Rotarix rotavirus vaccine contaminated, officials say

(CNN) -- Federal health authorities recommended Monday that doctors suspend using Rotarix, one of two vaccines licensed in the United States against rotavirus, saying the vaccine is contaminated with material from a pig virus.


http://www.cnn.com/2010/HEALTH/03/22/rotavirus.vaccine/

"There is no evidence at this time that this material poses a safety risk," Food and Drug Administration Commissioner Dr. Margaret Hamburg told reporters in a conference call.

Rotarix, made by GlaxoSmithKline, was approved by the FDA in 2008. The contaminant material is DNA from porcine circovirus 1, a virus from pigs that is not known to cause disease in humans or animals, Hamburg said.

About 1 million children in the United States and about 30 million worldwide have gotten Rotarix vaccine, she said.

Rotavirus disease kills more than 500,000 infants around the world each year, primarily in low- and middle-income countries, she said. Before rotavirus vaccine became available, the disease was blamed for more than 50,000 hospitalizations and several dozen deaths per year in the United States, she said.

The FDA learned about the contamination after an academic research team using a novel technique to look for viruses in a range of vaccines found the material in GlaxoSmithKline's product and told the company, Hamburg said. The drug maker confirmed its presence in both the cell bank and the seed from which the vaccine is derived, suggesting its presence from the early stages of vaccine development, she said. The FDA then confirmed the drug maker's findings.

GlaxoSmithKline emphasized Monday that the pig virus is not known to cause illness in humans, saying "it is found in everyday meat products and is frequently eaten with no resulting disease or illness."

"No safety issue has been identified by external agencies or GSK," Thomas Breuer, the drug maker's chief medical officer, said in a written statement. "GSK is committed to patient safety and to the highest manufacturing standards for all our vaccines and medicines. We are already working closely and discussing this finding with regulatory agencies around the world."

Another vaccine, RotaTeq, is made by Merck and was approved in 2006. There is no evidence that the Merck product is affected, Hamburg said. Both vaccines are given by mouth to infants to prevent rotavirus disease, which is marked by severe diarrhea and dehydration.

Asked whether Merck would be able to meet the nation's demand, Merck spokeswoman Pam Eisele said, "Obviously, we will work with the ... FDA to evaluate supply needs."

In the next four to six weeks, the drug agency will convene an advisory committee to make recommendations and seek input on the use of new techniques for identifying viruses in vaccine, Hamburg said.

"We're not pulling it from the market, we're just suspending its use during this period while we're collecting more information," she said. "It should not be in this vaccine product and we want to understand how it got there. It's not an easy call and we spent many long hours debating the pros and cons but, because we have an alternative product and because the background rates of this disease are not so severe in this country, we felt that the judicious thing to do was to take a pause, to really ask the critical questions about what this material was doing in the vaccine, how it got there."

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said "a substantial amount" of the DNA was found in the vaccine. But, he stressed, "there is no evidence that it causes any disease. ... There is no evidence that it ever does anything."

The research group that discovered the contamination has asked not to be identified pending its paper's publication in a scientific journal, Hamburg said.

Anyone who has already received a dose of Rotarix should switch to the Merck product for the next two doses, Hamburg said. Preliminary testing of the Merck product has found no evidence of the porcine circovirus 1 DNA, she said. Doctors should be able to tell parents which of the two products their children received, she said.

Hamburg stressed that the suspension applies only to the United States. Public health officials in countries where the incidence of rotavirus is more severe may decide that the benefits of continuing to use the vaccine outweigh any concerns raised by the contamination, she said. "Such a decision would be very understandable," she added.

A similar virus, porcine circovirus 2, also does not cause disease in humans, but it does cause disease in its pig host, Hamburg said.

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An Unwelcome Third Wheel: Patient Vaccination Without Doctor Authorization

1N1 and seasonal influenza vaccines are now being given to sick hospital patients with or without their doctor’s consent. This is being done despite there being no data on the safety of doing so.

http://www.medicalvoices.org/vaccination/articles/vaccination-without-doctor-approval-in-a-us-hospital.html

I am a licensed, board-certified nephrologist, otherwise known as a kidney specialist, working in a large, city-based hospital. Because I rarely admit patients to the hospital other than for specific procedures, such as a kidney biopsy, I only recently became aware of my hospital’s policy regarding flu shots for sick people. Waking up to this new rule made me realize that Big Pharma is getting closer and closer to bypassing doctors completely to deliver direct patient “care”.

doctor1We have an elaborate electronic charting system at our hospital. All of the medications and procedure orders are placed into the patient’s record by doctors and nurses so that every person has access to all that is happening with the patient. A few weeks ago, I arrived to see my first patient of the day, a patient with a kidney ailment that leaks protein and usually progresses to complete kidney shutdown. When I opened her electronic chart, I expected my section to be empty. Instead, I saw an order for an influenza vaccine with my name on it. Even more shocking was that the order was highlighted bright blue, meaning, the shot had already been given. I thought perhaps I had opened the wrong chart or some sort of mistake had been made. But it was the right file; her name in the upper left hand corner. And my electronic signature was on the page after the order. My patient, with kidney failure and an autoimmune disorder had been given a flu shot without my consent.

I was informed that according to a hospital policy that had been in effect since 2007, a pharmacist is permitted to visit a patient and offer them a flu vaccine. If the patient agrees, the RN is instructed to administer the shot and document the event in the chart. The attending physician’s signature stamp is used to complete the order. No one called to ask, “By the way, your patient wants a flu shot; can we give her one?” I’m not sure what was said to her, but she obviously agreed, and I didn’t need to be involved. The pharmacist had written an order for an injectable substance that I considered toxic and inappropriate for my patient, and it was administered by the RN before I even got to the floor.

My dissatisfaction eventually made it to the Chief of Internal Medicine who challenged me to produce peer-reviewed journal articles in support of my objection. There were dozens of case reports of kidney disease or small blood vessel inflammation following influenza vaccination. In fact, one paper cited 16 patients in its written report(1). Under-reporting of adverse vaccine reactions is a known phenomenon. The National Vaccine Information Center estimates that only about two percent of adverse vaccine reactions ever get reported. It would follow that written and published case reports found in medical journals represent a miniscule sampling of the totality of vaccine injury cases. These implications should evoke at least some curiosity on the part of doctors and health care advocates.

The peer-reviewed literature was delivered to the department head. His initial response was to suggest that future vaccination orders be signed off by another physician so I didn’t have to be involved with the process of a nurse giving a “routine” flu shot. But the point had been missed; flu shots should not be given to sick patients.

I was challenging “routine orders” that had been in place since 2007. The defense for supporting the policy was that no side effects had been reported since the standing order had been instituted. I wondered to myself and then later inquired: How do you know that is true? Is it because nobody filed a formal report? If a patient became more ill after the shot, did you consider his condition to be a side effect of the vaccine, or was it simply called an unfortunate complication to the patient’s current illness? What if the patient was discharged from the hospital but readmitted several weeks later. Was the reason logged simply as a progression of his existing disease…or was the cause an overlooked, delayed side effect of the vaccination? If vaccine reactions are not considered as part of a patient’s differential diagnosis, how do you know? Without taking a vaccine history when considering a timeline of events, how could anybody possibly make the connection between a vaccine and a subsequent illness? How does anyone else know for that matter – that there were no side effects from the “routine” administration of flu shots, ordered by a pharmacist and given by a nurse, without doctor consent? The truth is, there is no real tracking and reporting system in place. And nobody is enthused about trying to start one. What has essentially happened is that the guards have all been told to go home and nobody is thinking to even look for the wolf.

I am sure there are thousands of unreported cases of kidney failure – and a wide range of other serious health conditions – because doctors fail to ask a very simple question as part of the admission evaluation: “When was your last vaccine?” And few doctors suspect any connection because the party line screams, “Vaccines are safe, effective and harmless. They keep people healthy and prevent infection.” If nobody looks, vaccine-related side effects and complications won’t be found.

There was a law passed in 1986, the National Vaccine Injury Compensation Act, that made vaccine manufacturers and administering physicians immune from legal recourse in the event of a vaccine injury. This has given manufacturers a dangerously long leash and has enabled them to push vaccines through FDA approval with little need to create a safe product. Now drug companies have extended their reach into the hospital right past doctors, and put the power to vaccinate in the hands of pharmacists and executive committees, allowing them to make decisions about what is best for a patient.

For years, I have suspected that vaccines affect the immune system in an unnatural way. Those who are trained in the sciences should know this has to be true. For starters, the partial and temporary effect of a vaccination is significantly different than the precise and long-lasting cellular responses that come from a natural infection. Vaccines contain more viral and bacterial particles than what we are told; there are known allowable contaminants in vaccine cultures and in vaccine vials(2). The solutions also contain heavy metals, carcinogenic chemicals and toxic preservatives. Vaccine-induced antibodies can become “confused”. They can then adhere or deposit in small blood vessels and the kidney filters called glomeruli, causing inflammation and degeneration, known as an “autoimmune response”; the person’s own antibodies attack and destroy the body. The incidence of autoimmune disease has sharply increased in recent years, and I believe that vaccines have played a role. That is why it has never made sense to me to vaccinate anyone, let alone someone who is sick--- but especially someone already sick with an autoimmune disease. While patients who are immunocompromised may be at a disadvantage when faced with infectious pathogens, giving them a flu shot with toxic chemicals cannot, in my estimation, possibly protect them. Moreover, it is known that elderly patients and those who are losing protein in the urine don’t necessarily mount a strong or protective response to flu vaccine injections. Despite these facts, the CDC and various medical organizations still recommend injecting sick, elderly patients with flu vaccines.

There is no scientific basis for this. Vaccine research is conducted on healthy people. Vaccine research does not include double blind placebo studies; rather they use a false placebo which is often the prior years’ flu vaccine. Once a vaccine is approved for general use, the shot is routinely given to everyone. Case reports (1, 3-7) support the notion that it is highly possible that an unhealthy person could develop an exacerbation of an underlying kidney disease or that a healthy person could develop a new kidney disease after a vaccine. It should be common sense that patients who are sick and have advanced kidney disease are much more vulnerable to the 25 micrograms of mercury in multi-dose flu vaccines than healthy persons with normal kidney function.

Doctors take note: You are not in control anymore. Your patients can be harmed by vaccines that you have not ordered-- while your back is turned.

Patients: Be vigilant and ask questions. Big Pharma has dozed past another barrier and now its reach has expanded past your doctor and right into your hospital room. Propaganda about vaccines and the flu will be posted around the hospital. If ever there was a time to become highly suspicious of the motives in the world of hospitals and pharmaceutical business, it is now. Take these suggestions to heart:

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When somebody other than your doctor enters your hospital room and offers you anything, even if they tell you the doctor ordered it, do not believe that you must accept it without first talking to the doctor in charge of your care. You have a right to know why you are being injected and what the risks are.
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If there is ever a good time to get a vaccine, it is not while you are sick. Please consider both sides of the vaccination debate before agreeing to one. You won’t be given a fact sheet with balanced pros and cons by a conventional medical doctor or by the hospital.
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You have the right to refuse any drug, any shot and any intervention at any time, as long as you are psychologically competent.

Mine is only one story, but it represents things to come with the corporate takeover of medicine and the massive push for vaccines. It has been insidious but it is now showing up everywhere: In the schools, in Wal-Mart, in the mainstream press. The doctor-patient relationship is no longer valued or honored. Guidelines, recommendations and one-size-fits-all treatment programs of all comers for the sake of profit are the real driving forces. Our “health care system” has little to do with health. Even the word “health” has been mutated and twisted to represent some distorted picture that looks more like desperation for survival than thriving vitality. Health care centers that vaccinate with complete disregard for the truth about what they are actually doing to people, are not delivering a sound product that can be trusted and relied upon by those who hope to have their health guarded and restored.



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Middle school investigates flu shot

http://www.signonsandiego.com/news/2010/jan/25/middle-school-investigates-flu-shot/

SAN YSIDRO — The San Ysidro School District is investigating how a 13-year-old middle school student received the H1N1 flu vaccination last week over her objections and against the will of her parents.

Jose Gomez, 39, said he signed a form last November stating his daughter, a student at San Ysidro Middle School, was not to get a shot and reaffirmed that position to two people last week. The school provided vaccinations on Thursday.

District Nurse Anita Gillchrest said she investigated the incident and has forwarded a report to Superintendent Manuel Paul, but she said she could not reveal the details.

Gomez said San Ysidro Middle School officials insisted he sign a consent form even though he did not want his daughter to receive the vaccination. He said he was instructed to write “refuse” on the form and turn it in, which he did.

Nonetheless, his daughter was pulled from class to get the vaccination. She advised the security guard who escorted her to the vaccination area that she was not supposed to get the shot and was told that maybe “her mom changed her mind,” Gomez said.

The girl also told the woman providing the vaccines from the county health department that she was not supposed to receive the shot, Gomez said.

“According to their safety guidelines, if any child said ‘No,’ they were supposed to contact the parent,” Gomez said. “My daughter said no and they didn’t bother to contact me or my wife.”

Gomez said he did not want his daughter to receive the vaccination because he did not know what the solution contained and because his youngest daughter has allergic reactions to vaccinations.

“I didn’t want to risk it,” Gomez said. “Everyone gives you a different story about this vaccine and it’s scary.”

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"Student advised the security guard who escorted her to the vaccination area that she was not supposed to get the shot, but was vaccinated anyway...."

You don't really think you have a choice do you people? The GOV could give a fuck less what you want for your children..........that's why we have to fight them and chase them from their positions of power!


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Swine flu was as elusive as WMD. The real threat is mad scientist syndrome

Remember the warnings of 65,000 dead? Health chiefs should admit they were wrong – yet again – about a global pandemic

http://www.guardian.co.uk/commentisfree/2010/jan/14/swine-flu-elusive-as-wmd

Let me recap. Six months ago I reviewed the latest bit of terrorism to emerge from the government's Cobra bunker, courtesy of Alan Johnson, home secretary. Swine flu was allegedly ravaging the nation. The BBC was intoning nightly statistics on what "could" happen as "the deadly virus" took hold. The chief medical officer, Sir Liam Donaldson, bandied about any figure that came into his head, settling on "65,000 could die", peaking at 350 corpses a day.

Donaldson knew exactly what would happen. The media went berserk. The World Health Organisation declared a "six-level alert" so as to "prepare the world for an imminent attack". The happy-go-lucky virologist, John Oxford, said half the population could be infected, and that his lowest estimate was 6,000 dead.

The "Andromeda strain" was stalking the earth, and its first victims were clearly scientists. Drugs were frantically stockpiled and key workers identified as vital to be saved for humanity's future. Cobra alerted the army. Morgues were told to stand ready. The Green party blamed intensive pig farming. The Guardian listed "the top 10 plague books".

If anyone dared question this drivel, they were dismissed by Donaldson as "extremists". When people started reporting swine flu to be even milder than ordinary flu, he accused them of complacency and told them to "wait for next winter". He was already buying 32m masks and spending more than £1bn on Tamiflu and vaccines. Surgeries refused entry to those with flu symptoms, referring them to a government "hotline" where prescription drugs were ordered to be made available without examination or doctor's note. Who knows how many died of undiagnosed illness as a result? Lines were instantly jammed. It was pure, systematic government-induced panic – in which I accept that the media played its joyful part.

This week the authorities admitted that, far from a winter upturn in swine flu, there has been a slump. From 100,000 a week at the peak, there were just 12,000 last week. After the coldest winter for decades, when deaths might be expected to rise, the rate is below that of seasonal flu. In the UK, 360 people have died under its influence, most with prior "non-flu" conditions. Swine flu is not nice – I have had it – but bears no ­relation to the government hysteria.

I accept that anyone can make a mistake, and authority has some duty to err on the side of caution. As Alastair Campbell implied on Tuesday, Iraq might have had weapons of mass destruction, so Blair was right to go to war just in case. But it is reasonable to ask, as the Chilcot inquiry is doing, why precaution on such a colossal and potentially ­destructive scale was justified when those who questioned the need for it have since been proved right. Is anyone asking about flu?

Swine flu is not the first time we have suffered this nonsense. I have a stack of predictions by senior scientists on BSE/CJD in 1995. It would "lead to 136,000 deaths" – a spurious exactitude used to convey plausibility – and "could infect up to 10 million Britons". This led to an obscene £5bn campaign of cattle destruction and compensation. When the prediction proved wildly wrong, the government excused itself with a classic Rumsfeld-ism: "The absence of evidence is not the evidence of absence."

This was followed by Sars 2003, a "panic gripping the world". The World Health Organisation declared that "One in four Britons could die". The medical doom-monger, Dr Patrick Dixon, said that Sars had "a 25% chance of killing tens of millions", whatever that meant. The madcap Tory health spokesman, Liam Fox, demanded the arrest and quarantining of all recent travellers from Asia, including 30,000 Asian students.

In the event, some 800 people died with Sars worldwide, against 21,000 who died in Britain in the seasonal flu epidemic of 1999/2000.

Undaunted, within a year the same alarmists were at work on avian flu. With now habitual hyperbole, Donaldson predicted 50,000 deaths, with "an upper limit", graciously conceded, of 750,000. When one dead swan slumped on a beach in Scotland, BBC reporters went crazy as inspectors stumbled through the seaweed, clad in anti-nuclear armour. Within a year the horror had passed. The global mortality was put at 262, with not one death in Britain. Another fiasco was brushed under the carpet.

The Blair government, and now Brown's, have proved adept at using scare politics to divert attention from other troubles. During foot-and-mouth Blair was quick to don a yellow jumpsuit for photographers and intone as if he alone stood between an illness (that is in fact harmless to humans) and armageddon. This time the swine flu coincided with two other "mystery diseases", MRSA and C-difficile, which killed 10,000 Britons in 2007 alone. But those deaths lay squarely at the doors of unclean NHS hospitals. Hence there were no scary stories or predictions about them from Donaldson.

Donaldson and his eager virologists will doubtless stick loyally to their predictions since it is "too early to be complacent". His allies at the BBC did their bit on Wednesday with a Horizon programme that turned a serious study of virology into grotesque scaremongering, with solemn music and voices crying, "there's no escape", "this could take a devilish turn", and "we don't even know how many viruses there are!" Children writhed in agony from smallpox.

Mad scientist syndrome is rampant. Had these scares been disseminated by a private firm, a local authority or a newspaper (as was anti-MMR), they would be damned from on high with demands that heads roll. As it is, the government's Scientific Advisory Group for Emergencies sails gaily on, still graced by the presence of Sir Roy Anderson, who ­happens also to draw a six-figure salary as a non-executive director of GlaxoSmithKline, which made hundreds of millions from the government's panic. Anderson, and GSK, vigorously deny any conflict of interest.

The Council of Europe's head of health, Wolfgang Wodarg, is one of the few who have dared blow the whistle on the links between "Big Pharma" and national and ­supranational agencies. He this week persuaded the council to stage a debate on the "enormous gains" made by GSK and others from the swine flu pandemic. He seeks details of relations between the companies and the WHO, given that stockpile contracts kick in the moment that ­organisation uses the word "pandemic". It did so for the first time last year, with reckless alacrity.

I am not aware of the WHO or the General Medical Council or any of the medical colleges investigating these matters, or any check on conflicts of interest of government doctors who work for drugs companies. I am not aware of any Whitehall or Commons committee, any National Audit Office or competition inquiry into the supply of these drugs. All I know is that a huge amount of health money, time and effort was last year diverted from possibly critical therapies into what looked from the start to be yet more terror virology.

This is why people are ever more sceptical of scientists. Why should they believe what "experts" say when they can be so wrong and with such impunity? Weapons of mass destruction, lethal viruses, nuclear radiation, global warming … why should we believe a word of it? And it is a short step from don't believe to don't care.

They played on our fears "To quote Al Gore" Big Pharma was a huge supporter of Barrack Hussein Obama during his campaign if you remember so it stands to reason that he would repay their contributions by created pandemic. They do what they always do, crank up the fear to get the public to fall in line then dismiss any criticism as extremist or tin foil hat wearing folk and conspiracy cooks!

The notion of using scare tactics to divert attention away from other things like oh lets see, pushing through an unpopular healthcare bill that the people do not want, falling popularity in the polls, scandal about a birth certificate, corruption within the administration, shouldn't suprise anyone here should it. Happens all the time - false flags, invented crisis', or the never ending ability to exploit a natural catastrophe for the same political gain and ruse.
Funny thing is that the people, at least here in the USA aren't buying it and there is an excess of leftover vaccines. Quite frankly the public either doesn't trust the government, or have been educated enough through the alternative media outlets online to the scam being perpetrated for profit, the false pandemic and the dangers of the vaccine.

Expect them to rachet up the hype in the coming months to try to con the rest of us to be vaccinated!

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