Funding, transparency issues hobble HHS? pandemic flu preparations
By REBECCA NEAL
October 14, 2008
If a pandemic flu outbreak occurs, the government plans to deliver vaccines to about 20 million people deemed critical. Those first recipients will include health care workers, law enforcement, key government officials, emergency responders and power-grid electrical workers.
The idea is to keep society running until a more effective vaccine, tailored to the specific pandemic-causing strain, is produced and distributed on a large scale. And that could take 20 to 23 weeks.
But a key glitch in that plan ? which would be carried out by the Health and Human Services Department ? is that the government has yet to notify the public of exactly who will receive those initial vaccines and medicines when and if that time arrives, experts said.
Marcia Crosse, the Government Accountability Office?s director of health care, said that?s a problem because the public needs to understand well ahead of time how the limited number of initial vaccines will be distributed, and why, in order to prevent chaos.
?The challenges are large in dealing with the state, locals and private sector and are not something they can control, hence preparation is so important,? she said in an interview.
In a report released two weeks ago, GAO called on HHS to finalize and make public lists of those who would be the first to receive medication.
GAO also said the department needs to improve plans for local and state involvement and to speed up developing and stockpiling vaccines and antivirals.
?We need to communicate to the public that the vaccine will not be available for everyone at first and get public input on who [should get it]. That way it?s not chaotic when they hear for the first time, ?There?s not enough available for me, and I need to stay home and stay well,?? Crosse said.
Rear Adm. Craig Vanderwagen, HHS? assistant secretary for preparedness and response, said the department recognizes the importance of informing the public, but is still working through details with local responders.
?There are significant ethical challenges in trying to manage the question of high demand and low availability asset use. We?ve been working with state and territory officers to try to address that mass medical care with scarce resources,? he said.
Dr. Robin Robinson, HHS? deputy assistant secretary and director of the department?s Biomedical Advanced Research Development Authority, said there is another challenge confronting the department?s preparation: funding.
HHS didn?t receive funding for medicine stockpiles in fiscal 2008 and is receiving none this fiscal year under the continuing resolution. Lack of funding will make it difficult to keep pace in stockpiling medicine, he said. He said he hopes Congress will pass a budget after it returns to a new session in January to fund 40 million doses for a stockpile, but he didn?t say how much funding would be needed.
Crosse said she also hopes Congress will tend to the funding issue, noting that vaccines and drug stockpiles have to be replaced every few years due to their finite shelf lives.
Six companies are working on vaccines now for licensing, Robinson said.
Two companies expect to submit vaccines for approval in 2009. The goal is to have the capacity to create 100 million doses within six months of an outbreak, Robinson said.
Some new technologies are promising, not only for pandemic flu but other illnesses.
?We may be able to make a patch with the [vaccine] in it to put it on an arm and provide it that way. It?s more effective, and the public will be much more accepting of having it that way than an injection or through the nose,? he said.
http://www.federaltimes.com/index.php?S=3770134
By REBECCA NEAL
October 14, 2008
If a pandemic flu outbreak occurs, the government plans to deliver vaccines to about 20 million people deemed critical. Those first recipients will include health care workers, law enforcement, key government officials, emergency responders and power-grid electrical workers.
The idea is to keep society running until a more effective vaccine, tailored to the specific pandemic-causing strain, is produced and distributed on a large scale. And that could take 20 to 23 weeks.
But a key glitch in that plan ? which would be carried out by the Health and Human Services Department ? is that the government has yet to notify the public of exactly who will receive those initial vaccines and medicines when and if that time arrives, experts said.
Marcia Crosse, the Government Accountability Office?s director of health care, said that?s a problem because the public needs to understand well ahead of time how the limited number of initial vaccines will be distributed, and why, in order to prevent chaos.
?The challenges are large in dealing with the state, locals and private sector and are not something they can control, hence preparation is so important,? she said in an interview.
In a report released two weeks ago, GAO called on HHS to finalize and make public lists of those who would be the first to receive medication.
GAO also said the department needs to improve plans for local and state involvement and to speed up developing and stockpiling vaccines and antivirals.
?We need to communicate to the public that the vaccine will not be available for everyone at first and get public input on who [should get it]. That way it?s not chaotic when they hear for the first time, ?There?s not enough available for me, and I need to stay home and stay well,?? Crosse said.
Rear Adm. Craig Vanderwagen, HHS? assistant secretary for preparedness and response, said the department recognizes the importance of informing the public, but is still working through details with local responders.
?There are significant ethical challenges in trying to manage the question of high demand and low availability asset use. We?ve been working with state and territory officers to try to address that mass medical care with scarce resources,? he said.
Dr. Robin Robinson, HHS? deputy assistant secretary and director of the department?s Biomedical Advanced Research Development Authority, said there is another challenge confronting the department?s preparation: funding.
HHS didn?t receive funding for medicine stockpiles in fiscal 2008 and is receiving none this fiscal year under the continuing resolution. Lack of funding will make it difficult to keep pace in stockpiling medicine, he said. He said he hopes Congress will pass a budget after it returns to a new session in January to fund 40 million doses for a stockpile, but he didn?t say how much funding would be needed.
Crosse said she also hopes Congress will tend to the funding issue, noting that vaccines and drug stockpiles have to be replaced every few years due to their finite shelf lives.
Six companies are working on vaccines now for licensing, Robinson said.
Two companies expect to submit vaccines for approval in 2009. The goal is to have the capacity to create 100 million doses within six months of an outbreak, Robinson said.
Some new technologies are promising, not only for pandemic flu but other illnesses.
?We may be able to make a patch with the [vaccine] in it to put it on an arm and provide it that way. It?s more effective, and the public will be much more accepting of having it that way than an injection or through the nose,? he said.
http://www.federaltimes.com/index.php?S=3770134