Morning Briefing
Summaries of health policy coverage from major news organizations
Allergan To Pay $200M To Settle With New York Over Opioid Crisis
The New York Times: Allergan Settles With N.Y. For $200 Million In Sprawling Opioid Case
A large pharmaceutical manufacturer has agreed to pay $200 million in a settlement reached just before closing arguments began in a monthslong opioid trial in New York, the state’s attorney general announced on Wednesday. The settlement with Allergan, a company that has made opioids but whose most well-known product is Botox, is the latest agreement in a trial jointly argued by New York State and two counties that began in June. The case was the first of its kind brought against the entire opioid supply chain, from pharmaceutical companies that manufacture the pills to the distributors and pharmacy chains that filled the prescriptions. (Nir, 12/8)
Stat: AbbVie Unit To Pay $200 Million To Resolve Closely Watched Opioid Lawsuit In New York
Allergan, which is a unit of AbbVie (ABBV) agreed to pay up to $200 million to resolve allegations made by New York state and two of its counties that the company helped fuel the opioid crisis and in the process, created a public nuisance that cost billions of dollars in public services. As a result, Allergan is no longer part of a trial that is close to completion. The case is continuing against Teva Pharmaceutical (TEVA), which has denied the charges. Several other pharmaceutical makers and wholesalers previously settled with the state, including Johnson & Johnson (JNJ), Endo International (ENDP), McKesson (MCK), Cardinal Health (CAH), and AmerisourceBergen (ABC). So far, the state has negotiated $1.7 billion in settlements over the opioid crisis. (Silverman, 12/8)
And the defense rests its case in the Theranos trial —
The Wall Street Journal: The Elizabeth Holmes Trial: The Defense Rests Its Case
Elizabeth Holmes’s lawyers rested their case Wednesday in her criminal-fraud trial, after the founder of blood-testing startup Theranos Inc. gave testimony over seven days in which she acknowledged regrets but also placed blame on her former deputy and boyfriend. She asserted she never defrauded anyone. Among the final questions from her attorney on Wednesday, Ms. Holmes was asked whether she ever tried to mislead investors. “Never,” she said. (Somerville and Randazzo, 12/8)
AP: What Elizabeth Holmes Had To Say At Her Trial: 5 Takeaways
Once-lionized entrepreneur Elizabeth Holmes wrapped up seven days of testimony in her criminal fraud trial Wednesday, having largely used the time to defend her actions as CEO of the startup Theranos. The company she founded had soared on the promise of innovative blood-testing technology only to crash in a sordid display of failure and alleged deceit. Holmes alternately took responsibility for her missteps as CEO and cast herself as the abused victim of her former lover and business partner Sunny Balwani. She also repeatedly said she couldn’t recall her actions at key points even when confronted with internal documents including her own emails. (Liedtke, 12/9)
In other pharmaceutical industry news —
Stat: Asthma Drug Study Failed To Include Children Who Could Benefit Most
If a drug maker tested an asthma treatment in children and found it significantly reduced attacks compared with a placebo, this would be considered good news, yes? But what if the children enrolled in the clinical trial were almost entirely white, even though asthma disproportionately affects Black and Puerto Rican children? This would dampen my enthusiasm, to say the least. And it would make me wonder why a company would fail to study enough of the children who are most in need. (Silverman, 12/8)
Stat: Biogen's Reckoning: How The Aduhelm Debacle Pushed It To The Brink
The shocking revelation came in a Saturday afternoon email, restricted to a tight circle of top executives within Biogen. Al Sandrock, the company’s most prominent scientist and chief of its entire research and development group, was leaving. There was no warning or explanation. After 23 years at Biogen, Sandrock, 64, had apparently decided it was time to retire. The real story, according to multiple people close to Biogen, is that Sandrock was pushed out by the company’s CEO, Michel Vounatsos — an effort to blame the scientist for the polarizing approval and disastrous commercial rollout of Aduhelm. Just five months earlier, the company heralded the drug as a revolutionary advance in Alzheimer’s disease, and the first new treatment in nearly two decades. (Feuerstein and Garde, 12/8)
Stat: Syrian Refugee Is Thriving Five Years After Last-Gasp Gene Therapy
In the summer of 2015, a 7-year-old named Hassan was admitted to the burn unit of the Ruhr University Children’s Hospital in Bochum, Germany, with red, oozing wounds from head to toe. It wasn’t a fire that took his skin. It was a bacterial infection, resulting from an incurable genetic disorder. Called junctional epidermolysis bullosa, the condition deprives the skin of a protein needed to hold its layers together and leads to large, painful lesions. For kids, it’s often fatal. And indeed, Hassan’s doctors told his parents, Syrian refugees who had fled to Germany, the young boy was dying. (Molteni, 12/8)
