Much of U.S. Healthcare Is Broken: How to Fix It (Chapter 2, Part 5)

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 increases in suicide and homicide caused by antidepressant drugs. Each Monday, a new section of the book is published, and all chapters are archived here.

In the ADM treatment of child and teen depression, is it possible to have a bigger scandal than the Celexa scandal?

You bet it is! And, the first place “award” thus far goes to GlaxoSmithKline (GSK) and its best-selling drug Paxil.⁹ Study 329 was a GSK-sponsored randomized, placebo-controlled, eight-week Paxil and imipramine (i.e., Elavil) efficacy and safety study treating child and teen depression. The background of this study was perhaps in response to the FDA’s black box warning concerning antidepressant (ADM) drugs and the risk of suicide. Despite the black box warning, there was not an appreciable drop in ADM sales with adults and, fortunately, there was a noticeable drop in ADM sales for children and adolescents associated with the black box warning about antidepressants and suicide in adults.

I can only speculate why GSK included imipramine in the study, perhaps to prove that current day Paxil was more effective and safer than the first-generation tricyclic antidepressants in treating depressed youth.  The main conclusion from the study was that Paxil and imipramine were more effective than placebo and were well-tolerated. In marketing the “research,” I believe Paxil became GSK’s top selling drug with sales of $340 million by the end of 2001. Prescriptions of Paxil and other SSRI drugs to children and adolescents saw increases of sales over the next decade. Many of these ADMs were used off-label to treat depressed children and I suspect the drug companies were secretly pushing these off-label uses to depressed children, which is contrary to FDA regulations.

A number of journalists and researchers spotted problems with Study 329’s data and its interpretation and raised these issues with the authors, their institutions, and the publisher (JAACAP). Despite this, Study 329 was hailed as a “landmark” study demonstrating the effectiveness and the safety of these drugs in treating child and adolescent depression.

In 2014, after years of struggling in the press, the courts, and the scientific community, a group of researchers finally gained access to at least some of the study data with GSK fighting against the light of day at every turn.¹⁰ The reanalysis revealed that suicide attempts were significantly higher than what the original study had reported, and there were many more unreported serious adverse events in the Paxil group. You might remember a previous comment that when the SSRIs emerged in the late 1980s, these new generation ADMs were said by the makers to be both more effective and safer than first-generation drugs! Also, the researchers who reanalyzed the 329 study data noted, unlike the original study, that the data re-analysis found the two drugs no more effective in treating child depression than placebo!

The scandal does not end here. The researchers involved in the reanalysis learned that Sally Laden, a medical writer paid by GSK—and not the original researchers—analyzed the data and wrote the research article for publication! Like many of these bogus studies, the journal article was peer reviewed before publication.

The JAACAP would not publish Study 329’s reanalysis (was it because GSK advertised in the journal?) and the latter reanalysis appeared in a British journal, BMJ,¹⁰ as noted above. Many involved in the fraudulent original study should have gone to prison, but I don’t think any were even charged with a crime. However, in 2004, the New York attorney general filed a consumer fraud action and collected $2.5 million in fines from GSK. In 2014, the Department of Justice brought an action of false and fraudulent claims to Medicare and Medicaid and GSK settled the suit for $3 billion, the largest fine in corporate history! Despite these fines, and perhaps dozens of malpractice suits, I suspect GSK still made big profits from the sale of Paxil to families of depressed children and teens.  If you, the reader, believe and bet against the fact that ADMs continue to be prescribed to depressed youth you would lose your money.

Mark Olfson et al.¹¹ looked at drug therapy and suicide in severely depressed children and adults who were on and not on antidepressant drugs at the time of the attempted suicide. Children and adolescents treated with ADMs had significantly more suicides and suicide attempts than depressed cohorts not on ADMs, although in adults ADM use had no effect on the attempted suicide rate. Perhaps adults on ADMs can better tolerate the brain-impairing effects of ADMs than can child and adolescent patients. Additionally, depressed adults from their greater life experiences are likely to be better problem solvers than depressed youth and less prone to suicide. The researchers in this study really have bad news for the drug treatment of depressed youth and this author believes the major conclusion of the study would be to keep antidepressant drugs away from depressed youth. However, the study researchers are obviously proponents of the drug treatment of depression, including such treatment of depressed youth. Instead of recommending not to use these drugs with depressed youth the researchers instead recommend careful monitoring of depressed youth during ADM treatment, which we will find is a frequent theme when such studies report a drug-suicide connection to any prescription drug.

Psychiatric drugs and violent behavior.

Almost without exception, school shooters have been on psychiatric drugs at the time of or before the shootings¹ and, in reviewing these reports, I became aware that most were on multiple psychiatric drugs, which is typical of many of the prescribing patterns I found in Preferred Mental Health Management’s psychiatric drug study described earlier. I have no data to support this, but I suspect many of the shooters were treated with drugs for their mental health problems by family physicians and not by trained psychiatrists. Any medication for treating depression should lower and not raise the risk of violence in depressed patients but there is clear evidence for the latter. A spin for this fact one frequently hears from drug proponents, which I am sure is the detail professionals tell physicians, is that SSRIs typically enhance energy before the ADM has taken effect and now the depressed person has the needed energy to take action in the form of suicide! The only problem with such a spin is that the suicide risk is also high in non-SSRI ADMs, which do not affect the serotonin system.

In reading case studies of murderers who did their violent deeds while taking a variety of psychiatric drugs, I became aware that some of the incidents of the crime and the killer’s behavior afterwards were bizarre and so extreme that they went well beyond my clinical experience in evaluating alleged murders in the court system. One father killed his son by throwing the son into a burning furnace! Are we seeing a different type of murderer of those murderers taking versus those not taking various psychiatric drugs? I think the following might be an explanation.

Yolande Lucire and Christopher Crotty^11a have contributed greatly to address this question in terms of possible violent consequences of agitation/akathisia side effects of antidepressant and antipsychotic psychiatric drugs. This side effect is motor restlessness, an inability to stay still, constant physical—and I suspect also heightened mental activity—that must be experienced as driven but not under the person’s control. The above study involved 120 patients diagnosed with akathisia/serotonin toxicity after taking psychiatric medications following compensable injuries or stresses during their employment. Eight of these patients had committed homicide and many became extremely violent on their antidepressant medications. Eighty-six of the 120 from history seemed to have been fully functioning workers or students experiencing various types of bodily or psychological stress who received psychiatric drugs as a part of their treatment. Twenty-six had taken or were taking various illicit drugs while on psychiatric medications. Eight of the 120 had committed homicide, three had committed suicide, and one had sleepwalked to her death. While I write this, I can hear many psychiatric proponents saying it was the illicit drugs that were responsible for these violent acts. I guess when drowning, any straw is perceived as a possible lifesaver.

Dr. Lucire restored 16 of these patients to their previous state of normality by slowly withdrawing these patients from all drugs. Fifty-six other patients stopped taking their drug with or without medical support, which took intervals of one day to several years. Some were forced by their prescribing physicians and the courts to continue taking the drugs by injections. The latter reminds me of the early 1990s, when the safety of Prozac became questioned when there were a number of suicides and homicides of people on these drugs. In response to this bad publicity, the American Psychiatric Association appointed a panel to investigate the matter (I do not recall if any psychologists were appointed to the commission), and after a year of study the panel gave Prozac a clean bill of health. I was not a believer in antidepressants at the time but perhaps being somewhat naïve with regard to research on the matter I accepted the panel’s conclusion as valid, but looking back I suspect the review was probably a whitewash. Was the deck stacked by empaneling psychiatrists who were all prescribers of these drugs rather than researchers of various professions with knowledge to contribute to the work of the Prozac commission? I have always been a great supporter of the ACLU but during this period, the ACLU held that all patients, including those acutely psychotic, had the right to refuse medication or any recommended treatment. I believe I have always been a civil libertarian, but from my experience treating acutely psychotic patients who were on psychiatric drugs at the time (before I became aware of the pertinent research), I believed the ACLU to be dead wrong in this matter but in hindsight the ACLU was right and I was the one who was dead wrong (see the following chapter).

With regard to agitation/akathisia, let’s put ourselves in a person’s mind who is experiencing severe motor restlessness and a mental inability to maintain any cognitive focus for more than a short duration of time. This would be sure terror because most of us, including emotionally normal and most mentally impaired people, are usually capable of maintaining some degree of control over thought and action. Would a person in such a state of impaired control make attempts to gain some control and focus? I am speculating here, but would topics laden with strong emotion give the person a greater possibility of regaining control (for example the urge to kill) than, perhaps, thinking of what one might have for dinner that evening? Moreover, even when some of us are intoxicated we do not completely suspend our ethical values—such as right from wrong—but in such a heightened state of restlessness can we forego our ethical values and commit suicide and/or bizarre violent acts such as murder?

Do antidepressant drugs lower the rate of suicide in drug-treated depressed patients?

Recently, in browsing the internet on healthcare blogs, I came across one on the very timely topic of the increasing suicide rate. In Kansas the rise in suicide was 45 percent! In the blog quoting a board-certified psychiatrist in Los Angeles who wrote “Getting depressed and becoming suicidal is a medical issue, it’s not about something happening in their lives or some deficit or trauma…those things trigger events, but that’s not what causes them.” Any reader who knows my point of view will know that I could not leave such a quote alone but had to make a comment to the blogger, part of which follows.

“This quote encapsulates what psychiatry (and Pharma) have been doing since the 1950s, i.e., ‘medicalizing’ behavioral health problems, calling them (mythical) brain diseases, which chemically imbalances the brain in these individuals, and that the psychiatric drugs restore the imbalance to normalcy. This “theory” of making mental health disorders into diseases is the biggest healthcare scam perpetrated on most physicians, the media, the health insurance industry and the general public; this disease myth paved the road for Primary Care Physicians, armed with the DSM and 150 or so psychiatric drugs, to become the principal mental health provider in the U.S. today! For 70 years the media has reported several hundred psychiatric drug and medical devise “breakthroughs” for treating these disorders; however, if indeed this is a period of drug progress shouldn’t disability and suicide in patients with these mental health disorders both be declining? However, disability from MH disorders and the rate of successful suicides (in Kansas a recent 45% increase) have both risen alarmingly during this period. The increases in disability and suicides of those with behavioral health problems have occurred not in spite of these drug breakthroughs but because of these drug ‘breakthroughs’!

Arif Khan and colleagues,^11b using the FDA clinical trial database from 1985-2000, tracked the successful suicides/suicide attempts of placebo and investigational drug cases in these clinical trials. First, these six- to eight-week trials exclude actively suicidal subjects from being included in any clinical trial and, because of this exclusion, one would expect fewer suicides and suicide attempts in these highly selected depressed populations. However, analysis of the data on 19,639 clinical trial subjects found 34 successful suicides and 130 attempted suicides. Rates of suicide did not differ between placebo and drug-treated groups, which is an unexpected result if antidepressants are indeed effective in treating depression in the short term. If drugs effectively treat depression shouldn’t ADMs lower the suicide rate in depressed patients?

The Kahn investigators projected from the FDA clinical trial real world suicide rates of 718/100,000 suicides for those on SSRI antidepressants (Prozac, Zoloft, Paxil, Luvox and Celexa) for the treatment of depression. In the Kahn data the projected suicide rate in the general population for those on atypical antipsychotic drugs (Risperdal, Zyprexa, and Seroquel) would be 752 suicides per 100,000 population!

In the Khan meta-analysis, symptom reduction with antidepressants was 40.7% with drugs and 30.9% with placebo, a statistically significant difference in favor of the drug but hardly an impressive one.

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To see the list of all references cited, click here.