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Merck Shingles Vaccine Appeal Will Test Controversial Mass Torts Case Management Tool
The federal trial judge overseeing a four-year-old multidistrict litigation over Merck’s Zostavax shingles vaccine decided in March 2022 that it was time for plaintiffs to put up or shut up.
The judge, U.S. District Judge Harvey Bartle of Philadelphia, had already granted summary judgment to Merck (MRK.N) in five bellwether cases by plaintiffs who claimed that the Zostavax vaccine caused them to develop shingles instead of protecting them from the virus.
Bartle ruled that the bellwether plaintiffs’ expert failed to offer scientifically reliable evidence that their illness was specifically triggered by Merck’s vaccine and not instead linked to the far more common strain of virus that lingers in the nerve cells of people who have had chickenpox.
The bellwether summary judgment process persuaded Bartle that the only surefire way to determine whether a plaintiff’s virus was linked to the Merck vaccine was through a laboratory test known as a polymerase chain reaction, or PCR, assay. Government researchers used PCR tests in a study to determine whether the Merck vaccine could trigger the shingles virus; Merck does not dispute that possibility but maintains that such cases are vanishingly rare.
Based on that “lesson” from the bellwether litigation, Bartle issued what is known as a Lone Pine order — an increasingly prevalent MDL case management tool — calling for nearly 1,200 plaintiffs in the consolidated litigation to submit laboratory test results showing that their shingles virus was specifically linked to the virus strain contained in the Merck vaccine.
Pfizer to Price COVID Drug Paxlovid at $1,390 per Course
Pfizer will price a five-day course of its COVID antiviral drug Paxlovid at $1,390 when the company starts to transition it to the commercial market later this year.
A company spokesperson on Wednesday confirmed the price, which was first reported by The Wall Street Journal. That list price, which is before rebates and other discounts to insurers and pharmacy benefit managers, is more than double the $529 the federal government paid for Paxlovid.
The government has purchased and distributed Paxlovid to the public for free since December 2021, when the FDA first authorized the treatment. But beginning in 2024, Pfizer will sell Paxlovid directly to health insurers, which comes as demand for COVID vaccines and treatments slumps nationwide.
Doctors, health experts and patient advocates have raised concerns that a higher price will curb access to the life-saving treatment, which has been shown to reduce the risk of severe disease and death from COVID among vulnerable patients, such as those with diabetes, heart conditions or a weakened immune system.
Feds Try to Head Off Growing Problem of Overdoses Among Expectant Mothers
When Andria Peterson began working as a clinical pharmacist in the pediatric and neonatal intensive care units at St. Rose Dominican Hospital in Henderson, Nevada, in 2009, she witnessed the devastating effects the opioid crisis had on the hospital’s youngest patients.
Pregnancy often motivates people to seek treatment for substance use, she said. Yet significant barriers stand in the way of those who want care, even as national rates of fatal drug overdoses during and shortly after pregnancy continue to rise. In addition to the risk of overdose, substance use during pregnancy can result in premature birth, low birth weight, and sudden infant death syndrome.
A federal initiative seeking to combat those overdoses is distributing millions of dollars to states to help fund and expand programs like Empowered. Six states will receive grant funding from the Substance Abuse and Mental Health Services Administration to increase access to treatment during and after pregnancy.
The Nevada Health and Human Services Department is distributing the state’s portion of that funding, about $900,000 annually for up to three years, to help the Empowered program expand into northern Nevada, including by establishing an office in Reno and sending mobile staff into nearby rural communities.
J&J Weighs Third Bankruptcy Try to Settle Baby Powder Suits
Bloomberg via Yahoo!Finance reported:
Johnson & Johnson said it is weighing a third attempt to use bankruptcy for an $8.9 billion settlement of tens of thousands of lawsuits that allege tainted talc in the company’s baby powder caused cancer.
Erik Haas, J&J’s lawyer in charge of litigation, said during the company’s earnings call Tuesday that the world’s largest maker of healthcare products is working with law firms representing “the vast majority” of talc victims to settle all current and future cases that could potentially cost J&J billions of dollars in damages if they go to jury trials.
“We’re pursuing a consensual resolution of the talc claims through another bankruptcy,” Haas said. He added that J&J also will continue to “vigorously defend itself” in talc cases that come to trial while it explores the bankruptcy option once again.
Courts have twice rejected J&J’s attempts to use the bankruptcy courts to force a talc settlement by setting up a trust to pay victims. Chapter 11 rules let corporations put money into trusts that decide how much claimants should be paid, instead of allowing juries to decide damages. Many J&J claimants have vocally opposed relying on a trust.
Recent Ruling Doesn’t Bolster J&J’s Defamation Case, Scientist Says
A scientist being sued for defamation by Johnson & Johnson over her research linking the company’s talc powder to cancer has said that a recent decision discounting her testimony in a different case does not bolster the company’s claims against her, urging a judge to dismiss the lawsuit.
Lawyers for Jacqueline Moline, in a filing Monday in New Jersey federal court, said the recent ruling only “shows the system working precisely as it should,” with J&J free to challenge the admission of expert testimony in trials, rather than by suing experts.
J&J faces more than 38,000 lawsuits alleging that its talc products, including Johnson’s Baby Powder, can contain asbestos and caused cancers including ovarian cancer and mesothelioma. The company has said its talc products are safe, do not contain asbestos and do not cause cancer.
Moline has testified for plaintiffs in trials against the company and has published papers linking talc products to cancer. J&J is suing several other expert witnesses in addition to Moline, in what legal experts have called a highly unusual, aggressive strategy. So far there have been no decisions in the lawsuits.
Clinical Challenges: Vaccines That Target Cancers — Positive Trial Results Are Generating Excitement About the Strategy
At the outset, cancer vaccines were plagued with false starts and modest success at best. But they now represent a promising therapeutic strategy in the immunotherapy of solid tumors.
“First, we know the type of immune response we need to eradicate cancer,” Disis told MedPage Today. “We need type 1 T cells, and these are both CD8 and CD4 lymphocytes — the CD4 lymphocytes secrete what are called type 1 cytokines. These are highly inflammatory, and they help the CD8 lymphocytes proliferate and kill. That’s not an open-ended question anymore — we need a type 1 T-cell immune response, and that solves a lot of issues in terms of vaccine design.”
The second big breakthrough, she said, “is that we know a lot of different immunogens or antigens — what we need to immunize against.” That’s important, she said, “because we are now able to create vaccines that are immunizing against the most important proteins driving a particular kind of cancer — and that has been somewhat of a game changer.”
Like the mRNA COVID-19 vaccine, mRNA-4157/V940 is based on messenger RNA. It is a personalized cancer vaccine consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient’s tumor.
NIH Nominee Walks the Line
Dr. Monica Bertagnolli, President Joe Biden’s nominee for director of the National Institutes of Health, didn’t bend to pressure from the Senate HELP Committee to state a position on prescription drug pricing during her confirmation hearing Wednesday, Erin reports.
“If you are confirmed to be the next NIH director, will you commit to reinstating and expanding the reasonable pricing clause in NIH contracts?” Chair Bernie Sanders (I-Vt.) asked.
Taxpayers deserve a fair return on their investment, Bertagnolli responded. She agreed to broadly ensure that the benefits of NIH research are affordable and available but stopped short of making the commitment Sanders asked of her. “I cannot give further specifics at this time about the execution of that plan,” she told him.
The exchange comes after Sanders held up the National Cancer Institute director’s nomination for months, vowing to oppose the administration’s health nominees until it took more actions on reducing drug costs. In September, after a deal between the federal government and the biotech company Regeneron that included a reasonable pricing clause, Sanders agreed to schedule Bertagnolli’s hearing.
Pfizer Wins Unconditional EU Antitrust Okay for $43 Billion Seagen Buy
U.S. pharmaceutical company Pfizer (PFE.N) gained unconditional EU antitrust approval on Thursday for its proposed $43 billion acquisition of cancer drug maker Seagen (SGEN.O).
Pfizer announced the deal in March, its largest purchase in a string of recent acquisitions thanks to a once-in-a-lifetime cash windfall from its COVID-19 vaccine and treatment.
The European Commission said the deal would not significantly reduce competition in the 27-country European Union nor would it have a negative impact on prices.
One Year Later, Where’s All the Adderall?
The U.S. is facing a mystery of missing Adderall — one for which nobody has an answer. Oct. 12 marked one year since the U.S. Food and Drug Administration’s formal announcement that pharmaceutical companies were unable to produce enough Adderall, one of the common amphetamine-based medications for attention-deficit/hyperactivity disorder (ADHD).
As a result, many of the 41 million ADHD patients nationwide who rely on the drug daily to stay focused and reduce impulsive behavior have faced refill delays and empty inventories at their pharmacies.
Eight drug manufacturers have reported shortages of Adderall, which also means other major ADHD medications are now in short supply after psychiatrists turned to other treatment options for patients. In a year with the highest rate of drug shortages reported since 2014, “this one really baffles me,” says Marta Wosińsk, a senior fellow and health care economist at the Brookings Institute. The scarcity of Adderall remains uniquely confusing, she says, not only because there is no plan to remedy it, but because the major players involved in making and regulating the drug have provided little explanation, choosing instead to point fingers at one another while the public is left to speculate.
Experts say the FDA bears some responsibility for the ongoing shortage, as its lax reporting standards for manufacturers are the primary reason why there are still only theories about the shortage’s cause, rather than answers. These potential causes, which include increased prescription rates and the U.S. Drug Enforcement Administration’s tight control of critical ingredients, are impossible to investigate because of how little information the parties are required to provide to the public and one another.
Bankrupt Rite Aid Resolves Drug Supply Dispute With McKesson
Pharmacy chain Rite Aid has settled a critical dispute with drug supplier McKesson Corp (MCK.N) to ensure that customers’ prescriptions will continue to be filled during Rite Aid’s bankruptcy, attorneys said on Tuesday.
Rite Aid, which filed for Chapter 11 bankruptcy on Sunday night in New Jersey, sued McKesson the following morning, seeking to stop it from terminating a drug supply agreement that accounts for 98% of the pharmacy chain’s prescription drug sales.
