. When, in response to an emergency, they are used in millions of people, if severe side effects occur, those affected would have no legal recourse. They could not sue for damages or have their medical care covered.

I don’t think Americans who support this legislation understand the full implications of this. Over 100 million doses of smallpox vaccine have been contracted for by HHS, yet in a clinical trial conducted by the manufacturer, one in 145 recipients showed evidence of heart inflammation, when their blood was tested. Due to known severe side effects, HHS cancelled a trial of smallpox vaccine in toddlers. But if the government specifies that an emergency is developing, even newborns will receive smallpox vaccine.

A safer version of smallpox vaccine, Modified Vaccinia Ankara (MVA), should have been purchased instead. But the government is still deciding how many doses it wants of MVA, and current plans are to give it only to a small proportion of the population, those with damaged immune systems, pregnant women and possibly infants.

If the new federal agency is allowed to operate in complete secrecy, there may be little incentive to purchase the safest products available for the stockpile.

Meryl Nass, M.D.
September 23, 2006
MDI Hospital
Bar Harbor, Maine 04609

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