The continuing stoow-ry of psychiatric research that has gone to the dogsIn my last book, How Dysfunctional Families Spur Mental Disorders, I discussed my theory that the drug companies of Big Pharma seem to go out of their way to demonize entire classes of drugs once they are mostly available as generics, so that practitioners will use their new brand named drugs instead - regardless of whether or not they are as effective or more dangerous. This happened with benzodiazepines, which now seem to be referred to absurdly as the most addictive and dangerous substances on the planet and full of "side effects" - which don’t actually occur in the real world in the vast, vast majority of patients who take them.(BTW. demonizing generics does not just occur in psychiatry. One patient told me that a relative was given an anticoagulant that was more dangerous than generic Coumadin because, according to the doctor, “That’s what the drug companies want us to do”).I wrote that I suspected that the same strategy is now being applied to antidepressants. Most of them have gone generic. (The ones that haven’t yet are Viibryd, Cymbalta, and Prestique. Although no more effective that the generics, it amazes me how many doctors seem to use them as first line drugs). All of sudden we are being deluged by both news and journal articles questioning whether the drugs are effective. I have written in previous posts on this blog that placebo response rates for antidepressants have gone up significantly every decade, indicating that the patient population being used in the studies is changing. Specifically, so-called contract research organizations are being given financial incentives for finding patients that they can diagnose with major depression, and potential patients are given financial incentives for exaggerating their symptoms so they can get paid for being research subjects. So the studies are using patients that don’t really have the diagnosis they are supposedly being treated for. No wonder they have a high placebo response rate. This higher rate makes the advantage of the drug over placebo in these studies seem highly questionable.A similar process is happening in doctors’ offices all over the country. Diagnostic interviews are getting sloppier and more slipshod all the time. A new study published by Psychotherapy and Psychosomatics, according to the June 2013 issue of the newspaper Clinical Psychiatric News, seems to be highly consistent with this idea. The authors ascertained whether patients who were identified by their doctors as depressed actually met DSM criteria for major depressive disorder. Results with 5639 participants showed that only 38.4% of these patients actually met the criteria!This phenomenon has led to a couple of ironic developments. First, the rabidly anti-psychiatry zealots point to the bad studies as “proof” that psychiatric meds are a hoax, while of course completely ignoring all the earlier studies that show that antidepressants are highly effective. The more severe the depression, the more likely a patient is to respond to them.Second, people both inside and outside of the psychiatric profession unfairly rail against the diagnostic manual, the DSM, for not having valid criteria, when the real problem is in many cases that many doctors are not applying the criteria to the patients in making "diagnoses!"Then there is the matter of the use of antidepressants in the depressed phase of bipolar disorder. Of course, as I have said many times, the duration and pervasiveness criteria for bipolar episodes, either manic or depressed, are more and more often ignored, which calls into question whether the diagnoses in studies are even correct.Anyway, in my book I brought up a study by Sachs and others in the New England Journal of Medicine, the most prestigious journal in all of medicine, that purported to show that antidepressants work worse than placeboin this population. I showed how the authors of the study used a sample of patients that were especially treatment resistant, having already failed a trial of at least one previous antidepressant, but did not acknowledge this fact in the paper at all. I was even able to question the author through a third party, since my e-mails directly to Sachs were ignored, and he steadfastly refused to answer the question, “What percentage of your sample had failed a previous antidepressant?”Now comes another bogus study that purports to show the same thing as the Sachs study. According to an article in Medscape on May 20, 2013, “Investigators at Brown University in Providence, Rhode Island, found there was no difference in hospital readmission rates among patients who received antidepressants and those who did not." Since the authors are strongly implying that the patients had to be readmitted because their antidepressant was not working, this is taken to mean that antidepressants don’t work in bipolar depression.That antidepressants do not work in bipolar depression is a flat out lie. Psychiatrists like myself have been using antidepressants successfully in bipolar patients for thirty five years. Of course, true bipolar patients need to be on a mood-stabilizer first, preferably lithium, so they don't switch from depression into mania.So what’s wrong with this study? Well, just about everything. First of all, we do not know if these patients were correctly diagnosed for the reasons discussed above. Another huge problem: all over the country, hospitalized patients with borderline personality disorder are being misdiagnosed with bipolar disorder because of the “everything is bipolar" craze, coupled with the fact that insurance companies will often not pay for hospital stays if the patients are given the correct, "lesser" diagnosis! The subjects in this survey were undoubtedly a very mixed lot. The study did not address whether the patients even took their medication after they were discharged. Non-compliance rates for all medications are very high according to every available study that has looked at this issue. Also, we do not know what percentage of these patients may have fallen into the “treatment resistant” category described above. Most depressed patients are treated as outpatients, not inpatients, so the ones that are hospitalized have often failed a trial of outpatient medication.Adding to this is the fact that antidepressants do not work for at least a couple of weeks, while managed care insurance companies will not pay for that length of stay. Therefore, patients on antidepressants are often discharged before the doctor knows whether a particular antidepressant even worked. Often patients do not respond to one antidepressant but do respond to a different one. Hence, discharge and re-hospitalization rates tell us pretty much nothing about the effectiveness of antidepressants in the depressed phase of bipolar disorder.The International Society for Bipolar Disorders (ISBD) Task Force recently released its long-anticipated recommendations on antidepressant use in bipolar disorders. "The take-home message is that antidepressants have a questionable benefit-risk and should only be used in certain cases in bipolar disorder," said Dr. Eduard Vieta, who presented the recommendations on behalf of the ISBD Task Force, in an interview.
Eduard Vieta"First, they shouldn't be used in mania or in mixed episodes, they should only be used in bipolar depression in patients with a history of a good response in the past to antidepressants and no history of rapid cycling or switches into mania right away," he said.“Further, antidepressants should not be used in patients with bipolar disease with mixed features during a depressive episode or some manic symptoms during depression.” The recommendations said that antidepressants should not be used as monotherapy for bipolar depression, or in rapid cycling. I have a few reactions to this. 1. Duh! We've known about the risks of using antidepressants alone in Bipolar I patients since the sixties. We've also known that they are perfectly safe and highly effective if a bipolar patient in a depressive episode is on an effective mood stabilizer, preferably Lithium. The way that the recommendation is made, however, is highly misleading. Antidepressants indeed should not be used as "monotherapy," but not because they are ineffective for depression. It may sound to some doctors that this is what is being said. The real reason is because patients need to be on a second drug to prevent switching into mania.2. What are they defining as "rapid cycling?" A majority of patients who get this diagnosis nowadays are not bipolar at all, but have anxiety disorders, mixed anxiety and dysthymia, and/or personality disorders - otherwise known as 'crappy childhood syndrome." A lot of drugs can cause these folks more harm than good if improperly used! Why single out antidepressants?3. How are we supposed to know if a patient will respond to an antidepressant in cases of patients who have never taken one, if we are not supposed to use them unless the patient already has a history of responding to them? That would be quite a trick! Additionally, a history of a switch into mania is not a contraindication for antidepressants unless this history took place when the patient had been adequately medicated with a mood stabilizer. If they switched when not taking one, that fact would be completely irrelevant. Even the Sachs study showed patients on a mood stabilizer don’t switch into mania with antidepressants.4. As for so-called mixed episodes, they are in reality manic episodes, with the difference being that the patient feels really uncomfortable instead of the more typical euphoria. Since they are in a manic state and not a depressed one, of course antidepressants should not be used!