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(2) Thomas Reilly’s Damning Complaint Against GlaxoSmithKline… Why Did Andrew Witty Do Nothing?…Emails seem to reveal a culture of cover ups and malfeasance at GSK..


“….Former GlaxoSmithKline (GSK) pharmaceutical manufacturing quality control expert Cheryl Eckard Meads was presented the “Lifetime Achievement Award” at the 15th Annual Taxpayers Against Fraud Education Fund (TAFEF) Conference for exposing rampant fraud at GSK’s Cidra, Puerto Rico manufacturing plant and for her efforts to forge alliances between whistleblowers and attorneys…”


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It’s surreal to think in the same year of 2015- that Thomas Reilly was informing former GSK CEO, Andrew Witty, of the serious compliance and manufacturing malfunctions across GSK’s entire fleet of plants worldwide (a former GSK employee) Cheryl Eckard– was receiving an award for exposing GSK compliance breeches at GSK’s Cidra plant.

Did Glaxo learn nothing from Cidra?

Was the 750 million fine no deterrent for them?

It seems not.

Cidra’s compliance issues are the stuff of notoriety and are legendary in terms of unethical and dangerous pharmaceutical company behavior.

At GSK’s Cidra:

“...There was reason to believe that some of the medications were contaminated with bacteria, others were mislabeled, and some were too strong or not strong enough. It’s likely Glaxo would have gotten away with it had it not been for a company insider: a tip from Cheryl Eckard set off a major federal investigation….”


If Thomas Reilly is right, that GSK’s entire manufacturing systems are all potential Cidras, could that explain the dozens of recalls of GSK drugs over the years? (before, during and after Cidra)

I documented them here

If GSK CEO Andrew Witty was aware of these dangers to consumers, from potentially contaminated meds etc, why did he do nothing? why did he ignore Thomas Reilly’s pleas? (see my first post here)

In the following series of emails- taken from the publicly downloadable documents from Reilly’s case on Pacer, it seems that many in GSK are, and were, aware of GSK’s major manufacturing compliance issues. This is a public scandal of epic proportions. How many people are harmed, year upon year, from GSK’s compliance defects and contaminated drugs and products is anyone’s guess. Why are the MHRA or the FDA not doing anything about this scandal and danger to public heath?

 


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“Our values still very much remain at the core of GSK,” she added. “That is something we do not want to compromise on.”


“…And Glaxo intends to keep things similarly limited on the sales rep side, too; sales professionals will have to go through integrity training and compliance training “to even be eligible” for incentive-based compensation, Mullen said.

“Our values still very much remain at the core of GSK,” she added. “That is something we do not want to compromise on….”


Absurd article about a GSK executive trying to justify bribing doctors and then further making a fool of themselves by trying to convince us that GSK have, or had, any values.

Values?

The GSK corporate integrity agreement has barely lapsed and GSK intends to get back to these antics, which is basically legalized bribery. Bribing its reps with increased money to push the drugs harder.

This is exactly the kind of thing that leads to unethical behavior.

https://www.policymed.com/2012/07/glaxosmithkline-gsk-settlement-and-corporate-integrity-agreement.html


“….The five-year Corporate Integrity Agreement (CIA) includes novel provisions that require that GSK implement and/or maintain major changes to the way it does business, including changing the way its sales force is compensated to remove compensation based on sales goals for territories, one of the driving forces behind much of the conduct at issue in this matter.

Under the CIA, GSK is required to change its executive compensation program to permit the company to recoup annual bonuses and long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct. GSK may recoup monies from executives who are current employees and those who have left the company.  Among other things, the CIA also requires GSK to implement and maintain transparency in its research practices and publication policies and to follow specified policies in its contracts with various health care payors….”

“Our five-year integrity agreement with GlaxoSmithKline requires individual accountability of its board and executives,” said Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services. “For example, company executives may have to forfeit annual bonuses if they or their subordinates engage in significant misconduct, and sales agents are now being paid based on quality of service rather than sales targets.” 


Anyhow none of this is even relevant anymore considering that GSK’s entire manufacturing fleet is not fit for purpose!

Even if GSK does give incentives to its reps to increase sales, the meds themselves are coming from factories with an entirely defective operating system, which means that there’s the potential for any GSK product to be like a (dodgy) Cidra -like product!

See Whistle-Blower Thomas Reilly’s publicly available lawsuit documents here


 

 

 

 

(1) The Most Scandalous Case In Pharma: GSK’s Manufacturing Cover Up Puts Millions At Risk Of Harm.


(you can download the evidence from the publicly available site- Pacer- or from here – from Exhibit 25)Exhibit 25

There’s a case brewing in the US (that I have been following attentively), which I think could be one of the most scandalous cover-ups in Big Pharma history. The documents I am about to reveal (all publicly available and downloadable through the Pacer Website) are absolutely damning for GlaxoSmithKline. However the public must be warned because lives are at risk.

The case basically involves a whistle-blower called Thomas Reilly who has taken a  wrongful termination case against GSK. Reilly was head of GSK’s Global IT systems (the computer systems that run GSK’s product manufacturing globally). In 2015- When Reilly tried to warn the CEO at the time- Andrew Witty- that there are serious problems, Witty seemed to brush him off (see excerpts below). If Thomas Reilly’s allegations of serious problems with GSK’s manufacturing are true (and I have no reason to believe that they are untrue, particularly considering the dozens of recalls – that I have documented- of their various products- over the years) then this essentially means that no GSK product can be trusted to be safe.

It also means that many millions of people globally, are at risk, of ingesting either a defective, contaminated, or just shoddily produced GSK product at any time. We are all at risk here, because we all need drugs/treatments from time to time, due to illness or injury etc, and GSK are one of the biggest suppliers of Pharmaceuticals/consumer health products in the world. Even those who work for GSK are at risk (they take meds too), and their family/friends etc are at risk also- because due to their dodgy manufacturing/defunct IT processes within their global supply chain- we simply do not know if a GSK product is ever safe or not (for a long, but not extensive, list – of GSK recalls- see this link)

Read from Exhibit 25 (page 4) –  screen grab below.

Link here-

https://www.pacermonitor.com/public/case/21357104/REILLY_v_GLAXOSMITHKLINE,_LLC

And see how GSK’s Andrew Witty (CEO at the time- 2005) glibly and nonchalantly dismissed IT Expert (and GSK employee at the time) Thomas Reilly’s serious concerns about GSK’s global manufacturing/IT systems.

Bear in mind, that GSK have had many criminal investigations against them over the past decades, and that they have previously been fined (as a felon) in a 3 Billion lawsuit – instigated by the Department of Justice and Whistle-blower Greg Thorpe in 2012.

They were also fined in China in 2014 for similar damning corruption and fraud allegations.

GSK has a long history of breaking ethics/morals and harming consumers (see the Seroxat and Avandia debacles for a taste of how bad GSK treat users of their products).

We have no reason to trust them in any sense whatsoever.  They have given us absolutely no reason to trust them- ever.

I have documented many dozens of their recalls, from various products – ranging from asbestos contamination, to splinters in toothpaste. (see here)

how many cases like this of bad batches of drugs/products slip through oversight and go unreported? how bad are GSK’s manufacturing processes? and how many people get harmed from using GSK products without even realizing it?

How many Cidra‘s has GSK got?

And why are the authorities allowing them to operate?

(if any  journalists/whistle-blowers are interested in this scandal – please contact me by email)

I will cover more of these publicly available and downloadable documents over the coming days.

This is just the beginning of another GSK scandal; a scandal that illustrates how everyone (across the globe)is at risk of harm from a dodgy GSK product because of their defunct manufacturing cover up.

GSK is no stranger to scandal, and no stranger to harming people with dodgy meds, but the sheer scale of harm to consumers from this current massive cover-up is staggering.


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A Brave And Courageous Psychiatrist Speaks Out…


“….after trying to take his own life in 2004 as a result of severe withdrawal symptoms when he attempted to wean himself off Seroxat.“….

 

 

https://www.heraldscotland.com/news/17692699.psychiatrist-peter-gordon-claims-royal-college-gaslighted-him-in-antidepressant-row/?ref=twtrec

 

Psychiatrist Peter Gordon claims Royal College ‘gaslighted’ him in antidepressant row

Exclusive by Helen McArdle Health Correspondent

Psychiatrist Dr Peter Gordon at his Stirlingshire home (Pic Gordon Terris)

Exclusive

Psychiatrist Dr Peter Gordon at his Stirlingshire home (Pic Gordon Terris)

A PSYCHIATRIST said he was “gaslighted” by his own professional body after openly criticising its stance on antidepressant withdrawal and conflicts of interest.

Dr Peter Gordon, an experienced old age psychiatrist from Bridge of Allan, resigned from the Royal College of Psychiatrists Scotland in November last year.

In his resignation letter – which he subsequently published on his online blog – Dr Gordon criticised the College’s treatment of patients who had suffered “less than positive, and sometimes harmful, effects of psychiatric interventions including prescribed medications”.

Read more: Antidepressants – So there is a problem, but we still don’t know how big

He said the College was too close to the pharmaceutical industry, adding: “as a direct consequence informed consent and realistic psychiatry are compromised”.

Within days, however, Dr Gordon was shocked to learn that Dr John Crichton – the chairman of the College in Scotland and vice-president of its UK body – had contacted the medical director of NHS Lothian directly to raise concerns about Dr Gordon’s mental health.

Dr Gordon, 51, said: “I was quite distressed by that. I was not unwell. At that point I thought, ‘I’ve just had enough of how I’ve been treated by the Royal College of Psychiatrists for trying to raise ethics of good medical practice, patient safety’.

“We’re supposed to be encouraged to have freedom to speak up and put patients first. That’s all I’ve tried to do.

“I just felt like I had been gaslighted.”

The term ‘gaslighting’ refers to manipulation of someone into doubting their own sanity.

In emails seen by the Herald, Dr Crichton, a forensic psychiatrist and adviser to the Scottish Government, denies this claim and insisted he had genuine concerns for Dr Gordon’s welfare at the time.

Dr Gordon, who works at St John’s Hospital in West Lothian, has been an outspoken campaigner for greater transparency around antidepressants after trying to take his own life in 2004 as a result of severe withdrawal symptoms when he attempted to wean himself off Seroxat.

Read more: Scots psychiatrist spearheading campaign for transparency in medicine

The married father-of-two had been originally prescribed the medication to alleviate anxiety and later spent more than a year very slowly reducing his dose.

Despite this, stopping Seroxat triggered his only episode of depression and left him feeling suicidal.

Dr Gordon, an NHS doctor for 26 years, resumed taking the antidepressant and said he is too scared to try stopping again.

Following Dr Crichton’s intervention in December, Dr Gordon was referred to NHS Lothian’s occupational health department who subsequently gave him a clean bill of health and confirmed he was fit to work.

He has recently returned to St John’s two days a week.

It comes as the latest workforce figures for NHS Scotland revealed that vacancies for consultant psychiatrists are at a record high, having doubled to more than 80 in the past four years.

Read more: The patients hooked on antidepressants – and harmed by withdrawal 

Dr Gordon believes he has been seen as a troublemaker by psychiatry’s leaders for speaking openly about his own experience of withdrawal, as well as campaigning for greater transparency around potential conflicts of interest such as links to drug manufacturers.

In 2014, Dr Gordon petitioned the Scottish Parliament for a ‘Sunshine Act’ which would require doctors to declare all payments and the cash value of gifts they had received on a publicly accessible register.

He said patients deserved to know whether medical professionals including GPs and psychiatrists, had been paid by commercial companies.

In the months before his resignation, Dr Gordon had also made a Subject Access Request to the College seeking copies of all communications relating to him.

In response, he received more than 300 pages of documents, of which 93 A4 sides were completely redacted and 94 had blacked out everything except a subject heading, date and address.

The remainder was also heavily redacted, but included an email where Dr Gordon was described as “being quite difficult”.

Dr Gordon is the only working psychiatrist in Scotland who has spoken out about antidepressant withdrawal to express his belief that the problem is more widespread than the pharmaceutical industry or profession want to admit.

He said: “I am absolutely certain that this was an effort to marginalise me and question my credibility, maybe even to silence me.

“But this is a doctor who knows nothing about me.

“I’m not a critical psychiatrist. It would upset me deeply if anyone thought I was trying to undermine people who have had positive experiences from antidepressants.

“I’m just openly asking questions about ethics, transparency and patient safety.”

Marion Brown, a psychotherapist from Helensburgh who has been petitioning MSPs on prescription pill harm, said: “This is happening to people who raise issues – they’re silenced.

“As patients and patient campaigners, people have tried to silence us. But they mostly just ignore us.

“But Peter Gordon, because of who he is, I’m sure he has been seen as a threat.”

A spokeswoman for the Royal College of Psychiatrists Scotland said: “All medical practitioners have a duty to protect patients and must raise concern about a colleague’s health if there is a patient safety concern.

“It would be inappropriate to comment any further.”

A spokesman for NHS Lothian said it was unable to comment on matters relating to individual staff members.

Cosy..


https://www.nwemail.co.uk/news/17683034.art-of-the-deal-at-donald-trump-business-breakfast/

 

Barrow woman sits beside Donald Trump at meeting with Theresa May

By Tom Murphy Audience and Content Editor
See both photos

The Barrow-born boss of a major pharmaceutical company sat next to US president Donald Trump at an event today.

Emma Walmsley, chief executive of GlaxoSmithKline, which has a plant in Ulverston, was among 10 business leaders invited to the business roundtable at St James’s Palace, co-hosted by Mr Trump and Prime Minister Theresa May.

Also around the table was Sir Roger Carr, chairman of BAE Systems, which has its Submarines facility in Barrow.

Five UK companies were chosen to attend the breakfast event, because of their large presence in America, along with five American firms.

It was part of Mr Trump’s three-day state visit to the UK.

Prince Andrew, The Duke of York and Mr Trump’s daughter Ivanka, also attended.

Mrs Walmsley said prior to the event: “The US is one of the most important sources of healthcare innovation in the world.

“Life sciences is also a strategic strength for the UK and there is a great opportunity for us to partner further to retain and accelerate both countries’ global leadership in this sector, generating better outcomes for patients and economic growth on both sides of the Atlantic.”

Sir Roger said: “Our relationship with the USA is long-standing and operates to our mutual benefit on the firm foundation of trust, transparency and true partnership.”

Mr Trump, who wrote The Art of the Deal, said the the US was already the UK’s largest trading partner and that he believed there was scope for further expansion.

Mrs May said that there were huge opportunities for Britain and the US to work together in the future.

She said: “I think the range of companies around this table shows us the huge scope of transatlantic business links that we have between the US and the UK.

“It is a great partnership, but I think it’s a partnership that we can take even further.

“That’s with of course a bilateral free trade agreement.

“I think there are huge opportunities for us to seize together, and challenges for us to work together on to tackle as well.”

Prior to the meeting, the Government said discussions were expected to focus on research, development and innovation and investment in infrastructure.

The Truth… at last.


https://www.psychologytoday.com/intl/blog/side-effects/201905/antidepressant-guidelines-tighten-in-the-uk

“…Doctors across the United Kingdom will soon be told to warn millions of patients taking antidepressants that ending treatment can cause “severe” adverse effects and last much longer than previously advised…”

 

 

“...One 2010 study from Japan found that 78 percent of people trying to taper off Paxil (Seroxat) experienced severe withdrawal symptoms. Last September, London-based researchers James Davies and John Read received global coverage when they concluded, based on a meta-study of 23 earlier peer-reviewed studies, that “more than half (56 percent) of people who attempt to come off antidepressants experience withdrawal effects.” Further, almost half of them (46 percent) described the effects as “severe.”

In a March 2019 article on antidepressant withdrawal for the New York Times, Benedict Carey added, “Dutch researchers in 2018 found that 70 percent of people who’d had trouble giving up Paxil or Effexor quit their prescriptions safely by following an extended tapering regimen, reducing their dosage by smaller and smaller increments….”

GSK Boss Emma Walmsley To Meet Trump..


https://news.sky.com/story/handful-of-ftse-100-chiefs-to-meet-trump-during-state-visit-11732128

BAE, Barclays, GSK, National Grid and RB all derive a significant proportion of their revenues from the American market.

Those expected to attend the meeting at St James’s Palace are: Sir Roger Carr, BAE chairman; Jes Staley, CEO of Barclays; Emma Walmsley, GSK chief executive; John Pettigrew, who runs National Grid; and Rakesh Kapoor, who is due to step down shortly as CEO of RB.

30 Years Too Late: The Royal College Of Psychiatry Changes Its Tune.


https://www.irishnews.com/magazine/science/2019/05/30/news/call-for-patients-to-be-warned-over-potential-antidepressant-withdrawal-symptoms-1631105/

“……Patients seeking treatment for depression should be informed of the potential for “severe and long-lasting withdrawal symptoms” when coming off medication, leading doctors have said.

The Royal College of Psychiatrists said official guidance on halting medical treatment for depression needs to reflect “the full range of patients’ experiences”.

Guidelines from the National Institute for Health Care Excellence (Nice) – which are currently being consulted on – suggest most people should be able to halt antidepressant use over four weeks…..”


 

“…..This led to a row with campaigners in which one of its experts was attacked as a “pharma whore” and “worse than Hitler”. After spending a year speaking to patients, the college has accepted that some of its critics have a point. “As psychiatrists, we are duty-bound to take on board the concerns of patients who’ve experienced more severe and long-lasting side effects of these medications,” said Wendy Burn, the college president….”

https://www.thetimes.co.uk/article/wean-patients-off-depression-pills-say-doctors-qnh2sj3nm

 

Interesting news today about the Royal College of Psychiatry UK changing its tune on the severity of withdrawal symptoms. Although I welcome this U-turn on advice from UK psychiatry, I am not comfortable with how they are trying to take credit for what effectively has been a patient-led-activist movement (mostly online) for the past 2 decades. I am also not comfortable with this U-turn being almost 30 years too late (Seroxat for example- was first licensed in 1991).

Since SSRI’s were first licenced in the 90’s people have been complaining about severe withdrawals, particularly online. There have been numerous SSRI forums, websites, blogs and you-tube videos/documentaries etc all attesting to the severity of withdrawals. This phenomenon has been well known for decades, and has always been much more common than has been reported by mainstream psychiatry.

Since last September, I basically badgered the Royal College, Wendy Burn, and her associates on Twitter. Firing off information and tweets at every opportunity for her to read and for her colleagues to think about. My activism culminated in a controversial post where I said that one of the grand-dukes of UK psychiatry (and Pharma Funding) Dr David Baldwin was a Pharma Whore.

The UK press caught hold of this and the Royal College spun them a yarn, which led to headlines such as these:

DB@DB1

 

The ‘worse than Hitler’ quote came from a comment (left on the David Baldwin post) by an SSRI damaged person who regularly reads my blog. See it here:

https://truthman30.wordpress.com/2018/09/09/professor-david-baldwins-lovefest-with-the-pharmaceutical-industry/

Whilst I welcome this u-turn on the severity of withdrawals (something I have been campaigning on for 13 years), I don’t welcome the Royal College trying to take credit for it. It has been because of the Pharma-Whoring ( and lies and spin) from the Royal College (and the APA: American Psychiatric Association) that patients have been duped about the harms of SSRI’s for many decades. Just because they are admitting it now, doesn’t wash away all the death, destruction and disablement of vulnerable people (that they have been responsible for) for almost 30 years.

Where is the apology for not warning people sooner?

UK psychiatry head- Wendy Burn- defended David Baldwin on Twitter when he was under fire for the “Pharma Whore’ debacle in the media, yet David Baldwin (and others of his ilk) are directly responsible for the misinformation about SSRI’s for many decades (and were paid handsomely for it by their Pharma sponsors too).

Where is the apology from people like Baldwin? David Nutt? Guy Goodwin? Andrea Cipriani, Carmine Pariante etc?

(all known Pharma compromised people who have taken Pharma Money to defend SSRI’s in the media for decades)

For more on this , see the following links-

https://truthman30.wordpress.com/2018/09/12/what-constitutes-a-pharma-whore-and-what-doesnt/

https://holeousia.com/2019/05/29/letter-to-professor-andrea-cipriani/


The Royal College should be apologizing to all those who have been harmed by SSRI’s , -and who have been harmed- by the Royal College’s own protocols of playing down harms and not listening to patient’s concerns. The college should also be ashamed of how Pharma has utterly corrupted its key opinion leaders over many decades.

It is because of campaigners like myself, Bob Fiddaman, Altostrata (from Surviving Antidepressants forum), Seroxat Secrets, MadinAmerica, Joanna Moncrieff, Luke Montague, Leonie Fennel, James Davies, Peter Breggin, Kevin P Miller, David Healy, Fiona French, Kristina Gehrki,  Dr Alec Grant, Marion Brown, Peter Gordon, Jill Davies, Robert Balfe, Peter Kinderman,  Wren Cage, Leigh Fanner, Dropthedisorder, Michael Hengartner, John Read, Dr Terry Lynch, Andy D’ Alessio, Kelly Martin,  Aine, Lucy Johnstone, Alyne Duthie, CEP, James Moore, Sarah Hancock, Ann Marcos, Aunty Psychiatry, Brian (from antidepaware) and many many more people* and organizations (too many to mention) who have been fighting (both online/Twitter and off-line) for recognition of the severity of SSRI side effects and withdrawals for many decades now- that this U-turn from UK psychiatry has come about.

Our relentless campaigning (in particular – on Twitter in recent months) has forced them to recognize the seriousness of the harms of SSRI’s.

This is where credit is due.

 

*if I have missed anyone… let me know!

 

 

Vulnerable Kids Prescribed Paxil (Seroxat) In Japan..


https://www.japantimes.co.jp/news/2019/05/28/national/social-issues/kids-arent-right-japan-struggles-protect-vulnerable-children-group-homes/

 

“….Miwa’s psychological state also isn’t discussed much in the records until she was a teenager. In 2008, she began having trouble sleeping at night. Soon after, doctors diagnosed her with pervasive developmental disorder, characterized by delays in socialization skills. A year later, they prescribed Paxil for depression, the files show.

By the time the welfare office sent Miwa back to her mother, she was 15….”

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