Who’s to blame for GSK’s Pandemrix Scandal?


The MHRA?, The FDA, The doctors on the pharma’s payroll? GSK? Governments?

Seems like another game of ‘pass the buck’ is about to begin in regards to GSK’s Narcolepsy causing vaccine- Pandemrix?

When so many are complicit in the game, it’s difficult to point the finger of blame ?

Clever game…


 

https://davidhealy.org/khashoggi-and-pandemrix/

 

“…The BMJ recently ran an extraordinary article by Peter Doshi, followed by an editorial from Fiona Godlee, that hinged on the fact that GSK’s swine flu vaccine Pandemrix causes narcolepsy. For lots of people this wasn’t new. For the many takers of the vaccine who were tortured by it and left unable to function afterwards, if not actually dismembered, particularly children, there was little doubt as to what had happened….”

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We Have Known This For 20 Years …


Psychiatry and the drugs industry have tried to suppress the reality of severe side effects for decades.. many people have been harmed because of this..


Antidepressant withdrawal symptoms severe, says new report

Existing guidance that symptoms are minimal leads to misdiagnosis and ‘harmful long-term prescribing’

 

https://www.theguardian.com/society/2018/oct/02/antidepressant-withdrawal-symptoms-severe-says-new-report

 

Half of all those taking antidepressants experience withdrawal problems when they try to give them up and for millions of people in England, these are severe, according to a new review of the evidence commissioned by MPs.

Guidance from the National Institute of Health and Care Excellence (Nice), which says withdrawal symptoms “are usually mild and self-limiting over about one week” urgently needs to be changed, say the review authors.

Dr James Davies from the University of Roehampton and Prof John Read from the University of East London say the high rate of withdrawal symptoms may be part of the reason people are staying on the pills for longer. They cannot cope, so carry on taking the drugs, or their doctors assume they have relapsed and write another prescription.

The review was commissioned by the all-party parliamentary group for prescribed drug dependence and follows a long debate about the Nice guidance, which critics say is out of date.

Modern antidepressants of the SSRI class, such as Prozac (fluoxetine) and Seroxat (paroxetine), were marketed in part on their safety. Studies showed that when taken alone, overdoses were rarely fatal, which was not the case with benzodiazepines. Also, stopping the drugs was said to be easier.

There have been plenty of anecdotal accounts of withdrawal symptoms, which include dizziness, vertigo, nausea, insomnia, headaches, tiredness and difficulties concentrating. But the Nice guidance said in 2004 that the withdrawal symptoms were slight and short-lived and was re-adopted without further evidence in 2009. It is similar to the US guidance, which says symptoms usually resolve within one to two weeks.

The review, published in the journal Addictive Behaviors, focused on 14 studies of antidepressants that had relevant data on withdrawal symptoms. The studies, which were diverse, showed that between 27% and 86% of people suffered from them, with a weighted average of 56%.

Antidepressants are now some of the most commonly prescribed drugs in the UK and US, say the authors. “In the UK, usage has risen since 2000 by 170%, with over seven million adults (16% of the English adult population) being prescribed an antidepressant in England alone last year,” says the review.

About half of antidepressant users have been taking the pills for longer than two years. In England, that is 3.5 million people – 8% of the population. In the US, 13% of the population (37 million adults) were on them by 2011-2014, official data shows. Half have been taking them for five years or more.

“This new review of the research reveals what many patients have known for years – that withdrawal from antidepressants often causes severe, debilitating symptoms which can last for weeks, months or longer,” said Dr James Davies.

“Existing Nice guidelines fail to acknowledge how common withdrawal is and wrongly suggest that it usually resolves within one week. This leads many doctors to misdiagnose withdrawal symptoms, often as relapse, resulting in much unnecessary and harmful long-term prescribing.”

The review includes comments from some of the studies where antidepressant users were interviewed about their experiences of trying to wean themselves off the pills.

One spoke of “horrible dizzy spells and nausea whenever I lower my dose”. Another said: “The withdrawal effects if I forget to take my pill are severe shakes, suicidal thoughts, a feeling of too much caffeine in my brain, electric shocks, hallucinations, insane mood swings … kinda stuck on them now coz I’m too scared to come off it.”

Sir Oliver Letwin MP, chair of the parliamentary group, said: “This systematic review provides important new data on antidepressant withdrawal which will be considered by Public Health England as part of their current review into prescribed drug dependence. The data suggests that existing medical guidelines in this area should be urgently updated to reflect the fact that antidepressant withdrawal is much more common, severe and long-lasting than previously stated. Furthermore, we hope that other medical bodies will take note of this new research, and update their own guidance accordingly.”

Nice said it is looking again at its guidance. “In July 2018, the committee met and concluded that the current evidence base needs updating to include research from July 2016 onwards. Nice agrees,” said Paul Chrisp, director of the Centre for Guidelines at Nice. “It is important that the final recommendations are based on the most up-to-date evidence possible. In addition to updating the existing evidence reviews, we will include new work on patient choice and a focus on shared decision making.

“We hope the final guideline will allow people with depression to be offered the best treatments and reach joint decisions about their care that reflect their preferences and values.”

This article was amended on 3 October 2018 to clarify how overdosing on SSRI antidepressants differs from overdosing on benzodiazepines.

The MHRA Need To Explain A Lot Of Things….


https://www.bmj.com/content/363/bmj.k4152/rr-19

Re: A tale of two vaccines – the MHRA need to explain

Everyone should be grateful to Clifford Miller for illuminating the MHRA’s methodology in breaking down adverse report data into statistical noise [1], and it would interesting know how widespread is this practice. Is it just for Pandemrix and HPV vaccines or for all products? Either way the agency urgently need to explain themselves.

Miller is however incorrect in suggesting I was claiming validity for the MHRA reporting – I thought I was pointing out its inadequacy while noting that only 6 million or so vaccinations had taken place according to their data despite contracts for 132m rounds, and this may have saved citizens a lot of harm {2].

[1] Mr Clifford Miller, ‘Re: A tale of two vaccines – MHRA Published Incomplete ADR Data’, 14 October 2018, https://www.bmj.com/content/363/bmj.k4152/rr-18

[2] John Stone, ‘Re: A tale of two vaccines – how the British people averted disaster?’ 13 October 2018,
https://www.bmj.com/content/363/bmj.k4152/rr-17

Competing interests: No competing interests

How Glaxo Feeds Its Doctors..


https://www.bmj.com/content/363/bmj.k4157

“…GSK’s 2013 ban on paying doctors came amid a major bribery investigation in China, which landed it with a record fine, and was part of an effort by former chief executive Andrew Witty to improve the company’s reputation.

There was speculation at the time that other companies would be forced to follow suit, but in the event that did not happen.

Witty was replaced as CEO in 2017 by Emma Walmsley, who has brought a sharp commercial focus to operations, including a drive to reallocate resources to priority new medicines.

In addition to payments for speaking engagements, the updated GSK policy also allows for reasonable travel costs for medics to attend company-organized meetings – except in the United States – and registration fees for remote congress webinars and webcasts….”


Interesting case from 2011 (see below) involving drug reps suing Glaxo for overtime. This document gives a good insight into the culture of GSK at this time. Timely piece, considering Glaxo have decided to backtrack on their promises not to pay physicians to speak for the company (I wonder did Emma Walmsley make that decision?). Obviously profits must always come before ethics with Glaxo- we couldn’t have it any other way with them could we?

Basically this kind of thing is legalized bribery, that’s the job of a drug rep- to legally bribe/persuade a doctor to prescribe Glaxo drugs over competitors. Glaxo has everyone bribed (legally). From the key opinion leaders in the psychiatric profession- through money for talks etc (and every other medical specialty), to universities (sponsorship of research/bursaries, academic departments), lawfirms (glaxo spends billions on legal fees, and it has a legal war chest that can crush anyone and often it does – see Eric Holder fiasco), regulators (revolving door between industry and FDA/MHRA – see Ian Hudson fiasco), Charities (Well Child etc), many lords, and MP’s, and other high level business elites have stocks and shares in Glaxo (vested interests at high levels), the media (sponsorship of journalists prizes for pro-industry slanted articles etc- see Ben Goldacre fiasco).

The list is endless. The Pharmaceutical industry has every facet bought. They have endless cash reserves to bribe every corner of society.

Utterly corrupt.

Anyhow, here’s snippets from the document (click on the link for full read):

 

 


https://caselaw.findlaw.com/us-9th-circuit/1555802.html

PSRs also try to build business relationships with physicians, respond to their concerns, and recruit them to attend Glaxo-organized dinners and conventions.

PSRs usually work outside of a Glaxo office and spend much of their time traveling to the offices of, and working with, physicians within their assigned geographic territories. Plaintiffs visited between eight and ten physicians each day, usually between the hours of 8:30 a.m. and 5:00 p.m. Plaintiffs claim that they worked between ten and twenty hours each week outside of normal business hours, for which they received no overtime wages. When not making calls on physicians, Plaintiffs studied Glaxo products and relevant disease states, prepared new presentation modules, answered phone calls, checked email, generated reports, and attended events on evenings and weekends.

Before a PSR makes his or her daily calls, Glaxo provides him or her with detailed reports about the physicians he or she will visit. These reports include information about a physician’s prescribing habits and drug preferences, the market volume of Glaxo products prescribed by the physician versus the volume of competitor products, and the volume of prescriptions filled in a particular region. Glaxo also provides each PSR with a budget to use for speaker programs and to engage socially with physicians.

Glaxo prepares and provides information about its products-called “Core Messages”-for PSRs to present to physicians during calls. Core Messages include information about product benefits and risks, dosage instructions, and the types of patients for whom Glaxo recommends each product. Glaxo expects PSRs to use the Core Messages and then “[d]evelop and deliver informative sales presentations based on customer needs.”

Plaintiffs received two types of pay-salary and incentive-based compensation. Incentive-based compensation is paid if Glaxo’s market share for a particular product increases in a PSR’s territory, sales volume for a product increases, sales revenue increases, or the dose volume increases. Glaxo aims to have a PSR’s total compensation be approximately 75% salary and 25% incentive compensation.4 However, the dollar value of incentive-based compensation is uncapped.

 

Where is the outrage?


https://www.bmj.com/content/362/bmj.k3948/rr-1

Pandemrix and narcolepsy

Where is the outrage? GlaxoSmithKline suppressed clear danger signals from vaccination with Pandemrix. The result, to begin with, was the suffering of a large number of children and adolescents who developed narcolepsy. Peter Doshi is to be commended for dispassionate reporting of the facts, but I am frustrated by his cool rhetoric in the face of what I believe are acts of greed and cruelty.

The facts reported by Doshi are new, but the pattern of behavior is not. The manufacturers and their professional surrogates are past masters at doing research that shows short-term vaccine efficacy but that does not reveal serious adverse effects. They always end up saying, as in this case, that “there is no proof of a causal association.” Such behavior might be forgiven if influenza vaccines were real lifesavers, but we still do not know if they have done more good than harm in the long run. I am not alone in making this assertion.

Not long ago Gaffney and Lexchin said that US and Canadian pharmaceutical systems, “…are dysfunctional. Costs are exorbitant, commercial goals distort drug development, misleading promotion fosters misuse, and medications are too often unaffordable for patients.” (BMJ 2018;361:k1039) Much the same can be said for the development and promotion of vaccines in the last 10-15 years.

I get frustrated and angry about the promotion of some drugs and vaccines, but I am saved from despair by the efforts of professionals like Doshi and his colleagues who keep plugging away at the facts.

Allan S. Cunningham

Competing interests: No competing interests

24 September 2018
Allan S. Cunningham
Retired pediatrician
Cooperstown NY 13326, USA

GSK’s Recent Drug Recalls..


Those who keep a finely tuned eye on GSK won’t fail to notice that they are involved in a lot of product recalls (see here) . Of course the Reilly versus GSK lawsuit is obviously related to GSK’s manufacturing (or lack of good manufacturing) and this malfunctioning system leads to substandard drugs being released. GSK were fined for their Cidra debacle, but how many more Cidra’s are there out there? who knows? Perhaps we will find out through another lawsuit- the blue-cross blue shield one?

In the meantime, more GSK products are recalled..

http://publicaffairs-sme.com/productrecalls/?p=1573

18-026 QA PRODUCT RECALL – GLAXO SMITH KLINE RECALLS 24 HR PREVACID DUE TO POSSIBLE MICROBIAL CONTAMINATION

Date:  4 OCT 2018                                                                                     Recall: # 18-026

Scope: WORLDWIDE RETAIL FACILITIES, DCs & ECOMMERCE

Out of abundance of caution, Glaxo Smith Kline announced a voluntary recall of Prevacid 24 Hr capsules due to possible microbial contamination. The Exchange currently sells the 14ct. capsules.

Hazard: Healthy people can develop mild illnesses from contact with some forms of microbial contamination, however; serious infections may occur in people in the hospital and/or with weakened immune systems.

Incidents/Injuries: To date, no illnesses have been reported in connection with this problem.  This recall is being conductined out of abundance of caution.

Description: The following product is affected.

Remedy: Customers who purchased the product are encouraged to return it to the store where it was purchased for a full refund.

Consumer Contact: Customers who have additional questions or concerns should contact the GSK Customer Service team at 1-800-743-4014, Option 5 for PREVACID® 24HR 15 mg Lansoprazole Capsules, Recall Event Number 134PREV18.

Sold at: Worldwide Exchange facilities, Online E-commerce and other retailers.

Manufacturer(s): Glaxo Smith Kline


 

https://www.staterbros.com/product-recalls-catalog/prevacid-24hr-capsules/

Prevacid 24HR Capsules

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC Voluntary Recal Prevacid 24HR Capsules

For Immediate Release

Items affected at Stater Bros Markets are:

PREVACID 24HR CAPSULES  14 CT   3-00676-28614-3  *SP ITEM     

PREVACID 24HR CAPSULES  42 CT  3-00676-28642-6   *SP ITEM

 

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC Date: September 26, 2018

184 Liberty Corner Drive
Warren, NJ 07059

Consumer Contact:

GSK Customer Service team at 1-800-743-4014, Option “5”, for PREVACID® 24HR 15 mg Lansoprazole Capsules, Recall Event Number 134PREV18.

Dear GSK Customer:

This letter is to inform you that GSK Consumer Healthcare is conducting a voluntary retail level recall of:

Prevacid® 24HR Capsules, 15 mg lansoprazole (14, 28, and 42 counts)

UCC: Please refer to Attachment 1 for full list of impacted UCC codes

UPC: Please refer to Attachment 1 for full list of impacted UPC codes

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

In keeping with our commitment to quality, GSK Consumer Healthcare has made the precautionary decision to voluntarily recall all Prevacid® 24HR Capsules lots within expiry at the retail distribution level. This decision is based on microbiological out of specification results obtained for one lot of Prevacid® 24HR Capsules that remains within GSK control and has not been distributed. Although all lots on the market and within expiry have met all release test specifications, current available data cannot exclude potential impact to released product. There is no evidence of a consumer safety concern based on a completed medical assessment that concludes the use of, or exposure to, the affected product is not likely to cause adverse health consequence.

Please note that product is being recalled at the retail level. This is not a consumer level recall.

Affected lots (within expiry) were manufactured between October 8th, 2015, and March 26, 2018, and distributed in the timeframe between January 7th, 2016 and September 2nd, 2018.

GSK Consumer Healthcare is committed to providing the highest quality products to our customers. We regret any inconvenience this recall may cause and appreciate your cooperation.

If you have any questions, please contact our GSK Customer Service team at 1-800-743-4014, Option “5”, for PREVACID® 24HR 15 mg Lansoprazole Capsules, Recall Event Number 134PREV18.

 

While Wendy Burn Plays Mind Games… People Die…


“…Half of all those taking antidepressants experience withdrawal problems when they try to give them up and for millions of people in England, these are severe, according to a new review of the evidence commissioned by MPs….

https://www.theguardian.com/society/2018/oct/02/antidepressant-withdrawal-symptoms-severe-says-new-report


A recent study touted in the media claims that up to 30% of people on SSRI antidepressants might experience severe withdrawal symptoms. This isn’t news to me, or the millions of people who have experienced severe withdrawal symptoms, and it isn’t news to the researchers, authors, bloggers, journalists, critical psychiatrists, documentary film makers, bereaved parents of SSRI tragedies, psychologists etc- but to the royal college of psychiatry, it seems to be.

Or is it?

It’s been known for at least 16 years in the mainstream UK (since around the time of the BBC’s Secrets of Seroxat documentary) that SSRI’s have a risk of serious withdrawals, however it seems that psychiatry, and psychiatrists (such as Wendy Burn) has been actively deflecting anything that would make SSRI’s look bad ever since.

Wendy (the Royal college of Psychiatrist’s UK president) seems to see her role not as a patient advocate as such, but more of a guardian of the psychiatric paradigm, and even the dogs on the street know by now- the psychiatric paradigm is owned by the Pharmaceutical industry, and has been for some time. Therefore, perhaps Wendy knows not who-or what- she really serves?

(or maybe she knows all too well?)

Wendy, claims that the study -touting 30% will experience severe withdrawals- is not scientific, and that also, we must

 

“…Remember this is a selected group, not randomly chosen. Terrible for those affected and we must try to help them but it is not 30% of everyone who ever takes an antidepressant…”

https://twitter.com/wendyburn/status/1049758874612506625


Let’s stop for a minute and consider that Wendy is correct (and she might be correct), let’s consider that it is not 30% of people who will have severe withdrawals, let’s bring down our guesstimate to 5% (a really low conservative guess) and let’s apply that to the real world.

A recent article in the UK press said that up to one in 6 people at any time in England will be on an SSRI drug.

….with over seven million adults (16% of the English adult population) being prescribed an antidepressant in England alone last year,” says the review….”

https://www.theguardian.com/society/2018/oct/02/antidepressant-withdrawal-symptoms-severe-says-new-report

That’s seven million adults in the UK. All on SSRI drugs.

If we take the most conservative estimate of 5%, not the 30% that has been touted in the media, and which Wendy of the college of psychiatrists, says is not an accurate number. Let’s go down by 25% to 5% as our most conservative estimate.

5% of 7,000,000 is

350,000

That’s 350,000 people who could be experiencing debilitating withdrawals, withdrawals so severe that they are ill for months, sometimes years. A Withdrawal so severe and horrific that they can’t work, they lose relationships, jobs, their lives, personalities, health and so on. Some might be in such pain from the severe withdrawal that they kill themselves. I felt that way on Seroxat, the despair in a severe Seroxat withdrawal is beyond words.

It’s Stephen King level horror… and then some.

There are no official guidelines for helping those in severe withdrawals, no supports, and outdated advice from NICE. Many people will be left alone in agony and some will die because of it.

But Wendy doesn’t see any of this as a problem.

She doesn’t see that severe withdrawals are a serious problem, and that denial of them is also a problem..

She doesn’t see conflicts of interest between psychiatry and pharma as a problem either.

Perhaps people like Wendy are the problem?

DpJgGHwWkAANesc.jpg

GSK Pandemrix jab fears reported two years before Irish recall..


Swine flu jab fears reported two years before Irish recall

Group fighting for narcolepsy sufferers ‘shocked and appalled’ by British Medical Journal report

The new UK study revealed that even in 2009 there were indications Pandemrix had a rate of adverse reactions far higher than other vaccines. Photo: PA
The new UK study revealed that even in 2009 there were indications Pandemrix had a rate of adverse reactions far higher than other vaccines. Photo: PA

Ralph Riegel and Eilish O’Regan

A leading medical journal has warned that serious safety “indicators” were raised over the swine flu vaccine Pandemrix in 2009 – almost two years before the vaccine was finally suspended from use in Ireland.

 

‘The British Medical Journal’ published a major investigation into the use of the drug across Europe where it is now linked to cases of narcolepsy or severe sleep disorders in children.

Last night, one solicitor acting for Irish children who developed narcolepsy said it was “a scandal” families have been fighting for justice for seven years while the State was aware of such data.

Support group Sufferers of Unique Narcolepsy Disorder (SOUND) said the report was “shocking and utterly appalling.”

The British report relies on multiple European investigations and ongoing legal actions over the drug, manufactured by GlaxoSmithKline (GSK).

Last August, a major Irish Independent investigation revealed some children received a double dose of Pandemrix when stocks of the vaccine were used from January 2011 amid fears there would be a shortfall for the normal winter flu jab.

Solicitor: Michael Boylan is handling many of the narcolepsy cases. Photo: Collins Courts
Solicitor: Michael Boylan is handling many of the narcolepsy cases. Photo: Collins Courts

Thousands of children received a single vaccine dose in 2009/2010 at the height of swine flu scare.

But the 2011 re-issue was almost two years after research data showed indicators that Pandemrix had a far higher rate of adverse incidents than other comparable vaccines.

Pandemrix was re-issued to GPs nationwide in 2011 despite the fact major studies were already under way in Sweden and Finland into potential links with narcolepsy.

Re-issued in Ireland on January 7, 2011, the vaccine was recalled on March 28, 2011 when both studies indicated there was a likely link to narcolepsy.

The new UK study revealed that even in 2009 there were indications Pandemrix had a rate of adverse reactions far higher than other vaccines.

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It calculated Pandemrix had a 500pc greater rate of “adverse events” reported than another swine flu vaccine.

In Ireland, Pandemrix was only made available before it had completed its testing protocols because the Government had offered GSK a full indemnity.

Almost 100 families are now suing the Government, Health Service Executive and GSK.

Many of the narcolepsy cases are being handled by solicitors Michael Boylan and Gillian O’Connor.

“The fact that the general public were not made aware by the Minister for Health or the HSE that Pandemrix was untested prior to or even during the vaccination programme as adverse data emerged is one of the reasons why we have now served the State defendants with claims for aggravated and exemplary damages,” Ms O’Connor said.

“It is a scandal and totally unacceptable that our clients have had to fight tooth and nail for accountability and appropriate redress for the dreadful injuries caused for the past seven years given that this information has been within the defendants knowledge all this time.”

GSK declined to comment given ongoing legal action.

SOUND said the group was “shocked and appalled” at the report.

“These revelations now present very serious questions for the State, the HSE and GSK as to what exactly happened with Pandemrix.

“These shocking revelations require immediate answers to who knew what and when. We need accountability now,” SOUND co-founder Tom Matthews warned.

The HSE insisted its vaccine selections in 2009 were on the basis of expert medical advice supported by an external panel of experts.

GlaxoSmithKline, Walgreen accused of negligence for allegedly selling Paxil to pregnant women


 

 

CHICAGO — A group of mothers are suing GlaxoSmithKline, which manufactured the antidepressant drug Paxil, and Walgreen Co., citing alleged strict liability.

Alexandria Hamilton, Deanna James and Kenneth West filed a complaint on Aug. 31 in Cook County Circuit Court, alleging the defendant companies failed to adequately warn of the alleged dangers of taking the drug paroxetine while pregnant.

According to the complaint, between 1998 and 2005, the mother plaintiffs were prescribed and used branded paroxetine, sold under the brand name Paxil, during their pregnancies, allegedly resulting in birth defects.

The plaintiffs request a trial by jury and seek an amount in excess of the court’s jurisdictional requisite, costs of the action and such further relief as the court deems proper. They are represented by Kenneth Brennan, Tor A. Hoerman and Steven Davis of TorHoerman Law LLC in Chicago.

Cook County Circuit Court Case number 2018L009501