Alliance for Human Research Protection

Sat, 29 Mar 2003

In our earlier Infomail today, the focus was on the Administration’s difficulty in recruiting volunteers for the anthrax vaccine trial. This Infomail focuses on the determined push to implement the smallpox vaccine program, despite the advice of medical experts who urge caution. {See New York Times and ABC News links, below]

The Washington Post reports (below) "federal health experts are investigating at least 18 cases of possible cardiac reactions, including three fatal heart attacks in recently immunized military personnel and civilian health care workers."

Despite the Administration's directive, the public is clearly not following in step. The Post reports that New York and Illinois have suspended the smallpox vaccine program entirely, with individual hospitals in Florida, New Hampshire and elsewhere doing the same. And in the District of Columbia, the health department indicated that only three of the 11 health department workers scheduled for inoculation yesterday showed up.

Similarly, the Wall Street Journal reported that the American public is not lining up to volunteer as test subjects in clinical trials testing the anthrax vaccine--—even with a $2,000 cash incentive. [See AHRP Infomail: Anthrax Vaccine Consent Form: Should You Roll Up Your Sleeve?]

See: Experts Support Move to Curb Some Smallpox Vaccinations
By DENISE GRADY, THE NEW YORK TIMES, March 27, 2003, B-14
http://www.nytimes.com/2003/03/27/international/worldspecial/27SMAL.html?pagewanted=print&position=top

U.S. May Be Pushing Smallpox Shots Too Hard, By Maggie Fox, Health and Science Correspondent, ABC News. http://abcnews.go.com/wire/US/reuters20030327_451.html

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http://www.washingtonpost.com/wp-dyn/articles/A44240-2003Mar28.html
THE WASHINGTON POST
2 States Halt Smallpox Shots
March 28, 2003
By Ceci Connolly
 

At least two states suspended smallpox immunizations, and the Pentagon reported its first fatal post-inoculation heart attack yesterday, even as federal scientists struggled to figure out whether the vaccine was triggering a series of cardiac-related problems.

Also yesterday, the government's leading vaccine experts recommended that the Centers for Disease Control and Prevention take additional precautions in the beleaguered program by screening out anyone volunteering for inoculation with known heart disease or risk factors such as hypertension, diabetes or high cholesterol.

Altogether, federal health experts are investigating at least 18 cases of possible cardiac reactions, including three fatal heart attacks in recently immunized military personnel and civilian health care workers. But William Winkenwerder Jr., assistant secretary of defense for health affairs, said the heart attack death of a 55-year-old National Guardsman was more likely related to the man's high cholesterol and smoking than the vaccination.

"That is very noteworthy in this case," Winkenwerder said in an interview. The evidence at this point, "indicates smallpox vaccination was not likely to be the cause of his death." More than 350,000 Defense Department employees have been inoculated since December.

Although historically the smallpox vaccine has not been linked to heart attacks or angina, the recent cases have added to widespread reluctance in the medical community to be immunized against a disease that has not been seen in three decades.

In the District, only three of the 11 health department workers scheduled for inoculation yesterday showed up, said Michael Richardson, the city's senior deputy director, medical affairs.

Illinois and New York suspended immunizations entirely, as did some individual hospitals such as Dartmouth Medical Center in New Hampshire. Other states, such as Florida, postponed inoculations until they could update volunteers on new safety measures relating to heart risks.

At the CDC offices in Atlanta, staffers were fielding nervous phone calls from people who had been vaccinated and worried they may be at risk for heart failure, said Dixie Snyder, associate director for science at CDC.

At the two-month mark, the Bush administration's effort to immunize millions is stalled, hampered by fears of the vaccine itself, doubts about the risk of a smallpox attack and the lack of compensation for people who suffer complications from the vaccine.

So far, 25,000 people have responded to President Bush's call for medical personnel to be inoculated, a tiny fraction of the 450,000 that state officials estimated they would need to set up mass vaccination clinics in the event of a bioterrorism attack. The House has rescheduled a vote on a compensation proposal for Monday, although Democrats complain the Republican bill falls far short.

"I think it's time to stop the program," said one early skeptic, Richard Wenzel, chief of internal medicine at the Virginia Commonwealth University Medical Center in Richmond. "Now is the time to say let's err on the side of caution until this is really sorted out."

A safety subcommittee of CDC's Advisory Committee on Immunization Practices recommended screening out anyone over age 50 and people under 50 with risk factors for heart problems, said John Neff, cochair of the smallpox vaccination safety working group and a physician at Children's Hospital in Seattle.

"This would provide the maximum degree of safety for the population," he said. "That is our major concern."

In an emergency two-hour meeting, however, the full committee stopped short of that position yesterday, in part because it fears the vaccination program would come to a standstill.

Eliminating everyone over 50 would make it "infeasible to develop the numbers we need for preparedness," said Guthrie Birkhead, a committee member and director of the Center for Community Health at the New York State Department of Health. "We are taking extraordinary precautions because of a theoretical concern."

A few committee members said they preferred to wait for more data before proceeding with the program.

"You can make the case the risks of this vaccine may be outweighing its benefits, and at least for the moment, we should temporarily suspend this program," said Paul Offit, chief of infectious diseases at Children's Hospital in Philadelphia. But his proposal for a temporary halt to the program was quickly dismissed.

CDC spokesmen said they did not know whether officials would adopt the committee's recommendation or stick to its decision this week to only weed out people with known heart disease, such as a previous heart attack.

While experts study the recent cases in hospital workers, growing evidence suggests that the 10 cases of heart inflammation in healthy, young Defense Department employees were related to the vaccinemilitary and CDC experts said. In every case, the sharp heart pains subsided after patients received painkillers, and physicians do not expect any long-term damage.

That discovery raised another challenge for administration officials trying to refine the civilian vaccination program. Until now, states have targeted older volunteers because research has shown the rate of serious reactions is much lower in people who had been previously vaccinated. But if the cardiac cases result in fewer older volunteers and more younger, first-time vaccinees, it is likely the number of heart inflammation cases is likely to rise, experts said.

Whatever the CDC decides, many physicians, hospitals and health departments are charting their own course. David Pearle, a cardiologist at Georgetown University Hospital, said he would err on the side of caution.

"The worry would be not so much the 35-year-old who smokes, but perhaps the 55-year-old who smokes and has a family history," he said, describing the complex set of factors to consider in deciding who could safely get the vaccine. "If there is a strong constellation of symptoms, I certainly would withhold vaccine until we know more."

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