Articles Posted in Medications

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.

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.

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.

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.

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.

covidshots-241x300The steady, global spread of the Omicron variant and the huge uncertainty about what menace it may pose also may provide a powerful prod for anyone still fence-sitting to finally get those coronavirus vaccinations, including booster shots.

Experts are furiously researching and may not know for weeks or longer whether Omicron will be worse than the Delta variant, which rages still in parts of the country, overwhelming health systems in the cooling North, notably in New HampshireMichigan and Minnesota.

But the Biden Administration and governments around the world are racing to get ahead of vigorous responses to Omicron.

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