Volunteers for study to be questioned for eight years

The Pentagon resumed its controversial mandatory anthrax vaccinations program for selected troops last week despite the fact that its own doctors are quietly conducting research into adverse effects of the vaccine, a RAW STORY investigation has found.

While the Defense Department maintains that the anthrax vaccine is safe and poses no long-term risks to recipients, a little-known program at Walter Reed – the National Vaccine Healthcare Center – seems to contradict the military’s assertions.

Documents obtained by RAW STORY, including a participant’s agreement, case history and government documents, show that military medical personnel have known since at least 1998 that there are genetic triggers between illnesses and some required immunizations, including the anthrax vaccine. They also reveal the military knew and did not implement routine pre-screening which could help reduce vaccine-related illnesses.

A flyer posted by the Vaccine Healthcare Center shows that Walter Reed is soliciting servicemembers who have suffered as a result of the vaccine. The flyer asserts that “adverse effects may include redness or swelling where the shot was given (larger than the bottom of a soda can) and/or more than 24 hours of headaches, muscle/joint pains, and/or fatigue (tiredness) that interfered with your daily activities.”

“Only one visit and only one blood draw is required,” the flyer says. “You will also receive annual e-mail or telephone follow-up surveys for eight years.”

(Click on the image to enlarge.)

US Army Medical Command Media Relations Officer Margaret Tippy made several efforts to put RAW STORY in touch with Vaccine Healthcare Center officials over the past several weeks. Defense medical officials, however, did not returned repeated request for information about the VHC program.

In 2004, a federal judge ruled that the military’s mandatory administration of the vaccine was illegal because the Food and Drug Administration had not approved its use for inhalation anthrax, only for anthrax contracted through the skin. After FDA approval, the judge allowed voluntary injections. The Defense Department resumed mandatory shots this month. The Pentagon continues to defend the efficacy and safety of the vaccine.

“I'll say once again, the vaccine is safe and effective,” Assistant Secretary of Defense for Health Affairs William Winkenwerder said last year.

Longstanding concerns

Doctors have raised questions about the vaccine for years. According to a transcript of an Apr. 16, 1998 meeting of the Armed Forces Epidemiological Board, military experts concluded that pre-vaccination screenings could be conducted because the military has "the technological and data capture capability" to do so, and that they should be done because "we're dealing with this problem with anthrax now and many other immunizations."

"There is going to be more in the future," the transcript added.

The existence of the Vaccine Healthcare Center complicates the mystery surrounding vaccine-related illnesses, suggesting either that pre-screening is not part of the vaccination process or that genetic triggers are not the only cause of vaccine related health effects.

Created in 2001 as a joint effort of the Centers for Disease Control and the Department of Defense, the VHC program and its network of treatment and research facilities are largely unknown even among the military community. Walter Reed Medical Center serves as the headquarters of the program, which also includes clinics at Fort Bragg, Lackland Air Force Base and Portsmouth Naval Medical Center.

Since its inception, the treatment component of the program has helped hundreds of soldiers suffering serious and sometimes debilitating side-effects from anthrax and other vaccinations to get the proper military medical treatment, vaccine exemptions and case management that they would not have access to otherwise. Many anti-vaccination advocates question why the VHC treatment program is not more widely publicized and why the VHC's research is not available to medical professionals and the public.

Dr. Meryl Nass, an anthrax expert and physician who has treated soldiers suffering from adverse reactions to the anthrax vaccine, believes the VHC's research findings should be released.

"I knew they were doing this kind of research, but they just wouldn't admit it," Dr. Nass said in a phone interview last week. "VHC has been conducting this type of research, but they haven't been publishing any of it. This could save more people from becoming ill."

Luis Hernandez's mystery lesion

Luis Hernandez, a recently-retired Navy reservist, is a current participant in the VHC study. Hernandez says he was approached last September by VHC researchers to take part during a routine visit to Walter Reed relating to his disability claim. (His affidavit for the program is available here. The sections of his file describing his symptoms and their impact on his quality of life are here.)

An Iraq War veteran who served in the US military for 25 years, the 51-year-old New Yorker received his first series of anthrax vaccinations when he was mobilizing for deployment in February 2003, a month before Operation Iraqi Freedom began.

A few days after receiving his third anthrax vaccination, Hernandez says, he developed a lesion on his leg that he was told was most likely a spider bite. He was put on a course of antibiotics and continued preparing for deployment.

"I had never had health problems," he said.

The lesion grew and other autoimmune problems developed. In May 2006, Hernandez was forced to return home to receive medical care.

"When I got back, I had 13 lesions," he said. "It was just too much for my immune system," he said of the vaccine. "They didn't know what the hell I had."

When he told the military he thought that his illness was related to the vaccine, he said, staff told him he was "delusional" and the relation between his mystery autoimmune illness and the shots "were in his head."

"For a while," he said, "I thought I was going crazy."

A private physician who had been attending to Hernandez's case referred him to Walter Reed's Vaccine Healthcare Center to seek additional tests in hopes of diagnosing the "mystery illness." Hernandez said no one in the military had ever told him of the program's existence.

According to Hernandez's medical documents, the reservist was suffering from muscle spasms, headaches, recurring skin lesions, chronic fatigue and depression when he first visited Walter Reed in January 2004.

"Hernandez' life has been profoundly effected [sic] by his clinical symptoms," VHC staff wrote. "He is in constant pain, has difficulty functioning at his civilian job and has used 400 hours of civilian sick leave."

RAW STORY will post excerpts from Hernandez's documents later today.

"We have noted in a number of service members who now exhibit chronic, refractory headaches as well as persistent musculoskeletal pain in temporal association with the receipt of the anthrax vaccine," VHC staff added. "Based on these observations, we are attempting to establish case definitions as well as diagnostic, treatment and vaccination options."

"When I got down there, they told me, 'we know what you got, but we can't fix you,'" Hernandez said of VHC staff. "They said they had seen other service members with the same symptoms."

Hernandez is now asking the same question many vaccinated soldiers already have: Is the vaccine safe? Did the military know the vaccine could cause health problems?

"The D.O.D. is telling us that the vaccine is safe, and yet they are conducting this multi-million dollar research project," he said. "It is too late for me, but the military is just going to pump these kids' bodies full of this stuff."

Dr. Nass, who practices medicine in Maine, believes the vaccine is unsafe and is responsible for a host of illnesses in U.S. troops.

"There are so many people who are damaged by this vaccine," she remarked. "Its use makes no sense."

The numbers of soldiers who have become ill as a result of the anthrax vaccine is largely unknown, primarily because conditions may not be not either properly diagnosed or recorded, and because many military studies are not available to health care professionals or the public.

In 2003, 22-year-old Army Reservist Specialist Rachel Lacy died shortly after receiving her first batch of vaccines. According to a military medical panel, the evidence surrounding Lacy's death "favored a causal relationship," but the panel decided that the "evidence was not conclusive." The cause of death was described as "a severe inflammatory process affecting her lungs, findings consistent with a diagnosis of systemic lupus erythematosus (SLE) or lupus."

Manufacturer says studies show product is safe

Created by Emergent BioSolutions (formerly Bioport), the anthrax vaccine is known as BioThrax or Anthrax Vaccine Absorbed and was first licensed by the Food and Drug Administration in 1970. It remains the only FDA-approved anthrax vaccine for use in the US.

In an interview with RAW STORY, Emergent Biosolutions spokesperson Dr. Tom Waytes said the anthrax vaccine has been studied more than just about any vaccine in the US and has been deemed safe and effective. He said the vaccine has no higher adverse reaction rate than most other vaccines. A recent report issued by the military reviewing the vaccine's safety, as well as a 2002 report issued by the Institute of Medicine, he added, have also backed the vaccine.

In the Institute of Medicine's report – which reviewed existing studies on the vaccine's safety and effectiveness – the committee found that "the available evidence shows that the currently licensed anthrax vaccine, Anthrax Vaccine Adsorbed (AVA), is reasonably safe and effective, with the caveat that the studies reviewed were carried out in populations of healthy adults only."

The IOM report also pointed out that "although the committee found no data indicating that vaccination with AVA is associated with later-onset adverse events or with any serious or lasting adverse events," few, if any, studies had been done regarding the vaccine's long term safety.

"DoD should carefully evaluate options for longer-term follow-up of the possible health effects of vaccination against anthrax (and other service-related exposures)," committee members urged in their report.

Last May, the Government Accountability Office (GAO) issued a report that called for "a better, alternative vaccine."

In the May 2006 report, the GAO said the "vaccine has not been adequately tested on humans; no studies have been done to determine the optimum number of doses; the long-term safety has not been studied and data on short-term reactions are limited."

Dr. Waytes asserted that the majority of soldiers' claims that the vaccine causes autoimmune disorders and serious illnesses are "in people's minds."

Dr. Nass disagrees.

"We really don't know about long-term safety," Nass said, noting that the majority of studies are focused on short-term effects. "The data just doesn't exist."

Late last year, another group of anonymous soldiers and civilians filed a new lawsuit to stop the resumption of the mandatory program. The Pentagon has filed a motion to dismiss the case, according to one of the lead lawyers for the plaintiffs, retired Air Force Lt. Col. John Michels.

"This whole thing just has this bureaucratic momentum," Michels said.

Larisa Alexandrovna and Muriel Kane contributed research to this report.