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.

bloodcrisis-300x108It has no artificial replacement. Patients can require enormous amounts of it, suddenly and quickly, as well as on a sustained basis. But safe, abundant supplies of blood are desperately needed now, the Red Cross says, having declared what it says is its first-ever national crisis with the country facing its most dire shortages in a decade.

The coronavirus pandemic has disrupted donations, which already were spare, says the nonprofit agency that collects 40% of the nation’s supply. In more regular times, just 3% of those who are eligible donate blood, and donations have fallen off a cliff since the pandemic started.

Demand, however, persists. As a selection of the agency’s reported statistics show:

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.

trafficsigns-171x300When it comes to serious traffic and road safety problems in the metropolitan Washington, D.C., area, to quote the late, brilliant cartoonist Walt Kelly of Pogo fame: We have met the enemy and he is us. We are the reckless, speeding, and law-defying motorists not only from the District but, yes, big numbers of bad-behaving folks from Maryland and Virginia.

As 2021 drew to a close, D.C. officials expressed their exasperation at the limits of their efforts to enforce laws to safeguard motorists, pedestrians, and bicyclists in the nation’s capital, especially with a giant legal block to doing so: cooperation and help among Virginia, Maryland, and the District to enforce traffic laws and citations, also known as reciprocity.

The Washington Post, in two separate news articles, quoted District officials’ frustration over this significant and growing problem:

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?

joy-300x268Here’s a bit of good news that may make patients jump for joy to start off 2022: Surprise medical bills mostly are supposed to end, effective Jan. 1.

Consumers still must watch out for potential big hits on their emergency transportation costs and they will need to ensure scheduled services with medical providers occur “in network.”

Just a reminder that Congress surprised its critics at the close of 2020 by passing in bipartisan fashion a ban of a practice that patients complained was one of the worst financial menaces in their medical care: surprise bills.

boozing-289x300The government statistics paint a persistently grim picture of the nation’s health, notably as it is measured in a fundamental way — our plummeting, average life expectancy. But who wants to be another tragic bit of mortality data?

Can we resolve to stay healthier in the year ahead — especially by slashing the skyrocketing numbers of us who are dying on the roads and due to the opioid abuse and drug overdose crisis?

The coronavirus pandemic led to surges, too, in excess alcohol consumption, which only  increased during the holiday festivities.

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