This autism analysis case takes place in Wisconsin and involves a teenager with a past medical history of autism, disruptive behavior disorder, hypogammaglobulinemia, intractable seizures from a very young age, and overall intellectual disability with an IQ of 50-60. The patient’s medications include Kineret injections, Privigen infusions, Keppra, Risperdal and Zithromax. The patient is dependent on his parents and a home nurse for assistance with virtually every task involved in daily living, and will remain so for the rest of his natural life. His parents have joint physical custody but are divorcing, and as a result they require a life care planner to evaluate the costs of their child’s future care.

Yes. Pending access to current records, caregivers, treating team, IEP if available, and onsite assessment, off-the-top-of-my-head initial recommendations would include, but would not be limited to, periodic (to be determined) medical follow-up: primary care, neurology, immunology, infectious disease, neuropsychology, a dentist who specializes in this population, nutritional, physical/occupational/speech-language for communication/recreational or play/behavioral therapy; possibly sensory integration therapy, music therapy, or others depending on evaluations of current status; associated diagnostic testing and periodic reevaluations for goals/maintenance for the above disciplines or for changes in condition, CT scans for encephalomalacia or hydrocephaly, EEG, sleep studies; possible referrals for new therapies, vagal nerve stimulation for seizure control; medications and associated diagnostics for side effects (Note: seizures typically increase during adolescence with changing hormonal levels and anatomical brain changes, and it may take some time to regain equilibrium); supplies and equipment replacement intervals/maintenance, vendors. If the child will travel between parental homes, it may be necessary to have increased levels of home health care depending on geography. If child will move to different home(s), architectural modifications for safety, bathroom access, and more will be needed. The noncustodial parent may need a modified vehicle for transport. Home health might include an awake overnight caregiver, case manager, and RN oversight for LPN or HHA providers, as well as respite care for the custodial parent. Considerations associated with aging may include: Guardianship when parent(s) are not able to continue as the primary care provider, transition to an external care facility, as well as increased physical needs associated with aging and the included evaluations and care. There may be further considerations depending on additional case details that are not yet available to me.

1.) Could you review this patient's medical records on the autism spectrum and evaluate the costs of her ongoing care?

Location: Massachusetts B.S., Nursing, Boston University M.S.N., Cardiovascular/Physiological Nursing Certification: Life Care Planning (LCP), Lifetime Nurse Care Planning Additional Certification: Certiï¬cation in Case Management (CCM), Rehabilitation Nursing (CRRN) Member, American Association of Nurse Life Care Planners Member, Association of Rehabilitation Nursing Former I********** C*********** C*** M****** Former A******** C******* D******* B*** D****** I*** Current F****** a* p****** l*** c*** p******* c********* f***

Midwest

Wisconsin

This registered nurse is holds a Master's degree in nursing, in addition to has four specialized nursing certifications, and has worked as a bed side nurse in several ICUs--general surgical, open-heart, and neurosurgery--for more than 20 years. She has taught nursing in a clinical setting and in a classroom environment to first and second year LPN students (for LPN to RN programs). She was also the staff development nurse for an ICU and critical care department for 6+ years.

Life Care Planner Evaluates Healthcare Costs For Intellectually Disabled Teen

This case takes place in Mississippi and involves a psychiatric hospital staff member who was attacked by a patient. The attacker had a diagnosis of schizophrenia with a long a history of violence, but there were allegedly no policies or procedures in place to restrict or otherwise monitor his access to common areas. He was previously on Risperdal a few years ago, but stopped due to the development of gynecomastia. He was then placed on Abilify and other medication, but was not responding well to any them. The patient had previously demonstrated a fixation on this member of the hospital staff, following her around the common areas and, on occasion, had made threats of violence against her. Despite reporting this behavior to her supervisors, nothing was done to restrict the patient’s movement or otherwise protect the staff member.

I worked for 13 years at a state hospital where we had a fair percentage of patients with violent histories. I have also worked in other settings where violence could be an issue, including emergency departments and crisis intervention programs and in prisons and jails. As I see it the standard of care involves (a) conducting a thorough diagnostic assessment (b) conducting a risk assessment that collects both risk factors and mitigating factors related to aggression toward self and/or others and (c) engaging in appropriate treatment targeting both the psychiatric diagnosis and the risk factors. Steps (a) and (b) may involve more than simply interviewing the patient - often, seeking outside information is very helpful in understanding the patient and in creating the appropriate treatment plan. In this instance, it may have been prudent to order that the patient was restrained. As a rule, physicians are responsible for ordering restraints, but there are occasions where nurses on the front line first initiate a restraint to manage an acute and ongoing emergency and only after the situation is settled to contact the physician for an order. In this case, it is clear that the staff member's complaints should have been listened to and acted upon sooner.

1. Please explain your qualifications to view this case. 2. Are you able to explain industry standards with respect to safety precautions involving patients with violent histories?

Location: MD AB, Dartmouth College MD, University of Maryland School of Medicine Internship, General Psychiatry, University of Maryland Medical System Residency, Psychiatry, University of Maryland Medical System Fellowship, Forensic Psychiatry, University of Maryland Medical System Board Certification: Psychiatry & Neurology, Forensic Psychiatry Member, American Academy of Psychiatry and the Law Member, American Association of Community Psychiatrists Member, International Academy of Law and Mental Health Former S**** P*********** B******** C***** O***** o* S******** A***** M******* R************* C****** B******** C***** R******* I*** Former A******** P*********** f** U***** C*** U********* o* M******* M****** S***** Former C********* P*********** U***** S***** P******** O***** N**** D******* o* M******* Former M****** D******* o* P********** U***** C*** U********* o* M******* M****** S***** Former D******* o* F******* T******** S********** H******* C***** Former D******* o* B******* M********* P****** S********** H******* C***** Current G****** a** F******* P*********** P****** P*******

Southeast

Mississippi

This Board Certified Psychiatrist has been practicing psychiatry for over 20 years, focusing on forensic and general psychiatry. He is a member of the Academy Association of Psychiatry and Law and the International Academy of Law and Mental Health, and has multiple publications in the field of psychiatry. He was the former Chief Psychiatrist for the Maryland Department of Public Safety and Correctional Services, and a former Director of Forensic Treatment at Springfield Hospital Center. Currently, he is a general and forensic psychiatrist at a private practice.

Patient Attacks Staff Member of Psychiatric Hospital

A middle-aged man taking Risperdal was diagnosed with severe gynecomastia. As his family sued the pharmaceutical company over the effects of the drug, he was forced to consider testosterone therapy to alleviate its side effects. The patient had been taking Risperdal for over half his life in order to combat a history of mental disorders and depression. However, the side effects of Risperdal became too severe to ignore after he began to gain excessive breast tissue and complain of nausea and muscular depletion. An expert in the drug and its potential side effects was asked to comment on the diagnosis and causal link between the man’s drug prescription and medical condition.

I am familiar with the methods of diagnosis of gynecomastia. The most likely relationship between Risperdal and gynecomastia is an elevation of prolactin that leads to hypogonadism and low testosterone levels in men, where the low testosterone level can result in gynecomastia.

1. Do you have experience diagnosing gynecomastia in patients? 2. Are you familiar with the possible link between Risperdal use and gynecomastia?

Risperdal User Sues Manufacturer over Severe Side Effects

A large pharmaceutical company was litigated against after they allegedly covered up the potential harmful side effects of the antidepressant Risperdal. The case claimed that the company had obscured evidence that the risperidone in Risperdal increased prolactin and caused gynecomastia in many of its patients. The case hinged on an early version of a company-run study that traced a link between increased prolactin levels and the onset of gynecomastia. These findings were allegedly obscured from the final paper, and an expert in statistics was needed to review the original report and re-analyze the data to determine whether or not the company should retract its research paper.

I am a biostatistician with over thirty years of experience designing, reviewing, and analyzing nearly five hundred clinical trials. I am well-versed in issues associated with biostatistics, data management, statistical programming, and regulatory affairs; my professional experience spans various therapeutics areas including psychiatry, neurology, oncology, endocrinology, infectious disease, cardiology, rheumatology, urology, and anesthesia. As a former Vice President of Biometrics at large pharmaceutical companies and contract research organizations, I have managed biostatisticians and statistical programmers in the pre-clinical, non-clinical, and clinical areas. I also led initiatives of implementing adaptive designs of clinical trials to improve clinical drug development.

1. Please describe any experience you may have conducting statistical analysis for drug trials or biomedical research.

Risperdal Pharma Company Sued for Obfuscating Negative Studies

This class action lawsuit focused on the pharmaceutical manufacturer of Risperdal, an antipsychotic medication. After multiple young men developed gynecomastia, with their breast tissue increasing at an alarming and unnatural rate, their doctors alleged that the condition was a side effect of their medication. A medical specialist with clinical and academic experience with the drug was required to expand on the drug’s potential effects on adolescent patients with a history of using antipsychotic medicine.

Though I do continue to prescribe Risperdal, the medication is not for everyone. Any doctor prescribing the drug must watch carefully for any side effects, which can include gynecomastia. Since all drugs have their side effects, the most important thing a doctor can do is monitor and carefully explain them to the patients and families to ensure informed consent. To prescribe Risperdal without any surveillance whatsoever is to practice below this standard of care. However, gynecomastia can be caused by other factors as well. Childhood obesity and other antipsychotic medicines are particularly common causes of gynecomastia, and many adolescents who develop it have never been exposed to Risperdal at all. In cases where the patient has taken Risperdal, the mechanism has to do with the hormone Prolactin. All antipsychotics block the neurotransmitter Dopamine, and when Dopamine levels go down, Prolactin goes up. As such, gynecomastia can be associated with other medications and conditions which decrease or block Dopamine. I would be interested in knowing which other treatments the patients received in the past, especially other antipsychotics, as well as to try and determine if the patients had other risk factors for gynecomastia. I would also like to know more specifics, such as the duration of treatment and the dose, how the patient was monitored for side effects, whether the medication benefitted the patient, and what other interventions have been explored to resolve the gynecomastia, if it is even still present.

1. Please discuss your clinical and academic background in Risperdal. 2. Is gynecomastia a common complication? What is its mechanism of action in relation to prolactin levels?

Risperdal Experts Discuss Prescribing Antipsychotics to Adolescents

This case involves several autistic male children who developed gynecomastia after taking the drug risperidone. It was alleged that the pharmaceutical company that marketed this drug hid evidence that would have alerted clinicians and regulatory authorities to the connection between risperidone, increased prolactin, and gynecomastia. An early study on the drug’s side effects allegedly included multiple data sets that reported a direct link between increased prolactin levels and side effects like gynecomastia. These findings were allegedly redacted from the published manuscript and the published version concluded that the drug produced no prolactin-associated side effects. An expert in statistics was sought to review the original drug report and determine whether this paper should be retracted and what data any retraction would cover.

I am a biostatistician with 30+ years of experience designing, reviewing, and analyzing over 420 clinical trials. I am well-versed in issues associated with biostatistics, data management, statistical programming, and regulatory affairs. My professional experience spans various therapeutics areas including psychiatry, neurology, oncology, endocrinology, infectious disease, cardiology, rheumatology, urology, and anesthesia. As a former vice president of biometrics at large pharmaceutical companies and contract research organizations, I have managed biostatisticians and statistical programmers in the pre-clinical, non-clinical, and clinical areas. I also led initiatives of implementing adaptive designs of clinical trials to improve clinical drug development.

1. Please describe your experience conducting statistical analysis for drug trials or biomedical research. 2. Have you lectured or been published in this field?

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Risperdal Expert Witness Case Studies

Life Care Planner Evaluates Healthcare Costs For Intellectually Disabled Teen

Patient Attacks Staff Member of Psychiatric Hospital

Risperdal User Sues Manufacturer over Severe Side Effects

Risperdal Pharma Company Sued for Obfuscating Negative Studies

Risperdal Experts Discuss Prescribing Antipsychotics to Adolescents

Statistics Experts Review Data Sets In Pharmaceutical Drug Report

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