Can Politicians Save the World?

August, 2, 2021 | 8 Comments

Comments

  1. ‘only one – headache –  ‘ …

    ‘Having accessed the data on harms the public could be asked how much is this drug worth?’

    UK Parliament

    GLAXOSMITHKLINE AND SEROXAT

    Motion text

    That this House condemns GlaxoSmithKline (GSK) for concealing for 15 years evidence that their anti-depressant drug Seroxat increases the risk of suicide and leads to `persistently worse’ depression; congratulates the US Food and Drug Administration for forcing GSK to confess that users of Seroxat `experience emergent suicidality or symptoms that might be precursors to worsening depression or suicidality’ and that `these symptoms may be severe and abrupt in onset’; and regrets the likely loss of life that has resulted from repeated denials of the lethal side effects of Seroxat by GSK, the Association of the British Pharmaceutical Industry and the Medicine and Healthcare Product Regulatory Agency in spite of the vigorous campaigns to reveal the truth by Professor David Healy, hon. Members, the Seroxat Users Group and Panorama.

    Supporters (40)

    https://edm.parliament.uk/early-day-motion/30692

    Seroxat: Statement from GlaxoSmithKline

    http://news.bbc.co.uk/1/hi/programmes/panorama/6291947.stm

    In developing Seroxat, GSK has always been strongly conscious of the duty it owes to the millions of patients who suffer from depression and refutes any allegation that it has failed in this duty.

    GSK utterly rejects any suggestion that it has improperly withheld drug trial information.

    Depression is a severe and disabling condition and a well-recognised tragic outcome of the disease, particularly among young people, is suicide.
    Careful monitoring of all patients is essential, regardless of whether they are taking medication or not.

    GSK conducted nine studies over eight years to examine the use of Seroxat in treating children, those under the age of 18, with depression and other psychiatric disorders as treatment options for these vulnerable patients are extremely limited.

    Results from these studies were documented and submitted to regulators in accordance with regulatory requirements.

    No suicides were reported in any of the nine paediatric trials conducted by GSK and when reviewed individually none of these trials were considered by GSK or independent investigators to show a clinically meaningful increase in the rate of suicidal thinking or attempted suicide.

    Only when all the data became available, at the end of the research programme, and were analysed together was an increased rate of suicidal thinking or attempted suicide revealed in those paediatric patients taking Seroxat.

    GSK brought this analysis to the attention of the regulatory authorities, including in the UK.
    Seroxat has never been approved by EU or US regulators as a medicine for those under 18 years of age and GSK’s UK product labelling has been entirely consistent with that position stating: “The use of Seroxat in children is not recommended, as safety and efficacy have not been established in this population.”

    Disclosure of paediatric clinical trial results

    From 1994 to 2002, nine paediatric trials were conducted in depression, obsessive compulsive disorder, and social anxiety disorder, involving over 1,000 patients treated with Seroxat.

    The study results from the individual trials were provided to regulatory agencies worldwide in accordance with regulatory requirements. Upon completion of the individual studies, safety and efficacy data were also communicated publicly in a variety of formats such as peer-reviewed journals, and poster presentations at scientific meetings, as is common practice in the disclosure of data.

    Study 329 was complete in late 1998 and was first submitted for journal publication in mid 1999. Full results of the trial were published in The Journal of the American Academy of Child and Adolescent Psychiatry in 2001. The study was also presented at several scientific meetings between 1998 to 2000.

    Study 377 was also completed in late 1998. It was presented at the American Academy of Child and Adolescent Psychiatry meeting in 1999 and was referenced in a number of psychiatry journals from 2000. However, opportunities to publish these data in a scientific journal were limited as the study failed to establish efficacy for Seroxat.

    Study 701 was completed in 2001. The data were presented as part of a combine publication at the scientific meeting NCDEU (New Clinical Drug Evaluation Unit) in 2002 and referenced in The Psychopharmacology Bulletin in 2003.

    Analysis of data from paediatric clinical trial results

    No suicides were reported in any of the nine paediatric trials conducted by GSK and none of these trials when reviewed individually by GSK or independent investigator showed a clinically meaningful increase in the rate of suicidal thinking or attempted suicide.

    In the case of study 329 although a numerical difference in adverse events was observed by the company and the study’s investigators, for patients taking Seroxat compared to placebo, these findings were not, by themselves, considered clinically meaningful due to the limited number of patients involved and the fact that suicidal thinking and behaviour is a recognised symptom of the underlying disease.

    Of the adverse events reported in this blinded study (where the patient, investigator and company do not know whether the patient received Seroxat or a dummy pill) only one – headache – was attributed by the independent investors to Seroxat. This opinion was published in the Journal of American Academy of Child and Adolescent Psychiatry in July 2001.

    The subsequent paediatric studies – 377 and 710 – also were not considered to show any increased rate of suicidal thinking or attempted suicide.

    Only when all the data became available at the end of the research programme and were analysed together was an increased rate revealed in those paediatric patients taking Seroxat. GSK brought this analysis to the attention of the regulatory authorities, including in the UK.

    Your reference to “the possibility of obtaining a safety statement was considered but rejected” needs clarification. This showed that GSK had an honest belief that these preliminary data on safety were reassuring as the company was considering whether to submit new (more positive) safety wording for inclusion in the product’s label to regulators for approval. However, it was recognised that any submission could only be made in the context of efficacy as well as safety. Given the failure of Study 377 to demonstrate efficacy, it was rightly concluded that a submission for new wording on safety should not be made.

    Promotion of Seroxat for treatment of paediatric depression

    Seroxat has never been approved by EU or US regulators as a medicine for those under 18 years of age. Any decision to prescribe a medicine outside its authorised indications, in the EU or the US, is made by a doctor on the basis of his/her clinical judgement and the interests of their patient.

    GSK does not promote its medicines for indications for which they are not approved and the company strongly refutes any suggestion that Seroxat was promoted to UK doctors for use outside the terms of the UK marketing authorisation, whether through clinical experts (KOLs) or any other route.

    Internal documents prepared by GSK’s US subsidiary were specific to that subsidiary and were not distributed to the company’s UK subsidiary or market.

    A memo sent to the company’s US sales force was produced to inform the sales force of the publication of study 329 in the Journal of American Academy of Child and Adolescent Psychiatry. As is clearly stated in the memo, this information was not to be used with, or distributed to, physicians, consistent with GSK’s global policy prohibiting off-label promotion. This memo was never issued or used by sales representatives outside of the United States, and would not have been seen in the UK.

    The company did periodically receive direct unsolicited requests from doctors for medical information about use of Seroxat to treat children and adolescents with depression. As is standard practice, a ‘medical information letter’, was sent to the individual doctor. This letter identified published literature and clearly stated that Seroxat was not authorised for use in depression in patients under 18 years of age.

    Can GSK Save the ….. ?

    Supporters ( ) …

  2. Exclusive Investigation (highlights refs to ‘surrogate endpoints’)
    FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway
    BMJ 2021; 374 doi: https://doi.org/10.1136/bmj.n1898 (Published 30 July 2021)

    What is surrogate endpoint in research?
    A surrogate endpoint is a clinical trial endpoint used as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit.24 Jul 2018

    I think One of the saddest consequences of the pandemic is the corrupt coercion of youngsters by offering incentives to accept vaccines The bribes in UK can amount to a hamburgher . Many have declined with rational reasons
    The younger generations are not one cohesive cohort but include the well off with access to information and the income and knowledge of adults in their lives to back them in running campaigns and making decisions -and many on the periphery who cynically and often knowingly take the burgher. But it seems all groups are into prescribed drugs – but how many aren’t?
    It would be interesting to know how many people are declining to take prescribed drugs opposed to those who do – and what the reasons would be across the board. That may be a hidden bit of optimism or lesson to be learned. ie whether there is evidence of any move away from accepting them. I know prescribing has increased overall but there may be a move away by some people in general not just through drug campaigning groups/orgs
    I guess We can’t rely on doctors to seriously challenge prescribing when they have been indoctrinated during training and accepted the way medicine will be practiced . Otherwise why not drop out? Or do other aspects of practice outweigh the issue of lack of evidence/data ,loss of professional skills.

    Where is the data kept? It must be somewhere. Who has the key? I just wonder if it was made available – what form would it take? Who would be trustworthy enough to present it ? And would it be comprehensive enough and understandable enough to all including to people who are prescribed medicines -so that it wouldn’t just depend on doctors reverting to doctor knows best if they did have access to the data? Instead of NICE knows best Data plus doctor knows best.

    • You refer to young people here Susanne and wonder if they will slowly start to refuse prescriptions for these drugs.
      Shane and I are in the VERY early days of trying to set something up along these lines. We have another couple working with us so far. Our plan is to start with the fact that the environment / wildlife etc. are affected by chemicals in our ‘waste’ from the huge number of ADs etc. being used. We hope to get in touch with youth group leaders in our local areas to see if this kind of information would supplement work already being done on the environment. We’d hope that this could eventually cause youngsters to think along the ‘refusal’ lines. Obviously, getting group leaders to be onside will not be easy but it’s worth a try.
      Alongside this we hope to meet with parent groups as we understand that many, in this immediate area, are at their wits’ end due to their youngsters’ anxiety issues. Our hope, in that area, is to share knowledge with such groups so that they at least know of the pitfalls that may face their children if they are prescribed these drugs. There is little that we can offer in the form of support, of course, but as we all here keep stating – LISTENING is such an important matter in itself and the fact that we, at least, understand their concerns.
      Meeting with youngsters already on ADs is another thought but we have not yet worked through our thought on that particular section. I shall keep you posted!

      • So interesting and Such great work you are doing Mary – huge respect to you. and Shane. (In the meantime re the youngsters’ anxieties issues -from today as I exxpect you know -youngsters of 16 and over are being ‘offered’ vaccines without need for parental or ‘carers’ involvement. Just what is the age of consent in UK these days? – it’s a minefield. I can also imagine adolescents using this in the ‘wrong’ way to show they can ‘do what I like’ – common teenage behaviour. ) I would love to hear of how ‘things go’ . Best wishes

  3. An Exceptional Article, it would be useful for all to read :

    The Danger of Putting Youth on Antidepressants

    Why medication shouldn’t be the default treatment for our kids’ mental health

    BY PATRICIA PEARSON

    ILLUSTRATION BY PETE RYAN
    16:49, Apr. 5, 2020 | Published 11:15, Sep. 20, 2017

    https://thewalrus.ca/the-number-of-youth-taking-antidepressants-is-growing-but-are-the-drugs-working/

    I remember sitting in my Honda looking at the sample package, with Clara beside me, and noting the package’s black-box label, which warned of a heightened risk of suicidal thinking and behaviour in children, adolescents, and young adults.

    “Why this drug?” I asked, “You don’t have major depressive disorder.”

    “You’re not a doctor,” Clara said, with trademark teenage scorn.

    Julie and her husband, Peter, now help run a website called rxisk.org,

  4. Petitions
    To -UK Government and Parliament -UK Citizens only can sign

    Petition
    Shift to a Wellbeing Economy: put the health of people and planet first
    We urgently need the Government to prioritise the health and wellbeing of people and planet, by pursuing a Wellbeing Economy approach. To deliver a sustainable and equitable recovery, the Treasury should target social and environmental goals, rather than fixating on short-term profit and growth.

    More detailsSign this petition
    38,391 signatures

    This response was given on 25 May 2021

    While traditional economic measures such as GDP remain important, the government is committed to broadening the range of measures it uses, including by better accounting for natural and human capital.

    Read the response in full

    At 100,000 signatures, this petition will be considered for debate in Parliament

    Share this petition
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    Created by
    Laura Evelyn Sharples
    Deadline
    26 September 2021
    All petitions run for 6 months

    • I think having anything to do with Wellbeing is a very bad idea. Its individual centred. And a rapidly growing industry where people eat veggie burgers, go to gyms and demand access to SSRIs

      David

      • The name Wellbeing has the yuk factor but this petition doesn’t seem individually centred to me The petitioner has wider concerns So even though petitions rarely change anything, as the usual slick response from government shows here , , I think somebody who is using means to highlight issues effecting public health and the planet is probably not jumping on the individualistic wellbeing bandwagon. Petitions won’t do it but the support they get may encourage further action The Official Wellbeing lead in Wales by the way has no powers whatsoever to enforce action She can highlight issues and make them public but has no real political or critics point ,out much influence at all

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