Articles Posted in Conflicts of Interest

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.

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.

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.

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.”

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.

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.

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