8,000 Students Become Guinea Pigs for Unapproved Vaccine

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vaccinationDrug company Novartis stands to gain from Princeton meningitis outbreak. Action Alert!

As widely reported in mainstream media, the Princeton University meningitis outbreak has sparked an alliance between the drug company Novartis and government agencies. The FDA and the Centers for Disease Control and Prevention (CDC) have approved the importation of Novartis’s menengitis vaccine Bexsero into the US despite it not being FDA-approved.

They are doing this even though the Princeton outbreak is not an epidemic, as only seven students have been infected, everyone has recovered, and the disease is not expected to spread off-campus.

This is a breakthrough for Novartis, as Bexsero has struggled to gain acceptance. Although approved in Australia and Europe, it was rejected by the UK’s Joint Committee on Vaccination and Immunisation (JCVI). Drug companies must also prove to individual EU countries that a drug should be adopted.

What’s the real story here? How did a drug rejected by the UK become acceptable for an Ivy League University? Is it safe? Does it work? Could this be the newest drug added to the CDC’s controversial vaccine schedule? Who stands to win from Bexsero’s unexpected boon—and who stands to lose?

ANH-USA delved into the past of this benighted vaccine, and answered the questions that mainstream media ignored.

Princeton plans to recommend that all undergraduates and all graduate studies students who live in dormitories, as well as various “other members of the University community” (about 8,000 in total) receive the Bexsero vaccine. Vaccination will be voluntary, though it’s easy to conceive that there will be considerable pressure to vaccinate. If anything goes wrong, we wouldn’t want to be in the university’s shoes.

Despite the green light for Princeton, US approval has been delayed, as Novartis and FDA couldn’t agree on a “reliable surrogate for efficacy” for mandatory Phase III studies. Translation: many drugs are approved not because they’re shown to have an impact on “real life” outcomes, but because they’re shown to have an impact on a symptom—a surrogate for efficacy.

Please note that drug companies are permitted to negotiate which outcome the FDA bases its approval on—clearly, this should be determined by independent experts with no financial stake in the drug’s approval. Secondly, the fact that Novartis wanted to pick and choose which symptom the FDA would base its approval on doesn’t exactly inspire confidence in the vaccine’s real-life worth.

Novartis needs Bexsero to be approved, as it has pinned its hopes on new products like this to “save” not only its $7.5 billion vaccine division, but the entire company. This is due to the monumental revenue losses looming with the patent cliff we told you about recently: increasingly desperate drug companies are turning to their vaccine divisions to pick up the slack. Most likely, this means we’ll see more and more vaccines getting rammed through the flimsy FDA approval process—and then legally mandated for our children.

In addition, there’s something of a Big Pharma “arms race” going on: Novartis and Pfizer are competing to be the first to market an FDA-approved vaccine for the B strain of meningitis. Currently approved meningitis vaccines cover only strains A, C, Y and W-135. As thirty-seven states mandate meningitis vaccines for college students, the first drug to win approval will also gain a lucrative monopoly in a state-mandated vaccine. In other words, it’s clear that Novartis gains a big advantage from giving its vaccine to Princeton students.

If the drug is proven to safely protect students, Novartis should be rewarded. So the big question is: Is Bexsero safe and effective? No one knows, really.

In part, this is thanks to the rampant problem of publication bias: as we discussed in June, about half of all drug trials aren’t made publicly available, and positive findings are twice as likely to be published as negative findings for the same drug. So, while there have been at least two published studies to show that Bexsero is effective, it’s entirely possible that there are many other studies showing Bexsero to be unsafe and/or ineffective—and that Novartis is simply withholding this information.

This is not a farfetched possibility: in fact, this is exactly what happened with Tamiflu, the stockpiled flu drug that cost US taxpayers $1.5 billion. Roche Pharmaceuticals was accused of withholding data about its Tamiflu pill—data that suggested the drug was not as effective as had been reported. In fact, it may be no more effective than aspirin.

Even with the two publically available Phase III studies of Bexsero (the final step before approval), there are problems. The first study found that Bexsero increased rates of fevers in the infants (there were 3,630 infants studied), which understandably raised alarms with regulators and investors alike. The second study looked at 1,200 patients, and found that there was no increased rate of fever.

The difference? The second Novartis-sponsored study was open label, meaning that the researchers conducting the study knew who was getting Bexsero—leaving the study wide open to both unconscious bias and willful manipulation. With billions as stake, these are valid concerns.

With so many questions about the Bexsero vaccine, what can students do to keep well without it? Here’s a list of safe, natural preventative measures from former ANH-USA president Dr. Sherry Tenpenny:

  • Students should sleep more, eat healthier, and get mothe re fresh air.
  • Don’t share food, glasses, water bottles, or eating utensils.
  • Don’t share tissues or towels.
  • Don’t share lip-gloss or lipstick.
  • Wash hands often with soap and water.
  • If you have had close contact with a person who has had a fever and meningitis is suspected, a seven-day course of prophylactic antibiotics—given with a good quality probiotic—may be prudent.
  • The bacteria that cause meningococcal meningitis live in the back of the nose and throat and are carried by 10% to 25% of the population. Gargling or washing out the nasal passages with a Lugol’s solution (iodine) or colloidal silver using a neti pot is a good idea, but should be done only with professional advice. Taking 3000 to 6000 mg a day of vitamin C ascorbates, subject to bowel tolerance, and keeping your vitamin D level around 80 IU/ml (but not over 100), can both be very supportive of the immune system.

We would add that the single most important step to take in supplementing is to keep vitamin D levels up.

Of course, the larger problem with vaccines is that they are developed in government/industry “partnerships.” Post-approval, the government often refuses to study vaccines’ long-term safety record (perhaps this is due to the government’s significant financial and political investment in these dangerous drugs).

Action Alert! Tell the FDA and CDC to ask that the IOM to study all vaccine AERs! It is irresponsible for the FDA and CDC to freely permit mass-vaccination—particularly with unapproved, foreign drugs—without careful analysis of side effects and serious adverse events. It’s vital that the short and long-term impact of vaccines, particularly those mandated for K-12 and college students, be carefully studied by an independent, nongovernmental body. After all, it is our childrens’ welfare at stake. Please take action today!

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  • Evan Eberhardt

    8 cases in 6 months. More students will die from binge drinking. Ridiculous naked profit scam. Be sure your kids opt out of this evil.

  • You ought to be thankful there is a vaccine out there, even if not approved in the US.

    Europe is MUCH stricter about allowing medications/vaccines on the market.

    The saying in the country (US) is………..don’t take ANY medication till it’s been on the market for 5 years.

  • Too many untested vaccines that are untested, no long term studies, that include a myriad of chemicals with adverse side affects such as the swine flu shot and Gardisal and all the victims swept away. I’m currently mailing a Amicus Brief on behalf of a victim hoping to have her case over turned in the US Supreme Court who was injected with Lurpron and the thousands of victims swept away under the carpet. Big Pharma, Wall Street, and Federal Government, and the huge donations to congressional candidates and presidential campaigns as well as high powered lobbyists paid big bucks by Pharmas. In fact there are reports of huge bribes in some cases to doctors and judges. It’s an enormous problem and the Pharmas are over powering the grievances by the victims and activists seeking proper long term testing, public review, and justice.

  • IOM needs to study all vaccine AERs! It is irresponsible for the FDA and CDC to freely permit mass-vaccination—particularly with unapproved, foreign drugs—without careful analysis of side effects and serious adverse events. It’s vital that the short and long-term impact of vaccines, particularly those mandated for K-12 and college students, be carefully studied by an independent, nongovernmental body. If Novartis and members of the FDA and CDC are adamant about doing a human study and have all confidence in the outcome of this study, then I suggest they reach out to their own immediate and extended family members to participate in this study. If they are not willing to do this, then they should not be so quick as to use someone else’s family as their guinea pigs or lab rats.

  • Clinton Bashore

    Finally someone has recognized the value of probiotics and colloidal silver.

  • Robert Cruder

    The European Medicines Agency (The European version of the US Food and Drug Administration) approved Bexsero on 11/15/2012. Millions have been vaccinated and one would not call them “guinea pigs”.

    Bexsero is “investigational” in the U.S. due to the lower frequency of the B strain here. Novartis has not even asked the FDA to approve the vaccine for the United States, where vaccines for serogroups A, C, W, and Y Neisseria meningitides are already sold. Would they not have done so if greed was the sole motive?

    Although individuals of all ages can succumb to it, meningitis B takes a heavy toll on young children, especially infants. Up to 10% of children with the disease will die as a result, and up to 20% experience brain damage, lifelong learning disabilities, and hearing loss, according to the World Health Organization. Serogroup B is the most prevalent in first world countries (10 times more in the UK and Europe as in the U.S.) and Princeton has many foreign students.

    The CDC already recommends vaccination of children and students against the U.S. serotypes before they head off to college. Colleges recommend vaccination when on-campus transmission has occurred because failure to notify and to encourage vaccination exposes the school to suit for negligence.

    Princeton has experience with the U.S. serotypes which have lower mortality. It applied a standard policy under advice from the CDC and the New Jersey Department of Health. The only difference is that it had to import an un-stocked vaccine. Amanda Cohn, MD, a CDC medical officer and meningitis expert emphasizes that vaccination is VOLUNTARY and says “the kids getting the vaccine fully understand that it’s an investigational vaccine.”

    An unrelated outbreak of a different strain of serogroup B occurred in the same month at the University of California, Santa Barbara (UCSB). Administrator, Mary Ferris, MD says that the university has conferred with the CDC and other agencies about making the meningitis B vaccine available to its student body. UCSB plans to monitor the proposed vaccination program at Princeton.

    It appears that someone was so eager to throw rocks at Novartis that facts did not get in the way.

  • Lisa

    Say no to dope, legal license to kill?

  • Marten The Canadian Libertarian

    Ignorance is bliss…And the robber Elites insist on keeping you and the Human Herd as blissful as possible

  • Jeannette

    They want to make regulate and control vitamis, but they give our children an unapproved vaccine. The FDA in bed with “big pharma” once more. Parents should tell their children to reject this. Will the drug company assume responsibility if it is not safe — they did not on the flu vaccine that cause some to acquire Gian Beret (spelling) and end up paralayzed. Do we really trust the FDA and drug companies?

    • Margo

      Also, It scares me to death that all those young teenagers were given the “cancer vaccine”. I hope someone is keeping track for the next 10 yrs or so to see how many of them develop cancer. I’ll bet the percentage is higher than those who did not take it. I remember in the 1980’s they came out with a “cure” for breast cancer. It was on the news every 15min. What they didn’t tell you was that it caused ovarian cancer. Does it really matter if you die of breast cancer or ovarian cancer. Cancer can be cured naturally…..just do some research.

  • Kim Chamberlain

    I have been trying to sign your petitions and yahoo will intercept the post and say page is unavailable after .5 seconds. i am frusrtated by not being able to sign the p

  • C McDonald

    Seems yahoo has blocked me from taking action

    • C McDonald

      my proof …
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      • Hello: Thank you so much for bringing this to our attention! I’ll notify our tech team immediately. Thanks again!

    • Joan

      Glad you are sharing this because it all is very important to let be known. However why are you only suggesting 80 to 100 IUs of D? Its a known fact that during the winter months we tend to become deficient in vit D3 because of the lack of sun. We easily need more like 1,000 – 5,000 IUs a day just to make up what we would get when the sun is shining in the summer time. This being confirmed after getting tested myself to see how accurate the info is that I have seen and heard in many places,

      • Searching for answers

        Joan, please read carefully,
        The articles is listing 80 IU/ml, this is normally a possible result of a Vit D test of the D3 level in the body, not the D3 supplement quantity.
        Not easy to get to this level, D3 is fat soluble and requires taking with good fats to adequately absorb…

  • Iris Kerman

    We need to very carefully test any drug or vaccine, in this country, before approval for use in this country.

    It is my opinion there simply are too many vaccinations given to our children.

  • Frances

    FDA approved gives me no comfort. They approve to many drugs that should never be approved because to many on the board stand to make money from the approval.
    It concerns me more that there are counties in Europe that have refused approval. They seem to be much more careful about approval of drugs than the FDA does.

  • Warren R

    Even if a vaccine is “approved”, that doesn’t make it safe.
    As an RN, I exercise the right to refuse a mandatory yearly flu shot.

  • brad

    Do we have ANY information on the 7 cases? We do KNOW that meningitis comes from that GMO blight known as Gardasil. A form of meningitis was proven to cause swelling of the cerebrospinal fluids near the base of the spine by the University of Calgary if i recall correctly. No guarantee there, but it WAS proven that many of the headaches complained of by Gardasil victims IS this form of meningitis – and it has proven fatal there.

    Some young women going into college and believing the lies about Gardasil efficacy (proven to be nowhere near as effective as claimed, and the Merck “studies” showing this are misinterpreted) and the dangers of HPV infection being grossly exaggerated may be inclined to believe they are doing a good thing to become vaccinated with this 4-virus/yeast genetically modified product of recombinant dna procedures.

    I suggest that the meningitis scare at Princeton may be due to Gardasil vaccinations causing some of it’s (too frequent) memingitis symptoms. It is at least possible.