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December 20, 2023

Big Pharma News Watch

Health Officials Push to Get Schoolchildren Vaccinated as More U.S. Parents Opt Out + More

The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.

Health Officials Push to Get Schoolchildren Vaccinated as More U.S. Parents Opt Out

Associated Press reported:

All states require children to have certain routine vaccines to go to public school, and often private school and daycare, to prevent outbreaks of once-common childhood diseases like measles, mumps, whooping cough, chickenpox and polio. All provide exemptions for children who have a medical reason for avoiding the shots. Most also offer waivers for religious beliefs. Fifteen allow a waiver for any personal belief.

Last school year, vaccination waivers among kindergartners hit an all-time high: 3% in total, according to a recent Centers for Disease Control and Prevention report. Waivers for religious or personal beliefs have been on the rise, driven by some states loosening laws, in others by vaccine misinformation and political rhetoric amplified during the COVID-19 pandemic.

Health experts say interventions on every level are needed to get more kids immunized: doctors talking to parents, social media campaigns, easier access to vaccines in some areas, enforcement by schools in others.

Last year, most states had an increase in waivers. Hawaii, which allows medical and religious waivers, saw rates double from the previous school year. Nearly 6.5% of kindergartners have an exemption for at least one required vaccine.

Just 15% of Canadians Got Updated COVID Vaccines This Fall, New Figures Show

CBC News reported:

Canadians raced to get vaccinated against COVID-19 in the first years of the pandemic, but data suggests there’s far less of a rush to get the latest shots available this fall.

Federal figures show only 15% of the population aged five and up had received an updated vaccine by Dec. 3. And while older age groups had higher uptake rates, more than half of higher-risk older adults still hadn’t gotten a dose by early December, either.

Judge Excludes Expert Witnesses Linking Prenatal Tylenol Exposure to Autism and ADHD

AboutLawsuits.com reported:

In a decision that will prevent families from moving forward with Tylenol autism and ADHD lawsuits in the federal court system, the U.S. District Judge presiding over the litigation has determined that expert witnesses will not be allowed to testify that prenatal exposure to acetaminophen causes autism and attention deficit hyperactivity disorder (ADHD) in children.

Tylenol (acetaminophen) has been widely used by pregnant women for decades, largely due to the widespread belief that it is safe for unborn children. However, a growing number of lawsuits have been filed in recent months 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.

Following the hearings, Judge Cote issued an opinion on December 18, granting the defendants’ motion to exclude the five plaintiffs’ expert witnesses from testifying, after determining that the scientific approaches and studies used were not sound enough to allow the opinions to be presented to a jury.

“With these rulings, the plaintiffs do not have admissible evidence to demonstrate that prenatal exposure to acetaminophen causes either ASD or ADHD in offspring,” Judge Cote determined in the ruling, which will likely result in the dismissal of all claims pending in the federal court system unless the decision can be reversed on appeal.

Weight Loss Drugs, Alzheimer’s Treatments and Gene Editing: Enormous Firsts Defined 2023 in Pharma

CNBC reported:

Drugmakers are closing out a year when they achieved several historic firsts that will shape the pharmaceutical industry in 2024 and beyond.

The weight loss drug market transformed into the pharmaceutical industry’s newest gold rush this year, as demand for costly but highly effective treatments from Novo Nordisk and Eli Lilly surged. Patients and investors also saw that the benefits of the medicines could extend beyond their original purposes.

What’s more, the world’s first vaccines against respiratory syncytial virus rolled out in several markets this fall, and U.S. regulators last week approved the first-ever gene-editing therapy, which will be used to treat sickle cell disease.

COVID vaccines and treatments were the biggest losers of this year, as demand plummeted to new lows while cases and public concern about the virus dwindled from their pandemic peaks. For the first time, those products became an enormous burden on the industry, prompting Wall Street to turn its focus to the breakthroughs in weight loss drugs and other treatments.

COVAX Winds Down With COVID Vaccine Shift to Regular Programs

CIDRAP reported:

The World Health Organization (WHO) today announced that COVAX, a program formed in 2020 to increase equitable distribution of COVID-19 vaccines, will close on December 31 as distribution shifts to regular immunization programs.

COVAX was jointly led by Gavi, the Vaccine Alliance, UNICEF, and the WHO. So far, it has distributed nearly 2 billion doses to 146 economies, the WHO said in a statement. The groups estimate that the vaccines distrusted through COVAX averted 2.7 million deaths and helped lower-income countries achieve 57% two-dose coverage, compared to the 67% global average.

India Bans Anti-Cold Drug Combination for Kids Aged Under Four

Reuters reported:

India’s drugs regulator has banned the use of an anti-cold drug combination in children aged below four and ordered that drugs should be labeled accordingly, in the wake of the deaths of at least 141 children globally linked to cough syrups.

The regulator said concerns raised about the promotion of an unapproved anti-cold drug formulation in infants prompted a discussion and a resulting recommendation to not use the combination for that age group.

The order comes as India draws lessons from a spate of child deaths since 2019 that authorities linked to toxic cough syrups made in the country, including at least 141 deaths in Gambia, Uzbekistan and Cameroon since the middle of last year.

The order by the regulator on the fixed-drug combination (FDC), issued on Dec. 18 and made public on Wednesday, requires drugmakers to label their products with the warning that the “FDC should not be used in children below 4 years of age.”

French Pharma Firm Ordered to Pay Millions Over Deadly Diabetes Drug

Barron’s reported:

A French appeals court on Wednesday ordered pharmaceutical firm Servier to pay more than $460 million in damages over a scandal involving a diabetes drug linked to hundreds of deaths.

The health scandal came to light in 2007 when a doctor raised the alert on heart risks linked to Mediator, a drug destined for overweight people with diabetes but that was also widely prescribed to others as an appetite suppressant.

The drug, which may have caused up to 1,800 deaths, was later banned in France where millions of people took it. It is also banned in the United States, Spain and Italy.

In the latest court ruling in more than a decade of legal proceedings, the Paris appeals court upheld verdicts of “aggravated fraud” and “involuntary manslaughter and injuries.” It ordered Servier to pay a 9-million-euro ($9.8-million) fine and pay back more than 415 million euros ($455 million) to the national social security agency and health insurance companies, much higher damages than in an initial ruling in 2021.

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