October 26

Soldier’s Death Tied to Vaccines / Experimental Ebola vaccine attracts no volunteers

Soldier’s Death Tied to Vaccines / Experimental Ebola vaccine attracts no volunteers

Wed, 19 Nov 2003

Two civilian medical panels that looked into the death of 22-year old Army reservist, Rachel Lacy, agreed that the death was “probably” or “possibly” an adverse reaction to a vaccine. Since Specialist Lacy had been inoculated with 5 vaccines a month before her death, the panel could not attribute the death to a single vaccine. The Army had vigorously denied that a vaccine caused her death. Col. John D. Grabenstein, of the Army surgeon general’s office, said that despite the finding, the military vaccine policy would not be changed.

When vaccines, whose purpose is to immunize, kill, they may be compared to casualties of "friendly fire." It is difficult to fathom why steps will not be taken to prevent other vaccine-related deaths.

The Washington Post reports that despite weeks of advertising a new experimental ebola vaccine trial is attracting no volunteers–save two. Understandably, volunteers are not lining up to be vaccinated with ebola considering that "The disease is notoriously lethal, rapidly killing 50 percent to 90 percent of its victims."

None of the public health officials who are seeking volunteers have volunteered themselves to be inoculated. Margaret McCluskey, the director of nursing at the NIH’s vaccine research center, has not volunteered but awaits 25 more people to participate in initial safety tests.

Only two human beings have so far volunteered: Steve Rucker, a registered nurse at NIH is the single human being who has thus far been inoculated using high-tech procedures. The other volunteer is a landscaper who works in McCluskey’s Silver Spring neighborhood. It is questionable whether a public official acted properly when she recruited a landscaper who is most likely uninformed about the potential risks. McCluskey conceded: “I basically raked him in.”

According to the Post, the informed consent document "spells out the risks — which are largely limited to soreness around the injection site." Such trivial disclosure hardly begins to provide adequate information about the risks posed by a largely unchartered experimental technique in which the DNA is manipulated. “The DNA enters subcutaneous skin cells, which use it to make Ebola proteins. Immune-system cells attack those proteins and then are primed forever to fight a real Ebola infection even more vigorously.”

While it is hoped that the vaccine will achieve the results sought, this is hardly a sure thing. Unintended consequences are very much a reality in experimental medical interventions. If safety were a certainty, those who are seeking to “rake in” volunteers would volunteer themselves first.


Soldier’s Death May Be Related to Vaccines

Published: November 19, 2003

A 22-year-old Army reservist who died in April may have succumbed to a combination of vaccinations, including those for smallpox and anthrax, the Pentagon said yesterday.

But an Army medical expert, calling the death “a rare and tragic case,” said the military’s vaccination policies would not be changed.

The soldier, Specialist Rachel Lacy, a reservist at Fort McCoy, Wis., died of “a complicated illness, diagnosed as `like lupus,’ ” said the expert, Col. John D. Grabenstein of the Army surgeon general’s office.

A month earlier, Specialist Lacy had received five shots to protect her against smallpox, anthrax, hepatitis B, typhoid, measles, mumps and rubella. Receiving that many shots at once is not unusual, Dr. Grabenstein said.

“Infants can get five in one day,” he said. “It’s considered safe practice.”

Specialist Lacy had no skin problems or immune system problems that would have excluded her from smallpox vaccine, he added.

She later fell sick with aches and fever resembling the cold that other members of her unit had. When the symptoms worsened, they resembled lupus, in which the body’s own immune system attacks it. Eventually, she died from bleeding in her lungs.

The Army said two civilian medical panels that looked into the case agreed that the death was “probably” or “possibly” an adverse reaction to vaccines, though they did not single out one.

Lupus may be touched off by a viral infection, and vaccinations, which use killed or weakened viruses, resemble viral infections, so it was a possible explanation, Dr. Grabenstein said.



Washington Post
November 19, 2003
Pg. 19

U.S. Soldier’s Death Is Tied To Vaccines

By David Brown, Washington Post Staff Writer

A 22-year-old female soldier who died last spring after getting multiple vaccines, including the one against smallpox, succumbed to an immune system disease apparently triggered by the immunizations.

That is the conclusion of a panel of experts reviewing the military’s experience with smallpox vaccine, which has been given to about 515,000 troops in the past year. A second panel believes that vaccination “possibly” caused the young woman’s death.

The woman received smallpox, typhoid, anthrax, hepatitis B and measles-mumps-rubella vaccine on March 2. On April 4, she died of lung complications caused by an acute attack of the autoimmune disease lupus.

She had never shown symptoms, but analysis of two blood samples stored in the military’s 30-million-sample repository showed that she had abnormalities associated with lupus as far back as 1998.

The vaccinations apparently triggered a first “flare” of lupus, which an Army official, Col. John D. Grabenstein, said has been observed a few times in civilians. Neither panel cited a specific vaccine as the cause.

A panel of scientists from the government’s Advisory Committee on Immunization Practices and Armed Forces Epidemiology Board said the evidence “strongly favors” the theory that vaccination led to the death. A committee convened by the Health Resources and Services Administration split on the issue, with three members saying it was “possible” and two that it was “probable.”

William Winkenwerder Jr., assistant secretary of defense for health affairs, said there are no plans to change the vaccination program.

A study published last summer reported 18 nonfatal cases of myocarditis, or inflammation of the heart muscle, among troops getting smallpox vaccine.


Volunteer Gets Experimental Ebola Vaccine

By Rick Weiss

Steve Rucker, a registered nurse at the National Institutes of Health, broke with his lunchtime routine yesterday, forgoing his usual visit to the cafeteria and opting instead to roll up his sleeve for a shot filled with the biological essence of Ebola — one of the world’s deadliest and goriest diseases.

Surrounded by a gaggle of doctors and scientists, Rucker stepped into medical history at 12:10 p.m., becoming the first person ever injected with an experimental vaccine designed to protect against Ebola, the disease that was highlighted in the real-life thriller “The Hot Zone” and that continues to take a bloody toll in Africa.

“I’ve had better lunches,” Rucker quipped as the shot’s 100 trillion strands of synthetic DNA began to make their way into the cells in his arm.

Rucker is a pioneer in a high-tech effort to beat Ebola. If the vaccine works in people as it has in monkeys, it could fell one of the world’s most horrid infectious scourges.

Alas, health officials say, despite weeks of advertisements and other pleas, only two people have volunteered to be part of the effort.

“People freak out about Ebola,” said Margaret McCluskey, the director of nursing at the NIH’s vaccine research center, where the new vaccine — the first for Ebola — awaits 25 more people to participate in initial safety tests.

When the NIH started testing an experimental vaccine for AIDS, many people with friends or lovers affected by that disease stepped forward. When it was for smallpox — a disease feared these days as a weapon of bioterrorism — a mix of patriotism and self-interest drew even more volunteers.

This time, however, the telephones are eerily silent. Almost no one, it seems, wants to get an Ebola shot. Indeed, the only volunteer so far other than Rucker is a landscaper who works in McCluskey’s Silver Spring neighborhood.

“I basically raked him in,” she conceded.

It is not surprising that people would hesitate about getting injected with anything labeled “Ebola.” The disease is notoriously lethal, rapidly killing 50 percent to 90 percent of its victims. Just the thought makes people irrational.

Already, the landscaper has been asked by some clients whether he is going to be bringing the disease to the neighborhood.

The irony, scientists and doctors lament, is that this first Ebola vaccine is probably the safest and most sophisticated vaccine ever made, without a single component coming from the virus itself.

Indeed, the product spray-blasted into Rucker’s arm (no needle necessary) is by any standard a marvel of biotechnological engineering. It was designed to rally the immune system even more than a real Ebola infection would, without causing any symptoms of the disease itself.

“It’s remarkably sophisticated technology,” said Gary Nabel, the virologist who is leading the Ebola effort in a fast-track program that has catapulted his basic research from the lab bench to the clinic in just three years.

Inexplicably, the frequency of Ebola outbreaks in Africa has been increasing. But it is not just Africans who will benefit, said Anthony S. Fauci, chief of the National Institute of Allergy and Infectious Diseases, which oversees NIH’s vaccine research center. Like the smallpox virus and the bacterium that causes anthrax — for which vaccines, though imperfect, at least exist — Ebola virus, too, is a potential bioterrorism agent.

“In its natural form it’s not the best,” Fauci said. “You need close contact for it to spread. . . . But an aerosolized form would be extremely treacherous. And from a psychological terror aspect, you don’t need a lot of people bleeding to get enormous terror in the population.” The virus causes clotting abnormalities and tears holes in blood vessels, causing victims to bleed to death from multiple sites, including eyes, mouth and nose.

A vaccine, Fauci said, might deter those who would think about using such a weapon and would be “a big cause of comfort” for citizens, who would know that protection is available.

Rucker, 36, said he got religion about the importance of vaccines while living in medicine-deprived parts of South America.

“It sounds funny to say I’m excited about an Ebola vaccine, but this really is an exciting trial,” he said. “It’s so rare in research that you get to help with something that’s so promising. And the pharmaceutical industry would never do this. There’s no profit in this.”

He has looked at the animal safety data and studied the informed-consent document that spells out the risks — which are largely limited to soreness around the injection site.

“There’s nothing in there about ‘You could end up bleeding to death,’ ” he said. “It’s not like the polio vaccine,” one version of which causes polio in rare cases instead of preventing it.

In fact, the Ebola vaccine is made of laboratory-synthesized strands of DNA designed to preclude that possibility and other side effects.

With nearly atomic precision, researchers at Vical, a biotechnology company in San Diego, made the strands to mimic those found in the Ebola virus — but with key components removed, including the part that triggers illness and the part that might allow the DNA to recombine with the DNA of some other virus to make a new and potentially disease-causing bug.

Volunteers will get three shots over three months. Blood tests will track their immune-system responses for a year.

The DNA enters subcutaneous skin cells, which use it to make Ebola proteins. Immune-system cells attack those proteins and then are primed forever to fight a real Ebola infection even more vigorously.

The long-term plan is to follow the DNA shot with a booster made of an adenovirus engineered to contain Ebola DNA. In a test of four monkeys given that one-two punch, all four were unfazed by an Ebola attack, while four monkeys given dummy shots all died, said virologist Anthony Sanchez of the Centers for Disease Control and Prevention, which helped develop the vaccine.

Because it would be unethical to expose humans to Ebola to test the vaccine’s efficacy, scientists will simply compare their immune responses with those that proved effective in monkeys and other animals. Much larger human studies will eventually be conducted to provide final proof that the vaccine is safe for large populations.

But first things first. To get 25 more volunteers, McCluskey is starting to focus her efforts on groups that might have a special appreciation for Ebola’s African toll — employees at the World Bank, for example, and Peace Corps people.

“When people read in the newspaper a few years from now that we’re on a plane stopping an outbreak, they’ll know they helped,” McCluskey said.

© 2003 The Washington Post Company

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