Articles Posted in Product Safety

vaper9112021-220x300The federal Food and Drug Administration punted on a scheduled showdown over e-cigarettes, delaying decisions on whether to allow Juul and other market-dominating firms to keep selling trendy “smokeless” devices while also banning millions of vaping products from other, mostly smaller manufacturers.

The agency argued with a defensive and defiant tone that it had acted on 6.5 million filings and 93% of the requests for approval to market e-cigarette and vaping-related products, rejecting most (including millions of flawed  applications from a single applicant).

But the FDA said it needed more time — how much it didn’t say — to weigh evidence from big e-cigarette makers who hold sway over 40% of the market. They claim their products’ benefits in helping adults stop smoking tobacco, especially killer cigarettes, outweighs the harms they cause to young people, likely addicting new generations to health-damaging nicotine and opening a gateway to tobacco and marijuana consumption.

dcautowreck2-300x191The nation keeps zooming toward a tragic and preventable fatality measure: Our roads are staying as deadly as they became during the coronavirus pandemic, and 2021 is racing to be one of the most lethal vehicular years in a decade.

As the Washington Post reported of data on the year’s first quarter from the National Highway Traffic Safety Administration:

“The first quarter of 2021 was the deadliest start of a year on the nation’s roads in over a decade, with car crashes killing an estimated 8,730 people from January to March, according to a new estimate from the National Highway Traffic Safety Administration. The numbers indicate that a surge in road deaths that began with the coronavirus pandemic has continued into this year, although they offer some early glimmer of hope that unusually high fatality rates might be beginning to come down. NHTSA said the ongoing high death rate appears to have been caused by drivers continuing to take risks by speeding, getting behind the wheel after drinking or using drugs, and not wearing seat belts. To coincide with the new estimates, NHTSA … released an updated version of a guide to improving highway safety, largely focusing on encouraging more-conscientious behavior on the roads and deterring risk-taking.”

pewopioidharmsfigure-300x238In a landmark opioid painkiller case, a federal bankruptcy judge has approved what potentially may be a $10-billion settlement.  It included a plutocratic clan winning sweeping protections from further civil lawsuits by pledging to fork over $4.5 billion from their family fortunes.

Despite the seeming bounty in this case, the Purdue Pharmaceutical payout also may go in the legal books as unacceptably mean and little.

Robert Drain — the jurist who presided over the dissolution of Purdue, the enterprise that enriched the Sackler family in unimaginable fashion through the peddling of powerful prescription pain drugs like OxyContin — not only conceded the company’s bankruptcy was a bitter end. He also spelled out that term, B-I-T-T-E-R, letter for letter for the court record.

bugatti-300x118If big hospitals really want to keep surgeons happy and provide them with greater comfort during procedures, why not build giant, sanitary glass garages next to operating rooms and let docs park their Bentleys, Lamborghinis, and Bugattis there for ogling and maybe even to take a break under the vehicles’ hoods?

Okay, maybe we’re being a bit too snarky.  Yet that hyperbolic scenario just might be cheaper and more medically justifiable than the sustained embrace by specialists and profit-seeking institutions of fancy robotic surgical devices costing more than $1 million annually — and for which patients, ultimately, pay. Here’s what the New York Times reported of yet another published meta-analysis of dozens of studies on the devices and their outcomes found:

“Surgical procedures performed with the aid of a robot is sometimes marketed as the ‘best’ form of surgery. But a recent review of 50 randomized controlled trials, testing robot-assisted surgeries against conventional methods for abdominal or pelvic procedures, suggests that while there may be some benefits to robotic surgery, any advantages over other approaches are modest … Some surgeons believe that these robots allow more precision during the operation, shorter recovery time, and generally better clinical outcomes for patients. But the review found that in many ways, compared outcomes from the robotic and conventional procedures showed little difference.

cpaprecall-300x139Millions of patients with serious, diagnosed sleep disorders now are wrestling with a daytime nightmare: Medical devices designed to help them avoid damage from their conditions have been recalled for major and concerning defects.

But consumers complain that they’re getting poor and too little information about their health options until the device maker more fully addresses the products’ problems.

The manufacturer under regulatory and consumer fire is Royal Philips NV, which has recalled its “devices known as CPAP and BiPaP machines,” the Wall Street Journal reported, adding that the products “gently push air into the lungs and are primarily used to treat sleep apnea.”

medscrewsuw-171x300Patients, regulators, hospitals, and doctors themselves need to open their eyes and ask tougher questions about the eyebrow-raising trend occurring among a specialized set of “sawboneses” — orthopedists and neurosurgeons.

Hundreds of them are profiting handsomely, not on their  medical skills  but rather their investments in and relationships with surgical hardware. The specialists also are increasingly reliant, in dubious fashion, on medical device salespeople.

Fred Schulte, an investigative reporter with the independent, nonpartisan Kaiser Health News service, has written a pair of detailed news articles raising yet more questions about medical devices, specifically the $3 billion that floods a peculiar pipeline between those who operate on patients’ backs, knees, hips, and shoulders and the companies that provide the surgical hardware for the procedures.

aduhelm-150x150The 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.

fdahvad-230x300The federal Food and Drug Administration too often fails to protect patients from defective and dangerous medical devices because it lets manufacturers self-police themselves, cozies up to companies rather than trying to compel safety fixes, and inadequately informs the public and medical community about problem products.

If that sounds like too broad and harsh an indictment of poor performance by a purported watchdog agency, just read the deep dig by ProPublica, the Pulitzer Prize-winning investigative journalism site, into the FDA’s record with the HeartWare Ventricular Assist Device, or HVAD.

ProPublica details the unacceptable actions that put thousands of patients at risk with a heart pump that cost $80,000, required major surgery, and that the FDA knew had significant problems but still allowed highly vulnerable people to have implanted. As reporter Neil Bedi found:

kffvaxvunvaxhospitalized-300x235Kids are flocking back to school for in-person, fall classes — and they are getting eye-opening views of how grownups continue to react to the gravest public health crisis in a century. What kinds of lessons are the next generations taking away from us?

Public health officials are moving with urgency not only to get youngsters 12 and older vaccinated but also to persuade decision-makers in districts across the country to ensure that the young cover their faces and distance — measures that have helped reduce the coronavirus’s spread.

The world, of course, is well past weary of the pandemic. But with the Delta variant causing spikes in cases (now averaging 100,000 per day), hospitalizations, and deaths (averaging 500/day), officials say they have few choices but to rely on public health measures that have helped to quell viral outbreaks.

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.

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