So Much For Ben Goldacre’s AllTrials …

Trials by year

Since Jan 2006, GlaxoSmithKline completed 809 eligible trials and hasn’t published results for 183 trials. That means 22.6% of its trials are missing results. See all its completed trials on .

Who’s not sharing their trial results?

Trials registered on should share results on the site shortly after completing, or publish in a journal. But many organisations fail to report the results of clinical trials. We think this should change. Explore our data (last updated October 2016) to see the universities, government bodies and pharmaceutical companies that aren’t sharing their clinical trial results.

Trial sponsors

We’ve ranked the major trial sponsors with the most unreported trials registered on Click on a sponsor’s name to find out whether it’s getting better at reporting completed trials – or worse.

Good News For Pandemrix Victims…

A court ruling has paved the way for almost 100 UK victims of a trial vaccine to receive substantial compensation.

The Court of Appeal rejected a government bid to overturn a defeat in a lower court in 2015 that led to £120,000 being awarded to a boy damaged by the Pandemrix vaccine aged seven.

The child, now 14 and known only as John, developed narcolepsy after being given the vaccine during the 2009-10 swine flu pandemic.

The case, brought by London law firm Hodge Jones & Allen, is seen as test case that will trigger payments under the Vaccine Damage Payments Act to all 94 known victims.

It is also likely to lead to civil claims against Pandemrix manufacturer Glaxo-SmithKline.

The Government previously agreed to indemnify the drugs giant against claims at the time the vaccine was released for use on six million  Britons, mainly the young and elderly or patients at risk of swine flu.

The link with narcolepsy was then unknown.

The Department for Work and Pensions had accepted the vaccine caused narcolepsy in John but denied his disabilities were bad enough to pass a 60 per cent threshold to trigger a payout.

Today’s ruling, from three appeal justices headed by Master of the Rolls Sir Terence Etherton, said the lower court was “quite right” to dismiss the Government’s previous attempt to overturn a ruling in favour of John.

Solicitor Peter Todd, who brought the case, told the Standard: “I am pleased the Secretary of State’s appeal has been rejected as his arguments would have made it virtually impossible for genuine cases to obtain any compensation.”

The DWP said: “We are aware of the judgment of the court and are carefully studying the court’s reasons.”

Adam Cartwright, 47, a surveyor and father of two from Horley, Surrey, one of the victims awaiting the outcome of John’s case, told the Standard: “What I want is an admission and an apology, and for them to say, ‘We did do something wrong’.”

How Many Avandia Deaths?…

How many Seroxat/Paxil deaths? and how much harm?

How much Myodil dye caused agonizing disablement to how many people?

How many Pandemrix cases of Narcolepsy in kids?

How much Tafenoquine damage to soldiers?

How many millions will you have when you retire Sir Witty?

What price is human life?

We need transparent trials to keep confidence in medicine

Controversies about the safety of medicines given to millions of people can’t be settled unless data is made more freely available

heart art
Putting your heart into it

Simon Danaher

TENS of millions of people took Vioxx for their arthritis between 1999 and 2004. Tens of thousands probably had a heart attack as a result. It was a similar story with the anti-diabetes drug Avandia. In both cases, the drugs’ makers were accused of withholding trial data that would have revealed the risks to doctors and patients.

Access to data is at the centre of many controversies in modern medicine – not just to do with the usefulness of drugs, but also of treatments (such as exercise for chronic fatigue syndrome) and screening programmes (for breast cancer in younger women, say). Big trials are hard to organise, and so researchers often keep a tight grip on the data they create.

As preventative medicine has become more common, concerns have risen that we may be missing key evidence about the effects of drugs given to huge numbers of people. Recently, statins – given to manage cholesterol levels in those deemed at risk of heart attacks – have come under scrutiny.

The trials run to assess statins’ efficacy didn’t focus on possible adverse effects. Those most worried about these – debilitating muscle pain is often cited – have so far been unable to assess the data for themselves. Other critics say there isn’t strong enough evidence for mass prescription of statins (see “Cholesterol wars: Does a pill a day keep heart attacks away?“).

That has provoked a furious war of words with those who do have access to the data. They say complex ownership and usage conditions mean it can’t be released widely. That’s a familiar problem: similar issues dogged the release of raw data from the 2011 PACE trial of chronic fatigue syndrome treatments, which a tribunal finally ordered to be released last year.

So the controversy over statins, whether well founded or not, rages on with no resolution in sight, damaging confidence in medicine. This simply isn’t good enough. When it comes to treatments for millions, data should be gathered with a view to its eventual release. That won’t be easy. But evidence-based medicine requires no less.

This article appeared in print under the headline “Hearts on our sleeves”

GSK’s Tafenoquine… Another Scandal Emerging?
The Townsville RSL hosted a national health forum to discuss use of controversial use of two anti-malaria drugs. Speaker Stuart McCarthy. Picture: Zak Simmonds
The Townsville RSL hosted a national health forum to discuss use of controversial use of two anti-malaria drugs. Speaker Stuart McCarthy. Picture: Zak Simmonds

Pilot outreach program rejected

A PROPOSAL for a pilot outreach program to help veterans affected by antimalarial drugs has been rejected, with the Department of Veterans’ Affairs saying existing support services are adequate.


The decision has angered veterans who participated in controversial ADF sanctioned mefloquine and tafenoquine trials, and their families, some of whom are caring for those with mental health issues.

They now want to meet with Prime Minister Malcolm Turnbull, who has previously committed to tackling veteran suicides, an issue linked to the use of the drugs.

Lavina Salter, whose husband Chris has suffered adverse mental health after taking mefloquine during a deployment to East Timor, said the proposal rejection had left her feeling defeated.

“By their own admission, DVA has said they don’t know the full extent of the number of veterans affected by these drugs so why don’t they do something?” she said.

“We will keep trying because we can’t give up on these guys.”

The Quinoline Veterans and Families Association submitted a proposal to Veterans’ Affairs Minister Dan Tehan in December for a first-of-its-kind Veterans Outreach Program. The initial budget was $2.25 million per annum for an initial period of five years.

The program would include new research, the identification of all personnel administered mefloquine or tafenoquine during their ADF service and assist affected individuals.

QVFA co-convenor Major Stuart McCarthy, who was prescribed both mefloquine and tafenoquine by the ADF, said rejecting the program was “indefensible” because existing services were clearly not adequate.

“I can accept that Dan Tehan wouldn’t necessarily have signed up to the proposal straight away, but to come back with a blunt no and to not enter into further discussion or dialogue is unacceptable,” he said.

“We have made repeated efforts to engage with DVA and work with them to develop health outreach both for veterans and their families and that’s why we did the proposal because those needs are not being met.

“It’s really time now for the Prime Minister to provide leadership on this, because the departments of Defence and Veterans’ Affairs have completely failed.”

In a short statement, Mr Tehan told the Bulletin yesterday he believed the Federal Government was already responding to concerns about the use of mefloquine by the ADF.

“The existing services and additional support the Government has implemented are meeting the needs of the ex-service community concerned,” he said.

Doctor Calls Out Paxil (Seroxat) And Its Damage To Teens..

Years ago, Big Pharma company SmithKline Beecham (now part of GlaxoSmithKline) published a prominent study in the Journal of the American Academy of Child and Adolescent Psychiatry that concluded the popular antidepressant medication, Paxil, was safe and effective for teenagers.

But in September 2015, the British Medical Journal posted a re-analysis of the original data — and concluded that the opposite is true.

There have been many reports of young people taking or withdrawing from antidepressants, especially Paxil, and committing violent acts, even suicide.

The original study compared the responses of adolescents taking Paxil or a placebo to a group taking an older antidepressant called imipramine. The Paxil group did not perform better than the other groups for depression.

After the study was published, SmithKline Beecham submitted the trial to the FDA for approval in treating adolescents.

Of course, the FDA approved their application and Big Pharma ramped up their marketing of Paxil for teenagers.

Guess what happened next? Prescriptions of antidepressants to our youth increased by 36 percent from 2002 to 2003.

The 2015 article that reanalyzed the data reported that Paxil has no clear effectiveness, and there was mislabeling of serious side effects.

Antidepressant drugs are a disaster. They barely perform better than a placebo. Exercise outperforms antidepressants in nearly every study that compares the two.

I don’t think these drugs need to be pulled from the market completely, but they should not be as widely prescribed.

There are many natural therapies that can combat depression. The best therapy starts with the basics: Drink an adequate amount of water and eat a healthy diet.

In Memory Of Adrian Keegan..




Adrian Keegan’s life was cut short from Seroxat.

Today would have been his 35th birthday.

GSK have never apologized to the families of those killed, or harmed, from Seroxat suicides or side effects. They have never apologized for Study 329, a bogus Seroxat (Paxil) study which was touted to psychiatrists and doctors as a successful study promoting the treatment of Seroxat to adolescents.

Why were Adrian’s parents not warned about the dangers of Seroxat?

I think the parents of Adrian, and the families of all the other Seroxat victims, and the victims themselves- deserve an apology from GSK don’t you?

“..One of the cases that sparked fears was that of Adrian Keegan, 19, who had been taking the drug for 26 days when he committed suicide. In 2001, following the breakdown of his relationship with his girlfriend, he was diagnosed with depression and prescribed Seroxat by his GP. His father Christopher found his body hanging in his flat.

Mr Keegan, from Market Drayton, Shropshire, said: “There needs to be more information and better control as it is given out far too easily, like sweets.””..

This has always been obvious to me…

This perspective has always been obvious to me, and talk to most depressed people and you’ll find it has been obvious to them also… however it’s nice to see the truth about depression being discussed…

so many needless psych-drug prescriptions and so many needless SSRI deaths…

Psychologists Think They Found the Purpose of Depression


Photo: Julia Davila-Lampe/Getty Images

Depression is pervasive: In 2015, about 16 million — or 6.7 percent of — American adults had a major depressive episode in the past year. Major depression takes the most years off of American lives and accounts for the most years lived with disability of any mental or behavioral disorder. It is also expensive: From 1999 to 2012, the percentage of Americans on antidepressants rose from an estimated 6.8 to 12 percent. The global depression drug market is slated to be worth over $16 billion by 2020.

The National Institute of Mental Health defines a major depressive episode as “a period of two weeks or longer during which there is either depressed mood or loss of interest or pleasure, and at least four other symptoms that reflect a change in functioning, such as problems with sleep, eating, energy, concentration, and self-image.” This falls in line with what Matthew Hutson, in a new feature for Nautilus, describes as the disease model of depression: that depression is “a breakdown, a flaw in the system, something to be remedied and moved past.” In his compelling and challenging piece, Hutson profiles several researchers who advance an argument that depression can serve a possibly positive purpose in the lens of evolution. But rather than deifying evolution and trying to scry out what it meant for us, let’s focus on what’s more immediately useful for lived humans lives today: that, in some circumstances, depression may be, in the arc of a life, yielding of insights and personal meaning. All of this is in no way meant to minimize the suffering that depression can cause — but to suggest the uses that it may serve.

At the center of Hutson’s piece is Paul Andrews, an evolutionary psychologist at McMaster University in Canada. Andrews argues that depression may be “an adaptation for analyzing complex problems.” He sees it in the condition’s bouquet of symptoms, which include “anhedonia,” or an inability to feel much pleasure; people who are depressed ruminate frequently, often in spirals; and they get more REM sleep, a phase associated with memory consolidation. This reflects an evolutionary design, the argument goes, one that’s to, as Hutson summarizes, “pull us away from the normal pursuits of life and focus us on understanding or solving the one underlying problem that triggered the depressive episode.” Like, say, a “failed” relationship. The episode, then, is a sort of altered state, one different from the hum of daily life, one that’s supposed to get you to pay attention to whatever wounding led to the upset. For example, 80 percent of subjects in a 61-person study of depression found that they perceived some benefit from rumination, mostly assessing problems and preventing future mistakes.

For now, Andrews’s “analytical rumination hypothesis” is just that, a hypothesis, a term that combines the Greek hypo (under) with –thesis (placing). It’s a concept, an observation, one that acts as a structure for further inquiry. Still, already, there is something very powerful, and even actionable, in reconceptualizing (some) depressive episodes as having a function, as presenting a quest toward understanding for the sufferer to undertake. Other research helps to refract the light being shined here: Laura King, a psychologist at the University of Missouri, has spent a couple decades studying people’s experiences of meaning in life, and she told me in an interview at this year’s Society for Personality and Social Psychology meeting that the meaning people derive from difficult experiences depends not on the amount that they’re suffered, but the extent of reflection — or meaning-making — they’ve done on what prompted a given nadir. Following this logic, if the job of a depressive episode is to figure out what’s gone awry, what emotional knots need to be untangled, what attachment patterns need to be identified and addressed, then antidepressants are an incomplete treatment, just like you wouldn’t prescribe Percocet to a heal a broken ankle without also supplying a cast.

There are even larger, structural issues around the culture and industry of mental health at work here: If the healing of depression requires not just an alleviation of symptoms but a reworking of patterns within a person’s psychology, that’s a deeply subjective rather than objective process, meaning that the scientific method may have difficulty accessing it, and since it’s not objective, it’s perceived as less real or true, since it resides in your interiority, not out there in the readily testable world. Also, therapy — whether cognitive behavioral or psychoanalytic — requires lots of money and lots of time and is not, to say the least, well-supported by insurance companies in the U.S.

Still, this framing of depression as a space for reflection is empowering, and lends a degree of agency to the person being pressed down. Like anxiety, depression might be trying to tell you something. The language of therapeutic traditions is useful: a Jungian analyst would describe depression as katabasis, an Ancient Greek word for descent. Like Orpheus heading to Hades or Luke Skywalker in the swamps of Dagobah, it’s a journey into the underworld, where the adventurer is to “go through the door … immerse himself in the wound, and exit from his old life through it,” like Robert Bly writes in Iron John. Since it is subjective, the problems and solutions will be personal — of the person and their particular psychological history — and thus demand the individualized understanding of the sufferer of depression, perhaps with the assistance of a skilled therapist. That’s another theme: While disengagement from emotionality characterizes depression and other disorders, engagement with one’s inner world looks to to be the way out. Put more poetically: You exit through the wound.

“Most episodes of depression end on their own — something known as spontaneous remission,” Vanderbilt psychologist Steven Hollon tells Nautilus, noting that the depression-as-adaptation narrative may explain why. Indeed, “cognitive behavioral and problem-solving therapies may work precisely because they tap into and accelerate — in a matter of weeks — the very processes that have evolved to occur over the space of months,” he added. Katabasis leads to catharsis; not coincidentally, there’s a shared theme in the personal narratives of people who reach midlife with a sense of well-being and generativity toward others: redemption.

Hello To The World Health Organization (WHO)…

I get views regularly from organizations as diverse as the WHO (World Health Organization) and the MHRA, to the US government and the European Medicines Authority. It’s interesting that the WHO were viewing today, because it was back in 2002, that the WHO reported that Paroxetine (Seroxat/Paxil) topped the list of withdrawal symptoms for SSRI drugs.


“Dr Healy told BBC News Online, of the 100m people world-wide who were on Seroxat, one in 1,000 could have a suicidal reaction.”

Withdrawal problems

A World Health Organization report which ranked antidepressants in order of withdrawal problems found Seroxat was the hardest to come off.


How a Maine woman reclaimed her life after 30 years of drug therapy


How a Maine woman reclaimed her life after 30 years of drug therapy

Posted Feb. 06, 2017, at 1:46 p.m.
Last modified Feb. 07, 2017, at 12:39 p.m.

Jane Tholen is an angry woman on a mission. Living in low-income housing and getting by on her social security benefits, the 70-year-old former marketing professional says she lost three decades of her life, sacrificing her health, her happiness, her career and her personal relationships to a pharmaceutical nightmare.

About two years ago, bucking the skepticism of the doctors who were treating her, Tholen insisted on being weaned off a cocktail of antidepressants, sleeping pills and antianxiety drugs. What she discovered at the end of that arduous process was her authentic self — battered and exhausted, but mostly intact.

“I’m still here,” she told the Bangor Daily News, looking polished and put-together during a recent interview in her Falmouth home. “This waking-up process is excruciating … I am experiencing a clarity in the last few months that is remarkable, [but] that is also horrifying.”

Horrifying, she explained, as she comes to terms with all that she has lost, but exhilarating as she contemplates the mission ahead — to share her story and spread the word about the problems many people experience using psychoactive drugs.

After trauma, trying to ‘get back to normal’

Tholen was 39 years old, a successful marketing professional living in Boston, when she was mugged by two men in the stairwell of her apartment building. Just four months later, as she was beginning to recover from that trauma, she was attacked in her own living room by a robber who had climbed through the window of her second-floor apartment.

Deeply shaken by these attacks, Tholen sought professional help. She was swiftly prescribed a popular anti-anxiety drug to help her feel better in her life and function more productively in her high-powered career. That was in 1984.

“I thought it would be okay to take a drug to get back to normal,” she said during a recent interview in her rent-subsidized apartment. “But I never got back to normal.”

Instead, Tholen says she embarked on 30 years of pharmaceutical treatment with various combinations of anti-anxietals, antidepressants, sleeping medications, amphetamines and other drugs, prescribed by a series of psychiatrists and primary care providers, both in Massachusetts and in Maine.

Between 1984 and 2014, she used 16 of the 25 most commonly prescribed psychoactive drugs, including Xanax, Zoloft, Prozac, Ativan, Wellbutrin, Effexor, Valium, Concerta, Paxil and others.

Instead of relieving her symptoms, though, the drugs had the opposite effect, Tholen said. She experienced worsening anxiety and depression, as well as nightmares, suicidal thoughts, crushing fatigue, sleeplessness, hyperactivity and loss of ability to focus. Her performance at work suffered, as did her social relationships. She was no longer able to travel, to manage complex projects or enjoy personal activities, like gardening, that had always brought her pleasure.

She knew she was in trouble, Tholen said, but she didn’t know the cause.

“No psychiatrist or doctor ever suggested I get off [the drugs],” she said. Instead, they would tinker with her doses or layer on a new medication to address the side effects of an existing drug. They assured her that her problems were real, and that more medicine was the answer. No one ever suggested the drugs themselves might be the source of her troubles.

Worsening dysfunction, and a decision

By the mid 1990s, Tholen had left her job in desperation and moved to Maine to be closer to her aging parents. She found a position with a marketing agency in Portland, but couldn’t handle the complexity of it in her foggy and distractible frame of mind. She opened her own marketing office, but continued to have trouble following through on the needs of her clients.

In 2007, she filed for bankruptcy. She turned to the Town of Falmouth briefly for general assistance, closed her office and moved into Section 8 housing. In 2012, she was declared 100 percent disabled by her chronic depression and anxiety and started collecting disability payments. All the while, her doctors continued to prescribe the drugs that, she says now, were the cause of her problems.

“I didn’t know the extent of the effects [the drugs] were having on me until I stopped taking them,” she said.

In 2014, exhausted by her worsening symptoms and the grim changes in her life, Tholen started reading up on psychoactive medications and problems associated with them. She found books, websites and articles in professional journals that described her own experiences closely, and gradually, she determined to stop taking the drugs.

“I just got to the end of my rope,” she said, struggling against tears. “I knew I had to stop. I just had to. I knew I was still in here somewhere.”

It wasn’t easy to stop using the drugs her body had become so accustomed to. She experienced distressing side effects, which included hallucinations, pain, loss of muscle control and deep fluctuations in her anxiety and depression. Tholen says no one should ever try this approach without the support of a doctor and the watchful company of a close companion.

But for the last year and a half, Tholen said, she has been free of the pharmaceutical soup that for three decades disrupted her thoughts, clouded her perceptions, undermined her ability to function and, ultimately, deepened rather than alleviated her depression and anxiety.

“I can think again and I can get through a conversation without my brain hitching,” she said. “I’m still coping with some side effects, but I’m in the world again instead of being cut off from it.”

Use of psych drugs is widespread, not well understood

Current data on the use of antidepressant and antianxiety medications is hard to find. Most recent studies draw from 2008 data collected by the U.S. Centers for Disease Control and Prevention. Those figures show that an estimated 11 percent of Americans age 12 and older take an antidepressant. The largest group is white women between 40 and 60 years old.

More than 60 percent of adults who take antidepressant medication have taken it for two years or longer, and 14 percent have taken it for 10 years or longer.

The use of drugs such as Xanax, Ativan and Valium, antianxiety medicines in the benzodiazepine family, is also widespread. Again, data from 2008 show that more than 5 percent of adults between the ages of 18 and 80 had filled at least one prescription that year, many for long-term use. The prevalence of benzodiazepine use increased with age, with 9 percent of people 65 and older using the drugs. Over 30 percent of 65-to 80-year-olds who used a benzodiazepine had long-term prescriptions.

While there’s no doubt that psychoactive drugs are a great benefit to some individuals, there remain questions about the effects of their long term use, especially in combination with other medications. And for some people, the drugs may not be effective at all, or may actually do more harm than good.

Early psychoactive drugs developed in the 1950s included the anti anxiety drug Valium, still in wide use today, and Iproniazid, an early antidepressant no longer on the market in this country.

Hope in the psychiatric community ran high that such drugs, used in conjunction with traditional “talk therapy,” could help patients live symptom-free, according to psychiatrist Robert Croswell, medical director of mental health and substance abuse services at MaineGeneral Health in Waterville.

But, while drug developments in other fields of medicine have made significant progress in reducing illness and death, “That doesn’t seem to be the case in psychiatry,” Croswell said, “despite what the pharmaceutical companies would have you believe.”

In fact, he said, while drug companies have developed third- and fourth-generation antidepressants that claim to fine-tune the treatment of, for example, “sluggish depression” versus “anxious depression,” there’s little evidence the newer drugs offer a significant clinical benefit over the older ones.

“They may have fewer side effects, but they’re really no more effective at treating depression,” he said.

Croswell said doctors used to distinguish between “biological depression,” caused by a chronic chemical imbalance in the body, and “psycho-social depression,” caused by external events like Jane Tholen’s muggings. But current diagnostic guidelines classify all depression as biological, since even acute, one-time psychological trauma results in the release of cortisol and other chemicals in the brain.

The result, he said, is a tendency to prescribe long-term, even life-time, drug treatment, when in many cases, a shorter course of medication, in concert with counseling and lifestyle changes, can often set things right. Unfortunately, he said current changes in medical practice mean that doctors rarely interact on a personal level with their patients, and drug adjustments are often made by mid-level providers without the expertise to clearly understand a patient’s response and when a larger change is called for.

Generally, he said, if a psychoactive drug regimen isn’t effective against depression and anxiety after a few months, it’s time to re-evaluate the options, including the possibility that medication isn’t needed at all. And once a patient stabilizes, there’s no reason not to try cutting back the dose to see if medication is still needed.

Especially in older adults, he said, managing psychoactive drugs is a tricky business. Age-related changes in metabolism and the presence other medications in the body increase the risk of anxiety, confusion, memory loss and other cognitive side effects.

“It’s a shame she went as long as she did,” he said when told Tholen’s story, but he stressed that patients should never change or discontinue their medicines without the support of a physician. “They need to have an assertive conversation with their doctor,” he said. “Never give up your authority.”

Tholen says she’s lost 35 pounds since stopping her drugs. She has established a simple self-care routine that includes a healthy diet, daily exercise and regular social outings. She meditates to help with the lingering anxiety, headaches, anger and other troubles that she lives with. She has a new therapist she likes a lot.

Her interest in music and art is re-emerging, and she’s even toying with picking up some work recording voice-over tapes for commercials and public service announcements.

But her real mission, she said, is to get the word out that antidepressant and antianxiety drugs aren’t for everyone and that it’s essential to be an informed consumer and advocate for yourself, your friends and your family members. She’s hoping to polish her rusty public speaking skills and give talks to medical groups and others who need to hear her message. There may be a book in the works, too.

“I haven’t had any sense of self-worth for years,” Tholen said. “I have looked at the world with all the shades half-drawn.” But now, she said, the shades are wide open, and the world beckons.


This story has been corrected to clarify that Tholen did have the oversight of her physicians as she tapered off her drugs.

Glaxo’s Pandemrix Vaccine Causes Narcolepsy And Cataplexy In 7 year Old..

Parents of disabled children still fighting for compensation over swine flu vaccine

The DWP could be left with a £12m bill if it fails for a third time to overturn a ruling ordering it to pay £120,000 compensation to a 7-year-old who suffers from narcolepsy caused by the Swine Flu vaccine Pandemrix

The DWP could be left with a £12m bill if it fails for a third time to overturn a ruling ordering it to pay £120,000 compensation to a 7-year-old who suffers from narcolepsy caused by the Swine Flu vaccine Pandemrix. (Photo by Jeff J Mitchell/Getty Images)

On 10 December 2009, seven-year-old John was given a vaccination called Pandemrix against the pandemic influenza A (H1N1), commonly known as Swine Flu. Four months later, following extensive hospital examination he was diagnosed with narcolepsy and cataplexy, neurological conditions that will affect him for the rest of his life.

Narcolepsy is a very rare and incurable autoimmune sleep disorder caused by the destruction of the part of the brain that produces hypocretin, a peptide that regulates sleep. Sufferers regularly experience episodes of drowsiness or excessive daytime sleepiness. Cataplexy is a condition characterised by sudden, profound muscle paralysis, the onset of which takes several seconds, and often results in the sufferer collapsing.

These conditions may also be associated with hallucinations, behavioural and mood disturbance, as well as nightmares. John, now 14, experiences all of these symptoms.

Although millions of people in the UK received Pandemrix without complications, the 2009-10 pandemic vaccine has been found to have caused an epidemic of narcolepsy in the UK and in other European countries in which it was used. About 1,500 people across Europe are thought to be affected, of which about 100 have so far been identified in the UK. John, not his real name, is one of them.

Test case

Last month, the High Court heard an appeal from the Department for Work and Pensions (DWP) against a test case decision forcing it to pay £120,000 vaccine injury compensation to John.

In January 2012 he applied to the DWP for compensation under the Vaccine Damages Payments Act 1979. The claim was initially refused on grounds of lack of a causal connection between the vaccine and John’s development of narcolepsy and cataplexy.

“What I expect of a decent, caring society is that when vaccination programmes are implemented, they come with an implicit agreement between state and citizen that ‘should’ anything go wrong, that citizen will be looked after by the rest of us.”

Matt O’Neill, Chair, Narcolepsy UK

A few months later, a medical advisor to the government’s Vaccine Damages Unit said that there was, in fact, likely to be a causal connection, but that John’s condition had improved and his level of disablement was less than 60 per cent – the threshold required to meet “severe” disability criteria for awarding compensation. He was denied payment.

On 11 February 2014, then Secretary of State for Work and Pensions Iain Duncan Smith reversed his refusal decision of two years earlier, accepting that the vaccine had caused John’s narcolepsy and cataplexy. However, Mr Duncan Smith refused to accept that John was severely disabled, and his application for payment was therefore refused.

After John appealed the decision to the First Tier Tribunal, the DWP was ordered in September 2014 to pay out as it found his narcolepsy to be severe. The DWP refused and appealed to the Upper Tribunal, arguing that only problems John had now could be taken into account and not the future impact of his condition.

In June 2015, the Upper Tribunal rejected the DWP’s submissions and dismissed their appeal. The DWP agreed to and paid-out the £120,000 compensation to John. However, it decided to go to the Court of Appeal, maintaining that the proper approach to assessment of disability is to ignore any aspects of the disability that may be experienced in the future.

It is the first time the Court of Appeal is considering a case of vaccine injury compensation under the UK statutory compensation scheme. Its decision will be binding on all future assessments of disability brought under the 1979 Act. Payments were then fixed at £10,000. Now they are £120,000 per person, so with around 100 victims seeking compensation under the Act, the DWP will be faced with a £12m bill if it loses.

Defining an individual as ’60 per cent disabled’

At Thursday’s hearing Sir Terence Etherton who, as Master of the Rolls, is the second most senior judge in England and Wales, Lord Justice Davis and Lord Justice Underhill listened to the government’s case.  Adam Heppinstall, representing the Secretary of State, said the principal argument is that it was “wrong in law” for the Upper Tribunal to conclude that assessment of an individual’s disability under the statutory scheme require’s a decision maker to take into account that person’s likely future disablement in addition to his condition at the time of assessment.

“In this respect, the Upper Tribunal adopted a speculative approach, not called for by the legislation, which carries with it substantial problems and the risk of unfairness,” Mr Heppinstall said. “The Secretary of State calls for a more factual approach, in which only the present disablement can be taken into account.”

He told the court other grounds for appeal centred on how someone is assessed as “severely disabled” and that the case raises “fundamental issues” which go to the heart of how all claims under the 1979 Act should be assessed and decided by the Secretary of State.

George Peretz QC, representing John, told the court: “There is nothing ‘speculative’ about looking at the impact of that continuing disability on an 11 year old boy as he progresses into manhood, taking into account the additional opportunities and responsibilities which that transition in life brings with it.

“The Upper Tribunal adopted a speculative approach, not called for by the legislation, which carries with it substantial problems and the risk of unfairness. The Secretary of State calls for a more factual approach, in which only the present disablement can be taken into account.”

Adam Heppinstall, counsel, Secretary of State for Work and Pensions

“As the Upper Tribunal rightly pointed out, the fact that injuries such as loss of a hand are regarded as amounting to 100 per cent disablement, and that, amputation of one leg at the knee is to be regarded as 60 per cent disablement, may be useful in providing a broad framework or starting point in assessing whether John’s narcolepsy with cataplexy amounts to 60 per cent disablement.

“Such a check, for example, rules out any suggestion that 100 per cent disablement is akin to total quadriplegia or a persistent vegetative state or that 60 per cent disablement cannot be established where an individual is able to carry on a reasonable range of daily activities.”

Mr Peretz used the example of paralympian and double-amputee Oscar Pistorious, who is defined as “100 per cent disabled”, yet was still able to compete at the Olympic Games.

Sir Terence said that it was obviously an important matter – not just for John and his family, but for the 30 outstanding cases waiting on the result. The judges reserved their decision.

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I trust in you, O' Lord, my Savior, the One who died and rose again…. the One who brought me in and will carry me out, the Almighty waters and tides that bring us life. I come to You when there is no where else to turn, I come to You when there is. I look to You as my guiding Light, my Savior…. the One who created all I see- created my life and dreams before I knew myself~ created my talents and style before I knew the value~ I praise You and adore Your mystery. I will be strong and conquer as You would want for me. I beg of your blessings and miracles even though I am unworthy of Your power…. Yet, I trust in You~ and know You have already begun Your work. I love You. I don't know if that is a good enough word, "love"~ But I know You on a level---beyond words. Save me Lord. I will not let go of You. Hear me O' Lord. In Christ's Powerful Name Amen ~ By Brandon Heath

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