Monday, January 28, 2013

England: 10-16 fold increased risk of narcolepsy within 6 months of Pandemrix jab/ BBC

Thanks for telling us, BBC.  But this is no surprise.  You should be investigating why England denied having an increase in cases earlier.  Furthermore, the 10-16 fold increased risk of narcolepsy within 6 months will lowball the actual risk--as recent studies show some victims taking much longer than 6 months or a year to be diagnosed.  The older victims tend to take longer getting diagnosed.

UPDATE JAN 30 (CIDRAP):  "The investigators identified 2,608 narcolepsy cases in nearly 280 million person-years of follow-up, with a pooled incidence rate of 0.93 (95% confidence interval [CI], 0.90 to 0.97) per 100,000 person-years. Narcolepsy peaks were found between ages 15 and 30 years, with slightly more women affected than men, a pattern that was most pronounced in women of childbearing age.

Narcolepsy incidence in children ages 5 through 19 increased after the start of pandemic vaccine campaigns in Finland and Sweden, consistent with previously reported safety signals. However, the new study found increases in two Danish age-groups, children ages 5 to 19 and adults ages 20 to 59, even though Denmark had relatively low vaccine coverage."  (Note that the affected groups include everyone from age 5 through age 60.--Nass)

Researchers also found a narcolepsy increase after September 2009 in Finnish adults older than age 60..."  WHAT DID I TELL YOU? Vaccine-induced narcolepsy is not simply a disease of children, and narcolepsy may not be the only disease caused by Pandemrix.  When the authorities who excitedly contracted for fast distribution of novel adjuvanted-vaccines are responsible for identifying the adverse consequences to the public health, they are no longer excited about fast results.

IMHO, either the reason why the vaccine caused these illnesses will be found and appropriate measures taken, or if no reason is found, then no more Pandemrix and ASO3 should be used in anyone, since it has clearly been shown that the net harm from
the vaccine is much greater than the net benefit--number of lives that may have been saved.  If you don't know what happened, you won't be able to avoid the next disaster.

See comments from Sweden here.
A Health Protection Agency study found a 10-fold increased risk in cases of the sleep disorder in children seen in sleep centres who had received the jab. 
An increased risk of narcolepsy has been found among English children vaccinated with the swine flu vaccine, Pandemrix. 
Manufacturer GlaxoSmithKline (GSK) has been ordered to investigate the link.
Families who believe they were affected are now considering a group legal action.
Pandemrix was most widely used in the UK during the 2009-10 flu pandemic and given to almost a million British children between six months and five years old. The vaccine, which is no longer used, has already been linked to narcolepsy in youngsters from Finland, Sweden and Ireland.
Narcolepsy is a rare sleeping condition. The main symptom is falling asleep suddenly and it may also cause muscle weakness.
The HPA abstract paper, from Developmental Medicine in Childhood Neurology, was presented to a conference of paediatricians in Manchester and is now being considered for publication in full by the British Medical Journal. It estimates the risk was one in 52,000 in those vaccinated.
Specialists reviewed 75 children aged four to 18 who developed narcolepsy about the time Pandemrix was rolled out. Of these, 18 had received Pandemrix.
They found a 10-fold increased risk of the condition within six months of having the jab which "suggests a causal association consistent with reports from Finland and Sweden".
An expert in vaccines who was in charge of one of the paediatric clinical trials of Pandemrix, Prof Adam Finn from the University of Bristol, said: "The risk is so much increased that it seems very unlikely that this is a biased result.
"The bottom line is they have found they were somewhere between 10 and 16 times more likely to have had Pandemrix than other children. So that confirms what you would expect to see based on other studies done in Finland, Sweden and Ireland, which are all the same."

Research programmeThe European Medicines Agency (EMA) warned in 2011 that Pandemrix should only be given to children and teenagers at risk of H1N1 flu if other jabs are unavailable because of concerns of potential link to narcolepsy.
It has ordered GSK to commit to a complex research programme to look at the root causes.
GSK say they take the safety of patients very seriously and are working hard to better understand the research emerging from a select number of countries.
A spokesperson said: "Narcolepsy is a complex disease and its causes are not yet fully understood but it is generally considered to be associated with genetic and environmental factors, including infections.
"It is crucial that we learn more about how narcolepsy is triggered and how Pandemrix might have interacted with other risk factors in affected individuals. Throughout development there was no data suggesting a potential for an increased risk of narcolepsy among those vaccinated."
It is understood that one possible trigger is the high levels of adjuvant in the vaccine used to enhance the recipients response.
The UK government, which gave GSK a legal indemnity against having to pay compensation, could now face the prospect of a group legal action by families affected.The Department of Work and Pensions, which is responsible for administering Vaccine Damage Payments Scheme says there is currently insufficient medical evidence to show that the swine flu vaccine causes narcolepsy.
A spokesperson for the Medicines and Healthcare products Regulatory Agency said: "The results of the HPA study are consistent with earlier evidence from some other EU countries and support the regulatory action already taken in Europe to restrict the use of Pandemrix in those aged under 20 years."

Friday, January 25, 2013

CDC's flu stats for this week/ CDC

From CDC's Fluview:

Click on image to launch interactive tool

INFLUENZA Virus Isolated

I suggested it earlier, and now we know: Adults also got narcolepsy/ YLE

You read it here 3 days ago.  Just because Pandemrix caused a 700%-1300% increase in narcolepsy cases in children did not mean that cases of the vaccine-induced illness were confined to children.  And now we see they were not.  Grownups also get it.  And what else was caused by Pandemrix that did not shout out to be discovered?

But don't expect the ASO3 adjuvant to disappear any time soon.  Glaxo paid a very pretty penny for it.

From Finland's YLE.
Five young adults who developed narcolepsy after receiving the swine flu vaccine Pandemrix are suing the state for damages at Helsinki District Court.
Terveydenhoitaja vetämässä rokotetta lääkeruiskuun.
The 20–26 year-old plaintiffs were not awarded damages earlier as studies have so far only confirmed that the Pandemrix vaccine increased the risk of narcolepsy among 4–19 year-olds. 
Around a dozen adults [in Finland alone--Nass] are suspected of coming down with narcolepsy since taking the vaccine. The National Institute for Health and Welfare (THL) is currently investigating the H1N1 vaccine link to narcolepsy in adults. According to the organisation, some 50 new narcolepsy cases were diagnosed in Finland between 2009 and 2011.  
In 2009, swine flu jabs were offered to all Finnish residents free of charge in anticipation of an H1N1 influenza epidemic. 
The regional daily Aamulehti was the first to report the news.

Tuesday, January 22, 2013

800 Children Affected: Evidence grows for narcolepsy link to GSK swine flu shot / Reuters

An estimated 30-60 lives may have been saved in Sweden due to use of Pandemrix, but more than 200 Swedish children developed narcolepsy due to the Pandemrix vaccine.

So now Pandemrix, with the ASO3 adjuvant, won't be used in children.  

But the more important issue imho is why will it continue to be used in adults?  GSK’s Pandemrix was not a better vaccine for swine flu than the US version, which did not contain the ASO3 adjuvant.

The vaccine caused a lot more harm than any benefit it provided.  We still don't know the mechanism, but we can assume it was autoimmune.  What other problems might it cause when it is used with different antigens, in a population exposed to different viruses?

This is the first time narcolepsy was induced by a vaccine.  The worst-affected group was children. When vaccines cause Guillain-Barre, often the worst-affected group is adults.  What diseases might ASO3 cause next?  Why assume they will only be in teens?

We still lack a complete picture of what other problems may possibly be linked to Pandemrix.  We know about narcolepsy because the relative risk of this severe, rare disorder was 7-13 – in other words, vaccinated kids were 7-13 times as likely to come down it after vaccination, compared to the unvaccinated. 
The problem is, we know nothing about conditions that may be vaccine-related but which don’t occur at such an astonishingly high rate.

Reuters has written a detailed article on the narcolepsy-Pandemrix flu vaccine link.  This is a very important piece, and I advise you read the entire article here .
STOCKHOLM (Reuters) - Emelie Olsson is plagued by hallucinations and nightmares. When she wakes up, she's often paralyzed, unable to breathe properly or call for help. During the day she can barely stay awake, and often misses school or having fun with friends. She is only 14, but at times she has wondered if her life is worth living. 
Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy, an incurable sleep disorder, after being immunized with the Pandemrix H1N1 swine flu vaccine made by British drugmaker GlaxoSmithKline in 2009.
Finland, Norway, Ireland and France have seen spikes in narcolepsy cases, too, and people familiar with the results of a soon-to-be-published study in Britain have told Reuters it will show a similar pattern in children there.
Their fate, coping with an illness that all but destroys normal life, is developing into what the health official who coordinated Sweden's vaccination campaign calls a "medical tragedy" that will demand rising scientific and medical attention.
Europe's drugs regulator has ruled Pandemrix should no longer be used in people aged under 20. The chief medical officer at GSK's vaccines division, Norman Begg, says his firm views the issue extremely seriously and is "absolutely committed to getting to the bottom of this", but adds there is not yet enough data or evidence to suggest a causal link.
Others - including Emmanuel Mignot, one of the world's leading experts on narcolepsy, who is being funded by GSK to investigate further - agree more research is needed but say the evidence is already clearly pointing in one direction.
"There's no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries - and probably in most countries," says Mignot, a specialist in the sleep disorder at Stanford University in the United States.
In total, the GSK shot was given to more than 30 million people in 47 countries during the 2009-2010 H1N1 swine flu pandemic. Because it contains an adjuvant, or booster, it was not used in the United States because drug regulators there are wary of adjuvanted vaccines...
In his glass-topped office building overlooking the Maria Magdalena church in Stockholm, Goran Stiernstedt, a doctor turned public health official, has spent many difficult hours going over what happened in his country during the swine flu pandemic, wondering if things should have been different.
"The big question is was it worth it? And retrospectively I have to say it was not," he told Reuters in an interview.
Being a wealthy country, Sweden was at the front of the queue for pandemic vaccines. It got Pandemrix from GSK almost as soon as it was available, and a nationwide campaign got uptake of the vaccine to 59 percent, meaning around 5 million people got the shot.
Stiernstedt, director for health and social care at the Swedish Association of Local Authorities and Regions, helped coordinate the vaccination campaign across Sweden's 21 regions.
The World Health Organisation (WHO) says the 2009-2010 pandemic killed 18,500 people, although a study last year said that total might be up to 15 times higher.
While estimates vary, Stiernstedt says Sweden's mass vaccination saved between 30 and 60 people from swine flu death. Yet since the pandemic ended, more than 200 cases of narcolepsy have been reported in Sweden.
With hindsight, this risk-benefit balance is unacceptable. "This is a medical tragedy," he said. "Hundreds of young people have had their lives almost destroyed." 

Friday, January 18, 2013

Flu vaccine attitudes abroad differ from U.S. / CNN

Finally, a major US network, CNN, tells the truth about flu vaccine policy:
The flu hasn't hit Europe as hard as it has the United States, health officials say, but when and if it does, don't expect a call for vaccination of the entire population. 
Only the U.S. and Canada actually encourage everyone older than 6 months to get the flu vaccine. Apparently, not a single country in Europe asks the general population to seek that same kind of protection, according to Robb Butler, the World Health Organization technical officer in vaccine preventable diseases and immunizations in the organization's Europe office in the Netherlands. 
That's because global health experts say the data aren't there yet to support this kind of blanket vaccination policy, nor is there enough money. In fact, some scientists say the enthusiasm for mass vaccination in the United States may hurt efforts to create a better vaccine.
 And in the segments of the population that are most susceptible to the extreme effects of the flu -- like the elderly, who make up the majority of the cases of flu-related deaths -- the vaccinations are even less effective. [Or not ineffective--Nass] 
So is why is everyone urged to get vaccinated?   
Simply put, it's a clearer policy, and some protection is better than none at all, according to Dr. William Schaffner, the chair of the department of preventive medicine at Vanderbilt University. He was also on the national committee that made the decision to encourage everyone to get vaccinated. "It was debated by the CDC Advisory Committee on Immunization Practices for many years, and the indication for the use of influenza vaccine for an increasing number of groups on a piecemeal basis didn't make sense," Schaffner said. 
In 2010, the CDC expanded its guidance encouraging the vaccination of vulnerable population groups. 
"When you do the back-of-the-envelope calculations (of all the separate groups recommended for vaccination), you are actually already making a recommendation that 75% of the population get it," Schaffner said. "And when it became apparent the issue of shortages was largely put on the back burner, then in 2010, we said, 'Let's simplify this and recommended this vaccine for anyone over 6 months old.'"

It also helps that the flu vaccine is easy to get, he said. Pharmacies offer it. Companies sometimes bring in nurses to give shots to their employees on site. In Europe, only doctors are legally allowed to administer the vaccine, according to Butler. 
There may be another economic reason for more Americans to get vaccinated -- one in three U.S. workers get no paid time off when they are sick, according to the Bureau of Labor Statistics. Generally, Europeans have much more generous sick leave policies.
"Although flu can be unpleasant, if you are otherwise healthy, the illness will usually clear up on its own and you will recover within a week," according to Britain's National Health Service website. 
In a contrast to U.S. policy, the World Health Organization recommends only six "priority populations" get "the flu jab," as it's called in Britain. These six groups are nursing home residents, people with chronic medical conditions like asthma, the elderly, pregnant women, health care workers, and children from ages 6 months to 2 years, Butler said. They are more vulnerable to the severe effects of the flu or come into contact more often with this highly contagious virus. 
"We think the recommendations we have right now (are) a good start," Butler said. "Universal campaigns are quite challenging and expensive. 
"We have 53 countries in our region that all have different recommendations based on different studies and evidence, and the depth of evidence in Europe right now is pretty limited in terms of flu vaccines. We would need more evidence that more than these six key, target high-risk groups that are prioritized can benefit... "

Flu cases keep dropping as predicted/ CDC

from CDC's FluView

INFLUENZA Virus Isolated

Wednesday, January 16, 2013

Pedi Anthrax Trial: Experts Shade their Derrieres

You have to give credit to the two federal advisory committees tasked with advising the government on a trial of anthrax vaccine in children. THEY KNOW THE SCORE, whether they acknowledged it, or not.

The members knew this was one issue that could really burn them. They understood that this is a dangerous vaccine with the dirtiest history imaginable. And they knew they had been set up to take the fall if/when it came out that children were hurt or died.

The National Biodefense Safety Board was told nothing about the trial objectives, protocol, number of children involved, and whether a trial involving thousands of kids--needed for a vaccine safety study--could or would be conducted. Not to worry. The members approved the trial anyway, but added a caveat:  a federal ethics board needed to approve the trial as well. Smart move guys! You hit that hot potato right out of the field!

Kathleen Sebelius wasn't gonna hang on to that hot potato any longer than she had to. She immediately pitched it to the Presidential Commission for the Study of Bioethical Issues.

Were the Bioethical Members pleased? I think not... but they did a phenomenal job of squeaking past the danger. The Commission managed to hold 4 meetings to discuss the proposed trial (during which there were still no details provided about the protocol or why having a trial was so critical). They studiously managed to avoid having even one expert on anthrax or anthrax vaccine testify. Now that is no mean feat! Four meetings over one whole year, and if the devil was in the details, they were hell bent on avoiding those details. They heard not one witness who could answer questions about the government's safety and efficacy research findings for anthrax vaccine. Not from NIAID, FDA, CDC or DOD, all of which have extensive histories of anthrax vaccine research and analysis.

By the fourth meeting there were some terse moments. But the Commission pulled it out!  Twenty minutes before their public discussion of the issue ended, Walter Reed's Dr. Nelson Michael read a prepared statement [starting about minute 55 in the video] which urged that the proposed trial be started in 18-20 year olds, outside the pediatric range but adjacent to it. An age range where the child protection regulations do not apply. If all "went well" (Heh heh) the trial could gradually enroll children younger and younger, till DHHS got whatever it was that it wanted. Immediately after Dr. Michael read his statement, Amy Gutmann, the Chair of the Commission, practically banged a gavel down on the table, saying something to the effect of "Done Deal!"  She could just as well have said "Bingo!  We're kicking your hot potato down the road!"  Now some other expert somewhere will have to determine if the results in young adults permit kids to be tested. Good luck sucker!

Oh, by the way, the Commission is going to ask DHHS to compensate subjects injured in research.  They picked the right time to ask.

Naturally, no one asked how to find the existing but missing-in-action data already collected on thousands of 18 to 20 year old vaccine recipients, swallowed by some DOD, FDA and CDC black holes. Naturally.

After many millions of taxpayer dollars spent to create the appearance of two thoughtful deliberations by our nations's esteemed Biodefense and Bioethics experts, what did the taxpayer receive in return?  Bupkus.  We got to see a lot of grownups show they knew how to speak out of both sides of their mouth, and cared more for their derrieres than for any child subjects.

UPDATE:  I sent this article to the Commission's Communications Director, and asked her to point out any errors in the article, which I would be delighted to fix, were any to be found.

Monday, January 14, 2013

Health Care and Profits, a Poor Mix / NY Times

An excellent piece discusses how turning over aspects of healthcare to private industry led to greater costs without accompanying benefits, and compares the US with other first world countries.

Saturday, January 12, 2013

Possibility of scarcity spurs purchases of guns and flu shots

Today's NY Times' front page says, "Sales of Guns Soar in U.S. as Nation Weighs Tougher Limits.  

The Times' Quotation of the Day is:  "If I had 1,000 AR-15’s I could sell them in a week."

The quote is from Jack Smith, a gun dealer in Des Moines, Iowa, referring to a popular style of semiautomatic rifle.

And in the last few days we have heard about shortages of liquid Tamiflu for children (there is no evidence the stuff works, but worrisome evidence it caused a number of acute behavioral disorders and deaths in children, especially in Japan, where it was prescribed frequently).  At best, it might shorten the flu by one day.  Tamiflu is the Rumsfeld drug, in case you forgot.  Aspartame is the Rumsfeld sweetener.  Without Rummy, the consummate insider, likely neither product would have received FDA approval.

We are also faced with potential shortages of flu vaccine, we are told.  What?  With at least 6 companies making vaccine and so many doses ordered for the US supply? Actually, CDC has a webpage devoted to reasons for perennial vaccine supply interruptions, last updated in September.

In fact, 128.1 million doses of vaccine have been distributed.  The actual number of people getting the shots is a big secret.  If there is a shortage of vaccine this year, which is doubtful, you can thank the CDC-media partnership that brought you the frightening emergency that never was, yet agaiN.

UPDATE JAN 12:  A NY Times "City Room" article today says Governor Cuomo (refusing to be one-upped by Mayor Menino) has declared a NY State public health emergency and suspended a law preventing pharmacists from vaccinating children:

As officials have stepped up their efforts encouraging vaccinations, there have been scattered reports of shortages. But officials said plenty of the vaccine was available.
According to the C.D.C., makers of the flu vaccine produced about 135 million doses for this year. As of early this month, 128 million doses had been distributed. While that would not be enough for every American, only 37 percent of the population get a flu shot each year.
2nd UPDATE Jan 12:  CDC's Richard Besser told ABC News there is a "glimmer of hope" for the flu outbreak.  I even looked up the term:  it means "there is a slight chance that something positive will happen."  Dr. Besser said this could be the worst flu in a decade... then said the outbreak had peaked, as CDC's graphs indicate happened more than a week ago.  

We don't seem to be speaking the same language. Flu naturally peaks, then goes away over 2-3 months, almost every year.  Now it is on the downswing.  We are not facing a slight chance something good will happen with the flu outbreak, we are facing absolute certainty that it will continue to decline over the next 1-2 months.

Friday, January 11, 2013

CDC Stats Indicate Flu Winding Down

CDC posts its latest stats for flu on Fridays.  See how, despite the pandemonium over flu, things are improving, and it looks like this season is less severe than 2003-4, 2007-8, and 2009-10.

national levels of ILI and ARI INFLUENZA Virus Isolated

UPDATE #1:  January 12:  Aetna said this week it has seen a spike in flu cases this year but it is not resulting in more inpatient admissions and it is budgeting about $40 million to $50 million for a normal flu season. That compares with $100 million it spent during the flu season in 2009.  --   Thx to Sheri Nakken for the citation

UPDATE #2:  (FROM JAN 11, Gail Collins in the NY TIMES) 
“We have an epidemic of flu every year,” said the New York City health commissioner, Thomas Farley. If there are alarming headlines, he added, it’s because public officials are “trying to get out the message to get your vaccine.” In a phone interview, Farley explained that the city declares an epidemic when more than 5 percent of the people going to emergency rooms are complaining of flu symptoms, which is unusual only in the sense that it doesn’t happen in warm weather. He also managed to work “get your vaccine” into virtually every sentence...
Maybe the national über-angst is because the last two years were really light ones for flu, and we’ve forgotten what a bad one feels like. Also, it’s possible that we’re talking about it more because there isn’t all that much going on. 

Thursday, January 10, 2013

What Does State of Emergency mean?

What exactly is a "state of emergency"?

According to Association of State and Territorial Health Officials (ASTHO), state declarations "may also identify state rules and regulations that are waived or suspended during the emergency...  They can include:
  • Activation of statutory immunities and liability protections for those involved in response activities.
  • Suspension and waiver of rules and regulations (and statutes, if allowed).
  • Streamlining of state administrative procedures such as procurement requirements." 
Here is an 87 page guide to declared public health emergencies in NY State.  Each state is a little different regarding its legal framework for such emergencies, and municipalities are different as well.  But they are more similar than different.  Page 50 says the following: 
Executive Law §§ 29-a(1) [“Subject to the state constitution, the federal constitution and federal statutes and regulations . . . the governor may by executive order temporarily suspend specific provisions of any statute, local law, ordinance, or orders, rules or regulations, or parts thereof, of any agency during a state disaster  emergency.”]
ASTHO also tells us the following about the federal response:
Federal law imbues designated federal officials with broad powers that allow them to respond to and assist states and localities in responding to emergencies even without a federal emergency declaration ...
Federal emergency declarations activate legal and programmatic responses from federal agencies including: 
  • Activating federal assistance to states in the form of financial, personnel, services, logistical, and technical assistance.
  • Triggering emergency provisions in other laws including Social Security Act Section 1135 waivers and statutory immunities and liability protections, such as the Public Readiness and Emergency Preparedness Act (PREP Act) [which waives liability for manufacturers whose products are used under PREPA, even if they do not work and cause considerable injuries.  Swine flu vaccine was given under PREPA, so US children who developed narcolepsy could not sue the manufacturer.  Anthrax vaccine is given to civilians under PREPA as well.--Nass]
  • Easing regulatory requirements on individuals, organizations, and state and local governments.
Declared public health emergencies provide a potential back door to suspension of democracy.  By declaring frequent, bogus states of emergency for swine flu, flu and the next not-so-dread disease, Americans may be lulled into ignoring the suspensions of the rule of law that may accompany the declarations.  

It's the Patriot Act all over again.  The Patriot Act was enabled by the fog of war.  

Now it's the smog of pestilence that enables the killing of democratic traditions.  In the shadows, the republic is being killed by a thousand cuts.  This is how Hitler did it, too.

Wednesday, January 9, 2013

Flu Emergency? Go to CDC's flu stats website

CDC's weekly flu data with tables and graphs is here.  This flu season looks ho-hum, occurring earlier than usual but following a standard trajectory.  CDC, why the barrage of disinfo?  Can this really be only about the flu, or is it about encroaching on our civil rights and our bodies?
Pneumonia And Influenza Mortality
Here are even earlier flu seasons to provide additional perspective.

Pneumonia And Influenza Mortality

State of Emergency: 700 flu cases in Boston this season and 4 elderly deaths/ NY Daily News

Puh-Leeze.  A State of Emergency?  I'd laugh except declaring an emergency gives states new political powers.  Powers designed by CDC and Lawrence Gostin.  Begun by 1999, before the anthrax letters or comparable public health emergencies existed, CDC "called for strengthening the legal foundation for public health practice."

The Model Emergency Health Powers Act was only unveiled 4 weeks after the anthrax letters emergency, a time of confusion when legislators were inclined to approve legal fixes.  Yet good legal arguments can be made that the new powers are unnecessary, unethical and conflict with prior health law. On this issue the Heritage Foundation and I come together.
Under the original Model State Emergency Health Powers Act, upon the declaration of a "public health emergency," governors and public health officials would be empowered to do the following and more:
  • Force individuals suspected of harboring an "infectious disease" to undergo medical examinations.
  • Track and share an individual's personal health information, including genetic information. [The new electronic medical records do this already--Nass]
  • Force persons to be vaccinated, treated, or quarantined for infectious diseases.
  • Preempt existing state laws, rules and regulations, including those relating to privacy, medical licensure, and--this is key--property rights.
  • Control public and private property during a public health emergency, including pharmaceutical manufacturing plants, nursing homes, other health care facilities, and communications devices.
  • Mobilize all or any part of the "organized militia into service to the state to help enforce the state's orders."
  • Ration firearms, explosives, food, fuel and alcoholic beverages, among other commodities. 
"One of the most outspoken opponents of the MSEHPA, on which Article VI of the Turning Point Model is based, is George Annas, who eloquently outlines a few of the most popular objections to the act: (1) bioterrorism is inherently a federal issue, and only secondarily a state issue; (2) the premise that Americans must trade freedom for security in the event of a bioterrorist attack is wrongheaded, as is the presumption that the public and physicians would not cooperate except under threat of law; and (3) the arbitrary use of force by public officials with immunity from liability is incompatible with medical ethics, constitutional principles, and basic democratic values."   See his NEJM article here.

Last year (winter 2011-12) was the lightest flu season since records started being kept:  basically there was no flu epidemic.  The year before was also light.  That is how influenza works:  some years lighter, some heavier.  The heavier years give us more cross-immunity for future outbreaks.

Anyway, this year is [unsurprisingly] heavier.  One in 25 ER patients has flu.  As a former ER doc, that is something to yawn about.  But I'm not yawning about the emergency powers invoked--to do what, exactly?  From the Daily News:

The City of Boston declared a public health emergency Wednesday as the city and country deal with a historic outbreak of the flu.  The influenza-ravaged city has seen about 700 confirmed cases of the virus since Oct. 1, the unofficial start of the flu season, according to the office of Boston Mayor Thomas Menino, who declared the state of emergency Wednesday morning.

By comparison, Boston saw 70 confirmed cases during last year’s flu season.

The outbreak has so far killed four Boston residents, all elderly, since the season unofficially began.

“This is the worst flu season we’ve seen since 2009, and people should take the threat of flu seriously,” Menino said in a release...

Flu Vaccine/ UpToDate

From UpToDate, the highly regarded online textbook of medicine, on flu vaccine:
It has been difficult to demonstrate an improvement in survival after influenza vaccination in elderly patients in randomized controlled trials because mortality is a rare end-point. The systematic review cited above found a significant reduction in death from influenza or pneumonia [46], but some have suggested that frailty selection bias in cohort studies has led to an overestimation of any mortality benefit of influenza vaccination in elderly adults [60].
A pooled cohort study published after the systematic review demonstrated a small but significant reduction in mortality in vaccinated elderly individuals (1.0 versus 1.6 percent in unvaccinated individuals) [49]. A sensitivity analysis was performed to detect unmeasured confounders. Even when a higher rate of confounders was assumed, there was still a significant reduction in mortality. Other studies have supported this finding [61]. Any mortality benefit in elderly patients is increased with annual vaccination [52]. (See 'Need for annual vaccination' below.)
The difficulty of using observational data to evaluate the effect of influenza vaccine on mortality is further illustrated by a prospective case-control study of patients (mostly over the age of 65) with community-acquired pneumonia (CAP). The study assessed the impact of influenza vaccination on in-hospital mortality in patients admitted during the off-season for influenza [62]. A significant mortality reduction was observed in vaccinated patients (OR 0.49; 95% CI 0.30-0.79). However, when adjustments were made to address confounding factors (eg, functional and socioeconomic status), the mortality benefit became nonsignificant (adjusted OR 0.81; 95% CI 0.35-1.85). This study shows that the presence of bias may overestimate the mortality benefit of influenza vaccination [63].
In contrast to the studies described above, a large cohort study of community-dwelling elderly individuals did not detect a mortality benefit from influenza vaccination [59]. An important limitation of this study was the likely underreporting of vaccination status, which could have contributed to the vaccine appearing ineffective [64].

Tuesday, January 8, 2013

MISUNDERESTIMATED: Anthrax Vaccine's New Label Misses Most Adverse Events

The May 2012 updated anthrax vaccine package insert (a.k.a. label) provides cause for concern.  Would you give this vaccine to your dog, let alone your child?  Next week the Presidential Commission for the Study of Bioethical Issues will have their final meeting to discuss giving anthrax vaccine to children.  Whose children would be sacrificed?

1.  An arithmetic error reduced the rate of serious adverse events (SAEs) by a factor of ten.  
"The percent of serious adverse events was similar between the BioThrax combined groups (193/1303 or 1.5%) and the placebo group (38/260 or 1.5%)."  page 6
These fractions correspond to 14.8% in the study group and 14.6% in the placebo group, not 1.5%.  However, these numbers may not be correct.  The 2008 JAMA paper on the same trial indicated that about 40 subjects had multiple SAEs.  Whether the numerators correspond to the total number of SAEs or the number of people with SAEs is uncertain.  Of more importance is a breakdown of what symptom(s) each SAE represented clinically, its duration and whether it resolved.  This is missing from both the text and tables.  

According to CDC's P.I. for this trial, Jennifer Wright (slides 26-27) and FDA, a Serious Adverse Event is defined as "one that results in death, is life-threatening, leads to or prolongs hospitalization, results in persistent/ significant disability or congenital abnormality."  229 events fell into this category during the trial.  What were they?

Dr. Wright also notes that the trial analyses were completed in mid 2009 and a final report sent to FDA then.  The trial results have not been made public.

2.  Table 2 (pages 7 and 8 of the label) is a breakdown of local and systemic adverse events in trial participants.  However, half the subjects in the CDC trial are not included.  The number of subjects in Table 2 totals only 775, while there were 1563 trial subjects.  The adverse events for 788 anthrax-vaccinated subjects are missing.  The number of "moderate/severe systemic adverse reactions" in Table 2 totals 65. There were 127 "moderate/severe local adverse reactions".  Yet the 2008 JAMA paper reported 229 serious adverse events for which VAERS were filed.

3.  The vaccine is dangerous in pregnancy.  (Pregnancy Category D*)
"BioThrax can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus."  page 3 of the package insert
Yet during the CDC clinical trial, 
"Of women who received vaccine within 90 days of the estimated date of conception (n = 14), 2 spontaneous abortions and a first trimester intra-utero fetal death were reported, along with one report of a healthy term infant with mild right clubbed foot abnormality. "  page 6
Fifty-one pregnancies occurred during the trial (or 48 according to CDC's PI powerpoint presentation).  Why weren't women evaluated for pregnancy before receiving each vaccine dose, given the vaccine's known teratogenicity, and the trial protocol, which required subjects to use a birth control method and be non-pregnant?  Exclusion criteria for the trial included: 
"Pregnancy or plans to become pregnant for the duration of the study and/or not agreeing to exercise adequate birth control from the time of the screening procedures to one month after the last vaccination."  
The package insert tells practitioners, "Advise women of the potential risk to the fetus."  page 15                       
4.  The abbreviated CDC Gulf War Syndrome definition remains a reported adverse event in the package insert:
"Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, and musculoskeletal system." page 9
5.  The vaccine hurts more than other vaccines.  
"Up to 11% of subjects rated the brief pain or burning they experienced immediately after vaccine injection as 8 out of 10 or greater." page 5
6.  Women have significantly more local and systemic adverse events than men.  No numbers are given.  page 5

7.  The "Information for Patients" states on page 16:
What are the possible or reasonably likely side effects of BioThrax? 

  • Pain, tenderness, redness, bruising, or problems moving the arm in which you got the shot   
  • Muscle aches  
  • Headaches  
  • Fatigue  
  • Fainting

"There is positive evidence of human fetal risk based on adversereaction data from investigational or marketing experience or studiesin humans, but potential benefits may warrant use of the drug inpregnant women despite potential risks"

In terms of giving this vaccine to children and teens, potential harms that can reasonably be anticipated include syncope and risk to the fetus if a young recipient becomes pregnant.  Fifteen percent of subjects might experience a severe adverse event "that results in death, is life-threatening, leads to or prolongs hospitalization, results in persistent/significant disability or congenital abnormality."

Can such anticipated adverse events be justified in a pediatric trial for a condition that does not exist in children at this time, and probably never will?