Offline (mostly) until December 8--see you then!

Meantime, today we have had the Irish and US CDC reporting the epidemic has passed its peak, while federal health officials "fear that if they concede the flu has peaked, Americans will become complacent and lose interest in being vaccinated"; there is more tamiflu resistance appearing in both the US and Wales; Canada has had a recall of one lot of GSK vaccine, and a few deaths temporally associated with swine flu vaccinations; 'course it may just be coincidence; and a tiny cluster of mutant virus infections may have caused much more serious disease.

A future post will discuss the pivotal role of the swine flu pandemic in large-scale acceptance of new vaccine adjuvants, and how this has dramatically improved prospects for the vaccine industry. Here is a taste of the larger story, from the Associated Press:

Vaccines are no longer a sleepy, low-profit niche in a booming drug industry. Today, they're starting to give ailing pharmaceutical makers a shot in the arm.

The lure of big profits, advances in technology and growing government support has been drawing in new companies, from nascent biotechs to Johnson & Johnson. That means recent remarkable strides in overcoming dreaded diseases and annoying afflictions likely will continue.

"Even if a small portion of everything that's going on now is successful in the next 10 years, you put that together with the last 10 years (and) it's going to be characterized as a golden era," says Emilio Emini, Pfizer Inc.'s head of vaccine research.

Vaccines now are viewed as a crucial path to growth, as drugmakers look for ways to bolster slowing prescription medicine sales amid intensifying generic competition and government pressure to cut down prices under the federal health overhaul.

Swine Flu 'Emergency Use Authorizations' fail to meet the legal standard

The swine flu pandemic triggered a variety of government responses throughout the world. In the United States, plans to deal with the disease required that a variety of emergency procedures be used. Both the HHS Secretary and President had to declare emergencies. CDC advised FDA, which issued Emergency Use Authorizations. To invoke the Public Readiness and Emergency Preparedness Act (PREPA) the HHS secretary had to confer with the Homeland Security Secretary.

The laws require multiple consultations in order to prevent our leaders from frivolously invoking emergency powers.

However, in the present instance, the use of "Emergency Use Authorizations" did not conform with US law, in my opinion.

What does the law require in order to allow the use of unlicensed and potentially untested drugs, vaccines, masks and medical tests? Here is the actual language:

§ 360bbb–3. Authorization for medical products for use in emergencies

(b) Declaration of emergency

(1) In general

The Secretary may declare an emergency justifying the authorization under this subsection for a product on the basis of—

(A) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents;

(B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents; or

(C) a determination by the Secretary of a public health emergency under section 247d of title 42 that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.

Back in April, when we knew little about the potential impact of the swine flu virus on society, it was probably reasonable to assume that it could affect national security. However, we now know the swine flu has not overwhelmed the US medical system, let alone national security. Despite DHHS Secretary Sibelius saying that the government had built in "on ramps and off ramps" for its emergency response, especially in terms of its vaccines, neither the law nor the government have demanded a pause in our emergency preparations and a reassessment.

Almost everyone would agree at this point that the Swine Flu lacks "a significant potential to affect national security." Shouldn't that result in an acknowledgment that invoking a law requiring a national security threat is wrong, and we either need a new law for using untested products in purely medical emergencies, or we need to revoke the new Emergency Use Authorizations and rethink our preparedness strategies?

Academic Researchers’ Conflicts of Interest Go Unreported/ NY Times

Excerpts from another excellent Gardiner Harris piece:

In a report expected to be made public on Thursday, Daniel R. Levinson, the inspector general of the Department of Health and Human Services, said 90 percent of universities relied solely on the researchers themselves to decide whether the money they made in consulting and other relationships with drug and device makers was relevant to their government-financed research.

And half of universities do not ask their faculty members to disclose the amount of money or stock they make from drug and device makers, so the potential for extensive conflicts with their government-financed research is often known only to the researchers themselves, the report concluded.

Medical Faculty 'Ghostwriting' Equals Plagiarism: Senator Grassley/ NY Times

Sen. Charles Grassley has been pursuing various forms of medical malfeasance for years. On November 17 he honed in on the practice of 'ghostwriting,' in which medical 'opinion leaders' are sought after as authors of medical journal articles supporting a new drug, vaccine or medical device. Only problem is, the articles they 'author' were actually written by drug company employees or contractors. We're talking 5-10% or more of articles in the major medical journals, according to a JAMA study released in September. Who knows what this costs our medical system in quality and dollars?

Mr. Grassley said ghostwriting had hurt patients and raised costs for taxpayers because it used prestigious academic names to promote medical products and treatments that might be expensive or less effective than viable alternatives.

“Any attempt to manipulate the scientific literature, which can in turn mislead doctors to prescribe treatments that may be ineffective and/or cause harm to their patients, is very troubling,” the senator wrote.

“Students are disciplined for not acknowledging that a paper they turned in was written by somebody else,” Mr. Grassley wrote. “But what happens when researchers at the same university publish medical studies without acknowledging that they were written by somebody else?”

Note: Plagiarism by a research scientist constitutes scientific misconduct, and is defined as a federal crime in 65 Fed. Reg. 76260.

Doctors say most Britons reject swine flu vaccine/ Reuters

Excerpts from this Reuters article indicate, imho, that the pregnant patients have more sense than the doctors offering them vaccine.

... "In all the pregnant women we've offered it to, I think only about one in
20 has agreed," Dr Chris Udenze, a family doctor based in Nottingham, central
England, said in the survey...

Original estimates that as many as 65,000 could die from H1N1 in Britain
have now been cut to a prediction of around 1,000 deaths -- way below the
average annual toll of 4,000 to 8,000 deaths from seasonal winter flu.

Richard Hoey, Pulse's editor, said his survey showed that many patients,
and "a substantial number of doctors" were "unconvinced there is sufficient
evidence that swine flu
vaccination is safe and necessary".

A pandemic response to a disease of predominantly seasonal intensity/ Medical Journal of Australia

From Dr. Heath A. Kelly, head of the epidemiology unit at Victoria's Infectious Disease Reference Laboratory, comes this well-documented and clearly reasoned piece reviewing Australia's experience with swine flu. Here are the main points:

• From the recognition of the swine flu pandemic in late April 2009, health professionals, politicians and the public needed to know how serious pandemic (H1N1) 2009 influenza (swine flu) was in relation to other seasonal strains of influenza.

• The Victorian experience suggests that the circulation of pandemic (H1N1) 2009 influenza in the community was at most like influenza circulation in a season of moderate seasonal activity.

• We have no estimate of the total case count, but we know most infections have been mild. However, while disease in the community appears mild, and the risk of hospitalisation is low, a high proportion of patients hospitalised with swine flu required intensive care.

• Deaths from swine flu have not been as numerous as the modelled deaths from seasonal influenza, although people dying from swine flu are younger.

• Because we do not understand the laboratory-confirmed burden of disease due to seasonal influenza (as opposed to the modelled burden of disease), we could not base our response to the pandemic on an informed comparison of seasonal and pandemic influenza.

• We may not have needed a pandemic response to a disease that, although it has a different footprint, has been predominantly of seasonal intensity.

• It is critical to accumulate quality evidence about laboratory-confirmed influenza to guide our intervention policies for both seasonal and pandemic influenza.

Canadian Swine Flu Vaccine "Interim Order" uses identical language as US "Emergency Use Authorization"

Canada's Minister of Health, Leona Aglukkaq (a politician with no medical training) issued an "interim order" for the sale of swine flu vaccine in Canada on October 13, 2009.

Under the section titled "Authorization for Sale" are the following requirements that must be met to issue an interim order. These are:

"... it is reasonable to believe that

1. the vaccine may be effective in providing protection against the novel influenza A H1N1 virus, and
2. the known and potential benefits of the vaccine outweigh the known and potential risks."

What does the US regulation for an Emergency Use Authorization say?

"2. ... it is reasonable to believe that the product may be effective...

3. ... the known and potential benefits of the product outweigh the
known and potential risks ..."

WHO IS WRITING THE SCRIPT FOR BOTH COUNTRIES? IS IT THE SAME SCRIPT ELSEWHERE?

What does the interim order allow? According to GlaxoSmithKline's AREPANRIX vaccine package insert:

"Health Canada has authorized the sale of the Arepanrix H1N1 [vaccine] based on limited clinical testing in humans under the provision of an Interim Order issued on October 13, 2009."

It further states that no clinical data are available for influenza vaccines with ASO3 in the 6-35 month age group. Up to 1 in 1,000 recipients may have the following side effects: seizures, anaphylaxis, painful neuropathy or thrombocytopenia (presumably on an autoimmune basis, like Idiopathic Thrombocytopenic Purpura due to the MMR vaccine). Very rare side effects that occur in 1 in 10,000 doses or less include neurological disorders such as encephalitis, neuritis and Guillain Barre Syndrome and vasculitis (autoimmune inflammation/thrombosis of multiple blood vessels).

It seems that health agencies have decided to trade cases of severe respiratory disease due to the virus for cases of neurological and autoimmune diseases due to the vaccine. This meets the legal standard specified above for the US and Canada: requiring only that the vaccine "may be effective" and that its potential benefits outweigh its potential risks. Because there has been just "limited clinical testing" one can only guess whether the potential benefits outweigh the potential risks.

Politicians seem to always prefer errors of commission to errors of omission. They can't be caught sitting on their hands, after all. Their charge is to Do Something! And furthermore, they appreciate the opportunity to spend a few billion bucks.

• Should we thank them for this medical trade-off?
• Will we have any drugs and vaccines left for use when they are really needed?
• Is our northern neighbor reading from Washington's script?

Flu vaccination campaign a 'mess' that should be discontinued: Canadian health official/ National Post

Excerpts from an article in the National Post, detailing remarks by Dr. Richard Schabas, Ontario's former chief medical officer and a top health officer in the province:

"In eastern Ontario where I live and work the outbreak is effectively over. If we're immunizing people now essentially you're barring the barn door after the horse is well out the farm gate."

Dr. Schabas said outbreaks of the swine flu in populous parts of the country, including southwestern Ontario and British Columbia, are on the wane.

"I seriously question the continued focus on mass immunization, at least in those areas," he said....

"If the ground is shifting under our feet, if the disease is happening sooner than we expected and we can't immunize 25 or 30 million Canadians in an efficient manner before the outbreak, let's ask the question very seriously: is it worth continuing with this? Because I think increasingly the answer is no," said Dr. Schabas.

The hype and hysteria around the H1N1 pandemic, the millions of dollars spent so far on responding to it, and the dire warnings about it are all unwarranted, according to Dr. Schabas -- who even questions the pandemic label.

[UPDATE Nov. 16: Canada's chief public health officer said H1N1 is turning out to be less deadly than seasonal flu. Dr. David Butler-Jones told the National Post that between 2,000 to 8,000 Canadians die from the seasonal flu each year. So far, about 161 Canadians have died from H1N1.]

He [Dr. Schabas] spreads the blame among public health officials, governments and the media. The World Health Organization is jokingly referred to as the World Hysteria Organization, he said, and it set a tone in the spring with its messaging that was adopted around the globe.

"They've just been (champing) at the bit waiting for a pandemic for the last 10 years and I think they dramatically overreacted," said Dr. Schabas.

UPDATE from CBC:

"It's really not causing — and is not going to cause and nowhere has caused — significant levels of illness or death," said Dr. Richard Schabas, Ontario's former chief medical officer of health.
"But governments moved ahead regardless. They ramped up their response, spent a huge amount of money on vaccines and other things. I'm not sure the $1.5 billion includes the cost of new ventilators, the cost of Tamiflu stockpiles … the huge investment that's been put into planning for what has ultimately turned out to be, from a pandemic perspective, a dud."
Schabas is now the chief medical officer of health for Hastings and Prince Edward counties in eastern Ontario.
On Thursday, The Globe and Mail reported that Canada has so far spent $1.5 billion on the H1N1 vaccination campaign, twice as much as health officials had predicted. The H1N1 vaccine targets the strain of H1N1 influenza A virus causing the current swine flu pandemic.
Originally, it was estimated a single dose of the vaccine would cost $16. That cost has now risen to $30. The increasing cost is attributed in part to an unexpected surge in demand late last month.

FDA Commissioner acknowledges adjuvant risk: "There wasn't experience with that vaccine in other populations, including pregnant women and children"

U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg spoke at the Reuters Health Summit in New York, November 12, 2009. An excerpt from the Reuters article on her talk follows:

Some experts have suggested the government could have increased supplies by embracing adjuvant vaccine technology that is widely used in Europe.

Adjuvanted vaccines contain an additive to boost the immune system response and need less of the active ingredient than the unadjuvanted types approved by the FDA.

But Hamburg said they have not been widely tested and that the agency did not want to risk using them when standard vaccines worked well with a single dose.

"Had the shape of epidemic or the characteristics of the virus and the disease required it, we would have moved toward an adjuvanted approach," she said.

"Europe took a little bit more of a risk. Yes, there was experience with an adjuvanted vaccine but it was really only used in the elderly and there wasn't experience with that vaccine in other populations, including pregnant women and children."

Did US cases peak or not?

CDC updated its tables today with last week's data. Swine flu hospitalizations for the last week of October increased more than 1,000 from CDC's figure last week, presumably due to late reporting. Deaths similarly increased. However, the percentage of positive tests for flu has fallen over 20% from its peak, during the last 2 weeks for which data are reported. Thus it is not clear whether the epidemic has peaked, but it may have.

Suddenly there are many more deaths from swine flu, per CDC

Using modelling to estimate the number of flu-related deaths makes a lot of sense when many of those who die are in nursing homes, not hospitalized, and not tested for flu. "Many are close to death, with flu being only one factor leading to their demise," notes today's Washington Post. I would expect that several times the number of "proven" flu deaths from seasonal flu occur each year.

Flu deaths in children, particularly this year, are another matter entirely. CDC has asked medical providers to perform influenza tests on all patients hospitalized for presumed flu, and in all those who die of possible flu. Therefore, mathematical models are unnecessary for determining the number of flu deaths in hospitalized patients, since they are all being counted. This should include all children with serious flu-related illness. Thus CDC's surveillance of hospital deaths should already include every pediatric mortality case.

According to the Washington Post's David Brown, "The new estimate includes deaths that occurred outside hospitals, patients who tested negative for H1N1 but almost certainly had it, and other overlooked cases." Brown goes on to quote CDC's Dr. Schuchat regarding these new numbers: "We don't think anything has changed," Schuchat said. "We think our 540 number (for US child deaths) is a better estimate for the big picture."

Tested negative but almost certainly had it??? Overlooked cases??? By whose criteria? And children who die outside a hospital will almost certainly be autopsied, if the diagnosis is in question.

The front page of today's Bangor Daily News notes Maine's third swine flu death. The article, however, points out that all three people who died had "very serious underlying medical conditions." These are precisely the patients who die from flu each year. Though sad, such deaths aren't really front page news any other year.

Multiplying the number of known pediatric deaths, using a mathematical formula appropriate for deaths in nursing home patients, reflects a lack of scientific integrity and instead suggests fearmongering.

Today's new mortality estimates are consistent with CDC's known PR tactic of "predict[ing] dire outcomes" in order to increase vaccine uptake. See: Doshi, Peter. “Viral Marketing: The Selling of the Flu Vaccine.” Harpers Magazine. March. 2006.

Swine Flu: One killer virus, three key questions/ Nature

Nature (Brendan Maher & Declan Butler) report from three laboratories scrutinizing the pandemic flu virus.
This is an interesting article about basic research on the swine flu virus at CDC Atlanta, Mount Sinai School of Medicine, NY, and INSERM at Lyon. Plenty of background as in a Laurie Garrett story, but no amazing new insights.

Mandatory Vaccinations: No, we're not there yet, but why have we started going down that road?

"Once you start requiring doctors to get it, doctors are going to think it's reasonable to make patients get it. It starts you down that mandatory route, and I don't think we want to go there." So said George Annas, renowned bioethicist, NEJM columnist and department chair of Health Law at Boston University School of Public Health.

A ho-hum influenza pandemic appeared, and suddenly hospitals on the east coast, west coast and the heartland started demanding mandatory vaccinations of their employees. At first the hospitals didn't know whether they wanted mandatory seasonal flu vaccinations or swine flu vaccinations. There wasn't any seasonal flu virus around, and there wasn't any swine flu vaccine around, so what was the rush? [And it seems no one told these hospitals that they would be on the hook for all liability were their workers to be injured from a mandatory vaccine, like swine flu vaccine, subject to the PREP Act.] Simultaneously, an organization of infection control nurses popped up, demanding mandatory vaccinations and "accountability" from healthcare workers who considered refusing. New York State's Health Commissioner (not the Legislature or Governor but an agency appointee) demanded all healthcare workers in the state be vaccinated or fired. This was clearly orchestrated. But who was pulling the strings?

The federal government claimed it had nothing to do with mandates. On its flu.gov website the following appeared:

"In a few local jurisdictions, vaccination is being required for health care workers. That is a local decision, not a federal one."

However, DHHS's Health Resources and Services Agency instructed its grantees to:

"... strongly encourage health care workers to receive the Novel H1N1 vaccination. Grantees should employ strategies to increase the rates of vaccination for their health care personnel such as waiving administration fees for health care personnel, providing educational materials, sending reminder messages, holding informational staff meetings, monitoring employee participation in the vaccination initiative, and employing declination forms."

Okay, maybe the feds aren't mandating, but they sure are pressuring. Perhaps I'm missing something the experts understand. Did the demands for mandatory vaccinations come from thoughtful, well-informed medical people? Actually, no:

The infection control nurses didn't understand the rationale for mandated vaccines, claiming it was due to multiple strains circulating this year. (Multiple strains circulate every year, however.) NY state's health czar claimed that healthcare workers were already mandated to receive tuberculosis and rubella vaccines, to justify his flu vaccine mandate. However, since there is no tuberculosis vaccine in the US, it certainly isn't mandated.

If we mandate seasonal flu vaccines for healthcare workers and there is no seasonal flu this winter, as some experts have predicted, won't we be replicating the 1976 swine flu vaccine program, when 45 million Americans rolled up their sleeves for a nonexistent disease?

And now for a disclosure: I am less concerned about the danger of swine flu vaccines than I am about future vaccines, particularly those manufactured and used under a PREP Act declaration or an Emergency Use Authorization (EUA). Read the legislation and you'll see why I am worried. The EUA allows the use of unlicensed drugs and vaccines, including those that have never been issued an Investigational New Drug (IND) permit by the FDA. You require an IND to test a drug or vaccine in humans.

Do you see the implications? A drug or vaccine that was never given experimentally to a single human could receive an EUA and be rapidly administered to the whole country, under the legal justification that it "may be effective" for some "potential" emergency. Does that leave you feeling warm and fuzzy? Invoke the Public Readiness and Emergency Preparedness Act (PREPA) and if the drug injures or kills you, you are barred from seeking damages within the US legal system. Now consider that experimental adjuvants or other newfangled vaccine additives, biologics and drugs may be used.

Keep the program voluntary-- and with the assistance of a complaisant press, millions of Americans will line up for the new remedy with little understanding of the legal implications or risk. (Has the government advertised its use of PREPA for wholesale tort reform of drug and vaccine injuries during the current pandemic? Why would they do a better job informing us next time?)

Then again, next time that new drug or vaccine might be mandatory. That's where we seem to be headed and, like George Annas, "I don't think we want to go there."

Gulf War Syndrome: Additional information presented to House Vets Affairs Health Subcommittee by me in 2007

I happened to stumble across this Congressional website tonight. It includes my answers to additional questions posed by the Committee after I testified on GWS in July 2007. It also includes my Senate testimony on GWS of September 2007.

However, of special interest is a list of statistical analyses and informal studies conducted by the Army Medical Surveillance Activity (AMSA) related to anthrax and smallpox vaccinations. The list tells us that there is considerably more information available on anthrax and smallpox vaccine safety than has been accessible to the public and to servicemembers. I made the list available to the committee, hoping they would obtain the actual studies. But I never heard more about this.

What if you "suffer specified injuries" from a Swine Flu countermeasure?

Sorry for repeating myself regarding this new method of dealing with injuries, but this is what the US government (DHHS) says:

The PREP Act also authorizes a fund to provide compensation to eligible individuals who suffer specified injuries from administration or use of a countermeasure pursuant to the declaration. Any requests for compensation must be filed within one year of administration or use of the countermeasure...Again, the PREP Act is the exclusive Federal remedy for certain H1N1 countermeasure-related injuries.

"Exclusive remedy" means you will have no access to the US courts to sue for damages, nor access to any other federal compensation. The maximum amount of compensation for a death or total disability is about $300,000. In September, $14 million had been allocated to a DHHS compensation fund. DHHS will be the decider re whether you have an injury caused by a "covered countermeasure" and how much compensation the injury is worth. If dissatisfied with DHHS' answer, you may only appeal to another DHHS office.

My read of the word "certain" as in "exclusive Federal remedy for certain H1N1 countermeasure-related injuries" is that it means certain injuries are compensable, but others may not be eligible for any compensation, since the PREP Act precludes any other avenues.

The US government provides additional information here. Who has received a waiver of liability in the event of injury from swine flu vaccines or drugs?

• Manufacturers of countermeasures;
• Distributors of countermeasures;
• Program planners of countermeasures (i.e., individuals and entities involved in planning and administering programs for distribution of a countermeasure);
• Qualified persons who prescribe, administer, or dispense countermeasures (i.e., healthcare and other providers); and
• The United States.
  

Why did so many health care facilities, all at once, demand mandatory vaccinations of employees? Maybe it was because the DHHS was providing a strong "behind the scenes" push:

HRSA grantees should strongly encourage health care workers to receive the Novel H1N1 vaccination. Grantees should employ strategies to increase the rates of vaccination for their health care personnel such as waiving administration fees for health care personnel, providing educational materials (such as Vaccine Information Statements; see Item #16), sending reminder messages, holding informational staff meetings, monitoring employee participation in the vaccination initiative, and employing declination forms such as the one at www.immunize.org/catg.d/p4068.pdf .

New York Clinics See Few Crowds for Free Vaccine/ NY Times

Excerpts from this NY Times article:

... While the city’s health commissioner, Dr. Thomas A. Farley, said the clinics had the staff and enough vaccine to accommodate about 500 middle- and high-school students per clinic per hour — or as many as 31,500 vaccinations a day — a department spokeswoman put the total vaccinations administered on Saturday at 1,701.

So on Sunday, the clinics, operating out of public schools in all five boroughs, began offering the vaccine to pregnant women and increased the age limit for others to 24 from high school age. Still, the turnout was low: 1,749...

“We are also providing vaccines in the city’s elementary schools, and we’ve gotten about 23 percent of the consent forms returned. So we had those two numbers to work with. If we’d had 23 percent of the children in the city’s middle and high schools come, we’d have had very full clinics, indeed.”

Polish PM: Poland not buying swine flu vaccination unless it has been properly tested/ Canadian Press

Funny that I was only able to find one US news source (a Texas TV station) that carried this AP story. From the Canadian Press:

Polish Prime Minister Donald Tusk said Friday that his government won't buy vaccines for swine flu that have not been properly tested or from producers who won't take responsibility for possible side effects.

Tusk told reporters that vaccine producers were pressuring governments to buy, but were also demanding that all responsibility and compensation for possible negative side effects fall upon government shoulders.

"Today we are dealing with great pressure from pharmaceutical firms ... we are dealing with expectations that hundreds of millions of zlotys (dollars) will be spent on vaccine while no one wants to guarantee that it has no side effects," he said...

And from JAVNO: "The zealousness of certain countries (in administering the vaccine) seems exaggerated and out of step with the real epidemic," the Polish Prime Minister added.

The Flucase blog contains a video of Poland's health minister discussing this decision.

THE PANDEMIC VACCINE PUZZLE Part 4: The promise and problems of adjuvants

A well-researched piece on adjuvants from CIDRAP (Oct. 30, 2007), by Maryn McKenna. US citizens will need to be concerned about novel adjuvants when the next pandemic strikes, but people in the rest of the world will be offered swine flu vaccine with these adjuvants now. Excerpts:

There is currently no regulatory pathway by which adjuvants may be submitted for approval as products by themselves—or may be paired with a separately manufactured antigen, perhaps one produced by another company. Regulators acknowledge that could stand in the way of, for instance, converting the already-manufactured vaccine in the national stockpile (which was purchased under the 90-mcg-dose license granted Sanofi Pasteur earlier this year but is held in bulk) to an adjuvanted vaccine that could be stretched much further.

"There probably are more concerns about an antigen made with one manufacturing process and an antigen made with another manufacturing process and whether when those are mixed with ideal adjuvant X in two potentially different circumstances or time points, that could raise a bunch of issues about formulation, stability, immunogenicity, safety," Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said at the FDA meeting (see Bibliography: FDA 2007: Committee meeting transcript)....

"I have heard a lot of people say they expect problems with adjuvanted vaccines," said Hedwig Kresse, an associate analyst for infectious diseases with the British-based market analysts Datamonitor. "It is a technology that definitely has some potential, but there are a lot of issues that need to be addressed first" (see Bibliography: Kresse 2007).

Flu dogma being rewritten by a strange virus no one pegged to trigger a pandemic/ Canadian Press

Very nice summary article by Helen Branswell regarding assumptions scientists have made about influenza, and how many of these assumptions have had to be discarded, as swine influenza furnished plenty of surprising facts.

Did Swine Flu Cases Reach Their Peak?

According to CDC, weekly swine flu hospitalizations began dropping the last week of October; the death rate also dropped. UPDATE: I called CDC on Monday, November 9, to ask why this wasn't updated, as usually occurs on Fridays. I was told that 15 deaths (swine flu) and 3 deaths (non-subtyped influenza A) were reported last week and there is no number for total influenza hospitalizations yet. UPDATE November 12: Despite several calls and emails to CDC, no one I spoke with could update these numbers or explain why. However, European surveillance data for "Severe Acute Respiratory Infections" indicated cases fell last week after rising for the previous 6 weeks (figure 4). So did the percentage of swabs positive for influenza (figure 3). With luck, both North America and Europe have passed the 2009 peak.

Rulings stop mandatory vaccination for University of Iowa hospital employees/ Gazette Online

Another hospital’s mandatory flu vaccination program will end after rulings were made Monday in favor of two unions.

Who's fooling who? If, as the NEJM reported, the live nasal flu vaccine used last winter was only 29% effective in adults, mandatory vaccination of employees who use this vaccine will still leave 71% susceptible to the flu and all that may imply regarding occupational spread. What kind of hubris mandates such an ineffective therapy, claiming it is critically important to protect patients?

If this was really about protecting patients, then employees who were sick would be home on sick leave when they develop a respiratory illness associated with cough. Jobs that fail to provide paid sick leave or otherwise penalize sick employees put patients at risk. Where are the mandates for paid sick leave? UPDATE: Nov. 11 NY Times says "White House Endorses Paid Sick Leave Bill."

Peramivir Update/NY Times

By the NYT's Andrew Pollack; excerpts follow:

On Thursday, the federal government ordered, on an emergency basis, 10,000 treatment courses of peramivir for its national stockpile. It is paying $22.5 million, or about $2,250 a patient. Shares of BioCryst rose nearly 13 percent, to $11.39.

Peramivir is given intravenously, making it usable by hospitalized patients who are too ill to take two approved flu drugs that work against the virus in similar ways — Tamiflu by Roche, which is typically given as a pill, or Relenza from GlaxoSmithKline, which is inhaled.

Late Thursday, the government announced orders for intravenous versions of Tamiflu and Relenza, which are much cheaper — a development that could force shares of BioCryst to give up some of their gains on Friday.

...the efficacy of peramivir is still in question, according to the government. While some clinical trials showed the drug had an effect in resolving flu symptoms, others did not show statistically significant differences between peramivir and either a placebo or Tamiflu.

UPDATE: "Given there are limited safety data on peramivir, mandatory reporting requirements are important to defining the safety profile of this unapproved drug," the FDA states in a Medwatch Alert.

Blackout: Military Personnel Banned From H1N1 Vaccine Sites/Huffington Post

By Huffington Post's Allen McDuffee:

...Mandatory vaccine programs are a sensitive subject in the military, so it's not a huge surprise that swift and visceral reactions to the [swine flu vaccine] program gained speed.

With a vaccine that was so new and little known about it, like many Americans, troops were heading to the web to find answers to their very legitimate questions -- not only for themselves, but for their families who have the option of receiving the vaccine on base. What they found instead is that several websites and blogs with key information asking critical questions had been blocked from their viewing.

Among those that were repeatedly mentioned as blocked sites are the National Vaccine Information Center (NVIC), the site for Gary Matsumoto's book Vaccine-A, and vaccine expert Dr. Meryl Nass...

Read more at: http://www.huffingtonpost.com/allen-mcduffee/blackout-military-personn_b_346908.html&cp

GPs and practice staff on frontline turn down swine flu vaccine

Interviews with GPs in the UK/ Pulse Magazine:

...Dr Niall Finegan, a GP in Salford, Manchester – close to a hot spot in Trafford - said he, the four other GPs and six staff members at his practice planned to refuse the vaccine, and that he did not believe there was enough evidence it was safe.

’It’s not been around very long. The fact we are testing it out on pregnant women does not bear thinking about,’ he said....

Misrepresenting smallpox vaccine in pregnancy findings

Re: Evaluation of Preterm Births and Birth Defects in Liveborn Infants of US Military Women Who Received Smallpox Vaccine. Margaret A. K. Ryan, Gia R. Gumbs, Ava Marie S. Conlin, Carter J. Sevick, Isabel G. Jacobson, Katherine J. Snell, Christina N. Spooner, Tyler C. Smith, for the Department of Defense Birth and Infant Health Registry Team. Birth Defects Research (Part A) 82:533-539 (2008)

Last April I wrote a detailed critique in this blog of a paper by Ryan et al. on anthrax vaccinations in pregnancy and birth defects. In the paper I am discussing today, Ryan has studied birth defects in military servicewomen who received smallpox vaccine during pregnancy. In fact, there is likely significant overlap between the two groups of women Ryan studied, since both anthrax and smallpox vaccines have been given to all servicemembers deploying to Iraq, Afghanistan and Korea since 2003 (except during the period in 2004-2006 when Judge Emmett Sullivan stopped mandatory anthrax vaccines).

The findings of the two studies are, no surprise, very similar: women receiving smallpox vaccine during the first trimester of pregnancy had a rate of major birth defects in their offspring of 4.5%, while the offspring of women vaccinated post-pregnancy had a major birth defect rate of only 3.2%. The birth defect rate is therefore 40% higher if the mother was vaccinated during the first trimester.

The paper fails to explain significant problems with the military database, whose accuracy was previously studied by Ryan and discussed in my earlier blog. The sensitivity for identifying anthrax vaccinations in this database was less than 70%. How well does it correctly identify smallpox vaccinations?

Only 30 of 672 women vaccinated in the first trimester had infants born with major birth defects. So even though the birth defect rate was 40% higher, it did not achieve statistical significance. The authors then incorrectly concluded that, "smallpox vaccine, when inadvertently administered to pregnant women, is not associated with preterm delivery or birth defects in liveborn infants."

What would a true scientist have done with these results?

First, a true scientist would not have misrepresented the data. To be accurate, the paper should have said that a sizeable increase in birth defects was found, but given the numbers involved, did not reach statistical significance.

Second, the paper should have pointed out that a similar effect had been found for anthrax vaccination, in a larger but overlapping cohort of servicewomen, by three of the same authors. The two vaccines administered together probably caused confounding, making it impossible to determine how much each vaccine may have contributed to the birth defects (which were statistically significant at the 0.05% level for some of the anthrax findings).

Third, a true scientist would have expanded the sample size, to try and achieve statistical significance. This would have simply entailed using the same database over a longer duration. The paper was submitted in 2008, so there was time to obtain additional data on servicewomen vaccinated since 2004. Of course, then the result might no longer be used to support military vaccine policy.