Editorial Note: The image featuring Samantha Cameron and her husband, David, comes from the front cover of Private Eye, a British satirical magazine, who might have thought twice about adding to the pressure on Cameron if they had known what was going to happen next. This is the third in a Bruce Willis series – See Osama saves Millions and Obama kills Millions.
Its September 27 2014. A conservative MP (member of parliament) and minister in the government, Brooks Newmark, has just resigned.
The coalition government, with the Conservatives (Tories) as the lead party, are in a growing crisis. A UK Independence Party (UKIP) had formed in the early 1990s but was getting nowhere fast. In 2006, Nigel Farage took over as leader and moved it from being a single issue Get out Europe campaign to a broader anti-immigrant, right wing populist party. In local elections in 2013 and even more so in European elections in May 2014, UKIP made substantial gains largely at the expense of the Tories.
There was a general election scheduled for 2015. A number of Tory MPs had an affinity for UKIP’s anti-immigrant and anti-European positions. There was speculation some might defect to UKIP – who had no MPs.
The way the English political system works, it can be difficult to break in even if a new party is supported by millions of voters, so there was no guarantee that UKIP with even 10% of the vote around the country would get any MPs. Supporting a party is one thing, voting for a party who has no MPs is another. If they already had some MPs it would transform the psychology of voting.
In August 2014, a first Tory MP, Douglas Carswell, defected to UKIP ratcheting up the pressure on Cameron and rattling the Tories.
On September 27, another, Mark Reckless, defected. The Tories seemed to be facing annihilation. Ed Milliband, the Labour party leader, seemed likely to be the next Prime Minister. If you wanted to take a Labour party leader with you on holidays and had your choice of any of them from 1945 to now, I’d opt to take Milliband (or maybe Michael Foot). But its not enough in politics or maybe even in life to be decent, or even a human being – you have to be lucky.
While Reckless was defecting, Brooks Newmark entered stage left.
Brooks had been caught in a jaw-dropping sting. A male newspaper reporter posing as a woman engaged him in texting that became sexting and finally a picture of Newmark’s private member.
The Reckless defection was bad news but Newmark’s reckless act seemed to set the seal on the Tories. It had the whiff of decay that goes with a political party whose time was up.
In the immortal words of a former Irish premier Charles Haughey, as weaponized by his greatest political enemy, we had entered GUBU country – grotesque, unprecedented, bizarre and unpredictable. (Worth googling to get the full-story).
(The political wisdom until recently had been that there’s no recovery from GUBU – but it seems like politicians have learned to embrace and maybe even love GUBU, perhaps in part as a consequence of Cameron’s next move).
The Private Eye image shows Samantha eyeing something like a Tory private member working out how to advise her partner who seems to have missed the plot.
In order to keep the Tories from disintegrating, and take the wind out of UKIPs sails Cameron offered a referendum on EU member-ship. If you really want to withdraw from the EU, don’t vote UKIP – they have almost no MPs and can’t deliver it. The only party who deliver are the Tories. This desperate promise wasn’t made to win the election, it was made to avoid the Tories being annihilated.
On the night of the election a few weeks later as the polls closed the general anticipation was that Milliband would be entering Downing Street the following day. A few minutes later, the first exit poll predicted the Tories would win an overall majority. You could have heard a pin drop in the TV studios.
David Cameron was about to become the first Tory Prime Minister to be elected with a majority in over 20 years. Perhaps the “I can walk on water” moment went to his head. One of his first actions was to agree to follow through on a promise – he would commit the country to a referendum the following year.
The original Brooks Newmark event in its own right was nothing like as GUBU as the events that led Haughey to try and articulate how fate can twist. The time honoured – truth can be a lot stranger than fiction – didn’t seem enough. The events in Ireland that left the smoothest of political liars struggling for words began a sequence that has close to destroyed the Catholic Church globally.
But events in Britain since September 27 increasingly seem to bear the mark of GUBU. Who knows what pillars of modern life will come tumbling down before the malignant sprite or whatever it is decides its time for a nap.
Who needs conspiracy theories? They’re a relatively recent invention that in their efforts to make sense miss out on how bizarre things can get sometimes. Taking Occam’s razor to any explanation of the human situation favours a view that there really are Olympian Gods who trigger events out of boredom or perhaps just unleash malignant sprites to stress test human plans.Share this:
Copyright © Data Based Medicine Americas Ltd.
Expect whole libraries of books about the life and especially the scandals of Charles Haughey, the former prime minister, or Taoiseach, of Ireland – now deceased.
From gun running to cocaine, through corruption, murder and marital infidelity, it will be very hard to separate the truth from the frenzy of speculation now that the libel law no longer applies (you can’t libel someone who can’t sue you).
Even our interviewee this morning, biographer Bruce Arnold, spent most of the short time he had, just minutes after the news of Mr. Haughey’s death was announced, discussing the controversial rather than complimentary aspects of his history.
Permit me a little time to tell you just one story which illustrates why that is.
The title of this post comes from one of the easiest incidents to explain – and it still stretches credibility.
In 1982, a double murderer was arrested inside the house of the Republic’s senior law officer, the Attorney General.
The murderer was an eccentric Dublin character named Malcolm MacArthur, who decided to take up a life of crime once he had spent all his modest inheritance.
He needed a gun to carry out successful robberies, he decided. A farmer outside the city advertised a shotgun for sale, so MacArthur set out to steal a car to get to the farm.
He bludgeoned a nurse, who had been sunbathing in the park, and drove off with her dying in the back seat.
An ambulance crew spotted the unfolding drama, and mistaking the murderer for a doctor (because of the hospital sticker in the nurse’s car window) escorted them to the emergency room.
The murderer escaped, and abandoned the car.
Then, once he had managed to get to the farm by other means, apparently he murdered the farmer with his own gun, stole his car and drove back to the city.
MacArthur went back to what passed for normal life for him, while Ireland trembled at the story of two apparently motiveless murders.
A few days later, the murderer went to a sporting event with his friend the Attorney General, and listened to the law officer and the head of the Republic’s police force, the Garda Siochana, discussing the murders.
Eventually, MacArthur was taken into custody at the Attorney General’s house. The Attorney General went on holiday…
The fact that MacArthur was never charged with the murder of the farmer was just one reason the Haughey government at the time found it hard to distance itself from rumours about the case.
Later those rumours concerned a cover up of a paedophile ring involving those connected with the government.
Prime Minister Haughey called the affair “grotesque, unbelievable, bizarre and unprecedented”.
Hence GUBU: which became a handy phrase in Ireland to cover any bizarre or embarrassing political story.
Expect a lot more GUBU now.
The simplest solution is correct.
McArthur was/is a Paedophile who brought young children to Connolly’s house for him. A detective named Courtney decided to enter Connolly’s house and found McArthur – Haughey summoned him to his office and asked him “why did you not contact me first”….That detective Courtney was not heard of since – it is only the Gardai who cover up crimes that are promoted in Ireland – the Pharma/Paedophile Coloney of our Europe.
Haughey demanded Connolly come home from holiday and he subsequently resigned..no doubt with a lump sum and pension.
McArthur’s mother stated about her son “Why didn’t you do the right thing” ‘As suicide’ it was quoted….Seemingly it was his mother he wanted dead so to inherit her home and monies.
The young farmer Dunne in Co Offaly was another innocent victim as was the young nurse who decided to stop off on her way home to Meath to sunbathe in the Phoenix Park.
the members of the company will likely be enjoying a collective hard on and share holders positively lusting after another orgasm when seeing how J and J can get away with it not just once but twice that we know of (re respiridal scandal involving the same CEO and his spritely ‘team’) what will they be getting up to next? Does Occam’s theory suggest another scandal?
Is this an example of GUBU?
Watch: In never-before-seen video, Purdue’s Richard Sackler defends OxyContin marketing
By David Armstrong — ProPublica
August 27, 2019
The suspense ……………….what happens when the glass is empty ..
BOB FIDDAMAN @Fiddaman
PAST (Prescription Awareness & Support Team) Wales @PastWales
This guy was jailed for 157 years for prescribing opioids yet the pharmaceutical company had a minimal fine… Interesting interview.. #scapegoat
Guilt … the glass that keeps on giving?
I suppose on some occasions in the past history might to have appeared to have a clear narrative – by now there are so many that we can’t possibly say how anything really happened – but then Pascal possibly already anticipated the random scenario with Cleopatra’s nose. As a complimentary narrative I suggest that Cameron had committed to a referendum in order to be elected party leader in 2005 and was mightily relieved to be able to form a coalition with the Liberal Democrats in 2010 – by 2015 the Liberal Democrats were in the dog-house, and the SNP were rampant, leaving the amiable Milliband without hope and Cameron had to face the issue with his own party – with the defection of BJ to the Brexiteers a major trauma. Of course, there may be all sorts of different rift lines – as someone of old-fashioned liberal values I view the EU Commission with dark suspicion and also the motives of present day Liberal Democrats (I don’t like any of them) but I would agree that this is mostly not what is motivating the Brexit movement, or that Boris’s Britain is likely to be anything but a hideous opportunistic enterprise.
I was fascinated by Christopher Clark’s book, The Sleepwalkers, about the origins of the Great War but to my mind the main narrative was in a sense rather obvious, that it was Tsar Nicholas who was absolutely determined to upset the peace such as it was and that Sarajevo was the perfect catalyst – but after the event the scenario that Germany wasn’t to blame was hard to sell, and it wasn’t exactly politically sympathetic either. No doubt, Prussia had been the bully for generations. It is all a muddle. And yes, I am sure I would have been happier sitting at dinner with Ed Milliband than any of the people that now aspire to represent us.
GSK CEO Andrew Witty Joins David Cameron In China Amid Bribery Probe
David Cameron may risk diplomatic tensions by bringing Sir Andrew Witty, CEO of GlaxoSmithKline on his trade mission to China, while the pharmaceuticals giant is under investigation amid accusations that it acted as the criminal “godfather” of a massive bribery network.
David Cameron takes his ‘cronies’ to China
The chief executive officer of GlaxoSmithKline has been invited on the trip despite the fact that his company are embroiled in Chinese bribery case which has led to four employees being arrested.
The fact that his drugs firm has become embroiled in the bribery scandal in China led some to question whether he would accompany the Prime Minister.
Sir Andrew, who is also the Chancellor of the University of Nottingham, is a prominent member of Mr Cameron’s Business Advisory Group and has regular meetings with the Government.
David Cameron defends GSK during China trip
The prime minister gave public backing to the company on Tuesday during his three-day trade mission to China. He told reporters in Shanghai: “They are a very important, very decent and strong British business that is a long-term investor in China.
November 3, 2017 / 12:04 AM / 2 years ago
Former GSK boss to lead new UK accelerated drug access scheme
Many companies are worried that Brexit could start to undermine Britain’s position as a hub for drug innovation, given the close regulatory and trading links with the European Union.
Witty was also a member of the government for a while – wearing the title lead non-executive board member of Department of Business. Subsequent to his retirement from GSK in 2017 he was appointed to head the new Accelerated Access ‘initiative, for cutting red tape in introducing new drugs.
About Cameron we also recall
Which looks pretty GUBU to me. News International also managed to negotiate with Leveson not investigate Brian Deer’s investigation of Wakefield, which was not perhaps surprising he sat on the MMR case at one point. Nowadays, Leveson has stopped titling himself “Lord” and prefers to be known as Sir Brian Leveson, which could be designed to confuse,
The continuing march of GAVI: siphoning public funds for pharma with the help of David Cameron:
Gates could pay it all himself and not miss it so why does he have to screw the increasingly hard pressed citizens of the developed world? Because that’s the big-hearted guy he is!
So, farewell then, Jean-Paul Garnier
Jean-Pierre Garnier, the GlaxoSmithKline executive, probably expected an easy ride when he appeared on Radio 4’s Today to puff the firm’s anti-bird flu vaccine.
He didn’t get it.
TV and radio blog
When James Naughtie met his Waterloo
The Today presenter asked his question seven times. Frustrated, Jean-Pierre Garnier hung up. Politeness had won
Au revoir, M Garnier, and thanks for all the questions.
The BBC Confronts JP about Seroxat Scandal –
Prof. Peter Gøtzsche @PGtzsche1 15m
54 researchers from all over the world express concern – in an open letter with 96 references – that FDA’s decision to replace individual reviews with an “integrated review” may decrease the value of the Drugs@FDA resource. Another setback for patients. https://bit.ly/2PFEvrB
New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication
August 23, 2019
RE: Docket No. FDA-2019-N-2012 (“New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication”) https://www.federalregister.gov/d/2019-13751
We are academics and researchers that have used FDA’s action packages, today made available on the Drugs@FDA website. We believe it is an important and valuable public resource.
We have used the FDA scientific reviews and other documents contained in action packages in a variety of ways, including:
1. conducting systematic reviews and meta-analyses of medical products, and improving methods[1–13] 2. researching regulatory, publication, and drug approval processes[14–40] 3. comparing regulatory review times and outcomes across jurisdictions[41–44] 4. developing consumer and professional decision making tools and case studies of particular drug approval decisions[45–60] 5. evaluating the impact of federal policy[61–75]
We are writing to express our concern that FDA’s decision to replace individual original reviews with a new “integrated review” may decrease the overall value of the Drugs@FDA resource.
The FDA notice states: “This new [integrated] review template would replace the current documentation where each discipline provides a separate application review document.”
From the perspective of those outside the FDA, an integrated review in lieu of separate assessments would deprive researchers like us of valuable information and data including:
● Detailed information and data for the clinical studies and trials (both published and unpublished) submitted to FDA, which includes extensive medical and statistical reviews of trial design and conduct, statistical analysis, enrolled participants, and efficacy and safety outcomes. ● Detailed information on the postmarketing requirements, including clinical studies and trials imposed by the FDA, along with postmarketing commitments made by sponsors. ● FDA reviewer concerns with the application that were judged not significant enough to be included in a summary document like the integrated review. ● Sufficient context and granularity of detail to gain a robust understanding of individual FDA reviewer concerns, because a summary document like the integrated review is likely to only provide us with a general sense of the concern among the reviewers. ● Detailed documentation for the reasons a single reviewer might have to support a recommendation that an application is not approved. ● Detailed documentation of any differences of opinion between FDA reviewers.
The FDA should not replace individual reviews with an integrated review. Rather, an additional document that summarizes the individual reviews can be published, as FDA has already been doing in publishing “Summary Review” documents. Improving summary reviews can meet FDA’s stated goal of providing the lay and scientific public with “greater clarity on FDA’s application review.”
Further, it is critical that “integrated reviews” do not run counter to FDA initiatives such as the “Equal Voice” initiative (CDER MAPP 4151.8), which required that dissenting views be kept in the record and that supervisors who overruled reviewers had to fully document their reasons for doing so.
Finally, as researchers many of which have used clinical study reports in our work,[77–96] we wish to express our support for FDA to continue its efforts to release clinical study reports (CSRs). CSRs, written by sponsors, are not made redundant by FDA scientific review documents. Rather, they are complementary.
This letter is written in our capacity as individuals, and our affiliations are for identification purposes only.
Peter Doshi, PhD University of Maryland School of Pharmacy
See pdf. For signatories and refs..
‘This comment is being submitted on behalf of the signatories to the attached letter.’
Juan Gérvas @JuanGrvas 13h
FDA, please do not replace your original reviews of medical products with an “integrated review”.
Académicos e investigadores piden a la FDA que no cambie su proceso de aprobación de productos médicos.
Academics and Researchers Raise Concerns With FDA’s Plan for ‘Integrated Reviews’
Posted 28 August 2019 | By Zachary Brennan
The academics and researchers offered their support for FDA to continue its efforts to release CSRs, even though only one has been released so far. But BIO and PhRMA said that the release of CSRs should not be pursued by the agency.
BIO also called on FDA to work with the European Medicines Agency and Health Canada to better align its transparency efforts.
FDA Launches Initiative to Promote Clinical Trial Transparency
January 18, 2018
Shedding light on CSRs will provide more clarity on the FDA’s decision-making process, Gottlieb said. “We expect that making a CSR publicly available after a drug’s approval will provide stakeholders with more information on the clinical evidence supporting a drug application and more transparency into the FDA’s decision-making process,” he explained.
Gottlieb noted the effort represented the first time that the FDA is proactively disclosing CSRs from sponsors to the public. In October 2016, the European Medicines Agency launched a program to publish CSRs and protocols from all new drug submissions, regardless of approval status.
The End of History
I attempted to comment early this morning on Daily Mail report by Emine Sinmaz:
“Mumps hits a ten year high as anti-vaccine myths cause a surge of cases with thousands of outbreaks over a three-month period this year”
I posted the comment:
“Before 1988 when MMR was brought in the advice was against having mumps vaccine – the problem was recognised that because the vaccine was not long-lasting that it would postpone getting the disease from early childhood to an age when it was more hazardous, which of course is what happened, manufactured by public health. The present mumps component in MMR2 vaccine is the subject of litigation in the US relating to its ineffectiveness and false claims. Rather than pillorying critics it should be recognised there has been a problematic trade-off by health policy makers.”
At 6.33am (not more than 15 mins after posting) I received the following message:
“Hello John Stone,
“We have received a number of complaints about the comment you made on article “Mumps hits a ten year high as anti-vaccine myths cause a surge of cases with thousands of outbreaks over a three-month period this year??” (/news/article-7413165/Ten-year-high-mumps-anti-vaccine-myths-cause-surge-cases.html), at 31/08/2019
“Due to the number of complaints received, your comment has been removed from MailOnline.
“Should the situation change, we will review and consider re-publishing. Until such time, your comment will remain off the site. To avoid this happening again, please take the time to review the House Rules and site Terms and Conditions.”
At least the Daily Mail didn’t suggest ….. “a funny thing that happened with the au pair on the way to a dinner party”..
Heidi Larson @ProfHeidiLarson Aug 25
An excellent article “A dangerous balancing act: On matters of science, a well‐meaning desire to present all views equally can be an Trojan horse for damaging falsehoods” https://www.embopress.org/doi/10.15252/embr.201948706#.XWI9S3RRLak.twitter …
“The Ministry of Truth—Minitrue, in Newspeak [Newspeak was the official language of Oceania. For an account of its structure and etymology see Appendix.]—was startlingly different from any other object in sight. It was an enormous pyramidal structure of glittering white concrete, soaring up, terrace after terrace, 300 metres into the air. From where Winston stood it was just possible to read, picked out on its white face in elegant lettering, the three slogans of the Party:
WAR IS PEACE
FREEDOM IS SLAVERY
IGNORANCE IS STRENGTH”
George Orwell, ‘1984’ Part One, Chapter One, Page 6
Perhaps, one ought to add: SICKNESS IS HEALTH. It may be mentioned that by possible coincidencethe London School of Hygeine and Tropical Health, where Prof Larson works sits across the road in Malet Street from Senate House, the building upon which George Orwell modeled “Minitrue”.
Of course, surveillance technology is far in advance of anything Orwell could have imagined in 1948:
leaving aside Public Health England ransacking everyone’s records!!!
Of course, this is the resort of people who cannot answer the questions: the non-equivalence is precisely because people like Larson and Grimes, whom she cites, cannot answer.
Also perhaps significant that neither is a medical scientist and have no professional responsibility for their statements. Larson calls for questioning vaccine orthodoxy to be prosecuted as “hate crime”, but who is doing the hating?
I didn’t catch the “au pair” allusion which was apparently to Ben Goldacre complaining about journalists with insufficient expertise in epidemiology reporting about MMR to the Culture, Media and Sport Committee in 2009-10. Of course, it is a disturbing “appeal to authority” type argument but if we are going to play that game I don’t actually see any chain of expertise in the current situation, and not where the voices to be deferred to are the likes of Larson and Grimes. Nor, as it happens, in the days when I tried to challenge Goldacre over MMR epidemiology – as a humble member of the public ought to be able to do – did he ever answer me. Last up, when I quizzed the CMO about MMR safety, she cited the woefully thin review by Luke Taylor et al (2014). Frankly, all it showed was the unwillingness of government to provide proper data, (presumably because there isn’t any as recent exchanges in BMJ Rapid Responses with Larson, Offit and Plotkin appeared to demonstrate). Double-blind placebo safety data for the entire schedule appeared to be absent. Behind all the show of authority it is beginning to seem as if there is nothing there.
John -They know the cost of everything and the value of nothing……
In – Digital Health July 2019
NHS data worth £9.6bn per year, says Ernst & Young
Data held by the NHS could be worth nearly £10bn a year through operational savings, improved patient outcomes and benefits to the wider economy, a report from Ernst & Young has concluded.
‘Realising the value of healthcare data: a framework for the future’ offers an estimate on the total value of the NHS data set held across primary, secondary, tertiary and social care services.
The report considers the trading values of health and life sciences companies with “significant patient data assets”, as well as recent commercial transactions involving companies and patient data.
By taking into account the 55 million primary care records in the UK, as well as a “treasure trove of information detailing health, wellness, illness and the associated care pathways” held by the NHS, Ernts & Young (EY) puts the value of NHS data at £9.6 billion per year.
It concludes the value of the NHS data set could be as much as £5bn per annum, while delivering £4.6 billion of benefit to patients though personalised medicine and big data initiatives, as well as operational savings for the NHS and improved patient outcomes.
In addition to the 55 million primary care records, EY also considered the value of the estimated 23 million patient-episodic care records or electronic medical records (EMRs) that are captured when patients receive secondary or ‘specialist’ tertiary care.
Such information is held hospital trusts and includes details on admissions and medical interventions in accident and emergency departments.
EY estimates that EHR or EMR data has an estimated value of greater than £100 per patient record.
It notes that the value of data “will vary depending on its characteristics”.
“To measure the monetary value of data, one must first understand how these different characteristics increase or decrease its value,” the report continues.
Estimates were made by taking the number of patient records in each category and multiplying this by the relevant estimated value for each patient record.
The value of these data sets increases when they can be linked, such as by combining primary and secondary care with genomic profiles.
Further observations made by the report include:
Genomic data aggregators have raised capital from private equity and pharmaceutical companies at estimated valuations of over £1,500 per DNA sample
Deals combining genomic and phenotypic data from patient records have been valued between £1,000 and £5,000 per patient record
Partnerships combining genomic and phenotypic data from patient records have been valued between £1,000 and £5,000 per patient record
Fragmentation remains an issue
Yet delivering value from this data faces “significant process and technology costs associated with aggregation, cleaning, curating, hosting, analysing and protecting these transformed data sets,” the report notes.
Fragmented data sets and access restrictions are indicated as a major barrier.
“Interoperability between health care solutions and data platforms is pivotal to success,” the report reads.
“In the ideal world, every patient would have a single EHR, all records would be digital and centrally housed, and all health care platforms and data sets would be standardised and interoperable. But in reality, the NHS health care data ecosystem is made up of multiple fragmented and geographically dispersed data silos. Each data set contains multiple data types and formats.”
“Part of the challenge (and cost) of unlocking value is developing the most suitable processes and data workflows to aggregate, clean and convert these fragmented and isolated data records into a single high-quality, analysable data set.”
EY signposts the use of artificial intelligence (AI) and analytics platforms in making sense of – and unlocking value from – data sets held by NHS organisations.
“Early adoptions of AI within the health care ecosystems have been promising. Applying AI to the NHS data set will yield insights that can be used to improve patient outcomes through improved monitoring and better use of medicines.
“As a follow-on from this, AI can help reduce errors, provide better diagnostics and improve demand planning. Ultimately, improved patient health will also have implications for the UK economy and consequent positive impacts on public finances.
“AI could be applied to the NHS data set to make its operations more efficient and more accurate, including reducing adverse reactions to medicines, improving the speed and accuracy of diagnostics, and, from an operational perspective, leading to more effective and accurate theatre scheduling and capacity planning.”
EY provides strategy, analytics, cyber, valuation, risk and governance capabilities to digital healthcare company Sensyne Health, which is currently in agreements with George Eliot Hospital NHS Trust and Wye Valley NHS Trust that grant it access to anoymised patient data.
Responding to the report, Lord Drayson, CEO of Sensyne Health, said: “Data driven innovation will transform how healthcare is delivered in future. The quality and scale of NHS data, covering a population of over 50 million people from birth to death, provides the UK with a major competitive advantage and is a very valuable national asset.
“Enlightened policy that encourages ethical and fair collaborations between the NHS and the life sciences industry that use NHS data, could help to fund NHS services in future, as well as significantly improving the quality and affordability of care for patients.”
African swine fever threatens 200m pigs in China
The government may be covering up the severity of the crisis
Re your comment about the visit to China and Witty ,somehow I am not hopeful about the welfare of the pigs – would their pharmaceutical concerns by likely to include vaccination of the pigs? Who knows as David Cameron did have a peculiar interest in pigs when at oxford uni.
Indication for Use and Important Safety Information (by Neurorsigma)
The Monarch external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
The device is contraindicated for use by patients with:
implanted cardiac and/or neurostimulation systems
implanted metallic or electronic device in their head
Do not use the Monarch eTNS System:
in children under the age of 7 years
in patients with body worn devices (e.g., insulin pumps and t-VNS)
within 100cm of RFID readers that operate below 150kHz
in the presence of the following sources of radio frequency (RF) energy:
Magnetic Resonance Imaging (MRI)
Computed Tomography (CT)
Microwave or shortwave
Radiofrequency Identification (RFID) tags
Electronic article surveillance systems
TV transmission lines
High frequency (HF) equipment (e.g. surgical cauterizing tools and welding equipment)
Do not attach the electric patches:
anywhere on the body other than the forehead
on the neck
on the chest
over a defect in the skull (i.e. post brain surgery)
eTNS is generally well-tolerated. However, during the eTNS pivotal study, the following events occurred at a higher rate in the group treated with the eTNS system compared to subjects treated with the sham (placebo) device. Patients should consult their physician if any of the following events are observed:
Children 7 to 12 years receiving eTNS treatment should be closely supervised by an adult who has read the user manual and is familiar with the Monarch eTNS System.
The Monarch eTNS System should:
only be used by the individual for whom it is intended
be used with the guidance of a licensed physician
be used with caution in patients with heart disease or serious medical disorders
be kept out of the reach of infants and children under the age of 7 years
be used only as directed and be applied to healthy, clean, intact skin
not be used with other electronic therapeutic devices
not be applied on the neck or chest
not be used in the presence of electric monitoring equipment (e.g. cardiac monitors)
not be used in the bath or shower
not be used while operating machinery
not be cleaned while the device is in use
not be altered or repaired, nor should any of its components in the eTNS System be altered or repaired, as this may result in personal injury, damage to equipment and voiding the manufacturer’s warranty
not be dropped, shaken or handled roughly as the Monarch may be damaged , which may result in device malfunction, loss of treatment effect and/or personal injury.
be stored in a dry environment avoiding excess humidity, temperature, sunlight and dust.
not be stored near chemicals or gases.
The Monarch electric patches should not:
be used in patients with dermatitis or sensitive skin, as they are at higher risk of developing irritation.
be removed carelessly as this may damage the skin.
The Monarch lead wires should not be allowed to wrap around the neck.
The safety of the Monarch is unknown in the following conditions:
trigeminal neuralgia or injury to the trigeminal nerve
concurrent use of hearing aids
Long-Term Use: The long-term effects of using the Monarch eTNS System are unknown. The effectiveness of the Monarch for long-term use in the indicated population (i.e. for more than 4 weeks) has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use the Monarch for extended periods in patients with ADHD should periodically reevaluate the long-term usefulness of the device for the individual patient.
The Monarch eTNS System is only intended to be used in the electromagnetic environment specified in the Instructions for Use. Please refer to the instruction for use for additional information.
A full description of the safety information for the Monarch eTNS System is provided in the device’s Instructions for Use for use manual. Users should review the device’s Instructions for Use manual prior to using the device.
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‘The FDA reviewed the Monarch eTNS System through the De NOVO PREMARKET REVIEW PATHWAY….’a new regulatory classification………’
FDA granted marketing of the Monarch eTNS System to Neurosigma (above).
‘There are no serious side effects – the most common are drowsiness, increased appetite, trouble sleeping, teeth clenching, headache and fatigue’.
In his Mail on Sunday article this morning Peter Hitchens points out that one of Boris’s central clique, Munira Mirza, is from LM (alias Living Marxism alias Socialist Worker Party) who also run the journal Spiked:
Meanwhile, back at Spiked they are busy taking to task the Financial Times for backing Corbyn:
Which is just fine except that LM is also an ultra capitalist cell posing as Marxists with close associations with the Department of Business.
Of course, LM have also joined up with the Brexit Party (Fiona Fox’s big sister):
In all of this nothing is quite what it seems…
We are pleased to sign up to the AllTrials campaign for clinical trial transparency and support its call for the registration of clinical trials and the disclosure of clinical trial results and clinical study reports (CSRs).
At GSK, we are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment. We already publicly disclose a significant amount of information about our clinical trials. We register and post summary information about each trial we begin and share the results of all our clinical trials – whether positive or negative – on a website accessible to all. Today this website includes almost 5,000 clinical trial result summaries and receives an average of almost 11,000 visitors each month. We have also previously committed to seek publication of the results of all of our clinical trials that evaluate our medicines to peer-reviewed scientific journals.
Goldacre immediately took to Twitter to express his delight that GSK has signed up to the campaign, saying the firm’s backing was: “Amazing.Fantastic.Historic[…]This is the beginning of the end for a dark era in medical history.”
Catch, the catch …
A recent article in The Times reported that some medical schools have eased admission rules in order to increase diversity. The article revealed that some medical schools have dropped chemistry as a prerequisite to studying medicine, in an effort “to attract more girls and poorer pupils” and “break the stranglehold of affluent and privately educated students.”
Guessing Goldacre is a beneficiary of the ‘stranglehold’ but it hasn’t made him any more – what?
I.m all for evening up the opportunities but this is plain daft – all students should have training and qualifications (not necessarily A levels)specifically in chemistry if they are going to be prescribing medicines. Being able to read a guideline on a screen doesn’t do it.
A rather long snippet (re above ‘In Digital Health’) re the sort of people who are being paid by and are fleecing tax payers , especially NHS ‘users’ ,to advise on use of the health service in UK (previously the NHS, now morphed into a gigantic GUBU trough for such as E Y to slobber over.
Audit practices (from Wikipedia) It’s worth reading the whole thing…
Ernst & Young has been in accounting scandals – Bank of Credit and Commerce International (1991), Informix Corporation (1996), Sybase (1997), Cendant (1998), One.Tel (2001), AOL (2002), HealthSouth Corporation (2003), Chiquita Brands International (2004), Lehman Brothers (2010), Sino-Forest Corporation (2011) and Olympus Corporation (2011).
In 2004, Ernst & Young was punished for forming a lucrative business arrangement with one of its audit clients, PeopleSoft, thus creating a conflict of interest. As a result, the firm was barred by the SEC from accepting any new publicly traded companies as audit clients for six months.
In April 2004, Equitable Life, a UK life assurance company, sued EY after nearly collapsing but abandoned the case in September 2005. EY described the case as “a scandalous waste of time, money and resources for all concerned.”
In 2009, EY, the former auditors of Sons of Gwalia, agreed to a $125m settlement over their role in the gold miner’s collapse in 2004. Ferrier Hodgson, the company’s administrator, had claimed EY was negligent over the accounting of gold and dollar hedging contracts. However, EY said that the proposed settlement was not an admission of any liability.
Following allegations by the Securities and Exchange Commission that EY had committed accounting fraud in its work auditing the books of Bally Total Fitness, EY reached two settlements in 2008, including a fine of $8.5 million.
EY Hong Kong resigned from the audit of Standard Water on when it emerged that although EY Hong Kong had signed off the audit, it had been effectively outsourced to the affiliate in mainland China, which had received 99.98% of the fee. This was important because shareholders have less confidence in mainland auditors and because audit papers on the mainland are subject to state secrecy laws and can be withheld from outside regulators. EY’s quality and risk management leader (Greater China) even testified in the Court of First Instance that he was not sure whether there was a formal agreement covering the relationship between the two EY entities. The court case in 2013 came as US regulators were taking an interest in similar cases of accounting fraud in mainland China.
In October 2016, EY settled with the SEC because they were unable to detect financial statement fraud that was committed by the Weatherford tax department. Weatherford misstated their financial statements by manipulating the income tax line item in their financials. EY was Weatherford’s independent auditors when the fraud was perpetrated.
In October 2016, Mozilla stopped accepting WebTrust audits from Ernst & Young Hong Kong due to their failure “to detect multiple issues they should have detected” during their audits of WoSign.
In February 2017, in response to questions regarding misissued certificates, Symantec stated they would no longer accept WebTrust audits from E&Y Korea and E&Y Brazil due to deficiencies in these audits.
In 2009, in the Anglo Irish Bank hidden loans controversy, EY was criticised by politicians and the shareholders of Anglo Irish Bank for failing to detect large loans to Sean FitzPatrick, its chairman, during its audits. The Irish Government had to subsequently take full ownership of the Bank at a cost of €28 billion. The Irish Chartered Accountants Regulatory Board appointed John Purcell to investigate. EY said it “fundamentally disagrees with the decision to initiate a formal disciplinary process” and that “there has been no adverse finding made against EY in respect of the audit of Anglo Irish Bank.”
In 2009, EY agreed to pay US$200m out of court to settle a negligence claim by the liquidators of Akai Holdings. Separately the firm was alleged of falsifying and doctoring documents it presented to defend against the negligence claim by Akai’s liquidators. In a separate lawsuit, a former EY senior partner from 1984 to 1991, Cristopher Ho, and his listed company, Grande Holdings, paid over US$100m to Akai creditors to settle Akai’s liquidators’ claim that Ho conspired with Ting of stripping assets from Akai. Police raided the Hong Kong office and arrested an EY partner who had been an audit manager on the Akai account from December 1997, although audit documents had been doctored dating back to 1994. Akai was said to be the firm’s largest client for most of the 1990s from Hong Kong. The EY partner for the Akai account between 1991 and 1999, David Sun Tak-kei, faced no charges and went on to become co-managing partner for EY China. A few months later EY settled a similar claim of up to HK$300m from the liquidators of Moulin Global Eyecare, an audit client of the Hong Kong affiliate between 2002 and 2004. The liquidators described the Moulin accounts as a “morass of dodginess”.
The Valukas Report issued in 2010 charged that Lehman Brothers engaged in a practice known as repo 105 and that EY, Lehman’s auditor, was aware of it. EY was alleged of professional malpractice regarding the lack of disclosure of Lehman’s repo 105 practice in Lehman’s public filings. New York prosecutors announced in 2010 that they have sued the firm. David Goldfarb, a Lehman CFO who concocted the repo 105 balance sheet window dressing technique was a former senior partner of EY. EY said that its last audit of Lehman Brothers was for the fiscal year ending 30 November 2007 and that Lehman’s financial statements were fairly presented in accordance with Generally Accepted Accounting Principles. In March 2015, EY settled Lehman-related lawsuits with municipalities in New Jersey and California.
In 2014 tax arrangements negotiated by EY for The Walt Disney Company, Koch Industries, Skype, and other multinational corporations became public in the so-called Luxembourg Leaks. The disclosure of these and other tax arrangements led to controversial discussions about tax avoidance.
EY’s member firm in Japan, Ernst & Young ShinNihon, was fined ¥2.1 billion (US$17.4 million) for failing to spot irregularities during audit of its client Toshiba, which was Japan’s worst accounting scandal in years. The firm was also suspended from taking up new business for three months. An official from Japan’s Financial Services Agency (FSA) described that “[t]here was a grave breach of duty”. The firm’s CEO and chairman, Koichi Hanabusa stepped down the following month to take responsibility and monthly salaries for 19 employees were cut from 20 per cent to 50 per cent. In an unusual move, the FSA publicly named seven accountants involved in the audit who were said of failing to exercise due caution and signing off on false financial documents. The FSA also said the “firm’s operations were deeply improper”. ShinNihon, at the time, was Japan’s biggest accounting firm, with about 3,500 certified accountants and more than 4,000 clients. Ernst & Young ShinNihon audited about 960 listed companies in Japan, the most among the Big Four, as reported in 2015. Ernst & Young ShinNihon had audited Toshiba for over 60 years and the firm had around 70 staff serving Toshiba before the accounting scandal broke.
Ernst & Young Baltic, member of the EY network, used the emission assumptions of highly polluting EURO II trucks (manufactured before 2001) to falsely increase the socio-economic benefits of the new railway for the period 2026-2055 by 3 billion euros in the Rail Baltica Cost-Benefit Analysis. Total mistakes amount to more than 4 billion euros that constitute 20% of the total socio-economic benefits of the Rail Baltica. Correction of the mistakes makes the project unfeasible. EY has refused to provide any comments to the media regarding the public accusations.
EY UK also publicizes itself by sponsoring exhibitions of works by famous artists, such as Cézanne, Picasso, Bonnard, Monet, Rodin and Renoir. The most recent of these was Maharaja: the Splendour of India’s Royal Courts at the Victoria and Albert Museum.
in an effort to improve mathematics literacy in children.
In addition, EY publicizes itself by sponsoring the educational children’s show Cyberchase on PBS Kids under the PBS Kids GO! television brand,
EY in the UK sponsors the ITEM club.
EY in the UK has set up the National Equality Standard (NES), an initiative developed for business which sets clear equality, diversity and inclusion (EDI) criteria against which companies are assessed. The National Equality Standard (NES) is currently the only industry recognised national standard for EDI in the UK.
EY in the UK has set up EY Foundation, a new UK charity set up to support young people and entrepreneurs. (what will they be learning from this lot..)
On 8 September 2011, Rio 2016 made the announcement that EY would be an official sponsor of the 2016 Summer Olympics to be held in Brazil, as the exclusive provider of professional services – consulting and auditing – for Rio 2016 organizing committee.
EY has also been an Official Partner to The 2012 and the 2014 Ryder Cup
and so on……..keep the sick bag handy
Jacob Rees-Mogg apologises for likening doctor who warned of no-deal Brexit deaths to disgraced anti-vaxxer amid widespread condemnation
8 hrs ago
Jacob Rees-Mogg has apologised to a doctor after likening him to a disgraced anti-vaxxer who was widely blamed for the scare over the MMR jab.
The Commons leader was forced to apologise after he was criticised by England’s chief medical officer Professor Dame Sally Davies for comparing Dr David Nicholl to Andrew Wakefield on Thursday.
He said in a statement: “I apologise to Dr Nicholl for the comparison with Dr Wakefield.
She added: “Comparing an established medical expert to a man who was struck off the medical register by the General Medical Council, and described by them as ‘dishonest, irresponsible and showed callous disregard for the distress and pain of children’ is going too far and is frankly unacceptable.”
[Then on Thursday during a Commons business statement, Mr Rees-Mogg compared the doctor with Mr Wakefield, who in 1998 produced rubbished research over the MMR jab’s non-existent link to autism.]
The world is run by nauseating liars and bullies. The Department of Health and Social Care know perfectly well Wakefield was stitched up.
While I am sure the Guardian could be faulted on grounds of taste regarding their withdrawn article about Cameron’s privileged grief over the illness and death of his son Ivan, you wonder whether they weren’t on to something for once: that the fault lines in our society which led to the Brexit vote blowing up in Dave’s face must also have had a good deal to do with austerity. Of course, he won the election – the Tories got 36.9% of the vote but the turn out itself was only 66.2% so less than a quarter of the population actually voted for him. His policies were hugely unpopular but the opposition divided in unusual ways, and he nosed ahead to a majority.