Sex, Drugs and a Leap Year Proposal
See Sex, Drugs and Bureaucrats for the start of this correspondence. You will need both posts to understand next weeks Suicide, Drugs and Bureaucrats.
February 26 Rasi to Healy
Thank you for your letter of 31st January 2020 regarding SSRIs and PRACs latest recommendation on the risk of persistent sexual dysfunction after treatment with serotonin and noradrenaline reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs). I am sorry to hear about the suffering of your patients and would like to reiterate EMA’s commitment to public health and that it does everything it can to ensure that medicines are as safe as possible.
You are dissatisfied with the outcome of the assessment and state that patients with Post SSRI Sexual Dysfunction (PSSD) “had hoped for more than the very minimal set of words”. We are sorry that you feel this way. Please note that the wording of the product information reflects the outcome of the assessment. The issue will of course remain under review and the wording of the product information will be updated as necessary to accurately reflect any new knowledge of this risk.
We would like to clarify that sexual dysfunction is a well-known side effect described in the product information of SSRIs. For example, for the antidepressant Cymbalta, sexual dysfunction was highlighted in the product information when it was first authorised in 2004 and was extensively discussed in the initial assessment (report available here:
https://www.ema.europa.eu/en/medicines/human/EPAR/cymbalta).
Please also note that the guideline on clinical investigation of medicinal products in the treatment of depression
(https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigationmedicinal-products-treatment-depression en .pdf)
specifically states that investigators should pay “special attention to the effect on sexual function and libido”. PSSD has not been recognised before and the reasons are described in your letter but are also linked to their late onset making detection in an RCT setting difficult.
You challenge in your letter the way medicines are regulated. We would like to take this opportunity to clarify a few issues:
In line with current legislative requirements, EMA’s role is to establish full benefit-risk analyses for medicines. In order to do this EMA looks at all the evidence submitted to establish the benefits as well as the risk profile of a given medicine. Only if the benefits outweigh the risks for a given medicine can EMA recommend a medicine for marketing.
Like all medicines regulators worldwide, and in line with the principles of evidence-based medicine, EMA considers RCTs to be the gold standard for measuring medicine effects in most cases and provides guidance on their use to support licensing applications. For further information you may wish to consult the above-mentioned guideline which describes how this applies to antidepressants. It is not the case, as you claim, that a randomised controlled trial deliberately only looks at a particular benefit and ignores any side effects. RCTs are explicitly set up to investigate safety as well as efficacy and EMA assessment reports include extensive information on the safety profile of each medicine — indeed, it would scarcely be possible to provide a benefit-risk assessment if we did not require evidence on the risks to be collected. In this context the guidelines on clinical investigation also identify the specific side effects that should be monitored in clinical trials.
As for any clinical trial there is a legal obligation for companies to report all suspected side effects. For further information on the safety monitoring during clinical trials please refer to the following link:
https://ec.europa.eu/health/documents/eudralex/vol-10 en and in particular
htts://ec.europa.eu/health/sites/health/files/files/eudralex/vol10/2011 c172 01/2011 c172 01 en.pdf
Once authorised, the benefit risk balance of medicines is always monitored and confirmed through regular benefit risk analyses (so-called PSURs – https://www.ema.europa.eu/en/human—renulatory/nost-authorisation/pharmacovigilance/periodic-safety-undate-reports-psurs).
It is not only during clinical trials that side effects are closely monitored. Companies must always report any side effects that occur with a medicine worldwide, which are then analysed by regulators as part of their regular safety monitoring of medicines as mandated by legislation (Art 23 (2) of DIR200 1/83/EC).
We therefore strongly encourage you and affected patients to notify side effects to the relevant national competent authorities so that the reports can be taken into account for the safety monitoring of these medicines.
Please note that EMA, in collaboration with EU Member States, will continue to monitor sexual disorders as it does for all safety issues in general. EMA will take necessary action in case a new safety issue is identified. This may include a further update of the product information or other regulatory action. You can find more information about pharmacovigilance in the medicine lifecycle on EMA’s website:
https ://www.ema .europa.eu/en/human-regulatory/overview/pharmacovigilance
overview#pharmacovigilance-in-the-product-lifecycle-section
Finally, regarding your point on the redaction of personal data, please note that this is done to protect patients’ privacy, in line with current EU law which we are obliged to follow just like any private company or public institution. We would like to clarify that deleting personal patient data does by no means impact the causality assessment.
I assure you of EMA’s unwavering commitment to safeguard public health, and to do all it can to ensure that medicines are as safe as possible and that side effects are identified and assessed continuously, before and after marketing authonsation. In this context EMA acknowledges that despite many approved antidepressants (most of them approved many years before EMA came into being) and a reappraisal of the role of medicines vis-à-vis other treatments such as psychotherapy, there is still a need for new medicines with better efficacy and improved safety profile in patients with depression.
Yours sincerely,
Guido Rasi
February 29th
Dear Professor Rasi
Your February 26th letter elegantly slips by the points raised. Let me reframe them.
- Can EMA name a single medical or behavioural condition that leaves those affected able to rub chilli paste into their genitals or rub a hard-bristled brush up and down their genitals and not feel it? And for this condition to remain permanent?
- Your mention of the importance EMA attaches to sexual issues on antidepressants feels rather like closing the stable door after the horse has bolted. Genital numbness is still not mentioned the labels, even though SSSRIs can cause genital numbness within 30 minutes of a first tablet and EMA, when licensing dapoxetine, have had RCTs demonstrating essentially this.
- As described in the petition, two 1990s trials showed SSRIs reduce genital sensation.
- As described, all of the medical literature on PSSD identifies genital numbing as a side effect of these drugs, including a BMJ editorial this week.
- The named reports we provided from PSSD sufferers all identify genital numbing as a side effects of the drugs.
What else would it take to get genital numbing added to the label?
- As you can see from data sent to you over a year ago, full-blown PSSD can happen within days of a first dose so your point about it not happening in the timeframe of the usual RCT is irrelevant. Neither you nor I know if such cases have happened in RCTs without an RCT with this as a primary endpoint, especially when companies tell investigators not to ask any questions about sex. Are you waiting for one to be set up?
- I have indicated that there may be cases of PSSD in healthy volunteer studies of only 2 weeks duration carried out in the 1980s; has EMA reviewed any of these?
- You have not contested the point that between 50 and 100 million people across Europe are not able to make love the way they might wish. Given your reference to EMA concerns about public health, does EMA have any intentions of intervening in this public health matter of some political significance?
- Some people in contact with me have been affected for over a quarter of a century. Regulators in Britain seem to think British doctors can cure PSSD, but they have so far failed to name any doctors or treatments that might be used. Does EMA know of any doctors or treatments able to cure or even significantly alleviate PSSD?
- Why do EMA and other regulators not take the same approach to establishing cause and effect in the case of adverse events as pharmaceutical companies?
- Given the necessity of interrogating patients in order to establish cause and effect in the case of adverse events, have EMA taken any steps to reconcile this need with issues of patient confidentiality?
- Would you accept that regulators and guideline makers essentially never discover treatment related adverse effects?
Risk-Benefit
Your letter doesn’t take up the risk-benefit challenge posed to you. I’d appreciate any input on the origins and meaning of this term that EMA can offer. As mentioned, Dr. Jordi Linares placed great, almost sole, weight on RCT data when making a risk benefit assessment, but the effects of SSRIs on sex and the ability of RCTs to make effects like these to disappear almost entirely seem to blow a hole in that strategy.
I was involved in several industry cost-benefit analyses in the early 1990s. It was wonderful to be able to “prove” drugs like the SSRIs that cost 50 times more than imipramine, or risperidone which was 100 times more expensive than chlorpromazine, were actually saving money. It all depends on the data and assumptions you feed into the system. None of the SSRI modelling fed in figures of 5-10% of the population being hooked on them of the contribution this might make to declining birth rates in certain ethnic groups.
I’m sure that at some level you must see that it’s not realistic to view risk-benefit analyses as involving anything other than a baptizing of a new drug with a sprinkling of fairy dust.
On a wider front, it was clear in the RCTs used for licensing SSRIs there were more suicidal acts and both suicides and deaths on active treatment than on placebo in the subset of trials shown to regulators. I think it was right to license SSRIs, but I am flummoxed by your suggestion that the data allowed you to license them on the basis of a risk benefit analysis. Perhaps you can explain?
Licensing, with an acknowledgment of hazards that ensured clinical discretion would be brought to bear on when to use these drugs and how to respond in the event of an apparent hazard, would have been appropriate. But one of the first uses of risk-benefit terminology by regulators was in 1991 when FDA, faced with concerns about Prozac and suicide, opted not to warn stating this might put people off seeking a benefit.
This approach puts doctors in the firing line if they exercise clinical discretion or stick to their guns that SSRIs can and do make patients suicidal. People with PSSD can also tell you what it’s like to be ridiculed and referred for counselling or treated as lepers by doctors who, understandably, in the absence of a warning figure regulators like EMA endorse their denying that PSSD can be triggered by treatment.
Whenever there is a dispute about issues, an operational approach – like your supposed risk-benefit analysis – can look appealing. But, unless agreed to by all sides of a dispute, operational approaches are amoral. They do not take right and wrong or human suffering into account. Were any PSSD sufferers contemplating suicide to take a comparable risk-benefit approach, they might well consider it would be of greater benefit to other PSSD sufferers to take a suicide bomb into the offices of a major regulator than to kill themselves in a manner that disturbed as few others as possible. This would be immoral, however, and few people ever take an approach life this without the shield of a bureaucratic apparatus.
I hope you hear a call on your humanity here rather than a call to beef up the security of your building. I am confident that those with PSSD will act with humanity but less confident that regulators will.
Nicola Blackwood
I attach a letter from Nicola Blackwood, then in Britain’s Dept of Health to Wera Hobhouse MP, in response to a letter occasioned by one Ms Hobhouse’s constituents who has PSSD. This offers a galling example of politicians regurgitating stuff fed them by regulators that leads to patients and doctors being dismissed by people who know nothing.
Faced with an issue like PSSD, politicians say they are critically dependent on advice from regulators (MHRA now in Britain) and the framers of guidelines (like NICE). NICE and MHRA have made it clear in correspondence with me that it’s not their job to sort out issues of access to clinical trial data or police the ghostwriting of the medical literature. In a good example of the Deep State that fuels populist rage, both MHRA and NICE on one side and politicians on the other hide behind risk benefit mumbo-jumbo, which, deployed in sonorous tones like the Wizard of Oz once used, they hope will stop awkward questions.
It also leaves doctors, who in 1962 were thought to be a critical part of the regulatory apparatus, behind. Regulatory bureaucrats were supposed to listen to people like me but, when it comes to matters like this, doctors are like salt that has lost its saltiness – good for very little. They act like politicians who wait on bureaucrats to tell them what’s what.
I hope you do not find the tone of this letter too hostile. I blame my profession more than I blame you. I worry that our failure to recognize our role means that pretty soon we will survive in name only, effectively practicing as middle managers ensuring that nurses and others keep to guidelines and the labels of drugs regulators have approved – I initially said authorised.
I hope you appreciate the date of this proposal.
Yours sincerely
Share this:
One trick pony –
Look before you Leap…
Boeing 737 Max cleared to fly again ‘too early’
https://www.bbc.co.uk/news/business-55751150
Regulators in the US and Europe insist their reviews have been thorough, and that the 737 Max aircraft is now safe.
In his report, Mr Pierson claims that regulators and investigators have largely ignored factors, which he believes, may have played a direct role in the accidents.
Investigators believe both accidents were triggered by the failure of a single sensor. It sent inaccurate data to a piece of flight control software, called MCAS.
“Boeing and the Federal Aviation Administration (FAA) must finally become more transparent, and begin to provide information and data, so that independent experts can determine the worthiness of the work that’s been done.”
Howeverm he adds that “taking the limited information in any accident report… and making fresh interpretations of it, is not the same as conducting a new investigation”.
Boeing itself will not comment on whether the electrical and flight control problems highlighted by Mr Pierson may have played a factor in the two accidents, on the grounds that this is a matter for the investigating authorities.
But relatives of those who died aboard ET302 are continuing to urge the agency not to allow the 737 Max to operate in Europe, “until continuing concerns about the aircraft’s safety have been fully and openly addressed”.
Boeing’s $2.5BILLION payout for 737 MAX crashes: Aviation firm is ordered to pay $1.4million to EACH family of the 346 people killed in two airline disasters and $1.7billion to airlines who purchased the planes
https://www.dailymail.co.uk/news/article-9124061/Boeing-pay-2-5-billion-settle-charge-plane.html
Prosecutors described Boeing’s failings in withering terms, accusing the company of putting ‘profit over candor’ and of engaging in a ‘half-truths’ and a ‘cover up.’
Cleared to fly …
I was once almost working for a safety critical systems company in Maldon, Essex at one point, safety critical engineering can be a bit relentlessly heavy and a bit soul destroying as there are so many rules about hardware and software development. The key thing is to design a system to ensure the Mean Time Between Failures (MTBF) is a very large number usually it will be millions of years, fault tolerant safety critical engineering is all hardware voting on the Buses and MISRA C.
https://en.m.wikipedia.org/wiki/Mean_time_between_failures
https://www.rs-online.com/designspark/when-redundancy-is-a-good-thing
My feeling about Boeing and the 737 MAX is that alot of it is about greed. Boeing were in a race with Airbus. The new system was designed to automatically correct the trim, this was needed as the new powerful engines on the wings tended to force the 737s nose up. The Boeing 737 MAX was rushed out to beat Airbus and mistakes were made in the process.
I made an analogy with Boeing 737 MAX safety critical engineering and ssri medicines some time ago.
https://smallbusinessprogramming.com/safety-critical-software-15-things-every-developer-should-know/
….”hide behind risk benefit mumbo-jumbo, which, deployed in sonorous tones like the Wizard of Oz once used, they hope will stop awkward questions.”
Just brilliant.
This can be applied to most of what pdocs are feeding patients these days.
Thanks for all you do and are doing Dr Healy.
Ugh the whole Risk Benefit argument drives me nuts. Who determines this number? Is there a percentage thats decideds? If 99% of the people that take these drugs benefit and 1% will experience permanent life destroying side effects than its ok for the market.
I would personally like to see these Governments that have somewhat recognized PSSD Have a press release and national ad campaign warning about it. The way Health Canada basically said ok we’re aware of it and continue to monitor it in the future. No fuck heads you need to warn Canadians of this and reassess the safety of these. Not just sit back and wait for more people’s lives to be destroyed before taking it seriously.
Risk Benefit appeared in the early 1990s and scored big in the defense of Prozac in 1991. Pharma persuaded regulators that the RCT data provided the perfect cover for them to justify approving a drug and continuing to keep it on the market despite thousands of people being injured and killed. No journalist or academic would be able to argue without seeming irrational
D
With reference to next weeks post on sex drugs and suicides , there is a load of research published and being called for by International Association for Suicide Prevention (IASP) It would be surprising if there aren’t more people who suffer from PSSD dying of suicide or who are contemplating suicide as a result of the restrictions imposed by Covid. And they have compiled huge amounts of information which could be useful by this org. depending on how they use it – or not- of course.
There is nothing in the guidelines of this organisation to suggest they even admit SSRI;s and other drugs can be a factor When suicide could be exacerbated by Covid
this sis a serious ommission
Responding to global suicide-related risk arising from the COVID-19 pandemic
Statement from the Executive Committee of the International Association for Suicide Prevention.
On 11 March 2020, the WHO declared the COVID-19 virus a global pandemic. ………
However, evidence relating to previous public health emergencies, while limited, gives reason for concern.
Deaths by suicide increased in the USA during the 1918–19 influenza pandemic (Wasserman 1992), and studies on
Severe Acute Respiratory Syndrome (SARS) found an increase of suicide among the elderly (Cheung et al, 2008; Yip et
al, 2010, Chan et al, 2006), associated with social disengagement, mental stress, anxiety, and fears of being a burden
on the family. Recent informed commentaries suggest that the COVID-19 pandemic may lead to an increase in suicidal
behaviour due to the development or exacerbation of known risk factors for self-harm such as mental ill-health, social
isolation, entrapment, grieving, loneliness, hopelessness, unresolved anger, stigma, unemployment, financial strain,
domestic violence, and excessive alcohol consumption (Holmes et al, 2020; Gunnell et al, 2020)………..
The IASP urgently needs your help to develop and implement a strategic plan to
reduce COVID-19-related suicidal behaviour. We call upon you to work in collaboration with the IASP, sharing research
and other evidence from your country about the impact of the pandemic on suicidal behaviour so that we can collectively
integrate sources of key information and insights from your membership, from external stakeholders and, wherever
possible, from governments.
IASP is building a central pool of resources (expertise, research, guidelines for good practice)
The intention is to shut down certain aspects of reporting, some ‘advice’ reasonable enough maybe……but if people from the PSSD ‘community’ report – it would be interesting to see their response..
‘We call upon you to work in collaboration with the IASP, sharing research and other evidence from your country about the impact of the pandemic on suicidal behaviour so that we can collectively integrate sources of key information and insights from your membership, from external stakeholders and, wherever possible, from governments.’…
Read the entire statement here.
COVID-19 Suicide Research Studies
To share and inform on studies and research being undertaken in respect of suicide prevention and COVID-19, details of such studies are being collated and compiled in the directory below.
If you are running a relevant study please use the button below to share your study details.
Click here to submit a research study
You will find below a curated selection of research and publications related to suicide, suicide prevention and COVID-19. View the IASP Newsletter for further research and publication news beyond COVID-19.
The impact of the COVID-19 pandemic on self-harm and suicidal behaviour: a living systematic review. Given the likely rapidly expanding research evidence base on the pandemic’s impact on rates of suicide, suicidal behaviours and self-harm and emerging evidence about how best to mitigate such effects, it is important that the best available knowledge is made readily available to policymakers, public health specialists and clinicians as soon as is possible. To facilitate this, we are conducting a living systematic review focusing on suicide prevention in relation to COVID-19. Daily automated searches will feed into a web-based screening system. Following initial screening, articles will be reviewed daily by suicide prevention experts in our team. Key publications and evidence summaries will be shared with policy makers in the UK, Ireland and Internationally. The review is jointly lead by researchers from the University of Bristol and Swansea University. It is a collaborative effort involving colleagues from the Universities of Cork, Oxford, Manchester, Glasgow, and Ulster.
(Note the ‘initial screening by ‘experts’ – they are not listed – would be interesting to see who they block)
COVID-19 Suicide Research Studies Register
Register your COVID-19 Suicide Research Study
Please use the fields below to register and provide information on the study you are involved in. Once you have submitted your study you will receive an email confirmation. The directory itself is updated weekly.
I think NICE uses Qualys to draw up some of their quidelines. Another weird concept unless individuals are involved in making their preferences count
Benefits and risks of drugs: a wrong concept
EMA’s executive director Guido Rasi writes in a letter from 26 February 2020 to psychiatrist David Healy that, “In line with current legislative requirements, EMA’s role is to establish full benefit-risk analyses for medicines.”
Healy replies that drug regulators, other institutions like NICE and politicians “hide behind risk benefit mumbo-jumbo, which, deployed in sonorous tones like the Wizard of Oz once used, they hope will stop awkward questions.”
The terminology is misleading, as it implies that drugs always have benefits but not necessarily have any harms, only risks of harms. It is the other way around. Drugs always cause harm and sometimes they also cause benefits.
Thus, a more appropriate terminology would be possible benefits and certain harms, and since the harms are certain, they should be flagged first: certain harms and possible benefits.
Many years ago, I advocated for a change in terminology, both in CONSORT (which John Ioannidis also did) and Cochrane, and this was accepted so that at least some people now ask the more appropriate question: What is the balance between benefits and harms?
Unfortunately, many people – undoubtedly “inspired” by industry – use the illusive construct benefit-harm ratio, which can only exist if benefits and harms are measured on the same scale, e.g. total mortality, which is very rarely the case. In all other cases, it will be subjective and arbitrary what people think of the balance between benefits and harms according to the values they attach to various outcomes and how common they are.
Trying to weigh up all the factors to come to a desicion can be very complicated especially if one of the factors is persuation by others to take (or not) a drug. Years ago on a course I was shown a decision aid which could simplify decisions to some extent by writing down the various factors on a ‘decision tree’ and attaching a weight for difference preferences. I have never heard of it actually being used but it is horrendously difficult to keep all the factors/possibilities in our heads – are they a good idea – if they were to be used of course?
Pick a Pocket or Two …
‘since the harms are certain, they should be flagged first’
‘Watchful Waiting’
“These are the methods of the mob.”
Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Health Care
https://www.madinamerica.com/2013/09/deadly-medicines-organised-crime-big-pharma-corrupted-health-care/
“How come we have allowed drug companies to lie so much, commit habitual crime and kill hundreds of thousands of patients, and yet we do nothing? Why don’t we put those responsible in jail? Why are many people still against allowing citizens to get access to all the raw data from all clinical trials and why are they against scrapping the whole system and only allow publicly employed academics to test drugs in patients, independently of the drug industry?
“I know some excellent psychiatrists who help their patients a lot, e.g; David Healy uses watchful waiting before giving drugs to first-episode patients. I also know that some drugs can be helpful sometimes for some patients. And I am not ‘antipsychiatry’ in any way. But my studies in this area lead me to a very uncomfortable conclusion:
“Our citizens would be far better off if we removed all the psychotropic drugs from the market, as doctors are unable to handle them. It is inescapable that their availability creates more harm than good.”
Richard Smith, Former Editor-in-Chief of the British Medical Journal, reviews Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare
“Most of Peter’s book is devoted to building up the case that the drug industry has systematically corrupted science to play up the benefits and play down the harms of their drugs.
“As an epidemiologist with very high numerical literacy and a passion for detail, so that he is a world leader in critiquing clinical studies, Peter is here on very solid ground. He joins many others, including former editors of the New England Journal of Medicine, in showing this corruption.
“He shows too how the industry has bought doctors, academics, journals, professional and patient organisations, university departments, journalists, regulators, and politicians.
“These are the methods of the mob.”
Dr. Gotzsche says there’s no legitimate reason for doctors to prescribe antidepressants and many other psychiatric drugs to their patients. He says the drugs would have to incur “colossal” benefits to justify their use, given their terrible and toxic safety profiles.
https://learning.omnivistahealth.com/2015/10/antidepressants-cause-15-times-more-suicides-than-fda-reports/
But those “colossal” benefits just don’t exist.
Did regulators fail over selective serotonin reuptake inhibitors?
https://www.bmj.com/content/333/7558/92
GlaxoSmithKline’s recent letter to doctors points to a sixfold increase in risk of suicidal behaviour in adults taking paroxetine.1 This contrasts with the data in the UK Medicines and Healthcare Products Regulatory Authority’s expert working group report on suicide and antidepressants published in December 2004.2 Many people expect drug companies to be slow to concede that a drug causes hazards, but we do not expect our regulators to be even slower, so any hint that this might have been the case needs to be examined.
Regulatory problem
In February 1990 an article raised concerns that the recently licensed fluoxetine might trigger suicide acts in depressed patients.3 A series of meta-analyses of published and unpublished antidepressant trials subsequently failed to show benefit in terms of suicidal acts with active treatment compared with placebo.4–9 In fact, each analysis showed a small excess risk with active treatment for all classes of antidepressants, although the increases are compatible with chance and the original authors concluded there were no differences. For much of the 1990s campaigners were saying trials with placebo controls in depression were unethical, and these analyses were attempts to justify placebo controlled trials.
I recently participated in a cumulative meta-analysis of published trials that found an excess of suicide attempts in patients taking selective serotonin reuptake inhibitors (SSRIs) compared with those taking placebo.10 The numbers in the individual trials are small, so that although from 1988 onwards the point estimate indicates roughly a doubling of the risks of suicidal acts with SSRIs, the effect has only recently been consistently significant. Nevertheless, the trend should have been seen by both companies and regulators as something that required investigation before …
Analysis and Comment
“This failure, along with an apparent selection of data, and flouting
of basic scientific norms, can only deepen the questions hanging over
regulatory involvement in this issue.”
Kent Woods
Chief Executive, MHRA
https://www.bmj.com/content/333/7558/92/rapid-responses
Healy’s article ‘Did regulators fail over selective
serotonin reuptake inhibitors’ makes allegations about failure of MHRA to
warn about suicidal behaviour with SSRIs which require response1.
The MHRA moved swiftly …
‘since the harms are certain, they should be flagged first’ …
With thanks to the H H C which has published this book and so much else to reveal and publish – on similar lines to Samizdat Health
The Hidden History Center is a project of the Museum of Hidden History, a 501(c)(3) non-profit, established in Washington D.C. in April 2012.
What we do not see because of our assumptions and mis-education
What we cannot see because of our paradigms and lack of counter-narratives
What we are not allowed to see by the National Security State
At the Center, we will present narratives of the U.S. historical record that you’ve never heard – secrets about powerful figures, operations performed under the radar, and actions hidden from the public, that changed our country.
The Zyprexa Papers: Big Pharma Meets Big Diagnosis, Big Courts, and Big Psychiatric Hospitals
This book chronicles the battles on behalf of Bill Bigley, the psychiatric patient whose ordeal by Eli Lilly’s product made possible the exposure of the Zyprexa Papers. Written by James B. Gottstein, Esq. and published in 2020, The Zyprexa Papers are crucial documents in the fight to hold Eli Lilly accountable for hiding harm caused by Zyprexa and their illegal marketing of it.
It was just a normal day before Dr. David Egilman called me out of the blue on November 28, 2006. The days are short that time of year in Anchorage, Alaska, and it was getting dark by mid-afternoon. Dr. Egilman told me he had been hired as an expert witness by one of the law firms representing patients who had taken Zyprexa and contracted diabetes or other metabolic problems. He wanted to know about documents relating to Zyprexa I might have. In truth, he was feeling me out to see whether I might be willing to subpoena him, so he could legally send me secret documents. These documents revealed the pharmaceutical company Eli Lilly (Lilly) had from the beginning suppressed information showing Zyprexa caused these life-threatening conditions. In addition, they showed Lilly had illegally marketed this powerful and dangerous drug for use in children and the elderly. He wanted me to then send them to Alex Berenson, a reporter for The New York Times with whom he was already working on a Zyprexa exposé.
On December 17, 2006, The New York Times began a series of front-page stories about documents obtained from Alaska lawyer Jim Gottstein, showing Eli Lilly had concealed that its top-selling drug caused diabetes and other life-shortening metabolic problems. The “Zyprexa Papers,” as they came to be known, also showed Eli Lilly was illegally promoting the use of Zyprexa on children and the elderly, with particularly lethal effects. Although Mr. Gottstein believes he obtained the Zyprexa Papers legally, the United States District Court for the Eastern District of New York in Brooklyn decided he had conspired to steal the documents, and Eli Lilly threatened Mr. Gottstein with criminal contempt charges. In The Zyprexa Papers, Mr. Gottstein gives a riveting first-hand account of what really happened, including new details about how a small group of psychiatric survivors spread the Zyprexa Papers on the Internet untraceably. All of this within a gripping, plain-language explanation of complex legal maneuvering and his battles on behalf of Bill Bigley, the psychiatric patient whose ordeal made possible the exposure of the Zyprexa Papers.
Bill Bigley (25 Apr 2012)
__________________________________________
_______________________________________
REVIEWS
Heroes and Villains Populate the Pages of The Zyprexa Papers, by Susan Rogers, Key Update, May 18, 2020.
“The Zyprexa Papers” is a deep dive into the Bizarro World of psychiatry, Big Pharma, and the judicial system. As Jim writes, “To me, it is crystal clear locking people up and drugging them against their will is not ‘for their own good’ but instead very harmful to them. One of my goals in writing this book is to show this truth.” Mission accomplished.
David Healy, MD, Review on Samizdat Health Writer’s Co-operative, March 21, 2020.
This much is well-known. The papers have been widely distributed and have opened some peoples’ eyes. Gottstein doesn’t detail the content of these papers — what every non-person knew about the capacity of these drugs to cause diabetes, metabolic syndrome, suicidality and other problems. The fascination lies in how little of this appears to be known by the psychiatrists who might lock you and me up and inflict treatment on us and how pharma takes psychiatrists for idiots.
It’s rather like how little Germans during World War II knew about what was happening in their country. And just like German functionaries drew up specifications for drainage in vehicles to transport people to concentration camps, much as they would have done for transporting animals, so also Judge Weinstein dealing with Gottstein’s actions stuck rigidly to the legal specifications without questioning what in fact was going on. And if that sounds grimly American, everything we know about what pharma gets up to comes from legal actions in the US and a handful of lawyers like Gottstein. The rest of the world has made no contribution to what we now know.
Many people coming to this book might figure that the Bigley saga plays second fiddle to what is after all called The Zyprexa Papers. A switch from the dizzying heights of New York courtroom drama to an Alaskan backwater. But Bill Bigley’s case is the beating heart of this book. The Zyprexa papers are the bait for Gottstein’s masterly portrayal of how the system treated Bill and will treat you and anyone you know who comes into contact with it.
Pathways to Suicide One of the most obvious questions has just not been included . Which if any ,medications had been prescribed.
HomeJournalsBJPsych OpenVolume 7 Issue 1
First-person accounts of the processes and planning involved in a suicide attempt on the railway
Published online by Cambridge University Press: 20 January 2021
Ian Marsh
Lisa Marzano
David Mosse
and
Jay-Marie Mackenzie
Aims
To understand from first-person accounts the processes and planning involved in a suicide attempt on the railway.
Conclusions
By giving people free reign to describe in their own words the processes they went through in planning and undertaking a suicide attempt, and by not interpreting such accounts through a lens of deficit and pathology, we can arrive at important insights into how people come to think and feel about, plan and enact a suicide attempt. The findings have implications in terms of understanding suicide risk and prevention more broadly
B1 ‘… I just couldn’t sleep. It was impossible, every waking second I had these thoughts racing around my head and I just couldn’t stop it. I was on the internet, I was trying to figure out what was going on, couldn’t sleep and I suddenly thought about suicide. And my mind calmed down. That was the only way that I could describe it. Absolutely calmed down, and I went on the internet and started to research suicide methods basically.’ [survived a suicide attempt by another method, having considered but rejected a rail suicide]
A5 ‘They knew that I was having issues because I was shouting and throwing stuff about in my room and I’ve never done anything like it before, I was just going by feelings and thoughts. So I didn’t say, I don’t remember saying, but they knew that I was heading towards the train station, so that’s why they called, because I think they assumed the worst.’ [survived a suicide attempt on the railways]
A6 ‘I was very frightened because I was scared of the police from previous experiences, it was a horrible, horrible experience. And I got more and more frightened and I started to make my way to this bridge’ [survived a suicide attempt on the railways]
The interview approach we used may also have played a part in the creation of a particular narrative. We did, however, strive to ensure as much as possible that participants were given the time and space to recount their stories in their own words and in their own way.
Implications
First-person accounts may allow us to better understand how people decide upon a particular method, time and place for a suicide attempt. By giving people free rein to describe in their own words the processes they went through in planning and undertaking a suicide attempt, and by not interpreting such accounts through a lens of deficit and pathology, we can gain important insights into how people come to think about, experience, plan and enact a suicide attempt. These insights, we believe, have implications for how we understand the ‘suicidal process’ and people’s planning of suicide attempts.
The interviews also affirmed the importance of paying attention to the personal meanings involved in suicidal behaviour, ……….
Suicide, in the accounts from our participants, is described most often as a way out of profound psychological pain and distress. Ways to alleviate the suffering and pain experienced by people vulnerable to suicide should undoubtedly remain the focus of prevention efforts. However, if we interpret people’s accounts of their experiences (clinically and from a research perspective) only through a lens of individual deficit and impairment, our understanding of how people actually come to think about, plan and enact a suicide attempt may be unnecessarily limited.
Data availability
The Results section of this article provides illustrative examples of our data which have been anonymised. Owing to the qualitative nature of this study, we cannot make full transcripts, footage or survey data available as these could potentially identify our participantss.
It might be worth contacting the lead researcher to suggest a futher publication as despite being obviously sensitive they have completely missed that the turmoil described by some people who contributed might have been caused by the drugs some had probably been prescibed . For example A5
Dr Lisa Marzano
Associate Professor in Psychology
+44 (0)20 8411 6998
EMAIL:
L.Marzano@mdx.ac.uk
Knock knock – who’se there – not anymore on the basis of a video call
Mental Health Act: doctors should not use video assessments to detain patients during pandemic, say judges
BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n228 (Published 25 January 2021)
Guidance from NHS England that doctors may lawfully use video assessments during the pandemic to decide whether patients should be detained in hospital under the Mental Health Act was wrong, two High Court judges have ruled.1
The act makes it a legal requirement that doctors must “personally examine” a patient before recommending detention. A code of practice requires “direct personal examination of the patient and their mental state.” But guidance from NHS England just after the start of the first lockdown last March said that “temporary departures from the code of practice may be justified in the interests of minimising risk to patients, staff, and the public.” Revised guidance in May 2020 included a section drafted jointly by NHS England and the Department of Health and Social Care for England (DHSC) “for use in the pandemic only.” This stated, “It is the opinion of NHS England and NHS Improvement and the DHSC that developments in digital technology are now such that staff may be satisfied, on the basis of video assessments, that they have personally seen or examined a person ‘in a suitable manner.’ ”
The guidance added, “While NHS England and NHS Improvement and the DHSC are satisfied that the provisions of the Mental Health Act do allow for video assessments to occur, providers should be aware that only courts can provide a definitive interpretation of the law.” It went on, “Even during the covid-19 pandemic it is always preferable to carry out a Mental Health Act assessment in person. Decisions should be made on a case-by-case basis and processes must ensure that a high quality assessment occurs.”
The Devon Partnership NHS Trust asked the High Court for declarations that requirements in the act to have “personally examined” or “personally seen” the patient could be fulfilled by doing so remotely, if that was deemed sufficient in the judgment of the person applying the guidance.
Fenella Morris QC, for the trust, told the court that the guidance was ambivalent and “expressly steps back from providing certainty on the matter to professionals and the public.” She said the trust had carried out only one video assessment and, with one exception, other trusts had taken a similarly cautious approach.
Morris said doctors faced a choice of either carrying out a remote assessment and being found to have failed to comply with the act, “so that a patient is wrongly detained and the professional exposed to the risk of allegations of false imprisonment or, on the other hand, of carrying out an in person assessment and thereby jeopardising their health and that of their patients and the public.”
The other party to the case, Matt Hancock, the health and social care secretary for England, agreed with the trust in seeking the declarations. That meant that nobody was arguing the opposing case, so an advocate to the court was appointed to make sure the two judges heard all the arguments.
The judges, Dame Victoria Sharp, president of the Queen’s Bench Division, and Mr Justice Chamberlain, concluded that the phrases “personally seen” and “personally examined” required physical attendance on the patient, and refused the declarations. “We are acutely aware of the difficulties to which the statutory provisions—as we have construed them—give rise for the trust and for others exercising functions under the Mental Health Act,” they wrote in their judgment. “Nothing we have said should be taken as minimising those difficulties. Whether and how to tackle them will be for parliament to decide.”
The DHSC said NHS England would be revising its guidance on video assessments following the judgment.