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Up to Half of Healthcare Workers Intend to Refuse Swine Flu Vaccine

Some healthcare workers feel the swine flu vaccine is unsafe because they fear that there really hasn’t been adequate time to test side effects and long-term effects. However, more is known now than was known this summer, when reports of the UK and Australia using it really started to surface.

Fox News has reported that, "About half of Hong Kong’s health workers would refuse the swine flu vaccine, new research says, a trend that experts say would likely apply worldwide." The article went on to state that, "Most said they would pass on the H1N1 shot, which is not yet available, because they were afraid of side effects and doubted how safe and effective it would be."

In England, The UK’s Telegraph has reported that a poll of 1500 nurses has indicated that a third of nurses would not get vaccinated, and another third are undecided. 60 percent of those refusing the vaccine said that the reason for their decision was that they weren’t convinced that the vaccine was safe.

In Israel, the Jerusalem Post has reported that about a quarter of the Israeli population plans to refuse the vaccine.

An Australian news website, News.com.au reported that both Australian and UK doctors are discouraging the use of Tamiflu in children because, "it caused nausea and vomiting, which can lead to dehydration and other complications." The article went on to state that a study published in the British Medical Journal, "reported that more than half of 248 students given Tamiflu after a classmate fell ill with swine flu suffered side effects such as nausea, insomnia and nightmares. Most of the students did not have the flu when they were given the drug."

Though it was reported by the Associated Press that the FDA approved the vaccine, it was also stated that the UK’s NIH is still studying the vaccine for dosage and safety. Basically, one could conclude that it’s really still in the experimental stage. If the UK has actually had more opportunity to use it, and they have because swine flu is much worse there than it is here, then one might wonder why the FDA was so quick to approve it here.

According to the FDA's website, a company doing research on a new drug can request "Fast Track, Accelerated Approval and Priority Review." Since the swine flu has been declared a pandemic by the WHO, I would say that one could logically guess that any drug company who has been working on the vaccine has made that request of the FDA. But even on the fast track, it takes up to 60 days for the FDA to decide if they will agree to extend the fast track process to the requestor. If the FDA does agree, a drug company would, according to the FDA website, be eligible for a, "Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the application iscompleted before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA."

The website also states that, "When studying a new drug, it can take a long time — sometimes many years — to learn whether a drug actually provides real improvement for patients…this real improvement is known as a ‘clinical outcome.’" That being the case, something called a "surrogate endpoint marker" was developed which is, "a laboratory measurement, or physical sign — that is used in clinical trials as indirect or substitute measurement that represents a clinically meaningful outcome, such as survival or symptom improvement." So if a new drug just reduces symptoms, then the FDA assumes that it’s reasonable to assume that there is a real clinical benefit and will grant a "traditional approval for the drug," or in this case, the vaccine. But what about the long term effects or side effects of fast tracked drugs? No mention of that. It’s known that a similar vaccine used for the 1976 outbreak of swine flu caused more deaths than the actual swine flu, and that the vaccine was linked to a brain disorder called Guillain-Barre Syndrome (GBS) which not only causes paralysis and respiratory distress, but can also cause death. And this vaccine is similar to that one.

If the drug companies working on this drug received "Priority Review," as opposed to "Standard Review," for FDA approval, then it would take the FDA about 6 months to complete the review. One example of what the FDA considers in determining a Priority Review is, "evidence of safety and effectiveness in a new subpopulation, such as children" (emphases added). Though the web page does not specifically state that pregnant women are a "subpopulation," I can see where that could also be acceptable to the FDA, as only a few examples are listed as criteria in determining if a particular drug, such as a vaccine, are eligible for priority review by the FDA. And remember, all evidence does not need to be submitted in advance. That’s the point of a rolling review (part of the application process), which can go along with a priority review, which is part of the accelerated FDA approval process.

It would also explain why children and pregnant women will be the first ones to receive the vaccine. But there is no evidence yet about how the vaccine will affect the unborn baby. Will it cause disabilities or death? This ought to have every mother, father and God-fearing person outraged! The only upside to this is that if the limited research does not produce the projected results, then the FDA will withdraw its approval. But people may be seriously injured and lives may be lost before that ever occurs.

Though the WHO is predicting that there could be as many as 2 billion cases of swine flu worldwide, it is also stating that most victims suffer only mild symptoms.

DickArmey, a former Republican House leader has warned that there will be, "a hyped up outbreak" of swine flu this fall in order to incite fear and give Washington an edge concerning getting the healthcare bill to pass.

Source: examiner.com


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