Scientists are in agreement that millions of lives around the world will be affected by the H1N1 (Swine flu) in the next three to seven months. Those same scientists however are in disagreement as to the safety and efficacy of the vaccine being manufactured for distribution to combat the flu. Currently the vaccine is being manufactured in exactly the same way as the seasonal flu vaccine, which is approved for children six months and older.
Still, the vaccine is considered experimental, not yet approved by the U.S. Food and Drug Administration and could have unknown risks; that's why it is being tested on small groups of people around the country first.
Last week, the National Institute of Allergy and Infectious Disease said it had reviewed enough data, from adult trials of the H1N1 vaccine that began two weeks ago, to determine there were "no safety concerns in those trials that would preclude trials from proceeding in children."
Not everyone agrees
"It might be wise to eschew flu vaccines this season. The ounce of prevention, in this case, can be far more dangerous than the few pounds of misery if you get the flu," said Anthony Alfonso, a registered pharmacist and CEO of the Miami-based Nutri-Force Nutrition Company.
Alfonso also said he is not impressed with the progress being made to supply the necessary quality controlled flu vaccines into the healthcare distribution chain in the United States.
" My pharmacy background makes me a natural skeptic and the evidence continues to pile up that something is not right about these flu vaccines," said Alfonso in a telephone interview.
Alfonso's concerns center around a health alert in the Daily Mail in London, England, where it was reported that there have been two leaked letters revealing a link between swine flu vaccine and a lethal nerve disorder.
"The silence is almost deafening in the American press, when it comes to this information about the potentially lethal link between swine flu vaccine and the dreaded nerve disorder of Guillain-Barre syndrome," said Alfonso.
The information about the link recently reached the public in the United Kingdom when those two letters leaked to the Daily Mail were published. The letters were addressed to 600 senior British neurologists. One was from the UK's Health Protection Agency and the other, from the Association of British Neurologists.
"The specter of Guillain-Barre is too dangerous to be ignored, and the news that the swine flu vaccine might cause it should not be soft-pedaled in the United States," some health officials say.
Guillain-Barre syndrome is an acute inflammatory disorder and is an incurable autoimmune disorder that ravages the protective sheathing of the nerves, affecting the peripheral nervous system, brain and the spinal cord. An acute infectious process usually triggers it.
Guillain-Barre can cause death, permanent disability, or even paralysis to the point that patients, in order to breathe, must be put on respirators.
Neither scientists nor physicians know its exact cause, but physicians know it can be triggered by surgery or by vaccinations such as the swine flu vaccine - and the vaccine is currently the big concern, given the precedent of 1976.
That year, the U.S. government rushed to develop the swine flu vaccine and gave it to about 40 million people. Soon after the deaths of 25 people from paralysis and respiratory failure, the government strongly suspected the vaccine was the cause and ultimately withdrew it from the marketplace.
On the other hand, the swine flu itself, according to official records at the Centers for Disease Control and Prevention in Atlanta, killed only one person. The new strain of swine flu used in the new vaccine is slightly different, but strong concerns about Guillain-Barre remain the same.
"I will not have the swine flu jab because of the risk," said a Florida neurologist who asked that his name not be used in this story. "But if any of my patients ask me directly, I will also recommend they not take the proposed three-shot cocktail."
Another worry about the vaccine is the use of component oil called Squalene, and it's known side effects.
Squalene adjuvants are a key ingredient in a whole new generation of vaccines intended for mass immunization around the globe. Squalene is not just a molecule found in a knee or elbow joint - it is found throughout the entire nervous system and the brain.
When injected into the body, the immune system attacks it as an enemy to be eliminated. Eating and digesting Squalene isn't a problem. But injecting it galvanizes the immune system into attacking it, which can produce self-destructive cross reactions against the same molecule in the places where it occurs naturally in the body - and where it is critical to the health of the nervous system.
Once self-destruction begins, it doesn't stop as the body keeps making the molecule that the immune system is trained to attack and destroy. Many scientists say it is a dangerous additive and should be banned.
"Squalene also can set off autoimmunity and is associated with multiple sclerosis, Alzheimer's disease, ALS, and Parkinson's disease," according to Dr. Russell Blaylock, a prominent American neurosurgeon.
Many British experts also are worried about Squalene, going so far as to call the upcoming trials of the swine flu vaccine a "guinea-pig trials."
The two letters
The Health Protection Agency letter reminded physicians that, in the 1976 bout in the United States, more people died from the vaccination than the flu. More than 500 cases of Guillain-Barre were diagnosed and resulted in the vaccine's being withdrawn after just 10 weeks of distribution.
Guillain-Barre by the numbers: About 160 million doses of swine flu vaccine will be available this fall of 2009. In 1976, about one in 100,000 who got the swine flu vaccine developed Guillain-Barre.
The leaked letters beg doctors to be on the lookout for patients with Guillain-Barre symptoms, revealing deep doubts and fears in the UK about the safety of the new vaccine.
The letter from the Association of British Neurologists, for instance, informed physicians that the vaccine caused a possible eight-fold increase in Guillain-Barre during the 1976 U.S. swine flu bout.
According to a source at the CDC, once the FDA approves the vaccine for distribution, the U.S. government will spend $4.8 million dollars for a national advertising campaign, to assure citizens of the safety and efficacy of the vaccine.
JP Bender is a retired award winning investigative reporter with 35 years experience in the profession. He now spends his retirement living in Maryland with his children and grandchildren. He still reports on issues of national interest, while his peers claim he does not fully understand the meaning of the word“retired.”
Thanks for the information, JP. I am one with an autoimmune disorder. I am thankful I read this before getting immunized. I never have gotten a flu shot before but was considering this one.
Thanks Lorrie, I too have an autoimmune disorder. I have always received the seasonal flu shot but I am really ambivalent about this years swine flu shot. JP
» left by Mr. RedRock from USA East Coast (72 days 19 hours ago.)
Thank you for the information JP, I am another with an Autoimmune Disease and for me the struggle is not if I should get the H1N1 Vaccine or not, but should my children get it. At this point, I do not think anyone in my house will be getting it.
Thanks Mr. RedRock for your feedback. It is only recently the main stream media has been questioning the vaccine. I too want to see us protected but I don't understand why the media has beem the cheering gallery instead of being honest with the public.
Thank you for the information. My daughter developed autoimmune hepatitis 2 years ago after taking minocycline for acne. She recovered from that and has now been diagnosed with Hashimotos. I have been concerned about the h1n1 vaccine and this information has helped.
I think some of the sources are a little dubious though - the CEO of a company that produces nutritional supplements and natural remedies (some of which supposedly boost the immune system and help protect against things like flu) could stand to benefit by a widespread negative view of the vaccine, so their opposition to it is neither surprising nor objective.
The Daily Mail has an absolutely terrible reputation for its reporting of medical issues, with a number of vaccine "scare stories" behind it (most noticeably the MMR vaccine).
Since you wrote your article, the FDA have approved the vaccines:
"The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks"
The Health Protection Agency indicated, shortly after the story published in the Daily Mail, that it did not expect to find links between the new vaccine and GBS, and stated it wanted to monitor any connection between the flu virus itself and the syndrome.
There are risks associated with the vaccine (as there are risks with any vaccine, and indeed any medicine), but the Daily Mail and the CEO of a nutritional supplements company are not sources likely to give an objective opinion.
» left by Ashley from Florida (22 days 12 hours ago.)
I am 25 weeks pregnant and I have been told by all of my Dr's to get this H1N1 vaccine! But the horror stories i have heard about it are scaring me. I don't know what to do at this point considering it is not approved by the FDA and we are being used at test dummies. Also i heard that 28 pregnant women have died after recieving this vaccine. Can someone please help me?
» left by LeRoy from Payson, AZ (21 days 23 hours ago.)
About 15 years ago I received my one and only flu shot. Two days later I had the worst experience in my life. I happened to have a canker sore in my mouth at the time of the flu shot, which I only recently discovered is an autoimmune disorder, the canker sore spread to fifty sores in my mouth and lasted for two weeks. I had been plagued with canker sores my whole life, but with only one or two at a time. Fifty at one time was a living nightmare. The funny thing is, ever since, I have never gotten another canker sore. But this is where my story really begins. Since this event, I have had a relentless problem with sores on my hands that behave exactly like the canker sores had before. Twelve years I suffered with this. But I also started having heart problems as well. Now after my third heart attack, three stents, 5 heart lung catheters and now my lung function is totally waisted. I am now on oxygen at all times and have been diagnosed with some sort of autoimmune disease. I was a strong man, and now I am far too old before my time. My family seems to have this autoimmune gene and I have probably alway carried it inside. But I feel the flu shot triggered it to become systemic and now I must live with the consequences. I will never get another vaccination again. They may be just fine for some people, but for people like me, it's just not worth taking the risk of mutating this thing I have any further.
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