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Back-Pain-300x188As the nation rapidly grays, not only are middle-aged and older patients undergoing increasing numbers of knee, hip, ankle, and shoulder surgeries, back operations also have spiked — and a significant number of these procedures may be unwarranted and harmful.

Spinal surgery is a booming business for orthopedic surgeons and hospitals, with  Wall Street analysts forecasting, according to one report, that the “sales of spinal surgery implants, instruments, pharmaceuticals and other novel treatments for chronic and disabling back pain will … rise from $10 billion in 2020 to $14 billion -$ 16 billion by 2030.”

While rising numbers of patients, starting around age 42, complain of back pain and many eventually seek surgical relief, skepticism and concern may be deserved for the common, costly, and lucrative spinal fusion surgery, Modern Healthcare, an industry trade publication reported in its Oct. 5 edition.

mckinseylogo-300x169When Big Pharma gets jammed up by federal regulators overseeing what may be risky prescription drugs, what to do? How about hiring the help of a powerful, secretive business consulting company — which also happens to be advising the feds on how best to regulate drug companies?

That’s the gist of yet more disturbing findings about McKinsey and Co.’s sketchy dealings with Big Pharma and now the federal Food and Drug Administration.

The corporate consulting titan, though it was required to do so, failed over a decade to formally disclose its work for drug makers, including those involved in the opioid abuse and drug overdose crisis, at the same time as it won big contracts with the FDA, according to excellent digging by ProPublica, a Pulitzer Prize-winning investigative site.

fdaStemCells-300x200Yet 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.”

drkhan-150x150Doctors must step up and better police their own ranks, taking a helpful warning from medical malpractice lawsuits in dealing with problem practitioners or systemic wrongs.

That’s the wise view of Dr. Shah-Naz H. Khan, a neurosurgeon and a clinical assistant Professor of Surgery at Michigan State University (shown, right).

Her trenchant commentary — published on KevinMD, which describes itself asthe web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories” — is salient as medicine confronts a startling number of doctors, who, frankly, have run amok in putting forth health falsehoods in the midst of the deadliest public health emergency in more than a century.

govtrustpew-181x300It’s a small occupational hazard that accompanies membership in the Bar — the ribbing that all lawyers take at social functions with those groan-inducing lawyer jokes.

While the good-natured jests typically merit a chuckle and a pass, it’s worth noting, two decades after the 9/11 tragedy and with all the deeply divisive events that have occurred since, that there are clear indicators that the legal profession deserves more credit than jibes. Lawyers are striving at least to preserve their constitutional responsibilities as a pillar of truth-telling in the contentious world. Others? Maybe less so. And the public should not be confused about this.

When viewers see the splashy Netflix documentary Worth, for example, they should take judicial notice that it creates a fictionalized account about trial lawyers and the push to compensate victims of the Sept. 11 catastrophe, argues the Center for Justice and Democracy at New York Law School.

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.

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.

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

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