Mental Disability Category Archives — DC Medical Malpractice & Patient Safety Blog Published by Washington, D.C. Personal Injury Lawyers

October 5, 2021

FDA dithers dangerously on regulating sketchy ‘stem cell’ care and kid vaping

Yet more derelictions of duty by the federal Food and Drug Administration are happening now, in its handling of largely hokum treatments and health-threatening devices. The latest examples: drug safety regulators step back from their oversight of those who peddle sketchy “stem-cell” treatments for a bevy of ills. And twiddle their thumbs as who knows how many more young people get addicted to nicotine because experts just aren’t ready to regulate e-cigarettes and vaping.

Here’s what the Associated Press reported about the agency and how it has allowed a boom in unsupported therapies using so-called stem cells (real versions, shown above):

“Hundreds of clinics pushing unproven stem cell procedures caught a big break from the U.S. government in 2017: They would have three years to show that their questionable treatments were safe and effective before regulators started cracking down. But when the Food and Drug Administration’s grace period expired in late May — extended six months due to the pandemic — the consequences became clear: Hundreds more clinics were selling the unapproved treatments for arthritis, Alzheimer’s, Covid-19 and many other conditions. ‘It backfired,’ said Leigh Turner, a bioethicist at UC Irvine. ‘The scale of the problem is vastly larger for FDA today than it was at the start.’ The continuing spread of for-profit clinics promoting stem cells and other so-called ‘regenerative’ therapies — including concentrated blood products — illustrates how quickly experimental medicine can outpace government oversight. No clinic has yet won FDA approval for any stem cell offering and regulators now confront an enormous, uncooperative industry that contends it shouldn’t be subject to regulation.”

August 19, 2021

VA, in a slap at FDA, will decline to cover newly approved Alzheimer’s drug

by Patrick A. Malone

The nation’s largest integrated health system has declined to cover a drug approved by the federal Food and Drug Administration for treatment of early Alzheimer’s disease. The action is not only a rebuke by the Department of Veterans Affairs to the FDA, it also offers support of sorts to a plea by President Biden for a way that he says Congress could help slash at soaring prescription drug prices.

The drug that the VA says it will support only in highly select cases — due to safety and effectiveness concerns — for the 9 million patients in its system (military veterans and their loved ones) is made by Biogen and is called Aduhelm.

The FDA approved the prescription medication to the consternation of its own experts and leading specialists in dementia care based on multiple clinical trials which the company itself had deemed unsuccessful.

March 26, 2021

With kids’ return to sports, a reminder about serious risks of head trauma

by Patrick A. Malone

With coronavirus cases, hospitalizations, and deaths falling from scary winter highs, the easing of public health measures may see young athletes returning fast to what are supposed to be the fun and educational benefits of organized sports.

But will players, and more importantly grownups, ensure that appropriate practices are followed to ensure kids not only are safe from coronavirus infection but also don’t suffer serious and lasting head injuries?

The Washington Post has posted articles that could provide important reminders about the risks of chronic traumatic encephalopathy or CTE — the degenerative brain disease associated with the repeated blows to the head.

December 11, 2020

U.S. collars owners’ outlandish claims for flying ’emotional support’ animals

by Patrick A. Malone

Um, no, federal regulators have decided: The nation’s skies no longer will be a sort of bad airborne set for a pop psychology version of Fantastic Beasts and Where to Find Them. Instead, owners of so-called emotional support animals must keep their menagerie off commercial flights.

The federal Transportation Department has issued new rules halting what had become, in pre-coronavirus times, a flashpoint between airlines, their crews, and a preponderance of passengers. They were in growing conflicts with owners of critters they claimed they could not be without.

Airlines complained that they were barraged by not just a few, legitimate requests to board bona fide, trained service dogs (as shown in AKC photo, above) but also by hundreds of thousands of demands for what effectively were pets to be flown in the human spaces for free. The companies successfully turned away reptiles, ferrets, rodents, spiders — and even in one case a performance artist’s sizable peacock.

August 21, 2020

Loneliness and fear taking big toll on locked down elderly, sick, and injured

by Patrick A. Malone

For the old, sick, and injured who are institutionalized, the Covid-19 pandemic and the efforts to halt the spread of the disease into care facilities has created debilitating side-effects: isolation, loneliness, silence, fear, and worries of abandonment.

Facility lockdowns, combined with the relentless governmental bungling of the coronavirus response, are taking a terrible toll that may not soon be eased, the New York Times reported. Dr. Jason Karlawish, a geriatrician at the University of Pennsylvania, told the newspaper this about the situation in all too many nursing homes and other long-term care facilities:

“It’s not just Covid that’s killing residents in long-term care. It’s the isolation, the loneliness.”

March 6, 2020

Routine cognitive tests for seniors? Not for now, blue-ribbon panel advises

by Patrick A. Malone

It sounds like a good idea. Have primary care doctors learn about older patients’ cognitive health by putting all of them, during routine office check-ups, through a few minutes of tests in which they are asked to recall lists of words, draw a clock face, describe the day and date of their appointment, talk about current events, and take on other simple tasks.

Such screenings, some advocates for the aged say, can be an important way to diagnose early and try to provide for help for patients with dementia and its most common affliction, Alzheimer’s disease. But a blue-ribbon panel of experts that advises the nation on medical testing and procedures isn’t buying the argument: The U.S. Preventive Services Task Force (USPSTF) has given such screenings the group’s letter-grade rating of I, meaning the evidence is incomplete that a test or procedure is harmful or beneficial.

The panel, updating its 2014 findings, reported on the JAMA Network (the online medical journal collection) that:

December 20, 2019

Intoxicated drivers keep killing too many. New, targeted tactics may be needed.

by Patrick A. Malone

Politicians and police may need to step up their crackdown on drug- and alcohol-impaired drivers, targeting repeat offenders with substance-abuse and mental health problems who also are “disproportionately responsible for fatalities,” a leading traffic safety group recommends.

As the Wall Street Journal reported of new work by the Governors Highway Safety Association and its consultant Pam Fischer:

“Nearly 30% of all vehicular-crash deaths in the U.S. last year were alcohol-related … Last year, 10,511 people died in crashes involving at least one driver with a blood-alcohol concentration of at least .08%, the legal cutoff in every state except Utah, federal figures show. While that represented a 3.6% drop from 2017, alcohol-related fatality levels have largely stagnated for the past decade. ‘What we’re failing to do is get to the root cause of why they’re doing this, what’s behind the behavior,’ [said Fischer].”

October 29, 2019

Who will step up to deal with dementia and Alzheimer’s?

by Patrick A. Malone

With as many as 14 million Americans potentially suffering from various forms of dementia by 2040, including the common Alzheimer’s disease, and with the costs of the care for them forecast to soar soon to more than $500 billion, a frenzied race is on for ways to deal with the debilitating cognitive syndromes. But will individual initiative or Big Pharma products matter most for seniors and their loved ones in the days ahead?

Industry analysts and patient advocates alike were stunned when drug maker Biogen reversed itself and announced that it would seek federal Food and Drug Administration approval for aducanumab, which the New York Times reported “is a monoclonal antibody, an expensive type of drug that attaches to specific proteins in order to disable them. The drug clears a key protein in Alzheimer’s disease — beta amyloid — that accumulates in plaques in patients’ brains. Aducanumab is given as an intravenous infusion once a month.”

Biogen had spent heavily on multiple tests of this drug, suddenly pulling the plug on it last spring, declaring with the counsel of an independent advisory board that the prospective prescription medication — and possibly the line of inquiry about beta amyloids and Alzheimer’s that had led to its creation — was a failure.

August 12, 2019

Gun violence is a public health crisis. Research and treatment are needed now.

by Patrick A. Malone

With back-to-back-to-back incidents of mass gun violence killing almost three dozen children, women, and men, can this nation muster the political courage to treat this lethal scourge as a public health menace?

Can it, finally, green light and fund rigorous research that could inform public policies that both could protect Americans’ Second Amendment rights while also reducing the estimated 40,000 or so firearm deaths that occurred in 2018 alone?

For what it is worth, there is considerable and (what should be) convincing evidence that:

August 7, 2019

Loneliness, debilitation, and depression blamed for seniors’ rising suicides

by Patrick A. Malone

The nation’s rising suicide crisis torments seniors, too, with just under one out of five such deaths in 2017 occurring with individuals 65 and older. Men 65-plus, experts say, face the highest suicide risk, while seniors 85 and older, men and women, rank No. 2 in groups most likely to die by taking their own lives.

As the nation grays — 10,000 baby boomers a day turn 65, in a trend that will persist until 2029 — the already high concern about suicide, especially among seniors, is rising, National Public Radio reported.

NPR, noting that suicide already is the 10^th leading cause of death among all Americans, said that experts see loneliness, bereavement, grief, and depression as key factors in cases in which older individuals kill themselves. They find themselves isolated, overwhelmed, and with unending sadness when spouses and friends die. Their children, grandchildren, and other family members often live far away. They also struggle with their lives due to age’s increasing debilitation. As NPR reported: