In a research study examining seventeen prior studies, (Marta M. Maslej, Benjamin M. Bolker, Marley J. Russell, Keifer Eaton, Zachary Durisko, Steven D. Hollon, G. Marie Swanson, et al., "The Mortality and Myocardial Effects of Antidepressants are Moderated by Preexisting cardiovascular Disease: A Meta-Analysis," Psychotherapy and Psychosomatics 86, no. 5 (2017): 268-282, doi:10.1159/000477940), antidperessants showed increased mortality and new cardiovascular events in the general population. In individuals with cardiovascular disease, there was no significant increase in risk. Most antidepressants affect serotonin transmission, a chemical in the brain which is important in mood regulation. However, serotonin affects other parts of the body as well and may pose risk. In this study, in the general population, risk of death increased by 33% compared to people not taking antidepressants. Antidepressants also have blood thinning effects which may be theraputic in individuals with preexisting heart disease and may explain why there was no increased mortality risk in this population. Furthermore, in some individuals antidepressants save lives, but too often other effective therapies are not available that can treat anxiety and depression, such as cognitive behavior therapy, and antidepressants are sometimes used in individuals with autism, despite poor evidence, to treat conditions such as anxiety and compulsive behaviors, because individuals can not access other safer and effective treatments due to lack of funding.
Side Effects: My Brother at a Roadside ER
Exactly two weeks ago, when my mother, who is now 77 years old, was taking my brother Stuart, who has autism, back to New York from visiting his identical twin Matthew, who also has autism, and resides at the Judge Rotenberg Center in Massachusetts, Stuart would not stop coughing and was having problems breathing enough air. On some of these trips, Stuart has become agitated and attacked my mother, despite being on up to twenty medications, mostly for behaviors or to manage side effects. More than once, I have expressed concern to my mother about her and my brother's safety on these trips, but she feels my brothers need to spend some time together, so she takes this risk. Unlike Stuart, Matthew is on no medications and has a job. Furthermore, he loves the JRC so much, he refuses to come to New York for any visits, and insists the family come to him.
Coming home from this particular trip, my mother knew she had to bring my brother to an emergency room in Connecticut. He had a gastrointestinal obstruction, a side effect of his antipsychotic medications, and needed a nasogastric tube. My mother was also told if this did not improve, Stuart may need surgery. It was hard for me to hear the doctor on the phone as Stuart was screaming in pain and fear. Thank goodness he improved and was able to go home.
While New York placements offer almost no ABA, and response cost procedures (consequences for problem behaviors such as removing preferred items) is considered by New York Office for People with Developmental Disabilities (OPWDD) a human rights violation, we give the individuals medications, individuals who are more sensitive to life-threatening side effects, to manage their behaviors, which is the real threat to their life. We must change this!
Preventing Abuse, Psychiatric Illness and Brain Damage with ABA, Parent Training and Counseling
"Childhood maltreatment is a significant risk factor for a host of psychiatric, developmental, medical, and neurocognitive conditions, often resulting in debilitating and long-term consequences," (Brian C. Kavanaugh, Jennifer A. Dupont-Frechette, Beth A. Jerskey, and Karen A. Holler, "Neurocognitive Deficits in Children and Adolescents Following Maltreatment: Neurodevelopmental Consequences and Neuropsychological Implications of Traumatic Stress," Applied Neuropsychology: Child 6, no. 1 (2017): 64-78, doi:10.1080/21622965.2015.1079712). This study analyzed 23 prior studies. Childhood abuse and neglect were correlated with neurocognitive deficits in executive functions, intelligence, language, visual-spatial skills and memory. Furthermore, children with disabilities are at higher risk for maltreatment, (Miriam J. Maclean, Scott Sims, Carol Bower, Helen Leonard, Fiona J. Stanley. Melissa O'Donnell, "Maltreatment Risk Among Children with Disabilites," Pediatrics epub 139, no. 4 (April 2017): doi:10.1542/peds.2016-1817). **It is difficult for caregivers to maintain self-control when children are aggressive, self-injurious, destroying property, or screaming during the night. Providing ABA, parent counseling and training, as discussed in my book can help safely manage these behaviors and therefore decrease abuse. Yet, many children are not receiving ABA and many parents are not receiving parent training and counseling, although in New York State parents of all children with autism and other children in certain class sizes are legally entitled to parent training and counseling. We need to be providing ABA, parent training and counseling to prevent much more costly illness in the future and it is the ethical thing to do.
Intellectual Disability Increases Risk of Movement Side Effects from Antipsychotics
In a recent study involving 9,013 adults with intellectual disability and 32,242 adults without intellectual disability, there was an increased risk of movement side effects, which included among others, neuroleptic malignant syndrome, a rare but potentially deadly side effect, (Rory Sheehan, Laura Horsfall, Andre Strydom, David Osborn, Kate Walters, Angela Hassoitis, "Movement Side Effects of Antipsychotic Drugs in Adults with and without Intellectual Disability: UK Population-based Cohort Study," BMJ Open 7, (2017): e017406, doi:10.1136/bmjopen-2017-017406). Neuroleptic malignant syndrome consists of fever, rigidity and autonomic dysregulation- which is part of the nervous system. Neuroleptic malignant syndrome was three times more common in individuals with intellectual disability compared to individuals without intellectual disability. The rate of parkinson symptoms and akathisia was also increased. Akathisia, a feeling of restlessness and need to move constantly, sometimes manifests itself with increased levels of agitation, which may result in increased dosages of medication. People with intellectual disability may not be able to disclose symptoms, resulting in missing their diagnoses. This is another reason why we need ABA to treat behaviors rather than drugs.
FDA Accelerated Approvals Based on Poor Evidence of Effectiveness and Safety
In a recent study examining accelerated approvals between 2009 and 2013, less than half (42%) showed efficacy in post approval trials which were completed at least 3 years after approval, and studies done before and after approvals had limitations in study designs and end points used, (Huseyin Naci, Katelyn R. Smalley, Aaron S. Kesselheim, "Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration," JAMA 318, no. 7 (August 15, 2017): 626-636, doi:10.1001/jama.2017.9415). Accelaterd approvals are granted for drugs purported to treat serious or life-threatening conditions. From 2009 to 2013, 22 drugs received accelated approval for 24 indications. 14 of the 24 indications had not completed all the postapproval requirements. Some comfirmatory studes showed either no benefit, were terminated or delayed by over a year. In fact, five years after approval, 8 indications were still lacking evidence in confirmatory studies. Clinical trials that the FDA accepted were not blinded, meaning people knew if they were being treated or not, and were not randomized, meaning the subjects were not randomly put into different groups to compare treatment. In fact, comparator groups were not required. Furthermore, studies that go through the accelerated approval process only require surrogate outcome measures, that may not necessarily be predictive of better outcomes. For example, body mass index, as a surrogate measure for body fat, might be inaccurate, as muscle and bone mass also contribute to body mass index. In addition, for standard approvals, the FDA requires psychiatry medications to be tested against a placebo, and will not accept using an active comparator instead. Of course, it would be unethical for individuals with life-threatening behaviors to be placed on placebos. Therefore, results might not be able to be generalized to individuals with severe behaviors.