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FDA Sued for Failing to Act on RxISK’s Petition

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Legal gavel close up
Photo by Matthew Henry from Burst

In February 2018, we began work on a petition requesting warnings about post-SSRI sexual dysfunction (PSSD) and persistent genital arousal disorder (PGAD) to be added to SSRI and SNRI antidepressants.

The academic literature on these conditions had been steadily increasing, and our latest case series on persistent sexual dysfunctions had just been accepted for publication – see 300 Cases. It seemed like there was enough data to support a petition.

The intended recipients were the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The FDA had a formal citizen petition process that needed to be followed, so we had to consult their website on what to include as they had specific requirements. For example, we were required to include copies of all the articles cited in the petition which created a lot of extra work.

By the end of March 2018, we had completed the petition. Rather than just including our own group as signatories, one of our team suggested that it might benefit from being signed by a larger number of people. We therefore approached a number of additional medical professionals and researchers to endorse it as signatories. They were all either authors of the academic literature on PSSD and PGAD, or they had significant clinical experience of the conditions.

We also asked the International Journal of Risk and Safety in Medicine, the journal who had accepted our case series, if they would be willing to publish it. They agreed and generously made it open access at no extra cost – we had already paid an open access fee for 300 Cases.

For anyone who doesn’t know, journal articles are often paywalled and can only be accessed by paying a fee for the individual article or by subscribing to the journal. Open access for the petition meant that anyone could read it free of charge. This was important because we wanted everyone to have full access to it, and we hoped it would also help patients in their dealings with healthcare professionals.

On 4 May 2018, we ran a blog post to announce the publication of 300 Cases and the petition.

The petition was sent to Dr June Raine and Dr Ian Hudson at MHRA, and to Professor Guido Rasi at EMA. We submitted it to FDA on 10 May 2018 and received a standard acknowledgement letter the following day.

Europe

On 4 July 2018, EMA informed us that our petition had been forwarded to their Pharmacovigilance Risk Assessment Committee (PRAC) for further investigation. We received a further communication on 14 September 2018 to say they had begun a review of sexual dysfunctions after discontinuation of SSRIs and SNRIs.

We had a hunch that one of the major reasons why regulators were slow to act in the case of PSSD and PGAD, despite significant numbers of reports to them, was because those reports were usually anonymous. In legal terms, this means they are hearsay – little more than gossip. Because they are anonymous, regulators don’t follow them up and can therefore say that cause and effect has not been proven.

To block this escape route and to support their review, we contacted EMA with an offer to provide the names and email addresses of people who had reported these conditions and were willing to be contacted, if needed. EMA agreed but only gave us five weeks to submit the material.

We emailed virtually everyone in our database who had reported PSSD or PGAD, asking them to complete a report that we had designed for this purpose, and also to contact their doctor or another healthcare professional and try to get a supporting letter. Most people were reluctant to get involved or said their doctor would be unwilling to help, but we got enough responses to make it worthwhile. Putting it all together in such a tight timescale was difficult, both in terms of patients having to arrange appointments and obtain letters at short notice, and for us to collate all the information.

We sent it off to EMA and hoped it would be helpful.

Back to FDA

On 6 November 2018, we had received a second letter from FDA advising that a decision had not yet been reached.

Similar to what we had offered to EMA, we uploaded a message on 7 November 2018 offering to supply the names of people with PSSD and PGAD who were willing to share their details with FDA, many of whom would be able to provide supporting documentation from healthcare professionals.

We received no further response from FDA. The petition, the references, the acknowledgement letters, and comments from the public can all be found on FDA’s website at this link.

Canada

On 25 January 2019, we were contacted by the Marketed Pharmaceuticals and Medical Devices Bureau at Health Canada. They had become aware of our 300 Cases publication, our petitions to FDA and EMA, and they were seeking further data.

We provided them with named reports and letters from healthcare professionals as we had done with EMA. We also provided some pharmaceutical company correspondence that they requested and a significant amount of anonymised adverse event data from our database.

The warnings

In an email on 31 May 2019, EMA informed us that their review had now concluded, and they thanked us for our efforts including the patient reports that we had supplied. The review had concluded that “… sexual dysfunction, which is known to occur with treatment with SSRIs and SNRIs and usually resolves after treatment has stopped, can be long-lasting in some patients, even after treatment withdrawal.”

On 11 June 2019, EMA announced a recommendation that warnings about persistent sexual dysfunction should be added to all SSRIs and SNRIs. We wrote about this in a blog post which you can find here.

It took a lot longer to get a decision from Health Canada, and we had not heard anything since submitting the information in early 2019. We wrote to them again in March 2020 expressing our dissatisfaction with the lack of communication and continuing lack of warnings, but without any response.

It wasn’t until early 2021 that Health Canada announced it would be adding warnings to SSRIs and SNRIs about persistent sexual dysfunction. Our blog post about it is here and the outcome of the safety review is here.

Both EMA and Health Canada failed to provide the strength of warnings that we had requested in the petition. They didn’t add specific warnings about genital anaesthesia and pleasureless orgasm, and nothing was added about PGAD.

Legal action

On 20 May 2024, Dr Antonei Csoka, one of the people we had asked to be a signatory, commenced legal action against FDA for their inaction over the petition. Dr Csoka is being represented by Public Citizen and you can also read full details of the complaint.

Dr Csoka was one of the first people to write about PSSD in the medical literature. His paper with Stuart Shipko in 2006 was the first to attribute cases of persistent sexual dysfunction to the previous use of SSRIs.

We are supportive of the action by Dr Csoka and hope it will be successful.

It is difficult to know what the outcome will be. FDA could simply decline the petition, or they could grant it in part. The US label for fluoxetine already contains a warning about persistent sexual dysfunction after stopping the medication, so it’s possible that FDA might add similar warnings across all SSRIs and SNRIs.

The European and Canadian warnings were helpful in putting PSSD on a firmer footing, but many patients still report having difficult interactions with healthcare professionals and are often told that antidepressants don’t cause such problems. So, even if there is a positive outcome, it may fall short of the profound impact that some online commenters seem to be expecting.

News reports

The legal action has been reported by a number of media agencies including Reuters and the Daily Mail, as well as in online forums. Most of the reporting that we have seen to date is fairly accurate, although some is not.

Bizarrely, a member of the organisation, PSSD Network, who goes by the username “Mobius1014” appears to claim that their group submitted the petition, despite their organisation not actually forming until several years later:

“As you may be aware, the PSSD Network has initiated legal proceedings against the FDA due to their prolonged inaction on the citizen petition we submitted over five years ago.” (emphasis added)

An article in the Telegraph by Gwyneth Rees incorrectly states that the petition to FDA was led by Dr Antonei Csoka:

“As far back as 2018, the scientists, led by Dr Antonei Csoka, of Howard University, asked the FDA to alert people to the risk of PSSD…” (emphasis added)

We have contacted Gwyneth to clarify that the project was led by Dr David Healy, but so far we have not received a reply.

Australia

In a recent development on 23 May 2024, Australia’s Therapeutic Goods Administration (TGA) issued a safety update advising that all SSRIs and SNRIs are to include warnings about persistent sexual dysfunction after stopping the medication. It cites our 300 Cases paper as well as an article from Jody Rothmore, the author of a popular review article on antidepressant-induced sexual dysfunction, including PSSD, which was published in an Australian medical journal in 2020.

According to the safety update, TGA has received only 4 reports of persistent sexual dysfunction. Anyone who wants to report their case of PSSD or any other adverse event to TGA, can do so using this link.

Reader Interactions

Comments

  1. Above “Mobius1014” appears to claim that their group submitted the petition, despite their organisation not actually forming until several years later:
    “As you may be aware, the PSSD Network has initiated legal proceedings against the FDA due to their prolonged inaction on the citizen petition we (WE) submitted over five years ago.” (emphasis added)

    Seems to have been amended by Mobius1014
    Go to PSSD
    r/PSSD
    •
    9 days ago
    Mobius1014

    PSSD Network’s Legal Action Against the FDA Hits the Media
    As you may be aware, the PSSD Network has initiated legal proceedings against the FDA due to their prolonged inaction on the citizen petition that was submitted by a group of scientists led by Dr. David Healy over five years ago. This step was made possible through the invaluable support of Public Citizen, who filed the lawsuit on our behalf yesterday, the 20th of May.

    Sources:

    https://www.citizen.org/litigation/csoka-v-fda/

    Reply

    • S

      One of the issues is whether FDA or any actions by regulators makes any difference.

      I was asked recently if regulators mandate companies to mention problems. The reality – although it may be dressed up in different ways – is that no they don’t/ They get to tell companies to do what the companies have told regulators to tell them (the companies) what to do.

      This was most clear with EMA seeming to tell companies to have a mention (warning) re PSSD on all serotonin reuptake inhibitors except vortiox etine (Brintellix – Trintellix). Why not this one? Because its on patent and Lundbeck are still making money from it and even advertising it as a cure for sexual dysfunction.

      Lundbeck clearly told EMA to F— Off. What do EMA tell the world about this – they say we don’t have enough reports for PSSD linked to vortioxetine so we didn’t require this. RxISK could have provided them with plenty of reports and contact details for those affected but although told about this EMA didn’t ask for any.

      This all puts FDA in a bind. Can they afford to look stupid by asking for companies to mention in very small print there might be an issue and have one of those companies refusing to play ball and even pretty openly (in between the lines that is) pushing their drug as a cure for PSSD?

      Tricky

      David

      Reply

  3. I have deleted large chunks of the paper to keep it relevant to the case of Augusto Roux but the who is available free via the links
    International Journal of Risk & Safety in Medicine 34 (2023) 121–128 121
    DOI 10.3233/JRS-220043
    IOS Press
    Position Paper
    The coverage of medical injuries in company
    trial informed consent forms
    David Healy,∗
    , Augusto Germán Rouxb
    and Brianne Dressenc

    Accepted 18 January 2023
    Abstract. Best practice consent forms in company clinical trials detail the financial coverage for medical treatment of injuries.
    In trials undertaken for licensing purposes these arrangements can raise concerns. We detail three cases in which elements of
    the consent forms appear misleading and designed to elicit a consent to participation that might not be forthcoming if volunteers
    for these clinical trials were aware that what is outlined in principle is not likely to happen in practice. Beyond clinical trial
    participants, these consent forms have wider implications. Medical coverage of injuries sustained in a clinical trial is a nexus
    where business, scientific and ethical considerations meet. It is not clear that anyone to date has grappled with the issues posed.

    Keywords: Consent, injuries, cause and effect, licensing applications, medical treatment, COVID-19

    Press
    Position Paper
    The coverage of medical injuries in company
    trial informed consent forms
    David Healya,∗
    , Augusto Germán Rouxb
    and Brianne Dressenc

    bPfizer Vaccine Trial Participant (2020), University of Buenos Aires, Buenos Aires, Argentina
    cAstra-Zeneca Trial Participant (2020), NIH Vaccine Injuries Research Subject (2021)
    Received 6 July 2022
    Accepted 18 January 2023
    Abstract. Best practice consent forms in company clinical trials detail the financial coverage for medical treatment of injuries.
    In trials undertaken for licensing purposes these arrangements can raise concerns. We detail three cases in which elements of
    the consent forms appear misleading and designed to elicit a consent to participation that might not be forthcoming if volunteers
    for these clinical trials were aware that what is outlined in principle is not likely to happen in practice. Beyond clinical trial
    participants, these consent forms have wider implications. Medical coverage of injuries sustained in a clinical trial is a nexus
    where business, scientific and ethical considerations meet. It is not clear that anyone to date has grappled with the issues posed.

    The issue of medical coverage for injuries in clinical trials intersects with whether the injuries that
    happen have been caused by the agent under investigation. Where the trial is being done for licensing
    purposes, where little may be known about a novel agent, conceding that the agent in question may have
    caused an injury may have consequences for approval or for the label of the new treatment. (The label
    is written by the sponsoring company and covers the claims for benefits and harms that a regulator has
    licensed.)
    This problem cannot be solved by a company simply taking responsibility for events in a trial, on both
    the investigational agent and placebo, unless the event is something like slipping on a banana skin. Any
    independent treating facility will need to assess what role the investigational agent may have had in the
    *Address for correspondence: David Healy, MD, FRCPsych
    122 D. Healy et al. / The coverage of medical injuries in company trial informed consent forms
    resulting clinical condition and what the best treatment for their patient might be in the light of this.
    if a subject is more suicidal two weeks after taking the drug, the investigator will score this on a depression
    rating scale that has a default to seeing any deterioration as a manifestation of illness rather than an adverse
    event.
    A suicidal attempt or event may be recorded but in trials investigators are not encouraged to link these to
    treatment and rarely do so. If an investigator judges that an event is likely to have been linked to treatment

    .
    3. Pfizer-BioNTech COVID-19 Vaccine Trial
    In August 2020, in Argentina, 36-year-old Augusto Roux volunteered to participate in a trial of PfizerBioNTech’s COVID-19 vaccine, hoping to benefit his family, compatriots, and the wider world.
    The site specific injury section of the consent form (translated from Spanish) states that [11]:
    The sponsor, Pfizer, undertakes that, in the event that you suffer any harm, meaning an injury or adverse
    effects or consequences on your health, related to the study vaccine or with procedures performed as part of
    this clinical trial, you will immediately receive the necessary medical attention and treatment.
    Pfizer will cover the costs of medical care and treatment.
    124 D. Healy et al. / The coverage of medical injuries in company trial informed consent forms
    To that end, you will need to communicate (in person or by phone 24 hours a day) with:
    Dr. X, (011) 15 XXXXXXX. Phone 24hs (011) XXXXXX
    To guarantee cover of the risks or potential harm that could occur as a result of the study, the sponsor, Pfizer
    S.R.L, has taken out insurance with the firm
    La Meridional Compañía Argentina de Seguros S.A., located in Tte.General Juan D Perón No. 646 4th floor
    (C1038AAN), C.A.B.A., Argentina, policy number: 406483 as amended.
    By signing this informed consent, you do not waive the rights you have according to the Civil and Commercial
    Code and Argentine laws on civil liability for damages that may apply to you in case you suffer any injury as
    a result of your participation in this trial.
    Here is a more general statement of the same:
    Pfizer covers the cost for medical treatment for any injury or illness that occurs as a direct result of taking part
    in a Pfizer-sponsored study at no cost to the research subject. Pfizer does not use any exculpatory language in
    informed consent documents that will prohibit a research subject from obtaining appropriate compensation
    for research injuries [12].
    Mr. Roux had mild vaccine induced injuries after his initial dose of vaccine and marked injuries almost
    immediately following his second dose of vaccine. These included what may have been an initial
    rhabdomyolysis, pericarditis and what appears to be hepatitis or other hepatic injury.
    It is established that he was given the active vaccine and not placebo. There are radiological scans and
    blood tests in support of these injuries. He was hospitalized for his injuries and on discharge his hospital
    records offer a diagnosis of a vaccine induced injury. He has since been examined by 4 doctors who concur
    that he had/has a vaccine induced injury [13].
    After his injuries, with ongoing clinical problems, as per protocol, Mr. Roux contacted the research
    team to inform them of his situation and requested that the blind be broken in order to obtain the right
    treatment. He was told the blind could not be broken while he was in the study. He withdrew from the
    study for this reason and found after a complaint to the Argentine medicines’ regulator that he was on
    active vaccine.
    In the clinical trial documents, he was recorded as a protocol deviation, withdrawn for personal reasons
    rather than discontinued as a result of vaccine related injury. After his contact with them, the research
    team entered a diagnosis of Suspected Covid-19 in the adverse event log for the trial, and also diagnosed
    him as anxious; these are the final entries in paperwork sent from Pfizer to FDA [14].
    There is a mismatch between Mr. Roux’s contemporaneous medical record and the records kept by the
    research team. His medical record from an independent hospital records a vaccine induced pericarditis.
    This does not appear in Pfizer’s final submissions to FDA or in FDA documents laying out their view of
    what injuries occurred in this trial. A later FDA summary of events from this trial does not include his
    pericarditis [15].
    A submission by Pfizer to the European Medicines Agency review of significant adverse events from
    this trial includes 7 deaths of which 4 were linked to myocarditis [16]. In these cases, Pfizer note the
    investigator did not link the myocarditis to the vaccine, although a link between myocarditis and these
    vaccines is now widely accepted. Mr. Roux made submissions to FDA and EMA about his pericarditis
    and other problems, but current FDA and EMA public documents do not include this.
    The failure to endorse an obvious link between treatment and a closely related event fits with current
    World Health Organization advice to investigators in trials to make every effort to avoid linking injuries
    to vaccines [17–19].
    D. Healy et al. / The coverage of medical injuries in company trial informed consent forms 125
    As a result of this, Mr. Roux has not had the agreed coverage from Pfizer and has had to pay his own
    medical costs. His normal Argentine health insurance points to the trial consent form stating that Pfizer
    would cover his costs. He remains unwell and would appear to be unable get any medical assistance unless
    he lies about the origins of his problems. But if he lies he risks not getting the right medical treatment for
    his residual cardiac and liver problems, which need an assessment of the likely cause.
    What has happened to Mr. Roux is not an isolated incident. There is evidence from a US Qui Tam
    case of gross breaches of good clinical trial practice at other Pfizer sites in the United States [20]. There
    is evidence in Pfizer’s children’s trial that at least one subject, Maddie de Garay, was seriously injured
    but in the published article the company has eliminated any linkage between her injuries and the Pfizer
    vaccine [21].
    As in Study 329, the doctor best placed to acknowledge a link between Mr Roux’s injuries at the time
    of the trial, was the lead investigator, Dr Polack, in the centre Mr. Roux attended. Dr Polack, however,
    became a first author on the first article reporting results from the Pfizer trial in the New England Journal
    of Medicine [22]. This article recorded an efficacy of 95% based on 162 cases of COVID-19 in the placebo
    arm of the trial compared with 8 in the vaccinated arm – 0.47% of trial participants. The article reported
    a low incidence of adverse events. A later article (2) recorded 15 deaths on vaccine with 14 on placebo
    and a later analysis of the Pfizer and Moderna trials shows more hospitalizations on these vaccines than
    on placebo [23].

    5. Breaching the Blind
    Augusto Roux’s and Brianne Dressen’s cases raise another ethical issue. In 2020, whether he or she had
    an active vaccine was central to their proper medical treatment.
    He asked whether he had been on the active vaccine, but the research team refused to break the blind.
    He took his case to the Argentine regulator (ANMAT), as well as to Pfizer and others. It was agreed the
    blind should be broken in his case, but his efforts to establish this were described by the research team
    as paranoid, and this was written into his medical record by Pfizer operatives not qualified to make this
    diagnosis.

    adequate medical care is provided to a subject for any adverse events, including clinically significant
    laboratory values, related to the trial. The investigator/institution should inform a subject when medical
    care is needed for intercurrent illness(es) of which the investigator becomes aware.
    D. Healy et al. /
    6. Conclusion
    Mr. Roux’s (and Ms. Dressen’s )cases illustrate what now appears to be an established company approach
    that applies to all company vaccine and drug trials. It seems possible that this approach underpins a
    final result in the Pfizer trial where apparent protocol deviations on active treatment outnumber those on
    placebo by five to one (311 v 61) [30].
    In the case of vaccines, especially where these have been mandated, company concealment of injuries
    risks causing a consequent wider public health injury.
    In the case of drugs, as pointed out over twenty years ago, a sequestration of clinical trial data, especially
    data on harms, and the ghostwriting of trial reports which further conceals harms, puts everyone who later
    takes the drug in a state of legal jeopardy [28,29]. If participants in a trial have their injuries concealed,
    anyone else similarly injured, who seeks a legal or other redress, will face company claims that there is
    no evidence from their trials of a link between this injury and their medicine.
    Paying Mr. Roux’s or Ms. Dressen’s medical costs risks being portrayed as an admission a company
    vaccine or drug has caused problems. Such an admission risks being at odds with submissions to
    FDA, with latter FDA representations to the public [15,30], and at odds with the published medical
    reports of this trial [2]. This mismatch risks opening a company up to a fraud charge, as happened to
    GlaxoSmithKline with Study 329, but it would seem possible to manage this risk with judicious wording.
    Everything hinges on an approach companies have taken for two decades, which, as noted above,
    champions the idea that unless an effect happens to a statistically significant extent in a trial, then there is
    no evidence that this effect has been caused by the drug or vaccine. This is particularly problematic in that
    adverse events are never the primary outcome in licensing trials and events are unlikely to be detected and
    if detected testing for statistical significance is strictly speaking inappropriate. Adhering to this approach,
    companies can offer a consent form like the ones outlined here knowing that nobody injured in their trial
    is ever likely to be able to establish the therapeutic agent has caused an injury.
    This position stands at odds with common sense and normal judicial process as embodied by NIH in
    Ms. Dressen’s case and by the doctors in Hospital Aleman in which Mr. Roux sought treatment. In these
    cases, doctors practicing in accordance with standard medical practice have said both she and he have
    vaccine induced injuries.
    Company statements regarding prospective support for injuries incurred seem likely to predispose to
    consent to participate in the trials outlined here. This information, however, appears misleading, and likely
    applies to many company consent forms. This is a matter of concern, but it is not clear how to reconcile
    the business, scientific and ethical issues involved.
    Facing a novel, unexpected problem, in company trials, allied business and time pressures do not make
    it easy for investigators to determine causality. It is not clear how feasible it would be to offer all trial
    participants an independent review of causality for harms in real time, but this would be good medical
    and scientific practice.
    Conflict of interest
    Two of the authors are contributing from a position of lived experience.
    128 D. Healy et al. / The coverage of medical injuries in company trial informed consent forms

    References…………

    Reply

  4. With reference to the use of he/she has a ‘mental illness’ to undermine people raising concerns/complaints it is normal that having developed adverse effects would cause anxiety then being deliberately gaslit and given the so common runaround would exacerbate symptoms which can then be dishonestly recorded using check lists as mental illness eg depression or suicidal scores. Or any of the codes which undermine credibility most usefully. When people are being scored using check lists and coding do they know that at the time?
    There is a consensus by now that drugs can cause suicides but I also think that it is impossible to ‘save’ people from killing themselves by having black box warnings or the advice to go talk to a doctor – that is the persons who prescribes them who knowingly puts people at rixsk is then supposed to be trusted to admit how dangerous they are in reality. And Not all will want to risk the possibility of being admitted to a psychiatric unit.if talking about feeling suicidal.

    Reply

    • Yes indeed then you also have the TV commercial bombardment of :

      Welcome to SOS
      Silence of Suicide….contact us…..

      I’m wondering if anyone here has called them and asked if the person on the other end has heard of akathisia. I bet they would refuse to answer any questions before you gave them answers to their check box questions.

      Reply

      • Chris

        My experience with all these prevent suicide organizations is that they refuse to engage with the possibility that treatment may be causing the problem.

        This has led to a new post put up today – See Challenging Doctors

        David

        Reply

      • Chris I have contacted them ages ago and they trashed the information I sent in good faith. I hadn’t specifically asked about akathisia but it was in the info i sent. All they wanted was donations ans ‘support’ They are not so ‘nice’ behind the gloss.It is remarkable as you say how much cover they get but understandable when you see who is on their ‘team’ , The medium is the message ? Get names to front it and SOS has captive audience.
        Get this lot to fund it and there is no way they are going to risk losing support

        Here are the team members
        About us
        >
        Our Team
        Our Team, Supporters & Advocates…

        Michael Mansfield KC (I had hopes he might engage going on past cases he has dealth with – but no)
        Lead Trustee
        Michael Mansfield KC Lead Trustee of SOS, is one of Britain’s most well known Barristers and was called to the Bar in 1967. He then established Tooks Chambers in 1984 and became Queen’s Counsel in 1989. He now heads Nexus Chambers….

        Yvette Greenway
        CEO
        Yvette Greenway-Mansfield is our CEO and co-founder of SOS Silence of Suicide. Despite chronic pain and illness, and life changing medical conditions, Yvette has developed and grown SOS from tiny roots into the significantly larger charity that it is today,…

        Georgina Jones
        COO
        Georgina has over 20 years experience in operational delivery roles, both in the public and voluntary sector. Georgina is committed to being a part of change within the mental health space…

        Anthony Cash
        Trustee
        Anthony Cash acts as a Trustee and is also our advocate for people with SEN, alongside assisting with training and tech support at events. For a deeper understanding and statistics, check out the SEN page….

        Lorna Hackett
        Trustee
        Lorna Hackett is a barrister specialising in human rights and public law, and is head of legal practice at Hackett & Dabbs LLP. She has a particular interest in representing the most vulnerable in society…

        Erica Scott
        SOS Advocate for Volunteering
        Erica Scott SOS advocate for volunteering, is an outstanding member of our team and supporter of our work and aims, supporting the charity at every available opportunity. …

        Wendy Turner Webster
        Supporter
        Wendy is a TV Presenter and Producer, known for Pet Rescue and Absolutely Animals on Channel 4 and most recently for Crafty Beggars and Brits Rescue Romanian Dogs on Together TV and My5. …

        Lorraine Kelly
        Supporter
        SOS Silence of Suicide are delighted to welcome Lorraine Kelly OBE as an Ambassador Lorraine Kelly left school at 17 to work as a cub reporter on her local newspaper “The East Kilbride News”. …

        Gary Webster
        Supporter
        Gary Webster, an actor perhaps best known for his appearances in ‘Minder’ opposite George Cole, has spoken out bravely and publicly to the Big Issue about his problems with debt , its impact and how these issues can affect anyone of us….

        James Harknett
        Supporter
        SOS supporter James is not just passionate about mental health, but is top of the league in spray tanning….

        Lady Colin Campbell
        Supporter
        Lady Colin Campbell is a New York and London Times best-selling biographer whose work was described by The Detroit Free Press as ‘psychological portraiture’. …

        Read more
        SOS heroes & partners… it’s worth a look Chris There’s an enormous amount of backing for SOS

        SOS is lucky to have had the support of many organisations, businesses and individuals as our journey expands and continues. From local grant funders to national funders, from volunteers who can donate anything from 4 hours a week to over 10 hours a week and ambassadors and Trustees who work hard behind the scenes with the CEO exploring ways to maximise their help and support.

        SOS are grateful for all donations from the public, of which 100% goes back into services and for our primary funder this year, the Valour Foundation who have given this charity and its service users the ability to benefit in so many ways. SOS remain indebted to everyone who supports us, however they do this.

        SOS Charity Funders… ……………….There are too many to paste here.
        This section is dedicated to foundations, businesses, organisations and key funders who have helped our charity to survive, especially during the Covid crisis.

        We also remember, and thank, everyone that has donated to, and/or fundraised for us, in some cases raising some staggering amounts of money. But every penny counts and we are forever grateful for everything you have all done to help us because you believe in our aims and in what we do. Thank you to each and every one of you who have helped us survive and now, during very exciting times, develop and grow in line with our aims:

        Reply

        • Do they do anything other than gather information and then channel people to psych drugs, psychiatrists and maybe a side serving of art therapy for a glossy cover topping ?

          Reply

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