Incentives to Pharma Companies but Health Care Leaders Voice Doubts on Smallpox Inoculations

Incentives to Pharma Companies but Health Care Leaders Voice Doubts on Smallpox Inoculations

Thu, 30 Jan 2003

The New York Times reports (below) that serious doubts about the president’s smallpox vaccination plan emerged at a Senate hearing Wednesday. The Washington Post reports (below) that "The hearing illustrated the growing tensions between federal officials overseeing the vaccination program and hospitals, cities and states that must implement it."

Dr. Louis Bell, chief of pediatrics at Children’s Hospital of Philadelphia told a Senate committee: "From 1907 to 1975, 85 children and adults were infected by health care workers shedding virus, and 9 of them died. The risk was greatest to hospitalized children. Hospitals like his now contain many children on cancer chemotherapy or undergoing organ transplants, so the risks are greater, and there are more immuno-compromised health workers." [Those findings will soon be published in The New England Journal of Medicine.]

It is difficult to trust the judgment of public health officials whose pronouncements about the safety of the anthrax vaccine were unsubstantiated, and whose ill-advised plan to conduct a smallpox vaccine trial on 40 children was scuttled only after public outrage. [See, http://www.ahrp.org/children/smallpoxpubcomments.php]

Pronouncements by officials of the Center for Disease Control (CDC) are hardly reassuring in light of the fact that Congress at the behest of the Administration immunized vaccine manufacturers and those who carry out the program. The administration did not establish a fund to care for those who will suffer adverse vaccine effects and those who may become inadvertently infected by someone who was vaccinated.

The threat of bioterrorism is certainly good news for the pharmaceutical industry. In his state of the union message President Bush announced a multi- billion dollar proposal to entice pharmaceutical companies to develop vaccines against bioterrorist attacks: “Project BioShield.” The Post reports, "If approved by Congress, Project BioShield would give officials unusually broad authority to tap into a separate pot of money whenever they found a promising drug or vaccine, without the standard annual budget appropriations."

Whereas seemingly limitless public funds are made available as "incentives" for the pharmaceutical industry – whose profit margins hardly need incentives to produce vaccines which are now in demand – no funds have been set aside to care for those who will suffer adverse side effects, possibly become incapacitated, from the hazardous smallpox vaccine.

Who, in the Administration is listening to public concerns? The Times quotes Wendy Laprade, a registered nurse, who said: “We have issues with compensation — if you receive this and become ill, what happens?”

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http://www.washingtonpost.com/ac2/wp-dyn/A63430-2003Jan29?language=printer washingtonpost.com U.S. Hopes Incentives Will Push Vaccine Development By Ceci Connolly Washington Post Staff Writer Thursday, January 30, 2003; Page A08

The Bush administration is hoping that its promise of a guaranteed buyer will entice pharmaceutical and biotechnology companies to develop vaccines and treatments to counter bioterrorism threats, officials said yesterday.

The multibillion-dollar proposal announced in President Bush’s State of the Union address represents an unprecedented effort to rapidly expand the nation’s medical arsenal against deadly agents such as smallpox and anthrax. The proposal has been named “Project BioShield.” For years, American scientists have experimented with creative approaches for combating biological and chemical warfare. But the private sector, fearful there was little market for such seemingly esoteric products, has been reluctant to invest the money to develop them. Without a guaranteed buyer for a product such as an ebola virus vaccine, industry lobbyists have told the administration it makes better financial sense to devote time and money to products that are in steady demand, such as cancer therapies.

“We want to be able to assure drug companies there will be a market for their product, as opposed to making something that nobody will buy,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “This is a way to guarantee there will be a market whether it is used or stockpiled, and perhaps they will make a modest profit.”

In his address, Bush estimated the program would cost $6 billion over 10 years, although advisers said the price tag would depend on how quickly the private sector responds. If approved by Congress, Project BioShield would give officials unusually broad authority to tap into a separate pot of money whenever they found a promising drug or vaccine, without the standard annual budget appropriations.

The proposal, still in skeleton form, would also give federal health agencies wide latitude to expedite anti-terrorism projects. Fauci said it would enable the National Institutes of Health to lift salary caps to hire scientists with expertise in bioterrorism to renovate labs quickly and to streamline contracts.

The Food and Drug Administration would be given the authority to approve new drugs and vaccines for use in the event of a terrorist attack, FDA Commissioner Mark McClellan said. “We need to do a more aggressive job of developing these countermeasures,” he said.

As White House aides were scrambling to fill in the details of the president’s proposal, lawmakers were hearing a litany of complaints about the administration’s unfolding smallpox vaccination program. “The crush of the current smallpox vaccination activity is taking a large toll on public health agencies,” Patrick Libbey, executive director of the National Association of County and City Health Officials, told members of the Senate Appropriations subcommittee on health. Last week, officials began the first of what could be as many as 10.5 million inoculations of medical personnel and emergency responders.

Several unions are advising members not to volunteer for the program, citing the lack of compensation for anyone who is injured by the vaccine. About 100 hospitals also have announced their intention not to participate.

Louis Bell, division chief of general pediatrics at the Children’s Hospital of Philadelphia, said the institution does not intend to inoculate workers. “We are concerned that the introduction of newly vaccinated health care workers could expose our patients and employees to unnecessary risks,” he said. “It is instructive the number of hospitals around the country that are declining to vaccinate,” subcommittee Chairman Arlen Specter (R-Pa.) said.

Julie L. Gerberding, director of the Centers for Disease Control and Prevention, said she was optimistic that enough volunteers would come forward. “We knew that not every hospital would choose to participate,” she said. So far, 98,600 doses of vaccine have been shipped to 19 states and Los Angeles County.

The hearing illustrated the growing tensions between federal officials overseeing the vaccination program and hospitals, cities and states that must implement it. “The smallpox program is leaving us less prepared, and we are probably regressing in the progress we had made,” Libbey told the lawmakers.

In a survey of 718 local public health departments, Libbey’s organization found that the demands of implementing the smallpox vaccination policy forced half the agencies to delay or scale back other bioterrorism preparations and prompted 182 communities to postpone or cancel other public health programs such as childhood vaccinations. Part of the reason is the newness and complexity of the program, Libbey said. “It’s not like lining people up in a mall for a flu shot,” he said.

© 2003 The Washington Post Company

http://www.nytimes.com/2003/01/30/politics/30SMAL.html?pagewanted=print&position=top January 30, 2003 Health Care Leaders Voice Doubts on Smallpox Inoculations By DONALD G. McNEIL Jr. A-13

WASHINGTON, Jan. 29 – Serious doubts about the president’s smallpox vaccination plan emerged today at a Senate hearing from the very health care professionals who have been asked to get or administer the vaccine.

The chief of pediatrics at Children’s Hospital of Philadelphia, the nation’s largest children’s hospital, said his institution would not immunize its staff.

The health and safety director of a union representing 350,000 health care workers asked for a delay and said several of his chapters had advised their nurses not to cooperate.

Two public health officials said the Bush administration was seriously underestimating the costs of the plan and how much money it would take from public health programs for things like childhood vaccines and tuberculosis control.

Dr. Julie Geberding, chief of the Centers for Disease Control and Prevention, defended the administration’s plan, but said, “We appreciate the concerns and are going to take steps to make the program successful.”

The president’s program, announced on Dec. 13, calls for up to 500,000 health workers to be vaccinated in the coming weeks. The second phase is to include 10 million more health workers, firefighters, police and ambulance personnel.

All are to be volunteers. Four doctors were vaccinated in Connecticut on Friday, the first day the plan went into effect, but Connecticut health administrators were embarrassed when the nurses on their vaccination team backed out at the last minute, citing concerns like those expressed at today’s hearing before the subcommittee on labor, health and human services of the Senate Appropriations Committee.

The critics’ chief worries were that vaccinated health workers could suffer side effects themselves or accidentally infect their own family members or patients with the vaccinia virus. If they or a family member suffered a bad reaction – whether resulting in a day off work because of fever or a rare but life-threatening case of encephalitis or generalized vaccinia – they might not be covered by workers’ compensation, they said.

When the vaccine was last in routine use, in the 1960’s, it caused up to 52 life threatening complications and two deaths for every million people vaccinated. Some experts expect higher rates of complications today because more people have compromised immune systems and skin problems. On the other hand, the 1960’s figures were mostly for the first-time vaccination of children, while many health care workers today were vaccinated as children, and, of course, are adults and presumably know something about the risks of side effects.

Dr. Louis M. Bell, chief of pediatrics at Children’s Hospital of Philadelphia, in explaining his hospital’s decision not to join the plan, said, “The virus might spread from the arm of a health care worker to a hospitalized child.”

From 1907 to 1975, Dr. Bell said, citing a study that he said would soon appear in The New England Journal of Medicine, 85 children and adults were infected by health care workers shedding virus, and 9 of them died. The risk was greatest to hospitalized children. Hospitals like his now contain many children on cancer chemotherapy or undergoing organ transplants, so the risks are greater, and there are more immuno-compromised health workers.

Senator Arlen Specter, Republican of Pennsylvania, who was chairman of the hearing, called it “rather startling that an institution of your prestige should decide not to inoculate.” Mr. Specter later said a newspaper survey of 50 state health officials found that more than 80 of the country’s 3,000 hospitals, including some leading ones, had made the same decision.

Dr. Geberding of the disease control agency said the administration’s plan did not require every hospital to participate.

“We knew that not every one would choose to,” she added. “We planned for it.”

During her brief testimony, Dr. Geberding calculated that it would cost about $13 for each person vaccinated. An earlier estimate by the centers had been $85 a person.

Two witnesses disagreed. Patrick Libbey, director of the National Association of County and City Health Officials, said four of his members estimated their costs at $155 to $220 per person vaccinated, and Jane Colacecchi, the public health director of Iowa, estimated her costs at $400 a person. Both said their figures included training vaccination teams and paying their salary and travel costs, screening out people at risk, giving the vaccinations and bandages, following up on bad reactions and managing the data.

Dr. Geberding later said her estimate was only “the extra cost of putting vaccine in someone’s arm,” not what she called “infrastructure costs.”

James August, health and safety director for the American Federation of State, County and Municipal Employees, representing 350,000 health care workers, called for a delay in the program until workers could be taught more about the risks, and until all the worries about compensation for those suffering side effects were worked out.

Copyright 2003 The New York Times Company ~~~~~~~~~~~~~~~~~~

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