Prosecutors Close Arguments In Elizabeth Holmes Case
Media outlets cover the closing arguments, saying Elizabeth Holmes "willfully lied" about the blood testing technology at the core of Theranos' business. Calls for drug supply chain restructuring, an FDA rebuke for Endo, demotions at Amazon Pharmacy and CMS' "breakthrough device" rules are also reported in health industry news.
The Wall Street Journal:
The Elizabeth Holmes Trial: Prosecution Gets Final Chance To Sway Jurors
Prosecutors in Elizabeth Holmes’s criminal-fraud trial made their case one more time in closing arguments Thursday as jurors move closer to deciding the fate of the Theranos Inc. founder. Assistant U.S. Attorney Jeffrey Schenk gave jurors a summation of the government’s case against Ms. Holmes, arguing she knowingly and willfully lied about Theranos’s technology to salvage her startup as it quickly ran low on money. (Somerville, 12/16)
AP:
Elizabeth Holmes Jurors Hear Different Takes On Her Downfall
Jurors in the case of former Theranos CEO Elizabeth Holmes on Thursday heard starkly different interpretations of her motives and actions as her long-running criminal trial nears the finish line. A federal prosecutor cast Holmes as a desperate con artist who brazenly lied to get rich, while her lawyer depicted her as a well-meaning entrepreneur who never stopped trying to perfect Theranos’ blood-testing technology and deliver on her pledge to improve health care. (Liedtke, 12/17)
The Washington Post:
The Fortune Cover Made Elizabeth Holmes A Star And Might Send Her To Prison.
The story was 5,500 words of pure rapture about a Silicon Valley company few had ever heard of and its intriguing chief executive. Theranos, declared Fortune magazine in 2014, appeared to be on the verge of revolutionizing the health care industry with a wondrous new technology for diagnosing diseases with just a few drops of blood. The magazine’s cover put a human face on the company’s alleged breakthroughs. Theranos’s founder, a young woman named Elizabeth Holmes, stared at readers with serene blue eyes and a Mona Lisa smile. “This CEO Is Out for Blood,” the headline read. (Farhi, 12/16)
In other pharmaceutical and biotech news —
Modern Healthcare:
Provider Groups Call For Drug Supply Chain Restructuring To Avoid Shortages
The federal government should offer incentives to encourage drugmakers to manufacture critical medicines and active pharmaceutical ingredients, a coalition of provider organizations urge in a set of policy recommendations issued Thursday. Rewarding pharmaceutical suppliers for developing continuous manufacturing infrastructure in the U.S. and abroad could help mitigate drug shortages, the American Medical Association, American Society of Anesthesiologists, American Society of Health-System Pharmacists, Association for Clinical Oncology and United States Pharmacopeia urge in the report. (Kacik, 12/16)
Stat:
FDA Rebukes Endo For 'Anticompetitive Practices' And Asks FTC To Investigate
In an unusual move, the U.S. Food and Drug Administration has openly suggested that a brand-name drug maker attempted to delay competition after it petitioned the agency to reject generic versions of its biggest-selling medicine. As a result, the FDA plans to ask the U.S. Federal Trade Commission to investigate the company for “anticompetitive business practices.” (Silverman, 12/16)
Axios:
Scoop: Amazon Pharmacy Leaders Demoted
Amazon Pharmacy leaders T.J. Parker and Elliot Cohen have quietly been demoted to roles as consultants for the company, two sources familiar with the matter tell Axios. The leadership shakeup could either be an attempt at hammering out a clearer path forward or a sign of deeper troubles. Parker and Cohen have steered Amazon Pharmacy since 2018 when the tech giant acquired PillPack, their prescription drug startup. (Brodwin, 12/16)
Stat:
Prescription Apps To Treat Disease Face Uncertainty Over Coverage
In August, Pear Therapeutics, the company at the forefront of creating prescription software to treat health conditions, announced that it had landed a deal with Optum Rx, which administers pharmacy benefits for millions of people nationwide. It was a coup for an 8-year-old company, which had recently announced its intention to go public in a $1.6 billion deal, despite projecting just $4 million in revenue for 2021. According to the celebratory announcement, Pear’s three commercial smartphone apps, which deliver cognitive behavioral therapy for the treatment of substance use disorder, opioid use disorder, and insomnia, would have “formulary availability” with the country’s third-largest pharmacy benefits manager. (Aguilar, 12/17)
Modern Healthcare:
CMS To Propose New Medicare 'Breakthrough' Device Rule In 2022
The rule might differ from the Trump administration's version of the policy by requiring more evidence collection on how effective a device is for Medicare beneficiaries, and it may give the Centers for Medicare and Medicaid Services more say in the coverage determination process, said Tom Bulleit, a partner at Ropes & Gray. CMS repealed a rule last month that would have allowed Medicare to immediately cover medical devices designated as "breakthrough technology" by the Food and Drug Administration for four years after they received market authorization. (Goldman, 12/16)
KHN:
Seeking Refills: Aging Pharmacists Leave Drugstores Vacant In Rural America
Ted Billinger Jr. liked to joke that he would work until he died. That turned out to be prophetic. When Billinger died of a heart attack in 2019 at age 71, he was still running Teddy B’s, the pharmacy his father had started more than 65 years earlier in Cheyenne Wells, Colorado. With no other pharmacist to work at the store, prescriptions already counted out and sealed in bottles were suddenly locked away in a pharmacy that no one could enter. And Cheyenne Wells’ fewer than 800 residents were abruptly left without a drugstore. Pharmacies were once routinely bequeathed from one generation to the next, but, in interviews with more than a dozen pharmacists, many said the pressure of running an independent drugstore have them pushing their offspring toward other careers. (Hawryluk, 12/17)
In research news —
Fox News:
Advanced Gene Therapy May Reverse Hearing Loss Caused By Genetics: Study
Researchers at Boston Children’s Hospital found that replacing a mutated protein in the inner ear reversed severe hearing loss in mice, according to a study published in the journal Science Advances. The first-of-its-kind gene therapy technique involved replacing a mutated protein called stereocilin, (STRC), in the inner ear. The investigators said it reversed severe hearing loss in mice and in some cases, restored it to normal levels of hearing, according to a news release. The researchers explained in the release, that hearing loss has been associated with mutations of at least 100 different genes. The researchers stated that up to 16 percent of genetic hearing loss could be linked to the gene STRC, which they noted is also the second most common genetic cause. (McGorry, 12/16)
Stat:
As Aduhelm Faces Doubts, Biogen Plans Another Pivotal Trial For 2022
Biogen said Thursday that it expects to begin a large clinical trial next May to confirm the benefits of the Alzheimer’s disease treatment Aduhelm, pending clearance from U.S. regulators. The trial, a condition of Aduhelm’s Food and Drug Administration approval, could answer some outstanding questions that have kept many neurologists from prescribing Biogen’s drug. But it’ll be years before the company has data to show. (Garde and Feuerstein, 12/16)
