Articles Posted in Clinical guidelines

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.

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.”

chartgfrresults-300x197Medical specialists and researchers have taken a big step in recognizing that how they diagnose black patients with kidney disease may be racially biased and harmful to a group that already and disproportionately suffers the illness’s harms.

Doctors now should jettison race-based adjustments in equations used in a crucial and fundamental test to assess kidney function, according to studies and editorials published in the New England Journal of Medicine, the American Journal of Kidney Diseases, and the Journal of the American Society of Nephrology.

As the New York Times reported, this step will “affect hundreds of millions of kidney function tests performed yearly in hospitals and outpatient settings, both for acutely ill patients and as part of routine screening blood tests. By one estimate, one million Black Americans might be treated earlier for kidney disease if the diagnostic equation were not adjusted for race.”

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.

becerra-150x150biden-150x150With the Biden Administration battling the coronavirus pandemic and Democrats in the throes of determining what could be big spending for major changes in the U.S. health care system, even the president’s biggest supporters are baffled why he still hasn’t nominated a commissioner to head the federal Food and Drug Administration.

The FDA, entrusted to safeguard the safety and quality of the nation’s prescription drugs, medical devices, and foodstuffs, has a huge lift in the best of times.

In the Biden administration’s 10 months, the agency — demoralized and banged up, big time, by the Trump Administration and its politicization of health matters across the board — has found itself in a relentless crossfire in areas in which the 18,000-employee organization holds sway.

cdcwalensky-150x150The battle against the coronavirus pandemic is further splintering Americans into brittle groups, segments familiar because they long have been components of the inequitable U.S. health care system — let’s call them the have nots, the have somes, the have much, and the won’ts.

Regulators have decided that those who have some protection with lifesaving vaccines are now eligible for more — a third dose of the Pfizer vaccine. It will be given six months after the original two-shot regimen was completed to people:

  • older than 65

portalmedrecord-300x124As doctors and hospitals switch to electronic medical record systems and try to amp up the business efficiency of their enterprises by opening online consumer portals, more patients may access their caregivers’ files on them, including  doctor notes that may be shocking in their inaccuracy.

Heather Gantzer, a doctor practicing at Methodist Hospital in St. Louis Park, Minn., and immediate past chair of the American College of Physicians’ Board of Regents, told Cheryl Clark, a contributor to the MedPage Today medical news site:

“100% of medical records have errors. Some of them are nuisances, but some are really impactful and might make a huge difference for [example for] the person who was said to be on antibiotics” but was not.”

drugselderly-150x150The nation’s nursing homes, battered by the coronavirus pandemic, are under more fire for their resurgent reliance on powerful and risky psychiatric drugs and shaky diagnoses of mental illness to treat elderly residents, as well as for the institutions’ inability to safeguard the old, sick, and injured in their care by ensuring their staff are vaccinated against Covid-19.

Facilities across the country have recorded a 70% spike in dubious designations of elderly residents as schizophrenic. This means they may be dosed with potent antipsychotic drugs, which, critics say, act akin to pharmaceutical restraints and can reduce the vulnerable to near vegetative states, the New York Times reported, based on its investigation of the issue.

The newspaper noted that federal regulators and mental health professionals have campaigned for years to get nursing homes and other long-term care facilities to stop using certain medications, which once were more routinely administered and pack more than a wallop for the old:

dcflags-300x131Nineteen months after the coronavirus pandemic first began to rage, the nation has racked up mortality  and morbidity statistics that are tragic and horrifying:

  • 1 in 500 Americans now has died of the disease
  • People older than 85 make up only 2% of the population, but a quarter of the total death toll

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.

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