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Dismissal Entered in More Than 500 Tylenol Lawsuits Brought by Families of Children Diagnosed With Autism, ADHD
The U.S. District Judge presiding over all Tylenol autism and attention deficit hyperactivity disorder (ADHD) lawsuits pending in the federal court system has issued a final judgment dismissing hundreds of cases, after the Court excluded expert witness testimony that left families unable to provide that exposure to acetaminophen during pregnancy left their children with severe developmental problems.
For decades, Tylenol (acetaminophen) has been widely used by pregnant women, largely due to the widespread belief that it is safe for unborn children. However, a growing number of lawsuits have been filed in recent years by families nationwide, each raising similar allegations that drug makers failed to adequately warn pregnant women about the growing evidence that in utero Tylenol prenatal exposure may cause autism or ADHD.
In December, Judge Cote issued an opinion excluding plaintiffs’ expert witnesses from testifying, after determining the scientific approaches and studies used were not sound enough to allow the opinions to be presented to a jury.
The move has been seen as spelling the end of the Tylenol litigation in the federal court system since it left plaintiffs without required expert testimony to prove Tylenol caused developmental disorders when women took the painkiller during pregnancy.
Synthetic Opioids Are Claiming Lives at an Alarming Rate
Though the success of DC’s Stabilization Center is commendable, it’s vital not to overlook the urgent opioid crisis heavily fueled by synthetic opioids claiming lives at an alarming rate. These substances can require increased doses of conventional treatments and pose an even greater threat because of their heightened lethality. It is crucial that the public health emergency declaration on the opioid crisis that recently expired be reinstated to continue comprehensive efforts to address the opioid epidemic.
As it stands, all states and DC are mandated to establish policies or standing orders to facilitate first responders’ access to and utilization of Food and Drug Administration-approved reversal agents for opioid overdoses.
As we advocate widespread access to reversal agents, it’s equally crucial to implement comprehensive educational initiatives aimed at informing students and campuses about the dangers of accidental overdoses and the proper utilization of these lifesaving interventions. Currently, DC colleges and universities are exploring comprehensive strategies to educate their campuses about the risks of opioid overdose and provide harm-reduction tools to better equip each campus to manage potential overdoses.
According to data from DC’s Office of the Chief Medical Examiner, the involvement of fentanyl in overdoses surged from 72% in 2017 to 96% in 2022. We must educate the community about the preventive and treatment measures that exist and ensure access to FDA-approved overdose rescue agents, including those designed for synthetic opioids. These resources are urgently required, complementing the commendable efforts already underway in stabilization centers in DC and throughout the nation.
European Advisers Green-Light 2 H5N1 Avian Flu Vaccines
At its meetings last week the European Medicines Agency human medicines committee recommended approval for two human H5N1 avian flu vaccines, one called Celldemic and the other Incellipan. Both are inactivated adjuvanted cell-based vaccines manufactured by Seqirus.
Celldemic is intended for immunizing people during outbreaks coming from animals, including when public health officials anticipate a possible pandemic.
Incellipan is intended as a pandemic preparedness vaccine to be used only when a pandemic has been declared, which prompted the manufacturer to include the pandemic strain in the final version of its vaccine. The approval now, based on safety and efficacy trials, would speed the final authorization of a pandemic vaccine.
In Search of the One-and-Done Vaccine
Developing a vaccine that provides long-lasting protection against disease is the aim of researchers at the Houston Methodist Research Institute. The team is working to develop vaccines using ribonucleic acid (RNA)-based technology that could provide longer immunity from infectious diseases compared with the mRNA shots used against COVID-19.
The institute will receive up to $3.8 million to advance its work after winning a competition sponsored by the Coalition for Epidemic Preparedness Innovations, an international foundation working to develop vaccines for pathogens that could cause global outbreaks.
The project focuses on designing vaccine candidates using so-called circular RNA. The candidates will be evaluated in animal studies, initially targeting chikungunya, a mosquito-borne virus. How it works: Circular RNA vaccine technology uses a closed-loop RNA, which the researchers think will prove more stable and durable than mRNA vaccines, which are linear.
Because circular RNA doesn’t have ends that break down when they contact enzymes in the human body, it takes longer to degrade, said Dr. John Cooke, director of Houston Methodist’s Center for RNA Therapeutics, who leads the CEPI-backed project.
That means the RNA can continue to express the protein that it encodes, making immunity to a virus last longer than mRNA vaccines and potentially require only one shot instead of multiple, he told Carmen. Even so: It could mean more severe side effects because reactions would last longer, he said.
Q&A: Why the U.S. Is an Outlier on COVID Vaccines for Kids
U.S. News & World Report reported:
When it comes to vaccinations for COVID-19, the U.S. stands apart in recommending booster shots for children.
Centers for Disease Control and Prevention guidelines call for children 6 months and older to get an “updated” COVID-19 vaccine — a tweak in terminology from a “booster” to reflect a new formula for the shots. In contrast, England last year called for boosters for children as young as 6 months if they were in a clinical risk group, while the U.S. stance also has differed from recommendations of European Union members like Germany and France.
The World Health Organization additionally considers healthy children between 6 months and 17 years old to be a “low priority” for COVID-19 vaccination.
The Questions Eating Disorder Experts Have About Weight-Loss Medications
There is still much researchers don’t know about popular weight-loss medications — and those lack of studies could have consequences for eating disorders, according to experts.
The medication semaglutide, sold under brand names such as Ozempic and Wegovy, is a kind of glucagon-like peptide-1 receptor agonist or GLP-1 agonist. While originally prescribed for diabetes, semaglutide is becoming more and more popular for weight loss.
As the medication becomes more available, experts said they worry about the impact of these weight loss products on eating disorders.
Eating disorders affect nearly 1 in 10 people in the United States, according to the nonprofit National Association of Anorexia Nervosa and Associated Disorders, which provides support services for people with these conditions. Next to opioid addiction, it has the second-highest crude mortality rate of any mental illness, the association said.
Should Big Pharma Pay Poor Countries for Finding New Diseases?
Africa in particular is the source of many emerging diseases that could pose a risk to humans. Under the system being contemplated in the pandemic treaty talks, once a potentially dangerous virus is identified, developing countries would share access to viral samples with developed countries, home to the bulk of the world’s biopharmaceutical industry.
The industry would then take that information to begin developing medical countermeasures, like vaccines or new treatments. Then those new medicines would be shared equitably between the nations where they were developed and the nations that provided the raw materials for the diseases.
In exchange for providing pathogen samples, African nations want pharmaceutical companies to pay an annual fee to support a centralized system for sharing pathogen information and for sharing the medical products that are ultimately developed from that information, potentially managed by a major multilateral body like the WHO. They also want pharmaceutical companies to commit to making a certain percentage of the products developed from these pathogen samples (diagnostics, vaccines, medicines) available for free or for the cost of production in a future pandemic.
But Big Pharma opposes both compensating countries for sharing pathogen information and the creation of a centralized bureaucracy to manage that process, arguing that it would slow down the development of medical breakthroughs. Drug companies have been largely supported in that position by the US and European Union.
A ‘Renaissance in Neuroscience’ Could Deliver a Fresh Crop of Psychiatric Medicines
One by one, the companies behind Zoloft, Prozac, and Paxil soured on psychiatry.
It was the early 2000s, and as America warmed to the sounds of Sisqó and Shakira, the world’s largest pharmaceutical firms were running out of ideas to treat mental illness. Their blockbuster treatments for depression and schizophrenia had reshaped society and made billions of dollars in the process, but the old cash cows were soon to go generic.
Efforts to one-up the last generation of drugs mostly resulted in incremental changes to aging medicines. And when insurance companies balked at paying brand-name prices for extended-release generics, the money dried up and the industry moved out.
“The mindset of Big Pharma in those days was one pill for millions and millions of people,” said John LaMattina, who led Pfizer’s research division from 1999 to 2007. “Everyone was looking for the next Lipitor, and when that fizzled out, there was an exodus out of psychotherapeutic areas.”
