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flu vax and narcolepsy: could 80 cases be caused for each death prevented?

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> WHO statement on narcolepsy and Pandemrix vaccine

>

>

http://www.who.int/vaccine_safety/topics/influenza/pandemic/h1n1_safety_assessin\

g/narcolepsy_february2011/en/

>

> " 8 February 2011

>

> Since August 2010, following widespread use of vaccines against influenza

(H1N1) 2009, cases of narcolepsy, especially in children and adolescents, have

been reported from at least 12 countries. Narcolepsy is a rare sleep disorder

that causes a person to fall asleep suddenly and unexpectedly. The rates

reported from Sweden, Finland and Iceland have been notably higher than those

from other countries. The National Institute for Health and Welfare of Finland

issued a preliminary statement on 1 February 2011 following an investigation

into the cases in Finland. A systematic retrospective registry-based review was

conducted of all new narcolepsy cases diagnosed during 2006-2010 and cases in

2009-2010, born in 1990 or later, were reviewed using newly developed Brighton

collaboration criteria for the disease. During 2009-2010 they found a higher

risk of narcolepsy among those aged 4-19 years old who had received the

vaccination against influenza (H1N1) 2009 compared with those who had not been

vaccinated. The only pandemic vaccine used in Finland was Pandemrix, an

adjuvanted influenza (H1N1) 2009 monovalent vaccine manufactured by

GlaxoKline. Pandemrix vaccine was used in 47 countries worldwide during the

2009-2010 season. Studies are ongoing to determine if the apparent increased

risk of narcolepsy reported in Sweden is higher in vaccinated persons.

>

> The National Institute in Finland (on the advice of the Finnish National

Narcolepsy Task Force) has concluded that the risk of developing narcolepsy

among those vaccinated aged between 4 and 19 years is about nine times greater

than those unvaccinated in the same age group, corresponding to a risk of about

1 case of narcolepsy per 12,000 vaccinated in this age group. The increased risk

has not been seen in younger or older age groups. Narcolepsy is a condition that

has a strong genetic linkage, being almost uniquely seen in persons who have the

(HLA) DQB1*0602 genotype. Of the cases of narcolepsy tested so far in Finland

(n=22), diagnosed during 2009-2010, all have that genotype. The National

Institute considers it probable that the Pandemrix vaccine was a contributing

factor to this observed increase, and has called for further investigation of

other co-factors that may be associated with the increased risk. . . "

>

> MY (Meryl's) COMMENT:

>

> In the US, an average of about 75 children/year die from flu-related causes.

Most of these children have underlying, chronic medical illnesses. Usually

about 15-20 child deaths/year occur in otherwise healthy children in the US.

>

> There are over 50 million children in the US. If half were vaccinated, and

their rate of developing narcolepsy was the same as in Finland (one in 12,000),

we might expect 2,000 new cases of narcolepsy in vaccinated children. They

would need a certain HLA type (a specific genetic predisposition). But most

people with that HLA type do not develop narcolepsy; in Finland narcolepsy

appears to have been triggered by vaccination and possibly other unidentified

exposures.

>

> Narcolepsy is a serious medical condition, and in Finland, post-vaccination,

it has been associated with other neurological problems including personality

changes. Narcolepsy may be deadly when someone with the disorder falls asleep

at the wheel of a car.

>

> A risk benefit analysis might look something like this: two thousand

narcolepsy cases caused by flu vaccination versus 18 child deaths prevented.

(This assumes that 50% of children were vaccinated and the vaccine was 70%

effective. These are reasonable assumptions for a year in which the vaccine is

a good match to circulating flu strains.) [75 child deaths x 50% vaccine uptake

x 70% vaccine efficacy = 26 child deaths prevented. I have not thrown in a

factor for herd immunity since current vaccine uptake rates are not felt to lead

to significant herd immunity for influenza.]

>

> Granted, it is unclear what the risk of narcolepsy is for use of swine flu

vaccine in the US; and it is unclear whether the novel Glaxo adjuvant used in

Pandemrix swine flu vaccine outside the US may have contributed. But I just did

the math. And it appears that if Finland has a similar childhood death rate

from flu as the US, it could be seeing 80 cases of narcolepsy for every flu

death prevented.

>

> These are serious numbers, and WHO, EMEA, CDC and other public health agencies

must be terribly concerned about the findings and implications.

Meryl Nass, MD

Mount Desert Island Hospital

Bar Harbor, Maine 04609

W 207 288-5081 ext. 1220

C 207 522-5229

H 207 244-9165

pager 207 818-0708

http://anthraxvaccine.blogspot.com

On Feb 25, 2011, at 11:41 PM, Pandemic Response Project wrote:

> Yesterday (Thurs 2-24), PReP Manager Rich and Director Alan

met with the NC Public Health Director, Dr. Engel; our state senator,

Senator Kinnaird; and the NC Public Health's Chief of Regulatory and Legal

Affairs, Hoke, JD. Senator Kinnaird set up the meeting after previously

meeting with Rich and Alan in late December, in which meeting we discussed

points made in the Swine Flu Review (recently updated, at

www.pandemicresponseproject.com). The purpose of yesterday's meeting was to see

if we could get the state's support for exemptions to emergency vaccines and the

right to quarantine in homes. It was of course an uphill battle, and we expected

a 'no', but if we did happen to get a 'yes' to anything, it should be easy to

achieve with their blessing, and not require the much larger effort of rallying

the grass-roots troops and getting a majority of legislators on board to oppose

state health officials.

>

> To our surprise, the Chief assured us that state policy would allow exemptions

in a declared emergency, but I was confused; the religious exemption statute,

for example, states that it applies only to the vaccines required in that same

chapter, and the emergency laws are in a different chapter. So, I argued, that

policy is unclear (but I will review both chapters again as soon as time

allows). So, I asked if they would support an amendment clarifying this policy,

and they agreed. We will be working together to draft a proposed amendment, and

with public health's agreement, getting it passed should be a straightforward

process.

>

> I was previously criticized, understandably, for agreeing to soften the

approach when talking to state health officials, by leaving out information

about corruption and conflict of interest, at the request of the Senator. Please

be assured that we surrendered nothing in doing this, we simply were being

practical with this specific audience. It gets us nowhere to address state

health officials in a manner likely to cause them to dismiss us altogether. We

intend to address our concerns fully with state legislators, or to the fullest

extent that we determine any given one can hear what we have to say. We have

spent years along our own learning curves, and so must realize that others may

not be able to immediately grasp the full scope of what we have to say. But the

end goal does not change--truth and freedom accordingly.

>

> The State Health Officials predictably if disappointingly drew the line at

anything that would require them to surrender any authority. Specifically, they

do not agree to a philosophical exemption in any context (it is a " slippery

slope " ), and assured us that the policy regarding quarantine is to use the least

restrictive means necessary in any given situation, and so were not willing to

put limitations on their ability to enforce that, ultimately, in locations of

their choosing.

>

> Meeting with state health officials was our senator's idea, and not ours; she

indicated that getting health legislation passed requires (or is most easily

accomplished) by getting state health officials on board. But this was only a

first step of many to come. We got clarity on state policy, and know where we

will and won't have to get citizens and legislators on board to get the level of

freedom that we feel the true science and facts compel. So, we consider the day

to have been a resounding success--we expect to have clarification in NC law

allowing medical and religious exemptions in the emergency context soon--more

than we expected to come away with--and while that's only a first step, a small

victory, it was unexpected and therefore for us a big step forward. As the

saying goes, the journey of a thousand miles starts with the first step...

>

> [i may have previously misstated that we were meeting with NC's Secretary of

Health and Human Services. I apologize for that. Alan]

>

> --

> Alan , J.D., Director

> Rich , Manager

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