September 15, 2003

Mystery Deaths Fuel Vaccine Anxieties

By Timothy W. Maier

Once again, thousands are showing bizarre symptoms, and 'pneumonia' cases are being linked to anthrax or smallpox vaccinations.

Since Persian Gulf War II began about 6,000 soldiers have been shipped home for recovery. Of these, 1,200 were wounded in combat. Many of the others consider themselves part of an army of "walking dead" - troops who appear to be so physically and mentally exhausted that the military has no recourse but to discharge them. Why they are ill has become a matter of intense debate inside the Pentagon. Some claim a series of anthrax and smallpox vaccinations made them so gravely ill that they have trouble breathing or sleeping and have experienced a loss of memory. Others have been diagnosed with lupus and heart problems. At least six died shortly after rolling up their sleeves to receive the anthrax and smallpox shots. But the Pentagon dismissed related claims with such regularity and intimidation that many GIs tell Insight they no longer report the illness. They are told to "suck it up" and move on.

"Don't blame the vaccinations" has been a Pentagon mantra since it began inoculating nearly half a million troops almost two years ago and pumping millions of dollars into BioPort Corp., the Lansing, Mich.-based sole supplier of the anthrax vaccine [see "A Dose of Reality" and "Why BioPort Got a Shot in the Arm," Sept. 20, 1999]. But an alarming outbreak of more than 100 suspected pneumonia cases among Gulf War II veterans serving in Iraq and southwestern Asia has drawn the ire of Congress.

Rep. Chris Shays (R-Conn.) held eight congressional hearings on the safety of the vaccination while chairman of the House Government Reform subcommittee on National Security, Emerging Threats and International Relations, and issued a seething report that found serious safety and regulatory problems with the vaccine. Now Shays is asking again, "Could these vaccinations be hurting our troops?" The Pentagon reluctantly admitted that two Army soldiers - Spc. Joshua M. Neusche, 20, of Montreal, Mo., and Sgt. Michael L. Tosto, 24, of Apex, N.C. - died from complications arising from pneumonia on July 12 and June 17, respectively. The Army is investigating their deaths. Between 1998 and 2001, the U.S. Army Center for Health Promotion and Preventive Medicine reported 17 soldiers died from complications of pneumonia. The Pentagon has confirmed that this year at least 17 others have been placed on respirators but insists the vaccinations have nothing to do with the deaths or illness.

The two pneumonia-related deaths reported recently apparently are an understatement. Family members of Army Spc. Zeferino E. Culunga, 20, of Bellville, Texas, and Staff Sgt. Richard S. Eaton, 37, of Guilford, Conn., claim their sons died in August after being diagnosed with pneumonia. A third death involved Spc. Rachael Lacy of Lynwood, Ill. According to her autopsy, "smallpox and anthrax vaccinations" contributed to her death on April 4 after she first had been diagnosed with pneumonia.

When the victims' families reached out to Defense Secretary Donald Rumsfeld, he ordered a team of military investigators to Germany and Iraq to review the recent pneumonia cases. "We as a family are concerned that we are not being told the truth," wrote the family of Spc. Neusche in an Aug. 12 letter to Rumsfeld. Like the other families, they asked to see medical records in an effort to get a second opinion on the cause of death. Culunga died of acute leukemia. Lang was never deployed, so she is not considered part of the cluster of pneumonia cases. "It is our right to receive truthful, honest and unfiltered answers just as the military required truth, honesty and commitment from our son," says the Neusche-family letter to Rumsfeld.

But the Army is not investigating the deaths of Culunga or Lacy, and is awaiting autopsy results for Eaton.

Besides those who died from pneumonia-like complications, families of six others claim the vaccinations contributed to their sons' deaths - including two who committed suicide because, say the complaints, the vaccinations made them so seriously ill that it destroyed their will to live. While the U.S. Food and Drug Administration has acknowledged the nature of these deaths, the Pentagon has not because military doctors have refused to confirm that the vaccines contributed to the deaths of any of these victims.

Despite mounting criticism, the Pentagon repeatedly claimed the pneumonia cases had nothing to do with the anthrax or smallpox vaccinations. "In 200 years of vaccination, no vaccine has ever been shown to cause pneumonia, and there are multiple reasons to believe that the vaccines have no role," Col. John D. Grabenstein, deputy director for clinical operations at the Military Vaccine Agency, told United Press International.

Could Grabenstein be wrong? During congressional hearings on the vaccination program in 1999, Pentagon officials acknowledged there had been three reports of serious illness coincidentally associated with the vaccination involving hypersensitivity pneumonia. A study last year in Pharmacoepidemiolgy and Drug Safety said the vaccine was the cause of pneumonia in two soldiers. But Grabenstein dismisses such evidence. In fact, in his recent study of vaccination patients published in the Journal of the American Medical Association (JAMA), he insists there have been no deaths related to the smallpox shot. He ignores the Lacy case because she was never deployed overseas.

"Totally bogus," says Meryl Nass, a civilian doctor who has treated soldiers who became ill after receiving the vaccinations. "I e-mailed JAMA a copy of the death certificate for Lacy. I asked him why he didn't report it. He said, 'We don't accept diagnoses from outside the military.' The Mayo Clinic [in Rochester, Minn.] did the autopsy. They don't believe the Mayo Clinic!"

In fact, Lacy's death is not even listed in the military's Noteworthy Adverse Events report - an omission that critics suggest smells of cover-up. "My concern regarding the Lacy case is that it was parsed to death in an effort to keep it out of the official reports," says Jeffrey Sartin, a former U.S. Air Force doctor who now works in the Infectious Disease Department at the Gunderson Clinic in La Crosse, Wis. "If it could not be proven with 100 percent certainty that vaccines caused her illness, it was not going to be reported as such."

While Sartin says it should have been reported, Nass wonders if Grabenstein may have a serious conflict of interest that has prevented him from reporting such incidents. She notes Grabenstein sits on a number of pharmaceutical boards and is well known for advocating legislation that would allow pharmacists to administer vaccinations.

Some civilian doctors charge that the Pentagon mislabeled these cases in an effort to avoid making adverse-reaction reports that the military keeps to monitor vaccination programs. Indeed, Lacy may not be the only death overlooked. The death of NBC correspondent David Bloom, who died of a blood clot after receiving vaccination shots, as well as the death of a 55-year-old Missouri National Guardsman who had a heart attack under similar circumstances, also were disregarded. "I am not sure they had pneumonia," Nass says. "They are trying to obscure it. They have something else in the lungs and they're not telling us what it is. The Pentagon knows something, but they are not sharing it. And if it isn't pneumonia, what is it?"

What is known is that about one-half of these military patients with pneumonia also had elevated eosinophils in their blood. Eosinophils are responsible for allergic reactions and also help defend against parasites, says Sartin, who worked with a team of doctors that treated Lacy. "Elevated eosinophils were seen in the blood count of Rachael Lacy before she died, and both her autopsy and the heart biopsy of a servicemember who had myopericarditis showed eosinophilic infiltration of heart tissue," reports Sartin. "This suggests to me the possibility of an immune-mediated reaction to something such as a vaccine."

Another possibility, he says, could be Churg-Strauss syndrome, an autoimmune disease in which "you get asthma, pulmonary infiltrates [in other words, the chest X-ray can look like pneumonia] and eosinophilia." Sartin reports this can lead to vasculitis, which is what killed Bioport employee Richard Dunn. A coroner claimed the anthrax vaccine contributed to Dunn's death. "If we could get the test results on these patients, and in particular the autopsy results on Neusche and Tosto, we might be able to draw some conclusions about what caused their illnesses and whether it was vaccine-related," he believes.

Pointing to the sharing of information on the SARS outbreak and how that helped civilian doctors diagnose and treat the disease, Sartin argues that the same could be done with data about the sick soldiers. However, for now, the military would rather keep those records under wraps, which puzzles Sartin. "All of us close to the [Lacy] case, including her family members, wonder why a perfectly healthy young woman, in the top 10 percent of her PT [physical-training] testing, would get sick right after her vaccinations without any other explanation and the authorities would not consider that the vaccine probably, or at least possibly, caused her illness and death."

September 5, 2003

Project Bioshield Could Allow Withholding Drug Information From Military Personnel

By David Ruppe
Global Security Newswire

WASHINGTON — Congressional leaders may soon address a proposed law that critics say would reduce the U.S. military’s obligation to inform soldiers about the health risks of unlicensed biological defense drugs and vaccines they might be required to receive in an emergency.

The provision, contained in the House version of the Project Bioshield Act of 2003, would allow officials to respond to some emergencies by administering drugs to the nation that have not been approved by the Food and Drug Administration.

The law would require officials to inform potential drug recipients of the drug’s potential health risks and to get the recipients’ consent to administer the drug, but it would also permit the president and other senior officials to waive these requirements when delivering the drugs to U.S. military personnel.

Representative Christopher Shays (R-Conn.) recently criticized that provision.

“I am concerned that certain provisions of section 4 of the bill will unfairly treat the men and women of our armed services,” he said in a July dialogue with House Committee on Energy and Commerce Chairman Billy Tauzin (R-La.).

Existing federal law, that Shays helped draft following the 1991 Gulf War, already permits the president to waive the consent requirement for military personnel if obtaining consent is infeasible, contrary to the best interests of the individual, or not in the interests of national security. In addition, the law requires that potential recipients must be told that they have the right to refuse the drug, although they might be discharged from the military or jailed if they do so. It furthere requires that all recipients be first informed of the product’s unapproved status and of its potential side effects.

Under the proposed changes, the president would continue to be able to waive the consent requirement, but he would also be able to waive the requirement to notify potential recipients that they may refuse the drug. Furthermore, the Health and Human Services secretary could authorize delaying the notification of recipients of their potential health risks. The proposed law says the information would be provided to the drug recipient, or next-of-kin in case of a death, no later than 30 days after the individual received the drug.

Steve Robinson of the National Gulf War Resource Center, a veterans group, opposes the new language.

The military will say it’s “for the cause of good order and discipline, because if one person said ‘no,’ a thousand could. But we’re supposed to be the kind of society that evolves and I think our soldiers are smart enough to at least be told of the risks and, in certain cases for certain drugs, have a choice,” he said.

Tauzin said the disputed provision was intended only to eliminate an individual’s right to refuse a drug, not to deny drug recipients information on potential health risks, except in “extraordinary circumstances.”

Tauzin said his committee reviewed the language and found it could be confusing.

“We intend the waiver authority in this bill to be used only in the very extraordinary circumstances that we describe in the bill,” he said.

Tauzin said he would work with Shays “to make sure that the final version of this bill from the conference that we will have with the Senate, I am sure, provides that our military are informed of the drugs that are given before these drugs are administered.”