The United States government is set to undertake the most extensive vaccination program in American history this fall as it prepares to inoculate at least 160 million Americans against the swine flu, at a cost of as much as $18 billion in a worst-case scenario.
Inoculating half the population - the Obama administration's current goal - could still cost taxpayers about $9 billion.
Meanwhile, as the American government steps up its campaign, two surveys last week in the United Kingdom showed doctors decidedly reticent about taking the shots themselves - almost 50 percent in one poll said they would not take the shot, based on fears about safety and inadequate testing - and other physicians and experts have cautioned the public "to take a deep breath" about the swine flu pandemic.
The White House was doing anything but taking a deep breath. On Tuesday, the Obama administration fired off its latest salvo to persuade Americans to take the shot when it becomes available, releasing an assessment by the President's Council of Advisors on Science and Technology that up to 90,000 Americans could die from the virus this season.
"As the nation prepares for what could be a challenging fall, it is crucial that our public health decisions are informed by the very best scientific and technological information," said John P. Holdren, Assistant to the President for Science and Technology and a co-chair of PCAST.
The group's prime recommendations include accelerating the preparation of flu vaccine for distribution to high-risk individuals and pursuing "communication strategies" to broadcast public health messages. Those dispatches include a $4.8 million multimedia campaign to encourage people to get vaccinated, delivered in radio and television public service announcements, print ads, and on the Internet.
Harold Varmus, a PCAST co-chair and president of Memorial Sloan-Kettering Cancer Center, praised the administration for its efforts so far.
"The federal government's response has been truly impressive and we've all been pleased to see the high level of cooperation among the many departments and agencies that are gearing up for the expected fall resurgence of H1N1 flu," Varmus said.
The PCAST report to Obama said the H1N1 virus would likely infect 30 to 50 percent of the U.S. population this fall and winter, with symptoms occurring in approximately 20 to 40 percent, or 60 to 120 million people. The scientists also warned the virus could lead to as many as 1.8 million hospital admissions, and cause between 30,000 and 90,000 deaths in the United States, primarily among children and young adults.
Even before the report was released, the Obama administration had wasted no time in mass producing a vaccine. The government has already paid in the neighborhood of $2 billion to purchase 195 million doses, officials reported in July, and is prepared to buy enough vaccine for the entire population, if necessary.
That's 608 million doses - experts say two shots will be needed - and could push the vaccine costs alone to almost $6 billion.
And that doesn't include the cost of delivery. According to the Association of State and Territorial Health Officials and the National Association of County and City Health Officials, an extended and severe flu outbreak would cost public health agencies up to $3 billion for a 12-week response and another $9 billion in mass vaccination costs.
The $12-billion estimate does not include the cost of the vaccine or of tracking the vaccines administered, maintaining reminder/recall systems to ensure second doses are administered, or following up with individuals who experience an adverse event, the organizations stated.
Calmer heads
Despite the crisis-like environment brewing within the medical establishment and within the administration, others are not jumping on the bandwagon so readily.
In a Pulse Magazine survey last week of 115 general practitioners in Great Britain, 49 percent said they had decided against vaccination, 41 percent said they would take the shot and just under 10 percent were undecided.
In a separate GP newspaper survey of 216 general practitioners, 29 percent said they would not take the shot, and another 29 percent were undecided. Of those not getting the shot, 71 percent cited concerns about safety and lack of adequate testing.
Barbara Loe Fisher, president of the National Vaccine Information Center, has also weighed in, saying the vaccine has had less testing than Gardasil, the HPV vaccine given to young girls to prevent cervical cancer. A government report recently inked Gardasil to 32 deaths and other serious side effects, such as blood clots and fainting.
"And now, today, we have swine flu vaccines that are being rushed to market with even less testing that the fast-tracked Gardasil vaccine had, with the justification that there is a public health emergency," Fisher said on the NVIC website. "What public health emergency?"
Fisher said drug companies and the government were pushing the public toward hysteria.
"Why are we letting employees working for government agencies and pharmaceutical companies stampede us into taking vaccines that may not be necessary, safe or effective and - certainly - are not properly monitored for safety after they are given to tens of millions of children and adults?" she asked. "It is time to demand that government officials and drug companies stop conducting national vaccine experiments on the American people."
Others make more explicit claims about the links between the pharmaceutical industry and the government's stark assessments about the disease's potential deadliness and the need for mass vaccinations.
For example, Obama's co-chair of PCAST, Harold Varmus, has consulted with pharmaceutical companies, and as head of the National Institutes of Health in the 1990s dismantled the firewall between government research and pharmaceutical companies.
According to the Los Angeles Times, in late 1995, Varmus allowed agency directors to accept consulting payments from pharmaceutical companies, and ended a $25,000 annual cap on the amount of money an NIH employee could accept from outside employers, reporter David Willman wrote. Willman also said Varmus permitted NIH employees to accept stock or stock options from the industry.
Varmus is a well-known supporter of vaccinations. He is featured in a video on the Pfizer company website discussing, according to the company, "how a wider use of the new HPV vaccine could lower death rates."
How about the virus itself
Conflicts aside, just how dangerous is the H1N1 virus? So far, by all accounts, about as dangerous as any other influenza virus.
Some medical experts, such as Peter Collignon, an infectious diseases physician, microbiologist and professor at the School of Clinical Medicine at the Australian National University, says everyone should take a deep breath.
"Swine flu is not hyper-virulent," Collignon wrote in May. "While it spreads relatively easily it does not appear to be any more virulent that the strains we have circulating every year around the world."
Collignon has also said he believes the swine flu death rate is inflated - so far, it officially has been slightly higher than that of the regular flu, and the White House estimates the death rate will be between one in 1,000 and three in 1,000 - simply because many states reduced or stopped consistently testing for swine flu earlier this year and because many people with the disease never sought treatment.
The CDC itself estimates that there may have already been more than 1 million swine flu infections in the U.S., which would lower the death rate dramatically.
But will it mutate and become far more lethal this time around?
"It is argued by some that this strain could change tomorrow and become much more virulent," Collignon wrote. "This is always possible, but so can the strains that recirculate very year now."
So far, CDC officials said this week, the virus has not shown any signs of mutation.
The CDC had been concerned about mutation as the virus made its away across the Southern Hemisphere during its flu season, which is underway now, but in a briefing officials said that had not happened, and the number of cases seems to be dropping.
Meanwhile, concerns continue about the vaccine itself. The U.S. says it won't use doses containing additives called adjuvants, which boost immune system response, unless they are vitally necessary. Adjuvants have been linked to dangerous side effects and are not approved for use in the United States.
However, the U.S. has purchased 120 million doses just in case.
The lack of sustained clinical trials is also a concern, as the British doctors survey responses indicated.
Clinical trials of the vaccines only began July 22, and only then in adults, and while officials said last week they saw no red flags, they also acknowledged it was much too soon to assess long-term implications.
Taken seriously, after all these years
At least one epidemiologist, Tom Jefferson of the Cochrane Collaboration, a nonprofit group that studies the effects of health care interventions, says he's amazed at how bad pandemic predictions have been, and yet the media takes them seriously over and over again.
"One of the extraordinary features of this influenza - and the whole influenza saga - is that there are some people who make predictions year after year, and they get worse and worse," he told the publication Spiegel International in July. "None of them so far have come about, and these people are still there making these predictions. For example, what happened with the bird flu, which was supposed to kill us all? Nothing. But that doesn't stop these people from always making their predictions. Sometimes you get the feeling that there is a whole industry almost waiting for a pandemic to occur."
And just who might that industry include?
"The WHO and public health officials, virologists and the pharmaceutical companies," he said. "They've built this machine around the impending pandemic. And there's a lot of money involved, and influence, and careers, and entire institutions. And all it took was one of these influenza viruses to mutate to start the machine grinding."
Asked if he was worried about the swine flu and if he and his family were taking precautions, Jefferson said he was taking no chances.
"I wash my hands very often," he said.
