Login
Supreme Court Blocks Purdue Pharma’s Bankruptcy Settlement, Threatening Immunity to Sackler Family
It’s been a rough summer for pharmaceutical companies trying to resolve lawsuits by declaring bankruptcy.
Last month, a federal bankruptcy judge denied Johnson & Johnson’s second effort to Texas two-step its way to an $8.9 billion settlement to resolve talc claims. And now, the Supreme Court has blocked Purdue Pharma’s bankruptcy settlement, which granted the company’s former owners — the Sackler family — immunity from civil suits related to the opioid crisis.
The action is temporary as it allows the court to hear the Justice Department’s claim that a reorganization of a company under Chapter 11 can’t be used to extinguish lawsuits against “third party non-debtors” — in this case, the Sacklers — without consent of the claimants. The court will hear oral arguments in December.
In May of this year, a U.S. appeals court signed off on the settlement, which provided legal protection to the Sacklers in exchange for $6 billion. The ruling reversed a previous lower court decision, which removed legal protection for the family.
Family of Henrietta Lacks Files New Lawsuit Over Cells Harvested Without Her Consent
Just over a week after Henrietta Lacks’ descendants settled a lawsuit against a biotech company they accused of unjustly profiting off her cells for generations, the family’s attorneys have filed another claim against a different corporation.
The new lawsuit, which targets California-based biopharmaceutical company Ultragenyx, was filed Thursday in Baltimore federal court, the same venue as the recently settled case. Lawyers for the family have said they plan to bring a series of lawsuits against various entities that continue to reap the rewards from the racist medical system that took advantage of Lacks.
She died at age 31 in the hospital’s “colored ward,” but her genetic material lived on, the first human cells to continuously grow and reproduce in lab dishes. HeLa cells have since become a cornerstone of modern medicine, enabling countless scientific and medical innovations, including the development of the polio vaccine, genetic mapping and even COVID-19 shots.
The complaint says Ultragenyx has made a fortune by using HeLa cells to develop gene therapy products.
Dementia Risk Linked to Nexium, Prilosec, Similar Heartburn Drugs After Long-Term Use: Study
Long-term side effects of Nexium, Prilosec and similar proton pump inhibitor (PPI) medications may increase the risk of dementia, according to the findings of a new study that raises additional concerns about the risks associated with the popular heartburn drugs, which many individuals take for years.
Researchers at the University of Minnesota report that individuals taking proton pump inhibitors for longer than four years faced a 33% increased risk of being diagnosed with dementia. Their findings were published on August 9 in the medical journal Neurology.
PPIs are designed to reduce the amount of acid in the stomach, treating gastroesophageal reflux disease (GERD), as well as heartburn, ulcers in the stomach and small intestines, and inflammation of the esophagus. In addition to Nexium, Prilosec and Prevacid, the class also includes the brand name medications Protonix, Zegerid, AcipHex, Dexilant and Vimovo, as well as a number of generic equivalents.
While the drugs have been promoted for years as safe and effective, leading many to believe they carry few serious side effects, the manufacturers have faced thousands of Nexium lawsuits, Protonix lawsuits, Prilosec lawsuits and Prevacid lawsuits, each raising similar claims that plaintiffs were left with acute kidney injury, chronic kidney disease, end-stage renal failure and other unexpected health problems.
Doctors Can Prescribe Ivermectin for COVID: FDA Lawyer
Doctors are free to prescribe ivermectin to treat COVID-19, a lawyer representing the U.S. Food and Drug Administration (FDA) said this week.
“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during oral arguments on Aug. 8 in the U.S. Court of Appeals for the 5th Circuit. The government is defending the FDA’s repeated exhortations to people to not take ivermectin for COVID-19, including a post that said “Stop it.”
The case was brought by three doctors who allege the FDA unlawfully interfered with their practice of medicine with the statements.
The plaintiffs are Drs. Paul Marik, Mary Bowden, and Robert Apter. They say they were professionally harmed by the FDA’s statements, including being terminated over efforts to prescribe ivermectin to patients. Dr. Marik has noted that a number of studies support using ivermectin against COVID-19, as the FDA itself has acknowledged. Some other studies show little to no effect.
Novo Nordisk’s Wegovy Soars, Crossing $1 Billion Mark in a Single Quarter
As Novo Nordisk works through supply constraints, Wegovy again stole the show at the Danish drugmaker. For Novo overall, there’s “a lot to be proud of” in 2023’s second quarter, the company’s head of North American operations, Doug Langa, said in an interview.
First off, Novo’s sales climbed 30% to 107.7 billion Danish kroner (about $15.9 billion). That marks the “highest quarterly growth we’ve seen in the last 20 years,” Langa said. Those sales are being driven primarily by Novo’s GLP-1 business, which includes the star diabetes drugs Ozempic and Rybelsus, alongside the company’s newer obesity offering Wegovy.
Diabetes and obesity care sales climbed 37% to 99 billion DKK for the three-month period, with GLP-1 diabetes revenues specifically rising 50%, Novo said in a press release. Obesity care, meanwhile, grew a whopping 157% to 18.1 billion DKK, including 7.5 billion DKK ($1.1 billion) from Wegovy.
This is the first time that Wegovy has crossed the blockbuster threshold in one single quarter. Novo’s total obesity care business includes both Wegovy and its weight loss predecessor Saxenda.
New Alzheimer’s Drug Raises Hopes — Along With Questions
The FDA has approved Leqembi, the first disease-modifying treatment for early-stage Alzheimer’s and a precursor condition, mild cognitive impairment. Medicare has said it will pay for the therapy. Medical centers across the country are scrambling to finalize policies and procedures for providing the medication to patients, possibly by summer’s end or early autumn.
Unanswered questions abound as this new era of treatment begins for mild cognitive impairment and early-stage Alzheimer’s. Will Leqembi’s primary benefit — a slight slowing of decline in cognition and functioning — make a significant difference to patients and family members or will it be difficult to discern? Will its effects accelerate, decelerate, or flatten out over time?
Will demand for Leqembi (the brand name for lecanemab), a monoclonal antibody that requires infusions every two weeks, be robust or restrained? How many older adults in their 70s and 80s will be able and willing to travel to medical centers for infusions twice a month and have regular MRI scans and physician visits to monitor for potential side effects such as brain bleeds or swelling?
Leqembi basics. Leqembi is very effective at removing amyloid plaques (a protein that clumps between neurons) from people’s brains. But it doesn’t reverse cognitive decline or prevent future deterioration.
Woman Shares MRI Scan to Prove How Contraceptive Pill Gave Her Two Tumors
“I don’t want to scare women about birth control, but I do want to inspire women to be the CEOs of their bodies,” 30-year-old Makenzie Hammond told Newsweek.
The California-based marketing professional was diagnosed with two benign liver tumors in January, which her doctors claimed her contraceptive pill was to blame for. These tumors are called hepatic adenomas and are defined as rare tumors of the liver that are frequently associated with oral contraceptive pill usage by the National Center of Biotechnology Information’s National Library of Medicine.
Hammond has since shared her MRI scan online in a bid to encourage other women to think deeply about their contraceptive options. Her emotional video, which can be seen here, has already been viewed by over 1.2 million users since it was first shared on TikTok in late July.
Amid Hammond’s tireless graft to get more people to assess their choice of contraception, the effectiveness and safety of the contraceptive pill have continued to be called into question. The controversy surrounding the medication catapulted to a height in March after researchers at the University of Oxford managed to establish a link between the progestogen-only pill and breast cancer after this mode of the pill was long thought to be at little to no risk of triggering the disease.
U.S. FDA Approves Johnson & Johnson’s Blood Cancer Therapy
Johnson & Johnson (JNJ.N) said on Thursday the U.S. Food and Drug Administration had approved its antibody-based therapy for patients with a difficult-to-treat type of blood cancer.
The therapy, talquetamab-tgvs branded as Talvey, belongs to a class of treatments called bispecific antibodies designed to bring a cancer cell and an immune cell together so the body’s immune system can kill the cancer.
The FDA also placed its strongest “boxed” safety warning on the drug’s label, flagging the risk for a type of aggressive immune response or cytokine release syndrome and neurologic toxicity.
