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The Emperor’s New Drugs is a brilliant, brave and detailed book that exposes Big Pharma’s failure to produce effective drugs to treat depression.  If you or a loved one are taking an antidepressant, or are considering taking one, I would strongly urge you to read the book.  It could change your life.  

If you care about healthcare delivery in this country, then you should care about how Pharma is treating or not treating the 20% of the population who will someday experience a depression.  You should read the book.  And to be clear, I make nothing by promoting the book – it just speaks truth to power.

The book came out in March 2011 and although followed up with a 60 minutes interview on February 19, 2012, the information failed to ignite a firestorm against Pharma.

Well, it turns out that Dr. Kirsch's work was the first shoe, as we said in the day.  The other shoe, the one that really hurts, is that there is a drug with great promise to treat depression, if only we could get our hands on it.  Maybe that'll start the fire.

More below the fold:

Key excepts from "The Emperor's New Drugs: Exploding the Antidepressant Myth" by Irving Kirsch (Mar 8, 2011), backed up by detailed and unbiased statistical analysis:

“The belief that antidepressants can cure depression chemically is simply wrong.”

“Using these standards to judge the effectiveness of a (antidepressants) is voodoo science to the nth degree.”

“In their most recent analysis of the data, the FDA concluded that, when compared to (sugar pills), (antidepressants) double the risk of suicidal thoughts and behaviors in depressed patients up to the age of 24”

"(side effects of antidepressants include)...sexual dysfunction...seizures...mania..panic attacks...twitching...anorexia...hallucinations..."

"while only a minority report any particular side effect, the number of patients who report suffering from at least one of them is quite high, ranging from half...to the vast majority..."

In summary, antidepressants are more accurately viewed as dangerous, habit-forming, sexual inhibitors that have the occasional side effect of improving depression.  

Even the scientists are now admitting that the entire theory of levels of Serotonin affecting mood is wrong.   Much of the last 50 years of research has been digging in the wrong hole.  To the degree that antidepressants do work, it is because of the placebo effect in which people believe themselves into health, combined with a small and incidental drug effect.

How can you believe Dr. Irving Kirsch, the author of The Emperor’s New Drugs? Well, first there's his background, courtesy of Amazon:

...is Associate Director of the Program in Placebo Studies and a lecturer in medicine at the Harvard Medical School and Beth Israel Deaconess Medical Center. He is also a professor of psychology at Plymouth University in the United Kingdom, and professor emeritus of psychology at the University of Hull, United Kingdom, and ...
Second, if there was an error in his analysis of antidepressants, you could be sure that Pharma would have suppressed the book.  Crickets? I'm betting Pharma hopes you don't get a copy for Christmas.

What to do for those who suffer depression if not for a standard antidepressant?  Our friends in Pharma have had the answer to that for many years, but it’s likely you have never heard of it, or have heard something about something that is not quite ready for prime time.

That something is the drug Ketamine.   It was developed in the 1960’s and has been used as an operating room and emergency room anesthetic ever since.  Surgeons noted how happy their patients were after a procedure, and I know of one battlefield doctor who used Ketamine personally as an antidepressant.

Ketamine is a very safe drug.  An overdose can be lethal, but the dosage for depression treatment is already a small fraction of the dosage used for anesthesia. Other side effects are very minor, and only felt for an hour or so after administration of the drug.

There are issues that need to be resolved in order to use the drug for depression.  The most reliable method of administration is via an IV, which means treatment in a medical office with the appropriate equipment.   That structure will mean that the price of the service initially would be restricted to those who could afford to pay privately.

However, there is research underway to use other methods of administration, including a nasal spray and a liquid version.  Chances are that by the time the vast majority of people are ready to try it, the industry will have developed one of these methods into a commercially viable approach.

How good is Ketamine?  A traditional antidepressant, acting as a placebo plus a slight drug effect, will help about 33% of patients get better over the course of a couple of months.  (What Pharma doesn't advertise is that therapy, a self-help book or exercise would help just as many people just as quickly, and without the side effects of antidepressants.)

In comparison, Ketamine works for more than 70% of patients who have tried a therapeutic dose, and does so in less than one hour.  LESS THAN ONE HOUR.  I still have a hard time writing that, but I have personally experienced it and seen its’ effect in others.  How does it work?  As shown in the picture of two neurons below, Ketamine increased the level of synaptic branching in areas of the brain controlling mood by something like a factor of 4:

"Slide1"

I won’t get into the science of what is happening, because frankly we are all guessing at this point.  After being so wrong on earlier antidepressants, I would hope we’re a little more humble and egoless in our pronouncements of what is going on in something as complicated as the human brain.

Why haven’t you seen a single commercial for Ketamine, while you can’t escape commercials for other drugs?  Well, most people on this site will already intuitively know the answer – Pharma can’t make money with Ketamine, so it has an alternative strategy.

Since Ketamine is such an old drug, the manufacturer no longer has patent protection.  I can’t overstate the economic effect of that – the depression dosage of Ketamine sells for about $10 per month compared to patented antidepressants that drug companies can sell for as much as $500 per month.

In order for a drug company to market a drug for a particular illness, it needs to first do human studies that show the drug is safe and effective.  That can cost hundreds of millions of dollars.  Then the drug company spends billions in advertising dollars to educate the public about the benefit of the drug.  There simply is not enough money in a $10 per month drug to fund the human research, spend the money in advertising, capture enough profit to satisfy shareholders and to fend off competitors.

The answer in the mind of drug companies is to develop a new drug, hopefully superior in a meaningful way.  Of course, Pharma is quite capable of developing a drug that is not better in a meaningful way, but appears that way because of the dollars in advertising Pharma will spend.  To some extent, that has already started with Ketamine.  Researchers who are filing new patents for Ketamine on one hand are saying on the other hand that Ketamine is not an appropriate drug to use.  

For those of us in the reality-based community I offer you this: After 40 years of suffering seasonal downturns as part of being Bipolar, I’ve had one of the few depression-free autumns of my adult life.  

Check it out for yourself and your loved ones, and don’t take the first “no” for an answer.

Originally posted to AZ Desert Rat on Mon Nov 26, 2012 at 05:31 AM PST.

Also republished by Mental Health Awareness.

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Comment Preferences

  •  Very interesting... (6+ / 0-)
    Recommended by:
    Mrs M, DRo, DawnN, bluedust, The Marti, billlaurelMD

    Thanks for shining some light on a physical condition that still lives in the shadows. I will definitely check out this book.

    There's class warfare, all right, but it's my class, the rich class, that's making war, and we're winning. - Warren Buffett

    by NW Seamus on Mon Nov 26, 2012 at 05:53:12 AM PST

  •  NO! NO! (6+ / 0-)

    It's a RECREATIONAL drug. If you take enough of it, you could get HIGH!!! What you are suggesting MUST NEVER HAPPEN!

    Depressives committing suicide? Meh. No biggie.

    GOP: Bankers, billionaires, suckers, and dupes.

    by gzodik on Mon Nov 26, 2012 at 05:59:17 AM PST

    •  Andtidepressents (3+ / 0-)

      They don't claim to cure depression.  They claim to treat it.  My daughter has been taking an SSRI for over a year now to treat anxiety and the treatment has been very helpful to her.  While ketamine might provide additional hope for people who are not helped by SSRI's, the need for IV administering, plus its potential for overdose make it a very impractical choice right now.  

      I would also urge anyone to approach scientific information scientifically.  More study is needed before leaping to conclusions.

      "You must be the change you wish to see in the world." -Gandhi

      by Triscula on Mon Nov 26, 2012 at 06:06:08 AM PST

      [ Parent ]

      •  ketamine does not need to be administered (5+ / 0-)

        via IV.  if that were true, nobody would be taking it at parties.

        Please don't dominate the rap, Jack, if you got nothin' new to say - Grateful Dead

        by Cedwyn on Mon Nov 26, 2012 at 06:12:26 AM PST

        [ Parent ]

        •  Well, according to the diary (0+ / 0-)

          IV administration is what is being recommended by the author of the book.  Also, recreational IV drug use isn't unheard of.

          "You must be the change you wish to see in the world." -Gandhi

          by Triscula on Mon Nov 26, 2012 at 06:13:56 AM PST

          [ Parent ]

      •  I never said antidepressants don't work... (3+ / 0-)
        Recommended by:
        gzodik, The Marti, jplanner

        ... i said they only work a little better than a placebo.  you may have thought like many, that a placebo has no benefit, but that is not true.  The question a patient has to ask is if the side effects of antidepressants are worth the slight improvement in performance over a placebo or non-drug treatment.

        •  Answer: (3+ / 0-)
          Recommended by:
          gzodik, blueoasis, ER Doc
          The question a patient has to ask is if the side effects of antidepressants are worth the slight improvement in performance over a placebo or non-drug treatment.
          Yes.

          I don't think a  'spoonful of sugar' or therapy that I can't afford anyway will do the trick.

          And the improvement is more than "slight."

          ************************************************* "Stifling an urge to dance is bad for your health — it rusts your spirit and your hips." - Terri Guillemets

          by BitterEnvy on Mon Nov 26, 2012 at 06:40:28 AM PST

          [ Parent ]

          •  study the data, even from pharma... (1+ / 0-)
            Recommended by:
            jplanner

            ...antidepressants improve depression by an average of 1.8 points on the Hamilton depression scale, which is significant by very slight.

            as i've said elsewhere, the placebo effect is real, not imagined, and patients can benefit from it through belief in medicines, therapy, self help, etc. It's the patients' belief, not the treatment, that makes the difference.

          •  Not in my case. n/t (0+ / 0-)

            "Mitt Romney has more positions than the Kama Sutra." -- me "Social justice is love, made public." -- Cornel West

            by billlaurelMD on Mon Nov 26, 2012 at 10:18:44 AM PST

            [ Parent ]

          •  perhaps in that particular case (0+ / 0-)

            diarist said it worked in 33% of patients...so one of the lucky ones.
            Placebo effect is real if it works for you...it's just that in studies say 28% of those on Placebo get better.
            if something works on an individual, that is the criterea anyway.
            doesn't see like diarist disagrees.

        •  In my very extensive experience, (4+ / 0-)
          Recommended by:
          The Marti, mithra, billlaurelMD, qofdisks

          They don't work.

          GOP: Bankers, billionaires, suckers, and dupes.

          by gzodik on Mon Nov 26, 2012 at 06:40:47 AM PST

          [ Parent ]

          •  ok, here's the data, as well as i can tell.... (3+ / 0-)
            Recommended by:
            gzodik, The Marti, billlaurelMD

            ... 1/3 of patients get better on an antidepressant, with therapy, with exercise, basically with any attention that the patient believes is beneficial.  Most of that effect is due to the placebo effect, although there is a measurable, but slight advantage for some solutions over using a placebo.

            so 2/3 of people see no improvement with antidepressants, which would fit your experience.

          •  They work short term! (3+ / 0-)
            Recommended by:
            gzodik, AZ Desert Rat, qofdisks

            They are highly addictive. The only difference is the abscence of 'seeking behavior' which is prominent in other forms of addiction.  I did not know this before I started taking them for 5 years. I have been drug free for 3months but it's a living hell but its getting better. It's going to take 1 to 2 year before my body starts to make its own seretonin.

            Antidepressant Addiction

            How the antidepressant addiction develops

            How the antidepressant addiction develops

            There is an ongoing debate about whether or not antidepressants are addictive. The argument is fuelled by the fact that most antidepressants do not produce cravings. However, when the use of certain antidepressants is discontinued, withdrawal symptoms (fatigue, dizziness, nausea, confusion, low mood, flu like symptoms etc.) similar to that experienced with other drugs often occur. The physical and mental discomfort that some individuals experience when trying to stop using antidepressants can cause them to continue taking the drug, even when the initial reason for their prescription has passed, in order to avoid these unpleasant withdrawal symptoms.

            Additionally, any drug that we rely on to produce false emotions can become psychologically addictive; some individuals feel that they cannot function effectively without taking antidepressants and even go as far as ‘demanding’ repeat prescriptions from their GP; they are now addicted to their medication.

            Unfortunately, not all medical practitioners take sufficient heed of the 'discontinuation syndrome' (official terminology for antidepressant withdrawal symptoms) and the patient is often at a loss as to how to stop taking antidepressants without experiencing withdrawal. Devoid of appropriate support, the cycle of psychological addiction can establish itself quickly and individuals find themselves relying on antidepressants years after they were first prescribed.

            It is evident that many people are prescribed antidepressants for very valid reasons – depression and post traumatic stress disorder are common examples. For some people antidepressants are a vital part of recovery from a psychological trauma or persistent low mood. Conditions like these, however, should be treated with a dual approach; if medication is involved so should therapy.

            Whilst antidepressants may provide appropriate chemically induced stability, the patient needs to get to a state of mind where they can address the underlying reasons prompting the use of antidepressants.

            Any individual who abuses antidepressants or takes them beyond the manufacturer’s recommended time limit (often 6-12 weeks) places themselves at risk.
             

        •  You said: (1+ / 0-)
          Recommended by:
          ER Doc

          "To the degree that antidepressants do work, it is because of the placebo effect in which people believe themselves into health, combined with a small and incidental drug effect."

          This statement is way too definitive and unqualified to be accurate.

          So let me say:  It is beyond clear that ADs are overprescribed and wrongly, very wrongly, interpreted by many people (including too many doctors) as "happy" pills -- and that this wrongheadedness is implicitly fomented by manufacturers ("Depression hurts").

          That doesn't mean their impact on depression in many people is "incidental" or no better than a placebo.  

          For one thing, the placebo effect tends to wear off over time; the placebo effect of the medication might be 100% if  your depression is situational (triggered by recent emotional trauma like divorce) such that your mood would have stabilized over time anyway.  I am sure this explanation holds for many, many people.

          But for people who have real, extended depression during the course of their lives (think David Foster Wallace), the placebo effect of a drug is unlikely to be durable enough to explain the enhanced functioning they achieve using ADs, which can (not always and not perfectly) provide significant relief.  Likewise, for people whose deperssion is pretty clearly biochemical (post partum depression) treating biochemical pathways might be the best way to address it.

          I don't know anything about Ketamine, I have a lot of issues with using the FDA drug approval process as a proxy for advancing public health but I still find your post to be misleading in material ways.

          •  good questions, good answers (1+ / 0-)
            Recommended by:
            jplanner

            Unless you are an expert on placebos, I'd suggest you trust the  country's expert in the subject at harvard university, or do a little more reading.

            placebo effect does not wear off over time, and it does have a real and positive effect, FOR SOME PEOPLE, like 1/3.

            you are right that some people have a type of depression that a placebo won't help.  those appear to be the same people that anti-depressants don't work.

            everybody that is depressed has "real" depression, and yes, placebo can relieve the symptoms of depression indefinitely.

      •  NY Times, 2006: (2+ / 0-)
        Recommended by:
        AZ Desert Rat, qofdisks
        The results of two new studies may signal a substantial shift in the way psychiatrists and researchers think about treatment for severely depressed patients.

        In one, government researchers found that an injection of a powerful anesthetic drug dissolved feelings of despair in a small group of severely depressed patients in a matter of hours, and that the effect lasted for up to a week in some participants.

        http://www.nytimes.com/...

        This was six years ago.

        How many more lives must be ruined - ended? - while this is being "approached scientifically"?

        GOP: Bankers, billionaires, suckers, and dupes.

        by gzodik on Mon Nov 26, 2012 at 07:31:56 AM PST

        [ Parent ]

      •  Anxiety and depression are different things (0+ / 0-)

        Related, but different. My anxiety disappeared literally overnight when I took Paxil, but my depression was a different issue. I'm not sure how well it worked, but it was better than nothing.

        "A cynical, mercenary, demagogic press will produce in time a people as base as itself." - Joseph Pulitzer

        by CFAmick on Mon Nov 26, 2012 at 09:27:11 AM PST

        [ Parent ]

    •  Oops (0+ / 0-)

      I didn't mean for this post to be in reply to yours.  I meant to post it as a stand-alone comment.  My bad.

      "You must be the change you wish to see in the world." -Gandhi

      by Triscula on Mon Nov 26, 2012 at 06:06:53 AM PST

      [ Parent ]

    •  many drugs are misused as recreational... (2+ / 0-)
      Recommended by:
      gzodik, The Marti

      ...that is not a reason to avoid using them under controlled conditions.  Administering in an office is one way to control abuse.

  •  How did you get a hold of Ketamine? You say you (1+ / 0-)
    Recommended by:
    jplanner

    are for the first time depression-free-- is it because of the drug?

    That's one more thing to add to my long list of small problems. --my son, age 10

    by concernedamerican on Mon Nov 26, 2012 at 06:30:55 AM PST

  •  you have got to be kidding me (3+ / 0-)
    Recommended by:
    mithra, teachme2night, ER Doc

    i'm a retired icu nurse. we didn't even use ketamine of intubated patients.  ketamine is used to induce anesthesia.  in point of plain fact, we had to put our very old, dying dog down ten days ago.  the vet used ketamine by my request.

    we can't have hordes of people walking around stoned on ketamine.  

    and the potential for abuse....no.  just no.  

    you want to give suicidal people access to a potent  anesthetic?

    NO

    it will never happen.  the potential for harm is astronomical, and the potential for lawsuits, more so.  na.ga.na.hapn.

  •  'Anatomy of an Epidemic' (3+ / 0-)
    Recommended by:
    The Marti, AZ Desert Rat, qofdisks

    by Robert Whitaker also author of "Mad in America".

    To really comprehend the long-term devastating effect of these drugs,one has to study and do research on "seretonin discontinuation syndrom", which the big pharma refuses to do.

     http://www.amazon.com/...

  •  asdf (1+ / 0-)
    Recommended by:
    qofdisks

    SSRI discontinuation syndrome - Wikipedia, the free encyclopedia

    http://secure.bundlr.com/...

  •  TONS of info on K & depression: (0+ / 0-)

    as suggested above, google Ketamine and depression.

    Here's a "how it works" article.

    “If someone doesn’t value evidence, what evidence are you going to provide that proves they should value evidence? If someone doesn’t value logic, what logical argument would you invoke to prove they should value logic?” Sam Harris

    by teachme2night on Mon Nov 26, 2012 at 08:33:35 AM PST

    •  THE crucial issue, from article linked above: (3+ / 0-)
      Efforts to develop drugs that replicate the effects of ketamine have produced some promising results, but they do not act as quickly as ketamine. Researchers are investigating alternatives they hope can duplicate the efficacy and rapid response of ketamine.
      Those "alternatives" will, of course, be new and patentable -- and thus worth billion$. Until then, the "drug-resistant"chronically depressed are welcome to suffer needlessly...

      “If someone doesn’t value evidence, what evidence are you going to provide that proves they should value evidence? If someone doesn’t value logic, what logical argument would you invoke to prove they should value logic?” Sam Harris

      by teachme2night on Mon Nov 26, 2012 at 08:54:29 AM PST

      [ Parent ]

  •  DSTS (0+ / 0-)

    Psychiatric Drugs as Agents of Trauma by Charles L. Whitfield, MD — “Drug Stress Trauma Syndrome”

    http://beyondmeds.com/...

  •  Where could I get my hands on some Ketamine? (1+ / 0-)
    Recommended by:
    qofdisks
  •  Govt based studies? (1+ / 0-)
    Recommended by:
    AZ Desert Rat

    If it's not profitable for a drug company, could the Federal government underwrite safety and effectiveness studies? If it is safe and effective, then the money saved in paying VA/Tricare/Medicare/Medicaid costs on antidepressants would be considerable.

  •  How does it feel, cure or distraction. (0+ / 0-)

    You say that it cures depression within an hour. Is this simply a lessening of depression or a drug induced euphoria of some kind? There are plenty of drugs (some illicit) that will cover depression within a short time, for a short time. People take to all kinds of drugs to escape depression. That does not make them a cure.
    What does ketamine cause ?

    •  Teh Google is your friend. See Nature Medicine (0+ / 0-)

      http://www.nature.com/...

      Research is showing that ketamine quickly and effectively treats depression. I think it's premature to use the word cure.

      The antidepressant effect of NMDAR antagonists may result from enhancing the activity of the glutamate alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) receptor and activating the mammalian target of rapamycin (mTOR) intracellular signaling pathway, which ultimately leads to increased synapse-related proteins and neural trophic support

      look for my eSci diary series Thursday evening.

      by FishOutofWater on Wed Nov 28, 2012 at 11:20:35 AM PST

      [ Parent ]

      •  frankly, scientists are still guessing about.... (0+ / 0-)

        ...how ketamine works.

        they didn't expect it to work.  it did.

        they didn't expect it to be making a physical change in the brain.  it is.

        they thought it would be working by increasing BNTF.  they were wrong.

        most drugs, especially psychiatric one, are based on model of body processes that are right or wrong to varying degrees.

        we are early in the process of identifying how ketamine works, unless the drug companies are hiding a lot

    •  clearly not euphoria masking depression... (0+ / 0-)

      ...do check out the research.  people's lives change.  psychological tests show normal.  eeg's show normal

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