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

Common Household Drugs Often Used By Youth in Suicide Attempts

A new study finds that adolescent suicide attempts by self-poisoning often involve common household medications, such as ibuprofen or antidepressants.

The findings, published online in the journal Clinical Toxicology, also reveal that self-poisoning suicide attempts are more common in rural communities, particularly during the academic school year.

The study expands on previous research that looked at the incidence and outcomes from intentional suspected-suicide self-poisoning in children and young adults ages 10 to 24 years old from 2000-2018.

In that 19-year time frame, there were more than 1.6 million intentional suspected-suicide self-poisoning cases in youth and young adults reported to U.S. poison centers. The majority of cases were female (71%), and involved a pharmaceutical (92%).

“While most of these cases involved medications, with adolescents, any available medication can be a potential hazard,” said Henry Spiller, M.S., D.ABAT, director of the Central Ohio Poison Center at Nationwide Children’s Hospital, and co-author of the study.

“It’s not so much a matter of substance type, but rather a matter of access to the substance. Any type of medication can be misused and abused in ways that can unfortunately lead to very severe outcomes, including death.”

The two most common substance groups in all age groups were over-the-counter (OTC) painkillers such as acetaminophen, ibuprofen and aspirin, followed by antidepressants. In youth (ages 10-12) and adolescents (ages 13-15), ADHD medications were common, and had the highest risk of serious medical outcomes. Opiates only accounted for 7% of cases with serious medical outcomes.

“Because medications are so readily available in homes, many families do not take precautions to store them safely. Our findings suggest this is a big problem,” said John Ackerman, Ph.D., clinical psychologist and suicide prevention coordinator for the Center for Suicide Prevention and Research at Nationwide Children’s, and co-author of the study.

“Medications can be part of effective treatment, but they require an extra layer of care. The answer is not to stop prescribing medications to those who stand to benefit, but rather to emphasize the practice of safe storage and vigilance when administering any kind of medicine, especially when children and teens live in the home.”

The findings also show that states with a lower population per square mile (rural areas) had a greater number of reported cases with all outcomes and serious medical outcomes.

Results also revealed there was a significant decrease in the number of cases in school-aged individuals during non-school months of June through August (27.5% decrease in 10-12-year-olds; 27.3% decrease in 13-15-year-olds; and 18.3% decrease in 16-18-year-olds), compared with school months September through May.

Nationwide Children’s Big Lots Behavioral Health experts recommend that parents check in with their children regularly, and ask them directly how they are doing and if they have ever had thoughts about ending their life. These direct questions are even more critical if warning signs of suicide are observed.

Medications should be stored up, away and out of sight, preferably in a locked cabinet. Administration of medicine should always be supervised.

“It should concern us that youth in rural areas are about twice as likely as those living in urban areas to die by suicide. Although we are in dire need of more research to help us understand what places some people at more risk than others, available evidence indicates that include increased social isolation, stigma, access to lethal means and lack of appropriate mental health resources may play a role in this disparity,” said Ackerman.

His suicide prevention team provides comprehensive training to more than 140 central and southeast Ohio schools with the SOS Signs of Suicide program.

“It is vital that parents, teachers and other trusted adults start conversations about mental health early, and pay even closer attention during the school year, as rates of anxiety and depression are shown to increase during that time. Warning signs can often be detected and support is available for young people in crisis.”

Source: Nationwide Children’s Hospital

Kids Told Lies by Parents Can Face Psychological Challenges as Adults

A new study suggests that children who were told lies by their parents are more likely to lie as adults, as well as face difficulty in meeting psychological and social challenges.

According to researchers at Nanyang Technological University in Singapore, those difficulties include disruptiveness, conduct problems, experiences of guilt and shame, as well as selfish and manipulative character.

For the study, researchers asked 379 Singaporean young adults whether their parents lied to them when they were children, how much they lie to their parents now, and how well they adjust to adulthood challenges.

“Parenting by lying can seem to save time, especially when the real reasons behind why parents want children to do something is complicated to explain,” said lead author Setoh Peipei, Ph.D., an assistant professor in NTU Singapore’s School of Social Sciences.

“When parents tell children that ‘honesty is the best policy’, but display dishonesty by lying, such behavior can send conflicting messages to their children. Parents’ dishonesty may eventually erode trust and promote dishonesty in children.”

“Our research suggests that parenting by lying is a practice that has negative consequences for children when they grow up,” she continued. “Parents should be aware of these potential downstream implications and consider alternatives to lying, such as acknowledging children’s feelings, giving information so children know what to expect, offering choices and problem-solving together, to elicit good behavior from children.”

For the study, the 379 young adults completed four online questionnaires.

The first questionnaire asked participants to recall if their parents told them lies that related to eating; leaving and/or staying; children’s misbehavior; and spending money. Some examples of such lies are “If you don’t come with me now, I will leave you here by yourself” and “I did not bring money with me today, we can come back another day.”

The second questionnaire asked participants to indicate how frequently as adults they lied to their parents. It asked about lies in relation to their activities and actions; prosocial lies (or lies intended to benefit others); and exaggerations about events.

Lastly, participants filled in two questionnaires that measured their self-reported psychosocial maladjustment and tendency to behave selfishly and impulsively.

The analysis found that parenting by lying could place children at a greater risk of developing problems, such as aggression, rule-breaking and intrusive behaviors, according to the researchers.

Some limitations of the study include relying on what young adults report about their retrospective experience of parents’ lying.

“Future research can explore using multiple informants, such as parents, to report on the same variables,” suggested Setoh.

Another area yet to be investigated would be the nature of the lies or goals of the parent, she added.

“It is possible that a lie to assert the parents’ power, such as saying ‘If you don’t behave, we will throw you into the ocean to feed the fish’, may be more related to children’s adjustment difficulties as adults, compared to lies that target children’s compliance, e.g. ‘there is no more candy in the house.’”

“Authority assertion over children is a form of psychological intrusiveness, which may undermine children’s sense of autonomy and convey rejection, ultimately undermining children’s emotional well-being,” she explained.

The study was published in the Journal of Experimental Child Psychology.

Source: Nanyang Technological University, Singapore

Photo: NTU Asst Prof Setoh Peipei led a study which suggests that lying to children is associated with detrimental effects when the child becomes an adult. Credit: NTU Singapore.

Study: Fathers-to-Be Should Avoid Alcohol for Months Before Conception

Both men and women hoping to become parents should avoid drinking alcohol prior to conception to protect their baby against congenital heart defects, according to a new study published in the European Journal of Preventive Cardiology.

Previous studies investigating the link between alcohol and congenital heart disease have focused on prospective mothers, with inconclusive results. This is the first meta-analysis to also examine the role of paternal alcohol drinking.

According to the findings, babies have a 44% increased risk of congenital heart disease when their father drank alcohol three months before conception, compared to babies whose dads did not drink. When the mothers drank during this time period or during the first trimester, babies had a 16% increased risk of disease.

The researchers suggest that when couples are trying for a baby, men should not consume alcohol for at least six months before conception while women should stop alcohol one year before and avoid it during pregnancy.

In addition, binge drinking — defined as five or more drinks per sitting — was related to a 52% higher likelihood of having a child with birth defects among men and 16% among women.

“Binge drinking by would-be parents is a high risk and dangerous behaviour that not only may increase the chance of their baby being born with a heart defect, but also greatly damages their own health,” said study author Dr. Jiabi Qin, of Xiangya School of Public Health, Central South University, Changsha, China.

The researchers compiled the best data published between 1991 and 2019, which amounted to 55 studies including 41,747 babies with congenital heart disease and 297,587 without. The analysis showed a relationship between parental alcohol drinking and congenital heart diseases.

‘We observed a gradually rising risk of congenital heart diseases as parental alcohol consumption increased. The relationship was not statistically significant at the lower quantities,” said Qin.

The authors noted that this was an observational study and does not prove a causal effect, nor does it prove that paternal drinking is more harmful to the fetal heart than maternal drinking. The data cannot be used to define a cut-off of alcohol consumption that might be considered safe.

Regarding specific defects, the researchers found that, compared to abstinence, maternal drinking was correlated to a 20% greater risk of tetralogy of Fallot, a combination of four abnormalities in the heart’s structure.

“The underlying mechanisms connecting parental alcohol and congenital heart diseases are uncertain and warrant further research. Although our analysis has limitations — for example the type of alcohol was not recorded — it does indicate that men and women planning a family should give up alcohol,” said Qin.

Alcohol is a known teratogen (causes malformation of an embryo) and has been connected with fetal alcohol spectrum disorder (FASD). Around one in four children with FASD have congenital heart disease.

Congenital heart diseases are the most common birth defects, with approximately 1.35 million infants affected every year. These conditions can increase the likelihood of cardiovascular disease later in life, even after surgical treatment, and are the main cause of perinatal death.

Source: European Society of Cardiology

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

Seafood in Early Pregnancy May Improve Attention in Kids

A new study finds that eating a seafood-rich diet during early pregnancy is associated with better attention outcomes in children.

A team of scientists from the Barcelona Institute for Global Health (ISGlobal) evaluated 1,641 mother-child pairs from the INMA Environment and Childhood Project, a Spanish cohort study focused on the role of pollutants during pregnancy and their effects on children.

Over the course of their pregnancies, the mothers completed numerous food-frequency questionnaires which assessed how often they ate more than a hundred different food items, including various types of seafood, including fatty fish, lean fish, canned tuna and shellfish.

Data on the children’s dietary habits were also collected using the same questionnaire at one, five and eight years of age. At eight years of age, the children also completed the Attention Network Task (ANT), a computer-based neuropsychological test designed to assess attention function.

The researchers found that children whose mothers ate a diet rich in various types of seafood scored very well on the attention tests, as did children of women with a diet rich only in fatty fish. However, scores were lower in children whose mothers relied on canned tuna or shellfish for their seafood intake.

Brain development takes place primarily during pregnancy. Essential nutrients such as polyunsaturated fatty acids (PUFAs) play a fundamental role in this development.

“Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are the main omega-3 PUFAs involved in neurological development, and seafood is the main source of both of them,” said Dr. Jordi Júlvez, researcher in the Childhood & Environment programme at ISGlobal and lead author of the study.

“The consumption of seafood during the first trimester of pregnancy had a greater effect on children’s attention capacity than the consumption of seafood later in pregnancy or at five years of age, by which time some neurodevelopmental processes have already been completed.”

Because these nutrients participate in the development of fetal brain structure and function, they have a large impact on later neuropsychological development. Attention is a complex behavior that all children must learn, since it precedes other crucial functions such as memory.

“We focused on the attention function because attention-deficit hyperactivity disorder is common in school-age children,” commented Dr. Jordi Sunyer, head of the Childhood & Environment programme at ISGlobal.

Despite the promising results of this study, the authors of previous research have reported a link between the consumption of fish during pregnancy and childhood obesity and increased blood pressure.

As a result, experts insist on the need for more research on this subject to determine exactly which species of fish and what quantities may be beneficial to fetal development.

The findings are published in the International Journal of Epidemiology.

Source: Barcelona Institute for Global Health (ISGlobal)