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The Crisis in Psychopharmacology Provides an Opportunity for Neuroregulation Treatments to Gain Widespread Acceptance H

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The Crisis in Psychopharmacology Provides an Opportunity for Neuroregulation Treatments to Gain Widespread Acceptance H NeuroRegulation http://www.isnr.org The Crisis in Psychopharmacology Provides an Opportunity for Neuroregulation Treatments to Gain Widespread Acceptance H. Edmund Pigott Private practice Abstract Psychopharmacology is in crisis due to the increasing recognition that it does not work as claimed and has failed to meaningfully improve outcomes over what they were in the 1950s and ‘60s. Though still widely promoted to the public, the chemical imbalance theory of major mental health disorders is now openly acknowledged as not accurate by leading psychiatrists, thereby undermining the rational for this approach to care. A series of large comparative effectiveness studies funded by the National Institute of Mental Health (NIMH) were each essentially failed trials with disappointing results and found that second-generation psychotropic medications were no more effective than their first-generation cousins. The evidence from several of these studies are reviewed within the scope of major depression and attention-deficit/hyperactivity disorders, and then compared to research on promising neuroregulation treatments. The author then makes recommendations for neuroregulation clinicians to avoid a crisis similar to that experienced in psychopharmacology today. Keywords: psychopharmacology; neurofeedback; depression; STAR*D; MTA cooperative study; ADHD Citation: Pigott, H. E. (2017). The crisis in psychopharmacology provides an opportunity for neuroregulation treatments to gain widespread acceptance. NeuroRegulation, 4(1), 28–36. http://dx.doi.org/10.15540/nr.4.1.28 *Address correspondence to: H. Edmund Pigott, PhD, BCN, 430 N. Edited by: Lyra Circle, Juno Beach, FL 33408, USA. Email: Rex L. Cannon, PhD, Neurogifted, Boynton Beach, Florida, USA [email protected] Copyright: © 2017. Pigott. This is an Open Access article distributed Reviewed by: under the terms of the Creative Commons Attribution License (CC- Randall Lyle, PhD, Mount Mercy University, Cedar Rapids, Iowa, BY). USA Background (Lieberman et al., 2005), among other well-funded efforts. In an editorial, DePaulo (2006), past In the attempt to provide evidence-based guidance chairman of psychiatry at Johns Hopkins, termed to clinical practice and improve outcomes, the these studies as effectiveness-plus because each National Institute of Mental Health (NIMH) funded a used the best available treatment methods to series of large comparative effectiveness studies for optimize outcomes. Furthermore, there was no attention-deficit/hyperactivity disorder (ADHD), the blinding of treatments in each of these trials, thus multimodal treatment of attention deficit hyperactivity taking advantage of nonspecific placebo effects, disorder (MTA cooperative study): cost $21 million which inflate outcomes. Despite the costs, and (Jensen et al., 2007; Molina et al., 2009; MTA investigators’ best efforts, each of these studies Cooperative Group, 2004a, 2004b); bipolar disorder, were essentially failed trials with outcomes far less the systematic treatment enhancement program for than expected. DePaulo noted how the studies bipolar disorder (STEP-BD): $26 million (Bowden et taken together “underline the suggestion that al., 2012); major depression, sequenced treatment modern pharmacological treatments may be no alternatives to relieve depression (STAR*D): $35 more beneficial than older ones, despite their added million (Fava et al., 2003; Rush, 2002; Rush et al., cost” (2006, p. 175). Similarly, former NIMH Director 2006; Trivedi et al., 2006; Trivedi, Stegman, Rush, Insel (2009) observed that in each of these Wisniewski, & Nierenberg, 2002); and effectiveness-plus studies second-generation schizophrenia, clinical antipsychotic trials of psychotropic medications were no better than their intervention effectiveness (CATIE): $72 million first-generation cousins and then went on to 28 | www.neuroregulation.org Vol. 4(1):28–36 2017 doi:10.15540/nr.4.1.28 Pigott NeuroRegulation acknowledge, “The unfortunate reality is that current absence of other robust biological tools to medications help too few people to get better and probe brain function, these drugs may have very few people to get well” (p. 704). proved something of a scientific curse (p. 1– 2). As evidenced in a 2012 editorial by Fibiger, former Vice President of Neuroscience at Eli Lilly, DePaulo The widely acknowledged failure to improve (2006) and Insel (2009) are not alone in psychopharmacology outcomes has gotten so bad acknowledging the current state of that not only are academic psychiatrists actively psychopharmacology. Fibiger writes the following: disavowing the neurochemical imbalance theory of major mental health disorders, but some apologists Psychopharmacology is in crisis. The data claim that it was never even a theory held by are in, and it is clear that a massive responsible psychiatrists in the first place. Pies experiment has failed: despite decades of (2011), Editor in Chief Emeritus of PsyChiatriC research and billions of dollars invested, not Times, writes, “In truth, the ‘chemical imbalance’ a single mechanistically novel drug has notion was always a kind of urban legend—never a reached the psychiatric market in more than theory seriously propounded by well-informed 30 years. Indeed, despite enormous effort, psychiatrists” (p. 1). the field has not been able to escape the “me too/me (questionably) better” Pies concludes his editorial by stating that “the straightjacket (p. 649). legend of the ‘chemical imbalance’ should be consigned to the dust-bin of ill-informed and Fibiger (2012) goes on to note that each of malicious caricatures,” as though this horse that psychiatry’s classes of medication were discovered biological psychiatry rode to prominence—backed by “serendipitous clinical observation” (p. 649) and by billions in taxpayer- and industry-funded research would likely not have been discovered using current and many billions more in pharmaceutical drug discovery strategies. Thus, concluding that: companies’ deceptive marketing efforts—was not only a half-century long fool’s errand/scientific curse What the field has been doing for the past 3 “chasing down chemical imbalances that don’t exist” or 4 decades has failed to generate (Greenberg, 2013, p. 6) but it is now a “malicious effective, mechanistically novel caricature” (Pies, 2011, p. 2) to expose this fact. In psychopharmaceuticals…there is no choice response to Pies (2011), Hickey (2014) provides but to make changes in how we approach extensive documentation going back to the early the study of disease mechanisms, drug 1970s of eminent biological psychiatrists as well as discovery, and development in psychiatry. the American Psychiatric Association itself This will require major investments in propagating the chemical imbalance theory of neuroscience research, humility in the face mental illness and how this theory is featured of our ignorance, and a willingness to prominently on numerous authoritative websites as consider fundamental reconceptualizations well as on TV today. of psychiatry itself (p. 650). Major Depression Hyman (2012), another former NIMH Director, acknowledges how the initial serendipitous findings The STAR*D study (Fava et al., 2003; Rush, 2002; from the 1950s “motivated path-breaking research Rush et al., 2006; Trivedi et al., 2006) is the largest on neurotransmitter release, receptors, and antidepressant study ever conducted with over 120 transporters” but “what has happened—or rather not journal articles published by study investigators. happened—in the intervening half-century was as STAR*D enrolled 4,041 patients diagnosed with unexpected as the initial spate of discoveries” (p. 1). major depression, including patients with comorbid Hyman goes on to observe that: conditions; thereby increasing the generalizability of its findings, while also providing 12 months of free The molecular targets of all of today’s follow-up care to monitor the durability of treatment approved psychiatric drugs are the same as effects. The study provided up to four drug trials per the targets of their pre-1960 prototypes and patient with the hope of being able to give guidance their mechanisms of action are not in selecting the best next-step treatment for the understood beyond a few initial molecular many patients who fail to get sufficient relief from events…By capturing the imagination of their initial antidepressant and subsequent trials. researchers to excess, however, and in the Each drug trial/step lasted up to 12 weeks with an 29 | www.neuroregulation.org Vol. 4(1):28–36 2017 doi:10.15540/nr.4.1.28 Pigott NeuroRegulation additional 2 weeks added on for those patients predictions of dropout and the number of patients deemed close to remission. Antidepressants were who would have a satisfactory response and enter administered using measurement-based care that follow-up (Rush, 2002). The author obtained the involved assessing symptoms and side effects at protocol through a Freedom of Information Act each visit to guide aggressive medication dosing in request. The predictions were made by STAR*D’s order to ensure that the likelihood of achieving three most highly published researchers who had remission was maximiZed and that those who did over 1,900 published studies between them. not reach remission were truly resistant to the Regarding the predictions, the protocol states that medication (Trivedi et al., 2006). they were arrived at based on the independent estimates of Drs. Fava, Rush, and Thase, informed The researchers allowed patients to select treatment
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