Articles Posted in Ethics

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.

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.”

manchin-150x150Record numbers of poor, working poor, and middle-class Americans are signing up to receive federal help to get affordable insurance to safeguard their health and finances. But will congressional politicking cost them this invaluable coverage — just before the nation goes to the polls for midterm elections?

For months now, President Biden and the Democrats have labored to put together a multitrillion-dollar legislative package dealing with the nation’s health needs, climate change, and more. Because Capitol Hill is so riven — among Democrats, as well as between Republicans and Democrats — the ambitious aspirations of those in the party barely in power have needed to be wrapped into a sprawling measure that can sidestep the filibuster and survive a complex legislative maneuver and on to passage.

Let’s be clear that 50 Republicans in the Senate and hundreds of GOP House members have refused to act in any way like American lawmakers, declining at all to work on the package and to sticking to partisan position that Democrats will need by themselves to pass measures needed and popular with voters.

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:

nhomehall-300x200The battle to safeguard the elderly, sick, and injured residents of the nation’s nursing homes and other long-term care facilities is far from over — and the fight may be even tougher than advocates for the vulnerable may have imagined.

That’s because the facilities employ aggressive tactics to contest safety and other violations found by state and federal regulators in a system that favors them and shuts out the aggrieved while also keeping crucial information hidden from the public, the New York Times reported.

The newspaper said it investigated what happens when inspectors write up homes, finding a little-known system that owners and operators play to the max to protect a financially lucrative aspect of their operations: the “stars” awarded by the Centers for Medicare and Medicaid Services on its web site.

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.”

anxietygal-300x200Not all grievous injuries are apparent to the eye, as anyone who has experienced catastrophic illness or injury can attest. And now we’re learning a lot more about the hidden costs — mental, emotional, social, and spiritual — inflicted by the coronavirus pandemic.

Reporters Emily Baumgartner and Russ Mitchell of the Los Angeles Times surfaced intriguing points of view on what has now become normalized but widely aberrant behaviors in the age of Covid. They did so, as they dug into the reasons for the unacceptable increase in road fatalities at a time when the public, overall, drove less and many people had open byways. The deadly toll that took in 2020 was expected to, but did not, reverse in 2021.

It got worse — and the reasons why need urgent attention, sources told the newspaper, which reported:

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.

Infographic-Type-1-Diabetes-232x300Critics are alarmed about a news article published on the front page of the New York Times and headlined: A Cure for Type 1 Diabetes? For One Man, It Seems to Have Worked.

Really? We all fervently wish for a cure for the devastation of diabetes, especially type 1 which starts in childhood. But the problem, savvy readers found, is that the report falls far short of reasonable standards for a global news organization to trumpet the “c” wordcure.

Dig into the 2,000-word piece and skepticism should be the watch word. That’s because reporter Gina Kolata  focused on the earliest outcomes of a stem-cell treatment for type 1 diabetes undergoing clinical trials. So far, 17 patients have been treated. One patient, so far, has experienced positive results that have sustained for six months. The New York Times gave no clue about the outcomes for the 16 others.

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