Articles Posted in Clinical guidelines

aduhelm-300x250As the nomination of Dr. Robert Califf to head the federal Food and Drug Administration advances, he and the agency already are confronting a major regulatory crisis over Aduhelm, a prescription drug targeted for Alzheimer’s treatment and approved on the thinnest of evidence.

An FDA sister agency, the Centers for Medicare and Medicaid Services (CMS), has joined the Department of Veterans Affairs in sharply restricting Aduhelm’s use and coverage for payment.

Quickly after the FDA approved the drug made by Biogen and the maker priced it at $56,000 annually for patients, the VA said it would consider Aduhelm for use in one of the nation’s largest health systems only on a case-by-case basis.

gorsuch-150x150What is good for geese is not for ganders, the U.S. Supreme Court has decided.

The justices ruled 5-4 that the Biden Administration may force health employers to require their staff to get vaccinated or lose important federal funds, but in a 6-3 vote they rejected a vaccine-or-test mandate for companies with more than 100 employees for their workers in close contact with others.

The high court majority, assailed by dissenting justices, sided with conservative Republican state officials’ legal challenges and ripped away an important, proven way to quell the worst public health crisis in a century — a pandemic that is slamming the U.S. health system and is on its way to killing at least 850,000 Americans and infecting more than 65 million of us in recent months.

pregnant-300x200Expectant parents have gotten an ugly exposure to a rapacious aspect of modern medicine: Over testing, over diagnosis, and over treatment, specifically with a new, fast-growing high-tech twist.

The grownups — whether over-reaching to safeguard the unborn or in a simply silly way to determine the gender of their hoped-for bundle of joy — are ordering unnecessary, expensive, and too often alarming prenatal genetic blood tests. These rapid exams purport to tell whether a fetus may have the rarest of congenital diseases, the New York Times reported in some admirable digging, triggered by a stack of patients’ surprise medical bills.

Reporters Sarah Kliff and Aatish Bhatia found a big problem with the high-tech prenatal screens: The tests too often are dead flat wrong.

fdanulogo-300x126Critics are slamming the federal Food and Drug Administration for dropping the ball in informing the U.S. officials who run the Medicare, Medicaid, and veterans’ health programs about crucial regulatory decisions, leading the federal government apparently to pay hundreds of millions of dollars for patients to get a defective heart device and potentially to pay billions of dollars for a prescription medication targeted at Alzheimer’s but with questionable evidence of its effectiveness.

FDA officials insist that they acted in patients’ best interests when they posted on an agency website, along with thousands of other public communications, a warning letter issued to the maker of the HeartWare Ventricular Assist Device, or HVAD. That missive told the device maker HeartWare — and later its acquiring company Medtronic — that the FDA found serious problems with the HVAD tied to patient injuries and deaths.

The FDA eventually would amass “thousands of reports of suspicious deaths and injuries and more than a dozen high-risk safety alerts from the manufacturer,” ProPublica, the Pulitzer Prize-winning investigative new site found. “One horrifying device failure after another” led HVAD’s maker to halt the manufacture of the supposed life-sustaining heart pump. The firm has agreed to a long-term plan to deal with the calamity of patients who now cannot have the defective device removed.

emergencysign-300x134Nursing homes and other long-term care facilities are playing a sad, familiar, and disturbing role in the U.S. health system’s teetering on the verge of collapse in too many parts of the country due to the coronavirus pandemic.

The owners and operators of the care facilities for the aged, sick, and injured insist they have done as well as they could have under unusual, calamitous conditions. But after taking in billions of dollars of emergency taxpayer assistance, they apparently have not moved with the needed alacrity to deal with their previous problems or to assist in positive ways with the crisis now slamming the health care system.

Just a reminder that the U.S. health system has its own “supply chain” nightmare. Hospitals offer intensive care, and their beds and other treatment spaces are among the system’s most costly, and, in the pandemic, in the highest demand.

dccovidcasessoarnyt-300x186The coronavirus pandemic is tearing up the country with the Omicron variant shattering infection records and rates and this viral strain and the Delta variant overwhelming hospitals and threatening to break the already exhausted U.S. health care system.

Uncertainty has returned to conversations about the pandemic’s course, as educators decide whether to return students at least temporarily to online learning, travel has been disrupted, and businesses make tough health safety decisions.

dec22deathsvaxvunvaxnyt-300x180Patients and experts alike are pondering basic questions in dealing with the disease and its risks. These include whether deaths, a lagging indicator, will spike with Omicron as they did with the Delta surge, and are current responses — such as cloth or “surgical” face coverings, isolation, quarantine, and rapid testing — as effective with highly contagious Omicron?

hospitalbedhospice-300x200Profit-raking private investors, aka hedge funders, have taken aim at operations intended to help the elderly, desperately ill, and grievously injured experience a dignified death. The rapacious takeover of the hospice industry nationwide ought to be setting off political and regulatory alarms in a rapidly graying nation.

As is typically the case when MBA-driven interests buy up different kinds of enterprises, they not only don’t exhibit much concern about the whys or wherefores of a business. They focus, instead, on how they can build volume, while cutting services, staff, and costs, the Huffington Post reported, describing what private equity firms have targeted for hospices. As the online news site found:

“Today, private equity firms are acquiring American hospices at an astonishing rate. From 2012 to 2019, the number of hospices owned by private equity companies tripled. The pace of acquisitions seems to have only gotten faster during the Covid-19 pandemic. Industry brokers who have never before put together a deal involving private equity say they now field calls from private equity buyers multiple times a week. Tempted by a wave of retiring baby boomers, the-sky’s-the-limit Medicare payments, the mom-and-pop nature of the industry and a lack of regulation that is pretty startling even by U.S. standards, private equity now accounts for three out of every five new hospice acquisitions.”

The Omicron variant swiftly has become the nation’s dominant strain, with coronavirus infections skyrocketing from coast to coast.

Officials are anxiously awaiting data to gauge the severity of Omicron infections and if the sharp rise in cases involving this variant will mean overwhelming numbers of patients requiring care in hospitals, too many of which already have been swamped, treating those infected with the deadly Delta variant.

femalemd-300x209They excel through four years of rigorous undergraduate study, then battle their way through four more years of tough, tough medical school. They cram to pass their medical boards and  grind through exhausting internships. They also pursue years more of exacting, sleep-deprived training in residencies and fellowships.

But, wait a minute: Women doctors earn over a professional lifetime an estimated $2 million less on average than their men counterparts? They experience gender pay gaps of 25% to as much as 50% over the course of a 40-year career?

Yes, those are the disconcerting findings of published research that analyzed data from surveys of 80,000 doctors between 2014 and 2019, the New York Times reported:

It’s that time of year to offer seasonal greetings and best wishes for happiness, prosperity, hope, peace, and goodwill.

xmasvax-300x217May many good things especially go to the courageous, beleaguered, and stalwart folks struggling with the coronavirus pandemic 24-7 (including through the holidays), notably in health care, as first responders, and, of course, in service for our country.

To everyone who reads this blog, of course, all the best and, once more, a major appeal in these uncertain times:

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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