RxISK and Sharks

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August 23, 2020 | 31 Comments

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  1. This is the most powerful piece that I have read in a very long time. Running through it seems to be the message that whilst you hide in the dark, there will not be an answer to your problem. I am astounded that each section related to this problem seems to be working alone – surely everyone knows that there is more of a clout if you put your heads together and see what you can come up with. Why are they working apart? Do they not see the similarities in their conditions? To me, as an outsider, they ALL seem to be seeking exactly the same thing -NORMALITY.
    I do not know enough about PSSD or the other conditions to make any judgements about the reality of their hopes being fulfilled at any time. However, I DO know that unless they can group together and get us, who haven’t suffered, and those who probably have the condition but are unaware or not upset by its presence, to group together with them, then their chance of success is slim.
    As hard as it may be, there is a need too to come out in to the light. It will not be easy, of course, but so necessary. Some point out that even their own families and friends don’t know of their suffering. That is extremely sad. If family and friends don’t know, they cannot support. If WE don’t know, then we can’t support either. Just knowing that there is a certain number who own up to their condition but cannot be publicly named is not good enough.
    We have supported the Rxsik Prize Fund but it has yet to reach its intended amount. I have a strong feeling that one of the reasons that the donations are so slow in getting to the total is the fact that we don’t know who you are. It is rather difficult to support a ‘number’, much easier to support real names or faces.
    I truly hope that you will reconsider your splinter groups and all pull together, bringing yourselves out and asking us to support you in one almighty push forwards with your mission. You may be surprised by our willingness to put our backs behind you in sharing the reality of your daily struggles with the community at large.

    • Replying to this comment so this goes to the top so that people can see it:

      New PSSD website for UK sufferers to work together to coordinate activism.

      http://www.pssd-uk.org

      It would be great if people can get in touch and send their stories to go on the website.

      • There probably is a place for national sites – US, UK, Germany etc. But there is also a place for an international forum – activism in the UK alone, and confined to PSSD alone without PGAD, PFS and PRSD is not likely get anywhere. Other than in exceptional cases, activism without names risks being a harmless form of daydreaming

        Rx

        • Hi Doctor Healy,

          thanks for the feedback.
          I will try and reach out to the other groups you mentioned (PGAD, PFS etc.) to see if they are interested in cooperating to expand this.

          When I say ‘activism’, my initial hope was that we would try to create a network of people in related professions in the UK who acknowledge the conditions. I believe that this was something that RXISK had encouraged sufferers to do elsewhere on the site.
          It is my understanding that this has happened to some extent through the patient groups in other countries. Perhaps these national networks and country based organisations could then be in a position to help with organising the international forum that you referred to.

          I think it is useful for us to have a national online presence to show we are here.

          Although it would have more impact, it seems like it will be difficult to encourage people to go fully public with names.

      • PSSD Forum is up and running again

        A forum dedicated to collaborative research into PSSD (Post-SSRI Sexual Dysfunction).

        Welcome to the reincarnation of PSSD Forum.

        In January 2020, the forum went offline due to technical issues. The site admin, Moloch, was not able to fix the issues and ultimately left the community in part due to hostility from upset users. Fortunately, other admins had made backups of the forum data. After some troubleshooting and cleanup, we migrated the forum to a new site.
        We are looking for volunteers to moderate this forum. Please reach out if you are willing!

        Please read the Forum Rules posted in Announcements. As we get this new forum running, there may be some changes.

  2. “This leaves pleading with Heaven as the only option but the pleas remain unanswered because there is no Expert up there who knows what is going on or how to put it right.”

    It can be highly distressing when no one knows, few seem to care, and those who do aren’t really getting anywhere. Speaking just for myself, lately I’ve taken GREAT comfort in the thought that the Creator is the One who knows EXACTLY what’s going on in my body at those moments when my suffering is at its worst.

    With all of the suffering happening in the world I’ve decided to take my number and get in line. This change in perspective helps. No one owes me shit. But I am part of the larger process and believe that eventually things will be set right.

    Instead of pleading with Heaven for reality to change to my liking, I ask whether the Creator might use this suffering to transform and purify me? Might I receive help to accept the situation and participate in my own transformation? Through this kind of transformation might I gain true Power, the Creator’s power flowing through me to bring about that which fits the Universe, not necessarily what I seek?

    In my opinion, trying to force change is a recipe for madness. Action needs to happen for sure, but perhaps, dare I say, Spirit-led action.

  3. What needs to be done then, to walk around the walls of Jericho a few times, so they will fall?

    The whole system seems stacked against us: the doctors don’t believe us, the solicitors wont touch a case with a bargepole, the media wont run any programmes exposing PSSD or the truth about antidepressants, the MP’s shy away from doing anything that might make a real difference, and for a lot of us with PSSD, even our own families and friends don’t believe us, and often side with the doctors, who say the sexual side effects are all in our head.

    You end up, very, very alone and isolated, stuck with PSSD in a world where almost no one believes you, no one seems interested in helping you, and some people will actively exploit your situation for their own entertainment or benefit; and I am not just talking about bio hackers, in my situation even one so called friend, and one family member has exploited my PSSD, to humiliate me, and use it for their own benefit.

    It is not an exaggeration to say that having PSSD is indeed like being buried alive, with little hope of being dug up. It is a cruel form of mental torture, which is seemingly un ending, and where quite a lot of people choose to end their suffering by suicide.

    I have tried very hard for over a decade to try and help myself. I have told countless doctors about my PSSD (I have even pleaded with some of them to help and believe me), and I have got myself referred to neurologists, urologists, and psychosexual therapists, trying to find a possible solution, and a way forward.

    I have told almost every GP I have met since developing PSSD, about my PSSD, and I have also told a lot of staff at my local mental health unit, and also my ex psychiatrist, about PSSD. Apart from my current GP, not a single one has been interested in helping me, and even my current one took a lot of persuading to be willing to try and help me.

    I have written and spoken to countless solicitors in the early 2010’s about possible legal action (not a single one was interested, and one actually actively humiliated me about my PSSD).

    I have written to two MP’s about my PSSD, and have encouraged others with PSSD to do the same.

    I have reported my PSSD to the MHRA via the yellow card scheme (where two scientists sniggered between themselves on the phone about my sexual problems), and I regularly hound the MHRA about their inaction.

    I took a complaint about my PSSD all the way to the Parliamentary health service ombudsman (they didn’t believe a word I had to say about PSSD, and one woman there tried to humiliate me saying “and those sexual problems”, in a mocking tone).

    I have also written to the BNF and NICE asking about why they don’t officially mention about persisting sexual problems in their guidelines (the BNF completely ignored my email, and the NICE guidelines wrote back with a reply which wasn’t worth the paper it was printed on).

    I have also done a Rxisk report about my PSSD, and reported my PSSD to EMA, and both me and my mother have written to Impeto medical pleading with them to let Rxisk use their genital adapter for the sudo scan machine. I have encouraged countless others with PSSD to do Rxisk reports, and report their PSSD to the EMA, to try and get it officially acknowledged.

    I have also done a lot of other work in the background to try and raise awareness about PSSD, and I hope some of this has made a difference, and I have also encouraged a lot of others with PSSD not to give up hope, even while struggling with suicidal feelings myself.

    I have also done the best I can to optimize my chances of recovery, by getting off all prescription drugs, and having a healthy diet, and getting regular exercise. I don’t smoke, and after getting off benzodiazepines in 2015, I drink no alcohol.

    I have taken almost every single opportunity presented to me, to help myself, and others with PSSD.

    I don’t really see what else can be done at the moment, short of someone going on a killing spree at the MHRA (very, very tempting), but even if someone managed to do something like that, the reason behind it would likely be robustly covered up by the main stream media, passed off as a few individuals with mental health problems, and will be exploited to get people talking about mental health, with the underlying agenda of getting more people on antidepressants.

    I mean trying to overcome these obstacles to get the proper acknowledgement, research, and help for people with PSSD, at the moment seems almost insurmountable. We have had setback after setback, with Brexit stopping the Cross Parliamentary group on PSSD starting, and the lockdown because of coronavirus has also put a hold on things, and god knows how long that is going to go on for.

    Somehow, somewhere, we have to have some good luck with all of this; it is long overdue.

  4. Right behind you Spruce in doing everything that a right-minded person would do when knowing when an injustice has been done. The reactions you have received speak for themselves, PSSD is not something that is currently understood or accepted as a genuine problem. Chronic side-effects, withdrawal and akathisia are not generally accepted either with aggression, suicide and violence.

    As most of us know, who have been down your road in trying to tackle every known avenue for a bit of recognition, the harder you push the more it closes down. The most odious is how to stop the sniggering and put-downs.

    I would guess most of the donations for the RxISK Prize come from those who support your cause but who don’t have PSSD themselves, so there is an army of people, hundreds if not thousands who are right behind you.

    As you have described very clearly, everything you have done has fallen on deaf ears.

    Leading psychiatrists have lost positions by speaking out, Peter Gøtzsche at Cochrane is an obvious example. Many books have been written.

    David Healy has written to Matt Hancock and not been graced with a reply.

    When leading figures in the UK, in positions of sway, where something could be done to raise awareness, make a career out of denial then you know there is a serious problem with an establishment malaise when there is so much evidence to the contrary. I am talking about Simon Wessely and Clare Gerada here. These are political animals who play games and no one should underestimate how much damage they have done by continually deflecting away from real lived crisis caused by medications.

    NICE, MHRA have no interest. Suicide Prevention is not fit for purpose. Coroners rarely discuss medications and so there is an endless loop where any recognition is destined to fail.

    Short of suing the Royal Colleges for misrepresentation of data, what can we do to get the power balance correctly enforced?

    After all, most psychiatrist take their lead from these outdated institutions and, of course, this filters down to your general gp who feigns to be oblivious and hides away behind the general consensus.
    Getting away with murder.

    Certainly we all need a change in tactics as the damage increases We need to come up with some bright ideas as to how to get the message across that ruining people’s sexuality, ruining people’s health and ruining people who were perfectly well before an archaic system fell upon them is not remotely acceptable.

    We are in grave danger from an institutional corruption that feels that it is so sure-footed it is willing to sacrifice so many lives and each and every one involved in censoring what is right in front of their eyes is a disgrace to humanity.

    Being silenced and ‘cancelled’ has become a way of life in the worst way possible.

    The Politics of being Press-Ganged in to submission by Authoritative Regimes will remain in place unless we repeat “Don’t Die of Ignorance”

    Tombstone and Iceberg
    https://ethicalmarketingnews.com/past-campaigns-aids-dont-die-ignorance

    and face-up to the reckonings of the Stormy D’s…

  5. Spruce – we all acknowledge the hard work that you’ve put in to wake people up to the reality of these conditions. No man could have done more. However, I note that in all the areas covered you refer to ‘I have …….’; I take from this that you even find it difficult to get other PSSD sufferers on board – is that the way it is? If so, then why? Could we not get every single sufferer to write to their MP rather than you alone? Should you decide on such a move, I’m sure many of us would join in although we have no personal experience of the condition. To do so, we would possibly need to refer to numbers of known sufferers in UK and, possibly a few names of other MPs contacted at the same time. Is the APPG on PSSD due to sit once September comes. Have they already published the list of reps. who make up that group? That would be another avenue to follow – if they haven’t , then request one. if they have, let’s bombard them with messages before they start pontificating around the subject!
    Have you noticed a new BBC2 programme which is to start next week – about perplexing medical conditions? It seems they will have a panel of ‘experts’ listening to individuals (who I guess are also at their wits’ end and getting nowhere within the system) and making a diagnosis of the condition as presented. Once we’ve seen the first programme – I believe it will be a series of 4 – if it’s as good as it sounds, how about finding out who is behind this and contacting them? I see that it’s made by ‘Dragonfly film and television’. BBC website also lists the ‘experts’. I would be perfectly willing to do the contacting – but not without your permission, since I’m not a sufferer.
    I fully understand that you HAVE your diagnosis, but couldn’t this type of programme maybe, just maybe, be brave enough to take an interest? Would it be an additional avenue to try?
    I feel your desperation, Spruce, every time you comment on here and am willing to do anything I can to help raise awareness of these conditions.

  6. Thanks Annie and Mary H for your support.

    Mary H; In regards to your point about getting lots of people with PSSD to contact their MP’s, I have asked 4 who I know in the UK to contact theirs. Two have told me they done so.

    I am happy to chase the other two up soon, and I will try and convince some other PSSD sufferers to write too.

    I think Rxisk contacted most of the people they know with PSSD in the UK, about contacting their MP, back in 2019, and hopefully that had some effect.

    I don’t know what is happening with the cross parliamentary group to do with PSSD, I think it is lying dormant until the corona virus situation dies down, but that could be a couple of years away, so it might be better if we try and re start it somehow.

    Mary feel free to contact the BBC about making a programme. I will be interested to hear how it goes, and will do what I can to help if you have any success.

    • Spruce – I shall get in touch with the company behind this new programme, rather than the BBC, as I feel there may be a better chance of success ( slim as it still may be!). I notice that their managing director has, at some point, received a MIND award – that is why I feel they are worth contacting. Shall keep you posted IF they reply!

  7. The Endgame version 2.
    I used to live in Greenford where a pharmaceutical company once had its HQ. Being a white lab coat sort of a guy and what with birds of a feather and being interested in stocks & shares of companies with investment potential to add to my portfolio, I naturally asked a lot of questions of their employees who drank in the local pubs, to gain some insights. Anyway, this biographical snip-it is just to show how I became aware of genetic medicine even before the NewScientist started to report it. Off and on have been following the topic ever since. This is a very short summery, of what I have been watching unfold (grab tinfoil hats and one for the cat if you have one).

    The early biolabs on silicon chips, although primitive by today’s standards, promised a revolution in healthcare, by the way of providing quick diagnostics at a price that would be affordable to all. [1]

    Just a few years later the phrase ‘Personalized Medicine’ started its rounds of the medical literature. Doctors would be able to find out who should take certain medications and who will suffer side effects. All by using genetic profiles to make treatment choices for individual patients. [2] [3]

    One hurdle to this, was it would require building and filling a huge database with genetic information from as many people as possible. Then find a way to cross-reference, identify and match that information with each individual’s confidential health records. From that, it would be possible to extract and discover, the polymorphic variations, which are possible contraindications for any drugs normally used to treat any particular medical condition.

    One efficacious ‘back-door’ way of obtaining access to confidential health records was promoted by a warm hearted philanthropist. [4] He even offered to design a complete Information and Document Management System free of charge for the NHS as long as his company could host all the data.

    Obtaining the raw genetic data turned out just to be a question of carefully targeting money. [5] With spanners thrown anonymously into the works of any organisation that held privacy to be more important than $$$$$$.

    Of course, the pharmaceutical companies involved, will need to get a return for their investment in all this high tech wizardry, that goes on behind the green curtain in the land of Oz.

    The system which incorporates the best profit gearing (accountant speak for squeezing the customer until his pips squeak) is a Multi-Tiered System of Support. Where one pays a monthly fee just to belong, and then more for extra tailored packages. Don’t confuse ‘tailored’ with the dictionary definition. In this case, it means each package tends to be almost-but-not-quite complete, requiring the purchase of yet another package (most of which you’ll never use but have to pay for all the same) stitched on to the deal. I’ve linked to an IT example of which a certain philanthropist is willing to let all his friends use free of charge. It is a tried, tested and proven model . [6]

    Therefore, I don’t see new ‘side effect free’ drugs in the offing but a monthly Tiered System of Life Support (which will crash, with the equivalent of a Blue Screen of Death, if one’s financial health fails before you do). It works for the IT industry, no reason that it won’t for healthcare. For no matter how high the cost of living rises, it will never go out of fashion.

    Before you believe all this though, remember. Ever since I hung up my lab coat for the last time I haven’t been involved any real research. Just done a lot of ‘abductive reasoning’ which starts with an incomplete set of observations and proceeds to the likeliest possible explanation for the group of observations. It is based on making and testing hypotheses using the best information available or which I could find. It often entails making an educated guess after observing a phenomenon for which there is no clear explanation. [I am very productive at making guesses, I wish I could sell them on eBay].

    Therefore, I suggest you look for more evidence (?) rather than putting any unexamined faith in my (maybe slewed) analysis. So with sceptical eye, compare it to this explanation by Mikki Willis. He co-directed the documentary “Neurons to Nirvana” His latest documentary has (secretly) become essential viewing to people interested in healthcare.[7] [If doctors say they have been watching it in secret, why do they then tell everybody? Do you beat your wife? No and only secretly.] He delves deeper into the machinations going on behind the green curtain with first hand accounts and testimonies.
    As for what any politician(s) can do. All sides have one hand tied behind their backs. Watch how democracy has been privatized by high tech industries. [8]

    References:
    [1] A microfabricated device for sizing and sorting DNA molecules https://www.pnas.org/content/96/1/11
    [2] Pharmacogenomics and Personalized Medicine. https://www.nature.com/scitable/topicpage/pharmacogenomics-and-personalized-medicine-643/
    [3] Protein microarrays for personalized medicine https://pubmed.ncbi.nlm.nih.gov/20075183/
    [4] Boost to NHS information systems as NHS signs Microsoft deal
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1173065/
    [5] The Guardian. Your DNA is a valuable asset, so why give it to ancestry websites for free?https://www.theguardian.com/commentisfree/2020/feb/16/dna-hugely-valuable-health-tech-privacy
    [6] Microsoft support packages
    https://support.microsoft.com/en-gb/help/4341255/support-for-business
    [7] https://ise.media/video/plandemic-ii-indoctornation-23.html
    [8] https://banned.video/watch?id=5f37fcc2df77c4044ee2eb03

  8. Head To Head
    Covid-19: Should doctors recommend treatments and vaccines when full data are not publicly available?
    BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3260 (Published 24 August 2020)
    Cite this as: BMJ 2020;370:m3260
    Read our latest coverage of the coronavirus outbreak
    Raymond M Johnson, associate professor of medicine (infectious diseases)1, Peter Doshi, associate professor2, David Healy, professor3
    Author affiliations
    Correspondence to: R M Johnson Raymond.Johnson@yale.edu, P Doshi pdoshi@rx.umaryland.edu
    W

    • ‘I see no ships’ — Horatio Nelson

      All trials collect data but some trails omit collecting the most pertinent data.
      The ICAN organisation has filed several citizen petitions and emergency stay petitions demanding that the clinical trial design for several Covid 19 vaccines be updated to require that all adverse reactions for the entire period of the clinical trial be tracked. Here below is a copy&past of one of them. Can’t provide links as yet as this news arrived by email.

      Pfizer and BioNTech have also rigged the clinical trial of their COVID-19 vaccine, BNT162b, to avoid capturing many potential life-altering adverse reactions that may occur from this experimental vaccine. ICAN’s legal team again filed an emergency petition to stop this unethical conduct.

      While Pfizer and BioNTech have now included a placebo control group in their clinical trial, these companies have decided to play a different game to avoid capturing safety issues that could prevent licensure of their COVID-19 vaccine, BNT162b. 

      The study design for the clinical trial for BNT162b provides that — despite reviewing efficacy for at least 2 years — it will only capture “adverse events” for 1 month and “serious adverse events” for only 6 months after each dose.

      The adverse events captured beyond a month after injection should not be limited to “serious adverse events,” since there are many autoimmune, neurological, and chronic health disorders which have a major impact on the quality of life, yet are categorized by the FDA as “adverse reactions” and not categorized as “serious adverse reactions.” To wit, there are a myriad of post-licensure adverse reactions reported by consumers and physicians and are also listed in the package inserts for one or more vaccines that any individual living with would categorize as “serious”; yet the FDA, under its current guidelines, may not. These include, but are not limited to: alopecia, autoimmune disease, lupus erythematosus, vasculitis, Bell’s Palsy, hypotonia, migraine, myelitis, neuropathy, seizures, mental disorders, rhinitis, and vertigo. 

      The study design for BNT162b nonetheless provides that these adverse events should be captured for only 1 month after vaccination while “serious adverse events” are captured for 6 months. These artificial limitations are unethical and make any claim of safety for this product based on this trial specious at best.  

      Incredibly, the efficiency of Pfizer and BioNTech’s vaccine in this trial will be tracked for two years. As such, the only reason to not track safety for this same duration is to avoid detecting any safety issues that would prevent licensure. If BNT162b causes a systemic autoimmune issue to arise two months after vaccination, it would be irresponsible and unethical not to capture that reaction just because an autoimmune issue falls into the artificially defined zone of being an “adverse event” or “non-serious adverse event,” rather than what the FDA has decided to label a “serious adverse event.”

  9. FDA may fine clinical trial sponsors that don’t report data
    BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3322 (Published 24 August 2020)

    The US Food and Drug Administration has said it will penalise sponsors of clinical trials that do not report data to the ClinicalTrials.gov database, but it has not indicated whether it will go after all offenders.

    The move came after the US Department of Health and Human Services, the FDA, and the National Institutes of Health were sued for failure to require reporting of clinical trial results and to make the results public.1 They lost the case earlier this year, after a federal court ruled that clinical trial sponsors …

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      POLITICS
      Trump has launched an all-out attack on the FDA. Will its scientific integrity survive?
      By LEV FACHER @levfacherAUGUST 27, 2020Reprints
      d trump pointing
      SOMODEVILLA/GETTY IMAGES
      WASHINGTON — President Trump has instigated an all-out crusade against the Food and Drug Administration at a critical point in the federal government’s fight against Covid-19.

      Three senior FDA officials and several outside experts told STAT that Trump’s attacks threaten to permanently damage the agency’s credibility — especially when combined with a disastrous series of public misstatements on Sunday from Stephen Hahn, the cancer doctor who became FDA commissioner in December.

      Beyond long-term concerns, these officials expressed a more immediate fear: that political incentives could interfere with approval decisions surrounding a Covid-19 vaccine, which Trump has repeatedly suggested could come before the Nov. 3 election. A premature approval, experts said, could further weaken Americans’ confidence in vaccine safety, especially if it appears rushed or politically motivated.

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      “It’s a political agency, and it has a political appointee at the head, but it has maintained a reputation for decades of being a science-focused agency,” said Holly Fernandez Lynch, a health policy expert and University of Pennsylvania professor of medical ethics. “There have definitely been slip-ups, but the level of interference that we’re seeing from the White House is so concerning.”

      In the past two weeks alone, the Trump administration has installed a right-wing journalist best known for her gun-rights advocacy as the FDA’s top spokeswoman — empowering her to aggressively reshape the FDA’s typically nonpolitical, straight-laced public messaging. On Saturday, Trump, with no evidence, accused the FDA of taking part in a “deep state” political conspiracy to harm his reelection campaign. And two key White House aides, including Trump’s chief of staff, have taken the rare step of criticizing the agency publicly, with one reportedly advocating for the approval of an unproven plant extract as a Covid-19 cure.

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      Presidents have sparred with the Food and Drug Administration for decades: over birth control, over tobacco, and over Americans’ right to take untested drugs that aren’t yet proven to be safe. But taken together, the actions represent an extraordinary new frontier for presidential attacks on the scientific agency.

      Even before the latest examples, the president repeatedly challenged the agency’s decision-making on a litany of potential Covid-19 treatments, misleadingly casting scientifically dubious treatments as “breakthroughs.” The FDA ended up issuing emergency authorizations for two of the products: the malaria drug hydroxychloroquine and blood plasma from recovered Covid-19 patients. Trump has even agitated for the FDA to approve oleandrin, an unproven plant extract, touted, without evidence, by the CEO of MyPillow.Com, a major Trump backer, though the agency has made no move to sanction its use.

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      In a statement, White House spokesman Judd Deere told STAT: “Every decision the FDA has made under the Trump administration has maintained the agency’s gold standard for safety and been data-driven to save lives,” and labeled accusations that politics influence approvals as a “false narrative.”An FDA spokeswoman declined to comment.

      Political interference at the agency “has been an issue in past administrations Republican and Democratic,” said Margaret Hamburg, the FDA commissioner who served under President Barack Obama from 2009 to 2015 who had a major dust-up with Obama’s health secretary, Kathleen Sebelius, over emergency contraceptives. “But never at this level, and never accompanied with the kind of public derision and undermining of both the employees who work at the agency and, frankly, the very mission of the agency.”

      Support STAT: If you value our coronavirus coverage, please consider making a one-time contribution to support our journalism.
      The most striking change at the agency is the appointment of ultra-political conservatives — an emerging pattern that some FDA insiders see as the start of a takeover of an otherwise largely apolitical agency.

      The appointment of Emily Miller, a right-wing activist who has ping-ponged between government and conservative journalism for the past two decades, has particularly dispirited FDA staff, senior agency officials said, speaking on the condition of anonymity.

      Miller joined FDA on Aug. 17 as assistant commissioner for media affairs. The position is typically filled by nonpolitical civil servants, not overtly political activists, making her appointment all the stranger. Miller is now the agency’s top spokeswoman and liaison to the public, wrangling Hahn’s media interviews and providing information to journalists covering the agency.

      Related: As Covid-19 pressures mount, political newcomer Stephen Hahn struggles to protect an FDA under siege
      Miller is an unconventional choice. She has no experience in science or medicine, and her work in politics and journalism has focused far more on foreign policy or gun-rights issues than on health care.

      Miller’s book, titled “Emily Gets Her Gun: But Obama Wants to Take Yours,” is a treatise on gun rights and the difficulties of buying firearms in Washington, D.C. (Miller writes that a D.C. home break-in motivated her to purchase a gun, though her description of the incident is factually inconsistent with police reports.)

      As a Washington Times columnist, Miller penned articles with titles including, “Maryland’s bathroom bill benefits few transgenders, puts all girls at risk from pedophiles,” and, referencing advertisements promoting insurance coverage for birth control, “New Obamacare ads make young women look like sluts.”

      She later worked as a correspondent for the cable channel One America News Network, a right-wing news source openly allied with Trump and known for promoting conspiracy theories.

      Related: Straight talk on the FDA’s tumultuous weekend — and new questions about its independence
      Her presence is already evident: A press release sent soon after Miller joined the agency, announcing the emergency authorization of blood plasma as a Covid-19 therapy, took a political tone that unnerved longtime FDA observers: The emergency approval, it said, represented “Another Achievement in Administration’s Fight Against [the] Pandemic.”

      Shortly thereafter, Miller aggressively defended Hahn, the agency chief, after he made scientifically misleading claims about plasma’s medical benefits while standing alongside Trump at a press briefing Sunday night. In a series of tweets, she falsely asserted that the treatment, known as convalescent plasma, “has shown to be beneficial for 35% of patients.”

      The misleading claim alarmed agency scientists, according to two senior FDA officials: Not only did it misrepresent scientific data, they said, but it was seen as a politically motivated attempt to co-opt the FDA’s message to bolster Trump’s reelection bid.

      “Trump is in a reelection battle,” said Daniel Carpenter, a Harvard professor of government and FDA expert. “And unlike past presidents, he’s willing to use the FDA as part of his arsenal.”

  10. This was posted earlier today by Chris on Post-Finasteride Syndrome and Amino Acids
    In reply to Bill F.
    (2000mg) L-Arginine and (300mg) French Maritime Pine Bark Extract daily will help immensely. I can’t respond to everyone’s posts but hopefully a lot of people see this. I was on Proscar for 6 years, using it for hair loss. All the issues people have experienced I had.

    I’ve been on prescription Testosterone replacement therapy (Androgel) and take the dosages above of L-Arginine and Pine Bark daily. Cut down on all trans-fat, Sugary drinks. Drink lots of water instead. Eat as healthy as you can.

    My libido is back, morning erections, fullness in my genitals (no tightness) and I’m motivated. If someone has questions I’ll try to get back to you.

    I’m just a regular guy that made a big mistake taking proscar. For me the mix above has saved me. I hope it does for you too!

  11. Hi Dr. Healy,

    Though realistic, this article is quite depressing.

    While there is obviously no cure at this time, do you have any suggestions regarding symptomatic treatment of this condition? It sounds like members often email you regarding any improvements they may have experienced. Have you noticed any themes with respect to drugs or classes of drugs taken.

    I’ve been on the forum and discord chats for some time, and from what I’ve observed, the drugs with the highest potential for symptomatic relief seem to be of the following classes:

    Dopamine-releasing agents, post-synaptic 5ht1a agonists, and hormones (TRT, steroids, SERMs, HCG), PDE5is, PT141

    I believe you mentioned benztropine as a possible experimental drug to try for PSSD. Why do you believe this drug could provide symptomatic relief?

    You also mentioned that you don’t believe in the androgen hypothesis. In my opinion, this is the most sound theory at this time. How can it be explained that some sufferers take high doses of extremely androgenic substances and feel as if they’re injecting water?

    • I’m a living proof of that, been on trt for 4 years before taking the SSRI and all hormones stopped working for me instantly, im NOT exaggerating…not just sexual side but the actual mental response which is not easily perceived by the “normal” person(which isn’t so normal anymore with the sea of endocrine disruptors we face every day)

      neurotransmitters are really just the messengers that they use to bury the nasty going on

  12. From propeciahelp:

    Airforlife, 16 days ago: So I emailed Professor Mohit Khera three months ago and he confirmed it.

    The work is already being reviewed by a scientific journal and will be released – the deadline is September.

    Then I spoke to the American Foundation and they said that – The researchers who studied our problem in Baylor found tens of thousands of gene damage. They were so shocked by this that they started double-checking their results and doing additional analysis for another 2 years.

    https://forum.propeciahelp.com/t/baylors-study-will-be-published-september-deadline/45148

    • Good to see this will be published but it would be useful to get a commitment to making the raw data available also. People are probably dead because of this secrecy – David Stopkooper for instance who had been persuaded that there was an epigenetic cause to his PSSSD.

      Hearing that are tens of thousands of gene damages in the Baylor data is meaningless – most drugs cause thousands of changes round the body. It takes someone who knows something about genes and epigenetics to say whether any of these changes are significant rather than just incidental. There are people out there who would likely to be able to spot whether there are interesting things in the pattern – or put another way you want people who know neurology and endocrinology and pharmacology to have a look at stuff like this so see if there are any useful leads in here. Of course we could always ask Ryan Ballow.

      D

  13. Teva is levering it’s molecules (sounds so sweet somehow) but it will be lethal to some who take it.

    Teva Announces FDA Approval of Austedo (deutetrabenazine) Tablets for the Treatment of Tardive Dyskinesia in Adults

    Tardive dyskinesia is a debilitating and often irreversible movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. The condition affects about 500,000 people in the United States and can be caused by certain medications used to treat mental health conditions or gastrointestinal conditions.
    “We are pleased to bring forward this second indication for Austedo to treat the underserved tardive dyskinesia population,”
    . “The launch of Austedo demonstrates our continued commitment to the treatment of movement disorders.”
    Teva offers Shared Solutions®, a free service to provide support to patients starting or taking Austedo. The toll-free number for Shared Solutions® is 1-800-887-8100.
    Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines,
    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding AUSTEDO® (deutetrabenazine) tablets, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
    Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

    Those ‘bothersome’ side effects again.
    Austedo Side Effects
    Generic Name: deutetrabenazine
    Medically reviewed by Drugs.com. Last updated on Jan 10, 2020.

    Professional Managing Side Effects
    Note: This document contains side effect information about deutetrabenazine. Some of the dosage forms listed on this page may not apply to the brand name Austedo.
    In Summary
    Common side effects of Austedo include: drowsiness. Other side effects include: depression, agitation, akathisia, fatigue, and restlessness. See below for a comprehensive list of adverse effects.

    For the Consumer
    Applies to deutetrabenazine: oral tablet

    Depression and Suicidality in Patients with Huntington’s DiseaseDeutetrabenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington disease. Anyone considering the use of deutetrabenazine must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician.Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington’s disease. Deutetrabenazine is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

    Side effects requiring immediate medical attention
    Along with its needed effects, deutetrabenazine (the active ingredient contained in Austedo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
    More common
    Body aches or pain
    chills
    diarrhea
    difficulty with breathing
    difficulty with swallowing
    discouragement
    drowsiness
    dry mouth
    fear
    feeling sad or empty
    fever
    headache
    inability to sit still
    irritability
    lack of appetite
    loss of balance control
    loss of interest or pleasure
    mask-like face
    need to keep moving
    nervousness
    relaxed and calm feeling
    restlessness
    shuffling walk
    sleepiness or unusual drowsiness
    slow movement or reflexes
    slurred speech
    stiffness of the arms and legs
    tic-like (jerky) movements of the head, face, mouth, and neck
    tiredness
    trembling and shaking of the fingers and hands
    trouble concentrating
    trouble sleeping
    trouble with balance
    unusual tiredness or weakness
    Less common
    Agitation
    dizziness
    problems passing stools
    Get emergency help immediately if any of the following symptoms of overdose occur while taking deutetrabenazine:
    Symptoms of overdose
    Blurred vision
    confusion
    dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    fixed position of the eye
    inability to move the eyes
    increased blinking or spasms of the eyelid
    mood or mental changes
    nausea
    seeing, hearing, or feeling things that are not there
    shakiness in the legs, arms, hands, or feet
    sticking out of the tongue
    sweating
    trembling or shaking of the hands or feet
    uncontrolled twisting movements of the neck, trunk, arms, or legs
    unusual facial expressions
    vomiting
    Side effects not requiring immediate medical attention
    Some side effects of deutetrabenazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
    Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
    More common
    Bruising
    large, flat, blue patches on the skin
    Less common
    Muscle aches
    sore throat
    stuffy or runny nose
    For Healthcare Professionals
    Applies to deutetrabenazine: oral tablet
    General
    The most common adverse reactions occurring in greater than 8% were somnolence, diarrhea, dry mouth, and fatigue.[Ref]
    Nervous system
    Very common (10% or more): Sedation/somnolence (11%)
    Common (1% to 10%): Dizziness[Ref]
    Dermatologic
    Common (1% to 10%): Contusion[Ref]
    Gastrointestinal
    Common (1% to 10%): Diarrhea, dry mouth, constipation[Ref]
    Genitourinary
    Common (1% to 10%): Urinary tract infection[Ref]
    Other
    Common (1% to 10%): Fatigue[Ref]
    Psychiatric
    Common (1% to 10%): Insomnia, anxiety, depression, suicidal ideation, akathisia/agitation/restlessness[Ref]

  14. Few people of the Italian group have long been very active in spreading awareness on the web about PSSD, through groups on social networks, blogs, chats, youtube videos, consultations on sites where you receive answers from doctors etc.. Anonymously, it’s true…
    In these last months I have found an increasing number of worried people who get in touch before or during SSRI intake, afraid to take PSSD because they have found information on the internet even if doctors do not say or deny it. Information that could not be found a few years ago. We need to be able to handle these circumstances in a balanced way. Personally I avoid making alarmism and only criminalize the drugs, beyond when I express my personal tragedy. I know that there are people who defend them because for them they are like life-savers and therefore they oppose and feel disturbed by information about PSSD. They don’t want to worry and be alarmed and prefer to consider them as fake news. I think that the right perspective to highlight is that these drugs are like Russian roulette in both positive and negative effects. For some they are life-saving, for others almost fresh water, in some cases they cause permanent damage. Those who have PSSD would like to go back and stay away from them. I don’t feel like telling these people what to do, better to advise them in a calm way, and anyway, if they are still taking SSRI and they are worried, I prefer to tell them that seems in most cases the sexual dysfunctions are reversible, and that they could gradually decrease the drug to get rid of it. On the sites of medical consultations still get inadequate answers (fake news, it’s not possible, it’s psychological, it’s not proven…), some rare doctor instead seems to have just opened his eyes on the new evidence after EMA update.

  15. Man sacrifices his health
    in order to make money.
    Then he sacrifices money
    to recuperate his health
    And then he is so anxious
    about the future that he does
    not enjoy the present: The result
    being that he does not live
    in the present or the future:
    he lives as if he is never going to die
    And then dies having never really lived.
    Dalai Lama

  16. Producers are pretty elusive unless setting their own agenda but this was a bit of a breakthrough for UK TV – albeit there was the arty component to make it more acceptable.

    Me and My Penis: Channel 4 documentary hailed … – Me and My Penis was described by the programme’s executive producer, Susanne Curran, as a vehicle to discuss what the multiplicity of what it means….All4.com Homepage
    My4 just need to register with e mail for free to view video
    programme sponsor
    Me and My Penis
    Men talk openly about their penis, the realities of sex, masturbation and erections. They also tell of infertility, violence and sexual abuse, as they question taboos around the penis.

  17. PS Susanne Curran (above Me and my Penis) also made a programme last year – 100 Vaginas – video on all4. (She also made a great film about an environmental campaigner called KIRI)
    Maybe an opportunity for someone(s) , women or men,with the problems documented on Rxisk to contact Susanne C She is on twitter
    All4.com
    100 Vaginas
    About the programme
    Documentary artist Laura Dodsworth photographs women and hears their intimate, shocking, moving, powerful or funny stories about how their vaginas have shaped their lives
    First shown: 19 Feb 2019A ll4.com

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