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Archive for the ‘Vaccinations’ Category

Criminals Conduct FDA Research

Last Updated: Thu, 10/22/2009 – 3:01pm

Government scientists convicted of fraud conduct essential drug and biologics research because the notoriously derelict federal agency responsible for protecting public health and safety doesn’t bother removing them.

To avoid compromising the safety of crucial clinical trials that determine the approval of drugs and medical devices, federal law bans any research to be administered by individuals who have been convicted of fraud. Because they risk altering the integrity of important data, it’s the responsibility of the Food and Drug Administration (FDA) to banish them from all taxpayer-funded trials.

Instead, the FDA regularly fails to debar individuals who have been convicted of felonies related to the development, approval or regulation of a drug or biologic. The agency takes anywhere from a year to more than a decade to ban criminals from conducting drug trials, according to a lengthy congressional report published this week.

(more…)

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or “Train Wreck..Continued“.

Testing on healthy adults ages 18-65 began on August 10th.

If the first eight days of adult testing don’t raise any safety concerns, researchers will begin testing the vaccine in healthy children ages 6 months to 18 years.

Generally, researchers would wait longer before moving to test a vaccine in children, says Dr. Ina Stephens, a pediatric infectious disease specialist at the University of Maryland Center For Vaccine Development.

“For a lot of reasons this is not a typical vaccine trial,” says Stephens, whose center is one of the locations of the clinical trials. “Because of the urgency for getting this vaccine approved for public use, we need to hurry … we’re looking mostly for safety data.”

Healthy adults, healthy children. No pregnant women. That’s who this is being tested on.

Inclusion Criteria:

  • Are males or non-pregnant females aged 6 months to 17 years, inclusive.
  • Subjects of child-bearing potential must agree to practice adequate contraception that may include, but is not limited to, abstinence, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods during the study for at least 30 days following the last vaccination.
  • The subject must be in good health as determined by axillary (

Okay, healthy people who aren’t pregnant. Got it. Now tell me again…

Q Who should be vaccinated against swine flu?

A Eventually, everyone, except for people who have the same allergies — primarily, allergy to eggs — that make annual flu shots dangerous for them. But for now, the first vaccine batches are reserved for those most at-risk: health care and emergency workers; pregnant women; people caring for infants younger than 6 months old; people 6 months to 24 years old; and anyone younger than 65 who has a weakened immune system or such medical conditions as asthma, diabetes or morbid obesity.

Test it on healthy people who aren’t pregnant, then recommend it for pregnant and sickly people. Right. “I’m from the government, and I’m here to help you.” comes to mind for some reason.

Testing on children 6 months and older began in mid-August. That’s a good thing, right? They’re already running tests, so by the time flu season really hits we’ll have some test results to look at.

Or not.

From the ClinicalTrials.gov website:

Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels

Study Start Date: August 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Well, that’s reassuring.

Oh look, they’re doing one to “help determine how and when the H1N1 flu shot should be given with the seasonal flu shot to make it most effective.” That sounds awesome, when will we see the results for that one?

Study Start Date: August 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Oops.

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When Pigs Fly.

Let me just state for the record, I was skeptical about vaccinations long before this year’s “outbreak” of swine flu. From the time I was urged to vaccinate our firstborn against an STD the day after she was born, I’ve been leery of the reasoning behind routine immunizations. The arguments presented to me by medical professionals have been flimsy, at best. “You must inoculate your child against mumps or he/she can’t go to public school. You’ll be putting the other children at risk.”
Riddle me this, doc. If the vaccination is so effective, so what if my kid had the mumps? The inoculated kids won’t get it, right? This never fails to annoy them, and they’ve never had a good response. In other words, no down side.

Alright, enough reminiscing. Brass tacks time.

Here’s a few excerpts from an article on NaturalNews.com regarding the swine flu vaccine.

Urgent lawsuit filed against FDA to halt swine flu vaccines; claims FDA violated federal law

(NaturalNews) Health freedom attorney Jim Turner is filing a lawsuit in Washington D.C. mid-day Friday in an urgent effort to halt the distribution of the swine flu vaccine in America. On behalf of plaintiffs Dr. Gary Null and other licensed health care workers of New York State, the lawsuit charges that the FDA violated the law in its hasty approval of four swine flu vaccines by failing to scientifically determine neither the safety nor efficacy of the vaccines.
“The FDA is required by law to establish that a vaccine is safe and effective before it can be given to the public,” said Turner. “We are arguing that they did not establish that the vaccine was effective, and did not establish that it was safe. They are trying to get it on the market by a waiver.”

If the charges described in the lawsuit are true, it means the FDA has blatantly abandoned medical science and violated its own regulations in approving not only these four vaccines, but the potentially deadly adjuvant chemicals as well. To date, the FDA has produced absolutely no scientific evidence documenting safety tests for any of these swine flu vaccines. There are no published studies, no records of any clinical trials, and no publicly-available paper trail demonstrating that any safety testing was done whatsoever. There is no researcher who has publicly put their name on the record declaring the vaccines to be safe, and no FDA official has ever stated that scientifically-valid safety testing has ever been conducted on the vaccine / adjuvant combinations now being distributed across America.

By approving the four vaccines in the absence of such safety testing, the FDA itself stands in direct violation of federal law. “There is a law that they’re supposed to follow and they are not following it,” Turner added.

Why, then, did the FDA apparently violate the law and push these vaccines into full public distribution without securing the safety testing required by law? Turner suspects a profit motive may be involved: “They’re charging $24.95 to get a vaccine. Multiplied by 100 million people, that’s a lot of money. If you do the whole society, you’re talking about several billion dollars.” In fact, the U.S. vaccination push could ultimately target over 200 million Americans, generating nearly $5 billion in vaccine-related revenues. Cashing in on those revenues, however, requires three things:

1) Spreading fear about H1N1 swine flu by exaggerating its dangers.
2) Quickly making a vaccine available for sale, even if it has never been thoroughly tested for safety and efficacy.
3) Aggressively marketing the vaccines before the H1N1 swine flu fizzles out and can no longer be hyped up as “highly virulent.”

All three of these conditions are now being pushed aggressively in the U.S. by pharma-influenced health authorities at both the state and federal level. There is a mad, cult-like rush under way to vaccinate American citizens with an unproven, untested chemical that was thrust into distribution in apparent violation of federal law. And if this vaccine is not stopped, the price that may ultimately be paid in terms of lost lives could be quite dire.

Now, here’s the scary part. According to the FDA, the H1N1 vaccine did not exist as of June 18th, 09.

Vaccine

At present, there are no licensed vaccines approved for this new H1N1 influenza virus.

Which means it’s been developed just in the last few months. Which means there have been no long-term studies done.

Wait, it gets better..

(Okay, it gets worse. Much worse..)

2009 H1N1 Influenza Shots and Pregnant Women: Questions and Answers for Patients

October 2, 2009, 5:00 PM ET

General Public

Why does CDC advise pregnant women to receive the 2009 H1N1 influenza (flu) vaccine (shot)?

Getting the flu shot is the single best way to protect against the flu. It is important for a pregnant woman to receive both the 2009 H1N1 flu shot and the seasonal flu shot. A pregnant woman who gets any type of flu has a greater chance for serious health problems. Compared with people in general who get 2009 H1N1 flu (formerly called “swine flu”), pregnant women with 2009 H1N1 flu are more likely to be admitted to hospitals. Pregnant women are also more likely to have serious illness and death from 2009 H1N1 flu.

Gee, that sounds serious. It’s a good thing all these super-smart people are looking out for our well-being

The National Institutes of Health is set to begin testing the vaccine in pregnant women in the next month or two. “We’re still awaiting word from our institutional review board [which signs off on all clinical trials], so we don’t yet know who will be included,” says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which is part of NIH. Although he says there’s no reason not to include pregnant women at the earliest stage of pregnancy, the review board could “out of an abundance of caution” limit the trials to women who are beyond the first 12 weeks of pregnancy. Unfortunately, he adds, safety and efficacy data won’t be available from those pregnant women trials when the vaccine initially becomes available in late October.

“We haven’t tested it yet, but go out and get it to protect your baby!”

Thalidomide, anyone?

In Europe and Canada during the early 1960s, thalidomide was prescribed to treat morning sickness in pregnant women.
Thalidomide was soon banned worldwide when it was discovered that it caused tragic birth defects.
Thalidomide was recognized as a powerful human teratogen (a drug or other agent that causes abnormal development in the embryo or fetus). Taking even a single dose of thalidomide during early pregnancy may cause major birth defects.

Hmm, maybe that ‘testing’ thing should have been done first. Oh well.

Lesson learned, right?

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