Articles Posted in Ethics

fdanulogo-300x126The federal Food and Drug Administration may be putting patients’ safety at serious risk by allowing medical device makers to self-police their products, notably in making crucial determinations in reporting to the agency the severity of harms the devices inflict.

Using artificial intelligence techniques to scan a sampling of filings made by makers to the FDA over nine years, Christina Lalani, MD, of the University of California San Francisco, and colleagues found that just under a quarter of the documents mis-categorized cases in which medical devices were tied to patient fatalities.

These were not reported as deaths in an important FDA information source known as MAUDE (the Manufacturer and User Facility Device Experience database). Instead, they were “classified as either malfunction, injury, or missing (the report was not put in any category),” reported the medical site MedPage Today.

debtmedicalnytjuly2021-300x250A scandal of the U.S. health system may be far worse than imagined, with the medical debt sold to collection agencies alone amounting to a staggering $140 billion.

The $140 billion estimate came from researchers who published in a medical journal and found that such unpaid sums had increased significantly from an $84 billion calculation in a similar 2016 study, the New York Times reported (see excellent chart, courtesy of the newspaper).

The newspaper noted the debt estimate is an ugly number hanging over the finances of tens of millions of patients who are too often poor and uninsured — debtors who could benefit significantly, if politicians in their states had expanded Medicaid coverage for them as allowed under the Affordable Care Act:

lotsapills-300x200Consumers have gotten eyebrow-raising views of Big Pharma’s ugly business practices and the tough and sometimes sketchy efforts to rein in the industry’s ravenous pursuit of profits — in settling claims over distributors inundating the country with lethal painkillers, or with a maker’s behind-the-scenes campaign to win U.S. approval of an Alzheimer’s medication based on dubious data.

Patients are unlikely to come out ahead, or even satisfied with the outcomes of the cases involving how Johnson & Johnson (J&J), Cardinal Health, AmerisourceBergen, and McKesson handled opioids, and how Biogen and the Food and Drug Administration have dealt with Aduhelm.

A major opioids settlement

cdcnytopioidcrisisjuly2021-183x300“It’s huge, it’s historic, it’s unheard of, unprecedented, and a real shame. It’s a complete shame”

That quote, reported by the New York Times and made by Daniel Ciccarone, a professor of medicine at the University of California, San Francisco, tragically summarizes the latest  federal data on the opioid abuse and drug overdose crisis. As the newspaper and others reported:

“Drug overdose deaths rose nearly 30% in 2020 to a record 93,000, according to preliminary statistics released … by the Centers for Disease Control and Prevention. It’s the largest single-year increase recorded.”

Coronavirus infections have increased in just a week by 70%, with hospitalizations increasing 36% and deaths rising by 26%.

Public health officials blame the Delta variant for fueling the latest surge in the coronavirus pandemic, the New York Times reported, noting:

aidpoor-300x200Cash is king. That truism may hold for thrifty savers and businesses and individuals buffeted by economic uncertainty. But this realistic view also may be turned on its head for poorer, uninsured patients trying to cope with bankrupting medical bills.

That’s because hospitals — a leading driver of health care costs — gouge with their premium prices those who pay with cash, the Wall Street Journal reported.

The newspaper, working with previously secret pricing data that institutions across the country must disclose now, has given consumers yet another eye-popping view of the elasticity of hospital charges and how they punish the poor:

fentanylillustration-300x99Just as attorneys generals for more than a dozen states inch toward a multibillion-dollar settlement with a drug maker faulted for its big role in the start of the opioid abuse and drug overdose crisis, that health menace is taking a new, deadly turn in the region around the nation’s capital.

In Washington, D.C., Maryland, and Virginia, officials report they are grappling with spiking overdose deaths, numbering in the hundreds, and blamed on the rise of fentanyl. It is a synthetic, prescription painkiller developed to assist late-stage cancer patients. It packs a wallop. And Big Pharma companies pushed for its wider use with aggressive marketing and sales campaign that landed some drug executives in jail.

The excessive promotion of fentanyl also led to its illegal manufacture, notably in chemical factories in China. Its increasing abuse, along with other opioids, also opened the door to big problems with illicit drugs.

aduhelm-300x250The  Food and Drug Administration has back-tracked on a major part of its  accelerated approval of Aduhelm, a prescription medication targeted at Alzheimer’s patients.

The  FDA green light for the drug also has created such consternation among medical specialists, insurers, policy experts, and politicians — including with news reports of hidden, cozy dealings between a top regulator and the medication’s maker —  that the acting agency chief has asked the independent inspector general to investigate what happened.

The fury over Aduhelm is occurring even as another drug maker is pushing legal action that authorities argue also could saddle taxpayers with other soaring costs for other expensive drugs.

jJlogo-300x139boyscouts-261x300juullogo-150x150No matter what the carping critics may claim about the shortcomings of the civil justice system, when Big Tobacco, Big Pharma, and big organizations exploit and harm the vulnerable, lawsuits and what follows may provide a  concrete, productive way for the wronged to see remedy and recompense for injuries inflicted on them.

Recent news articles provide more than a billion bits of evidence why, even in terse summaries of what has occurred in big, complex cases:

  • The Boy Scouts, for example, have agreed to an $850 million settlement to try to resolve thousands of suits seeking to hold the venerable youth organization responsible for failing to police its ranks to remove sexual predators and prevent the sexual abuse of minors. Lawyers connected with the cases say the agreements they have struck may result in one of the highest payouts in U.S. legal history for sexual abuse claims involving children — and it opens the way to further payouts from insurers that will only add to the whopping costs of the Scouts’ decades of ignoring or trying to cover up grownups’ gross and unacceptable misbehavior. The settlement offers a painful reminder of how many colleges and universities, as well as the Catholic Church have been ripped by costly, terrible scandals involving sexual abuse of the young.

billsmedical1-300x200Federal regulators have taken a welcome initial step to bar insurers and health care providers from holding patients hostage in their all-too-common fee fights, with draft rules out now to crush “surprise” medical bills.

The politically riven, do-nothing Congress shocked critics by ending 2020 with an actual new law, included in legislation dealing with the coronavirus pandemic, that gave patients new protection from nightmares created when insurers and big corporation sought to reduce their health care costs with so-called narrow networks of pre-approved health care providers.

This scheme allowed insurers and companies to negotiate with doctors, labs, hospitals, and others for preferential prices, and, effectively, guarantees of patient business, in exchange. Patients began howling when their long-time caregivers were excluded from insurer networks, which also often also excluded big-name practitioners as well as well-known academic medical centers and big hospitals.

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