‘Even in today’s enlightened age . . .’


New Post From Ethical Psychiatrist Peter Gordon …

Hole Ousia

The above is a quote from Roy Porter a historian specialising in the history of medicine. It is an old quote as sadly Roy Porter died at a young age in 2002.

It is some weeks now since I resigned from the Royal College of Psychiatrists having been a member for almost a quarter of a century. My intention is to switch focus to my other areas of interest.

The following is a summary of the two main areas that I raised in my letter of resignation [it is my understanding that the Royal College of Psychiatrists does not intend to reply to this letter].


The first area of concern related to:

This College statement includes the following:

[In previous posts I have used information available in the public domain to construct visual summaries of the competing interests of some key opinion leaders. I have done so in the spirit…

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Odd…


http://www.koreabiomed.com/news/articleView.html?idxno=4871

 

GSK sales manager leaps to death
  • By Lee Han-soo
  • Published 2019.01.04 14:57
  • Updated 2019.01.04 14:57
  • comments 0

A GSK Korea sales manager in charge of consumer healthcare division jumped to his death off the company headquarters in Yongsan-dong, Seoul, on Thursday.

According to local reports, police arrived at the scene after someone reported that a man had jumped off the building. The sales manager, surnamed Song, had already died when the police arrived at the scene.

The reason behind Song’s death is still unknown and the police are investigating the incident based on CCTV recordings.

Medipana, an internet medical media outlet, reported that the police have also found Song’s suicide note.

“Based on the fact that Song left a suicide note, acquaintances of Song are worrying that he may have fallen to his death due to stress at work,” it said.

The Silence.. Manchester Orchestra…


 

[Verse 1]
Why do I deserve the signs to feel better about you?
At a loss I lost my cool
I denied that I found you
I tried to be a basket case
I did not surprise you
I’m trying to find a signal fire
Let me know when I should move

[Chorus]
But you, amplified in the silence
Justified in the way you make me bruise
Ma
gnified in the science
Anatomically proved that you don’t need me

[Verse 2]
Why do I desire the space?
I was mourning after you
I was lost and lost my shape
There was nothing I could do
I don’t want to waste away
It was all I gave to you
Take me back and take my place
I will rise right up for you

[Chorus]
But you, amplified in the silence
Justified in the way you make me bruise
Magnified in the science
Anatomically proved that you don’t need me

[Bridge]
All the while you waste away, you’re asking
“Did I really need another one to take me down?”
Everybody knows it’s something that you had to live with, darling
Nobody’s gonna tear you down now
There is nothing you keep, there is only your reflection

[Outro]
There was nothing but quiet retractions
And families pleading, “Don’t look in that cabinet
There’s far more bad than there’s good, I don’t know how it got there”
That was something your father had burned in me
Twenty hours out of Homestake eternity
“You can go anywhere but you are where you came from”
Little girl, you are cursed by my ancestry
There is nothing but darkness and agony
I can not only see, but you stopped me from blinking
Let me watch you as close as a memory
Let me hold you above all the misery
Let me open my eyes and be glad that I got here

The Royal Colleges and Sunshine Legislation


The UK Medical Community (Psychiatry In Particular) Has No Interest In Transparency…

Hole Ousia

[No response received by the end of 2018]

[Despite repeated polite reminders there has been no response from the General Medical Council by the end of 2018]

The Royal College of Surgeons of England has tended to defer to the Academy of Medical Royal Colleges (AoMRC) on this issue who can represent the collective view of medical royal colleges. There have already been voluntary moves to improve transparency around payments to healthcare professionals which the Academy has been involved in. As a College we generally support transparency in healthcare and with the AoMRC we would be happy to review any proposed wording of sunshine legislation if it were introduced to the UK.” [30 November 2018]

The Royal College of Physicians has discussed this issue and we do not oppose a move towards more transparency regarding relationships between pharma and clinicians. However, we believe there are more pressing issues that require legislation at…

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GSK’s Murky Experiments On Babies In Ireland…


I reported on GSK’s involvement in the Tuam (Irish) baby trials several years ago on this blog, so it’s good to see that others have taken up the baton and now there is a lot online about these very dodgy trials. Great research from whoever wrote the article below and an interesting slant also when comparing GSK’s past trials on Irish orphans with its not so long ago- Study 329 Paxil (Seroxat) Trial-

 

“….In Study 329 you were informed that participation in the trial would not lead to any different treatment from standard clinical care. Well standard clinical care for the use of imipramine in adults at that time would have been to use doses of around 150 mg or less. In their adult trials running at the same time, GSK were using a 150 mg dose. But in Study 329, the protocol from the get go mandated pushing every child who got imipramine up to 300 mg if possible. It’s difficult to see any rationale for this other than by making imipramine look so toxic, Paxil might look good by contrast….”

Check out tuambabies.org for more on these hideous experiments.


 

 

 

GSK’s Tafenoquine…


https://tendaily.com.au/news/politics/a181204blz/soldiers-anticipate-long-awaited-inquiry-report-into-anti-malarial-drugs-20181204

Soldiers Anticipate Long-Awaited Report Into Anti-Malarial Drugs

Defence force personnel left with debilitating psychological effects from taking anti-malarial drugs are looking forward to the release of a long-anticipated report into the use of two separate medications.

Anti-malarial products mefloquine and tafenoquine have been prescribed for Australian defence personnel — as well as general civilians — for many years.

While mefloquine was registered with the Therapeutic Goods Administration as early as 1988, with tens of millions of prescriptions globally, recent years have shone a light on the drug’s potential side-effects.

A months-long federal government inquiry into the use of the two drugs, and any “adverse health effects” of their use, is due to report this week after being twice delayed.

The Department of Defence outlines that most symptoms are “minor”, and can include sleep problems, vivid dreams, anxiety and depression. In around 10 percent of cases, the department said, users can experience dizziness or headaches.

In one percent of cases, the department noted, side-effects can include “agitation, restlessness, mood swings, panic attacks, confusion, hallucinations, aggression, psychosis and suicidal ideation”, as well as balance problems and seizures.

(Getty Images)

The American Food and Drug Administration (FDA) added warning labels to mefloquine products in 2013, warning of possible psychological issues including dizziness, balance issues or ringing ears.

Much attention has been paid to the use of the drugs by defence force personnel around the world, including in the US and UK, with countless members sharing personal stories with journalists.

More than 1300 ADF members were prescribed mefloquine in a trial in Timor Leste in the early 2000s, while others — including retired army officer Stuart McCarthy — were given the drug, and another called tafenoquine, in other overseas missions to developing countries to combat malaria.

(Getty Images)

“I had a lot of chronic health issues that I could never really get to the bottom of. I was given tefenoquine in Bougainville in 1999, and I didn’t really think much of it connected to the subsequent health problems I had,” McCarthy told 10 daily.

“Even though I was given a very high dose during the trial, and the purpose was to eradicate malaria, I still got malaria regardless.”

McCarthy said he also later developed a range of serious psychological conditions, including depression, and other “subtle but noticeable” issues like vertigo and what he classed as general “cognitive decline”.

He claimed up to 3000 people may have been affected by these drugs, saying he had spoken to “hundreds” of families and was aware of some suicides allegedly linked to the use of the anti-malarial drugs.

“The evidence now is these drugs can cause a permanent brain injury. There’s a very distinctive set of symptoms including psychiatric ones, like depression, anxiety, and neurological symptoms,” he told 10 daily.

“The drug trial I was involved in, tafenoquine, my experience was there was very little if any info on side effects, other than you might have some gastro for a few days. There was no mention of possibility of brain damage.”

(Getty Images)

Around 140 Australian personnel were prescribed mefloquine between 2010 and 2016, according to the defence department.

“A Senate report will be released today on the use of anti-malarial drugs, which has had direct input from veterans throughout Australia and I look forward to reading the findings,” Veterans Affairs minister Darren Chester told 10 daily on Tuesday.

“I am focussed on putting veterans and their families first and delivering the essential services they rely on, with more than $11 billion provided each year.”

The Senate inquiry into ‘Use of the Quinoline anti-malarial drugs Mefloquine and Tafenoquine in the Australian Defence Force’ attracted nearly 140 submissions.

Those who used the drugs have complained the drug trials were incorrectly administered, and that the government has not provided appropriate access to health or support services to deal with ongoing side-effects.

“There is clear, extensive evidence of the harmful effects of mefloquine and tafenoquine, including lasting impact on many hundreds of Australian quinoline veterans and their families,” the Quinoline Veterans and Families Association (QVFA) said in its submission.

“Despite claims by Commonwealth officials that adequate help is available, the government has consistently denied the fact that these drugs are able to cause permanent brain damage resulting in widespread chronic neuropsychiatric illness and in some cases suicide.”

“There is a compelling need for the Commonwealth to implement a comprehensive program of outreach, rehabilitation and research, led by experts in ABI and clinical neurotoxicology.”

(Getty Images)

In its own submission, the Department of Defence defended the use of mefloquine, saying it was not commonly used and only as a “third-line” treatment when people could not use two other more popular treatments.

But it acknowledged side-effects had been experienced by some personnel.

“Defence has always acknowledged that mefloquine can cause side effects, including neuropsychiatric problems, while individuals are taking the drug,” the department wrote.

“Generally, symptoms will disappear when the individual stops taking the drug but they can persist for some time afterwards due to the drug’s long half-life of two to four weeks. Defence also acknowledges that neuropsychiatric side effects have been known to continue and become long term in a small number of individuals.”

The Senate report is due to be delivered this week.

McCarthy acknowledged concerns raised by himself and others affected by the drugs had been well-received by federal officials, but said the government needed to take action.

“There needs to be a royal commission,” he told 10 daily.

“Most important, we need dedicated outreach and rehab programs for people affected by these drugs. We want the government to set up a program of referrals, so anyone with these symptoms can be referred to the appropriate medical specialist, and also appropriate social support.”

Widow asks SCOTUS to toss GSK’s win in lawsuit over Paxil labeling, lawyer’s suicide


GlaxoSmithKline  

Asserting a Chicago federal appeals panel wrongly invalidated a jury’s verdict, attorneys for the widow of a Chicago lawyer who committed suicide after taking the generic version of the antidepressant drug Paxil, have asked the U.S. Supreme Court to throw out the appellate ruling and order more proceedings on whether pharmaceutical company GlaxoSmithKline should be made to pay for allegedly not revising their drug’s warning label to reflect an increased risk of suicide.

On Dec. 19, attorneys for Wendy Dolin filed a petition with the U.S. Supreme Court, asking the nation’s high court to take up their appeal of the decision from the U.S. Seventh Circuit Court of Appeals in Chicago, which had found a federal jury was wrong to order drugmaker GSK to pay Dolin $3 million. In that decision, the appellate judges had essentially found GSK could not be held liable for the content of the warning label on its medication, because those labels were controlled by the U.S. Food and Drug Administration.

“The Seventh Circuit’s decision creates a world where a drug manufacturer is permitted under the First Amendment to promote its drug for non-FDA approved indications, … but a drug manufacturer is prohibited from issuing warnings concerning life threatening risks associated with its drug,” Dolin’s attorneys wrote in their petition.

The petition was filed about four months after a panel of three Seventh Circuit judges threw out the verdict in favor of Dolin, widow of lawyer Stewart Dolin, who killed himself in 2010 in a downtown Chicago transit station. Wendy Dolin alleged her husband was taking paroxetine, the generic version of GSK’s Paxil. She alleged the drug’s label, which was written by GSK and is identical for the name brand and generic versions, did not adequately warn the drug could increase the risk of suicide. Dolin alleged GSK knew of the alleged increased risk, yet chose not to revise the warning label.


Bijan Esfandiari   Baum Hedlund Aristei & Goldman P.C.

GSK, however, said it tried several times to secure approval from the FDA to revise the label, but the FDA declined.

After years of proceedings in federal district court in Chicago, a jury found in favor of Dolin at trial. GSK appealed, and the Seventh Circuit overturned the verdict.

In the appellate decision, the judges, led by Circuit Judge David Hamilton, found GSK had asked the FDA four times to change the labels, but the FDA had ordered GSK to use standard language the FDA approved for paroxetine and other antidepressants. This showed GSK had no control over the labels, Hamilton said.

In their petition to the Supreme Court, however, Dolin’s lawyers said this finding represented a misreading of the case. They asserted the FDA had not disallowed the revisions, but rather had directed GSK to publish suicide risk warnings as a supplemental warning, known as a Changes Being Effected, or CBE, provision.

Dolin’s attorneys further argued the Seventh Circuit’s decision ignored key legal precedents, including the Supreme Court’s 2009 ruling in Wyeth v Levine, which held drug companies can revise labels to enhance warnings, without FDA approval.

Dolin’s attorneys painted the Seventh Circuit ruling as “unreasonable,” as it came despite contrary findings from “nine jurors and two distinguished district court judges reviewing the same facts” who “found that GSK was not prohibited from issuing stronger warnings.”

“There is no evidence the FDA ever rejected a paroxetine-specific adult suicide warning,” Dolin’s lawyers claimed. “The FDA’s invitation to GSK to use the CBE (which GSK could use unilaterally without the FDA’s invitation) to issue a paroxetine-specific adult suicidality warning in a place within the label that is outside the class labeling section can hardly be considered or interpreted as a rejection of a paroxetine-specific adult suicide warning.

“…It is akin to being invited to dance but construing that invitation as clear evidence of rejection.”

Dolin’s lawyers noted the Supreme Court is scheduled to hear arguments in a similar case, Merck v Albrecht.

In that case, the U.S. Third Circuit Court of Appeals came down on the question opposite the Seventh Circuit. In their decision, Dolin’s lawyers assert, the Third Circuit judges determined such labeling questions were appropriate for a jury, and “a reasonable juror could conclude that ‘the ball was in (drugmaker) Merck’s court’ to submit a revised CBE for the correct enhanced warning.”

Dolin’s lawyers asked the Supreme Court to delay action on their petition until resolving the Albrecht case. But after Albrecht, the lawyers asked the high court to vacate the Seventh Circuit decision and remand the case for new proceedings.

The petition was filed by attorneys Bijan Esfandiari, of the firm of Baum Hedlund Aristei & Goldman P.C., of Los Angeles, and David E. Rapoport and Mathew S. Sims, of the Rapoport Law Offices P.C., of Chicago.

GSK has been represented by attorney Lisa Blatt, of Arnold & Porter Kaye Scholer, of Washington, D.C., and by the firms of Dentons US LLP, of Chicago, and King & Spalding, of Atlanta.

Antidepressant Dependence Discussed At The Seat Of The Welsh Government…


https://www.madinamerica.com/2018/12/antidepressant-dependence-welsh-government/

 

 

 

Antidepressant Dependence Discussed at the Seat of Welsh Government – Video

James Moore

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On December 11, 2018, a Welsh charity, www.PAST.Wales arranged an awareness day to be held at the Senedd in Cardiff, home of the National Assembly for Wales. This presented an opportunity to discuss and debate issues of iatrogenesis, dependence, overprescription and prescribed harm within earshot of Welsh Assembly Members. The Assembly has devolved authority for health and can act independently of Westminster, so this was a chance to directly address policymakers. A relationship to the Assembly Members was provided by a petition to the Welsh Assembly raised by campaigner Stevie Lewis, which called for recognition and support for prescribed drug dependence across Wales.

Part 1 – The Presentations

Speakers were Dr David Healy, Stevie Lewis and myself and the event was arranged and hosted by Aled Jones. Aled, whilst working within recovery and substance misuse services, heard many speaking of the lack of understanding or support for withdrawal from medications. His own disastrous encounter with antidepressants and pain medication gave him the awareness of the issues that can arise from their use.

Dr David Healy speaking first, focussed on identifying the context and why pharmaceutical drugs such as antidepressants constitute a political problem. He explained the endemic nature of ghostwriting in clinical trials of psychiatric drugs and that these anonymous writers do not have access to the original trial data. This lack of access to the original data permeates the system such that neither peer reviewers, regulators or treating physicians can access the data they need to make decisions about safety or efficacy. He discussed the clinical trials of antidepressants including Prozac (a drug promoted as one that would make us ‘better than well’) noting that Prozac distinguishes itself as having more negative trial outcomes than any other antidepressant drug. Despite these negative outcomes, the ghostwritten trial reports mostly conclude that the drugs are effective and these are the reports that are used by regulators such as the FDA in the US and MHRA in the UK to licence the drugs for use. He also described how readily patient experiences are discounted and those that experience difficulty are labelled as ‘rotten apples’ when actually, the problem is better conceptualised as a ‘rotten barrel’ problem.

Speaking next was Stevie Lewis, a campaigner with lived experience of antidepressant dependence and withdrawal and someone who had endured a lengthy period of withdrawal and an extremely unpleasant and lengthy post-withdrawal syndrome. She discussed systematic work undertaken by herself and colleagues Dr Anne Guy and therapist Marion Brown, that identified key failure points in the prescribing of antidepressant drugs. These failure points encompass critical moments in the doctor/patient relationship where chances to provide informed consent or to address potential dependence issues are missed. Stevie also reminded attendees that 158 lived experience accounts had been shared through the Scottish and Welsh petitions. She related that two of the people who had submitted accounts for the Scottish petition had recently taken their own lives, unable to endure the physical and emotional toll that withdrawal had taken on them and the disruption to their lives.

The first, 28-year-old Katalin Balint from Hungary, wrote the following in her submission to the Scottish petition. She took her life on October 1, 2018:

Jo-Quote-768x550

The second, Jo Denison ended her life on November 2, 2018, aged just 35. In her petition submission, she said:

Kata-768x332.jpg

Stevie reminded us all that we must hold two truths in mind with antidepressant drugs. One is that they help people and save lives, but the other reality that we must confront is that they can harm people and take lives too.

For my part, I briefly shared my own experience of being prescribed and then withdrawing from an antidepressant and my recent involvement in campaigning and awareness-raising. I went on to outline why the official guidelines from the National Institute for Health and Care Excellence (NICE) are of little use for anyone who wishes to withdraw slowly and safely. I addressed some of the options available to those who do wish to withdraw slowly and went on to talk a little about potential solutions including Tapering Strips developed in the Netherlands and written about in a study in the journal Psychosis.

Following the formal talks, an audience question and answer session was held in which we discussed more about the link between talking therapies and increased prescribing through referrals, functional medicine as opposed to the medical model and how we can raise more awareness and try to deal with the problems discussed. We also heard moving personal testimonies from attendees of their experiences of taking and withdrawing from a range of psychotropic drugs.

Part 2 – Audience Q&A

I think we all felt that it would have been good for more Assembly Members to be present throughout, but the fact that these issues were being publicly discussed on their turf was a significant achievement.

In parts of Wales, one in six adults takes antidepressants and this is higher than England or Scotland. Support for anyone struggling with dependence or withdrawal issues is patchy and inconsistent and much of it depends upon whether your doctor has had any prior experience of such difficulties. North Wales has a prescribed medication service which joins a very small number of officially recognised support services, including the R.E.S.T. service, previously written about on Mad in America. Other support is most commonly in peer-led initiatives such as P.A.S.T Wales, The Bristol and District Tranquilliser Project and Oldham Tranx which arose from an initiative led by veteran benzodiazepine awareness campaigner Barry Haslam.

In the UK there does seem to be momentum building with a review into drugs that can lead to dependence led by Public Health England with support from the Council for Evidence-Based Psychiatry, more reporting on TV and in newspapers of the problems of dependence and withdrawal and more engagement on social media with the Royal College of Psychiatrists and other campaigners.

What action the Welsh Assembly takes in response to this thorough airing of an issue that is slowly gaining mainstream attention remains to be seen, but I personally feel that we have taken a huge step forward in confronting the problems associated with a less than cautious approach to prescribing.

GSK CEO, Emma Walmsley, Resigns To Pursue Career As Stand-Up Comedienne


Emma1

 

It seems that Glaxo CEO, Emma Walmsley, has perhaps quit her job at Glaxo to become a stand up comic? (as evidenced by the screen-shots).

However, there’s nothing funny about Glaxo’s 3 Billion Dollar Fine with the US department of justice (How many people were killed from dodgy off label prescribing from fraudulent behavior for this fine alone?)

There’s nothing funny either about concealing data, which results in the deaths or disablement of unsuspecting patients.

Nothing humorous in any of Glaxo’s crimes.

There is however, something very funny about the images of Emma Walmsley sprouting on about trust, particularly when you consider Glaxo are still currently under investigation by the serious fraud office in the UK, and also in light of Thomas Reilly’s case against them (currently pending).

It seems along with Glaxo’s ethics, its humanity and its morals, its entire manufacturing system is also not fit for purpose too (how many people are unknowingly being harmed from that fact alone?). How many dodgy meds end up maiming unsuspecting patients from Glaxo’s long list of product recalls?

See here for an extensive list..

It seems that Glaxo is a very tragic comedy act indeed.


“…..A senior whistleblower at GlaxoSmithKline is suing the drugs giant over claims his warnings about allegedly dangerous botched IT projects were hushed up by his superiors who eventually ended his 16-year career at the company.

Thomas Reilly worked around the world designing, installing and troubleshooting major IT projects at GSK production plants and at its UK and US data centres. 

He claims he warned for years of serious issues in IT systems in many countries that caused numerous factory shutdowns.

Yet, in a lawsuit filed against the firm in the US, he says his concerns were not properly acted upon by his superiors in Britain. In one case, he says his warnings about a Latin American plant were covered up by his manager for fear of alerting auditor PricewaterhouseCoopers….”

 

https://www.standard.co.uk/business/glaxosmithkline-faces-new-whistleblower-claims-over-unfair-dismissal-a3842706.html

 

Emma2