U.S. government faces no-win fight with flu

[Pathfinder]

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Wed Oct 28, 2009 12:41pm EDT



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By Maggie Fox, Health and Science Editor - Analysis
WASHINGTON (Reuters) - First came the jibes about the U.S. government rushing out an untested swine flu vaccine. Now, critics say it is not fast enough.

"The premise that 'you can't win' is part of the equation," said Dr. D.A. Henderson, who advised the administration of former president George W. Bush on pandemic preparedness.

It is a lesson playing out in real time by U.S. government health officials as the H1N1 pandemic turns from a scientific and logistical battle to a political one.

Plans have been in the works for handling a flu pandemic since 2003, when H5N1 avian influenza re-emerged in Asia. Health officials held roundtables and ran tabletop exercises, with journalists, bloggers and activists.

They knew it would take time to make a vaccine against a new flu strain and handle the delicate balance between communicating the need for the vaccine without sparking anxiety if manufacturers were unable to deliver it on time.

Now that the H1N1 flu pandemic has arrived, health officials are facing the inevitable, Henderson, who helped lead the vaccination effort that eliminated smallpox in 1979, said in an e-mail.

"If one anticipates a potential disaster and is successful in having enough done to head it off, there is criticism of the energy and money expended for something that didn't happen. The converse is obvious."

QUESTIONING NEED AND SAFETY

For the most part, public health experts have praised the administration of President Barack Obama for how it has dealt with H1N1. Companies formulated a vaccine in a record five months. Antivirals and other supplies from the Strategic National Stockpile were pushed out.

The National Institutes of Health is conducting research on new antivirals and how best to slow the spread of flu.

The Centers for Disease Control and Prevention has briefed the media frequently, and the agency is using new media such as pages on Facebook, updates on Twitter and videos on YouTube.

But now Health and Human Services is under fire for having miscalculated how much vaccine would become available and when. Officials said 40 million doses of vaccine would be available by the end of October, with 20 million a week rolling out after that. As of Tuesday, 22.4 million were ready.

HHS Secretary Kathleen Sebelius began making appearances in which she promised that every American who wanted a vaccine would get one and said 250 million doses were on order.

"The one thing they have to stop saying is there is a dose for everybody," said Mike Osterholm, a former Minnesota public health official and expert on pandemic preparedness at the University of Minnesota.

"The virus has been in a race with the vaccine and the virus is winning. It doesn't matter if there is a dose for everybody if it doesn't get to them before they become ill."

MILLIONS INFECTED

CDC has stopped trying to count how many people have caught swine flu, saying only that it is millions. Officially, 1,000 U.S. deaths have been attributed to H1N1 since April.

Members of Congress have begun to question the vaccine numbers. Republican Senator Susan Collins took Sebelius to task on Monday for having released estimates too soon, then herself demanded a new timetable of estimates.

Dr. Bruce Gellin, head of HHS's National Vaccine Program Office, defended the decision to give numbers as they became available and change them as necessary.

"I think that all along was the pledge to be as transparent as we could at the time," Gellin said in a telephone interview.
States would have been overwhelmed if they had been told they would only get a few vaccines and then millions were dumped on them, he said.

The United States has ordered up to 250 million doses of H1N1 swine flu vaccine from five companies -- MedImmune, a unit of AstraZeneca, Sanofi-Aventis, Australia's CSL, GlaxoSmithKline and Novartis.

Except for MedImmune, all had problems making vaccine at first and are still struggling to make the virus grow in eggs, the first step to manufacturing influenza vaccine.

MedImmune has prolific production -- officials say the company can make 200 million doses of its nasal spray vaccine -- but only had 40 million sprayers to deliver it. The company is working with the federal government to perfect a device to drip the vaccine into the nose.

"How did we do with this one? From my vantage point, we could have done far better had due attention been paid to history," said Henderson, a veteran of the last two flu pandemics in 1957 and 1968.

http://www.reuters.com/article/newsOne/idUSTRE59J58H20091028?pageNumber=2&virtualBrandChannel=0

 

[Roehl_JC]

Re: U.S. government faces no-win fight with flu

I fear this will soon become another political football to kick around? Did the gov get enough vaccine, was it too much given the fact that some large sector of the civil society may not get vaccinated and would this be due to the politicians or more appropriately assigned to those in the MSM who have been downplaying the risks of H1N1 ever since the pandemic was first announced? Was it state governments who were/are to blame for not ordering enough vaccine products for their own state's citizenry or is that also in the final analysis a problem for national political leadership? And should the US have given some of its own emergency supplies to other nations in need?

 

[Pathfinder]

Re: U.S. government faces no-win fight with flu

Top officials defend flu vaccination campaign

By Rob Stein
Washington Post Staff Writer
Thursday, October 29, 2009

The Obama administration gave its most aggressive defense of the government's swine flu vaccine campaign, with top officials saying Wednesday that despite shortages, the program has been more successful than expected in some ways and that millions of doses are quickly becoming available.

While acknowledging that many Americans have been frustrated by their inability to get the shot, two Cabinet members held a briefing for reporters to ask the public for their patience, saying the program is expected to speed up quickly.

"What we want to do is reset, in a way," Homeland Security Secretary Janet Napolitano said during the briefing with Health and Human Services Secretary Kathleen Sebelius, which was broadcast on the Internet.

"It is frustrating to stand in line and wait for vaccine. For those who have been ill and even those who have had loved ones who passed away, our sympathies couldn't be higher," Napolitano said. "But this is not a situation that is cause for panic."

The briefing occurred as the administration came under criticism for the slow pace of the vaccine's availability. Sens. Joseph I. Lieberman (I-Conn.) and Susan Collins (R-Maine) sent a scathing letter to Sebelius demanding details about the lag in production.

Officials had projected that as many as 120 million doses of vaccine would be available by now, but later downgraded that projection to 40 million and then 28 million. So far, 23.3 million doses have become available.

Napolitano and Sebelius reiterated that the problems were unavoidable, to make sure the vaccine was safe and effective, and that the program ran into unexpected snags, including the virus growing much slower than expected and problems at factories filling vials and syringes. They recounted the administration's various efforts, including hastily arranging for 150,000 sites to distribute the vaccine and the recent emergency approval of a new antiviral drug.

Sebelius said that the first vaccine became available slightly earlier than expected and was produced in a record six months instead of the usual nine months. She added that it turned out that one shot would be sufficient for most adults instead of two, as initially believed, meaning that the amount of available vaccine will go twice as far.

"There's no question production started more slowly than anyone would have liked, but many of the other things that could have gone wrong have gone right," Sebelius said.

http://www.washingtonpost.com/wp-dyn/content/article/2009/10/28/AR2009102803822.html?hpid=topnews

 

[Roehl_JC]

Re: U.S. government faces no-win fight with flu

'Americans first' before US donates H1N1 flu vaccine
(AFP) ? 1 hour ago

WASHINGTON ? The United States will not donate swine flu vaccine to poor countries until at-risk Americans have been inoculated against H1N1, an official said Wednesday.
"As vaccine becomes more available, I think evaluation will be made as to when it's appropriate for donation to begin, but I can tell you at this point the priority is getting the vaccine to citizens in this country, and that's what we're working on 24/7," US Health Secretary Kathleen Sebelius said.

"It has always been the president's intention that the safety and security of the American people be a priority in the production and distribution" of the vaccine against the new strain of H1N1 flu, Sebelius said.

The White House pledged last month to make US stocks of H1N1 vaccine "available to the World Health Organization on a rolling basis as vaccine supplies become available, in order to assist countries that will not otherwise have direct access to the vaccine."

The WHO has said donations of the vaccine from a US-led group of rich nations to about 100 developing countries could begin as early as November.

But since the first doses of vaccine were rolled out in the United States three weeks ago, officials have been forced to admit that H1N1 shots and nasal spray doses were not being delivered as quickly or in the quantities initially projected.

In mid-October, as H1N1 deaths rose and flu spread across the United States, vaccine manufacturers warned of production slow-downs and health officials said supply would fall about 10 million doses short of the 40 million doses they had expected to have by the end of this month.Long lines formed outside vaccination clinics around the United States, with many people turned away as supplies ran dry.

Sebelius said 23 million doses of vaccine have been made available to state health authorities since the vaccine was first rolled out three weeks ago. Nine million doses came into the distribution pipeline in the past week alone, she said.

The states are giving the vaccine to people in five at-risk groups -- children and young adults, pregnant women, people with underlying health conditions such as asthma, health care workers and caregivers of infants younger than six months who cannot themselves be inoculated.

Those five priority groups for vaccination number around 150 million people. Orders have been placed for 250 million doses of vaccine, but "it was never going to be available all at the same time," said Sebelius.

http://www.google.com/hostednews/afp/article/ALeqM5g5Iuh6GCkbs8R0X6R3LLWk47scbw

 

[AlaskaDenise]

Re: U.S. government faces no-win fight with flu

Vaccine Shortage Is Political Test for White House

WASHINGTON ? The moment a novel strain of swine flu emerged in Mexico last spring, President Obama instructed his top advisers that his administration would not be caught flat-footed in the event of a deadly pandemic. Now, despite months of planning and preparation, a vaccine shortage is threatening to undermine public confidence in government, creating a very public test of Mr. Obama?s competence.

The shortage, caused by delays in the vaccine manufacturing process, has put the president in exactly the situation he sought to avoid ? one in which questions are being raised about the government?s response.

Aware that the president would be judged on how well he handled his first major domestic emergency, the Obama administration left little to chance. It built a new Web site, Flu.gov ? a sort of one-stop shopping for information about H1N1, the swine flu virus. It staged role-playing exercises for public health officials and members of the news media.

It commissioned public service announcements, featuring the fuzzy Sesame Street characters Elmo and Rosita singing in English and Spanish about ?the right way to sneeze.? The president added a swine flu update to his regular intelligence briefing ? he also receives an in-depth biweekly memorandum on the prevalence of the disease worldwide and in the United States ? and appeared in the Rose Garden to urge Americans to wash their hands.

Early on, Mr. Obama told his aides he wanted them to ?learn from past mistakes,? said John O. Brennan, Mr. Obama?s domestic security adviser, who has been coordinating the flu-preparedness effort.

Mr. Obama and his top aides studied earlier flu outbreaks, including one in 2004, when a vaccine shortage created a political problem for President George W. Bush, and another in 1976, when President Gerald R. Ford ordered a mass vaccination campaign for an epidemic that never materialized ? and faced intense criticism for it.

In late June, Mr. Obama invited veterans of the 1976 effort to a private meeting in the White House Roosevelt Room, and asked what his own role should be. (Mr. Ford was photographed being vaccinated; Mr. Obama has not yet received his flu shot because children, pregnant women and people with underlying health conditions are being vaccinated first.)

?We talked very realistically,? said Dr. David Mathews, who was Mr. Ford?s health secretary, ?about the fine line he has to walk in being responsive and showing people that he cares, and that the federal government is on top of the issue, and on the other hand not provoking undue fear or irrational responses.?

Dr. Mathews advised Mr. Obama, ?You?ve got to be willing to take the criticisms for being over-prepared, because there?s no defense for being underprepared.?

Now, with officials at the Centers for Disease Control and Prevention reporting that H1N1 is widespread in 46 states, public health experts and leading senators are giving the Obama administration only mixed grades. ?I would give them a B for performance so far,? said Dr. Eric Toner, a senior associate at the Center for Biosecurity at the University of Pittsburgh Medical Center, who has advised the administration on pandemic planning.

The administration gets high marks for its public education campaign, as well as the scientific effort to develop and test a vaccine. ?The vaccine was miraculously developed,? said Senator Joseph I. Lieberman, the Connecticut independent who was chairman of an oversight hearing last week on the government?s response to the outbreak.

But the administration, and in particular Health and Human Services Secretary Kathleen Sebelius, have come in for strong criticism from those who say they created a false sense of expectations with overly optimistic predictions about the availability of the vaccine.

?The fact that there are vaccine shortages is a huge problem,? said Senator Susan Collins, Republican of Maine and co-chairwoman of last week?s hearing with Mr. Lieberman. ?I believe the administration took the pandemic seriously, but I also believe administration officials were so determined to show that everything was under control that they sent the wrong signals about the adequacy of supplies of the vaccine.?

Ms. Sebelius has said she was relying on estimates from manufacturers, who reported in July that 120 million doses of vaccine would be available by the end of this month ? a figure that was later lowered to 40 million doses, and then lowered again. She said Wednesday that 23.2 million doses had become available, including 9 million in the last week alone.

Accepting the manufacturers? assurances may have been ?na?ve on our part,? Ms. Sebelius said in an interview. But she said Mr. Obama recognized that the matter was beyond the government?s control. ?If we could wave a magic wand or have the tools in our government shop to fix this,? she said, ?I think there would be a different expectation.?

For a president whose aides regard him as the best communicator in the administration, Mr. Obama has been relatively low profile during the pandemic. When he declared a national emergency over the weekend, he used a written proclamation. His Rose Garden appearance lasted just five minutes. His last public reference to H1N1 came on Sept. 23 ? one line in a speech to the United Nations General Assembly, in which he promised to contribute vaccine to the World Health Organization.

Anita Dunn, Mr. Obama?s communications director, said the president?s ?voice has been heard, and will be heard again.?

But for any president, epidemics pose a tricky challenge. The public typically prefers to get its health information from trusted medical professionals, not politicians. The topic of how the president should engage came up in the Roosevelt Room session about the lessons of 1976.

?We talked about the role of the president,? Dr. Mathews said, ?and our advice was, ?If you?re not visible at all, it seems like a dereliction of duty, but you really need not to get so far out in front that it seems political.? ?

If the pace of vaccine production picks up, and the shots reach the public in time to keep people from getting sick, Mr. Obama is unlikely to come in for personal blame.

But flu outbreaks are notoriously unpredictable; if the pandemic takes a turn for the worse, the president may be held accountable even for a situation that is beyond his control, said Robert Blendon, a professor of health policy and political analysis at the Harvard School of Public Health.

?Where people start holding political actors accountable is when they develop an expectation for what is to happen,? Dr. Blendon said. ?If very few people get sick and those who do are not very seriously ill, the public will have a much higher tolerance than if there are people who are dying.?



http://www.nytimes.com/2009/10/29/us/politics/29shortage.html