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.
The Dark Side of Medications: These Drugs Do More Harm Than Good
A groundbreaking study conducted by researchers from the University of Cambridge and the University of Melbourne, published in the journal Science Advances, sheds light on the effects of certain drugs on cognitive function. The study involved 40 healthy participants between the ages of 18 and 35, and its results challenge the notion that drugs like Adderall and Ritalin enhance cognitive abilities.
According to Peter Bosarts, a professor of neuroeconomics at the University of Cambridge and one of the study’s authors, “Our results suggest that these drugs do not actually make the takers ‘smarter.’” Despite the expected increase in motivation and effort due to the release of dopamine caused by these drugs, the study revealed that their usage leads to overthinking, resulting in unstable cognitive performance.
It is common for individuals without an ADHD diagnosis to believe that prescription drugs like Ritalin can enhance their concentration. However, the study findings indicate that these drugs have the opposite effect on certain individuals.
The results of this study highlight the necessity for additional research to determine the true efficacy of stimulant drugs in neurotypical individuals. Understanding the potential harms and limitations of these drugs is crucial for providing accurate information to those seeking cognitive enhancement.
Pfizer, Moderna and Novavax Gear Up for Fall COVID Vaccine Rollout With an Important Head Start
The U.S. Food and Drug Administration’s COVID strain selection for the next round of shots puts Pfizer, Moderna and Novavax on track to deliver new jabs in time for the fall — a decisive win for the vaccine makers as they gear up to compete against one another.
The FDA on Friday advised the three companies to manufacture single-strain jabs targeting the Omicron subvariant XBB.1.5, one of the most immune-evasive COVID variants to date.
Facing pressure to deliver new shots by the fall, Pfizer, Moderna and Novavax began development on versions of their vaccines targeting XBB.1.5 months before the FDA’s decision. Preliminary data those companies presented last week indicates that their jabs produce strong immune responses against all XBB variants.
Pfizer said on Thursday it will be able to deliver a shot targeting XBB.1.5 by July. Moderna and Novavax did not provide specific timelines for their versions. Still, the FDA’s decision means that all three companies will likely deliver their updated jabs on time.
‘Designing a Vaccine That Covers All Cancers Is Hard’: Biotech Pioneer Lindy Durrant
“Cancer is my game,” says Prof Lindy Durrant, an immunologist, founder and chief executive of Scancell, which is developing vaccines that could offer needle-free protection against COVID as well as novel treatments against cancer.
Founded in 1997 on the back of her Nottingham University research, the Oxford-based company’s work on treatments that stimulate the body’s immune system to fight cancer and infectious disease has put it in a cluster of promising British biotechnology firms.
While most vaccines are taken preventively, there is no jab to avoid cancer (apart from the HPV one for the virus that triggers most cervical cancer). “Probably 50% to 60% of people will get cancer and die of it,” says Durrant. “There are probably 200 different types of cancer. Each of them has a very different signature. So to design a vaccine that covers them all is really hard.” Instead Scancell developed therapeutic jabs that aim to halt or reverse its spread, earning Durrant the Waldenström award from the Swedish Society of Oncology in 2019.
Scancell began testing its vaccine against COVID variants in October 2021. By that time, the U.K. had the AstraZeneca/Oxford University jab and because they, and Pfizer and BioNTech, “moved at lightning speed, the decision was made, we can’t compete with big pharma,” Durrant says.
However, early clinical results were positive and Scancell is looking for a partner to take its vaccine forward as a booster, as the virus continues to mutate. An estimated 10% of people will experience symptoms of long COVID, with at least 65 million people worldwide estimated to have it.
Study Reveals 23% Lower COVID Risk in Those ‘Not Up-to-Date’ With Vaccinations
In a compelling counter-narrative to prevailing views on COVID-19 immunization, a recent study from the Cleveland Clinic Health System reveals that individuals not considered “up-to-date” with their COVID-19 vaccinations, as per the Centers for Disease Control’s (CDC) definition, may have a lower risk of contracting the virus compared to their “up-to-date” counterparts.
This unexpected finding emerges as the dominant XBB lineages of the virus circulate, leading researchers to question the efficacy of bivalent vaccines against these new variants and the existing CDC guidelines for determining vaccination adequacy.
The study included 48,344 participants, from which 1,445 were omitted due to employment termination. By the study’s conclusion, 12,841 participants were “up-to-date” with their COVID-19 vaccination. Most received the Pfizer vaccine, while a smaller group was administered the Moderna vaccine. Over the study period, 1,475 employees tested positive for SARS-CoV-2.
The study concluded that the risk of contracting COVID-19 was 23% lower in the “not up-to-date” group as compared to their “up-to-date” counterparts. The study found no apparent difference in COVID-19 risk between the two groups when stratified by the most recent infection date.
Sanofi Says Arbitration Court Rejects Boehringer’s Zantac Claims
Sanofi (SASY.PA) said on Tuesday that the International Chamber of Commerce rejected rival drugmaker Boehringer Ingelheim’s (BI) claims to be indemnified by Sanofi in cancer lawsuits linked to heartburn drug Zantac in the United States.
Shares in France’s Sanofi, which added that the decision cannot be appealed, gained 2.4% shortly after the 0700 GMT market open, reaching a three-week high.
Thousands of U.S. lawsuits claiming Zantac causes cancer have been disputed by drugmakers that have sold either the branded or generic version of the drug since it was initially approved in 1983. It went on to become one of the first medicines to top $1 billion in sales.
Similac Infant Formula Lawsuit Claims ‘Human Milk Fortifier’ Caused NEC Diagnosis for Premature Baby
A New York mother has brought a lawsuit against Abbott Laboratories, Inc., alleging that Similac “Human Milk Fortifier” caused her premature child to develop necrotizing enterocolitis (NEC), a devastating intestinal disease associated with the use of the cow’s milk-based infant formula.
The complaint was filed by Tess Wallace last month in the U.S. District Court or the Northern District of Illinois, indicating that the manufacturer has known about the risks associated with the use of Similac among premature infants, but continued to market the product without adequate warnings for parents and the medical community.
Wallace now joins other families of preterm infants nationwide who are now pursuing an NEC lawsuit against the Similac makers, with a number of similar claims also being pursued against Mead Johnson over problems linked to their competing cow’s milk infant formula products, marketed under the brand name Enfamil, alleging that the desire for profits has been placed ahead of the safety of babies, and driven many families away from safer breastfeeding or donor milk alternatives.
Drugmakers Aim to Strike Down Medicare Drug-Price Negotiations at Supreme Court
The pharmaceutical industry is aiming to strike down Medicare’s historic new powers to slash drug prices for seniors through a Supreme Court ruling, legal experts say.
Drugmaker Merck, the U.S. Chamber of Commerce and Bristol Myers Squibb filed separate lawsuits within days of each other this month asking federal courts in Washington, DC, the Southern District of Ohio, and New Jersey to declare the price negotiations unconstitutional under the First and Fifth Amendments.
The lawsuits are the opening salvo in what will go down as a historic and potentially decisive battle over the federal government’s efforts to control rising drug prices.
The Inflation Reduction Act, passed in a narrow party-line vote last year, gave Medicare the power to negotiate prices for the first time in the program’s nearly 60-year history — a watershed moment that the Democratic Party had long fought for. The pharmaceutical industry views the program as posing a major threat to revenue growth and profits. The companies claim the program will stifle future drug development in the U.S.
Novo Nordisk Sues Clinics Allegedly Selling Copycat Versions of Ozempic and Wegovy
Novo Nordisk said it has filed lawsuits Tuesday against multiple medical spas, weight loss clinics and compounding pharmacies for allegedly selling unauthorized versions of the drugmaker’s popular medicines Ozempic and Wegovy.
For months, the drugmaker has been threatening to take legal action against clinics and compounding pharmacies offering what they claim to be semaglutide — the active ingredient in both Ozempic and Wegovy — amid an ongoing shortage in the United States.
The lawsuits were first reported by The Wall Street Journal.
Novo Nordisk is the sole patent holder of semaglutide and does not sell the ingredient to outside entities, raising questions about what is actually being sold to consumers.
Eli Lilly’s Mounjaro Is Primed to Overtake Novo Nordisk’s Popular Diabetes and Obesity Duo: Report
In the battle for superiority in the field of next-gen diabetes and obesity treatments, Novo Nordisk holds the lead as the developer of the metabolism-regulating treatment semaglutide.
But Eli Lilly is quickly gaining ground and is primed to become the market leader with its rival Mounjaro (tirzepatide), according to a new report from GlobalData.
Approved in May of last year for Type 2 diabetes, Mounjaro has already had a strong launch. In the first quarter, it clobbered expectations, posting $569 million in sales.
Now, Mounjaro appears on the verge of an approval to treat obesity. In April, the company posted its second late-stage trial win in the indication, with patients on the drug losing an average of 15.7% of their body weight. An FDA nod could come by the end of the year.
Exclusive: WHO Says Toxic Syrup Risk ‘Ongoing’, More Countries Hit
There is an ongoing global threat posed by toxic cough syrups, the World Health Organization (WHO) told Reuters, saying it was now working with six more countries than previously revealed to track the potentially deadly children’s medicines.
The U.N. agency has already named nine countries where tainted syrups may have been on sale, after the deaths of more than 300 infants on three continents last year were linked to the drugs.
He warned that contaminated medicines could still be found for several years, because adulterated barrels of an essential ingredient may remain in warehouses. Cough syrups and the ingredient, propylene glycol, both have shelf-lives of around two years.
Unscrupulous actors sometimes substitute propylene glycol with toxic alternatives, ethylene glycol and diethylene glycol, because they are cheaper, several pharmaceutical manufacturing experts told Reuters.
Source: The Dark Side of Medications: These Drugs Do More Harm Than Good + More • Children’s Health Defense