Jury Awards Victim $8 Billion in J&J Risperdal Case

A Philadelphia jury awarded a young man, Nicholas Murray, $8 billion in punitive damages after he claimed he was not warned of a significant side effect — breast growth — of an atypical antipsychotic medication called Risperdal (risperidone).

Risperdal is made by Janssen Pharmaceuticals, a Johnson & Johnson (J&J) company.

Murray was originally prescribed Risperdal in 2003 when he was 13 years old for treatment of autism spectrum disorder. Risperdal was not yet approved by the U.S. Food and Drug Administration (FDA) for the treatment of autism in 2003. But doctors can prescribe an FDA-approved medication for any condition they choose.

Murray, now 26, was previously awarded $1.75 million in the lawsuit in 2015, but the amount was reduced to $680,000 in a state appeals court. Murray claimed the company failed to warn that teenagers and young men using Risperdal could grow breasts.

Risperdal is typically prescribed (and FDA-approved) to treat bipolar disorder, schizophrenia, and other mental health disorders. Murray’s lawyers claimed the drug can create a hormonal imbalance, causing the formation of female breast tissue in men (a condition called gynecomastia).

The FDA approved Risperdal for children and teens (5 to 16 years old) diagnosed with autism in 2007.

This is not the first legal action taken against J&J due to its marketing of Risperdal.

In 2013, the U.S. Justice Department settled a $2.2 billion claim against J&J for Risperdal allegations. In that settlement, the Justice Department alleged that despite repeated warnings from the FDA, J&J’s Janssen division continued misleading marketing messages to physicians.

From that 2013 article, it was also noted that Janssen apparently marketed Risperdal for use in children with behavior challenges, despite known health risks to children and adolescents. Until late in 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly advised the company that promoting its use in children was problematic and could violate the law.

According to additional legal filings, J&J apparently faces some 13,400 lawsuits tied to Risperdal and its potential side effect of breast growth in boys who take the drug. More than 7,000 of those lawsuits are pending in state court in Philadelphia.

According to ClassAction.com, J&J has settled more than 80 cases related to Risperdal for undisclosed amounts from 2012 to 2013. In 2016, a jury awarded $70 million to Andrew Yount, “ruling that the company not only failed to warn Yount about the issues surrounding Risperdal but had destroyed evidence related to the case,” according to Fox Business News.

They also noted that, “In August of 2012, J&J agreed to pay $181 million to 36 states and the District of Columbia to settle fraud charges related to its unlawful marketing of Risperdal.”

“This jury resoundingly told J&J that its actions were deliberate and malicious,” Tom Kline and Jason Itkin, two of Murray’s lawyers, said in an emailed statement to Bloomberg.

The $8 billion sum is likely to be reduced on grounds that it violates due process. J&J said that it will appeal the ruling, claiming the amount was “grossly disproportionate.”

J&J is also involved in lawsuits related to its marketing of opioid painkillers. It recently settled two Ohio opioid-related lawsuits for more than $20.4 million. J&J formerly marketed the painkillers Duragesic and Nucynta.

Opioids were involved in 400,000 overdose deaths in the United States from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention. The company claims the settlement includes no admission of liability.

Source: Wire reports

Vulnerability for Hearing Voices in Schizophrenia May Be Set By Infancy

A new study suggests that a person’s vulnerability to hearing “voices” in schizophrenia may be established many years before symptoms begin, and possibly while still in the womb.

The findings are published in NPJ Schizophrenia, a Nature Partner Journal.

Hearing voices affects more than 80% of schizophrenia patients and is considered one of the most prevalent and distressing symptoms of schizophrenia. These auditory hallucinations, which usually begin in adolescence and young adulthood, sound very real to patients and can have a devastating impact on their quality of life, as the “voices” are typically distressing and distracting, sometimes compelling the person into suicidal or violent actions.

Uncovering the biological origins of auditory hallucinations is essential for reducing their contribution to the disease burden of schizophrenia.

To study the biological origins of hearing “voices” in patients with schizophrenia, a research team led by the Icahn School of Medicine at Mount Sinai used ultra-high field imaging to compare the auditory cortex of schizophrenia patients with healthy participants.

They found that schizophrenia patients who experienced auditory hallucinations had abnormal tonotopic organization of the auditory cortex. Tonotopy is the ordered representation of sound frequency in the auditory cortex, which is established in utero and infancy and which does not rely on higher-order cognitive operations.

The study findings suggest that the vulnerability to develop voices is probably established many years before symptoms begin.

“Since auditory hallucinations feel like real voices, we wanted to test whether patients with such experiences have abnormalities in the auditory cortex, which is the part of the brain that processes real sounds from the external environment,” said Sophia Frangou, M.D., Ph.D., Professor of Psychiatry at the Icahn School of Medicine at Mount Sinai. ”

Specifically, the researchers used an ultra-high field scanner with a powerful 7 Tesla magnet to produce high-resolution images of brain activity while participants listened passively to tones across a range of very low to very high frequencies.

In healthy brains, these sounds are processed in a very organized fashion; each frequency activates a specific part of the auditory cortex forming a tonotopic map.

The team obtained tonotopic maps from 16 patients with schizophrenia with a history of recurrent auditory hallucinations and 22 healthy participants. The team found that schizophrenia patients showed greater activation in response to most sound frequencies.

In addition, the mapping of most sound frequencies to parts of the auditory cortex appeared “scrambled” in patients with schizophrenia, suggesting that the normal processes for the organized representation of sound in the brain are disrupted in schizophrenia.

“Because the tonotopic map is established when people are still infants and remains stable throughout life, our study findings suggest that the vulnerability to develop ‘voices’ is linked to a deviance in the organization of the auditory system that occurs during infancy and precedes speech development and the onset of psychotic symptoms by many years,” Frangou said.

“This is particularly exciting because it means that it might be possible to identify potential vulnerable individuals, such as the offspring of schizophrenia patients, very early on.”

According to the authors, in addition to helping doctors identify patients who are likely to experience hallucinations before the symptoms appear or become severe, the auditory cortex may be an area of consideration for novel treatment methods to help patients who already have symptoms.

Next, the team plans to repeat and expand the current observations in larger samples to determine their relevance to hallucinations across different diagnoses.

Source: The Mount Sinai Hospital/ Mount Sinai School of Medicine

Serious Mental Illness at Young Age Can Have Lasting Impact on Future Employment

A new study has found that people who have been hospitalized due to a mental disorder before the age of 25 have considerably poorer prospects of finding a job, as well as poor education and low income.

Researchers at the University of Helsinki found that the employment rate was the lowest among individuals who were hospitalized for schizophrenia. Less than 10 percent were employed during the follow-up period of the study, researchers reported.

Additionally, less than half of the individuals hospitalized for mood disorders worked after the age of 25.

The earnings of people with serious mental disorders in their youth were quite low and did not improve later, the study found. More than half had no earnings over the follow-up period.

The study involved more than 2 million individuals living in Finland between 1988 and 2015, who were monitored between the ages of 25 and 52.

“People suffering from mental disorders drop out from the labor market for a wide range of reasons,” said Dr. Christian Hakulinen, a postdoctoral researcher from the University of Helsinki. “However, opportunities for contributing to professional life and acquiring an education should already be taken into consideration at the early stages of treating serious mental disorders, provided the patient’s condition allows it.”

The study was published in the Acta Psychiatrica Scandinavica journal.

Source: University of Helsinki

Challenging the inevitability of inherited mental illness

Clients with family histories of mental illness sometimes feel defeated right out of the gate, but counselors can spread an empowering message that genetics aren’t necessarily destiny when it comes to mental health.

The post Challenging the inevitability of inherited mental illness appeared first on Counseling Today.

Uninsured Kids With Mental Health Emergencies Often Transferred to Another Hospital

Children without health insurance who present to the emergency department (ED) for mental health issues are more likely to be transferred to another hospital compared to kids with private insurance, according to a new study by researchers at the University of California (UC) Davis Children’s Hospital and the UC Davis Department of Psychiatry.

Previous research has shown a significant increase in the number of children and teens presenting to the ED for mental health issues. Between 2012 and 2016, hospital EDs saw a 55 percent jump in kids with mental health problems, according to findings presented at a meeting of the American Academy of Pediatrics in 2018. The increase is highest among minorities.

Transferring a child from one hospital to another creates additional burdens for the patient, family and health care system as a whole. It can add to overcrowding in busy emergency departments, higher costs of care and higher out-of-pocket costs for the family.

For the study, the researchers analyzed a national sample of 9,081 acute mental health events among children in EDs. They looked at the patient’s insurance coverage and a hospital’s decision to admit or transfer patients with a mental health disorder.

“We found that children without insurance are 3.3 times more likely to be transferred than those with private insurance,” said Jamie Kissee Mouzoon, research manager for the Pediatric Telemedicine Program at UC Davis Children’s Hospital and first author on the study.

“The rate was even higher for patients presenting with bipolar disorder, attention-deficit and conduct disorders and schizophrenia.”

The findings, published in the journal Pediatric Emergency Care, reveal gaps in providing equitable and quality care to pediatric patients with mental health emergencies based on their insurance coverage.

According to James Marcin, senior author on the study, there are regulations in place to prevent EDs from making treatment decisions based on the patients’ insurance. Transferring a patient for any other reason than clinical necessity should be avoided.

“Unfortunately, the financial incentives are sometimes hard to ignore and can be even unconscious,” said Marcin, who also is director for the UC Davis Center for Health and Technology and leads the telemedicine program at UC Davis Health.

“What we have found in this study is consistent with other research that demonstrates that patients without health insurance are more likely to get transferred from clinic to clinic or hospital to hospital.”

Marcin is currently looking into how telemedicine — video visits delivered to the children who seek care in remote EDs — might be a solution to the tendency to transfer the patient to another hospital.

Source: University of California – Davis Health

Study IDs Gene Sets Tied to 5 Mental Disorders

An international study has revealed specific sets of genes associated with the development of ADHD, autism spectrum disorder, bipolar disorder, major depression and schizophrenia.

Researchers analyzed more than 400,000 individuals to determine the genes behind these five mental health disorders.

Researchers from The University of Queensland and Vrije Universiteit in Amsterdam discovered several sets of genes marked all five disorders.

“Before this analysis, we knew a lot of psychiatric disorders were related to each other due to their hereditary nature,” said UQ psychiatrist Professor Christel Middeldorp.

“We often see multiple family members with mental illness in one family, but not necessarily with the same disorder.

“We investigated if specific sets of genes were involved in the development of multiple disorders, which genes are not only related to say, ADHD, but also to the other four psychiatric disorders.

“These are genes that play a role in the same biological pathway or are active in the same tissue type.

“Genes that are highly expressed in the brain were shown to affect the different disorders, and some genes were related to all the illnesses we studied.

“It shows that there is a common set of genes that increase your risk for all five disorders.”

Study leader Dr. Anke Hammerschlag believes this occurs because of biological pathways shared by the genes in the brain. Research findings appear in the journal Psychological Medicine.

“We found that there are shared biological mechanisms acting across disorders that all point to functions in brain cells,”  Hammerschlag said.

“We also found that genes especially active in the brain are important, while genes active in other tissues do not play a role.”

The finding is important as new pharmaceutical drugs could potentially target the shared pathways.

“Our findings are an important first step towards the development of new drugs which may be effective for a wide range of patients, regardless of their exact diagnosis,” she said.

“This knowledge will bring us closer to the development of more effective personalized medicine.”

Source: University of Queensland