Articles Posted in Clinical guidelines

fdanulogo-300x126The 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 important FDA information source known as MAUDE (the Manufacturer and User Facility Device Experience database). Instead, they were “classified as either malfunction, injury, or missing (the report was not put in any category),” reported the medical site MedPage Today.

cdcjanjuly21covidcases-300x180The 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 paid $100 by states from coronavirus relief funds to get the shots, President Biden has suggested.

lotsapills-300x200Consumers 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 Aduhelm.

A major opioids settlement

candidacdcauris-300x135Alarms 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 experts’ attention because it shows signs of a different way of spreading — patient-to-patient transmission.

covidhotspotsjuly242021mayo-300x219As 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 is past time to require health workers to get vaccinated. These valuable individuals already work under mandates for other inoculations and the latest coronavirus surge, which could result in spiking deaths in the fall, is cause enough for a vaccination mandate, the group said.

davincirobot-300x176Hospitals 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 and Kaleida health systems. The company has denied one aspect of the media reports about the suits — that it shut down its robots remotely in the middle of a patient’s operation, forcing a surgeon and his team to improvise and finish the procedure (without problems) using standard techniques.

cdcnytopioidcrisisjuly2021-183x300“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.”

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 nicknamed “Dr. Death?”

Coronavirus infections have increased in just a week by 70%, with hospitalizations increasing 36% and deaths rising by 26%.

Public health officials blame the Delta variant for fueling the latest surge in the coronavirus pandemic, the New York Times reported, noting:

fentanylillustration-300x99Just as attorneys generals for more than a dozen states inch toward a multibillion-dollar settlement with a drug maker faulted for its big role in the start of the opioid abuse and drug overdose crisis, that health menace is taking a new, deadly turn in the region around the nation’s capital.

In Washington, D.C., Maryland, and Virginia, officials report they are grappling with spiking overdose deaths, numbering in the hundreds, and blamed on the rise of fentanyl. It is a synthetic, prescription painkiller developed to assist late-stage cancer patients. It packs a wallop. And Big Pharma companies pushed for its wider use with aggressive marketing and sales campaign that landed some drug executives in jail.

The excessive promotion of fentanyl also led to its illegal manufacture, notably in chemical factories in China. Its increasing abuse, along with other opioids, also opened the door to big problems with illicit drugs.

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