Smallpox Vaccine plan: HHS Messengers Still Stumble

October 9, 2002

Smallpox Vaccine plan: HHS Messengers Still Stumble_NYT_WP

The Administration’s shift in its smallpox vaccination policy is meeting with criticism from medical experts who are unconvinced that it is wise or justified to put millions of people at serious risk in (what amounts to) a massive human experiment–without evidence to support the claim that a bioterrorist attack using smallpox virus is likely or imminent. The Washington Post reports: “Because there is limited scientific data, it is difficult to predict the risks of a person spreading the virus in the vaccine to others.”

The failure of officials of DHHS and the Center for Disease Control to provide credible information to the public in the aftermath of the anthrax attacks, does not generate public trust in their judgement. Dr. Lawrence Altman of The New York Times reports that officials of DHHS “still stumble” and fail to level with the American public.

Though the vaccine is not yet licensed, the new plan would set in motion massive vaccinations: the military would receive one million vaccine doses by November, and by the year 2004, the vaccine would be offred to every American. However, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, indicated that: “”Between 30 million and 50 million Americans should not be given the vaccine because they have weak immune systems.”

Dr. Meryl Nass points out that the real issues have not yet been addressed: “The real questions are a) whether the vaccine itself is safe, and b) whether it is effective before and after diluting it.” Dr. Nass refers to two recent articles in The New England Journal that found a dose related difference in the rates of efficacy in the diluted version: Frey SE et al. NEJM vol 346 #17 April 25, 2002, pp 1275-80 states that only 70% of the 1:10 dilutions were effective. Frey SE et al. NEJM, pp1265-74 states that 97.8 of those who received undiluted, 1:10 dilution, and 1:100 dilutions had a “take”.

Clearly, important questions need to be answered. Yet, the NYT reports that at an important DHHS briefing on Friday, Dr. Julie Gerberding, director of the Center for Disease Control, left the meeting wtihout responding to questions from reporters. “If Friday’s performance is any indiction, officials at the Department of Health and Human Services have a long way to go to get their communication skills up to speed.”

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http://www.nytimes.com/2002/10/08/health/policy/08DOCS.html?pagewanted=print&position=top

October 8, 2002

At the Health Department, the Messengers Still Stumble

By LAWRENCE K. ALTMAN, M.D.

WASHINGTON, Oct. 6 — Providing information about an outbreak of communicable diseases — quickly, candidly and in plain language — is essential in gaining public trust, and in a public health emergency it can be a matter of life and death.

Accurate communication can be as important as the medical detective and laboratory work in preventing the spread of the disease because it prevents misinformation and rumors that can undermine confidence and produce panic in any outbreak.

Effective communication requires clear thinking and preparation. But if the performance of officials in a news briefing at the Department of Health and Human Services on Friday is any indication, officials have yet to fully remedy the communication problems that plagued the department in the anthrax bioterror attack a year ago.

When Tommy G. Thompson, the secretary of health and human services, misspoke about the initial case of anthrax in the bioterror attack last year, and other agencies under his charge did not provide reliable information quickly, many health workers and other people harshly criticized his leadership.

Mr. Thompson oversees the Centers for Disease Control and Prevention in Atlanta, which has acknowledged its failure to prepare adequately to communicate during the anthrax outbreak. In the first days of the outbreak, C.D.C. did not take the leadership in providing vital medical and epidemiologic facts to state health departments, practicing physicians and the public. Spokesmen for the centers said the information was supposed to come from Mr. Thompson’s office.

The C.D.C.’s new director, Dr. Julie L. Gerberding, who took over in July, has vowed that the agency will improve its skills in communicating speedily what is known and not known about disease threats to the public. The pledge for new openness has encouraged journalists and health care workers.

Now the threat of smallpox’s return in a bioterror attack is a major concern. Until it was eradicated in 1980, smallpox killed about 30 percent of its victims and scarred and blinded many of its survivors. Because the nation stopped routine vaccinations in 1972, tens of millions of Americans have no protection against the disease, and the immune status of those who were vaccinated is uncertain.

But the vaccine carries risk, so public debate about vaccinations is heating up.

Last Wednesday, Mr. Thompson’s office sent an e-mail message to journalists to “strongly encourage” them to attend a briefing on smallpox on Friday at the department’s headquarters here. The briefing would not “make news,” the message said, but it would give reporters a chance to learn about the latest scientific findings about smallpox as well as logistical matters regarding vaccination and preparedness.

But the message was inaccurate. Among other things, officials at the briefing said they were recommending that smallpox vaccination eventually be made available to all American who want it, a recommendation that was a big change from previous policy and that was front-page news around the nation.

The day before, at a scientific meeting of the World Medical Association here, Dr. Gerberding said the government had learned from the anthrax attack how important it was to “communicate, communicate, communicate.” The Friday news briefing, she said, would in part show Mr. Thompson’s efforts to improve communications.

But in practice the new effort stumbled, from the big things to small ones.

Much of Friday’s briefing centered on clarifying the options and what officials had recommended to Mr. Thompson and President Bush. But before reporters could question Dr. Gerberding about this unexpected news development, she suddenly left the stage, leaving two participants, Jerome M. Hauer, an assistant secretary of health and human services and director of the department’s Office of Public Health Preparedness, and Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, to field the questions.

Dr. Gerberding’s departure created another point of confusion. Many people in the audience concluded that she was urgently summoned by a White House staff member who had been listening to the briefing and might have been dissatisfied with something she said or did not say.

Not so, Mr. Hauer said in an interview after the briefing. Dr. Gerberding had to leave to participate in another briefing with the Environmental Protection Agency on West Nile fever, Mr. Hauer said.

But by then, the scheduling conflict had created its own confusion.

Also, reporters entering the auditorium at Mr. Thompson’s headquarters on Friday afternoon passed packets about smallpox stacked on a table. The reporters were not allowed to take them until they were distributed after the news briefing began. So reporters were deprived of an opportunity to inform themselves before asking questions. But, as it turned out, the packets contained little new information and no summary of the messages the top officials were trying to make in the briefing.

When Mr. Thompson’s office wants to get its message across, it often posts a transcript of news briefings hours within hours on its Web site, www.hhs.gov. Reporters and the public can often find needed information in the transcript. But as of Monday afternoon, no transcript of Friday’s briefing could be readily found on the site.

Failing to deliver health information messages could be lethal in a real emergency. If a smallpox case occurs in a major city, for example, many people may flee. Yet that could be the worst situation. Overall public health would suffer because some of those leaving might be carrying the virus and spreading it to new areas. And those who have the virus may also suffer more because their vaccinations may be delayed as they travel to new places.

If Friday’s performance is any indication, officials at the Department of Health and Human Services have a long way to go to get their communication skills up to speed.

Copyright The New York Times Company

http://www.washingtonpost.com/wp-dyn/articles/A45549-2002Oct4.html

Voluntary Smallpox Vaccination Urged Offer to General Population Represents a Shift in Policy By a Washington Post Staff Writer Saturday, October 5, 2002; Page A01

The Bush administration’s top bioterrorism advisers said yesterday they support a voluntary smallpox vaccination program that would begin with 500,000 health care workers, expand to 10 million emergency responders and extend to the rest of the population as early as 2004.

It was the first time high-ranking administration officials acknowledged they are considering offering the risky vaccine to the public prior to an attack and it represented a profound shift in thinking from the June recommendations of a government advisory panel to inoculate about 20,000 medical personnel. “We live in a society that values individual choice,” said Julie L. Gerberding, director of the Centers for Disease Control and Prevention. “If we have vaccine and we have data to accurately assess the safety, one school of thought is that informed people may want to have the choice of getting vaccine or not.”

In a 90-minute briefing at the Department of Health and Human Services, the group of officials responsible for implementing a bioterror response plan laid out the options before President Bush, stressing that he has yet to make a decision on who could be vaccinated and when. If a smallpox case were detected, officials would assume the nation was under attack and would quickly move to nationwide vaccination.

Developing a “pre-attack” vaccination policy, however, has proven to be “extremely difficult” because of the challenge in balancing the possible risks of the vaccine against the risks of an attack, said Jerome M. Hauer, assistant secretary for emergency health preparedness.

Although they have no way of knowing the likelihood of a smallpox attack, health experts fear such an attack because the virus is so contagious and so deadly. About one-third of people who get the disease die, yet the vaccine itself can cause serious, sometimes fatal, complications.

Concerns that Iraq or another hostile nation may have acquired the virus have added urgency to the vaccination debate. “We need to be mindful that the context of this decision has changed a bit” since the far more conservative June recommendations, Gerberding said.

Vice President Cheney has speculated that the threat from Iraqi President Saddam Hussein may necessitate mass vaccination. Privately, sources said Cheney has vigorously advocated a broad vaccination policy. White House spokesman Scott McClellan said last night the policy “is under review” but he could not elaborate on a timetable or factors involved in the decision.

Since last fall’s anthrax attacks, federal health officials have moved swiftly to build up the nation’s smallpox vaccine stockpile. If an attack occurred today, they said they could safely dilute the existing supply to inoculate every American. By the end of next year, they expect to have 209 million doses of new vaccine on hand. None of the vaccine has been licensed by the Food and Drug Administration, but officials expect the first batches will be approved by November.

At the request of the Department of Defense, Hauer said HHS will provide the first 1 million doses of licensed smallpox vaccine to the military within the month. Pentagon spokesman James Turner refused to comment.

For civilians, the HHS team favors a policy of “ever-expanding access to vaccine” that could be phased in as more vaccine is licensed and scientists have time to monitor early reactions to it. Using licensed vaccine would be much easier logistically than administering it as an experimental treatment that involves tricky liability issues.

The approach envisions vaccinating the people considered to be at greatest risk if an outbreak occurs. That would include public health investigators, emergency room workers and even janitors and security guards at local hospitals. The goal in the early stages, Gerberding said, “is to maximize our ability to respond to an attack should one occur.” In the second phase, as many as 7.5 million medical workers would be offered vaccine, along with the nation’s 3 million firefighters, police officers and rescue workers, Hauer said. Inoculating that many emergency personnel “would make it even easier to respond” to an attack, Gerberding explained. It is possible Bush would combine the first two phases and opt to inoculate the majority of first responders immediately.

At some later date, perhaps in early 2004, vaccine could be offered to every American. “Right now, our thinking is in favor of making vaccine available to the general public,” Gerberding said.

Federal health officials rejected the advice of its advisory panel to designate certain smallpox hospitals because Hauer said it was unrealistic to think patients would follow those guidelines. America stopped routine vaccination in 1972, which means about 45 percent of the population has never been inoculated. It is unclear how much immunity remains from vaccines given 30 or 40 years ago.

Between 30 million and 50 million Americans should not be given the vaccine because they have weak immune systems, said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. That includes people who have received chemotherapy, have eczema or are infected with the AIDS virus. For every 1 million vaccinated, 15 people are likely to suffer life-threatening complications and one or two would die.

Because there is limited scientific data, it is difficult to predict the risks of a person spreading the virus in the vaccine to others. Administration aides are still grappling with the liability issues of reviving a vaccination program. State health officials have until Dec. 1 to file plans for mass vaccination within five to 10 days of an attack, Hauer said. In the event of an attack, he observed, “Five days might be a luxury.”

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