Wendy Burn’s Baptism Of Fire: Welcome To The Twitter-Verse…


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Twitter is a firestorm at the best of times. It’s a veritable inferno filled with opinions, trolls and cranks. But it’s also the primary PR tool of our times. It’s where current opinions pulsate and the zeitgeist resonates. It’s where consensus builds, and movements cause social change. It’s where the news becomes news in real time. A tweet can ruin, or make, a celebrities career, or it can start world war III; even the US president Trump loves twitter and his tweets cause global media storms daily. It’s not for the fainthearted though- that’s for sure, particularly if you want to get a message across, or if you are trying to represent an organization or ideology (or maintain the status quo). That’s why I was surprised to see Wendy Burn, the president of the Royal college of UK psychiatrists (no less), enter the fray, when she was passed the top job baton by previous president, Simon Wessely, not too long ago.

Whereas Simon was aloof, impersonal, detached, and would block any critical tweeters quicker than you could say lobotomy-Wendy (it has to be said)- has been trying her best to engage with the twitter-verse. Truthfully though, I feel that it can’t be easy for her, particularly when you have a constant avalanche of criticism coming from people who have been harmed by her profession (psychiatry), and particularly also when you have experienced bloggers, such as Bob Fiddaman and others (including myself) putting her on the spot with awkward questions about side effects, conflicts of interest, and the various other gripes us (peeved off) bloggers, tweeters and activists have been brewing on (and researching about) for years.

I never thought I would say this about a senior psychiatrist (considering it is psychiatry that harmed me in so many ways), but I genuinely feel sorry for Wendy. As I said, it can’t be easy entering such a hostile technological social media space like Twitter, particularly for a lady in her position and with her status to defend. However, it also has to be said, that psychiatry has a lot to answer for, and perhaps who better to give answers for psychiatry than the actual president of UK psychiatry?

Personally I have found engaging with Wendy fascinating. I am honestly intrigued to know her opinion on all the stuff that I have been blogging about. For instance, I’d love to know what she thinks of Seroxat/Paxil study 329? or GSK in general as a corporation. I’d like to know what she thinks of the data on psychiatric drugs, does she think it’s reliable? does she think that we can trust drug companies, considering that they have paid tens of billions in fines over the last few years. Fines resulting from misrepresenting data, corrupting doctors and psychiatrists, committing fraud and harming patients etc.

I have tried to engage Wendy with some of these topics. For instance, I asked her several times what she thought of the well documented scandal of Seroxat harming teenagers, or Zyprexa causing diabetes, or Risperdal causing breasts to grow in young men. All of these side effects have been well documented; there have been 18,000 cases settled in regards to Johnson and Johnson’s Risperdal causing breasts in boys, and Ely Lilly also settled a similar amount of legal claims in regards to Zyprexa causing diabetes. Seroxat is still under the spotlight, with a case won recently in regards to Seroxat side effects causing harm to a man (during his youth) in the Netherlands (see here). I’d love to hear Wendy’s opinions on these cases, and others, however, she has not been forthcoming as of yet.

I’d also love for her to read though my blog because I genuinely feel that she is grossly misinformed about the many topics in the arena of mental health that she works in. I feel that she is blinded by ideology and caught up in a reductionist ideological gaze (of psychiatric mindsets) which leaves little room for openness to differing experiences and opinions. For example, she didn’t know that Seroxat can cause bleeding, even though this is a common enough side effect on SSRI’s like Seroxat. In my case, my nose bled regularly, and also blood was in my stool a lot. I literally felt like my stomach lining was on fire whilst on Seroxat; it seemed to be poisoning and burning my entire digestive tract. The nose bleeds stopped when I came off it and I have no idea what kind of damage in my brain happened with Seroxat, and I’m not sure I even want to. However, what is worrying is Wendy doesn’t seem to know what side effects to expect with SSRI’s. Seroxat has a litany of side effects, that seems to grow with its PIL every couple of years (see here). As the head of the royal college of psychiatry, (and a virulent promoter, believer and prescriber of these drugs) Wendy should surely know the full side effect profiles of them?



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There are many other concerns I have, and which I would like to discuss with Wendy, however so far it seems, she engages and then disengages just as quick, leaving topics unexplored, questions hanging in the air, and discussions left unsettled. At this rate, it seems that the maelstrom of tweets in the various topics unresolved will likely tangent off into something else, or just hang there. I understand that Wendy is a very busy lady, with a very busy role, but I really feel that if she is going to engage with us (the public) that she should at least address things properly.

I’d appreciate if Wendy would give her opinion on Zyprexa (an anti-psychotic) causing diabetes. In particular I’d like to ask her what she would say to those harmed by Zyprexa, or to the manufacturers Eli- Lilly, who suppressed these side effects for years?

“…..Eli Lilly and Co. announced last month that it has entered into settlement agreements with attorneys representing thousands of patients who claim they were harmed by the company’s second-generation antipsychotic medication, Zyprexa (olanzapine). All told, the settlements could amount to payouts equaling $1.2 billion…”

https://psychnews.psychiatryonline.org/doi/full/10.1176/pn.42.3.0001a


I’d also be interested to know what Wendy thinks of Seroxat/Paxil harming teens. GSK were caught lying about Seroxat side effects too, in particular in relation to suppression of data about suicidal side effects in teens, young people and children. What would Wendy say to the families of these young people prescribed Seroxat? What would she advise others worried about these side effects?

“…..An influential study which claimed that an antidepressant drug was safe for children and adolescents failed to report the true numbers of young people who thought of killing themselves while on it, re-analysis of the trial has found

Study 329, into the effects of GlaxoSmithKline’s drug paroxetine on under-18s, was published in 2001 and later found to be flawed. In 2003, the UK drug regulator instructed doctors not to prescribe paroxetine – sold as Seroxat in the UK and Paxil in the US – to adolescents….”

https://www.theguardian.com/science/2015/sep/16/seroxat-study-harmful-effects-young-people

Furthermore, I’d like to ask Wendy what she thinks of Risperdal causing breasts to grow in young boys, surely this horrible side effect would be extremely distressing for already vulnerable young men under psychiatric care? What does she think of drug companies that put profits before patients? surely the ‘mentally ill’ demographic are the most easily exploitable cohort of consumers? and if so, doesn’t this make it worse that they are treated with such callous disregard by Pharma (the main sponsors of psychiatry and individual psychiatrists)?

 

“….Johnson & Johnson has been fined over $3 billion for marketing the antipsychotic drug Risperdal to children. Over 18,000 boys and young men are now suing the company over a side effect of the drug called gynecomastia, which causes adolescent boys to develop female breasts….”

https://petapixel.com/2017/05/11/boys-grew-breasts-portraits-effects-risperdal/

There are many debates currently brewing (or burning -whichever way you see it yourself) with Wendy Burn on Twitter.

I sincerely hope Wendy continues to engage on Twitter, because I feel these are very valuable debates to have, and her contribution is also very much valued and appreciated too.

But I hope also that she genuinely addresses our concerns and questions, and doesn’t just stick her head in the sand, ignore and deny, like so many psychiatrists tend to do.

 


 


 

 

 

 


 

 

 


 


 

Maybe Wendy will appreciate the music below. They are extremely emotional pieces of music, and perhaps that’s what is missing about how psychiatrists perceive the world, and the people in it. Emotions are the driving force for people, not brain chemistry. Attempting to modify emotions through prescribing chemicals does not fix emotional distress. We don’t love with our brains, we love with our hearts, our minds and our feelings. We don’t grieve from our brains, we grieve from our entire beings; we long from our mysterious souls, from undefinable depths in our psyches.

If an emotion triggers brain chemistry it’s still the emotion (which is unquantifiable) that comes first. Psychiatry needs to recognize emotions more not less. All this focus on the brain has not progressed our understanding of the human condition.

In fact, it has hindered it- a lot.

Maybe Wendy will enlighten psychiatry out of its darkness? Or maybe not?


 

 

 

 

 

 

 

 

 

 

 

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“…It was struggling to maintain its global standard at the factory..” : GSK Shuts Down Bangladesh Drug Plant…


So what exactly are GSK’s global standards?

According to this lawsuit (by ex GSK employee and IT expert – Thomas Reilly) they are worryingly bad..

https://truthman30.wordpress.com/2018/06/23/thomas-reilly-versus-glaxosmithkline-glaxos-manufacturing-processes-are-not-fit-for-purpose/

 

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

“….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.


https://www.thedailystar.net/backpage/medicine-production-bangladesh-gsk-shuts-its-unit-after-six-decades-1611799

Medicine Production in Bangladesh

GSK shuts factory after six decades

Closure to affect 1,000 people employed at its unit in Ctg

GlaxoSmithKline (GSK), one of the world’s leading research-based pharmaceutical and healthcare companies, has decided to close its medicine manufacturing unit in Bangladesh after over six decades of operation.

The company made the decision at its board meeting held at a city hotel yesterday, two of its directors told The Daily Star.

The closure would affect around 1,000 people it employs at its factory in Fouzderhat of Chittagong.

GSK, however, will continue with its consumer healthcare unit that produces Horlicks, Sensodyne and Glaxose-D in Bangladesh as the company makes a healthy profit from this segment.

“There is no way that GSK Pharmaceuticals can survive in Bangladesh,” one of the directors commented.

Responding to a query about GSK’s efforts to sell its pharmaceuticals unit, he said the company evaluated all options, including sale, but nothing worked.

“Who is going to buy this white elephant?” the director said. “It’s a very old plant and has been incurring losses for years. Also, GSK was struggling to maintain its global standard at the factory,” said the member of the board.

The London-based pharmaceuticals giant makes vaccine solutions for Hepatitis A and B, Cervical Cancer, Chickenpox, Measles, Mumps and Rubella, Rotaviral diarrhoea, Pneumonia etc. Its portfolio includes leading brands like Engerix, Rotarix, Cervarix and Synorix.

The company also manufactures antibiotics, medicines for respiratory diseases and dermatological items. Ventolin Evohaler is a well-accepted   treatment in Bangladesh. In anti-histaminic market, Piriton is still one of the top preferences.

In addition to decades-old machines in the factory, there were some other issues behind the closure, according to a top official of the company.

Some of the rival Bangladeshi companies have modern manufacturing units that produce generic medicines, the official said.

Bangladesh also imports low-cost medicines from countries like China, which poses another big challenge for GSK’s business in Bangladesh, the official added.

The Daily Star contacted GSK Bangladesh’s Managing Director Nakibur Rahman through the company’s public relations firm for comment on the issue.

Nakibur said: “At our Q2 Business Update in July 2017, GSK announced that we will run Pharmaceuticals in our Emerging Markets region as an integrated operation, putting in place the right commercial structure in markets to deliver a sustainable growth ambition. We are unable to comment further at this time.”

Asked about the impact of GSK’s decision, SM Shafiuzzaman, general secretary of Bangladesh Aushad Shilpa Samity, a forum of local pharmaceuticals companies’ owners association, said it would be nothing significant.

“GSK makes medicines based on its research, but we produce generic medicines. Some local companies with their top-class plants can make the medicines GSK made in Bangladesh,” he said.

THE PLANT

About 500 employees of GSK Bangladesh demonstrated in front of the factory in Fouzderhat yesterday protesting the closure, our Chittagong office adds.

Head of the GSK’s regional supply chain Raju Krishnaswami announced the permanent closure of the company’s pharmaceuticals production, distribution and marketing in Bangladesh around 4:45pm, said Mohammed Ilias, president of the employees’ union of GSK Bangladesh.

He told The Daily Star around 7:45pm that their leaders were in a meeting with Krishnaswami.

He said there were about 500 permanent and 500 temporary employees at the factory.

In a statement GSK Bangladesh said GSK would treat all affected employees with respect and dignity, and provide them with support during this challenging time.

Bangladesh has a very vibrant and strong local pharmaceutical industry. All of GSK’s medicines are substitutable with generics and therefore patients should be able to access a range of suitable alternatives, the statement said.

According to the statement, GSK Vaccines, which are purchased via Unicef and funded by Gavi, the Vaccine Alliance, will continue to be available in Bangladesh.

GSK set up its Bangladesh production facilities in 1963. It is a publicly traded company at the Dhaka Stock Exchange since 1976.

Now The Evil Bastards Of GSK Might Have Access To Your DNA Information…


https://www.nbcnews.com/health/health-news/drug-giant-glaxo-teams-dna-testing-company-23andme-n894531?cid=sm_npd_nn_tw_ma

 

Drug giant Glaxo teams up with DNA testing company 23andMe

DNA test results will be used to develop drugs under a new agreement.
by Maggie Fox /
Image: A 23andMe genetic testing kit

A 23andMe genetic testing kit.Kristoffer Tripplaar / Sipa USA via AP

Home DNA test results from the 5 million customers of 23andMe will now be used by drug giant GlaxoSmithKline to design new drugs, the two companies announced Wednesday.

It’s the biggest partnership yet aimed at leveraging the increasingly popular home genetic testing market, in which customers pay for mail-in saliva tests that are analyzed by various companies. 23andMe dominates the market.

“By working with GSK, we believe we will accelerate the development of breakthroughs,” 23andMe CEO Anne Wojcicki wrote in a blog post.

23andMe patrons are asked if they want to participate in scientific research. The new agreement moves this consent firmly into the field of active drug discovery research.

“As always, if our customers do not want to participate in research, they can choose to opt out at any time,” Wojcicki wrote.

Glaxo has invested $300 million in 23andMe and the companies have a four-year deal that gives Glaxo exclusive rights to collaborate with the DNA testing company to develop drugs.

Peter Pitts, president of the Center for Medicine in the Public Interest, said the companies should pay the 23andMe customers whose DNA is used in any research.

“Are they going to offer rebates to people who opt in so their customers aren’t paying for the privilege of 23andMe working with a for-profit company in a for-profit research project?” he asked.

“It’s one thing for NIH (the National institutes of Health) to ask people to donate their genome sequences for the higher good,” Pitts told NBC News.

“But when two for-profit companies enter into an agreement where the jewel in the crown is your gene sequence and you are actually paying for the privilege of participating, I think that’s upside-down.”

Pitts also questioned whether there were solid protocols for protecting the privacy of 23andMe customers.

The first project will look at possible new drugs for treating Parkinson’s disease, based on a gene called LRRK2 that is mutated in some Parkinson’s patients. A study released Wednesday found that the gene may play a significant role in Parkinson’s even among patients who don’t have mutations.

Glaxo is already working on drugs that might work based on LRRK2 activity.

The partnership was dreamed up by the companies’ two chief scientific officers: Hal Barron of Glaxo and 23andMe’s Richard Scheller. The two previously worked together at another drug company, Genentech, they told CNBC.

“When you get a genetically validated target and you pursue it, it’s twice as likely to end up being a medicine,” Barron said in an interview on CNBC.

“The over 5 million customers that 23andMe has gained access to is really many larger … 10 times larger, than some of the other databases out there,” he added.

One of the big obstacles to genetics research is getting enough people to donate their DNA and paying to sequence it. The 23andMe database delivers a huge number of customers who have already consented and whose DNA has already been partly sequenced.

The company can go back and do more sequencing on people who have genetic variations that are of interest.

“We are also excited to leverage the patients, to have them be part of this drug discovery process,” Barron said.

23andMe has been doing some of its own drug development and will now share that information with Glaxo under the agreement

What Will GSK’s Confidential Business Files On Its Cervarix Drug Reveal?…


It seems the only way for us to access the truth about the medications we take is through the court system. How unfair is that?

 

https://www.cbc.ca/news/canada/nova-scotia/judge-orders-health-canada-to-hand-over-pharmaceutical-data-1.4745302

 

 

Health Canada ordered to release confidential drug company data on HPV vaccines

Federal government insisted drug companies’ clinical trial data is ‘confidential business information’

Researchers have been fighting Health Canada for access to industry data without the restriction of confidentiality agreements for years. On July 9, a Federal Court judge ruled in favour of a Maryland-based researcher. (Matt Rourke/The Associated Press)

 

A Federal Court judge has ordered Health Canada to release reams of pharmaceutical clinical trial data on five medications to an American researcher, undercutting the federal government’s attempts to keep the information confidential.

The July 9 ruling stems from a request by Maryland-based researcher Peter Doshi for access to clinical trial data submitted to Health Canada by the manufacturers of the HPV vaccines Gardasil, Gardasil 9 and Cervarix, and the anti-viral medications Tamiflu and Relenza.

He wanted to conduct a “systematic review” of the findings, but Health Canada said it was confidential business information and it would only hand it over if he signed a confidentiality agreement.

Doshi refused and took the federal government to court.

“I hope my case sets a precedent and allows researchers, clinicians, and the public easy access to clinical trial data,” he said in an email to CBC News.

“Regulators shouldn’t have a monopoly on judging the risks and benefits of medicines or hinder others from doing the same via confidentiality agreements,” said Doshi, assistant professor at the University of Maryland School of Pharmacy and an associate editor at the BMJ (formerly known as the British Medical Journal).

Some types of HPV can lead to cervical and other cancers, and vaccines are offered to girls and many boys in Canadian schools. Health Canada says the vaccines are a safe and highly effective way of preventing the types of HPV infections that could lead to cancer.

Tamiflu and Relenza are used to treat influenza.

The court decision earlier this week is the first to interpret and apply Vanessa’s Law. The legislation came in the wake of the 2000 death of an Ontario teenager, to allow Canada’s minister of health to disclose drug information to certain people, such as those who protect or promote public health.

On Thursday, Health Canada said in a statement it is working on regulations that would publicly release the “vast majority of information in clinical trial reports” for a wide range of medications.

It said it expected the regulations would come into effect by the end of the year.

But in court, it nonetheless fought Doshi’s request, arguing it remained its practice to treat unpublished pharmaceutical company trials as confidential business information.

Health Canada’s position ‘unreasonable’

The ruling by Federal Court Justice Sébastien Grammond, who called Health Canada’s stance “unreasonable,” is being welcomed by experts such as Matthew Herder, director of the Health Law Institute at Dalhousie University in Halifax.

Herder has watched the case closely and said he hopes the ruling will encourage researchers, even those outside Canada, to start requesting data on other current drugs on the market.

Matthew Herder, assistant professor of medicine and the director of the Health Law Institute at Dalhousie University, said the Federal Court was correct to rule in the public interest. (Rachael Kelly/Dalhousie University)

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“The court said very clearly the public interest in ensuring access to this information, so that independent researchers can scrutinize it, fundamentally outweighs any sort of interest in terms of protecting commercial interests,” he said in an interview.

“The court didn’t say a confidentiality agreement is never appropriate, it didn’t go that far, but it certainly enshrined the importance of being able to disseminate findings.”

In his ruling, Gammond said publicly disclosing clinical trial results may benefit public health and uncover biased testing, selective publishing and regulatory failures, or overturn previous conclusions on the reliability of drugs.

“Clinical trials are undertaken by researchers under contract with pharmaceutical companies. Their results are usually kept secret,” Gammond wrote. “Pharmaceutical companies have insisted that they constitute confidential business information that regulators should not make public.”

He noted that Vanessa’s Law was enacted after the 15-year-old girl’s father, Terence Young, who later became a Conservative MP, fought for stronger measures to protect the public from unintended side-effects of drugs. Vanessa died following a heart attack while taking the prescription drug Prepulsid.

Dr. Nav Persaud, a staff physician at St. Michael’s Hospital and assistant professor at the University of Toronto, said the judgment is a positive step forward.

Dr. Nav Persaud, a staff physician at St. Michael’s Hospital and assistant professor at the University of Toronto, spent years trying to access confidential industry data to determine the efficacy of the popular morning sickness drug Diclectin. (Craig Chivers/CBC News)

 

Persaud had to sign a confidentiality agreement to get access to information on the anti-morning sickness pill Diclectin. In 2015, Health Canada threatened him with legal action if he broke the agreement.

He hopes the ruling will lead Health Canada to rethink its approach.

“I don’t view this information as confidential business information. Information about the effects of medication people are taking are not confidential,” said Persaud in an interview.  “That type of information should be available to people taking the medication.

“I think it’s important because sometimes re-analyses of this data overturns conclusions. So you could go from thinking a medication is effective to not effective.

“That’s what I think happened in the case of Diclectin. But, unfortunately, because there are so many barriers to doing this type of research, it’s relatively rare that this research is done. The confidentiality agreement is one example of a barrier that regulators like Health Canada put up. And that had the effect of deterring this kind of research.”

Persaud plans to resubmit his request for information on Diclectin to Health Canada and insist that he not be asked to sign a confidentiality agreement.

Judge says department restricted freedom of expression

The ruling added that the department’s refusal to give Doshi the data ignored his fundamental rights to freedom of speech under the Charter of Rights and Freedoms.

Had he signed the agreement, Grammond wrote, and his clinical trial concluded that the drugs were ineffective or revealed new side-effects, Doshi would not have been able to summarize or paraphrase the contents of the documents, or reproduce the company’s conclusion in a paper outlining the results of his research.

“It is difficult to understand how, in practice, Dr. Doshi could meaningfully communicate the results of his research under such constraints,” wrote Grammond.

“Health Canada … simply reiterated a policy that predated Vanessa’s Law. The objectives of that policy are unstated and unclear. As far as one can understand, they appear to contradict the purposes of Vanessa’s Law. The mere fact that the policy is aligned with the preferences of the pharmaceutical industry would be insufficient to justify a restriction on Dr. Doshi’s freedom of expression.”

GSK director (Judy Lewent) sued over US opioid epidemic


https://www.ft.com/content/b0ebbf32-7ec7-11e8-bc55-50daf11b720d

UK pharma company removed work history at Purdue from Lewent’s biography 

David Crow in New York 5 hours ago

A director of GlaxoSmithKline, the British pharmaceuticals company, has been sued by the state of Massachusetts for her alleged role in fuelling the US opioid addiction epidemic. Judy Lewent, who served on the board of opioid drugmaker Purdue Pharma for more than four years until 2014, was named as a defendant in a lawsuit filed by the state’s attorney-general last month. The legal action comes as US authorities step up their campaign against those they hold responsible for a crisis that resulted in 42,200 opioid overdose deaths in 2016. The litigation, described as a “ tidal wave” by experts, is designed to raise funds to cover the costs of the epidemic, including addiction treatment centres and expanded morgue capacity. The epidemic — which has been declared a “public health emergency” by Donald Trump — has attracted international attention, but GSK appears to have recently scrubbed all mention of Ms Lewent’s time on the Purdue board from its annual report and company website.

In the company’s 2016 annual report, Ms Lewent’s biography said she was “previously a non-executive director” of Purdue and an associated company until December 2014. But the 2017 report, released in March this year, omitted that reference. Screenshots from GSK’s annual report in 2016, left, and 2017: the reference (highlighted) to Ms Lewent’s connection to Purdue Pharma and associated groups was removed A similar change was made to the company’s website some time after November 2017, according to a preserved copy from The Internet Archive, a not-for profit group that maintains a library of historical webpages. A spokesperson for GSK said: “It is not appropriate for GSK to comment on legal matters faced by another company. Board biographies are updated and approved by directors during the routine annual report process. “Reference to Ms Lewent’s role as non-executive director of the private company Purdue Pharma, which ended on 31 December 2014, was disclosed in previous annual reports.”

Following the FT’s enquiries, the company said it would update its website so that Ms Lewent’s biography mentioned her tenure as a director of Purdue. Ms Lewent declined to comment via a GSK spokesperson and did not respond to direct enquiries. More than 30 US states, cities, counties and other local authorities have filed lawsuits against Purdue, a privately-held company that was among the biggest producers of opioid painkillers, as well as other drugmakers, wholesalers and pharmacy groups. Although most fatalities are caused by heroin spiked with fentanyl, a synthetic opioid, the majority of victims first became hooked on prescription painkillers like Purdue’s OxyContin before progressing to the illegal street drug.

However, the lawsuit filed in Massachusetts last month represented a new front in the legal fight because it targeted individual executives and directors of Purdue such as Ms Lewent and members of the wealthy Sackler family, which owns the company.

Ms Lewent, who is chair of GSK’s audit and risk committee, was paid $476,000 in fees by the British pharmaceutical company last year and $496,000 in 2016. A former chief financial officer at Merck & Co, the US drugmaker, she also serves as a director of Thermo Fisher Scientific and Motorola Solutions. OxyContin, made by Purdue Pharma, has been criticised for serving as a gateway to opioid addiction The legal complaint filed by Massachusetts alleges that Ms Lewent and the other defendants deceived patients and doctors on the risks of prescription opioids. It alleges that Purdue marketed the painkillers to vulnerable people, including the elderly, and encouraged physicians to prescribe them for long periods of time. Ms Lewent, who joined the Purdue board in 2009, and other directors were paid “hundreds of thousand of dollars” by the company, according to the lawsuit. The lawsuit says the directors were kept apprised of “signs that patients were being harmed” via regular reports, which “came in by the hundreds and even thousands”. Such reports were allegedly sent to Ms Lewent on eight occasions between April 2010 and July 2013.

A spokesperson for Purdue said it shared the attorney-general’s “concern about the opioid crisis”, but added: “We are disappointed, however, that in the midst of good-faith negotiations with many states, [Massachusetts] has decided to pursue a costly and protracted litigation process.” The spokesperson said the company “vigorously” denied the allegations and that it would continue to “work collaboratively with the states towards bringing meaningful solutions to address this public health challenge”. Purdue has not yet filed a response to the Massachusetts suit, but has filed motions to dismiss legal actions bought by other local authorities. One of its main lines of defence is that its medicines were approved by the US Food and Drug Administration for the treatment of chronic pain, which gave it the right to market them to doctors. “We believe it is inappropriate for [Massachusetts] to substitute its judgment for the judgment of the regulatory, scientific and medical experts at FDA,” said Purdue.

 

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GSK’s Pandemrix Damage: These NHS Staff Were Told The Swine Flu Vaccine Was Safe, And Now They’re Suffering The Consequences


https://www.buzzfeed.com/shaunlintern/these-nhs-staff-were-told-the-swine-flu-vaccine-was-safe?utm_term=.yax9NnNkVk#.mrZzO9OA8A

These NHS Staff Were Told The Swine Flu Vaccine Was Safe, And Now They’re Suffering The Consequences

Dozens of NHS workers are fighting for compensation after developing narcolepsy from a swine flu vaccine that was rushed into service without the usual testing when the disease spread across the globe in 2009. They say it has destroyed their careers and their health.

Posted on

When nurse Meleney Gallagher was told to line up with her colleagues on the renal ward at Sunderland Royal Hospital, for her swine flu vaccination, she had no idea the injection she was about to have had not gone through the usual testing process.

It had been rushed into circulation after the swine flu virus had swept across the globe in 2009, prompting fears thousands of people could die. From the moment the needle broke Gallagher’s skin, her life would never be the same.

“I remember vividly we were all lined up in the corridor and we were told we had to have it. It wasn’t a choice,” she claimed. “I was pressured into it. We were given no information.”

The date was 23 November 2009 and Gallagher was one of thousands of NHS staff vaccinated with Pandemrix, a vaccine made by pharmaceutical giant GlaxoSmithKline (GSK).

Eight years later, her career in the NHS is a memory and she’s living with incurable, debilitating narcolepsy and suffers from cataplexy, a sudden, uncontrollable loss of muscle tone that can cause her to collapse without warning. Because of her condition, she can no longer work or drive.

People with narcolepsy experience chronic fatigue and difficulty sleeping at night. They can have night terrors, hallucinations, and a range of mental health problems.

Gallagher is not alone. More than a dozen frontline NHS staff are among around 1,000 adults and children across Europe who are believed to have developed narcolepsy after being given Pandemrix. Today BuzzFeed News can reveal for the first time their battle to gain acknowledgement for a government decision that they say ruined their careers and has dominated their lives since.

Gallagher and four other NHS professionals – two nurses, a community midwife, and a junior doctor – have told how they felt pressured into receiving the vaccine, were given misleading information, and ultimately lost their careers.

They are all suing GlaxoSmithKline seeking compensation for what they believe was a faulty drug that has left them with lifelong consequences and means they will require medication and support for the rest of their lives.

Meleney Gallagher

Photo by Bethany Clarke / edited by Laura Gallant / BuzzFeed

Meleney Gallagher

They have been forced to take legal action, along with almost a hundred other sufferers, to force the company and the government to accept the consequences of the rushed vaccination programme eight years ago. In contrast to the UK, European countries have already compensated people whose narcolepsy was linked to the swine flu vaccine.

The revelations come the same day that health secretary Jeremy Hunt launched new measures to improve patient safety in the NHS, in response to research conducted by experts at the Universities of Sheffield, Manchester, and York that showed prescription errors cause 1,700 deaths each year, could contribute to as many as 22,000 deaths, and cost the NHS £1.6 billion.

The BuzzFeed News investigation raises serious questions over the advice that was given to NHS staff at the time by the government’s chief medical officer, the chief nurse, and the national flu director that the vaccine had been “thoroughly tested” and was safe to use. That advice was shared in a joint statement by the Department of Health (DH), medical royal colleges, and trade unions, including the British Medical Association and Unison.

Normally vaccines undergo testing to make sure they are safe, and vaccination has been proven to save millions of lives across the globe. But Pandemrix was different. It had not gone through the normal process and was fast-tracked without the usual clinical trials.

Staff were also not told that the government had agreed a unique deal with GSK to indemnify the company for any problems with the vaccine.

The investigation also turns the spotlight on decisions by the UK government to continue using the vaccine even after other European countries suspended its use once evidence of a problem emerged.

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Peter Carter, then chief executive of the Royal College of Nursing, told BuzzFeed News it was “a matter of huge concern” that the vaccine had not been properly tested, contrary to what he was told at the time.

Meleney Gallagher was diagnosed in 2013 but only after years of being unable to stay awake and having cataplexy attacks several times a day, sometimes caused simply by laughing.

Meleney Gallagher

Photo by Bethany Clarke / edited by Laura Gallant / BuzzFeed

Meleney Gallagher

She switched jobs to be a district nurse, but the problems got worse. She said: “I was falling asleep in the clinic and driving home. I had cataplexy attacks when I was in the room with patients. I knew I wasn’t safe to practise.”

Although she sought help from occupational health services, her GP employer reported her to the Nursing and Midwifery Council and she was medically retired in April 2017. She received just 12 weeks’ pay for 20 years’ service in the NHS.

She said she had been denied an informed choice over the jab. “They can’t just do what they want with vaccines, otherwise it’s like Russian roulette and you can’t do that. I just want someone to stand up and to say they were wrong and apologise. Someone to be sorry for what they have done. I feel really angry.”

Gallagher’s vaccination was part of a concerted effort by the Department of Health to immunise as many workers as possible. At the time, there was widespread global concern about the spread of the swine flu virus and fears it could replicate the Spanish flu of 1918.

While the concern was to save lives, it is alleged that senior figures in the department, including the chief nurse, chief medical officer, and national flu director, did not give a full picture of the vaccine.

A swine flu leaflet produced by the DH for staff and patients ahead of the nationwide vaccination said: “The European Commission carefully considered all the evidence and recommended that [the vaccine] could be used.”

But it made no mention of the fact the European Medicines Agency had licensed Pandemrix under “exceptional circumstances” based on “mock vaccines” that did not include the actual ingredients that would eventually be injected into people. The EMA confirmed this approach was “unique to pandemic preparedness vaccines”.

Matt O'Neil

Chris Bethell for BuzzFeed

Matt O’Neil

The DH leaflet also made no mention of the government’s agreement to indemnify GSK for any problems with the vaccine. This was not widely known at the time, and the indemnity deal has never been published. In the summer of 2009, Wolf-Dieter Ludwig, chair of the German Medical Association’s drug commission, had warned EU governments not to bear the risk for pharmaceutical companies.

Nationwide vaccinations started in the UK on 21 October 2009, despite the fact that experts at the DH had known since May the flu was milder than first thought. On 22 October, ministers agreed to revise down the worst-case scenario from 19,000 deaths to 1,000.

Ahead of the vaccinations starting, Dame Christine Beasley, then chief nursing officer for England, told Nursing Times: “We’ve gone through exactly the same procedures as we do with seasonal flu vaccine and it’s as safe as a vaccine can be.”

On the day immunisations began, the RCN’s Peter Carter was quoted saying he was “entirely satisfied” the vaccine was safe because it had undergone “rigorous testing”.

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Carter told BuzzFeed News: “At the time, Liam Donaldson, the chief medical officer, and Professor David Salisbury, the DH’s director of immunisation, were assuring people this vaccine had been thoroughly and properly tested, so people like me, in good faith, had no reason to disbelieve that and were happy to encourage people to have the swine flu vaccine.

“It is a matter of huge concern that several years later it’s now apparent this was not properly tested, and this will obviously shake the confidence of people for any future pandemic flu immunisation programmes. People have a reasonable expectation that what they are being told is accurate and it is a matter of regret that it clearly wasn’t.”

Matt O'Neil

Chris Bethell for BuzzFeed

Matt O’Neil

Salisbury told BuzzFeed News he believed a normal clinical trial would have been too small to pick up the problems with Pandemrix. “Given its rarity, any excess risk could only be detected after huge population exposure done through post-marketing surveillance,” he said.

He declined to comment on staff saying they felt pressured or on issues around informed consent.

Sir Liam Donaldson did not respond to a request for comment.

NHS trusts received six letters between September and October alone urging them to vaccinate staff.

In November 2009, Ian Dalton, then national director for NHS flu resilience and now chief executive of NHS Improvement, wrote for the Health Service Journal that vaccinating staff was the “highest clinical priority”. He stressed the need for staff to have information about “how it has been tested to ensure safety”.

By 4 February 2010, it was clear swine flu was not going to be the catastrophe many had feared and ministers agreed not to extend vaccinations to the public. The NHS vaccination campaign went on because staff were considered a priority group.

Dalton wrote to trusts again saying he expected improvement in the uptake rate despite the “predominantly mild illness”. In an update for the Health Service Journal, he warned against complacency and said the programme was a “key governance responsibility” for NHS boards.

Photo by Bethany Clarke / edited by Laura Gallant / BuzzFeed

By April 2010, around 40% of the NHS frontline staff had been vaccinated with Pandemrix, which was more than double the seasonal flu vaccine uptake of 17% in 2008.

Among them were Hayley Best, an intensive care nurse working in Craigavon, Northern Ireland, and Shane Keenan, a senior emergency nurse practitioner in Oxford, who worked for 35 years in the NHS.

Both said they felt pressured to have the vaccine. Keenan said he felt it was “emotional blackmail”, adding: “We weren’t informed it wasn’t properly trialled.” Best agreed: “It wasn’t that you were asked if you wanted it; you were told this was your appointment.”

Keenan told BuzzFeed News that after he got the Pandemrix jab his life “started to fall apart… By early February [2010], I was having nightmares like you wouldn’t believe and visual hallucinations.”

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Best said the effect on her was similarly dramatic, with severe suicidal thoughts within weeks.

Both said their symptoms were initially dismissed as depression and fatigue. Keenan was referred to specialists in December 2010. He struggled with work and was put through a capability assessment by his trust and moved down a pay band, decreasing his salary by £500 a month.

Shane Keenan

Laura Gallant / BuzzFeed

Shane Keenan

Eventually he realised he couldn’t continue. “I was a potential danger to patients. I went to occupational health and suggested ill health retirement.”

He said narcolepsy had “completely destroyed my life and my career. I worked damned hard to get to the pinnacle of my career. I lectured at Oxford University; now I can’t even stack shelves. I was injured in the line of duty. NHS staff are collateral damage.”

Best wasn’t diagnosed until October 2014. She switched jobs to become a district nurse but still struggled. “It really came to a head in 2014 when I started falling asleep behind the wheel of my car. I just got to the point where I would have driven to somebody’s house and not be able to remember doing it.” She was medically retired in October 2016, just before her 40th birthday.

She said: “I was given a vaccine that wasn’t properly tested. I am a big advocate for vaccination; my children have every vaccine that is offered.

“I was a good nurse, I know I was a good nurse. So where are my employers now? Where is my NHS? Where is my government? If you are going to encourage your frontline staff to have vaccines then the least you can do is have facilities in place if they happen to react to it. I feel completely betrayed. I have been abandoned. The NHS should have something in place if and when it goes wrong.”

Not everyone had been convinced the vaccine was safe for use. Switzerland’s medicine regulator Swissmedic refused to license it for use on under-18s in October 2009, and Michael Kochen, president of the German College of General Practitioners and Family Physicians, told the BMJ that same year that it had not been sufficiently tested to be declared safe.

The first hard evidence of a problem with Pandemrix emerged in 2010 when doctors in Finland noticed a dramatic increase in children with narcolepsy. Since then a number of studies in Europe and the UK have shown the vaccine is linked to an increased risk of narcolepsy in children and adults.

But even then, the Department of Health was not finished with the vaccine. While other European countries suspended its use in August 2010 due to the concerns, the UK used it to fill gaps in the seasonal flu jab supply in January 2011.

Professor Salisbury said at the time it was not a “second-class vaccine” and patients were “getting an effective vaccine and a safe vaccine”.

According to the EMA, more than 980 people across Europe have been reported as developing narcolepsy because of Pandemrix, with 872 people reported as developing cataplexy, including more than 500 children.

Shane Keenan

Laura Gallant / BuzzFeed

Shane Keenan

More than 120 children and adults are believed to have been affected in the UK – some because of vaccinations that took place in winter 2010-11, after the first studies showing the side-effects had emerged and a year after the swine flu scare.

Around 100 UK families are suing GSK claiming the vaccine was a faulty product. Their law firm, Hodge Jones & Allen, declined to comment but the case has been ongoing since October 2013. It could result in a compensation bill as high as £100 million.

In 2016, judges ruled in favour of Josh Hadfield, who received a maximum £120,000 via the Vaccine Damage Payments Act after the Department of Work and Pensions (DWP), which administers the scheme, admitted Pandemrix caused Josh’s narcolepsy when he was vaccinated aged 4.

His mother, Caroline, described the effect of the vaccine to BuzzFeed News: “He would like to have a bath on his own but he can’t because there is a risk that he is going to fall asleep and drown. He is very introverted and doesn’t like going out on his own because he is scared of what might happen.

“He sleeps two to four hours a day at school and that is when he is fully medicated. He has his own small bedroom at school. He doesn’t have a normal childhood.”

She added: “I am not saying all vaccines are bad and people shouldn’t have them. It’s the fact the government won’t help people after something goes wrong.”

During a parliamentary debate in March last year, Tracy Brabin MP accused the government of “foot dragging”, which was “causing unacceptable and upsetting suffering and distress for the families involved”.

She said in Sweden, Finland, Norway, Iceland, and France people who developed narcolepsy due to Pandemrix have already been compensated.

In 2014, 23-year-old nursery assistant Katie Clack died after jumping from a multi-storey car park. In a note to her family written on the day she died, she described the effects of narcolepsy as unbearable and urged her family to continue her legal action against GSK.

For the NHS staff who have developed narcolepsy, their ordeal has been compounded by being forced to battle with the health service and the government for recognition.

Junior doctor Ruth Tunney was in her third year of medical school on placement at Salford Royal Hospital when she volunteered for the vaccine.

“It was bundled in with the seasonal flu,” she told BuzzFeed News. “I don’t remember reading anywhere that it hadn’t been tested. I didn’t see anything that told me it was a different vaccine. It was a generic consent form.”

She added: “I appreciate at the time they thought people were going to die and they had to act. I am completely pro-vaccination but they should acknowledge what has happened and do something about it rather than just denying it, which it feels is what is happening. It’s changed my life for the worse forever.”

Community midwife Susan Hamilton was formally diagnosed in 2012 after falling asleep while driving with her son. Her career was over, and six years on she faces having to sell her family home.

Hamilton said she tried reaching a compromise with her NHS trust but “was told categorically that they could not make a job for me and didn’t have any obligation to make a job for me”.

She said: “I have been forced out of my job because of a faulty drug and a trust who would not help me work around my condition or wait until I was stabilised on my medication. The NHS has abandoned us. We are damaged goods.”

Like other staff, she said was not given information about the vaccine: “We weren’t given a choice. It wasn’t informed consent.”

In response to this winter’s severe seasonal flu there are increasing calls for NHS staff to face mandatory vaccinations. On Twitter, former NHS England and Department of Health medical director Sir Bruce Keogh responded to such calls by saying: “I think a serious debate around mandatory flu vaccination is inevitable before next winter.”

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Speaking to Buzzfeed News, Keogh said: “Every winter flu puts a significant strain on the NHS and a lot of people die. Both can be reduced with sensible vaccination programmes. A debate is emerging on how best to protect both vulnerable patients and staff in the NHS, particularly since there is such a big difference in vaccination rates between NHS organisations and over a third of flu is transmitted by asymptomatic people, meaning staff could unwittingly be spreading flu to their patients. No one wants that.

“Some people are in favour of mandatory vaccination, which could be across the board or only as a prerequisite for working in certain areas. Others are opposed on the basis of freedom of choice. My sense is that staff should have their choice informed by evidence of benefit to themselves, their patients, and their organisation along with any potential personal risks or preferences.

Hayley Best

Photo by Barry Cronin / edited by Laura Gallant / BuzzFeed

Hayley Best

“My view is that the focus on increasing staff vaccination rates should be on ensuring that organisations can demonstrate they have offered every single member of staff the chance to have a vaccine and made it easy for them to do so. This is what organisations with high vaccination rates do.”

On the specific issues around Pandemrix and the lack of support for the staff affected by the vaccine, Keogh said: “It would seem both fair and reasonable and in keeping with the values of the NHS that if somebody suffers as a result of trying to do the right thing for others that they would be looked after appropriately.”

Matt O’Neill, chair of Narcolepsy UK, a charity supporting some of the families affected, believes there should be a public inquiry into the use of the vaccines, what was known at the time, and how staff have been treated since.

He said: “NHS staff vaccinated with Pandemrix have been treated pretty disgustingly. Having a vaccination is an act you take on behalf of the community, for the benefit of the herd. When it goes wrong it makes sense that the herd should look after you.”

“More staff would sign up for vaccines if they saw the NHS admit when it went wrong and that it supported staff. At some point, there will be another pandemic and we will need staff to have confidence they will be looked after if something goes wrong.”

In 2010, Andy Burnham, the Labour health secretary at the time, and other ministers contributed to a review of the handling of the pandemic. It said: “[Management] personally would prefer to be criticised for doing too much rather than the alternative, where there could have been unnecessary deaths from doing too little.”

Guy Leschziner, a consultant neurologist at Guy’s and St Thomas’ Foundation Trust, has treated a number of people who developed narcolepsy after having the swine flu vaccine.

On the use of Pandemrix, he told BuzzFeed News: “It’s always easy with the benefit of hindsight. What we have to remember was what was going on at the time, which was that we thought we were going to have an epidemic of a very severe flu. Now today, knowing we didn’t have quite the epidemic we thought we were going to have, you might come to a different conclusion, but at the time we didn’t know that Pandemrix was associated with narcolepsy in comparison to the other vaccine.”

GSK refused to answer questions from BuzzFeed News but issued a statement saying further research was needed to understand what role Pandemrix played in the development of narcolepsy. The company did not renew its licence and the vaccine is no longer authorised by the EMA.

On its website, the EMA said: “Understanding the link between narcolepsy and Pandemrix remains the subject of investigations and may have implications for the future use of similar vaccines.” It said GSK had agreed to continue investigating the vaccine.

Guido Rasi, the executive director of the European Medicines Agency, said: “Immunisation has helped us to bring some major human diseases under control. Worldwide, vaccines are saving the lives of approximately 9 million people every year, more than the whole population of Austria. Today, no child in Europe has to die from formerly common childhood diseases.”

He accepted vaccines were not 100% risk-free but added: “No medicine is. There is a one in a million chance that an adverse event happens. In Europe, we are actively monitoring the safety of medicines, including vaccines, and also looking at all reported side effects. These are recorded in a database and reviewed regularly to identify any potential problem at an early stage.” Around a million reports are made every year.

The Department of Health said its decision to use the vaccine was based on evidence and advice from experts but declined to comment due to the ongoing legal action. Although the DWP has previously admitted causation in the case of Josh Hadfield, it refused to answer questions, saying it would not detail its policy on Pandemrix unless a Freedom of Information Act request was submitted.

Hayley Best

Photo by Barry Cronin / edited by Laura Gallant / BuzzFeed

Hayley Best

Swine flu was a potential health crisis and there are no suggestions ministers, the DH, or GSK acted with anything other than the best of intentions to save lives. But fear of the virus and misplaced confidence in the vaccine’s safety led to staff feeling pressured to have the jab, and not being given all the facts. Eight years on, those staff are still waiting for their sacrifice to be recognised.

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“It has been soul-destroying to lose my career,” said Meleney Gallagher. “I used to say if I could go to work and make one patient smile then I’d have done my job, but I couldn’t do that because I couldn’t even risk laughing with a patient in case I collapsed.

“I am angry. I put a lot into my career, I gave a lot. I would have expected a bit of respect for the effort I put into the NHS.”