Bait and Switch: the Great Ketamine “Breakthrough”

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March 4, 2019 | 27 Comments

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  1. I didn’t suffer from depression until I was falsely diagnosed with bipolar 1 and aggressively drugged for 11 years….causing drug-induced depression (& many other ‘symptoms’=side-effects). I’m ‘officially’ free of all diagnosis today (paperwork!), my exit ‘gift-tag’ being ‘unpecified’ anxiety, F41.9……no f*cking kidding.
    Having said that….depression is becoming the ‘new’ (recycled) marketing target for the industry machine. Bipolar is still a ‘darling’ of the industry, but folks are beginning to notice it’s massive lack of credible diagnostic code application, regardless of it’s infinite expansion of ‘symptoms’.
    Depression never went away, just distracted by ALL the other newly manufactured disorder-codes & vague treatments whose results are skewed, creatively edited, & tailored to fit the ‘new approach’ to old complaints.
    The FDA has a poor track record standing for integrity regarding trials & results dealing with Pharma (“follow the …”, well, u know), this is no different, but the marketing should be a ‘slam-dunk’, familiarity in name-recognition translating to an illogical but easier acceptance by consumers.

    Scary, indefensible, dangerous to trusting sufferers; venality never stopped them before & won’t with esketamine….& all the ‘knock-offs’ to follow. And NO, it will never ‘cure’, there will be NO ‘recovery’; just “lifelong” ‘maintenance….the treatment-paradigm that is the industry’s definition of a ‘successful’ drug. Deaths while ‘on’ the drug will be spun to create ‘urgency’ for the ‘new epidemic’ of depression & suicide=more sales. The bipolar “gold-rush” model rides again. The “pediatric-depression” faux-emergency is coming to media any second now…

    We’ve seen this movie.

  2. Janssen knows it’s way around bullsh*t claims of efficacy & imaginary safety regarding psych drugs. They’re extremely comfortable & polished with this hustle.
    Have some Topamax while you’re waiting for your Spravato.

  3. ‘Oh my goodness gracious!’
    Now, they are enticing people by putting this stuff into a funky rocket missile type contraption.
    One instant shot and you will be as good as gold. All your troubles will be blasted away!
    It is safe and effective just like the other notorious claims of well known brands.
    I am always sceptical when they claim that something is safe and effective.
    There is always an element of risk and doubt when I hear/read the word safe and effective.
    If meds are safe and effective, people like myself would not be here on RXISK , retelling our tragic stories.
    Sadly, we are paying a very high price for speaking up and it saddens me that we are told that we live in a country of democracy when the powers of corruption impact every aspect of our lives.

    • It is Very funky! Looks similar to the cool looking vapes marketed to people who wanted to give up fags.Maybe they could make a few different choices of design to attract more users – photos of a few celebs who have ‘come out’ about their depression and these funky little pocket rockets can be on the street in no time. heroin and other stuff gets easily shoved up the nose so Johnson and Johnson have learned a good trick there.
      On China Time (Annie’s link above) – only certified prescribers can get this drug..! When it’s being promoted like a magic fix they know that’s not likely – there;ll be dealers cooking it up already. ‘It functions differently to other anti depressants and can ease symptoms in 1 day!! Strewth imagine a trip on that! Another selling point is that this is a drug targeted especially for people suffering long term depression and who often turn to suicide. Good to know they care. China Times (which has just bigged up the rocket propelled drug- Zhongshi Newsletter Cares About You. Protect Yourself and Stay Away from Drugs’.

  4. I fail to see the attraction of this “medication”.
    In the first instance, those already hurt by, or struggling on, the usual drugs are not going to touch this one with a barge pole are they? Surely, it’s a case of ‘once bitten, twice shy’.
    On the other hand, those who find the usual ADs beneficial (?) are not going to be tempted away from them are they? Their mantra being “these have saved my life” surely means they would be idiotic to change prescription.
    So, at who exactly do the manufacturers aim this new drug? It’s my guess that it’s aimed at youngsters, new to the need for a prescribed drug, who may well find a ‘squirt up the nose’ more acceptable than taking a boring, old-fashioned tablet any day of the week!

  5. Ketamine-like drug for depression could get UK licence within the year

    Esketamine could initially become available through private clinics but potential side effects raise concerns

    https://www.theguardian.com/science/2019/jul/12/ketamine-like-drug-for-depression-could-get-uk-licence-within-the-year

    Hannah Devlin Science correspondent

    Fri 12 Jul 2019 17.04 BST

    “We haven’t had anything really new for 50 or 60 years. What’s particularly exciting is the arrival of a new type of treatment and that’s ketamine,” he said. “It’s got a different pharmacology. It’s not just the same old steam engine, it seems to work in a different way and it seems to work more quickly.”

    “The cost of esketamine is dramatically high and comes with a very large and scary side-effect profile,” he said. “It is so potentially dangerous that clinicians are required to sit with patients for two hours after they are administered the drug. There is no other antidepressant that I know of that requires one hundredth of that kind of observation after administration. The upshot is that the drug is an over-hyped ripoff.”

  6. FDA Overlooked Red Flags In Drugmaker’s Testing of New Depression Medicine

    https://khn.org/news/fdas-approval-of-new-depression-drug-overlooked-red-flags-in-its-testing/

    The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, raising red flags Janssen and the FDA dismissed.

    The FDA, under political pressure to rapidly greenlight drugs that treat life-threatening conditions, approved it anyway.

    James Moore Retweeted

    Dr. Terry Lynch‏ @DrTerryLynch 10h

    @CEP_UK @dropthedisorder @PaulMinotMD @leoniefen @barneyhound @Mad_In_America @jf_moore @HengartnerMP @ClinpsychLucy @joannamoncrieff @alyne_duthie @truthman30 @balfe_robert @jill_d35 @galavpsychology @DrAlecGrant @nhunterpsych @MITUKteam @ReadReadj @recover2renew @benzosarebad

    https://doctorterrylynch.com/the-media—and-the-public—must-apply-a-critical-approach-to-mental-health-information/

  7. James Moore‏ @jf_moore

    “There’s grounds to think this drug can be useful,” says David Healy, professor of psychiatry at Bangor University. “But the version that has been brought to market is probably going to do more harm than good.”

    Has esketamine been vastly overhyped?

    By William Ralston

    20 July 2019

    The first new antidepressant since Prozac is… ketamine. OK, not quite. There is no patent on the infamous party drug, but big pharma is now marketing a derivative with worryingly unclear outcomes

    https://www.gq-magazine.co.uk/lifestyle/article/esketamine-antidepressant

    Esketamine is a drug that divides opinion, but one certainty is that it’s been vastly overhyped. Another is that nobody really knows what the long-term effects of esketamine consumption are and there are concerns about the drug’s withdrawal effects after three of the study’s participants committed suicide within 20 days of its end, despite continuing on traditional antidepressants.

    The FDA report said “it is difficult to consider these deaths as drug-related”, due to the small number of cases and the severity of the patients’ underlying illness, and Janssen said data from the trials did not suggest that esketamine is associated with increased risk of suicidal ideation or behaviour. Nevertheless, by rushing these drugs to market without clear evidence as to their safety and efficacy, we risk disappointment and suffering for those who need them most.

  8. Worrying trend, towards ‘treatment-resistant depression’ drug approval

    Sage Therapeutics to pursue high-risk, high-reward plan for experimental depression pill

    By Adam Feuerstein @adamfeuerstein

    July 24, 2019

    https://www.statnews.com/2019/07/24/sage-therapeutics-to-pursue-high-risk-high-reward-plan-for-experimental-depression-pill/?

    Sage Therapeutics is advancing its experimental pill SAGE-217 into a pivotal clinical trial for people with treatment-resistant depression, the company said Wednesday.

    Treatment-resistant depression will be the third proposed indication for SAGE-217, a once-daily oral medicine that has already established efficacy in postpartum depression and is being investigated in an ongoing Phase 3 study of major depressive disorder. The Cambridge, Mass.-based company intends to start a Phase 3 study in treatment-resistant depression before the end of the year, said CEO Jeff Jonas said in an interview.

    • James Moore‏ @jf_moore 22h

      New buzzword to look out for ‘neurosteroids’ New antidepressants on horizon – http://ScienceBlog.com

      New antidepressants on horizon

      October 29, 2019

      https://scienceblog.com/511637/new-antidepressants-on-horizon/

      For example, when I saw the data for the postpartum drug brexanalone, I would point out that the aim wasn’t only to treat postpartum depression but that neurosteroids potentially had broader uses. Those included clinical depression in men and women, anxiety and treatment-resistant depression. And as early data first came in on the latest drug, SAGE-217, it became clear that it could be effective in men and women with depression and that we probably should study it further in patients with treatment-resistant depression. That’s our plan here at the Taylor Family Institute: to evaluate neurosteroids in patients whose depression has not been relieved by other drugs because that’s where we could see the greatest impact.

  9. recovery&renewal‏ @recover2renew 1h

    recovery&renewal Retweeted The BMJ
    OMG …

    The BMJ‏ @bmj_latest

    So far the evidence suggests that patients stand to benefit from ketamine-related drugs. We need a strong monitoring system—which must include ketamine as well as esketamine” @rcpsych

    Rupert McShane: A drug not a miracle—why we need a new system for monitoring ketamine

    July 26, 2019

    https://blogs.bmj.com/bmj/2019/07/26/rupert-mcshane-a-drug-not-a-miracle-why-we-need-a-new-system-for-monitoring-ketamine/

    The European Medicines Agency and the UK drugs regulator will make a decision in November on licensing esketamine—if approved it would become available through private clinics. And early next year, the National Institute for Health and Care Excellence is scheduled to decide on whether to approve it for NHS use.

    The MHRA, NICE, NHSE, DHSC, pharma, Royal Colleges, NHS and private providers need to thrash out how this could work. The problem doesn’t clearly lie with any one agency.  But if we ignore ketamine because its use is off-label, or ‘out of scope’, or because there isn’t a precedent for multi-drug monitoring, or because it’s difficult to see how to fund it, we risk descent into overuse, backlash and stigma.   

    So far the evidence suggests that patients stand to benefit from ketamine-related drugs. We need wide access with strong monitoring—which must include ketamine as well as esketamine—to ensure that this is not just a flash in the pan. 

  10. Revealed: Doctors pushing new drugs don’t have to admit they are funded by the pill’s makers … and a treatment for depression using Class B drug ketamine is just the latest example

    More than four in ten British health professionals who take money from drug companies don’t disclose those payments or say where the money came from 
    There is no requirement that they do so as all disclosure is voluntary in the UK
    One example being pushed by doctors is use of ketamine to treat depression 

    By John Naish

    Published: 23:06, 26 August 2019 | Updated: 23:14, 26 August 2019

    https://www.dailymail.co.uk/health/article-7396961/Doctors-pushing-new-drugs-dont-admit-funded-pills-makers.html

    Recently, leading depression experts lined up at a London briefing to explain how an engineered version of the drug, called esketamine, promises a breakthrough in providing fast-acting help to sufferers of treatment-resistant depression.

    What was not made clear in reports of the briefing is that Professor Young, Dr McShane and Dr Zarate have conflicts of interest that could potentially compromise their independence as advocates of ketamine and esketamine.

  11. EMA Panel Backs Esketamine Nasal Spray for Resistant Depression

    Megan Brooks

    October 18, 2019

    https://www.medscape.com/viewarticle/920058?src=soc_fb_share&fbclid=IwAR2Si1wHQLjSAGBgw9Sz1G-VX348xba2H7Thj6MWld9oFhNrB-VWzXt5TmY

    The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of esketamine nasal spray (Spravato, Janssen-Cilag) in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) for adults with treatment-resistant major depressive disorder (TRD).

    Patients are considered to have TRD if they have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

  12. A concluding summary of the efficacy and safety of esketamine from the data presented by Janssen to the FDA

    https://www.bmj.com/content/366/bmj.l5572/rr-11

    Public Health England (PHE) has just published a review of drug classes causing dependence and withdrawal, including opioids, benzodiazepines, z-drugs, gabapentinoids, and antidepressants, concluding that one in four Britons are on these drugs, a widespread issue of concern [4]. When each of these classes of drug were introduced into clinical practice they were said to have ‘safe profiles’, and were approved for use based on short-term studies in the absence of comprehensive long-term safety studies. Recognition of the damage these drugs have done to many patients caught in a cycle of dependence and withdrawal effects has taken decades.

    https://www.bmj.com/content/366/bmj.l5572

    No one will thank the MHRA if they introduce another drug that leads to long-term medical complications and significant problems with dependence and withdrawal, just because it has a ‘novel’ mode of action.

  13. James Moore Retweeted

    Mark Horowitz‏ @markhoro 1h

    Puncturing the hype about esketamine’s woeful efficacy. A very good summary of @eturnermd1’s recent Lancet Psychiatry article https://bit.ly/32NaFmf . Not to mention the concerning safety issues with this drug, more here: https://bit.ly/2Qk8xiY

    FDA’s Rapid Approval of Esketamine for Severe Depression Questioned

    Pauline Anderson

    November 13, 2019

    https://www.medscape.com/viewarticle/921248?src=soc_tw_191116_mscpedt_news_mdscp_esketamine&faf=1

    While some experts have hailed intranasal esketamine (Spravato, Janssen) as a “game changer” for treatment-resistant depression (TRD), others are concerned over the US Food and Drug Administration’s (FDA) rapid approval of the drug.

    In an editorial published online October 31 in Lancet Psychiatry, Erick H. Turner, MD, who sits on one of the FDA advisory committees that recommended approval of Spravato, said the drug did not meet standard criteria for FDA approval and that there was little evidence to support its safety and efficacy based on data from three short-term, phase 3 trials and one withdrawal trial.

    Turner, who is a psychiatrist at Oregon Health and Science University in Portland, noted that only one of the three trials that led to the drug’s approval was positive.

    “Accepting just one short-term trial as being enough is an historic break from precedent,” Turner told Medscape Medical News.

    “Based on the evidence provided in Janssen’s application, the FDA should not have approved the drug,” Spielmans, who researches antidepressant medications, told Medscape Medical News.

  14. Why a spray almost identical to ‘party’ drug ketamine is set to be approved to ‘treat’ depression

    Esketamine is set to be approved as a wonder cure for people with depression 
    This prompted protests from experts who say the tests on it were inadequate
    The drug ketamine is legally used as a horse tranquilliser and an anaesthetic 

    By John Naish for the Daily Mail

    Published: 01:13, 19 November 2019 | Updated: 01:15, 19 November 2019

    https://www.dailymail.co.uk/health/article-7699191/Why-spray-identical-party-drug-ketamine-set-approved-treat-depression.html

    This has prompted protests from experts who argue that the tests on esketamine have been inadequate and that even in those tests, involving some 1,600 people, esketamine was associated with six deaths.

    Last month, a European Union regulator unexpectedly recommended approval for esketamine to be used as a depression drug across the EU.

    The news prompted warnings by leading experts and scathing attacks in the medical journal The Lancet.

    In September, Public Health England published a landmark report warning of the addictiveness of prescribed drugs for depression and other common psychiatric problems.

    MPs on the All-Party Parliamentary Group (APPG) for Prescribed Drug Dependence believed that UK approval for the drug was to be discussed this month by the drug-safety watchdog, the Medicines and Healthcare products Regulatory Agency.

    The APPG repeatedly wrote to the agency asking about this meeting, so it could present its objections, but heard nothing.

    Instead, last month, the APPG learned that Janssen had sent an application for European-wide approval to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, the EU regulator, and that this has now been granted provisional approval.

    However, in March, esketamine was approved for use by the Food and Drug Administration (FDA) in the U.S. in patients with treatment-resistant depression, sparking fears it may subsequently be approved in the UK.

    Head of neuroscience at Janssen, Dr Husseini Manji, said they are pleased with CHMP’s recommendation: ‘For decades there have been no new treatment options for patients with treatment-resistant depression. Esketamine represents a new way to manage this.’

  15. Ketamine-like drug for depression gets UK licence

    Psychiatrists divided on ‘game-changing’ esketamine due to potential for addiction

    https://www.theguardian.com/science/2019/dec/19/ketamine-like-drug-depression-uk-licence-esketamine?CMP=share_btn_tw

    Hannah Devlin Science correspondent
    @hannahdev

    Thu 19 Dec 2019 18.02 GMT

    John Read, a professor of clinical psychology at the University of East London, who was among the critics, said: “The fear is that in a few years we will be having a Public Health England review into people who can’t get off esketamine. At this stage we really should be cautious.”

    According to Young, esketamine is the first of a wave of new drugs in the pipeline for depression, including the psycho-active drug psylocibin, found in magic mushrooms, which is currently the subject of trials.

    “We’re seeing lots of work with new chemical entities that are very different from old SSRIs,” he said. “Hopefully this will be the harbinger of a new era for treatments.”

    John Read
    @ReadReadj

    THE DISTURBING CASE OF THE STREET DRUG KETAMINE Are Our Regulatory Bodies Prioritising Drug Company Interests Over Public Safety?

    https://www.madintheuk.com/2019/12/regulatory-bodies-prioritising-drug-company-interests-over-public-safety/

    The UK’s Medicines & Healthcare Products Regulatory Agency [MHRA] is refusing to respond to the concerns of psychiatrists, parliamentarians, patients and other experts about the impending licensing of the street drug ketamine as a treatment for depression.

    In March this year, the USA’s Food and Drug Administration approved Spravato (esketamine), on the basis of just one efficacy study.

    Mark Horowitz
    @markhoro

    Another examination of Janssen’s FDA application for esketamine finds the drug to be ineffective as an antidepressant, and associated with a host of worrying side effects.

    Esketamine for treatment resistant depression: a trick of smoke and mirrors?

    https://www.cambridge.org/core/journals/epidemiology-and-psychiatric-sciences/article/esketamine-for-treatment-resistant-depression-a-trick-of-smoke-and-mirrors/F8BB2D5C3F290FE671639CBB0F31C7E9

    Finally, we argue that the EMA should take into due account all these critical issues when assessing the marketing authorisation of esketamine for Europe, and, more broadly, we call for a radical change of current regulatory rules for psychotropic drug approval.

  16. Trump touted a new antidepressant as a solution for veterans. Only 15 have been treated

    By Megan Thielking @meggophone

    January 6, 2020

    https://www.statnews.com/2020/01/06/only-15-vets-treated-esketamine/?utm_source=STAT+Newsletters&utm_campaign=f2fc7721ab-Pharmalot&utm_medium=email&utm_term=0_8cab1d7961-f2fc7721ab-149674737

    In August, President Trump proudly proclaimed that he had directed the Department of Veterans Affairs to buy “a lot” of a drug known as esketamine, the first new major depression treatment with a novel mechanism to hit the U.S. market in decades.

    “Its results are incredible,” Trump said at a veterans convention in Kentucky. “I’ve instructed the top officials to go out and get as much of it as you can.”

    As of mid-December, the VA had treated just 15 veterans across the country with the drug. The nasal spray, which was developed by Janssen and named Spravato, was only available at seven of the agency’s facilities — out of more than 1,200.

    The VA treated its first patient with Spravato in June.

    “[The studies] are not robust. They’re not strong results. You pull one thread and the whole thing unravels,” said Turner.

  17. https://www.bmj.com/content/366/bmj.l5572
    1. Correspondence to: S Jauhar Sameer.jauhar@kcl.ac.uk
    We should cautiously welcome this new therapeutic option
    On 5 March 2019 the US Food and Drug Administration approved esketamine nasal spray in conjunction with an oral antidepressant for people with treatment resistant depression.

    2. Esketamine for treatment resistant depression is not recommended by NICE
    BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m329 (Published 28 January 2020)

    Esketamine for treatment resistant depression
    An esketamine nasal spray may not be made available on the NHS for patients with treatment resistant depression because of uncertainties over its clinical and cost effectiveness, says draft guidance from the National Institute for Health and Care Excellence.1

  18. NHS watchdog rejects use of party drug ketamine as antidepressant despite hype over treatment

    Officials say there is not enough evidence ketamine works long-term 
    NICE also said the £10,000 course price is too high for the NHS to fund 
    The drug delivered via nasal spray is chemically similar to the party-drug version

    https://www.dailymail.co.uk/health/article-7934897/NHS-watchdog-rejects-use-party-drug-ketamine-antidepressant-despite-hype-treatment.html

    By Ben Spencer Medical Correspondent For The Daily Mail
    Published: 00:01, 28 January 2020 | Updated: 00:11, 28 January 2020

    A radical depression treatment derived from party drug ketamine is set to be rejected for use on the NHS.

    There has been months of hype over the treatment – the first antidepressant with a new mechanism of action to be licensed in 30 years.

    But NICE say there is not enough evidence it works long-term, and the price – which exceeds £10,000 for the average course – is too high for the NHS to fund.

    ‘Many psychiatrists have been concerned at the lack of evidence that esketamine is really a helpful treatment for depression.

    ‘There are also unanswered questions about the extent to which it might cause unwanted effects and how it could be safely used in practice.

  19. John Read – UK Esketamine Approval – Not so Fast

    https://www.madinamerica.com/2020/02/john-read-esketamine-approval/

    By

    James Moore

    February 1, 2020

    John joins us to discuss the UK licensing of esketamine nasal spray (Spravato) for so-called ‘Treatment Resistant Depression’. John led a group of 12 academics and professionals who wrote to the UK regulator expressing concerns about esketamine.

    How there was no response from the MHRA to the concerns raised by John’s group.

    In addition, no reply was made to concerns raised by Sir Oliver Letwin writing on behalf of the All Party Parliamentary Group on Prescribed Drug Dependence as well as letters from independent researchers from Kings College London and a group of service users.

    A recent response to the approval by the UK National Institute for Health and Care Excellence.

    A response to the NICE announcement from the Science Media Centre.

  20. Lawmakers Investigating Whether Trump Pals Had Stake in Risky Drug He Pushed for Veterans

    https://www.madinamerica.com/2020/03/around-web-lawmakers-investigating-trump-pals-stake-risky-drug-veterans/

    From ProPublica: “House Democrats are expanding their investigation of outside influence at the U.S. Department of Veterans Affairs, examining whether a push to use a new antidepressant from Johnson & Johnson was advanced by a group of unofficial advisers who convened at Mar-a-Lago, President Donald Trump’s private club.

    Inside Trump’s VA

    Trump Endorsed a Risky Antidepressant for Veterans. Lawmakers Want to Know if His Mar-a-Lago Pals Had a Stake in the Drugmaker.

    https://www.propublica.org/article/donald-trump-veterans-spravato-antidepressant-johnson-and-johnson

    House Democrats requested emails and financial records as they investigate why the president told the VA to “corner the market” on a Johnson & Johnson drug.

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