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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.

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.

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:

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.

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.”

COgeneratorrisk-300x140If you or someone you know has concerns enough about extreme weather events and the electrical failures that too often accompany them  to look into buying a portable generator, be sure to take great care to examine the pricey device’s safety features.

Thousands of consumers have been poisoned or killed by carbon monoxide (CO) fumes from emergency household generators, according to ProPublica, the Pulitzer Prize-winning investigative site, which joined the Texas Tribune and NBC News in digging into records on the dangers posed by the combustion engines that can provide power in critical moments.

But just as motorists must take care to avoid running their vehicles in closed environs, and consumers should not run fuel-burning heaters in confined, indoor spaces, so too, users of portable generator  must safeguard themselves and those in a wide area around them from their units’ powerful but odorless fumes. The generators, costing from $400 to $2,500, should not be run near or inside homes. As ProPublica and its partners found:

sacklerdendurtemple-225x300Fortunately for desperate regular folks, Big Pharma doesn’t always carry the day with its rapacious schemes.

Just look at how a federal judge has upended a plutocratic family’s ploy to shield themselves from a wave of lawsuits over their company’s deceitful inundating of the country with powerful painkiller, or how public furor has pummeled a firm that wanted to charge nosebleed prices for a dubious prescription medication targeted at treating Alzheimer’s.

Officials from the District of Columbia and Maryland helped stymie the wealthy Sacklers from an ugly legal bargain in a multilbillion-dollar bankruptcy case involving the family-run Purdue Pharmaceuticals and thousands of lawsuits over the company’s OxyContin painkiller.

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:

carolynmaloneypresser-300x184Regular folks have known it, chapter and verse, forever. They experience it every time they pay for their prescription drugs. But Democrats in the U.S. House report in a 269-page study that they have spent three years on, have concluded that Big Pharma runs a world-class cash-raising racket that would make street crooks blush.

Well, formally, the House Committee on Oversight and Reform majority has assailed U.S. “drug-pricing practices that are ‘unsustainable, unjustified and unfair,’” the Washington Post reported. As the newspaper also said:

“[C]ompanies studied by the committee raised prices of common brand-name drugs during the past five years by nearly four times the rate of inflation. The report seeks to debunk industry contentions that companies’ price strategy is needed to plow money back into researching and developing new medicines, finding that revenue is substantially greater than those investments.”

coviddeathspreventable-300x140
The coronavirus pandemic is nearing another grim mark: 800,000 deaths in this country in its two-year run, with 1 in 100 of the fatalities occurring among those 65 and older.

The pandemic toll exceeds the population of cities like Washington, D.C., Seattle, Denver, Boston, and Memphis, and is heading toward the equivalent of spots like Charlotte and Fort Worth. The virus for some time now has proven to be deadlier than the military casualties the country experienced combined in World War II plus the Vietnam and Korean wars.

Still, millions of shoppers are cramming into stores and malls seeking seasonal bargains and gift-giving wonders. Tens of millions of travelers are ready to jump into cars, trains, buses, and planes for holiday and year-end journeys,  to gather with friends and family.

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