This 2020 closes in the middle of Covid19 and with the package leaflets of SSRI and SNRI antidepressants just updated in Europe with a new but evasive Warning:
‘Cases have been observed where symptoms of sexual dysfunction have persisted after discontinuation of treatment‘.
Doctors, did you notice?
Here I am. My sexual symptoms caused by an antidepressant have indeed persisted. They have persisted for 7 years without improvement.
I would like most doctors to know about PSSD, Post-SSRI Sexual Dysfunction.
We who already suffer from it cannot expect ready-made help from you, that’s true: there is currently no cure.
However, it would be fortunate for those who will come to see you next year if you were one of those doctors who were up to date. Who knew the literature warning of these possible consequences So you could assess together with us who come to you whether we should expose ourselves to these risks.
Many young people with severe post-SSRI syndromes, with persistent symptoms of both sexual dysfunction and emotional numbness, kick themselves and would cut off an arm to be able to go back and not take their prescribed medication for situations that might have been otherwise addressable.
They would like to have themselves back. Too late.
I have known the double face of antidepressants. An SSRI helped me to suffer less. At the price of tearing away from me, perhaps forever, one of the things that was most precious and meaningful to me. Something that had grown with me. Something I dreamed would bring me into intimate contact with other people. My sexuality was silenced when I was 25.
I had a past of much suffering but I would never have imagined that I could encounter such a traumatic and painful condition. Sometimes “it never rains but it pours”.
Some of you say you have never heard of PSSD. Some listen to us complain about it but even after reading about it in the literature continue to deny it. Some of you are arrogant. Some brush us off hastily, sending us home with a new prescription or referring us to psychotherapy because “it’s all in your mind”.
Some of you intervene when we talk about the serious risks of the drugs you prescribe, defending them because they are ‘life-saving’ for many people.
We are looking for common ground.
We are talking about people who are suffering because they find themselves having to bear a very harsh condition induced by a drug that was intended to be helpful. A condition without cure, and will remain so while you deny it and deny us.
Bad as the condition is, it can always be made worse by inadequate and arrogant responses from disgruntled doctors.
I know that many of these situations can be complicated to understand, but you need to have an open heart, brain and ears to be able to discern.
If psychotropic drugs, such as SSRI and SNRI antidepressants, can save the lives of some people and help others, they can also ruin the lives of others in a very serious and irreparable way.
If my judgement afterwards is that it was a risk worth taking or if I rather than you pushed for it, then its on my head. If this is not what happened between us, then that is something else.
I say to you. Do you really want to turn a blind eye. Do you really want to sweep under the carpet the cases where these drugs have ruined people, because they are inconvenient? Have you not noticed you are quietly doing it?
Do you really want to silence us?
We are your patients too. Who if not us will make our voices heard? Do you want us dropped into oblivion, along with our uncomfortable and sad truth?
When you claim that antidepressants are life-saving, who are you really protecting? Us or you?
I believe these drugs help people. I hear that from them. But others are being harmed. Sometimes irreparably, as in PSSD.
All of this happens in an unpredictable way. But knowing how serious this condition can be, I think that if you/we were concerned for people’s well-being, there would be many prescriptions where the risk would make the attempt at treatment unjustified.
There may not be a miracle cure with no side effects. But these drugs could be used more safely if more research were done to understand the cause of PSSD. Perhaps the risk could be avoided. In this sense, research into PSSD is not only of interest to those who already have it and just want to get a cure, but to all people who may at some point in their lives get a prescription for SSRIs or SNRIs and expect to get benefits from them. And it is in your interest who prescribe them.
There could be more preparation and more transparency, honesty, listening and attention from you. Even for the boring amongst us for whom the treatment went wrong.
I hope for 2021 that your conscience comes alive, that you recognise that in some cases what you have done (with good intentions, or in the haste to follow a procedure) may have given a very dramatic present to some people.
I hope that you can have compassion for those of us who are now suffering more than we were before and that you can humanely stand by our side too. We are patients not consumers.
I am your patient too.
This post is by a woman who liaises with RxISK and has done a lot to make a difference.
L says
Thank you for this. The EMA recommendation goes back to 2019 but I have seen the new warning on the printed information leaflets in the last few months in fact.
I think, excluding the really malicious and dishonest doctors who would deny in the face of all evidence as long as it suits them (hoping they are few), we need doctors who ‘simply’ become aware; and they are increasing.
mary H says
A very powerful post indeed. I think every one of us should attempt to bring this to the attention of our doctors. After all, one thing that we have in common, whoever we are and wherever we are, is the fact that we have access to a doctor. Maybe it has to be indirect access, especially in present circumstances, but even so, if we find the website for our doctor we will find contact details – an email takes just a few minutes to write and send. We accept that it takes a little longer for them to read it. Maybe a first email suggesting that we’d like to send information their way would be an idea. Maybe we won’t hear back from them. Silence should not mean rejection! Their silence gives us the opportunity to send this post along to them. Again we could be faced with silence – that would be the time to send a second reminder of these problems. By drip dripping the message who knows, maybe someone will take the time to read and digest the words that we have sent.
If we do nothing – nothing will change.
TK says
Thank you for this post! Very strong and powerful.
Adeline Loing says
They didn’t save anyone. These drugs destroy lives.
Mike says
A good post thanks for this and to all who continue to bring this and other issues to the attention.
I recently mailed the EMA to ask why there is no clearer label on the outside packaging itself instead of it hidden away in the leaflet. They responded with a link to the PRAC recommendation to update the leaflet (which I had already mentioned in my question to them) and with the following:
“Boxed warnings are only rarely used in the EU product information or on the medication boxes.”
A shame really since apparently in the US there is a yellow label and black label on the packaging. This would be helpful for people in Europe and other places too.
Spruce says
I saw something on the news this morning that made me feel very angry.
A spokeswoman from the MHRA was saying how at the MHRA, “the health of the public always comes first”, and how the MHRA “robustly and vigorously checks the safety data for medicines and vaccines”.
I know from having extensive contact with the MHRA for over a decade, and from researching a lot about the MHRA, that both of these statements are very false.
It makes me so angry that they can publicly lie like this, and use sophisticated weasel words like “robustly”, “vigorously”; and I have heard them use other weasel words like “justified”, “proportionate”, and “reasonable”, to sugar coat their b*lls**t, so that an unsuspecting public who know very little about the MHRA, will swallow the lie, that they are serving and protecting the public.
They are not serving and protecting the public, they are serving and protecting the pharmaceutical industry.
In fact they get 100% of their funding from the pharmaceutical industry, so no conflict of interest there!
https://www.theguardian.com/society/2004/oct/04/health.businessofresearch1
I can’t believe the BBC will allow the MHRA to publicly announce such brazen untruths, so publicly, for the whole nation to hear.
A few weeks ago I also heard on the news people saying how wonderful the MHRA are, how they do an excellent job, and how they are the best drug regulator in the whole world, and how the corona virus vaccine is safe and effective, because it has been approved by the MHRA (I have heard that one before, and SSRI’s are considered safe and effective by the MHRA, but they seriously harm hundreds of thousands of people worldwide each year).
Knowing the truth about what the MHRA do, how they operate, and how they have repeatedly betrayed people damaged by prescription drugs, this makes me feel very angry.
I don’t have a single shred of respect for the MHRA, and something really needs to be done to expose their lies to the wider public!
mary H says
The public in the UK appear to be both deaf and blind Spruce. They are very easily led down the wrong path; both Brexit (where we were lied to but many of the gullible believed those lies) and Covid ( where many have turned a blind eye to the poor show by Government and fail to keep the safety rules) have shown very clearly that, generally, the public see, hear and react only to whatever best suits themselves. “I’m alright Jack” ( or Jill) has never been as apparent as it is now. What happens when the reality of ‘Brexit’ bites? Will we ever see a real explanation of government waste of taxpayer cash during the pandemic? I doubt it.
Since this is the reaction to matters that affect all of us, what chance is there to gain Jack and Jill’s attention to a minority issue? Having said all that, we must fight on, not in opposition but in trying to attract attention by sharing knowledge wherever we can.
susanne says
Researchers have been working on and publishing research for the past twenty years going on dates of publication below. And of course at Rxisk. The existence of PSSD is a fact – whether an individual medic has ‘beliefs’ or not should be irrelevant by now. Would it be useful to copy this to the disbelievers? Whether they would engage or not is unpredictable as years of trying proves – it’s not in their gift to ignore ‘official’ warnings though – maybe add in the information leaflet mentioned by L -above
From —Faculty Opinions »
Welcome to Faculty Opinions SmartSearch!
the article alerting service that learns about your interests to pinpoint the most relevant new articles for you
Initial Seed
Towards Improving Post-SSRI Sexual Dysfunction by Using Nutriceuticals: Lessons from a Case Study.
Calabrò RS, De Luca R, Manuli A, Portaro S, Naro A, Quattrini F. J Sex Marital Ther 2019; 45(6):562-565
Towards Improving Post-SSRI Sexual Dysfunction by Using
This suggested name is based on the initial seed article.
Genetic and clinical predictors of sexual dysfunction in citalopram-treated depressed patients.
Perlis RH, Laje G, Smoller JW, Fava M, Rush AJ, McMahon FJ. Neuropsychopharmacology 2009 Jun; 34(7):1819-1828
Show Abstract
Persistent sexual side effects of finasteride for male pattern hair loss.
Irwig MS, Kolukula S. J Sex Med 2011 Jun; 8(6):1747-1753
Show Abstract
Current benign prostatic hyperplasia treatment: impact on sexual function and management of related sexual adverse events.
Mirone V, Sessa A, Giuliano F, Berges R, Kirby M, Moncada I. Int J Clin Pract 2011 Sep; 65(9):1005-1013
Show Abstract
Persistent sexual dysfunction after discontinuation of selective serotonin reuptake inhibitors.
Csoka AB, Bahrick A, Mehtonen OP. J Sex Med 2008 Jan; 5(1):227-233
Show Abstract
Strategies for managing sexual dysfunction induced by antidepressant medication.
Taylor MJ, Rudkin L, Bullemor-Day P, Lubin J, Chukwujekwu C, Hawton K. Cochrane Database Syst Rev 2013 May 31; (5):CD003382
Show Abstract
Incidence of sexual dysfunction associated with antidepressant agents: a prospective multicenter study of 1022 outpatients. Spanish Working Group for the Study of Psychotropic-Related Sexual Dysfunction.
Montejo AL, Llorca G, Izquierdo JA, Rico-Villademoros F. J Clin Psychiatry 2001; 62 Suppl 3:10-21
Show Abstract
Reduced treatment-emergent sexual dysfunction as a potential target in the development of new antidepressants.
Baldwin DS, Palazzo MC, Masdrakis VG. Depress Res Treat 2013; 2013:256841
Show Abstract
The impact of severe mental disorders and psychotropic medications on sexual health and its implications for clinical management.
Montejo AL, Montejo L, Baldwin DS. World Psychiatry 2018 Feb; 17(1):3-11
Show Abstract
Post-SSRI Sexual Dysfunction: A Literature Review.
Bala A, Nguyen HMT, Hellstrom WJG. Sex Med Rev 2018 01; 6(1):29-34
INTRODUCTION: Selective serotonin reuptake inhibitors (SSRIs) are a widely used class of drug. Post-SSRI sexual dysfunction (PSSD) is a condition in which patients continue to have sexual side effects after discontinuation of SSRI use. The prevalence of persistent sexual side effects after discontinuing SSRIs is unknown. The recognition and study of PSSD will increase our knowledge base of this underreported and distressing condition.
AIM: To provide coverage of the current literature on PSSD, update information on the pathophysiology of PSSD, and discuss potential management options.
METHODS: Comprehensive review of literature pertaining to PSSD.
MAIN OUTCOME MEASURES: The symptoms, classification, pathophysiology, diagnostic considerations, and management of PSSD were reviewed.
RESULTS: Common PSSD symptoms include genital anesthesia, pleasure-less or weak orgasm, decreased sex drive, erectile dysfunction, and premature ejaculation. Different theories have been proposed to explain the pathophysiology of PSSD: epigenetic gene expression theory, cytochrome actions, dopamine-serotonin interactions, proopiomelanocortin and melanocortin effects, serotonin neurotoxicity, downregulation of 5-hydroxytryptamine receptor 1A, and hormonal changes in the central and peripheral nervous systems. The diagnosis of PSSD is achieved by excluding all other etiologies of sexual dysfunction. Treating PSSD is challenging, and many strategies have been suggested and tried, including serotonergic antagonists and dopaminergic agonists. There is still no definitive treatment for PSSD. Low-power laser irradiation and phototherapy have shown some promising results.
CONCLUSION: PSSD is a debilitating condition that adversely affects quality of life. Further studies are warranted to investigate the prevalence, pathophysiology, and treatment of PSSD. Bala A, Nguyen HMT, Hellstrom WJG. Post-SSRI Sexual Dysfunction: A Literature Review. Sex Med Rev 2018;6:29-34.
Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Hide Abstract
Towards Improving Post-SSRI Sexual Dysfunction by Using Nutriceuticals: Lessons from a Case Study.
Calabrò RS, De Luca R, Manuli A, Portaro S, Naro A, Quattrini F. J Sex Marital Ther 2019; 45(6):562-565
L says
The prevalence of serotonin syndrome in an intensive care unit: A prospective observational study
Dr.Sanjay Prakash D.M.(Neurology) Dr.D.M.Chaturbhuj Rathore (Neurology) Dr.D.M.Kaushik Rana (Neurology)
https://doi.org/10.1016/j.jcrc.2020.12.014
About 7.8% patients fulfilled the Hunter criteria of SS.
None of the cases fulfilling the Hunter criteria were diagnosed as SS by the treating team.
SS may develop in ICU setting, and it may be a comorbid diagnosis over primary illness.
susanne says
How the MHRA – an arm of governments is colluding with shafting thousands of people who have already agreed to be vaccinated in good faith after being told two doses , the 2nd after 2/3 weeks are vital to providing protection from infection.
And Revolting Drs! Will they stick by what they are saying however much they will be bullied?
The Guardian -today
Vaccines and immunisation
Oxford/AstraZeneca vaccine rollout plan changed following approval
Concern over move to give millions first jab with a wait of up to 12 weeks for second dose
Wed 30 Dec 2020 21.02 GMTFirst published on Wed 30 Dec 2020 07.09 GMT
‘Safety first’: UK health regulatory officials approve Oxford vaccine – video
Millions of people across the UK at risk from Covid will be offered a single first dose of the Oxford/AstraZeneca vaccine, with a booster jab within three months, in a bid to return the country to some normality by the spring, the prime minister has said.
But the MHRA and the government’s advisory Joint Committee on Vaccinations and Immunisation delivered a surprise by announcing approval of a regime that was not trialled. Both the Oxford vaccine and the Pfizer/BioNTech jab which is already in use will be given to people as one shot, followed by another up to 12 weeks later, in order to extend some protection to as many people as possible as quickly as possible.
The approval of the vaccine by the MHRA after weeks of examining trial data was greeted with excitement and relief by experts.
Amid the widespread praise for Oxford University and AstraZeneca in gaining UK approval for a vaccine that is vital to the global prospects of ending the pandemic because of its low cost and normal refrigeration, some experts were anxious at the proposed mode of use. They said it was pragmatic to try to ensure as many people as possible had a first shot, giving them some protection, but that there were unanswered questions.
The Guardian Today newsletter:
Pfizer/BioNTech said that their vaccine was not designed to be used in two shots 12 weeks apart. In a statement, the firms said there was no evidence the first shot continued to work beyond three weeks.
“Data from the phase 3 study demonstrated that, although partial protection from the vaccine appears to begin as early as 12 days after the first dose, two doses of the vaccine are required to provide the maximum protection against the disease, a vaccine efficacy of 95%. There are no data to demonstrate that protection after the first dose is sustained after 21 days,” they said.
The decision to approve the Oxford/AstraZeneca vaccine followed “rigorous clinical trials and a thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness”, the DHSC said.
Talking to BBC Radio 4’s Today programme, its chief executive, Pascal Soriot, said the company could provide the UK with as many as 2m doses a week and would start shipping the first doses “today or tomorrow”.
Speaking to BBC Breakfast, he said: “Because we’ve got enough of this vaccine on order to vaccinate the whole population – we’ve got 100m doses on order – add that to the 30m doses of Pfizer and that’s enough for two doses for the entire population.
“So I can now say with confidence that we can vaccinate everyone, except of course for children because this vaccine has not been trialled on children, and anyway children are much, much less likely to have symptoms from the disease.”
The MHRA in effect dismissed the finding from the trials that there was 90% efficacy in that subset, which was made up of fewer than 3,000 people in the UK, who were mostly under the age of 55, so was not typical of the population’s most vulnerable. However, the MHRA said it was not the age of the participants that caused the high efficacy rate. Instead, it suggested it may have been because there was a longer gap between the administration of the first and second doses of vaccine. More details of their assessment was to come, the authority said.
Overall, the MHRA said, the efficacy of the vaccine reached about 70% between three weeks and 12 weeks, when given as a single standard dose. The second dose, not later than 12 weeks afterwards, was necessary because the effect may not last without the booster shot, it said.
The MHRA acknowledged there was limited data on the effects of the vaccine in elderly people. Ongoing trials in the UK and US will supply more evidence, but it said it was satisfied the vaccine was safe and effective in the older population.
Prof Andrew Pollard, the director of the Oxford Vaccine Group and the chief investigator of the Oxford trial, said: “The regulator’s assessment that this is a safe and effective vaccine is a landmark moment, …
As 2021 begins …Doctors say they will defy Government orders to give a second dose of the Pfizer coronavirus vaccine to elderly patients who were promised one when they got their first jabs.
But doctors have revolted and said they won’t deny vulnerable patients the vaccines they promised them amid concerns the jabs won’t work as well with just one dose.
GPs blasted the policy as ‘grossly unfair’ and frustrated scientists warned that clinical trials of the vaccine only tested how well it worked with a three-week gap, so there is no evidence the new regime would work long-term.
Former Department of Health vaccination chief Professor David Salisbury said: ‘Every time we give a second dose right now, we are holding that back from someone who is likely, if they get coronavirus, to die.’
Professor Chris Whitty, England’s chief medical officer, said in a letter with his counterparts in Scotland, Wales and Northern Ireland that single dose could offer between 70 and 90 per cent protection against Covid-19, and having this in a larger number of people would be more effective than 95 per cent protection in half as many.
The Government has not yet laid out whether there will be sanctions for doctors who refuse to switch to the one-dose policy, with one doctor saying NHS bosses had told her to use ‘clinical discretion’.
But thousands of others across Britain will see their second appointment delayed so the NHS can focus on delivering jabs to more people.
A total of 944,539 people across the UK had received the first dose of a Covid-19 vaccine by December 27, according to the Department of Health.
The Hospital Consultants and Specialists Association (HCSA) warned the ‘ill thought-out’ plan to delay the second dose would leave many vulnerable staff in limbo.
Doctors across the country say they will carry on with the original three-week vaccination plan for patients who were promised it when they got their first jab.
PFIZER HITS BACK AT UK PLAN TO GIVE PEOPLE ONE DOSE NOT TWO
Pfizer warned yesterday there is ‘no data’ to show a single dose of its coronavirus vaccine provides long-term protection after the UK scrapped its original jab rollout plan.
The UK medical regulator is now recommending Covid jabs are given in two doses three months apart, rather than four weeks apart, to allow millions more people to be immunised over a shorter time period.
The strategy will apply to both Pfizer/BioNTech’s vaccine and the newly approved jab by Oxford/AstraZeneca, despite limited data around the effectiveness of the initial doses.
AstraZeneca praised the move and revealed it had tested the three-month strategy on a small sub-group of trialists in its studies.
But Pfizer said there was ‘no data’ in its studies to show its vaccine protects against Covid when taken 12 weeks apart.
In a thinly-veiled swipe at the UK, the US firm warned that any ‘alternative’ dosing regimens should be closely monitored by health authorities.
‘Data from the phase three study demonstrated that, although partial protection from the vaccine appears to begin as early as 12 days after the first dose, two doses of the vaccine are required to provide the maximum protection against the disease, a vaccine efficacy of 95 per cent,’ Pfizer said in a statement.
‘There are no data to demonstrate that protection after the first dose is sustained after 21 days.’
And Dr Helen Salisbury, from a surgery in Oxford, told BBC Radio 4’s Today programme that it was about not ‘reneging on our promise’.
She said: ‘We were… told we could use our clinical discretion, and that’s what we are doing.
‘There are several reasons. One is the science – we really don’t have any data, as far as I’ve been able to ascertain, maybe there’s data they haven’t released – but we don’t have data about immunity after the first dose beyond 21 days when people got their booster in their trial, so we don’t know what happens.
‘But the second and, I think, more important, is about our patients and our very vulnerable patients, the elderly, who we want to protect most and the relationship we have with them. Their trust in us, their trust in science and the vaccine.
‘When you’ve started a patient on a course of treatment and you’ve said ‘This is what the plan is, here’s one jab, please come back in three weeks, it’s really important you have the second jab to be fully protected’ and then, to turn round five minutes later and say, ‘Don’t worry about that, it’s okay, you can have it in 12 weeks not three weeks’ – I don’t think that’s good enough, actually.’
In a statement published by the UK’s chief medical officers last night they said the decision had been made on a ‘balance of risks and benefits’.
The medical officers are Professor Whitty (England), Dr Frank Atherton (Wales), Dr Gregor Smith (Scotland) and Dr Michael McBride (Northern Ireland).
mary H says
Just as we expected isn’t it Susanne! The great excitement over the Oxford/AstraZeneca vaccine roll-out quickly quashed by a stupid idea to ignore the science and change to a set of “home made” rules. Honestly, you couldn’t make it up could you. Can these “leaders” not ‘lead’ under any circumstances? Haven’t they learnt yet that leaving science to the scientists would ruffle far fewer feathers than jumping in with an ill-thought through plan? We know the NHS is under tremendous strain but couldn’t this ‘new plan’ actually create further strain if it turns out that leaving a longer space between doses could cancel the benefit of those first doses? I hope doctors stick to the rules as given when they started the Pfizer roll-out – in other words, put their patients first rather than follow the new botched plan.
I do feel that 2021 is going to be the year when the people of the UK begin to stand up for things that they feel are right. Teachers and now, hopefully, doctors are leading the way. Fishermen will be all too happy and ready to show their discontent too I reckon.
One telling sentence from the MHRA’s Munir Pirmohamed who fronted the cameras over the Oxford roll-out :- “We agree with this as far as we can see FROM THE DATA THAT WE WERE SHOWN”. Take from that what you will!
One last point of interest – those Nightingale hospitals which were set up to cope with covid patients during the first wave are now being set back up TO TAKE NON-COVID PATIENTS. As I say, we couldn’t make this up!
susanne stevens says
Munir P certainly gave the game away Mary – yet nobody took it up…hmm Those who took the vaccine need to start speaking out now – as well as those who are paid to advocate for them. yet again people in vulnerable positions will be used as research fo used as research fodder
susanne says
Respect to the GP revolters
As for the bribe of £1000 Who will honour their commitment – the BMA is acting honourably – the College of GPs not so
BMA ‘will support’ GPs who honour existing appointments for second dose of Covid vaccine
Eleanor Philpotts
04 January 2021
The BMA has said it will support GPs who honour appointments already made to administer the second dose of the Covid vaccine within three weeks of the first dose.
The Government said that GPs should cancel appointments they had already made to administer the second dose of the Pfizer vaccine within three weeks because it wanted more people to receive the first dose sooner.
But doctors’ groups have warned of the problem of cancelling second appointments for patients over 80, with the Doctors’ Association UK (DAUK) warned there was ‘chaos ensuing’.
It comes as NHS England has made an additional £1,000 available to the first wave primary care networks to support with administrative costs in rescheduling appointments.
Pfizer initially stated that its vaccine must be taken in two doses, three weeks apart.
However, the chief medical officers and Joint Committee on Vaccination and Immunisation announced last week that healthcare professionals should instead deliver second doses after 12 weeks, to get more people vaccinated with their first dose in a shorter timeframe.
The BMA has said that it had heard of the ‘significant impact re-booking thousands of elderly patients’ and at-risk healthcare workers’ appointments will have’.
He added: ‘In conversations with NHSEI, I have made clear that expecting GPs to rebook appointments in a few days’ time is unreasonable and totally unfair, and we expect that those practices who honour existing appointments booked for the next few days should be supported to do so.’
‘The BMA believes it is only right that patients who have already been promised, by the NHS and local clinicians, that they will receive a second dose of Pfizer vaccination next week do so, and that these appointments for at-risk groups should proceed as planned. These patients have given their consent to receive their vaccination and, quite rightly, are expecting to have it. Therefore, if GPs decide to honour these booked appointments in January, the BMA will support them.’
However, the RCGP is disagreeing with the BMA. Taking the ‘unusual step’ of addressing GPs on New Year’s Day, chair Professor Martin Marshall said: ‘This might feel uncomfortable and it will be hard work, but it is the right thing to do for our patients and the health of the wider population.
‘So much of what we do in general practice is in the interests of our patients’ long-term health and lives but these are effective interventions with immediate impact.
‘The current infection surge – and its impact on the NHS and patients’ lives – makes it imperative to protect as many people as possible, as quickly as possible. People will still need to receive two doses but releasing the ‘reserved for second dose’ vaccine will release, we are told, close to a million more doses, which means we can give more first doses to higher numbers of our vulnerable patients and get healthcare workers vaccinated more quickly.’
But Professor Marshall did note that NHS England’s guidance allows for ‘some clinical discretion for practices to go ahead with second vaccinations where necessary’.
Dr Vinesh Patel, who sits on DAUK’s GP committee, singled out the ‘poor communication’ behind the new strategy and dosing regimen. Describing this as representing ‘an attempt to stem public health failings’, Dr Patel said: ‘There appears to have been little to no involvement with frontline clinicians in making this decision, and subsequently chaos is ensuing. We can see the principle behind the recent CMO and JCVI advice; the priority is to provide some degree of protection for as many as possible’.
DAUK’s concerns include that there is ‘no data regarding administration of dose 2 vaccine >23 days after the initial dose’. It points out that Pfizer stated that it has ‘not evaluated the safety or efficacy of Covid-19 mRNA Vaccine BNT 162b2 when administered outside of the intervals evaluated in the Phase 3 study’.
NHS England/Improvement’s primary care bulletin, issued on 31 December, stated: ‘As 2020 comes to an end we are at a critical point in the pandemic and it is therefore imperative that we prioritise the first doses of vaccine for as many people as possible on the priority list.
‘We recognise that the request to re-schedule second appointments is operationally very difficult, especially at short notice. We have written to CCGs to outline a package of support to help you do this. We have made an additional £1,000 available to the first wave PCNs to support with administrative costs in rescheduling appointments and free support is also available from a CSU, via your CCG who have stood up a call centre which can be used to contact patients to reschedule vaccinations.’
susanne says
Copy of letter circulated by the amazing Altostrata
Wishing you health and happiness in 2021
12:30 AM (11 hours ago
Surviving Antidepressants
SurvivingAntidepressants.org wishes you the very best for the new year.
I hope your healing is progressing. This last year has been a tumultuous year for us all. Good news: Progress has been made in educating doctors about antidepressant withdrawal.
Following peer activist campaigns and journal articles by Drs. Jame Davies, John Read, and Mark Horowitz, among others, throughout 2019, in September 2020, the UK’s Royal College of Psychiatrist’s published a leaflet Stopping Antidepressants in September that for the first time described tapering processes in any detail for prescribers. (I was invited to consult on this leaflet.)
Anyone may download this leaflet to show it to a prescriber.
Dr. David Taylor’s journal Therapeutic Advances in Psychopharmacology added a special section Discontinuing Psychotropic Medication, edited by Mark Horowitz, who with Dr. Taylor had co-authored the highly influential Horowitz, M. A., & Taylor, D. (2019). Tapering of SSRI treatment to mitigate withdrawal symptoms. The Lancet Psychiatry, 6(6), 538–546. https://doi.org/10.1016/S2215-0366(19)30032-X
The concept for this paper came from a 2014 discussion on SurvivingAntidepressants.org.
This was followed in 2020 by Horowitz, M. A., Murray, R. M., & Taylor, D. Tapering Antipsychotic Treatment JAMA Psychiatry. https://doi.org/10.1001/jamapsychiatry.2020.2166
On December 24, 2020, Therapeutic Advances in Psychopharmacology published Protracted withdrawal syndrome after stopping antidepressants: a descriptive quantitative analysis of consumer narratives from a large internet forum. Dr. Michael Hengartner was the lead author; I was a co-author. Data from 69 cases of protracted withdrawal syndrome was taken from SurvivingAntidepressants.org, a substantial study that should affect the discussion of protracted withdrawal from all psychiatric drugs.
Additional papers about psychiatric drug withdrawal syndromes and tapering are in press for 2021.
In August 2020, SurvivingAntidepressants.org presented an excellent film about drug overprescription and withdrawal, Medicating Normal, followed by a group discussion you can see on YouTube here. MadinAmerica.com interviewed me in November; transcript and podcast can be found here. There have been many articles on blogs about these papers and events.
So the public health issue of psychiatric drug withdrawal syndromes is gaining prominence. The approximately 6,000 member-authored narratives on SurvivingAntidepressants.org have been invaluable as a basis for research. If you haven’t stopped by for a while, the community would very much like to hear from you. Please update your Introductions and Updates topic (or start one!) and let us know how you’re doing.
If you have fully recovered from withdrawal syndrome — as we most sincerely hope — please give back to the community by adding yours to our Success Stories. Although retrospective of that difficult time may be painful, you know how much it means to people wondering if they will ever recover. Every success story lifts spirits.
L says
Protracted withdrawal syndrome after stopping antidepressants: a descriptive quantitative analysis of consumer narratives from a large internet forum.
Michael P. Hengartner, Lukas Schulthess, Anders Sorensen, Adele Framer
First Published December 24, 2020 Research Article
https://doi.org/10.1177/2045125320980573
This should make everyone realise how relevant it can be to write one’s truth on the web, to find journalists to be interviewed by, or simply to comment in large numbers on forums or under Rxisk posts etc. If everyone did this it would show that we are not a few and would attract more attention and interest.
the part on pssd in this study:
… except for post-SSRI sexual dysfunction (PSSD), which persisted, despite treatment with mianserin, for 38 months, until her suicide.
In multiple Internet support groups, she had expressed distress about her ongoing sexual dysfunction. Her last post on SurvivingAntidepressants.org was in October 2019: “To be honest, now I’m in absolute hell. I don’t see much hope in this situation anymore. It’s been 3+ years and I’m still in pretty much the same situation. I don’t know how much longer I’ll be here honestly”. The next day, she killed herself. She had recently turned 21 years old.
sexual symptoms were excluded from this analysis because they were reported by two people only (2.9%).
Our sample included two people who suicided and who attributed their motivation to protracted withdrawal symptoms (in one case, persistent sexual dysfunction)
Spruce says
I knew and used to chat to both of the women in this analysis, who unfortunately killed themselves; one of them went by the name of “potions” on surviving antidepressants. I spoke to her regularly for almost 2 years, and we had a number of video calls to one another as well, where we discussed in detail about PSSD, and the prospect of recovery.
She would often talk of suicide, and I repeatedly tried to encourage her not to give up, but it seems living (or more aptly: existing) with PSSD, eventually became too much for her.
I cant say I blame her. I know of one other person with PSSD who has recently told me they are going to end their lives soon, because they have struggled on for many years with no sign of progress, and they cannot bear an ongoing future as an emotional and sexual “empty vessel”. Each year I hear of more people committing suicide because of PSSD.
Very sad, and I believe mostly avoidable, if the medical professionals they had been in contact with, had believed and listened to them.
I remember potions once telling me the psychiatrist who had prescribed the SSRI that had given her PSSD, had shouted at her once “in all my years working as a psychiatrist I have never heard of anything like it”, when she tried to convince him that the SSRI had caused her persisting sexual dysfunction. On another occasion she told me she had given up trying to tell “nasty denying doctors” (those were her exact words) about PSSD, because they never believe anyone with PSSD.
I also remember her once saying that if she commits suicide, she was thinking of writing ‘PSSD’ on the walls of her room in blood, because she was worried her suicide would be blamed on “other factors”, and not PSSD.
At least their suffering and suicides got a small amount of public recognition in this study/analysis, and thankfully the cause of potions suicide was correctly identified: it was PSSD.
susanne says
Michael H; Lukas S; Anders S; Adele F. published the article referred to in Altostrata’s letter above in –
Therapeutic Advances in Psychopharmacology
Protracted withdrawal syndrome after stopping antidepressants: a descriptive quantitative analysis of consumer narratives from a large internet forum
Show all authors
Michael P. Hengartner, Lukas Schulthess, Anders Sorensen, …
First Published December 24, 2020 Research Article
https://doi.org/10.1177/2045125320980573
Article Information Open epub for Protracted withdrawal syndrome after stopping antidepressants: a descriptive quantitative analysis of consumer narratives from a large internet forum
https://www.karger.com/Article/FullText/371865 0 0
–
The criteria they used to select people used in the analysis are from the checklists drawn up 5 years ago. by Chouinard and Chouinard. There is no reference there to the sexual symptoms described in detail by contributors to Rxisk and elsewhere. The issues included refer only to male premature ejaculation and genital hypersensitivity. The analysis by C and C which despite highlighting it’s limitation has been used by Cand C only considers symptoms which occurr after 6 months. It seems that the work of C and C wh needs updating and may cause problems if current researchers rely on it . If their work become part of the accpted advice used by doctors people whose experience do not agree with the analysis will likely still have their accounts dismissed or trivialised Especailly as M H and colleagues state in their analysis that
‘However, it could also be that persistent sexual dysfunction and post-acute psychotic symptoms are truly rare events and that their prevalence among protracted withdrawal symptoms is indeed low. Only large prospective cohort studies with systematic assessment of symptoms will be able to answer these fundamental questions.’
Here are some snippetts from a very detailed report -in
Psychotherapy and Psychosomatics
Free Access
New Classification of Selective Serotonin Reuptake Inhibitor Withdrawal
Chouinard G.a, b · Chouinard V.-A.c
Psychother Psychosom 2015;84:63-71
https://doi.org/10.1159/000371865
When treatment with a CNS drug is discontinued, patients can experience classic new withdrawal symptoms, rebound and/or persistent postwithdrawal disorders, or relapse/recurrence of the original illness [6,9,14]. New and rebound symptoms can occur for up to 6 Withdrawal symptoms can be relatively short-lasting, lasting for a few hours to a few weeks with complete recovery, while others may persist and last for several months [1,15,16].
Table 1
Types of withdrawal from SSRIs and SNRIs, compared with relapse and recurrence
Recently, Fava et al. [1] have conducted the first systematic review of SSRI withdrawal. The authors analyzed 23 studies (15 randomized controlled studies, 4 open trials, 4 retrospective investigations) and 38 case reports of SSRI withdrawal, and found both early and late onset, and short and long duration of withdrawal symptoms. This important report provides substantial evidence for SSRI withdrawal prompting the need for a new classification of withdrawal phenomena associated with SSRIs. Based on results from Fava et al. [1] and additional reports, we will illustrate three different types of withdrawal occurring when discontinuing SSRI and SNRI antidepressants. We will derive a classification for SSRI withdrawal based on withdrawal symptoms common to different CNS drug classes and specific symptoms common to SSRIs and SNRIs. Existing checklists, such as the Discontinuation-Emergent Signs and Symptoms (DESS) [20], and criteria for SSRI withdrawal symptoms [12,21] do not differentiate between different types of withdrawal. Thus, we propose diagnostic criteria for the identification of the three different types of withdrawal seen with SSRIs, including new withdrawal symptoms, rebound, and postwithdrawal persistent disorders. We will also present 3 cases, which illustrate postwithdrawal persistent disorders. Moreover, we will focus on SSRI withdrawal, noting that SNRIs produce similar types of withdrawal [1,22]. Our proposed classification aims to improve the detection and management of SSRI withdrawal, differentiating it from relapse and recurrence of the original illness. To reduce or withdraw from SSRIs with the goal of finding a minimal therapeutic dose, we must more effectively distinguish between the different types of SSRI withdrawal.
New Withdrawal Symptoms
Table 2
SSRI new withdrawal symptoms: specific serotonin-related symptoms and nonspecific symptoms (adapted from Fava et al. [1])
The diagnostic criteria that we propose for new SSRI withdrawal symptoms require a duration of at least 6 months of continuous SSRI use prior to reduction or discontinuation (table 3, criterion A). We deem this treatment duration requirement necessary, so that the pharmacologic effect of the drug is well established, allowing for differentiation between withdrawal phenomena and relapse or recurrence of the original illness. If a patient has taken an SSRI for <6 months, the clinician may use a checklist, such as the DESS [20], to assess new withdrawal symptoms. Criterion B requires ≥1 new symptom, common to CNS drugs, including nausea, headaches, tremor, sleep disturbances, decreased concentration, anxiety, irritability, agitation, aggression, depression, or dysphoria. Criterion C requires ≥2 specific new symptoms related to the serotonergic system, in particular 5HT2A and 5HT1A receptors [28], which may be involved in SSRI withdrawal. In addition, noradrenergic CNS hyperactivity [28] likely contributes to SSRI withdrawal symptomatology. Symptoms in criteria B and C should also be characterized by a peak of onset within 36-96 h (depending on the drug duration of action) and by a symptom duration of up to 6 weeks (depending on drug elimination half-life). Symptoms cause clinically significant distress or impairment in important areas of functioning, and cannot be due to a general medical condition, another mental disorder, or substance use.
Table 3
Diagnostic criteria for SSRI and SNRI new withdrawal symptoms
susanne says
June Raine from MHRA is feeling ‘excited and optimistic’ We have been treated to her broadcasting twice in one day to reassure us the vaccine(s) are safe Could be the public is not so excited if she is being rolled out so often ,first for those of us at home in the morning then later on the R5 pm news
– on R5 Live Sounds at 2:05:27 – with a bit of faffing atound from Boris Johnson PM first
Naga Munchetty – 04/01/2021 – BBC Sounds
Released On: 04 Jan 2021Available for 29 daysReleased On: 04 Jan
annie says
Christopher Lane
@christophlane
·
13h
NEW: The largest study to date on protracted antidepressant withdrawal syndrome (PWS) finds 6 drugs implicated in 80 percent of cases.
My latest @PsychToday
Christopher Lane Ph.D.
Side Effects
SSRIS
Protracted Withdrawal Syndrome After Antidepressant UseWithdrawal from widely prescribed drugs is common but mostly unstudied.
Posted Jan 04, 2021
https://www.psychologytoday.com/gb/blog/side-effects/202101/protracted-withdrawal-syndrome-after-antidepressant-use
In their corrective study, “Protracted withdrawal syndrome after stopping antidepressants,” published at the turn of the year, Hengartner and colleagues Lukas Schulthess, Anders Sorensen, and Adele Framer—respectively of Zurich University of Applied Sciences, the Nordic Cochrane Centre, and SurvivingAntidepressants.org, a peer support site focused on withdrawal from antidepressants—present the largest, most-detailed quantitative analysis to date of protracted withdrawal syndrome (PWS). “To the best of our knowledge,” they write of their 69-subject study, “the largest [previous] study specifically examining PWS comprised only seven case reports.”
In multiple Internet support groups, one of the women who had suicided repeatedly “expressed distress about her ongoing sexual dysfunction”—Post-SSRI Sexual Dysfunction (PSSD)—which had persisted, despite treatment with mianserin, for 38 months. Her last post on SurvivingAntidepressants.org was in October 2019: “To be honest, now I’m in absolute hell. I don’t see much hope in this situation anymore. It’s been 3+ years and I’m still in pretty much the same situation. I don’t know how much longer I’ll be here honestly.” The following day, she killed herself. She had recently turned 21 years old.
The second woman had endured 69 months of PWS, clearly and repeatedly expressing anguish over her iatrogenic condition before she, too, killed herself.
Framer emphasized the suffering behind the data: “I hope readers of this paper sense the heartbreak behind these statistics. Protracted withdrawal syndromes destroy lives. SurvivingAntidepressants.org is only one node in the vast online peer support network for psychiatric drug withdrawal, which sees thousands of ongoing human tragedies every day. The ignored or unexamined risks of psychiatric drugs are not theoretical; they cause real harm. Medicine should be doing everything it can to prevent these adverse outcomes.”
Anon says
There is no doubt in my mind whatsoever, that the respect, has to definitely go back to the people who have had no voice over impoverished health issues that were induced, out of one’s control, particularly in regards to the medicines/vaccines/unnecessary tests or faulty procedures that have maimed and killed many innocent lives.
The professionals who were designated to care, did no one a favour, including themselves especially, when they have let many of their patients down, have left many in a lurch and their patients had absolutely no one to turn to in times of need because they were not believed or supported.
We, the people who have been maimed, are alive for a reason.
A responsibility we did not take lightly when we decided to voice our concerns and make others aware of the perils of western medicine. Í am so sorry if we have stood in your way. With all honesty, we had no choice but to do what we consider is right!
We confront, challenge and fight for our fellow man, without being seen or heard and if we achieve positive results, it is for the ‘good of all’.
Although, we are seen as a threat and hindrance, I like to believe we are playing a small part to create the necessary changes, we all have been longing for.
Deep down inside I also believe that there are some practitioners that are glad we are assisting them, through the process of necessary change.
Right now, I would encourage everyone to ask about the safety and efficacy of the Covid -19.
As the media, political health officials, epidemiologists, scientists and world health organizations are all stating they are safe.
There is no such thing as ‘safe and harm free’, as we on RXISK are already fully aware and conscious about being lied to.
I can foresee many lawsuits in the near future because many professionals failed to inform healthy, or medically compromised patients of the unforeseen risks, associated with the Covid-19 vaccines.
A standing ovation needs to also go to the RXISK team who have given us that voice. It means a great deal to all of us who contribute to rxisk.
Thank you kindly for your support and understanding, in relation to issues that are considered still taboo in our 21st century.
susanne says
Anon –
Access thebmj.com – The BMJ
Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data
January 4, 2021
Five weeks ago, when I raised questions about the results of Pfizer’s and Moderna’s covid-19 vaccine trials, all that was in the public domain were the study protocols and a few press releases. Today, two journal publications and around 400 pages of summary data are available in the form of multiple reports presented by and to the FDA prior to the agency’s emergency authorization of each company’s mRNA vaccine. While some of the additional details are reassuring, some are not. Here I outline new concerns about the trustworthiness and meaningfulness of the reported efficacy results.
“Suspected covid-19”
All attention has focused on the dramatic efficacy results: Pfizer reported 170 PCR confirmed covid-19 cases, split 8 to 162 between vaccine and placebo groups. But these numbers were dwarfed by a category of disease called “suspected covid-19”—those with symptomatic covid-19 that were not PCR confirmed. According to FDA’s report on Pfizer’s vaccine, there were “3410 total cases of suspected, but unconfirmed covid-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”
With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing covid-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% (see footnote)—far below the 50% effectiveness threshold for authorization set by regulators. Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29% (see footnote).
If many or most of these suspected cases were in people who had a false negative PCR test result, this would dramatically decrease vaccine efficacy. But considering that influenza-like illnesses have always had myriad causes—rhinoviruses, influenza viruses, other coronaviruses, adenoviruses, respiratory syncytial virus, etc.—some or many of the suspected covid-19 cases may be due to a different causative agent.
But why should etiology matter? If those experiencing “suspected covid-19” had essentially the same clinical course as confirmed covid-19, then “suspected plus confirmed covid-19” may be a more clinically meaningful endpoint than just confirmed covid-19.
However, if confirmed covid-19 is on average more severe than suspected covid-19, we must still keep in mind that at the end of the day, it is not average clinical severity that matters, it’s the incidence of severe disease that affects hospital admissions. With 20 times more suspected covid-19 than confirmed covid-19, and trials not designed to assess whether the vaccines can interrupt viral transmission, an analysis of severe disease irrespective of etiologic agent—namely, rates of hospitalizations, ICU cases, and deaths amongst trial participants—seems warranted, and is the only way to assess the vaccines’ real ability to take the edge off the pandemic.
There is a clear need for data to answer these questions, but Pfizer’s 92-page report didn’t mention the 3410 “suspected covid-19” cases. Nor did its publication in the New England Journal of Medicine. Nor did any of the reports on Moderna’s vaccine. The only source that appears to have reported it is FDA’s review of Pfizer’s vaccine.
The 371 individuals excluded from Pfizer vaccine efficacy analysis
Another reason we need more data is to analyse an unexplained detail found in a table of FDA’s review of Pfizer’s vaccine: 371 individuals excluded from the efficacy analysis for “important protocol deviations on or prior to 7 days after Dose 2.” What is concerning is the imbalance between randomized groups in the number of these excluded individuals: 311 from the vaccine group vs 60 on placebo. (In contrast, in Moderna’s trial, there were just 36 participants excluded from the efficacy analysis for “major protocol deviation”—12 vaccine group vs 24 placebo group.)
What were these protocol deviations in Pfizer’s study, and why were there five times more participants excluded in the vaccine group? The FDA report doesn’t say, and these exclusions are difficult to even spot in Pfizer’s report and journal publication.
Fever and pain medications, unblinding, and primary event adjudication committees
Last month I expressed concern about the potential confounding role of pain and fever medications to treat symptoms. I posited that such drugs could mask symptoms, leading to underdetection of covid-19 cases, possibly in greater numbers in people who received the vaccine in an effort to prevent or treat adverse events. However, it seems their potential to confound results was fairly limited: although the results indicate that these medicines were taken around 3–4 times more often in vaccine versus placebo recipients (at least for Pfizer’s vaccine—Moderna did not report as clearly), their use was presumably concentrated in the first week after vaccine use, taken to relieve post-injection local and systemic adverse events. But the cumulative incidence curves suggest a fairly constant rate of confirmed covid-19 cases over time, with symptom onset dates extending well beyond a week after dosing.
That said, the higher rate of medication use in the vaccine arm provides further reason to worry about unofficial unblinding. Given the vaccines’ reactogenicity, it’s hard to imagine participants and investigators could not make educated guesses about which group they were in. The primary endpoint in the trials is relatively subjective making unblinding an important concern. Yet neither FDA nor the companies seem to have formally probed the reliability of the blinding procedure, and its effects on the reported outcomes.
Nor do we know enough about the processes of the primary event adjudication committees that counted covid-19 cases. Were they blinded to antibody data and information on patients’ symptoms in the first week after vaccination? What criteria did they employ, and why, with a primary event consisting of a patient-reported outcome (covid-19 symptoms) and PCR test result, was such a committee even necessary? It’s also important to understand who was on these committees. While Moderna has named its four-member adjudication committee—all university-affiliated physicians—Pfizer’s protocol says three Pfizer employees did the work. Yes, Pfizer staff members.
Vaccine efficacy in people who already had covid?
Individuals with a known history of SARS-CoV-2 infection or previous diagnosis of Covid-19 were excluded from Moderna’s and Pfizer’s trials. But still 1125 (3.0%) and 675 (2.2%) of participants in Pfizer’s and Moderna’s trials, respectively, were deemed to be positive for SARS-CoV-2 at baseline.
Vaccine safety and efficacy in these recipients has not received much attention, but as increasingly large portions of many countries’ populations may be “post-Covid,” these data seem important—and all the more so as the US CDC recommends offering vaccine “regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection.” This follows on from the agency’s conclusions, regarding Pfizer’s vaccine, that it had ≥92% efficacy and “no specific safety concerns” in people with previous SARS-CoV-2 infection.
By my count, Pfizer apparently reported 8 cases of confirmed, symptomatic Covid-19 in people positive for SARS-CoV-2 at baseline (1 in the vaccine group, 7 in the placebo group, using the differences between Tables 9 and 10) and Moderna, 1 case (placebo group; Table 12).
But with only around four to 31 reinfections documented globally, how, in trials of tens of thousands, with median follow-up of two months, could there be nine confirmed covid-19 cases among those with SARS-CoV-2 infection at baseline? Is this representative of meaningful vaccine efficacy, as CDC seems to have endorsed? Or could it be something else, like prevention of covid-19 symptoms, possibly by the vaccine or by the use of medicines which suppress symptoms, and nothing to do with reinfection?
We need the raw data
Addressing the many open questions about these trials requires access to the raw trial data. But no company seems to have shared data with any third party at this point.
Pfizer says it is making data available “upon request, and subject to review.” This stops far short of making data publicly available, but at least leaves the door open. How open is unclear, since the study protocol says Pfizer will only start making data available 24 months after study completion.
Moderna’s data sharing statement states data “may be available upon request once the trial is complete.” This translates to sometime in mid-to-late 2022, as follow-up is planned for 2 years.
Things may be no different for the Oxford/AstraZeneca vaccine which has pledged patient-level data “when the trial is complete.” And the ClinicalTrials.gov entry for the Russian Sputnik V vaccine says there are no plans to share individual participant data.
The European Medicines Agency and Health Canada, however, may share data for any authorized vaccines much earlier. EMA has already pledged to publish the data submitted by Pfizer on its website “in due course,” as has Health Canada.
Peter Doshi, associate editor, The BMJ
Competing interests: I have been pursuing the public release of vaccine trial protocols, and have co-signed open letters calling for independence and transparency in covid-19 vaccine related decision making.
Footnote
Calculations in this article are as follows: 19% = 1 – (8+1594)/(162+1816); 29% = 1 – (8 + 1594 – 409)/(162 + 1816 – 287). I ignored denominators as they are similar between groups.
L says
if you take 1 minute to leave a comment here you can do good thing. i think the feedback is important so that it is noticed and copied on other sites even in other languages
https://www.psychologytoday.com/us/blog/side-effects/202101/protracted-withdrawal-syndrome-after-antidepressant-use
L says
Antidepressant use in England soars as pandemic cuts counselling access
Exclusive: more than 6m people receive drugs as experts warn of Covid pandemic’s effects on mental health
https://www.theguardian.com/society/2021/jan/01/covid-antidepressant-use-at-all-time-high-as-access-to-counselling-in-england-plunges
mary H says
” Pandemic cuts counselling access”? – what ‘counselling’? Has been almost non-existent in our neck of the woods for years! Pandemic a handy excuse now I suppose.
Anon says
Hello Suzanne,
Thank you for the interesting data and statistics.
You are always informative and full of knowledge ~ thank you.
Indeed, very concerning!
The transparency, is no where to be seen?
I question the integrity of all pharmaceutical companies manufacturing the Covid-19 vaccines.
The negative clinical data trials will be flawed and incongruent with what some people are experiencing. The long term side effects or adverse events will be excluded. Only a few will be highlighted.
This is so consumer will not be alarmed.
Hence, people will not be given all the information pertaining to safety and efficacy of the vaccines.
Pfizer and other pharmaceutical companies will only portray a rosy outcome from these vaccines. All the negative clinical data trials will not be highlighted or else the vaccine will not sell and people will only believe that the same adage that experts so commonly use: The benefits outweigh the risks! ~Will they?