Much of U.S. Healthcare Is Broken: How to Fix It (Chapter 2, Part 4)

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Editor’s Note: Over the next several months, Mad in America is publishing a serialized version of Les Ruthven’s book, Much of U.S. Healthcare is Broken: How to Fix It. In this blog, he addresses sexual dysfunction on antidepressants, increased suicidality on antidepressants, and explores a ghostwritten study claiming effectiveness of antidepressants for children and adolescents. Each Monday, a new section of the book is published, and all chapters are archived here.

pills and money

Sexual dysfunction side effects of modern antidepressants.
Is this what psychiatry means by “restoring the chemical balance in the brain for those with major depression”?

There are reports by a number of women treated with SSRI antidepressants (ADMs) having unexpected orgasms while taking these drugs. One woman while shopping alone in a store experienced an orgasm, which seemingly came out from nowhere. Needless to say, it must have been startling and the woman reportedly stopped using the drug immediately even though she said she did enjoy the experience!

A psychiatrist and other colleagues of the Department of Psychiatric Medicine at the University of Virginia conducted an observational study of the frequency of antidepressant-induced sexual dysfunction at 1,101 primary care clinics in the U.S.7 The researchers (Clayton et al.) studied the incidence of sexual dysfunction on eight of the most widely used current generation ADMs. Of a target population 6,297 patients, the researchers selected 802 patients who were least likely to have sexual dysfunction from non-drug causes and who had never been on psychiatric drugs other than ADMs. Patients had to have been on one of the eight antidepressants for at least three months for inclusion in the study. The researchers found the prevalence of sexual dysfunction in the study group to be 37%, ranging from 22% in bupropion induced sexual dysfunction to 43% for Paxil.

Prior to the study, the participating physicians had estimated the incidence of antidepressant sexual dysfunction to be about 20%, which is a little more than half the rate the study found. Some researchers estimate the rate to be from 50 to 70% in the real world. This estimate is made because patients are often on more than one psychotropic drug, unlike the Clayton study. Moreover, some of the study subjects may have been switched from another antidepressant because of drug induced sexual dysfunction. The researchers also noted that PCPs tend to use lower doses of ADMs than psychiatrists, resulting in a lower incidence of sexual dysfunction than in patients of their psychiatrist colleagues.  With such critical, pervasive adverse side effects how can the FDA justify approval of ADMs for treating depression?

Antidepressants are not the only culprit for drug-induced sexual dysfunction. In another study by Salerian, et al.7a the researchers retrospectively looked at 31 women and 61 men with psychotropic-induced sexual dysfunction. Of these patients, 64 were on SSRIs, eight on TCAs, 36 on non-SSRI antidepressants, 20 on benzodiazepines, 20 on mood stabilizers, four on stimulants, four on narcotics and nine on atypical antipsychotics. Interestingly, 62 (68%) of these 92 subjects with drug-induced sexual dysfunction were receiving more than one of these drugs. As an aside, when one sees patients on multiple psychiatric drugs it is very likely that the drug treatment of the behavioral health problem is not working, and the prescriber is looking for the exact drug combination that will fix this patient’s brain!

None of the commentators on the problem of drug-induced sexual dysfunction ever recommend the rational solution to the problem, i.e., of tapering the patient off the antidepressant (or another drug) and discontinue the drug treatment! Even if the physician does not refer the patient for behavioral psychotherapy, the return of the patient’s sexual capacity and sexual pleasure should help the depression or other MH problem, everything being equal. Is this a case of the propaganda disseminated by the drug companies to physicians that depression is a brain disease and the only possible solution must be to find the right drug for this person’s brain?

Cost of treating the drug-induced sexual side effects

In several articles on Viagra to treat treatment-emergent sexual dysfunction, no authority brought up the cost of Viagra to treat these cases or even the desirability of using Viagra in this way. One pharmaceutical journal berated some managed care companies for not paying for Viagra for drug-induced sexual dysfunction. I wrote a letter to the editor of this journal agreeing with a policy of disallowing payment for such Viagra use and I was surprised when my letter was published.

Let us say there are about 15 million of us on SSRIs for a year; approximately 5.25 million of us would have drug induced sexual dysfunction. At $10.00 a pill for Viagra, therefore, I would estimate the costs at about $15 billion a year, which may be more than the cost of the SSRIs themselves! I suspect that Viagra is more effective than an SSRI in treating depression and in a head to head FDA clinical trial Viagra would beat the SSRI quite handedly! However, I doubt that a pharmaceutical company would market Viagra as a treatment for depression; to do so one would have to diagnose depression as caused by an “insufficient blood supply to the genitals”!

Certainly, the accepted conviction that antidepressants have very tolerable side effects cannot be supported by the facts, yet this conventional wisdom prevails. Moreover, patients are not told that these drugs are addicting and there are major problems getting off these drugs and that often the primary drug requires one or more drugs to address side effects. I fear that most physicians prescribing these drugs to patients stress the benefit side to the patient and downplay serious risks.

Celexa and the notorious antidepressant drug, double-blind, placebo-controlled treatment study of child and adolescent major depression.

The above study, funded by Forest Pharmaceuticals, quickly boosted the sales of Celexa to depressed children and teens. This was a large multi-center, placebo-controlled study with some six researchers involving efficacy and safety of Celexa in treating depressed children. The “researchers” concluded that Celexa was both safe and effective in treating these children (see below). However, later it came out that Forest Laboratories had paid a ghostwriter to analyze the data and to write the research article for publication! It is very difficult to believe that all parties to this transaction, including the six investigators, would go along with such a ruse, and many would say a fraud—including me. At the very least, one should be a little skeptical of drug maker funding of any health research and the study under discussion is a case in point. First, let’s look at the study results and later I will go on with the Celexa story started above.

This was an eight-week inert placebo-controlled study comparing the safety and efficacy of Celexa (citalopram) for the treatment of depression in children (ages 7-11) and adolescents (ages 12-17) with MDD. The major conclusion was that treatment with Celexa reduced depressive symptoms to a significantly greater degree than placebo treatment and was well tolerated. However, let’s look at the results, which were reported in the publication by the ghostwriter.

The major finding was that the ADM group outperformed the placebo group by 36% to 24%, a difference of 12% in favor of drug treatment. In similar studies with depressed adult patients, there was an 18% superiority of the drug over inert placebo, which means that one has to give a drug to six depressed patients in order for one of the six patients to do better on the drug than if the six were all on placebo! The efficacy difference in drug versus placebo in the child-adolescent study would mean that one would have to give the drug to eight depressed youth to be sure that only one of eight would have a better outcome on the drug than if all eight had been on placebo! Would your physician prescribe blood pressure medication to you if in prescribing the drug to eight hypertensive patients he knew that only one of the eight would benefit from the drug over placebo? Of course not.

Moreover, in the Celexa study the investigators had to fudge the data in order to come up with any drug-placebo difference. First, the investigators in the eight week study allowed in the fourth week a drug dosage increase for some of the drug treated trial subjects, apparently for those drug-treated subjects who were not responding well to the drug. I suspect to make the two groups “equivalent,” the placebo dosages were “increased”! Also, the drug dosage increase could have acted as a placebo in these depressed subjects, perhaps the dosage increase raising the subject’s expectation of a future drug benefit. The investigators authorized the drug dosage increase for the drug non-responders, which was certainly a major breach of even the appearance of any adequate scientific control in the study.

In subsequent litigation, the judge ordered Forest Pharmaceuticals to turn over all of the child-adolescent Celexa study data, including pertinent facts that did not appear in the publication. The ghostwriting team included in their data analysis eight subjects who had become aware because of a packaging error that they were taking Celexa. The blind was broken for these eight Celexa patients and these patients should have been removed from the data analysis, but the ghostwriter included these subjects in the data analysis in order to report “positive” findings for the drug.

A reanalysis by a third party of the outcome data with these subjects removed found no statistically significant difference in improvement between drug and placebo subjects! The study reported that nausea, runny nose, and abdominal pain were the only adverse side effects reported in over 10% of the Celexa treated patients. The study did, however, mention—almost as an aside—that two Celexa treated patients (no placebo treated patients) had the side effect of agitation. Agitation, however, is a very serious side effect since many behavioral health professionals believe that agitation/akathisia could play a role in both suicide and homicide. As one who has specialized in clinical neuropsychology, agitation to me implies that the brain (and person) is unable to maintain any specific cognitive focus in order to guide one’s behavior and thinking.

I am sure the investigators in the Celexa study (one or all) had to approve the write up by the ghostwriter and of course these investigators must assume responsibility for the final draft. I assume the three PhDs were psychologists and being trained scientists, they should have known better than to attach their name to such a flawed study. For example, in the subjects selected for the study 20% of the patients in the Celexa group and 18% of placebo patients received previous antidepressant treatment (these subjects should not have been included in the study), and approximately 15% of the Celexa patients and 16% of the patients in the placebo group had a history of nonresponse to antidepressant treatment. This means that 36% of the depressed youth had been on ADMs previously and 31% of those were antidepressant drug failures! We know from these numbers alone that there is no rational reason to even conduct the study since these numbers indicate that ADMs are not an effective treatment of childhood depression.

Celexa had finally broken into the large adolescent and child depression market, which had previously been rightly closed to the pharmaceutical drug industry because of the risk of cases of suicide ideation and suicide attempts during the adult antidepressant/placebo controlled FDA clinical trials. Celexa broke through the FDA Black Box warning about the risk of suicide events associated with antidepressant drug treatment in adults and the ban of such medications for child and adolescent treatment. I believe it is safe to say that in general the pharmaceutical industry in submitting ADM drugs for FDA approval has been less than candid in describing their drug’s adverse side effects.

To continue the Celexa story, after full disclosure that the published study seriously misrepresented the effectiveness of the medication and safety of the drug, 16 doctors, researchers, and academics, sent a letter to the president of the American Psychiatric Association pressing her to retract the tainted study promoting the benefits of Celexa for treating depression in childhood and teens, which had of course been widely distributed to physicians and the general public through the media.

The letter included the ghostwritten charges; however, thus far the president of APA and the association have taken no action on this matter. Borrowing a phrase of our current president, this fake study caused tens of thousands of children being needlessly prescribed ADMs and exposed these children to adverse side effects and possible long-term harm and, for some, violent behavior. If many in psychiatry are not in bed with the Pharmaceutical Industry, then at least the Celexa study shows that they may at least be next of kin.

The higher suicide events associated with Celexa is patent evidence that Celexa is cognitively impairing, which is something school children do not need. I have not looked into this, but I would not be at all surprised to learn that the largest funding source of the American Psychiatric Association comes from the pharmaceutical industry, which certainly seems to have shaped American psychiatry for the worse.

The above Celexa story was scandalous and terrible news for the pharmaceutical industry at large. The industry went on developing ADMs for children and adolescents despite knowing full well that ADMs are cognitively impairing drugs! Why would anyone with any ethics at all—or concern for children in the least—agree to market a drug that is impairing of the child’s ability to learn? I know the industry’s defense, but I don’t buy it: “Depression impairs learning in children as well as adults and if we can cure the depression we improve learning ability over all even if our drug is slightly cognitively impairing.” However, remember you also recommend life-time treatment with your antidepressant drug!

Why is the suicide rate for both adults and children continuing to climb?

Having been pretty much stable for many years, the Center for Disease Control (CDC) reports8a the suicide rate for the population as a whole from 2007 to 2017 increased by 30% while the teen suicide rate (age 10 to 24) increased by 56%! While the suicide rate was climbing, that decade saw attempts at prevention with the growth of suicide prevention centers, the growth of antidepressant drug prescriptions for adults, children, and youth, and the growth of school programs to identify at-risk students to see that these youths received help.

Apparently none of these, and probably other measures, were effective in stemming the tide of suicide. So, isn’t it time to try something else? Moreover, would the increasing rate of suicide have anything to do with the increased prevalence of psychiatric drug use in society during the period of increasing suicide, especially with depressed youth? I am sure psychiatry and Pharma would have a “good” explanation for why there is no causal relationship between the two. Add to it, despite the sound research on the connection between ADMs and suicide, the FDA continues to suggest that we need more data to determine any relationship between suicide and psychiatric drugs!

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24 COMMENTS

  1. “As an aside, when one sees patients on multiple psychiatric drugs it is very likely that the drug treatment of the behavioral health problem is not working, and the prescriber is looking for the exact drug combination that will fix this patient’s brain!”

    I’m sorry…who has the behavioral problem here? The lying, fraud committing malpracticing treatment providers? The ones making jokes about devastating, life altering effects of these toxins? Oh no, it’s the patients. Always the patients.

    This is so disgusting I couldn’t finish reading.

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  2. There’s no guarantee that the adverse effects of these drugs resolve after stopping the drug and many people have reported that these effects persist long after tapering off the drug. The below suggests an incorrect assumption that the adverse effects always resolve once the drug is stopped.

    “None of the commentators on the problem of drug-induced sexual dysfunction ever recommend the rational solution to the problem, i.e., of tapering the patient off the antidepressant (or another drug) and discontinue the drug treatment! Even if the physician does not refer the patient for behavioral psychotherapy, the return of the patient’s sexual capacity and sexual pleasure should help the depression or other MH problem, everything being equal.”

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  3. “…I would not be at all surprised to learn that the largest funding source of the American Psychiatric Association comes from the pharmaceutical industry, which certainly seems to have shaped American psychiatry for the worse.”

    Pharma did not shape American psychiatry. Psychiatrists shaped American psychiatry. It’s time for psychiatrists to accept responsibility for what they’ve done.

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  4. “Agitation, however, is a very serious side effect since many behavioral health professionals believe that agitation/akathisia could play a role in both suicide and homicide”

    Why do they keep akathisia under wraps if they see the connection between drug-induced akathisia and suicide/homicide? Why are there no pharma funded or APA funded PSAs about psych drug induced akathisia?

    I spent 30+ years on akathisia inducing drugs and never once heard the term akathisia. I learned about it through my own research after being spit out of the system.

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    • “Why do they keep akathisia under wraps if they see the connection between drug-induced akathisia and suicide/homicide? Why are there no pharma funded or APA funded PSAs about psych drug induced akathisia?”

      I’ve asked myself those very same questions for years and have come to the conclusion that they want to avoid lawsuits.

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    • Don’t say “allopathic medicine is sickcare”. Some forms of medicine may be terrible. However: root canals, implants, lithotripsy, plastic surgery (burns, scarring etc.), antibiotics, antivirals, vaccines, appendectomies, organ transplants, anaesthesia…we’d have considerably shorter and MUCH more painful lifespans without these things.

      You’d be the first person to go have your kidney stones removed if you had intolerable pain due to them.

      Keep psychiatry in psychiatry’s place and don’t drag the rest of medicine into it.

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      • True, just thinking that, antibiotics saved me from the dire effects and
        after effects of meningitis in 1995. Then I was falsely diagnosed by my PCP in 2004 for depression because of a situational problem and gave me a series of SSRIs, in a span of a3 months, which caused a suicide attempt and I was taken by a friend to a locked unit in my local, but good hospital. The situation was the cause, regarding bringing my 94 year old quite healthy dad, and 88 year old mother with dementia, (or was she just confused from so much traveling, she said my dad was a “road runner” which showed her good sense of humor, yet it was true) . They were to live in my home be taken care im my home because they lived 100 miles from me. My sister in the same town à I suddenly announced she would pull back to 20% of helping me because of her job and protective husband. Dad and mom needed help! They would be living in my large home helping me with expenses, with one full time untrained woman just arrived from Jamaica, to be the caregiver for my mother, a lively young, lovely person,a Jehovah’s witness, but did not know the USA, especially cold climates, did not drive, and could not shop for food, take mom to the doctor, et al. I would do that. I loved my parents, we were close, yet I saw that my 24 year freelance successful graphic design business run from my home office for years was going to be greatly neglected and affected by this new living situation for me.

        At a checkup with my PCP before they moved in to my large home, the last 5 mins of the appointment I erroneously and calmly told the doctor this incoming change for me, he pointed his finger to my face and said you are depressed, take this Lexapro I Han never seen a psychiatrist in my 52 years. I succumbed because a friend also pressured me to do so. She was a former nurse who was taking psychotic drugs I found out later, she successfully and sadly committed suicide serveral yeas later.

        I was a professional yoga teacher as well as designer, the first day I took the Lexapro pill I was at Rotary for lunch, a close friend told me he noticed my face was white, and after the lunch I went teach my yoga class at the high school, believe me, it was the weirdest class I ever taught.
        Now 20 year I am still taking drugs, now for “bi-polar” and have become clear and balanced because I sold my too big house, now living in pampered, lovely conditions with medication management, which is $8,069 a month! Of course full services that are excellent, yet still way too expensive for my income which is 1/2 that. I will not stay, have a good solution, though I feel I must still take prescribed medication, and it is all in place.
        20 years of medication has set my career back because of many hospitals and suicide attempts because I am allergic to most psychotropic medications. This put me in a low income bracket. My family, sister and 2 daughters are all for the “safe” situation I have now. I have great friends fortunately whom I will send this article to! Thanks for taking the time to read, it maybe the basis for an article of my own, and please read ~
        “Bitter Pill” an article in the New Yorker, an April issue about a teen from Greenwich CT four years ago, very revealing of this horrible oppression we can be put into by doctors and their propensity for prescribing all kinds of allopathic drugs!

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  5. U.S. healthcare is what’s sick because profit is its main objective; it’s impossible to cure from the inside because when all is said and done Big Medicine is Big Business.

    But there’s hope on the horizon FOR PEOPLE — thanks to YouTube videos like the following:

    “Challenging Psychiatric Norms with Dr. Roger McFillin”, one of many from Dr. Josef’s wonderful video series.

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  6. I took the time to reread this article and am glad I did. In a calmer frame of mind, I was able to absorb the information which, thankfully, Dr. Ruthven presents in a way that was understandable to me, which is saying a lot because when I see what seems like a lot of statistical detail, my brain shuts down from what feels like an oncoming anxiety attack. But (imo) this article does a good job presenting just how much the U.S. “healthcare” system is blindly led by drug happy people who foolishly call themselves “researchers”.

    But it also makes clear a much broader truth: that U.S. healthcare and western medicine in general DOES NOT BELONG in so-called “mental healthcare” because it starts from a wrong premise: that emotional, psychological and interpersonal problems have biological roots. Which brings up another point: you can’t fix what is fundamentally flawed at its core, nor can you speak to people already brainwashed by psychiatry’s medical model, which includes just about everyone. Which leaves only one alternative: grassroots education that bypasses the establishment through all means possible which includes reading the following book: “Smoke and Mirrors: How You Are Being Fooled About Mental Illness”, by Chuck Ruby.

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  7. I don’t know if the people who write about this understand the actual human cost of all of this, the ongoing, chronic, unsolvable, desperate, impossible situations that people wind up in because of this system. My adult son is in the most dire straits and I know better than to suggest he “get help”.

    If anything ever changes it will be too late for my son and I. 3 generations of suffering. My maternal grandmother was told by a doctor that the reason she had so much anxiety was because of her teeth. So in her early 30s, at the advice of her doctor, she had all of her teeth pulled. It did not cure the anxiety. My brother was diagnosed schizophrenic at age 19 and put on heavy duty drugs. He died in his early 50s. My other brother has been disabled all his life. I don’t know what his diagnosis is. We don’t speak. My sister was suicidal, had an eating disorder and alcoholism. She could afford to go to a nicer place and got a CPTSD diagnosis instead of the borderline diagnosis I got. I’ve been disabled for going on 20 years ever since the ECT. The decades of polypharmacy and medically induced trauma didn’t help. And now my son…I was in a locked psych ward the last 5 months of my pregnancy, verbally abused by a psych nurse. He grew up with all of the so called ACE scores. Every time I sought help they just humiliated me and stuck more labels on and then showed us the door. They take people who are traumatized, whose lives are painful, and layer so much more trauma and pain on top and then spit them out so addled they can’t even remember why they wound up in treatment in the first place.

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    • Most people have no idea the amount of the damage the mental health field is capable of doing — especially to the most vulnerable — and imo probably wouldn’t care if they did.

      I hope someday things improve between you and your son, KateL. You both deserve way better from life.

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    • Ketel, reading between the lines your sad story of the family history of the poor outcomes of psychiatric treatment suggests to me that modern psychiatry is almost 100 percent committed to looking for bio physical solutions to mental health problems such as psychiatric drugs, ECT, lobotomy, zapping the brain in many ways, using former street drugs to induce hallucinations in patients and others. Psychiatry has endorsed a disease model, looks for bio physical solutions and has turned away from critical psychosocial and environmental factors operating in the mental disorders. I am afraid there is no turning back for psychiatry.

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      • Thank you for responding and for acknowledging this. It’s indeed scary that most people still don’t realize how harmful it can be for someone to be any kind of mental health patient. Despite all evidence to the contrary, my family members, most of whom won’t even pick up the phone for my son, still think the answer to his problems is to “get help”, walk into an ER and tell them how he’s feeling and what he’s thinking about. He even has sought help before and they know that (he did a DBT program; he was committed at least once and received no assistance. Most recently he was seeing a therapist long enough to get a diagnosis of PTSD; then the therapist decided that he couldn’t help him and that my son should see a psychiatrist). Meanwhile, he has very little actual support from friends, family or anyone.

        The indoctrination is so strong.

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