Is pandemic flu preparedness adequate?
While many Americans believe governments at all levels are well prepared for a public health emergency, including pandemic flu, experts working in the field are concerned the federal government's plan for producing a pandemic flu vaccine does not reflect sufficient urgency and doesn't have the strong leadership it needs.
A report by the Project on Government Oversight (POGO), "Pandemic Flu: Lack of Leadership and Disclosure Plague Vaccine Program," says Congress should demand to know why the Bush administration has not named a permanent director for the Biomedical Advanced Research and Development Authority (BARDA) and why information about the vaccine program, including critical documents, are not readily available for expert review.
BARDA was created by Congress within the Department of Health and Human Services (HHS) a year ago to facilitate collaboration between government, industry, and academia in the influenza vaccine program and other programs dealing with public health emergencies.
POGO notes that an influenza pandemic could cause hundreds of thousands of deaths in the United States, billions of dollars in economic losses, and possibly a climate of fear and a breakdown of public order. At the start of a pandemic, the first and best defense is to quickly immunize as many people as possible.
Last July, HHS secretary Michael Leavitt said vaccine manufacturers would take the next five years to develop the capacity to produce and deliver enough vaccine for the American public within six months of the appearance of a pandemic virus. But POGO says the job can and should be done faster. "The government should be able to speed up the nation's ability to produce enough vaccine," the report says. "But problems with the current vaccine program, including inadequate leadership and limited public disclosure of information, may be impeding progress."
POGO is concerned that a year after BARDA was created, it still does not have a permanent director, and says the "magnitude of the threat to the nation calls for the immediate appointment of an exceptional person of near cabinet-level stature to lead the program who commands respect in the business and public health communitiessomeone willing to blast through financial and bureaucratic roadblocks."
Documentation not available
And POGO says the vaccine program suffers from the government's failure to make public disclosure an essential element. Without such disclosure, it says, problems and possible improvements to the program may not be discovered until too late.
POGO says Mr. Leavitt or the BARDA director should require the prompt disclosure of all relevant documents and information in the pandemic flu vaccine program, including government contracts for vaccine production and information about vaccine manufacturing capacity, U.S. dependence on foreign sources of material for vaccine production, intellectual property rights, alternatives to current vaccines, and the vaccine program budget. "It is essential," the report says, "that the disclosures include a justification of the current plan for vaccine production, and should spell out the reasons for rejecting or de-emphasizing alternative strategies."
"The failure to appoint a permanent director of sufficient stature who can marshal the international scientific and business community and other key players to speed up a viable vaccine production program is inexcusable and dangerously shortsighted," says POGO science advisor Ned Feder, MD, a former National Institutes of Health research scientist.
Asked to expand on the concern over a lack of director, Dr. Feder tells State Health Watch there are some very good scientists and administrators working with BARDA, but it needs leadership that can wield clout if necessary.
"If the director decides that major changes are needed, for example that much more funding is needed, the leader needs to have the stature to demand such changes," he explains. "I don't know if such changes are needed. But a knowledgeable person with stature could assess and determine if changes are needed."
To make the case, Dr. Feder refers to Donald A. Henderson, MD, who received the Presidential Medal of Freedom in 2002 in recognition of a career that included his work directing the World Health Organization's smallpox eradication effort. He says Henderson's stature as an international scientific expert allowed him to run the WHO program in such a way that it succeeded in eradicating smallpox in the world.
Timing difficult
Dr. Feder recognizes that the timing is not the best, with the end of a presidential term close by. "At this point," he says, "it would be very difficult to recruit someone other than a very public-spirited citizen." Dr. Feder also notes that due to the country's current economic woes, anyone in the position of BARDA director who demands more money for vaccine production would be very unpopular with the administration.
At the same time, Dr. Feder hastens to add that he doesn't know if more money is needed. And that's because the documents that could help experts understand how the program is being structured and run are not readily available.
According to Dr. Feder, the federal government has signed several multimillion-dollar contracts with vaccine manufacturers, but the documents are not available online for experts to review. If they were available, he says, experts could look at them for potential problem areas and recommend needed changes in vaccine production so American is prepared for a pandemic flu outbreak sooner.
Items POGO says should be released in addition to the vaccine manufacturing contracts include those related to: 1) manufacturing capacity and plans to increase capacity through government subsidies or price guarantees; 2) domestic manufacturer dependence on foreign production; 3) material transfer agreements, especially in cases in which the process is not working well; 4) intellectual property issues, including a justification for apparent plans to postpone compulsory licensing until the start of a pandemic; 5) foreign governments and the World Health Organization, especially a statement of what the U.S. government will and will not do for other countries when a pandemic begins; 6) alternatives to current vaccines, especially the plans for significant increases in government support for other kinds of vaccines; and 7) budget plans, in view of the call by some experts for a significant budget increase.
Vaccine alternatives
Of those items, Dr. Feder is particularly concerned about the alternatives to current vaccines, especially recombinant hemagglutinin vaccines, which are very different from those in production or planned. "We have no way of determining if, for instance, plans for pilot plants should be stepped up," he says. "Experts need to see these plans in detail and make some determinations."
Dr. Feder says he is concerned that the reason so little information has been made easy to find is a combination of bureaucratic inertia and a desire not to have the pandemic flu vaccine program be an easy target for criticism.
"Without such scrutiny," the report says, "problems and possible improvements for the program may not be discovered until too late. For instance, the government's current timetable for vaccine production may not be the best that can be reasonably expected. But only through full disclosure of all elements related to production and through the resultant debate can we know."
Download the report at: http://www.pogo.org/p/socialservice/so-080306-flu.html. Contact Dr. Feder at [email protected].
While many Americans believe governments at all levels are well prepared for a public health emergency, including pandemic flu, experts working in the field are concerned the federal government's plan for producing a pandemic flu vaccine does not reflect sufficient urgency and doesn't have the strong leadership it needs.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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