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 H1N1 Latest 
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Some truth about the new swine flu vaccine

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Yesterday at 5:36pm
From: Mark Crispin Miller
To: newsfromunderground@googlegroups.com
Sent: Fri, 9 Oct 2009 09:27:00 -0400
Subject: [MCM] Some truth about the new swine flu vaccine

According to the CDC and, therefore, the MSM (especially the New York Times), the new
swine flu vaccine has now been thoroughly tested, and is "good to go," so there is no good
reason not to get your shot.

In fact, there are good reasons to be wary of this new vaccine. People need to make their
own decisions on this matter, but such decisions ought to be informed by sober independent
experts, not (on the one hand) by a state bureacracy tied closely to Big Pharma, and not
(on the other hand) by random screeds in cyberspace.

Dr. Meryl Nass is such an expert. Here, then, is what she has to say about it, posted on her
blog today:


Why Am I Concerned about Safety of Swine Flu Vaccines?
Friday, October 9, 2009

http://anthraxvaccine.blogspot.com/2009 ... ty-of.html

My friend Mark Crispin Miller has urged me to be more specific about why I am concerned about the safety of swine flu vaccines in the US. In a nutshell:

1. Newness

I am always concerned about new drugs and vaccines. A former FDA Commissioner, Dr. Jane Henney, once said she did not use drugs during the first year they were on the market, and advised others to likewise avoid them. The reason is that some drugs and vaccines caused serious side effects that were not picked up, or not considered enough of a concern, during initial clinical trials. Rotashield vaccine is a good example: intussusception (causing bowel obstruction) did occur in prelicensure trials, yet a million babies received this vaccine before it was taken off the market in 1999. Rotashield caused 22 times the expected rate of intussusception in infants... which was nonetheless overlooked in the first months of usage.

Pre-licensure trials typically involve about 1,000 subjects for short periods of time.

2. The Currently Available Evidence is Thin


There are few published studies of swine flu vaccine. The Greenberg et al. study from Australia (Response after one dose of a monovalent influenza A H1N1 2009 vaccine--preliminary report; NEJM 2009; epub Sept. 10) is a relatively high quality study. How was vaccine safety evaluated? By using a diary card for 7 days post-vaccination. The 240 subjects returned on day 21 for a blood draw, and presumably some data were collected then, but it is not clear from the published report what safety information was obtained after 7 days. Local symptoms like a sore arm were reported by 46% of subjects, and systemic symptoms such as headache, muscle aches or malaise were reported by 45%. Subjects were healthy adults aged 18-64.

The authors stated, "No deaths, serious adverse events or adverse events of special interest were reported." The investigators did specifically query subjects about several neurologic and immunologic events, including Guillain Barre Syndrome. However, it is unclear how actively other adverse events were sought, if at all, after the initial seven days post-vaccination.

The authors acknowledge that, "The full safety profile of the H1N1 vaccine has not yet been elucidated. Population-based postlicensure surveillance will be required for all H1N1 vaccines, especially to assess rare outcomes, such as the Guillain-Barre Syndrome." And they point out that they studied a population of healthy adults, and "trials need to be conducted in other populations that may have different responses to the vaccine, such as the elderly, children, and those with impaired immunity."

What concerns me are the later side effects that will not be collected, or not attributed to the vaccine due to lack of "biological plausibility." Since there do not exist reliable scientific criteria for assigning causality to vaccine adverse events, those the vaccine causes are likely to be dismissed as coincidental. An example is the drug Chantix, used to help people quit smoking. It often causes a variety of paychiatric side effects including suicide, even after the drug has been stopped. It took years after licensure to figure this out. The brief periods of active surveillance in vaccine research seem grossly inadequate to me.

3. The Liability Waiver... blanket immunity in the absence of willful misconduct

As I've noted previously, manufacturers can only be sued for damages if they are guilty of willful misconduct. As long as they don't know about safety problems, they cannot be held liable for them. This thoughtless language may induce manufacturers to perform minimal safety testing in order to avoid potential liability. Don't you think corporate attorneys have so advised their clients?


4. When the program isn't transparent, the result is lack of trust.

I expect the government supplying swine flu vaccines to advise recipients honestly about them. Live flu vaccines have very low efficacy in adults, compared to injected subunit vaccines. How attractive would a nasal vaccine that was only 29% effective at preventing influenza be to you, when the injected vaccine had 72% efficacy? Yet this is what Monto et al. recently reported in the NEJM about last year's seasonal vaccine. It makes you wonder why live flu vaccines are even licensed for adults. And how good are they in children? Better--but the data are limited.

Some hospitals are refusing live nasal vaccines for employees. That is wise: they are concerned the live viruses could be transmissible to patients, especially those with impaired immunity. They should also be concerned about efficacy.

Schools offering these vaccines don't seem to be aware of these potential problems. We need to know what the effectiveness of a vaccine is before being vaccinated. If the benefit is low, being vaccinated is probably not worth the (unknown) risk.

5. Benefit and risk should be compared

Yes, there are serious swine flu illnesses and deaths in a young, healthy population. But how frequent are they? How good is the vaccine at protecting against them? The very best flu vaccines are about 70% protective against catching the disease, which is the measure you are interested in. Most studies measure the rise in antibody levels, which may not reflect actual protection.

During 4 weeks in September there were 182 confirmed influenza deaths in the US. Though not a small number, it is not a big number either compared to seasonal flu. Cities (like Boston and New York) that had a lot of swine flu cases in the spring are having few now, suggesting a large enough number of people (perhaps 50% or more to induce this effect) had subclinical infections then to generate herd immunity. It is likely many will be vaccinated who are already immune. In the Australian trial, 31.7% of vaccine recipients were later found to have had antibodies against swine flu before they were vaccinated, even though they had no symptoms of disease.

If you have a neuromuscular disorder or lung disorder, you are at higher risk of a serious outcome from flu. Thus your benefit from vaccination is greater.

The benefit should be balanced against the risk, but we don't know the risk yet. I do my best to balance the known risks and benefits as I advise people regarding vaccination, and I hope readers of this blog do also.


Sat Oct 10, 2009 3:10 pm
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Joined: Sun Apr 05, 2009 9:25 am
Posts: 2568
Location: Timeline 39, Earth-Moon L1 Lagrange point
 Timeline Changed!
Timeline changed for Good!

You may find this file usefull!!!
http://tinyurl.com/yz3gzgw
The Card!
Instructions: (please press the left button of mouse and drag)


Open the pdf of the record card. Print out at 100% of page size, do not use page scaling.
The card is double-sided, so print on both sides of the card stock.
Trim the card along the trim lines indicated on the back side. (Hint: cut the long way first, dividing the piece in to two long sections, to avoid losing the remaining trim lines.) This will result in 6 cards, each 3 3/8" x 4 1/4".
Fold each card so that the front panel reads "Influenza Vaccination Record."


:heart

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Thu Oct 15, 2009 5:26 pm
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Post Re: H1N1 Latest
Study explains immunity to H1N1 in older people

Wed Oct 14, 2009 10:51pm BST
By Julie Steenhuysen
http://uk.reuters.com/article/idUKTRE59 ... 14?rpc=401

CHICAGO (Reuters) - Older people who have been infected with or vaccinated against seasonal flu may have a type of immunity produced by cells that protects them from the swine flu virus, U.S. researchers said on Wednesday.

They said the pandemic H1N1 virus has parts found in earlier flu strains, and some people past age 60, who may have been exposed to similar viruses in their youth, may have some latent immune cells that protect them.

"These findings indicate that human populations may have some level of existing immunity to the pandemic H1N1 influenza and may explain why the 2009 H1N1-related symptoms have been generally mild," said Carol Cardona of the University of California Davis School of Veterinary Medicine. Her study appears in the journal Emerging Infectious Diseases.

Cardona said cell-based immunity may be serving to weaken the effects of swine flu.

"The meaning clinically is you are going to get sick but it may not be as severe if you had no immunity whatsoever," Cardona said in a telephone interview.

Cardona said much attention is given to antibodies that recognize and destroy foreign invaders.

The body also makes cells, known as cytotoxic T-cells, which secrete antiviral chemicals that kill infected cells and clear the virus from the body. It is these cells that may be offering protection.

"It's part of the primary immune response. It just is not the one that is classically measured," Cardona said.

Cardona and colleague Zheng Xing analyzed data from prior studies of the H1N1 virus, looking at short stretches of proteins known as epitopes found in regions of the virus that are less likely to change from strain to strain.

"We simply went in and reanalyzed it," Cardona said.

They found more than a dozen of these epitopes on the H1N1 virus also are found in seasonal flu viruses that have been circulating for years.

"Not every single person can process these stretches of the protein," said Cardona, which may explain why some people who get the H1N1 flu have severe illness while others have milder cases.

According to the U.S. Centers for Disease Control and Prevention, most serious cases and deaths from swine flu have been in people under the age of 65.

"It's the younger ones who are being hospitalized," the CDC's Dr. Tim Uyeki told a meeting of the Pan American Health Organization on Wednesday.

Dr. Yoshi Kawaoka of the University of Wisconsin said studies showed people born in 1918 or earlier had many antibodies against the new pandemic H1N1 and said it may more closely resemble its distant 1918 cousin.

(Editing by Maggie Fox and Bill Trott)

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Thu Oct 15, 2009 6:39 pm
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