EU Takes Emergency Measures Over Glaxo’s ‘Flu Vaccine – Causes Narcolepsy in Children

GlaxoSmithKline’s ‘Flu vaccine causes four-fold increase of cases of narcolepsy in children and adolescents (below 20 years of age) who received Pandemrix compared with unvaccinated people  of the same age according to preliminary results of the Swedish registry study from October 2009 to December 2010 on Pandemrix.  

Clearly this vaccine was not properly tested, like many other childhood vaccines.

Full Text of EMEA news release 15 April 2011 below.  Download links below to French and Swedish agencies’ reports on the narcolepsy problem.

And do vaccines cause autistic conditions? If you read nothing else we strongly recommend you read this: PDF Download – Text of email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkisson

We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.

Despite all the lies and deceit by health official worldwide, the question “do vaccines cause autism” was answered when the Hannah  Poling story broke in the USA [see CHS article here].  Hannah developed an autistic condition after 9 vaccines administered the same day.  Under the media spotlight numerous US health officials and agencies conceded on broadcast US nationwide TV news from CBS and CNN. In the US Federal Court children have been compensated after findings they developed autism and other injuries. Full details with links to the original sources can be found in this CHS article: Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines. [Blue Text added 10 April 2011]

_____________________________

News Release

European Medicines Agency recommends interim measures for Pandemrix – 15/04/2011

Updated prescribing advice highlights preliminary results from epidemiological studies on narcolepsy; further research needed

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Pandemrix should be amended to advise prescribers to take into account preliminary results from epidemiological studies on Pandemrix and narcolepsy, and to perform an individual benefit-risk assessment when considering the use of Pandemrix in children and adolescents. This is an interim measure pending the outcome of the European review, expected to conclude in July 2011.

The CHMP reviewed all available data, including new findings from Sweden and France on the suspected link between narcolepsy in children and adolescents and Pandemrix. The CHMP concluded that, following the earlier results of an epidemiological study from Finland, the new evidence strengthened the signal in children and adolescents, but that the data had methodological limitations. The relationship between Pandemrix and narcolepsy is still under investigation.

Preliminary results of the Swedish registry study from October 2009 to December 2010 on Pandemrix vaccination and the risk of narcolepsy indicates a four-fold increase of cases of narcolepsy in children and adolescents (below 20 years of age) who received Pandemrix compared with unvaccinated people of the same age. The additional risk corresponds to an additional 3-4 narcolepsy cases per 100,000 vaccinated subjects. These results are broadly in line with the study results from Finland indicating an association between Pandemrix and narcolepsy in children and adolescents. The study did not identify any increased risk in adults. The CHMP concluded that the study was well conducted, although it has inherent limitations.

An analysis of narcolepsy reports in France provides some further evidence.

The lack of a clear increase in reports of narcolepsy following Pandemrix in other EU and non-EU countries may point towards the influence of other unknown factors affecting the trend seen in some countries. Also, there is currently no clearly identified biological plausibility for an association between Pandemrix and narcolepsy, and further non-clinical studies, especially in the juvenile setting, are needed.

The CHMP considers it important to gather more data on the use of Pandemrix and related vaccines in a variety of countries to further assess this concern. A variety of research efforts are now ongoing. These include an epidemiological study of narcolepsy and pandemic vaccines conducted by the European Centre for Disease Prevention and Control (ECDC) through a network of research and public health institutions (VAESCO) in nine European Union Member States, and an epidemiological study conducted by Glaxo Smith Kline (the marketing authorisation holder of Pandemrix) in Canada. Preliminary results of the VAESCO study and of the Canadian study are expected by July 2011.

The CHMP is working with experts from across the EU to assess the possible safety concern and any impact on the benefit-risk balance of Pandemrix. The CHMP plans to hold an expert meeting with participation of international experts, the World Health Organization (WHO) and ECDC.

The European Medicines Agency will provide updates as new information becomes available.

Notes

  • The exact wording to be included in the Pandemrix product information reads as follows:“Preliminary reports form epidemiological studies in two countries (Sweden and Finland) have indicated a 4-9-fold risk increase of narcolepsy in vaccinated as compared with unvaccinated children/adolescents, corresponding to an absolute risk increase of about three to four additional cases in 100 000 vaccinated subjects. This risk increase has not been found in adults (older than 20 years). Similar epidemiological studies have not yet been conducted in other countries.The relationship between Pandemrix and narcolepsy is still under investigation.When considering the use of Pandemrix in children and adolescents, an individual benefit risk assessment should be performed taking this information into account.”
  • Narcolepsy is a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly. Its precise cause is unknown, but it is generally considered to be triggered by a combination of genetic and environmental factors. Narcolepsy occurs naturally at a rate of around 1 case per 100,000 people every year.
  • Pandemrix, an (H1N1) v influenza vaccine, has been authorised since September 2009, and was used during the 2009 H1N1 influenza pandemic in at least 30.8 million Europeans.
  • The H1N1 influenza strain continues to be the predominant strain in this season.
  • The review of Pandemrix and the occurrence of cases of narcolepsy was initiated at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004, on 27 August 2010, following an increased number of reports on narcolepsy in Finland and Sweden. Related press releases dated 27 August 2010, 23 September 2011 and 18 February 2011 are available on the Agency’s website.
  • The report from the Swedish registry study can be found on the website of the Swedish Medicines Agency (MPA).
  • The report from the French observed expected study can be found on the website of the French Medicines Agency.
  • More information about the network of research, public-health institutions and regulatory agencies VAESCO, funded by the European Centre for Disease Prevention and Control, can be found on its website.

News Stories From Google

European Regulators: Weigh Potential Narcolepsy Risk of Glaxo’s Pandemrix

Wall Street Journal (blog) – Katherine Hobson – ‎14 hours ago‎
Since last August, European regulators have been investigating reports that GlaxoSmithKline’s H1N1 vaccine, Pandemrix — which isn’t approved for use in the US — may be tied to the sleeping disorder narcolepsy in some children and

EU agency flags narcolepsy risk on GSK flu shot

Reuters – ‎17 hours ago‎
By Ben Hirschler LONDON (Reuters) – European regulators have recommended changes to the product label for GlaxoSmithKline’s pandemic flu vaccine Pandemrix to highlight the potential risk of narcolepsy in children or adolescents.

EU Panel Recommends Pandemrix Product Information Be Amended

Wall Street Journal – Ian Walker – ‎21 hours ago‎
LONDON (Dow Jones)–The Committee for Medicinal Products for Human Use, or CHMP, said Friday it has recommended that the product information for Pandemrix (Influenza vaccine (H1N1)) (split virion, inactivated, adjuvanted), from GlaxoSmithKline

Glaxo Pandemic Flu Vaccine’s Narcolepsy Risk Highlighted

Fox Business – ‎19 hours ago‎
By Sten Stovall LONDON -(Dow Jones)- European regulators have recommended changes to the product label for GlaxoSmithKline PLC’s (GSK) pandemic flu vaccine Pandemrix to reflect a potential higher risk of the sleeping disorder narcolepsy in children or

European Medicines Agency Recommends Interim Measures For Pandemrix

Medical News Today (press release) – ‎20 hours ago‎
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Pandemrix should be amended to advise prescribers to take into account preliminary results from epidemiological


Amazing US News Report – Autism Strikes US Reporter Bob MacNeil’s Grandson After MMR & Other Vaccines

See the same old story of a mother describing how her child developed autism after 7 vaccines in one day – the MMR and other vaccines [like the Hannah Poling case – 9 vaccines in one day: US Government In US$20 million Legal Settlement For Vaccine Caused Autism Case]. 

What is different is that this video with transcript is about the grandson of a US reporter and is from his TV show – see Robert MacNeil’s Public Broadcasting Service show: Autism Now: Robert MacNeil Shares Grandson Nick’s Story – REPORT AIR DATE: April 18, 2011

STOP PRESS – View listen and read transcript of Part II – Tonight’s Show April 19 here:

Amazing US News Report – Part II – US Reporter Bob MacNeil – Autism more serious for US children than cancer, diabetes and AIDS combined.

Robert MacNeil, is co-founder of the PBS NewsHour. Until his retirement in October 1995, MacNeil was executive editor and co-anchor of The MacNeil/Lehrer NewsHour, a 20-year nightly partnership with Jim Lehrer on PBS.

And do vaccines cause autistic conditions? If you read nothing else we strongly recommend you read this: PDF Download – Text of email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkisson

We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.

Despite all the lies and deceit by health official worldwide, the question “do vaccines cause autism” was answered when the Hannah  Poling story broke in the USA [see CHS article here].  Hannah developed an autistic condition after 9 vaccines administered the same day.  Under the media spotlight numerous US health officials and agencies conceded on broadcast US nationwide TV news from CBS and CNN. In the US Federal Court children have been compensated after findings they developed autism and other injuries. Full details with links to the original sources can be found in this CHS article: Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines.

Transcript

ROBERT MACNEIL: In recent years, the diagnosis of autism has shown startling growth, now affecting one in 110 American children. For over two decades, parents desperate for answers and feeling slighted by the medical community have helped force to create services for their children, raise money for research and campaign for wider awareness of autism and for support from the government.

Today the picture is changing. Researchers now believe there is no simple genetic cause, that autism may involve multiple genetic pathways, and toxic materials in the environment may trigger the symptoms of autism. Autism once was considered only a brain disorder. Now, more doctors say it often involves serious physical illness.

And that’s our first story tonight. Frankly, I have a personal motive in telling it, because it’s about my grandson Nick, who is 6 and lives in Cambridge, Mass.

It’s not easy connecting with Nick. We live in different cities. All my grandchildren are a little shy when we first meet again. But Nick’s shyness is different.

One of the marks of autism is difficulty making eye contact and communicating, even with family members.

I’ve been a reporter on and off for 50 years, but I’ve never brought my family into a story, until Nick, because he moves me deeply. Also because I think his story can help people understand his form of autism and help me understand it better.

This was Nick when he was 9 months old, a healthy, alert and engaged baby with no apparent medical problems. Now at 6, my grandson seems like a different child, showing the classic symptoms of autism, a disorder in development, his difficulty connecting. Nick struggles with language, the rigidity and resistance to change Nick shares with other children with autism.

“I think pain in a child with autism is a very difficult thing to assess because a child with autism can’t vocalize that. He will very often not come to you and say, ‘I’ve got a bellyache.’ He can’t use those words.”

– Dr. Timothy Buie, Massachusetts General Hospital

NICK: Now go home.

ROBERT MACNEIL: A tendency to suddenly appear absent, to withdraw into an emotionally detached inner world of his own.

Those symptoms are characteristic of the autism spectrum — severe to mild — in Nick’s case, relatively mild. But beyond such mental difficulties, Nick has serious physical illness: in his digestive system, his mitochondria, the energy needed by his cells for normal activity, plus frequent small brain seizures, and extreme sensitivity to light and sound. How Nick was transformed from that healthy boy to Nick today is still devastating to his mother, my daughter Alison.

ALISON MACNEIL: When Nick was diagnosed, I actually hired a babysitter so that I could go sit in my car in a parking lot and cry because I couldn’t do it here with the kids.

ROBERT MACNEIL: Alison was trained as a psychiatric social worker, but like many parents, has made virtually a new career of caring for her son with autism.

ALISON MACNEIL: I remember one day I was sitting at the computer, and he was about 16 months old. And I caught out of the corner of my eye that he was spinning one of Neely’s doll’s plates. And I’d never seen a child play that way before — ever.

And I went in to interrupt him, and he wouldn’t stop. And there was an intensity about it. And I had this sinking feeling in the pit of my stomach, because I knew something was wrong.

ROBERT MACNEIL: That worry sent Alison to a developmental pediatrician who confirmed their fears: Nick had autism.

ALISON MACNEIL: Nick was irritable, crying, inconsolable and now is not on track developmentally at all. He’s gone backward.

So we went from a 15-month appointment where this child was A-OK, supposedly, and given the MMR, the DTaP and the Hib vaccines.

People say to me, Alison, it’s a coincidence. Alison, how do you know this happened? Well, it’s impossible for me to know. But what I will say is this: It was not a coincidence that my child was diagnosed with autism at the same time that his whole system shut down. Something happened to my child.

ROBERT MACNEIL: I understand Alison’s suspicion, but public health authorities say there is no scientifically valid evidence that vaccines cause autism. And Alison found little support from the developmental pediatrician.

ALISON MACNEIL: When I said to her this child has not had a formed bowel movement since the 15-month shots, she said children with autism have diarrhea.

When I said that he was crying inconsolably, she said this is part of autism. They can’t regulate their emotions. So it was all lumped under, “yes, we always see that with autism. It’s just autism.”

ROBERT MACNEIL: Nick’s complex problems demanded a broader view of autism. Some call it a new paradigm, or a systemic illness, or a whole-body experience. One of the leaders of that new thinking is Dr. Timothy Buie, a pediatric gastroenterologist at Massachusetts General Hospital.

DR. TIMOTHY BUIE, Massachusetts General Hospital: Six months ago, he was so lethargic and so out of it that he came into the office and literally laid on the chair for a 30- or 40-minute visit. He never moved.

He wouldn’t interact. He wouldn’t give you any eye contact whatsoever. And at the end of the appointment, Mom picked him up and took him out and went home.

ROBERT MACNEIL: Dr. Buie found changes in the lower GI tract he called lymphoid-nodular hyperplasia — inflammation and damage in his small intestine.

How does that affect the life of a child like Nick? For instance, does it give him pain?

DR. TIMOTHY BUIE: I think it can give pain. And I think pain in a child with autism is a very difficult thing to assess because a child with autism can’t vocalize that. He will very often not come to you and say, “I’ve got a bellyache.” He can’t use those words. So he may exhibit that as a child who doesn’t sleep well. He may exhibit that as a child who has a lot of increased agitation or hyperstimulatory-type behaviors.

And part of the problem with that is that we’ve accepted that those are behaviors that we often see in children with autism, and we’ve written it off to their autism. So it’s very difficult to think through whether that’s a marker for pain in some of those kids if we’re unwilling to look for other reasons.

(Nick laughs)

ALISON MACNEIL: You’re not leaving yet, come on. You’re going to come here. No.

DR. TIMOTHY BUIE: He’s looking remarkably better. He’s active. He’s happy. He’s playful. He’s turning off the lights, which some people would find to be a negative challenge. I don’t think so. I think that’s a child who’s testing. And I think it’s really interesting to see. And he walked right over happily, smiling, sat down — a much different child.

ROBERT MACNEIL: Do you think the medical community and your contact with it understands this wider definition of autism?

ALISON MACNEIL: Emphatically no. They can’t just refer these kids to early intervention and consider this a psychiatric or neuropsychiatric situation. They’ve got to stay involved and help the family get referrals for gastroenterology, to neurologists to look at whether or not there’s seizure activity.

ROBERT MACNEIL: From its lowest ebb two years ago, Nick’s condition has greatly improved as Alison found different doctors to diagnose and treat his other problems. But achieving even that level of progress, Nick’s autism is having a profound effect on the family. All of their lives ultimately revolve around his needs. Certainly, that’s how his 10-year-old sister, my granddaughter Neely, sees it. She’s in a different kind of pain.

NEELY: I just don’t like how autism affects the family. It just – it seems like it takes up too much time, and you usually get really bored of autism, because it’s in your life all the time.

ROBERT MACNEIL: What things would you do if you didn’t have a brother with autism?

NEELY: It just seems that a lot of money is spent on Nick’s vitamins and Nick’s doctors’ appointments and Nick’s everything, and it would change if we didn’t have to get all that stuff.

ROBERT MACNEIL: I see. Are you worried about Nick?

NEELY: Yes.

ROBERT MACNEIL: Tell me what you’re worried about, about him.

NEELY: Well, if he’s going to stay autistic for the rest of his life.

ROBERT MACNEIL: Yes. And what would that mean, if he were?

NEELY: I don’t know. It would get harder when he gets older, and there wouldn’t be as much services to help him. Sometimes I worry that he might get lost because he doesn’t really know what to do.

ROBERT MACNEIL: When you think about the future with Nick, what do you feel about that?

NEELY: Well, I hope that I — I hope that he doesn’t have to stay with me, kind of, and that I hope that he gets healed soon. Sometimes when other people, they — their lives seem perfect, and when yours — when yours — you have to do something that you don’t like, you don’t usually want to do it, and though your autistic sibling does, and it seems unfair. And it seems like they get what they want and you don’t.

ROBERT MACNEIL: Well, one of the things about life is that we all learn we have to do things we don’t want to do, whether there’s autism around or not.

NEELY: Yes, but it seems like it happens too much. I mean, there’s going to be a few times when that happens, but it seems with an autistic brother or sister, it always happens.

ALISON MACNEIL: I don’t know. I can’t take the autism out of her life. You know? We try to make things — you know, we try to do the best we can with it. But she’s right, you know. In some ways, this is really unfair.

I would have to say that every family living with an autistic child makes massive sacrifices in every way. It takes a phenomenal amount of teamwork. And I think Dave and I have been pleasantly surprised to find that it has brought out probably the best in us. It doesn’t leave a lot of energy left over.

ROBERT MACNEIL: Like the energy Nick’s father, Dave, expends every evening.

DAVE: Hey Nick. What do you want to do do?

NICK: Go on buses.

DAVE: In a little bit, sure. Can I get a high five?

NICK: We have to go on the 72.

DAVE: OK.

ROBERT MACNEIL: Nick loves to ride on buses.

NICK: We have to go on the bus.

DAVE: Yes, we might do that. We might go some other places, too.

NICK: After the 72 bus.

ROBERT MACNEIL: So every day after work as a senior account executive at a public-relations agency, Dave devotes 90 minutes to a bus outing that Nick yearns for all day.

NICK: 72 to Belmont.

DAVE: Yes, we can go on the Belmont if you want.

ROBERT MACNEIL: On our day there, we change Nick’s schedule so we can all go to the park before dark.

NICK: No. Go to Harvard Station.

ALISON MACNEIL: Yes, and you’re going to go to Harvard Station later with Dad.

NICK: After?

ALISON MACNEIL: After we’re done at the playground.

NICK: A bus ride?

ALISON MACNEIL: Yes, you’re going to have one with Dad.

NICK: Sad.

ALISON MACNEIL: I know you’re sad, sweat pea.

ROBERT MACNEIL: For exercise, they walk from their apartment the half mile to Harvard Square to wait, but not just for any bus.

NICK: We’re going to go on the 72 bus.

ROBERT MACNEIL: The 72 takes them on a 20-minute loop through Cambridge and back to Harvard Square for the walk home. But tonight the 72 doesn’t come and doesn’t come.

NICK: That’s the 71.

DAVE: Nope, that’s the 73.

ROBERT MACNEIL: The eager little boy scans each arriving bus as though it carries all his happiness. And still it doesn’t come.

DAVE: Want to go on the 73?

NICK: No.

ROBERT MACNEIL: After nearly an hour of waiting, looking sadder and sadder.

Nick, if the 72 doesn’t come, should we take another bus?

NICK: Another bus.

ROBERT MACNEIL: He’s persuaded with no tantrum to take another bus home.

Part of his improved physical condition has brought more patience, more tolerance for change.

DAVE: Alright, Nick. High five, bud.

ROBERT MACNEIL: We made a promised trip to the toy store.

So which one is Thomas?

Here you can see the disconnect between us.

Nick, which one is Thomas?

For me, the father of four children with four other grandchildren, seeking connection with Nick is a very poignant experience. To have a grandson who can tune me out or simply ignore me like this, make no eye contact for long stretches of time, gives me a strange and painful feeling.

ALISON MACNEIL: Say thank you to Grandpa.

NICK: Thank you to Grandpa.

ALISON MACNEIL: OK, there we go.

ROBERT MACNEIL: Thank you.

It warms my heart that Nick’s physical problems are improving, and I’m lost in admiration for the patience and courage Alison and Dave bring to his constant care. I see my daughter, like many autism mothers, not only perplexed but sometimes amused and always intrigued by what may be going on in her son’s mind.