February 20, 2000


Garth L. Nicolson, The Institute for Molecular Medicine, Huntington Beach, CA 92649
Meryl Nass, Parkview Hospital, Brunswick, ME 04011
Nancy L. Nicolson, The Institute for Molecular Medicine, Huntington Beach, CA 92649

In 1999 2.4 million U.S. Armed Forces personnel, including more than one million reserve and National Guard members, were ordered to receive anthrax vaccine over a period of several years.

This was justified to counter an increasing threat from hostile countries and possibly terrorist groups that now or in the future will likely possess the capability of fielding weaponized anthrax spores as a Biological Weapon (BW). This decision has resulted in courts-martial and disciplinary hearings among U.S. Armed Forces personnel who have refused the anthrax vaccine on safety grounds. Are these individuals overreacting to misperceived risks from the anthrax vaccine that the military considers safe, or are there real safety concerns that should be considered?

Bacillus anthracis as a BW Agent

Bacillus anthracis is a relatively common spore-forming soil bacterium found rarely in the U.S. but more commonly in some areas of the world as an endogenous infectious agent. Bacillus anthracis infection can cause death within six days of exposure to a lethal dose, usually by inhalation of spores. To be effective as a BW agent a microorganism must be highly infectious, very pathogenic and stable in the air and environment for the period of time needed for dissemination and infection of large numbers of people. Spore-forming bacteria like Bacillus anthracis are ideal for this purpose.

Spores are relatively inactive metabolically and are much more resistant to sunlight, heat, dryness and chemicals than the replicating microorganism. ‘Weaponized’ versions of anthrax spores are more pathogenic and survive better than spores from native strains of Bacillus anthracis. It is estimated that as few as 50,000 weaponized anthrax spores can kill a human after inhalation and fewer can kill small primates.

Although weaponized anthrax spores are probably the most easily manufactured BW weapon, they are only one of dozens of lethal and incapacitating (causing nonlethal sicknesses) BW agents that have been produced in large quantities suitable for BW deployment and tactical use. Bacillus anthracis is also one of the few BW agents for which a vaccine exists that is capable of preventing some (but not all) lethal infections. Although dozens of additional microbial candidates for BW have been produced in various quantities by several countries, such as bacteria (Clostridium botulinum, Brucella melitensis, Yersinia pestis, Clostridium perfringens, Bacillus cereus, Francisella tularensis, Coxiella burnetii, among others), toxins (ricin, aflatoxin, Clostridium botulinum toxin, Staphylococcal enterotoxin B toxin, tricothecene mycotoxins, etc.), viruses (Ebola, West Nile fever, Marburg, small pox, etc.) and miscellaneous BW (rickettsias, mycoplasmas, fungi, etc.), weaponized Bacillus anthracis is considered one of the greatest threats because of the ease of its production, storage and dissemination (spores) as a lethal BW agent.

There are basically three methods to counter anthrax BW: active immunization, passive immunization and prophylactic antibiotics. Antibiotics have to be administered shortly before or after exposure, otherwise they won’t be effective, and they cannot prevent a lethal infection once the Bacillus anthracis has produced signs of illness. Passive immunoprophylaxis requires quantities of immune sera or monoclonal antibodies not currently available, and their administration in a monitored, hospital setting. Active immunity using vaccines on the other hand can be administered years before exposure as long as immunity is maintained. Thus vaccines can be effective as long as there is enough immunity to neutralize the Bacillus anthracis before it starts rapidly replicating en masse from its inactive spore form and producing lethal toxins. From a practical standpoint, only antibiotics and vaccines can protect the large numbers of people who could be exposed in a BW attack, and antibiotics are more effective when the BW agent(s) and its(their) antibiotic sensitivity are identified so the appropriate antibiotic(s) can be used.

Are anthrax vaccines then a reliable method of protecting against Bacillus anthracis BW? Not necessarily. Although vaccines can protect against accidental exposure of relatively small doses of anthrax spores that infect skin wounds, such as encountered occasionally in meat processing, it remains unproven whether anthrax vaccines will actually protect against a lethal aerosol dose of inhaled anthrax spores of the weaponized variety that are used as BW agents. This is especially true if mixtures of BW agents are used instead of single BW agents.

The Anthrax Vaccine: Safety Concerns

The anthrax vaccine in use remains unproven in its ability to stop a lethal dose of weaponized Bacillus anthracis spores, and there are questions about its safety. According to the U.S. Army Medical Research Institute for Infectious Disease (USAMRIID) at Fort Detrick, MD, the anthrax vaccine used by the military was determined to be safe, and adverse reactions were found to occur only at the rate of one per 50,000 doses (less than 0.002%). This has now been revised to a rate of 0.02-0.2% or higher. Moreover, in recent testimony by one of us [M.N.] to the National Academy of Sciences the safety of the anthrax vaccine and the rates of adverse reactions were questioned. Using Dover AFB as an example, the rate of chronic health problems after receiving the anthrax vaccine may be as high as 7%. The difference is that the official rates are for acute reactions only. The Department of Defense (DoD) claims that the rate for vaccine chronic reactions is zero.

A major part of the problem in assessing vaccine safety is in how vaccine adverse effects are reported. Many people who suffer from adverse anthrax vaccine effects are reluctant to step forward to seek medical care, because
they have seen their colleagues' concerns dismissed as due to depression or stress. They also fear that they could lose their ability to perform their duties, as a number of the pilots and airmen at Dover AFB are now on DNIF (duties not including flying) status because of undiagnosed illnesses that began after they received their anthrax vaccinations. Lt. Colonel Randy Randolf, director of the U.S. Army’s vaccination program, counters that all vaccines, the anthrax vaccine included, can produce adverse effects, such as soreness, redness, itching, swelling, and lumps at the injection site. He has stated that about 30% of men and 60% of women report these local reactions, but they usually last only a short time. Lt. Col. Randolf further describes that beyond the injection site, from 5% up to 35% of people have noticed muscle aches, joint aches, headaches, rash, chills, fever, nausea, loss of appetite, malaise, or related symptoms. It is commonly thought that these symptoms go away after a few days, and apparently there has been no completed studies of long-term side effects of anthrax vaccine using active surveillance. Although the DoD began such a study at Tripler Army Medical Center, Honolulu in September, 1998, they have yet to release any preliminary data on long-term problems that developed after anthrax vaccination.

The difference between what military and civilian physicians conclude about adverse reactions and the anthrax vaccine seems to be based on whether you accept that vaccines can cause chronic illnesses beyond the initial reporting period of vaccine adverse effects. The high incidence of unusual chronic health problems at Dover AFB include systemic signs and symptoms, such as vomiting, diarrhea, polyarthralgias, fever, splenic tenderness, cognitive problems, polymyalgias, weakness and numbness, and these problems can occur well after the usual reporting period for vaccine adverse effects. Patients with preexisting autoimmune illnesses such as rheumatoid arthritis, lupus, multiple sclerosis, among others, are probably more likely to suffer a serious adverse reaction, as are those with neurologic disease, such as those who had polio in childhood. Stevens Johnson Syndrome, a severe allergic reaction in which there is loss of epidermis (skin) and the lining of the GI tract, was found in some patients as well as more classic allergic signs and symptoms. Even more serious, many anthrax vaccine recipients report seizures with complete loss of consciousness. Respiratory distress and a variety of pulmonary illnesses have also been reported. Because these types of reactions have rarely been identified with other vaccines and because few of those reporting illness have been subjected to an exhaustive medical evaluation, including sophisticated immunological testing, the mechanisms by which anthrax vaccine may be causing illnesses have not been elucidated. Furthermore, the entire stockpile of anthrax vaccine is owned by the DoD, and none has yet been made available for thorough, independent testing.

The Anthrax Vaccine: Source

One of the most difficult problems in dealing with anthrax vaccine safety is obtaining specific information on the anthrax vaccine and how it was determined to be safe. Most military vaccines in the U.S. are from ‘sole-source’ manufacturers. In the case of FDA-approved vaccines, a number of strict production and safety requirements must be fulfilled, and evidence for effectiveness in humans must be presented to the FDA before approval for production and sale is granted. However, in the case of the anthrax vaccine there seem to be missing elements in this safety net.

The sole producer of the anthrax vaccine was originally Michigan Biologic Products, Inc., a state-owned corporation that obtained U.S. Government approval for the anthrax vaccine at a time when FDA approval was not required. The anthrax vaccine was approved by the Bureau of Biologics at NIH in 1970, two years before efficacy data and approval were required by the FDA. In the case of the anthrax vaccine, long-term safety data were not supplied with the license application, and none has yet been supplied to the FDA. As it turns out, the Bacillus anthracis vaccine now being produced may be different or the procedure for vaccine preparation modified from the original vaccine approved by NIH. The usual requirement is that any new product or modification in preparation must be examined and approved by the FDA, but the FDA has apparently not examined or approved every modification made to the current vaccine for anthrax.

The original license and the facility producing the anthrax vaccine was owned by Michigan Biologic Products, Inc. of the Michigan State Department of Health. The new owner of both is a company called Bioport, Inc., owned by a group of investors lead by Admiral William Crowe, Jr., former head of the Joint Chiefs of Staff, DoD, and Faud El-Hibri, a German citizen of Lebanese descent who has since obtained American citizenship. The facility was sold to Admiral Crowe’s investor group after the DoD decided to vaccinate all of its servicemen and servicewomen against anthrax. Recently Bioport ran into financial problems and negotiated a series of changes in its DoD contract that increases by three-fold the per dose price of the anthrax vaccine supplied to the military. This and other problems have resulted in a congressional investigation into the financial relationship between DoD and the new owners of Bioport, which may constitute a conflict of interest.

The Anthrax Vaccine: Safety

Problems with the anthrax vaccine have raised questions about previous vaccine programs. The former commander of the USAMRIID, Dr. Phillip Russell, admitted in an infectious disease journal (Infectious Disease Clinics of North America, 1990) that unlicensed anthrax vaccines were used on Armed Forces personnel before the Gulf War. There is, of course, no record of safety available for unlicensed vaccines. In fact, there were no published studies of safety or efficacy for the current anthrax vaccine until very recently, well after the decision was made to vaccinate. A recent brief publication from the USAMRIID in JAMA provides some safety information about the anthrax vaccine, but it refers to previously unpublished data that are not available for evaluation.

The normal procedure for post-marketing vaccine evaluation requires that the FDA must review adverse vaccine reactions collected through the Vaccine Adverse Event Reporting System (VAERS). Adverse events are usually recorded independently by a FDA-approved contractor. The contractor then sends their data to the FDA, and the FDA assembles a committee that then evaluates adverse events for the likelihood that the vaccine might have caused them, and it can recommend further study. However, in the case of the anthrax vaccine, military physicians were instructed that only certain adverse effects could be vaccine reactions, such as classic immediate allergic reactions, and others, such as joint pain, cognitive disturbances, etc. could not be due to the vaccine. Physicians treating these patients had no access to published data on anthrax vaccine side effects, and there is no entry for anthrax vaccine in the Physicians Desk Reference (PDR). The package insert for the vaccine is based on data collected from an earlier anthrax vaccine, and it does not list the range of possible reactions that could occur. Thus until recently none of the long-term chronic effects of the vaccine were even reported by medical providers. In the case of the anthrax vaccine, only reactions that resulted in hospitalization or immediate loss of 24 hours of duty time were reported to a military clearing-house for vaccine reactions. This has changed recently, and it appears now that other adverse vaccine effects will be entered in the medical records of patients, but whether they are always reported remains questionable. We feel strongly that traditional and accepted means of FDA vaccine evaluation must be implemented for military vaccines, just as they are required for commercial vaccines. Only then can the safety of the anthrax vaccine be evaluated. The anthrax vaccine should be treated just like any other commercial vaccine and not given special waivers or treatment in the evaluation process. Only then will the public be satisfied that the current anthrax vaccine is safe.

The Anthrax Vaccine: Quality

For years Michigan Biologic Products Inc. had been warned by the FDA of intent to revoke their license to produce vaccines because of violations in the production and testing of their vaccines. As recently as 1997, MBPI received formal written notification from the FDA that they had not complied with FDA-mandated requirements. However, since MBPI was the only manufacturer of anthrax vaccine, they were given a waiver and allowed to remain open, pending FDA compliance. During this time vaccine lots were distributed to the military. In 1998 some of these vaccine lots were retested, and only 6 out of 31 lots passed initial supplemental testing. Most of the retested vaccine lots had expired or had been redated for an additional 3-year period once or even twice. This is obviously unacceptable.

The question has been raised whether expired or failed vaccine lots were used for vaccinating military personnel during the Gulf War. Since supplemental testing on anthrax vaccines used in the Gulf War was not undertaken, and some of these lots apparently also had previously expired and had been redated, some personnel could have received out-of-date vaccines, or worse, contaminated vaccines. Information is not available on whether U.S. Forces received contaminated vaccines (no such testing has been made public), but the British Gulf War veterans report that several vaccine lots from the Gulf War were reported to be contaminated with “unknown microorganisms.” Thus some of the health problems associated with the anthrax vaccine could be related to possible vaccine contamination.

Vaccines and the Gulf War

Before military personnel were deployed to the Persian Gulf Theater of Operations, they had to pass physical examinations and be fit for active duty. After passing their physical exams, they received several types of vaccinations, mostly with commercially available vaccines. In the Persian Gulf area this was usually done by administering as many as two dozen vaccine doses over a period of a few days, even if the vaccines were normally required to be given over a course of several months to over a year. In contrast to previous wars, service personnel were not allowed to keep a record of these vaccinations, and according to the DoD the shot records of hundreds of thousands of deployed personnel have since disappeared. Some health personnel administering the vaccines were also warned that they would be courts-martialed if they kept any record of vaccines given to military personnel. According to nurses that took part in the vaccination program, many soldiers became sick after the vaccines were given, but few were allowed to report the adverse effects of the vaccines, unless they were hospitalized. Most had to return to active duty, even if they suffered adverse effects directly attributable to the vaccines. The records of these adverse effects are for the most part also missing.

The problem with administering multiple vaccines all at once is that this can result in immune-depression and leave individuals susceptible to opportunistic infections, such as the types that the vaccines were supposed to protect against. To be effective, the vaccines used in the Gulf War should have been given in several steps, the initial vaccination followed by several boosters given over months to over a year to maximize immunity. If given all at once, these vaccines are more likely to cause adverse reactions and produce diminished immunity be useless in protecting an individual, and they may even make the vaccinated person more susceptible to opportunistic infections due to immune-suppression.

February 15, 2000

Pilots Punished for Refusing Vaccine

The Associated Press

INDIANAPOLIS (AP) - At least a dozen Indiana Air National Guard pilots in Fort Wayne are barred from flying for refusing an anthrax vaccination required for an upcoming mission overseas, pilots say.

Members of the 122nd Fighter Wing, which is scheduled to be sent to the Middle East in April, have until Sunday to begin the series of six shots. The vaccination program had been voluntary until now.

"Everybody is worried about safety," said Capt. Bruce Everett, a commercial pilot barred from flying for the Guard in January for refusing the vaccine. ``I don't know if it's unsafe. All I know is that there hasn't been enough research to prove that it is safe.''

The Pentagon has ordered all of its 2.4 million active and reserve personnel be inoculated against anthrax, a deadly germ that can be used in biological warfare.

About 200 to 300 people have refused the vaccine so far, according to the Pentagon. Several men and women have been prosecuted, and many reservists have quit because of the shots.

Twelve pilots now barred from flying at Fort Wayne plan to resign or transfer to avoid inoculation, said Everett, Lt. Col. Tom Heemstra and two other pilots who spoke on condition of anonymity.

Lt. Col. Perry Collins, chief of staff of the 122nd Fighter Wing, confirmed only that some pilots are not being allowed to fly. He said squadron commanders do not want to spend money training the pilots until they decide to stay with the base.

The Guard said those who refuse to take the vaccine by Sunday's deadline will be disobeying a written order and could face additional penalties, including discharge.

February 13, 2000

GI thinks anthrax vaccine is responsible for illness

By J.S. Newton, Staff writer

Many service members are putting their careers on the line, refusing to take the shot. Kevin Edwards started feeling sick about a month after his third anthrax shot.
The Army specialist, who was based in Korea when he fell ill in November 1998, thought it was just the flu.

‘‘I really didn’t think much of it at the time,’’ Edwards said. ‘‘As it progressed, it just felt different than the flu.’’

Edwards is a 1989 graduate of Terry Sanford High School. He is 28 years old.

Nobody can say for certain what caused Edwards’ illness.

All anybody can really agree on is that whatever he came down with was gruesome to look at -- and it almost killed him.

Edwards thinks the anthrax vaccine made him ill. Hundreds of other service members are putting their military careers on the line, refusing the vaccine because they fear the same thing could happen to them.

When Rep. Walter Jones of North Carolina saw pictures of Edwards laid up in an Army hospital, he could barely keep his composure.

‘‘I was horrified,’’ he said. ‘‘I have actually kept those photographs. But I don’t look at them.’’

Bleeding sores covered the soldier’s body. He looked as if he had been burned head to toe.

In fact, the Army treated him like a burn victim. With a hole punched in his throat so he could breathe, he was flown from South Korea to Brooke Army Medical Center at Fort Sam Houston, Texas, so he could be treated by the Army’s best burn specialists.

Army medical officials’ diagnoses ranged from an adverse reaction to anti-inflammatories to Steven Johnson Syndrome to staphylococcal scalded skin syndrome. Both syndromes are considered exfoliating skin disorders, which can cause skin lesions and scarring.

Edwards, his family and his lawyer think his illness was caused by his anthrax vaccinations.

‘‘The timetable seems irrefutable,’’ said Todd Conormon, a Fayetteville lawyer who specializes in military law and who is examining legal options for the soldier. ‘‘It seems to me more likely than not that this was a reaction to the anthrax (vaccine) -- particularly in the absence of any other logical cause.

‘‘It would seem to me that no reasonable person could look at the sequence of events and conclude that Kevin’s reaction was anything but an adverse reaction to the anthrax vaccination. It would be disingenuous to suggest that there was some other cause.’’

While some military doctors told Edwards his illness was not related to his anthrax vaccine, Edwards’ medical records indicate otherwise.

In September of last year, the Army took the unusual step of exempting Edwards from his last three remaining anthrax shots.

On Dec. 10, 1999, doctors at Brooke Army Medical Center, at Fort Sam Houston, Texas, filed an anthrax ‘‘adverse event report’’ with the Center for Disease Control to see if there was a ‘‘correlation’’ between the vaccine and Edwards’ illness.

And they also filled out a follow-up ‘‘anthrax adverse event’’ form on Jan. 5.

Army officials would not comment on Edwards’ case because it is ‘‘ongoing.’’

‘‘It would be inappropriate to comment on the specifics of the case until the proper authoritative agencies have concluded their work,’’ said Craig Martin, a spokesman for Brooke Army Medical Center.

Rep. Jones, who has written letters to the military on Edwards’ behalf, said the anthrax vaccine cannot be ruled out as a possible cause of Edwards’ illness.

Mandated vaccine
The Department of Defense requires that its troops be given a series of shots to make them immune from anthrax exposure.

Through November, nearly 358,000 service members had received 1.2 million doses of the vaccine.

Military officials say the vaccine is the safest way to protect U.S. forces against the deadly bacterial disease.

Anti-terrorism experts say anthrax is a threat to U.S forces because it can be sprayed into the air, or delivered to the battlefield by armies using ballistic missiles.

Between now and 2003, the vaccine will be given to the entire U.S. military force -- about 2.4 million people.

‘‘Anthrax vaccine is safe and effective,’’ said Lt. Col. Gaston Randolph, who works with the Office of the Army Surgeon General. ‘‘There is a vast array of compelling scientific evidence to support this claim: 44 years of experience with this vaccine, 30 years of commercial use, and 12 studies involving the safety of the vaccine. Repeated safety studies conclude most side effects are comparable to other common vaccines.’’

As the vaccinations continue, a number of American service members have complained about being forced to take the shots.

Jones, the North Carolina Third District congressman, is sponsoring a bill to make the program voluntary. Jones is a member of the House National Security Committee. His district includes Seymour Johnson Air Force Base.

He said he has had dozens of calls from service members who have had reactions to the vaccines or don’t agree with the military’s anthrax policy.

He has 32 co-sponsors for his bill. He says he is gaining sponsors by the week.

Jones said there are too many questions surrounding the vaccine not to allow service members to decide on their own if they want to take it.

He cites General Accounting Office reports that are critical of the manufacturing process of the vaccine. He cites the Army’s inability to rule out the anthrax vaccine as a cause for Edwards’ illnesses.

‘‘You have to question, is this shot safe?’’ Jones said. ‘‘There is never going to be a shot that’s 100 percent safe. But there are too many questions.’’

Jones said the State Department, which often operates in places where there is a high threat of terrorism, has a voluntary anthrax program for its employees.

Refusal consequences

Military members who refuse the shots face court-martial.

A number of service members, including Air Force Maj. Sonnie Bates, may lose their careers over the issue. Bates is the highest-ranking service member to face disciplinary action for his refusal to take the shots. He was recently featured on “60 Minutes.”

‘‘It is a tragedy in this country when men and women in uniform would leave the military or be willing to be court-martialed over this shot,’’ Jones said.

Dr. Peter Gilligan is an associate professor at the University of North Carolina School of Medicine. He is knowledgeable on anti-terrorism issues and works in two departments at UNC -- microbiology and immunology, and pathology and laboratory medicine.

He said the anthrax vaccine is probably safe for most people who take it.

‘‘I don’t think (Defense Secretary) Bill Cohen would take this vaccine if he thought it was dangerous,’’ he said. ‘‘But I understand the fear these folks have. We just don’t know enough about the vaccine.’’

He said delayed reactions -- Edwards’ illness began a month after his third shot -- are not the norm.

‘‘I’m not going to say never,’’ he said. ‘‘But it is much more convincing if it is close by.’’

But he said he takes a ‘‘never-say-never’’ attitude on whether anthrax might be the cause of Edwards’ illnesses.

Edwards and his father say the batch of vaccine he took could have been contaminated. Edwards’ lawyer is researching the issue.

The General Accounting Office has reported manufacturing problems. It said the Food and Drug Administration found manufacturing deficiencies in a 1998 inspection. Those deficiencies included some “that might affect only one or a limited number of batches that were produced and those that could compromise the safety and efficacy of any or all batches.’’

The Army said there were no irregularities with Edwards’ batch.

‘‘Lot 017, like all other lots released by the FDA, passed tests for potency, purity, sterility and general safety prior to release,’’ said Gaston Randolph of the Office of the Army Surgeon General. ‘‘No lot has been associated with more serious adverse events than any other lot.’’

Gilligan, the UNC microbiologist, said Edwards’ illnesses might have been caused by a virus.

But he said the military should do more to ‘‘understand what the risks are and make the adverse reactions well known.’’

He said military experience should make officials more curious about potential long-term effects.

‘‘No one ever thought, ‘Oh, Agent Orange causes cancer,’’’ he said. ‘‘The Army and military needs to be carefully studying this vaccine.’’

Randolph said the Army has seen no long-term side effects associated with the vaccine.

And more important, Randolph said, ‘‘We have not found any disease that is occurring more often among vaccinated troops than is expected among unvaccinated troops.’’

Gilligan, the microbiologist, said he doesn’t want the big picture to get lost in this one case.

‘‘The basic theory about vaccines -- as it has always been -- is we talk about it as the greater good,’’ he said. ‘‘Vaccines have saved countless number of lives in this world.’’

Gilligan said ‘‘there is always going to be a risk that somebody might have a negative reaction to the vaccine.’’

Soldier’s life on hold

Toney Edwards, Kevin Edwards’ father, has cancer that he said he got from exposure to Agent Orange in Vietnam.

The pesticide was sprayed along the Ho Chi Minh Trail to defoliate the jungle canopy so U.S. aircraft pilots could better see their targets.

Toney Edwards fears his son could have long-term health problems, like the ones he is experiencing from Agent Orange exposure.

‘‘I can see the writing on the wall,’’ he said, tears welling in his eyes in an interview in Fayetteville recently.

Toney Edwards works in Fayetteville for Mutual Realtors.

His son is now out of the hospital. He works at Fort Sam Houston greeting people, answering phones and shredding paper.

He is developing chronic eye problems, which require him to put drops in his eyes every few minutes. Scarring from his illness has damaged his eyes, he said.

He wears sunglasses often. Soldiers in the dining hall often tell him to take them off because they don’t meet the military dress code.

He is scared to take medicine, worried that his body will react as it did before.

At one point in November 1998, Army officials called to tell his parents he might not make it.

Open rashes and blisters were all over him. Internally, he said it felt as though he had swallowed hot coals.

He can recall portions of the time he was sick: the flight home, the five trips he made to the clinic in two days seeking help from the pain, the medics who told him he was just dehydrated when he went in for help.

‘‘A lot of it was a blur,’’ he said. ‘‘The pain was clear.’’

‘‘When I was going through it, I literally prayed for death,’’ he said. ‘‘I made my peace with God. It hurt that bad.’’

At Fort Sam Houston, his father and mother went to see him.

His father grabbed his hand and squeezed. The son, who could not speak or see, squeezed back.

‘‘They gave me a lot of comfort,’’ Kevin Edwards said.

It made him want to live. A month later, he was able to be released.

Now, more than a year and four months later, he said he has little to look forward to.

Once, he entertained a passion for music. He majored in music at Fayetteville State University, where he played the trumpet. He is single and enjoys watching sports.

At work, he used to be a soldier with a secret clearance and a job in a signal unit.

It had meaning, he said. He loved his job. He loved the Army life.

Now he fears he is losing his sight.

The dryness in his eyes causes him constant discomfort. He can’t ride in cars with the windows down.

Where once he looked forward to a successful military career, now he looks forward to treatment days.

He said he understands that the military must do what it can to protect troops from anthrax. But he questions whether the military is going about it the right way.

‘‘They should sit back and consider whether this should be mandatory and whether it is safe,’’ he said. ‘‘I do what I’m told. I did that. And this is what happened.’’

February 1, 2000

DoD's medical credibility disputed

American Health Line

Dozens of protesters demonstrated Saturday outside Dover Air Force Base, throwing their support to Maj. Sonnie Bates, the pilot who refused to take a mandatory series of injections against anthrax.

Bates could face a court-martial for refusing to take the vaccine. Protesters carried signs that read: "Free Major Bates," and "My husband will take a bullet for America but not the Anthrax vaccine." Demonstrator Gloria Webb said, "The people who refuse this vaccine are being raped of the same civil rights they fight to protect." Maj. Frank Smolinsky, base spokesperson, said, "These people had a right to express themselves. Freedom of speech is one of the things the military fights to protect" (Washington Post, 1/30).

The roots of the current anthrax dispute "lie in the Defense Department's long term loss of medical credibility with the population it serves," writes James Terry Scott, director of national security programs at Harvard University's Kennedy School of Government and a retired lieutenant general in the U.S. Army, in the Washington Post. While he says that his own experience was "positive," the "level of trust began to deteriorate with the Defense Department's failure to come to grips with reports of the toxic effects of Agent Orange." This was followed by "perceived reluctance to resolve the complex questions raised by Gulf War syndrome," including "its apparent inability to refuse the assertion that at least some of the reported medical problems were caused by hastily conceived combinations of medicines administered to soldiers to protect them from the potential effects of Saddam Hussein's biological and chemical weapons."

Military personnel's confidence in the system has further deteriorated because many families "feel vulnerable as they watch the overstretched military medical system crumble from chronic underfunding" and many "doubt that adequate military medical care will be there for them and their families in the future."

In point-counterpoint style in the Baltimore Sun, former Connecticut Air National Guard pilots Thomas Rempfer and Russell Dingle, who refused to be inoculated, and Charles Cragin, principal deputy undersecretary of defense for personnel and readiness, face off on the use of the anthrax vaccine. Rempfer and Dingle argue that the Defense Department's claims of the vaccine's safety "are inconsistent with statements by department personnel, medical literature, congressional oversight and FDA inspections."

They cite sources, including Army Surgeon General Ronald Blanck, who stated in 1994 that the "anthrax vaccine should continue to be considered as a potential cause for undiagnosed illness in Persian Gulf military personnel" and Col. Arthur Freidlander, who concluded that the anthrax vaccine "is unsatisfactory," as evidence.

They argue, "Protecting our armed forces from unnecessary risks includes protecting the troops from unsafe military medical policies that are shaky under established medical and legal standards. The troops deserve better than expedient and misguided protection efforts, promoted through the hyping of threats and the cliche of 'good order and discipline.' It would be irresponsible not to suspend this program immediately pending the unbiased review" (Rempfer/Dingle, 1/30). Rempfer also wrote an op-ed in Sunday's Washington Post.

Cragin responds that the anthrax vaccine is the "best chance for survival" among those exposed to the chemical and touts the vaccine's safety, writing that it has "an excellent safety record since it was licensed and approved by the FDA in 1970." Cragin writes that what the military is doing "is no different from what we have always tried to do: We are taking prudent measures to protect the armed forces." Further, he maintains that the military is "working tirelessly to alleviate [concerns about the vaccine] through an intensive educational and leadership outreach effort." He concludes, "If we were to deny our military personnel protection from anthrax, we would be denying them the protection they need to undertake the critical missions they are called on to perform. ... In short, we have an obligation to give our personnel the best protection available from all anticipated threats - anthrax is one of those threats; and the vaccine offers safe and effective protection" (Cragin, 1/30).