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The federal Food and Drug Administration may be putting patients’ safety at serious risk by allowing medical device makers to self-police their products, notably in making crucial determinations in reporting to the agency the severity of harms the devices inflict. Using artificial intelligence techniques to scan a sampling of filings made by makers to the FDA over nine years, Christina Lalani, MD, of the University of California San Francisco, and colleagues found that just under a quarter of the documents mis-categorized cases in which medical devices were tied to patient fatalities. These were not reported as deaths in an…
The sunny optimism that the coronavirus pandemic might finally be quelled is fading as fast as a two-scoop ice cream cone in the summer swelter. The stark rise of the Delta variant, with its fast-surging infections, hospitalizations, and deaths, has reminded experts and the public of the pandemic’s gravity, as well as its ability to not just sustain but to mutate rapidly and require quick-changing responses. Officials across the county are urging people anew to cover their faces indoors, distance, and, for heaven’s sake, to get vaccinated if they have not done so already. Maybe the unvaccinated could be
The early coverage of the 2021 Summer Olympic Games in Tokyo has been dominated by an unexpected but rising concern — the importance of mental health to our overall wellbeing. Courageous efforts by young women superstars like Simone Biles and Naomi Osaka have helped raise consciousness globally about the importance of this issue, especially for elite competitors. Their outspoken candor has made refreshingly inarguable the short-hand formula that says: mental health = health. The two are inseparable. But can this country, with its go-go, get-ahead mentality, also absorb crucial lessons that athletes struggle with, including the power of…
A scandal of the U.S. health system may be far worse than imagined, with the medical debt sold to collection agencies alone amounting to a staggering $140 billion. The $140 billion estimate came from researchers who published in a medical journal and found that such unpaid sums had increased significantly from an $84 billion calculation in a similar 2016 study, the New York Times reported (see excellent chart, courtesy of the newspaper). The newspaper noted the debt estimate is an ugly number hanging over the finances of tens of millions of patients who are too often poor and…
Consumers have gotten eyebrow-raising views of Big Pharma’s ugly business practices and the tough and sometimes sketchy efforts to rein in the industry’s ravenous pursuit of profits — in settling claims over distributors inundating the country with lethal painkillers, or with a maker’s behind-the-scenes campaign to win U.S. approval of an Alzheimer’s medication based on dubious data. Patients are unlikely to come out ahead, or even satisfied with the outcomes of the cases involving how Johnson & Johnson (J&J), Cardinal Health, AmerisourceBergen, and McKesson handled opioids, and how Biogen and the Food and Drug Administration have dealt with…
Alarms are sounding yet again that the nation’s nursing homes and other long-term care facilities may need to increase important infection control measures and reexamine what’s going on with the staff they need to safeguard patients. Details are still emerging. But federal officials say they have sufficient evidence to report a new outbreak of  Candida auris, aka C. Auris, highly drug-resistant fungus, in a nursing home in Washington, D.C., and at two Dallas-based hospitals. This “superbug” is considered a menace because infected patients do not respond to treatment with three major drug groups. This outbreak also has…
As coronavirus cases surge, hospitalizations rise, and deaths tick up — mostly among the unvaccinated — the national conversation has returned to familiar controversies over public health measures like getting people shots and getting them to cover their faces again. But with the Delta variant tearing mostly through those who haven’t gotten shots, a new twist also has emerged. Could the latest trend by dubbed, “enough is enough?” Patience with the resistant and reluctant — a little under half the U.S. population — may be running out. The largest hospital association in the country told its members that it…
Hospitals finally are saying bull feathers to the leading maker of surgical robots that cost institutions millions of dollars annually to buy and maintain. New lawsuits against Intuitive Surgical dispute the company’s business practices, including the exclusivity it demands for its costly services and products. But will the civil claims also crack open the door to bigger questions about daVinci robots and other such medical devices and whether they benefit patients or just add backbreaking costs to their hospital bills? Intuitive has declined to comment on the suits filed against it in federal courts in California by the Franciscan…
“It’s huge, it’s historic, it’s unheard of, unprecedented, and a real shame. It’s a complete shame” That quote, reported by the New York Times and made by Daniel Ciccarone, a professor of medicine at the University of California, San Francisco, tragically summarizes the latest  federal data on the opioid abuse and drug overdose crisis. As the newspaper and others reported: “Drug overdose deaths rose nearly 30% in 2020 to a record 93,000, according to preliminary statistics released … by the Centers for Disease Control and Prevention. It’s the largest single-year increase recorded.” Continue reading
Patients, politicians, and regulators may find it tough to believe, so they need sharp periodic reminders: While there are many terrific, dedicated doctors working today, there also are some truly terrible ones. And dealing with the harms of medical malpractice by the incompetent and abusive can require courage and vigilance. Perhaps a new, streamed Hollywood serial — starring the likes of Alec Baldwin, Christian Slater, AnnaSophia Robb, and Joshua Jackson — can underscore for the public how grisly the results can be until a rare criminal prosecution derails the likes of Christopher Duntsch, a Dallas surgeon so grim he is…