Christmas Break..


So another year comes to a close, and in January I’ll be blogging about this crazy stuff  for 11 years straight- that’s a long time!

Anyhow..

In the new year it will be interesting to see what the serious fraud office in the UK has to say about GSK’s long history of fraudulent activity, but I won’t hold my breath considering that the House of Lords in the UK are nearly all in the pocket of the pharmaceutical industry!

And don’t get me started on the rest…

I really hope that closure comes next year though, as this stuff can be tiring, however it does help to write (it’s cathartic), and someone has to hold those evil Glaxo-folks to account don’t they?

Happy Christmas 🙂

 

 

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Paxil/Seroxat And Birth Defects…


What this article fails to mention is that in the original Paroxetine (Paxil/Seroxat) clinical trials done by Glaxo it indicated that baby rat pups were dying when their pregnant mothers were fed paroxetine…

Yet despite this knowledge- Glaxo marketed Paxil/Seroxat directly to pregnant mothers regardless.

‘Attempted Corporate Manslaughter’ is the phrase I would use here..

http://theprovince.com/opinion/op-ed/jenna-wong-and-robyn-tamblyn-its-time-we-fixed-our-system-of-drug-surveillance

Jenna Wong and Robyn Tamblyn: It’s time we fixed our system of drug surveillance

Faith Gibson, with her daughter Meah, 11, who was born with a hole in her heart, fought a nine-year battle with U.K. pharmaceutical firm Glaxo SmithKline, along with other moms who took the drug Paxil during pregnancy, which resulted in their kids suffering heart defects. They’re part of a group who have reached a $6.2-million, class-action settlement with Glaxo SmithKline.

Mark van Manen / PNG

If you take prescription medications, what conditions do you take them for? Are they working for you? Have you experienced any negative side-effects from them?

It may surprise you to know that answers to these critical health questions aren’t well-documented for most Canadians. Yet the answers would provide the crucial information needed to ensure our medications are safe and worth taking after they’ve been approved for use.

Before prescription drugs are approved in Canada, they’re tested under controlled conditions on relatively small numbers of patients (several hundred to several thousand) with selective characteristics (patients of certain ages, races, ethnic groups or genders). But once medications are approved, they aren’t monitored as closely as they should be.

We need to significantly improve our system of post-market surveillance for prescription drugs in Canada to make sure we are continually monitoring their safety and effectiveness in real-world settings.

Why?

First, adverse drug reactions may surface that weren’t previously detected in smaller pre-regulatory trials. Recall the unfortunate case of 15-year-old Vanessa Young. who was taking cisapride for her gastrointestinal symptoms and died after suffering a heart arrhythmia — a life-threatening side-effect of the drug that surfaced only after it was released onto the market.

Second, the use of a drug may broaden over time to include milder forms of the disease or even different medical conditions that weren’t assessed during the drug’s pre-market trials. Take antidepressants, for example. These medications are being increasingly used for conditions other than depression. New research has found that nearly one in three antidepressant prescriptions are written for unapproved (“off-label”) conditions — most of which aren’t backed by sufficient evidence.

To adequately monitor the safety and effectiveness of medications in real-world settings, we need a timely, post-market, drug-surveillance system that can identify the reasons why patients are taking their medications and follow patients to detect adverse drug reactions and determine if their medications are working.

How are we doing so far? Not great.

Identifying the reason for drug use

The medical reasons for prescriptions aren’t often explicitly documented in patient charts, nor is this information required for patients to fill prescriptions or receive reimbursement for drugs. So, when it comes to drugs like antidepressants that can be prescribed for different medical conditions, not knowing why a patient is taking a drug creates major challenges for assessing the drug’s effectiveness and appropriateness of use (i.e., whether the use is backed by regulatory approval or scientific evidence).

Detecting adverse drug reactions

Canada’s Adverse Drug Reaction Reporting System has many flaws, including the fact that it relies upon voluntary reporting by physicians via a reporting process that is time-consuming and outside of routine procedures. In fact, it’s estimated that less than five per cent of all adverse drug reactions are reported to Health Canada.

Tracking medication effectiveness

Once drugs are released onto the market, their real-world effectiveness isn’t systematically monitored. It’s troubling to know that we currently have no large-scale mechanisms in place to track whether patients are experiencing the anticipated benefits from their medications.

So, what’s the solution?

We need a national, post-market, drug-surveillance system that mandates the systematic collection of data on the reasons for drug use, adverse drug reactions and effectiveness, and governs the use of health-information technologies to collect these data.

Health-information technologies offer the chance to seamlessly collect such data as part of the care process and even enhance patient care. For example, electronic prescribing systems could prompt physicians to record the reason for treatment when drugs are prescribed and alert doctors to potential prescribing errors or present alternative treatment options when prescriptions aren’t evidence-based.

When prescriptions are cancelled, renewed or modified, electronic medical record systems could prompt physicians to record details about adverse drug reactions and effectiveness, which would also ensure that details about a patient’s treatment history and experiences with past therapies are documented.

Many Canadian provinces have implemented centralized drug-information systems to track all medications that patients are receiving. If these systems are to contribute toward an effective, post-market, drug-surveillance system, they need to additionally collect information on the reasons why medications are being prescribed and the outcomes that they produce.

Medications can be life-saving. But they’re only as good as our knowledge about them. It’s time we stepped up our game and kept better track of our experiences with medications. 

Jenna Wong will begin a post-doctoral research fellowship in the department of population medicine at Harvard Medical School beginning in 2018. Robyn Tamblyn is an expert adviser with EvidenceNetwork.ca and James McGill is a professor in the departments of medicine and epidemiology, biostatistics and occupational health at McGill University in Montreal.


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New Post From Bob Fiddaman Blows The Lid On The Gates Foundation And Its Dodgy Links To GSK…


Well worth a read..

Great post Fid.

https://fiddaman.blogspot.ie/2017/12/british-medicines-watchdog-announce-new.html

 

Monday, December 11, 2017

British Medicines Watchdog Announce New Partnership

http://www.facebook.com/plugins/like.php?href=https://fiddaman.blogspot.ie/2017/12/british-medicines-watchdog-announce-new.html&send=false&layout=standard&show_faces=false&width=450&action=like&font=arial&colorscheme=light&height=35

First off, watch the short announcement from the MHRA’s CEO, Dr. Ian Hudson.

He looks almost apologetic, don’t you think? Either that or he is embarrassed?

Before taking his role as CEO of the British Medicines Watchdog (MHRA), Hudson was the agency’s licensing director, responsible for the majority of its medicines licensing activities. Prior to that, he was the World Safety Officer for GlaxoSmithKline. He can be seen here defending Paxil, also known as Seroxat, (under oath) during a one-hour video deposition that was aired during the Tobin Vs GlaxoSmithKline case. A case which saw the Jury return a verdict against GlaxoSmithKline and, indeed, Paxil. (Fig 1)

Fig 1
 
 
Who Are The Gates Foundation?
Better known as the Bill & Melinda Gates Foundation, it was launched in 2000 and one of its primary aims is to “enhance healthcare and reduce extreme poverty.”
What Are They Currently Involved In?
Well, aside from teaming up with the MHRA and having a say on the safety monitoring of medicines in low and middle-income countries, they are also embroiled in serious issues regarding a vaccine study they sponsored that was carried out in India in 2009.
Bill and Melinda’s foundation funded the Program for Appropriate Technology in Health (PATH) to carry out the studies in which 5 young girls died after receiving the Human Papilloma Virus (HPV) vaccine, Gardasil, manufactured by Merck.
According to The India Times, “…consent for conducting these studies, in many cases, was taken from the hostel wardens, which was a flagrant violation of norms. In many other cases, thumbprint impressions of their poor and illiterate parents were duly affixed onto the consent form. The children also had no idea about the nature of the disease or the vaccine “
In 2015, Judges in India’s Supreme Court demanded answers regarding the violations. An investigation carried out by the British newspaper, The Daily Mail, found that “children as young as nine suffered side-effects after being used as unwitting human guinea pigs for the new drug.”
The Daily Mail adds:

An investigation by an Indian parliamentary committee had previously concluded that the trials amounted to a serious breach of trust and medical ethics amounting to child abuse and ‘a clear cut violation of the human rights of these girl children and adolescents’.

The committee’s report said it had been established that clinical trials of the vaccines had been carried out ‘under the pretext of an observation/demonstration project’ in violation of all laws and regulations laid down by the government for such trials.

GSK is also embroiled in the controversy. Shortly after the Gardasil debacle, two more deaths were reported from Vadodara, Gujarat, where tribal children were also vaccinated with another brand of HPV vaccine, GSK’s Cervarix.
Earlier this year, things got so bad that India’s health ministry decided to take over funding responsibility for the immunization program backed by the Bill & Melinda Gates Foundation. The reason? “A possible conflict of interest arising from the foundation’s tied to pharmaceutical companies.” (Business Standard)
MHRA
So now, we seem to have gone full circle with today’s MHRA announcement from Dr. Ian Hudson, who claims…

“We are delighted to be involved in such an important global initiative. New drugs and vaccines are being brought to the market for the first time in public health programmes in settings where the safety monitoring and regulatory systems need strengthening. The expertise we can bring to the project will help national safety monitoring centres identify risks and benefits early and take appropriate regulatory action to support global health.”

So, let’s get this straight. Bill and Melinda Gates funded an immunization program in India. That program kills a number of children and the protocol was found to be ‘a clear-cut violation of the human rights of children’. Next, Ian Hudson, the former World Safety Officer at GSK, announces that Bill and Melinda Gates will be teaming up with the MHRA to strengthen “the safety monitoring and regulatory systems.”
Someone pinch me.
If this hasn’t got you thinking outside of the box, ladies, and gentlemen, then maybe this will?
An article published in 2012 entitled, ‘The Gates Foundation connection to the Glaxo drug fraud scandal’, is a fascinating read. It highlights, amongst many things, that Tachi Yamada, former head of global health for the Bill & Melinda Gates Foundation was formerly the head of research and development for GSK.
Yamada, while he was head of global health for the Gates Foundation, was accused in a U.S. Senate hearing of bullying a scientist to not publish negative findings of a GSK diabetes drug called Avandia. The same drug that Glaxo failed to report important data to the FDA showing that it increased heart risks in patients by 43%. Despite agreeing to a misdemeanour count in 2012, GSK still maintains “the civil settlement is not an admission of any liability or wrongdoing in the selling and marketing of Avandia.” However, they agreed to pay $3 billion imposed on them by The Department of Justice for failure to report Avandia safety data.
I’m sure Ian Hudson knows of the links between GSK and the Gates Foundation. Probably why his announcement (in the video at the top of this post) looks like it’s being delivered by someone who has soiled his underpants. Either that or he has become nauseous after being trapped in the incestuous revolving door at the MHRA!
Bob Fiddaman

This Is Also Why We Blog..


“…My girlfriend died from a brain aneurysm after taking Seroxat for several years. I think the medication may have caused the aneurysm, but there’s no way of proving it really….”

 

The comment above was left on a recent post I wrote about Seroxat. I titled the post: ‘Just Another Paroxetine/Seroxat related death.

Seroxat caused nosebleeds regularly for me. My nose would literally gush blood – often for up to an hour- therefore it would not surprise me if Seroxat caused a fatal brain aneurysm in this man’s girlfriend.

GSK will never admit that Seroxat could cause this- of course, and they know that it’s difficult to prove these deaths. However we (the users) know that Seroxat causes all sorts of horrific side effects ; some of them not even being documented medically at all. How frightening is that?

The damage from Seroxat/Paxil- world-wide has been staggering. The human collateral has been horrific..

GSK don’t care about all this death, damage and destruction from Seroxat/Paxil..

I do..

And this is why I blog..

 

 

Australia Sues GSK Over Misleading Marketing Of Pain Gels…


So now GSK have moved some of their unethical marketing practices down under it seems..

Investigated for 4 years over Seroxat harming kids in the UK, and a an ongoing serious fraud office investigation there too (and accusations of fraud in several middle eastern countries and eastern European ones)- not to mention being fined 500 dollars in the biggest bribery scandal in China in 2014, and also their 2012 fine of 3 Billion in the US (biggest health care fraud of the time) it seems that GSK has now turned to the countries of the southern hemisphere to continue its fraudulent practices?…

Fair play to Australia for not tolerating GSK’s nefarious conduct..

https://economictimes.indiatimes.com/news/international/business/australia-takes-gsk-novartis-to-court-over-misleading-claims/articleshow/61941800.cms

https://www.ft.com/content/841831d6-da33-11e7-a039-c64b1c09b482

Australia sues GSK and Novartis over ‘misleading’ marketing Watchdog takes local units to court in crackdown on pharmaceutical sector

Australia’s consumer watchdog is taking the Australian subsidiaries of GlaxoSmithKline and Novartis to court over alleged false or misleading marketing of their pain relief gels. The action is part of a crackdown on “misleading representations” across the pharmaceutical sector by the Australian Competition and Consumer Commission. Last year Reckitt Benckiser, the UK consumer goods group, was fined a record A$6m by an Australian court for making misleading claims about Nurofen, the pain relief drug.

 

The ACCC’s case against GSK and Novartis centres on what it alleges are “false or misleading representations” claims in the marketing of Voltaren Osteo Gel and Voltaren Emulgel pain relief products. It alleges the companies marketed Osteo Gel as specifically formulated for treating osteoarthritis conditions and more effective than Emulgel, when the products had identical formulations. “We allege that consumers are likely to have been misled into purchasing Osteo Gel thinking that it is different to Emulgel and more effective for treating osteoarthritis conditions, when this is not the case,” said Rod Sims, ACCC chairman. The ACCC found that Osteo Gel was “sold at a significant price premium to Emulgel”, and alleges that the companies engaged in a deliberate commercial strategy to differentiate the products in a manner to mislead consumers. In price sampling at supermarkets and pharmacies, the ACCC found that Osteo Gel cost as much as 33 per cent more than Emulgel.

“The alleged conduct is particularly concerning, given the significant penalties handed down by the court against the makers of Nurofen for what we consider to be similar conduct,” said Mr Sims. Last year the ACCC successfully sued Reckitt Benckiser for misleading consumers over Nurofen’s painkilling effects, in a legal case and penalty that represented a blow to pharma groups that use branding and marketing to increase sales of medicines. Days after the Australian court ruling, the British Advertising Standards Authority began its own investigation into the marketing of Nurofen in the UK. GSK said it was disappointed by the ACCC legal action.

“Our intention in marketing certain products around symptoms is to help consumers choose a product containing an appropriate active ingredient for their condition from the vast array of options available,” it said in a statement.

“In response to new guidance from the ACCC around expectations of industry regulators and consumers, we proactively made changes” to the packaging of Voltaren Osteo Gel to make it clearer that the formulation is the same as Voltaren Emulgel, GSK added. “We continue to co-operate with the ACCC.” GSK acquired Novartis’s Voltaren products in 2016 and has since been responsible for marketing and selling the products. Novartis said it was aware of the proceedings but directed queries to GSK. “As the ACCC has stated, in 2016 GSK acquired Novartis’s portfolio of Voltaren products and has been responsible for marketing and selling Voltaren products since that time,” Novartis said. The ACCC is seeking declarations, injunctions, pecuniary penalties, a publication order, a compliance programme and costs against the companies.

 

More News On GSK’s Tafenoquine…


 http://www.townsvillebulletin.com.au/news/dr-seeks-review-into-ruling-about-antimalarial-drugs/news-story/a307634087a4ce9348ff85dac451a662
Dr Jane Quinn has done research into antimalarials drug like mefloquine.
Dr Jane Quinn has done research into antimalarials drug like mefloquine.

Dr seeks review into ruling about antimalarial drugs

AN INDEPENDENT statutory body will review a Repatriation Medical Authority ruling that there is insufficient evidence controversial antimalarial drugs cause chronic brain injury.

 

The Federal Government’s Specialist Medical Review Council has confirmed it has been asked to review the RMA’s August ruling against establishing Statements of Principles (SoPs) in respect of “chemically acquired brain injury caused by mefloquine, tafenoquine or primaquine”.

SoPs are used in determining claims for liability for injuries, diseases and deaths under federal legislation.

Neuroscientist Dr Jane Quinn applied for the council review, which must be made within three months of an RMA decision.

Dr Quinn said she sought the review as she felt the original RMA investigation was “fundamentally flawed”.

“The way the original investigation had been worded made it very difficult for evidence to be provided,” she said.

“If SoPs can be established, it provides an avenue for people to be recognised, compensated and treated for a condition they believe they have.”

Mefloquine has been banned for use by soldiers in Germany and the US Army Special Operations Command.

It is also a drug of last resort in Australia, the US, UK and most recently Canada. Tafenoquine, which has been trialled on Defence personnel, is yet to be approved by the Therapeutic Goods Administration.

The two drugs and primaquine were given to Australian soldiers in a number of trials between 1999 and 2002.

The medications have been the subject of claims from veterans that they are linked to acquired brain injuries and chronic mental illness.

Last month, Anthony Cole, a former Irish army sergeant, sued the State in the High Court of Ireland as a result of lasting side effects he claimed to have suffered from taking mefloquine.

British newspaper The Sunday Times reported on Sunday that Mr Cole received a “significant payment” but there was no admission of liability, and the settlement involved withdrawing any claim relating to the Defence Force’s choice of mefloquine as the antimalarial drug for soldiers.

Mr Cole reportedly did not withdraw his claim that the drug had caused long-term psychological damage.

Dr Quinn said the Irish case set a legal precedent.

“If we’re having people have claims accepted for the DVA equivalent in America and now there has been the successful court ruling in Ireland, it would be a very sensible approach to use the instruments the Australian Government has to provide people with appropriate treatment and care rather than go down the path of litigation,” Dr Quinn said.

For advice on the preparation of written submissions contact the Council Secretariat on 3223 8840, or via the website http://www.smrc.gov.au.