[Show abstract][Hide abstract] ABSTRACT: Medicating ADHD is a controversial subject that was acutely inflamed in 1995 when high rates of ADHD diagnosis and treatment were documented in southeastern Virginia. Psychologists in southeastern Virginia formed a regional school health coalition to implement and evaluate interventions to address the problem. Other professionals with strong ties to the pharmaceutical industry launched ad hominem attacks on the coalition's research and work. These attacks contributed to the work being terminated in 2005. In the ensuing years, ADHD drug treatment continued to escalate. Today, the national rate of ADHD diagnosis exceeds all reasonable estimates of the disorder's true prevalence, with 14 % of American children being diagnosed before reaching young adulthood. Notable key opinion leaders continue to claim that there is no cause for concern, but with a message shift from "the prevalence is not too high" to "high prevalence is not too concerning." This paper provides an object lesson about how innovative research can be derailed to the detriment of sound medical and mental health care of children when industry interests are threatened. Tenure may be the only option for protecting innovative research from specious attacks. The authors offer a summary of the data on ADHD drug treatments, suggest judicious use of such treatments, and add their voices to others who are once again sounding a cautionary alarm.
Journal of Contemporary Psychotherapy 01/2014; 44:43-52.
[Show abstract][Hide abstract] ABSTRACT: Randomized controlled trials (RCTs) are a useful tool to check the effectiveness of drugs but have come to shape the culture of medicine in a manner that increasingly compromises medical care. Dependence on RCT evidence is compromised by the well-known problems stemming non-publication of trials, lack of access to trial data, ghostwriting of those trials that are published and a variety of coding and other strategies to hide harms. But what is less appreciated is that whenever a drug and an illness can produce the same benefit or harm that the outcomes of RCTs can be profoundly misleading. This article gives examples of how RCTs can produce the wrong answer.
The International journal of risk & safety in medicine 01/2013; 25(2):111-121.
[Show abstract][Hide abstract] ABSTRACT: This paper raises the question about whether the data on the medications we call antidepressants justify the label of antidepressant. The authors argue that a true antidepressant should be clearly superior to placebo, should offer a risk/benefit balance that exceeds that of alternative treatments, should not increase suicidality, should not increase anxiety and agitation, should not interfere with sexual functioning, and should not increase depression chronicity. Unfortunately, these medications appear to fall short on all of these dimensions. Many of the "side effects" of these medications have larger effect sizes than the antidepressant effect size. To call these medications antidepressants may make sense from a marketing standpoint but may be misleading from a scientific perspective. Consumers deserve a label that more accurately reflects the data on the largest effects and helps them understand the range of effects from these medications. In other words, it may make just as much sense to call these medications antiaphrodisiacs as antidepressants because the negative effects on libido and sexual functioning are so common. It can be argued that a misleading label may interfere with our commitment to informed consent. Therefore, it may be time to stop calling these medications antidepressants.
[Show abstract][Hide abstract] ABSTRACT: This study evaluated a treatment combining bupropion with a novel acceptance and relationship focused behavioral intervention based on the acceptance and relationship context (ARC) model. Three hundred and three smokers from a community sample were randomly assigned to bupropion, a widely used smoking cessation medication, or bupropion plus functional analytic psychotherapy (FAP) and acceptance and commitment therapy (ACT). Objective measures of smoking outcomes and self-report measures of acceptance and relationship processes were taken at pretreatment, posttreatment, 6-month, and 1-year follow-up. The combined treatment was significantly better than bupropion alone at 1-year follow-up with 7-day point prevalence quit rates of 31.6% in the combined condition versus 17.5% in the medication-alone condition. Acceptance and the therapeutic relationship at posttreatment statistically mediated 12-month outcomes. Bupropion outcomes were enhanced with an acceptance and relationship focused behavioral treatment.
[Show abstract][Hide abstract] ABSTRACT: The pharmaceutical industry has made it very difficult to know what the clinical trial evidence actually is regarding psychotropics. Consequently, primary care physicians and other front-line practitioners are at a disadvantage when attempting to adhere to the ethical and scientific mandates of evidence based prescriptive practice. This article calls for a higher standard of prescriptive care derived from a risk/benefit analysis of clinical trial evidence. The authors assert that current prescribing practices are often empirically unsound and unduly influenced by pharmaceutical company interests, resulting in unnecessary risks to patients. In the spirit of evidenced based medicine’s inclusion of patient values as well as the movement toward health home and integrated care, we present a patient bill of rights for psychotropic prescription. We then offer guidelines to raise the bar of care equal to the available science for all prescribers of psychiatric medications.
International Journal of Clinical Medicine 01/2011; 2:353-359.
[Show abstract][Hide abstract] ABSTRACT: This study was designed to determine whether a physician-delivered bibliotherapy prescription would compare favorably with the prevailing usual care treatment for depression in primary care (that often involves medication) and potentially offer an alternative. Six family physicians were trained to write and deliver prescriptions for cognitive-behavioral bibliotherapy. Thirty-eight patients were randomly assigned to receive either usual care or a behavioral prescription to read the self-help book, Feeling Good (Burns, D. D. (1999). Feeling good: The new mood therapy. New York: HarperCollins). The treatment groups did not differ in terms of overall outcome variables. Patients in both treatment groups reported statistically significant decreases in depression symptoms, decreases in dysfunctional attitudes, and increases in quality of life. Although not statistically significant, the mean net medical expenses in the behavioral prescription group were substantially less. This study provided empirical evidence that a behavioral prescription for Feeling Good may be as effective as standard care, which commonly involves an antidepressant prescription.
Journal of Clinical Psychology in Medical Settings 09/2010; 17(3):258-71. · 1.49 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: In a rapid response Leo and Lacasse critiqued a study published in JAMA for not mentioning that a psychosocial intervention was as effective as an antidepressant for post-stroke depression and for failing to record relevant conflicts of interest.1 JAMA’s editors have since contacted Leo and his superiors. …
BMJ Clinical Research 12/2008; 338. · 14.09 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Since the FDA held hearings in February 2004 on the safety of antidepressants in children, there has been a great deal of controversy regarding the use of antidepressants in children, culminating in the well publicized black box warnings about increased risk of suicidal behavior in children and young adults (up to age 25) caused by these medications. Using questions that a parent might ask, the current article attempts to summarize the efficacy and safety data on the use of antidepressants in children so that psychologists, with or without prescription privileges, may be able to inform parents of young patients about the science behind this treatment. This article is based on a presentation at the 2007 American Psychological Association conference by the author in acceptance of the 2006 APAHC Bud Orgel Award for Distinguished Achievement in Research. Much of the information described in this article is drawn from the recent APA Report of the Working Group on Psychoactive Medications for Children and Adolescents. (Brown et al. 2006; available at www.apa.org/pi/cyf/childmeds.pdf ) culminating in a book by the same authors (Brown et al., Childhood mental health disorders: Evidence base and contextual factors for psychosocial, psychopharmacological, and combined interventions 2007).
Journal of Clinical Psychology in Medical Settings 07/2008; 15(2):92-7. · 1.49 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Lenzer and Brownlee hit the nail on the head regarding the important issue of data access.1 We owe all human subjects who volunteer for behavioural and medical research more than they have been getting. For years, the top scientific journals have required that all clinical trials be publicly registered before data collection begins, in order to be eligible for publication. This was an important step designed to reduce publication bias, but it did not go far enough. …
[Show abstract][Hide abstract] ABSTRACT: A presidential task force on external funding was established by the American Psychological Association (APA) in 2003 to review APA policies, procedures, and practices regarding the acceptance of funding and support from private corporations for educational and training programs; continuing education offerings; research projects; publications; advertising; scientific and professional meetings and conferences; and consulting, practice, and advocacy relationships. This article, based on the Executive Summary of the APA Task Force on External Funding Final Report, presents the findings and unanimous recommendations of the task force in the areas of association income, annual convention, research and journals, continuing education, education, practice, and conflicts of interest and ethics. The task force concluded that it is important for both APA and individual psychologists to become familiar with the challenges that corporate funding can pose to their integrity. The nature and extent of those challenges led the task force to recommend that APA develop explicit policies, educational materials, and continuing education programs to preserve the independence of psychological science, practice, and education.
American Psychologist 01/2008; 62(9):1005-15. · 6.87 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Depression is a prevalent and expensive condition. Many patients are seeking and receiving treatment for depression in the
primary care setting where pharmaceutical interventions prevail as the predominant treatment. While psychotropic medications
can certainly help ameliorate mental and behavioral problems, all medical interventions carry with them certain risks and
side effects. A natural multiple-baseline (across participants), single-case experimental design was used in a pilot study
to evaluate the feasibility of “behavioral prescriptions” for cognitive-behavioral bibliotherapy with five depressed patients
in a primary care setting. Results indicated that final depression self-report scores were lower than baseline and pre-treatment
reports for every participant. At three month follow-up, three out of five participants reported no symptoms of depression,
one participant reported minimal symptoms of depression, and one participant reported mild symptoms of depression. Behavioral
prescriptions for cognitive bibliotherapy warrant further controlled research and may offer a cost-effective and practical
treatment alternative to the pharmaceutical intervention of depression in primary care.
Journal of Clinical Psychology in Medical Settings 08/2007; 14(2):152-159. · 1.49 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The pharmaceutical industry has contributed to many life-saving innovations in medicine and has become one of the most successful industries in the world. As a result, pharmaceutical industry financial and marketing influences extend to federal regulatory agencies, professional organizations, medical journals, continuing medical education, scientific researchers, media experts, and consumer advocacy organizations. These extensive influences have created conflicts of interest that have undermined the credibility of medical research and education. As professional psychology pursues and achieves prescription privileges, it will likely be faced with increasing influences from the industry. To preserve the integrity of psychological science, the authors propose an aspirational "firewall" designed to separate industry marketing from the science of psychology.
American Psychologist 01/2004; 58(12):1028-43. · 6.87 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Bupropion SR (Zyban) has been shown in randomized controlled trials to be an efficacious pharmacological aid for smoking cessation; however, recent reports have raised serious concerns about the breadth of its applicability without complications or contraindications.
We examined this issue in a well-documented medical population, i.e. veterans volunteering to participate in a smoking cessation treatment research program involving the use of bupropion SR.
Overall, 22% of the 78 subjects who met the study criteria were appropriate for and completed the course of medication.
Thus, bupropion SR in nicotine-dependent veterans may not be broadly applicable when conservative prescribing guidelines are carefully followed.
Psychotherapy and Psychosomatics 01/2004; 73(4):252-4. · 9.37 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This pilot study applied a theoretically derived model of acceptance-based treatment process to smoking cessation, and compared it to a pharmacological treatment based on a medical dependence model. Seventy-six nicotine-dependent smokers were randomly assigned to one of two treatments: Nicotine Replacement Treatment (NRT), or a smoking-focused version of Acceptance and Commitment Therapy (ACT). There were no differences between conditions at posttreatment; however, participants in the ACT condition had better long-term smoking outcomes at 1-year follow-up. As predicted by the acceptance process model, ACT outcomes at 1 year were mediated by improvements in acceptance-related skills. Withdrawal symptoms and negative affect neither differed between conditions nor predicted outcomes. Results were consistent with the functional acceptance-based treatment model.
[Show abstract][Hide abstract] ABSTRACT: We assessed blind integrity in a double-blinded study comparing paroxetine 20 mg with inert placebo in 20 volunteer subjects who were attempting to stop using methamphetamines. At the end of the study, the blinded clinicians reviewed subject charts and attempted to identify the assigned conditions for the 13 subjects who completed two or more weeks of the study. The three subjects who completed the entire study also attempted to identify their conditions on a questionnaire. We conclude that the blind may unwittingly be broken when the treatments under study are placebo and the selective serotonin reuptake inhibitor (SSRI) paroxetine. The integrity of the blind should be tested in all double-blind SSRI studies.
Journal of Behavior Therapy and Experimental Psychiatry 07/2002; 33(2):67-71. · 2.23 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Anxiety affects approximately 30 million Americans at some point in their lives. The most common treatment modalities used to treat the continuum are the administration of psychotropic medications and the application of behavioral therapy. The following case details an adult female who suffered from severe panic attacks for a period of 10 years wherein numerous interventions, including psychotropic medications, had failed to ameliorate her suffering. The patient was treated using the Mastery of Your Anxiety and Panic protocol. Prior to treatment, the patient reported that she experienced an average of seven panic attacks per week, her Beck Anxiety Inventory score was 58, and her Beck Depression Inventory was 23. At the completion of treatment, the patient reported that the number of panic attacks was reduced to one per week. At 4-week, 6-week, and 16-week follow-up, the patient had not experienced any panic attacks.
[Show abstract][Hide abstract] ABSTRACT: Posted July 15, 2002. In a meta-analysis of the Food and Drug Administration (FDA) database of controlled trials used in the initial approval for the most popular antidepressants, I. Kirsch, T. J. Moore, A. Scoboria, and S. S. Nicholls (2002) found that antidepressants demonstrated a clinically negligible advantage over inert placebo. These results are surprising, because they come from studies underwritten by the drug manufacturers. This analysis probably overestimates the antidepressant effect because placebo washout strategies, penetration of the blind, reliance on clinician ratings, use of sedative medication, and replacement of nonresponders may penalize the placebo condition or boost the drug condition. These findings do not appear to justify the popularity of antidepressants, which may have been fueled in part by publication bias and outstanding marketing. Psychotherapy may offer an effective alternative with fewer medical risks. (PsycINFO Database Record (c) 2012 APA, all rights reserved)