Posted on: Wednesday, December 20th 2023 at 11:00 am
Originally published on www.childrenshealthdefense.org
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.
Bayer Hit With $857 Million Verdict on Toxic Monsanto Chemicals
Bayer AG was ordered to pay $857 million to former students and parent volunteers at a Seattle-area school who blamed exposure to the company's hazardous chemicals at the facility for causing brain damage and other ailments.
A jury in Washington state on Monday found that levels of polychlorinated biphenyls, or PCBs, at the school, weren't "reasonably safe" and awarded $73 million in compensatory damages and $784 million in punitive damages to two parents who volunteered at Sky Valley Education Center along with five former students, according to court filings.
The decision marks the eighth time Washington state juries have found that students, teachers and parents who spent time in the facility were harmed by exposure to PCBs used in fluorescent light fixtures. Jurors have awarded a total of more than $1.5 billion in damages in those cases, which Bayer is appealing.
Bayer, which bought Monsanto in 2018 for $63 billion, has been dealing with a host of legal issues inherited from the U.S. maker of seeds and herbicides, including thousands of lawsuits alleging that its Roundup weed killer causes cancer.
Bayer's top-end exposure in PCB contamination claims from U.S. states and individuals could exceed $2.5 billion, according to Bloomberg Intelligence. The company has already paid out more than $650 million in settlements of lawsuits filed by U.S. cities and counties over pollution of waterways.
Patients Facing Death Are Opting for a Lifesaving Heart Device -- but at What Risk?
Arvid Herrman, a 68-year-old Wisconsin farmer, chose the pump, called a HeartMate 3 -- currently the only FDA-approved device of its kind in use. Instead of extending his life, though, the device led to his death, according to a lawsuit filed in December 2020 by his daughter Jamie Edwards.
Herrman's death was reported to a Food and Drug Administration database where the public can learn about device-related deaths, serious injuries, and malfunctions. The event was also described in the peer-reviewed Journal of Heart and Lung Transplantation.
In September 2021, Ramon Flores Sr. had the same device implanted at Methodist Hospital of San Antonio. A lawsuit his family filed in August alleges that the locking mechanism defect led to air embolism strokes. Flores died eight days after surgery, at age 76.
After the deaths of Herrman and Flores, Thoratec Corp., the device's manufacturer, evaluated the pumps involved. In both cases, Thoratec, a subsidiary of Abbott Laboratories, confirmed a bent locking arm. But "a direct correlation" between the HeartMate 3 and the deaths "could not conclusively be established," the manufacturer reported to the FDA.
Abbott did not respond to questions about the deaths or the alleged defects. The manufacturer denied liability in both cases. It settled Herrman's lawsuit this fall, and the Flores case is ongoing.
Wanted: A COVID Booster That Actually Works
The public's waning concern over COVID is the main reason cited for plunging stock prices and impending layoffs at Pfizer. The company bet big that people would sign up for annual COVID-19 mRNA boosters the way they do for flu shots. But people aren't: On Friday, Dec. 15, the Centers for Disease Control and Prevention reported that only 18% of adults had gotten the latest COVID shot, compared with 42% who'd gotten a flu shot.
One challenge facing the fall booster campaign is the lack of a seasonal pattern for COVID. With the flu, there's a predictable seasonal pattern and getting a shot in the fall can protect the vulnerable through the worst of the winter wave. By contrast, COVID continues to show surges of activity all year.
But the bigger problem is the quality of the new COVID boosters. Past boosters have offered weak, fast-waning protection against infection. And there's little evidence that they prevent transmission. The CDC is still arguing that they prevent the spread of the virus, but some respected infectious disease experts call this incorrect. Some experts also argue there's no evidence that giving young people multiple boosters does anything to lower their odds of infecting grandma or grandpa.
Merck Gets FDA Decision Date for New Pneumococcal Vaccine
The Food and Drug Administration has granted a priority review of Merck & Co.'s experimental pneumococcal vaccine, agreeing to decide on approval of the shot for adults by June 17, 2024.
Referred to as V116, Merck's conjugate shot is designed to protect against 21 strains of pneumococcal bacteria to prevent pneumonia and disease in adults. The pathogen presents a greater risk to older adults or those who are immunocompromised, and V116 is meant to offer broader coverage than available vaccines.
If approved, V116 will add to Merck's pneumococcal vaccine franchise and compete against Pfizer's leading Prevnar 20 shot.
Merck and Pfizer have been major players in the lucrative market for pneumococcal disease vaccines, but Pfizer has had the upper hand with its blockbuster Prevnar franchise. Prevnar 20, which was approved by the FDA in 2021, succeeded the earlier Prevnar 13 shot and has helped boost the company's vaccine sales.
Inhaled COVID Vaccines Stop Infection in Its Tracks in Monkey Trials
Delivery of COVID vaccines directly to the lungs and nose can stop SARS-CoV-2 infections in their tracks, according to a trio of new studies in monkeys. The research offers a boost to the wave of 'mucosal' COVID-19 vaccines now in development -- and provides clues about how they might be improved.
Until now, there has been little evidence that mucosal vaccines, which are taken by nose or mouth, shield people against infection any better than existing COVID-19 jabs do. Even so, some countries have already approved such vaccines, and key trials are underway in the United States, with others set to start.
Together, the studies show that how and where vaccines are delivered can have a profound effect on the immunity generated and the protection conferred. The latest results also raise hopes that mucosal vaccines that offer 'sterilizing' immunity -- complete blockage of infection -- could become a reality.
AbbVie Lawsuit Says Rival Adcentrx Stole Anti-Cancer Secrets
Pharmaceutical company AbbVie (ABBV.N) has sued startup Adcentrx Therapeutics in California federal court, accusing it of stealing trade secrets to develop competing cancer-fighting antibodies by hiring away an AbbVie scientist.
AbbVie said in the lawsuit, filed on Friday, that the "very existence" of its antibody program was secret before Adcentrx and former AbbVie researcher Danny Lee allegedly took the company's confidential information and disclosed it in patent applications and investor materials.
AbbVie's lawsuit said that the North Chicago-based company has been developing "antibody-drug conjugates" since 2015 that deliver cancer-fighting "payloads" directly to cancer cells.
San Diego-based startup Adcentrx hired Lee, a key scientist on the program, in 2021, according to the complaint. AbbVie accused Lee of taking confidential information to Adcentrx that the startup allegedly used to apply for ADC-related patents.
German Court Quashes CureVac Patent After Challenge by BioNTech
A German court on Tuesday invalidated a patent that was the basis of a patent violation lawsuit brought by CureVac against its domestic rival BioNTech, in a blow to CureVac's claims for a share in billions of euros in COVID-19 vaccine revenues.
CureVac's Nasdaq-listed shares plunged 35% to a record low after the verdict.
The patent in question is one of several intellectual property titles related to messenger RNA technology in vaccines that CureVac (5CV.DE) claims were infringed in ongoing legal proceedings.
CureVac's efforts to develop an mRNA-based COVID-19 vaccine did not come to fruition during the pandemic, whereas BioNTech and its partner Pfizer (PFE.N) chalked up more than $40 billion in combined vaccines sales in 2021 and 2022.
CureVac, which is working with GSK (GSK.L) on next-generation mRNA shots, said in a statement it would appeal before the German Federal Court of Justice and that Tuesday's court ruling did not affect its ongoing litigation related to seven other intellectual property titles against BioNTech.
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