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Big pharma mobilising patients in battle over drugs trials data


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The pharmaceutical industry has “mobilised” an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.

Drugs companies publish only a fraction of their results and keep much of the information to themselves, but regulators want to ban the practice. If companies published all of their clinical trials data, independent scientists could reanalyse their results and check companies’ claims about the safety and efficacy of drugs.

Under proposals being thrashed out in Europe, drugs companies would be compelled to release all of their data, including results that show drugs do not work or cause dangerous side-effects.

While some companies have agreed to share data more freely, the industry has broadly resisted the moves. The latest strategy shows how patient groups – many of which receive some or all of their funding from drugs companies – have been brought into the battle.

The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and outlined in a memo to senior industry figures this month, according to an email seen by the Guardian.

The memo, from Richard Bergström, director general of EFPIA, went to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and many smaller companies. It was leaked by a drugs company employee.

The email describes a four-pronged campaign that starts with “mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data”. Translated, that means patient groups go into bat for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare.

The lobbying is targeted at Europe where the European Medicines Agency (EMA) wants to publish all of the clinical study reports that companies have filed, and where negotiations around the clinical trials directive could force drug companies to publish all clinical trial results in a public database.

“Some who oppose full disclosure of data fear that publishing the information could reveal trade secrets, put patient privacy at risk, and be distorted by scientists’ own conflicts of interest. While many of the concerns are valid, critics say they can be addressed, and that openness is far more important for patient safety.”

Tim Reed, of Health Action International, a group that has previously exposed the pharmaceutical industry’s financial links with patient groups, said: “It’s incredibly ironic that this is a transparency initiative and we’ve now got clear indications that the pharmaceutical industry is ready to use patient organisations to fight their corner.

“It underlines the fact that patient groups who are in the pay of the pharmaceutical industry will go into battle for them. There’s a hidden agenda here. The patient groups will say they think it’s a great idea to keep clinical trials data secret. Why would they do that? They would do that because they are fronts for the pharmaceutical industry.

“Patient groups get traction because they are assumed to represent the voice of the suffering. But industry uses them to say we’re not going to get innovative medicines if the industry is deterred from investing by having to be transparent about their clinical trials,” he added.

A recent review of medical research estimated that only half of all clinical trials were published in full, and that positive results were twice as likely to be published than negative ones.

A source in the European parliament, who is close to the negotiations over the clinical trials directive, said he had experienced intense lobbying from patient groups. “We’ve witnessed this sort of activity in recent months, and it’s a concern if the pharmaceutical industry is behind some of it. They are trying to weaken some of the transparency proposals and that’s clear from the amount of lobbying we’ve had,” he said.

The patient groups focus on the concern that if companies release all of their clinical trials data, the information might be misconstrued, or intentionally cherry-picked, and spark damaging health scares around certain drugs or vaccines.

“These aren’t completely unfounded concerns, but the risk already exists, and those things already happen. The answer is to have a responsible scientific community that can counteract the allegations and claims,” the source said.

Two other strands of the campaign include discussions with scientific associations about the risks of data sharing, and work with other businesses that are concerned about the release of trade secrets and confidential data. The final strand calls, in the long term, for a network of academics across Europe that can be called on to correct false interpretations of the data. “That is deemed to be happening in any case,” the memo concedes.

In response to queries from the Guardian, GSK said: “This is not something we are doing. One of the reasons we’re involved in this is we want more companies to move towards greater transparency. I don’t think it’s for us to be mobilising patient groups to campaign on a negative level.”

A Roche spokesperson said the company consulted patient groups to understand their concerns about clinical trials, but “to our knowledge Roche has not been involved in any EFPIA’s potential activity in mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data”.

A Lilly spokesman said: “Lilly is committed to working with Europe-based patient advocacy organisations for the benefit of patients in a way that is true to the EFPIA code of practice and Lilly’s integrity in business policy.”

Individuals who received the memo at several other companies, including AstraZeneca and Novartis, did not respond.

Tracey Brown, director of the campaign group, Sense about Science, and co-founder of AllTrials, a campaign to get all clinical trials registered and all results reported, said: “We now have the prospect of really significant developments to end the secrecy and make clinical trial reporting a practical reality and, finally, some sound commitments from parts of industry.

“In this context, the industry associations’ strategy to get others to raise further spurious problems is backward. It should embarrass anyone associated with it. I would say to the individual companies that they should publicly distance themselves from any association with EFPIA and PhRMA’s strategy now,” she said.

The EFPIA told the Guardian it had been working with PhRMA on a “commitment to enhance sharing of clinical data” to researchers and the public, and intended to make an announcement this week.

“Knowing that some people want all data to be made available to everyone, EFPIA is engaging with stakeholders to share concerns with harmful ‘re-use’ of data. We will engage not only with patient groups, but also with the scientific community,” it said.

Matt Bennett, senior vice-president of PhRMA, said in a statement: “EMA’s proposed policies on clinical trial information raise numerous concerns for patients. We believe it is important to engage with all stakeholders in the clinical trial ecosystem, including the patients who volunteer to participate in clinical trials, about the issue.

“If enacted, the proposals could risk patient privacy, lead to fewer clinical trials, and result in fewer new medicines to meet patient needs and improve health.”

via Big pharma mobilising patients in battle over drugs trials data | Business | The Guardian.

Sweden: A Cautionary Tale About Vaccines


In 2009, the swine flu hit Europe in pandemic levels.

The countries rushed to acquire a vaccine called Pandemrix, made by GlaxoSmithKline in the UK.

The vaccine had been fast-tracked for use due to the human swine flu crisis.

One wealthy nation, Sweden, snapped up a large amount of the Pandemrix vaccine and launched a nationwide campaign, eventually vaccinating 59% of the population against the swine flu.

This may sound familiar — the vaccine was promoted by national health organizations, the main stream news, schools, workplaces and on television to encourage everyone to get the jab.

800 children across Europe diagnosed with incurable neurological disorder

A few months later a strange medical trend developed.

Medical professionals began seeing case after case of children suffering from narcolepsy.

And these children had one thing in common: they had been injected with the Pandemrix vaccine.

More than 800 children across Europe have been diagnosed with this incurable neurological disorder and the evidence is overwhelming in the implication of the vaccine.

The drug contained squalene which was used as an adjuvant.

Squalene is the most likely culprit in the vaccine. (Source)

The Tragic Story of Emelie

One young girl, Emelie Olsson, has had her life forever devastated as a result of narcolepsy, the onset of which occurred after receiving the swine flu vaccine in 2009.

The 14 year old girl has had her life devastated.

She cannot sleep at night.

When she does sleep, she is plagued with nightmares and hallucinations, sometimes waking more than 70 times in the night.

Sometimes when she wakens she is completely paralyzed and unable to breathe well or call out for help.

During the day, she can hardly keep her eyes open because of the lack of sleep.

If she laughs she has something called a cataplexy — when a strong emotion causes sudden muscle weakness that leaves her unable to stand.

When Emelie tries to have fun with friends, the happiness, literally, causes her to collapse to the ground.

She said in an interview:

”I can’t laugh or joke about with my friends anymore, because when I do I get cataplexies and collapse.

I can not laugh anymore and it makes me very, very sad.

It is the worst of all.”

Can you honestly imagine, as a parent, an adult or a human being, having to warn a child — “Stop that!  Don’t laugh!!!!”

But Emelie’s mother has to do just that.

In an interview, Marie Olsson expressed terrible guilt and regret.   (translated from Swedish)

“Yes, I feel guilty.

We are parents supposed to protect our children and instead I have asked Emelie take this vaccination, which has made her so sick.

If I had read on better and questioned more then maybe she had not been vaccinated themselves.

Before then, Emelie had been healthy.”

Emelie, age 14, must now take stimulants during the day, narcotic sleep aids at night and medications that stabilise her emotions so that she can feel neither sadness or joy.

She must take these medications for the rest of her life.

Emelie’s struggle is outlined in the documentary “After the Syringe.”

Lest the pro-vaccine crown think that Emelie’s story is merely anecdotal, there is enough evidence to support claims that GSK’s toxic concoction caused the 800 reported cases of narcolepsy to convince experts like Emmanuel Mignot, of Stanford University, who one of the world’s leading experts on narcolepsy.

”There’s no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries — and probably in most countries.”

Europe’s regulatory board, the European Medicines Agency, has now directed that the vaccine should not be given to anyone under the age of 20.

One public health official in Sweden has gone on the record stating that things should have been different.

Goran Stiernstedt, the director for health and social care at the Swedish Association of Local Authorities and Regions, was at the helm of the vaccination campaign across Sweden.

He estimates the vaccine may have saved the lives of 30-60 people, but now over 200 recipients suffer from narcolepsy. (source)

“The big question is was it worth it?

And retrospectively I have to say it was not…

This is a medical tragedy…

Hundreds of young people have had their lives almost destroyed.”

Some experts say the risk is still worthwhile.

David Salisbury, the UK’s director of immunization, seems to think that the quality of life of 800 children is a small price to pay.

He told Reuters:

“In the event of a severe pandemic, the risk of death is far higher than the risk of narcolepsy.

If we spent longer developing and testing the vaccine on very large numbers of people and waited to see whether any of them developed narcolepsy, much of the population might be dead.”

Salisbury, of course, is neck-deep in his involvement with the very ethically questionable World Health Organization.

He has served as the Chairman of WGO Strategic Advisory Group of Experts (SAGE) on vaccines, and as a member of WHO’s Global Advisory Committee on Vaccine Safety.

He is the Co-chairman of the Influenza Pandemic Preparedness Group for the Global Health Security Action Group of G7 countries.

Indeed, his pro-vaccine interest in the “greater good” far outweighs his concern about the risks to children like Emelie.

No Responsibility Taken

No one seems willing to take responsibility for the lifelong damages suffered by these children.

Sweden gave GSK indemnity when they purchased the drug, which means that those affected by the vaccine cannot ask for damages from the manufacturer.

To receive compensation, the state is asking parents to

”…forever renounce the right to ask anyone to account in court for what has happened.

The condition has no counterpart in any other type of insurance, and only have the task of protecting drug manufacturers from lawsuits.”

Margareta Eriksson, President of Narcolepsy Association, responded:   (translated from Swedish: source)

We can never write such a thing.

We parents requiring instead that:

The state clearly take responsibility for our children’s future, and ensure that our children receive full compensation for economic losses without limiting insurance.

All the vaccine itself and then got narcolepsy should be entitled to compensation — without having to fight for it against the insurer.

The state ran a vaccination campaign that gave our children a life-long severe illness.

Now, the state must also take responsibility for the consequences.  (Source)

Still Pushing Vaccines

One health official in Norway has called the Pandermix tragedy a medical catastrophe.

“Narcolepsy following Pandemrix [vaccination] was completely unexpected and surprising, and a catastrophe.

Preben Aavitsland, who was responsible for monitoring contagious diseases at Norway’s Institute of Public Health in 2009 when the Swine Flu hit, cited studies in Finland, Sweden and here.

He told NRK these concluded that children given the Pandemrix vaccine had a 10 times-higher risk of developing narcolepsy than adults, calculations he states that Norwegian experts had not carried out. ” (Source)

Despite these statistics, there is still a push for the influenza vaccine in the Scandinavian countries.

“The Institute of Public Health declares the current flu vaccine is not the same as the Pandemrix vaccine and urges that those in risk groups such as those over the age of 65 or suffering from other health problems consider vaccination.” (Source)

What Can We Learn from This?

There are a few take-home lessons from this tale:

First of all, something vastly under-tested was brought to the market.

That vaccine was not merely made available, it was pushed, promoted and practically forced on people using a campaign of fear and guilt.

Children have been forever damaged by this vaccine.

No one wants to take financial responsibility for a life sentence of mental suffering, expensive daily medications and serious health issues.

Officials know these things are true but want you to continue to be vaccinated (and have your children vaccinated) anyway.

This story is a cautionary tale.

It tells us (and simply reaffirms for many of us) that we cannot accept anything that Big Pharma and their cohorts at the FDA and the CDC tell us.

If they lied to people in Europe can we really think they are telling us the truth in the United States and Canada?

We cannot accept what the media tells us at face value — who do you think sponsors the news programs?

Pay attention to the ads — you’ll see commercials for over the counter medications, SSRI antidepressants and other Big Pharma goodies interspersed throughout.

Whether the goal is to line their own pockets, to control the masses or to depopulate, this illustrates that our children are seen as nothing more than human laboratory animals.

These medications that are brought to market and all but forced on us are just a big science experiment.

The mind control and brainwashing by the mainstream culture is a psychological game, convincing people that it’s all for their own good.

You can turn on the TV right now and flip through a few channels and see the identical agenda at work in North America, where nearly every newscast mentions at least once during the 30 minute program, where, how or why you should rush out, roll up your sleeve, and get your flu shot.

What happened in Sweden is a direct example of what is going on, RIGHT NOW, across the western world, regarding the flu shot.

The tragedy that has afflicted these families could easily occur here.

If you can’t see the correlation between the two, your eyes and mind are willfully closed.

Don’t be fooled.

Don’t be brainwashed.

Don’t end up like Emelie and her parents.

via Vaccines Autism — Flu Swine Flu Children — Vitamin D3 — Robert Kennedy.

via Vaccines Autism — Flu Swine Flu Children — Vitamin D3 — Robert Kennedy.

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