Unbelievable Poisoning of Our Children

Source: MedPage Today

No Safety and Efficacy Testing Required Prior to Mass Vaccination FDA announces that vaccine need only work in less than 3 out of 10 recipients

The FDA is likely to approve 2009 H1N1 (swine flu) vaccines before trial data can prove their safety or effectiveness against the virus. This announcement comes despite the fact that the 1976 mass swine flu vaccination program resulted in thousands of vaccine injuries, numerous deaths and $3.5 billion in damage claims by U.S. citizens.

The FDA also announced that a vaccine will be accepted if it creates antibodies in 4 out of 10 recipients (40%), with at least 70 percent of those 4 achieving an antibody level believed to provide benefit. This means that an acceptable vaccine candidate would provide “protection” for 28% of vaccine recipients (70% of the 40%), or less than 3 in 10 recipients. The requirement drops to 18% efficacy for those over 65 years of age (60% of 30%).

Alarming as this is, approving a vaccine without safety and immunogenicity (efficacy) data is not uncommon, FDA officials said during a daylong meeting of the Vaccines and Related Biological Products Advisory Committee. The committee met to hear updates on H1N1 trials from the FDA, NIH, and the five companies that are applying for FDA approval of pandemic H1N1 vaccines.

The FDA approves seasonal influenza vaccines every year using its "strain change" process, in which it doesn't require vaccine manufacturers to provide safety and efficacy data. What is different about how the FDA is likely to handle approval for a vaccine for pandemic H1N1, however, is that the agency doesn't normally approve vaccines while major clinical trials of safety and immunogenicity are ongoing.

Norman Baylor, PhD, director of FDA's Office of Vaccines Research and Review, explained the FDA's probable decision to go ahead with the “simplified approval process”, rather than its customary demands for compelling safety and immunogenicity data.

The government expects Novartis, Sanofi Pasteur, CSL, and GlaxoSmithKline to supply inactivated H1N1 vaccines to the U.S. market, while MedImmune will produce a live attenuated H1N1 vaccine, according to the document.

The FDA said it would like the sponsors of the study to perform double-blind or observer-blinded studies in which patients are administered two doses of the vaccine, 21 days apart. Manufacturers should stratify their patients into four age groups: infants and toddlers, ages 3 to 9, 18- to 64-year-olds, and older than 65. The FDA did not request an adolescent group because those data can be interpolated from the other age groups, the document said. It also didn't specify a study protocol for babies less than six months, because such studies will have to be designed to evaluate the entire series of infant vaccinations.

The FDA said that 100 patients in each arm of the trials "is sufficient to provide a description assessment of immunogenicity with a reasonable degree of confidence in that estimate." If a control arm is used, it should contain at least 25 patients.

The FDA recommended that patients should be followed for six months after the second vaccination to monitor for serious adverse events, and for one year if the second vaccine contains an adjuvant, the FDA said.

The vaccine will be considered as having an immunogenic response if:

* The lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving seroconversion for H1 antibody should meet or exceed 40%, or 30% for those over 65.
* The lower bound of the two-sided 95% CI for the percentage of subjects achieving an H1 antibody titer more than or equal to 1:40 should meet or exceed 70%, or 60% for those over 65.

The FDA will be working with manufacturers and government agencies to coordinate surveillance plans, after the vaccines are administered, according to the briefing document. It is expected that the National Institutes of Health will also sponsor some H1N1 vaccine studies, and the agency will present its plan to the advisory panel.

Having a licensed vaccine doesn't mean that an immunization program will kick-off immediately -- that call has to come from the Secretary of Health and Human Services (HHS). But given the prediction that H1N1 infection rates will pick up this fall, immunization programs are likely to begin before safety and immunological data collection is completed. That trial data will begin trickling in during August and continue through early 2010. The World Health Organization (WHO) and the NIH have said they want to start vaccinating people by mid-October.

Of the five companies applying for FDA approval -- Novartis, Sanofi- Pasteur, CSL Biotherapies, GlaxoSmithKline, and MedImmune -- only CSL has already started human trials. The Australian company, which provides seasonal flu vaccines to the U.S., inoculated its first human trial participant Wednesday. Meanwhile, the NIH announced it was set to begin clinical trials in the United States of vaccines made by Sanofi-Pasteur and CSL.

Because an immunization program will likely run at the same time as the trial, the FDA said it would issue updates as the trials answer key questions. They include whether two shots are better than one, and how the vaccine interacts with seasonal flu shots. "That's the harder decision -- how those immunization decisions will be made as that data comes in," said Dr. Baylor.

There's a chance the early data will show the vaccine is ineffective at stimulating an immune response. If that's the case, the FDA might have to issue an "emergency use authorization" for an oil-in-water adjuvant that sparks a stronger reaction in the immune system, but causes more side effects.

There are currently no licensed influenza vaccines that contain an adjuvant, and Dr. Baylor said he couldn't recall a time when the FDA issued an emergency use authorization for a vaccine.

In other words, if the experimental vaccine doesn’t work, the FDA anticipates experimenting by adding an adjuvant, also not safety and efficacy tested. Some doctors and scientists have suggested that adjuvants in vaccines may be responsible for many of the side effects, including Autism, experienced after vaccination through what has been described as “brain fire”.

Adjuvants are chemical added to vaccines that “rev up” the body’s immune system response to the virus in the vaccine. This “revving up” of the brain and central nervous system of developing children has been suggested as a possible cause of the skyrocketing numbers of vaccine injuries.

Two companies, GlaxoSmithKline and Novartis, are applying for approval for vaccines that contain oil-in-water adjuvants. The NIH is also conducting a trial of an adjuvant-enhanced vaccine. The panel's consumer representative said if the FDA does issue an emergency use authorization for an adjuvanted vaccine, she would prefer as little adjuvant as possible to avoid side effects.

Another panelist, Theodore Eickhoff, MD, an infectious disease specialist at the University of Colorado, said adjuvanted flu vaccines have been used for a decade in Europe and have not been shown to harm vulnerable populations, such as children.

"I don't want FDA . . . to walk away from this meeting thinking we're all scared of adjuvanted vaccines," Dr. Eickhoff said. "Some of us are. I'm not. I'm delighted the options are there."

The government has already purchased a supply of 120 million adjuvant doses that it will add to its antigen supply if it there is a shortage of the vaccine, or if the standard versions are shown to be ineffective. The panel did not reach consensus on whether patients should receive one or two doses. Once trial data becomes available, it will be more apparent whether doses given 21 days apart are superior to a single dose, members indicated.

The committee agreed that pregnant women should be immunized, but did not recommend inoculation of babies under six months old. The chairman of the committee, a pediatrician, said the FDA might want to prepare for an infant vaccination program if surveillance data indicate a wider pandemic than expected. "I don't think it would be a bad idea to have a game plan to immunize babies under six months in case of emergency," said John Modlin, MD, a pediatrician at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

Any emergency plan to immunize babies would seem to contradict the statements in the FDA announcement that it didn't specify a study protocol for babies less than six months, because such studies will have to be designed to evaluate the entire series of infant vaccinations.

FDA officials also told the panel that vaccine manufactures are getting only one-third as much antigen from the pandemic H1N1 strain as they normally get from the seasonal flu virus. That might mean vaccine makers won't be able to make as many doses as they planned.

The CDC's Advisory Committee on Immunization Practices will meet in Atlanta next week to vote on which populations should be vaccinated first, among other issues.

It is this author’s opinion that compelling safety and immunogenicity (efficacy) should be of paramount importance prior to injecting hundreds of millions of people with this new, unproven chemical.

Clinical trials involving 400 participants (4 arms of 100 patients each) are woefully inadequate to insure safety and efficacy.

Adding adjuvant to flu vaccines without any long term studies on the possible harmful effects under an “emergency use authorization” is misguided and dangerous.

And most importantly, we must question the wisdom of putting hundreds of millions of people at risk by use of an experimental vaccine in order to possibly prevent what amounts to a bad cold, which is rarely life threatening or fatal.

Final Tally on Food Drive

We received 1269 pounds of food. and $70 cash. That is 10% of what the USPS donated in their recent food drive.

Interesting facts:
that is more than 1/2 ton
5 baby elephants
2 full grown dolphins
a male full grown alligator
a full grown quarter horse
or a Geo Metro!

When converting it to oreo's that 3,384,003 oreo's. Which equals 88,818.983 feet or 83 1/2 Effile towers :) or 59.9 Sears tower's (oops sorry Willis Tower's)!

Thank you to everyone who participated.

More from our food drive

Here are a few more pictures from our recent food drive. You can see more at His Harvest Stand.

Some of the food

This is the first section of food from our recent food drive as you enter our office.

Food drive 2009

I would like to thank everyone who participated in our 6th annual food drive for His Harvest Stand in Zeeland. We have not calculated the final count but I think this was our most successful food drive yet. This is a difficult time for them as many do not think if giving this time of year. With the kids home from school there is often more need. We feel blessed to have such wonderful practice members that allow us the opportunity to practice in this manner. When I have the final count on food I will post to share with everyone.

Is Tylenol killing you?

Some days I am completely amazed at how far behind mainstream media can be. For years we have known Acetaminophen (Tylenol) is very damaging to the body. A study which came out approximately 10 years ago said it was the #1 reason for admittance to the hospital for acute kidney failure. Two days ago this report was on MSNBC.

Visit msnbc.com for Breaking News, World News, and News about the Economy

If Tylenol is part of your morning "vitamin" routine you need to give us a call at 616.772.9255 or visit our website by clicking here.

Balanced Health Chiropractic Center
West Michigan's only NUCCA chiropractic office