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

October 15, 2021

Aching backs lead to dubious surgeries and billion$ in revenue$

As 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.

October 13, 2021

Nothing to see here? Consultant advises drug makers — and their regulators

by Patrick A. Malone

When 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.

October 12, 2021

Will Congress bog down or will it act on people’s health and other needs?

by Patrick A. Malone

It may be tempting to get caught up in cynical views of congressional lawmaking, budgeting, and spending — seeing it as gross “sausage making” or in sporting “who wins and who loses” score-keeping.

But for anyone who believes that health care in the wealthiest nation in the world ought to be a right and not a privilege, much is at stake in deliberations under way and, perhaps, soon to reach culmination.

It is difficult to predict exactly what will happen with President Biden’s agenda and his “Build Back Better” package, which contains major proposals that would improve Americans’ health.

October 10, 2021

As experts ponder vaccinating our kids, Covid orphans tens of thousands

by Patrick A. Malone

The battle to quell the coronavirus pandemic and especially its deadly Delta variant surge soon may extend to the nation’s children.

A drug maker has submitted required data and formally requested from federal regulators an emergency approval for a vaccine for youngsters ages 5 to 12. Officials say they will take up this request, pronto, with the possibility that parents by Halloween or early November can start to see the great relief of strong, safe protection for their children from the debilitating and deadly virus.

It already has taken a stark toll on youngsters, with an estimated 140,000 of them losing their main caregivers — parents or grandparents — between April 1, 2020, and June 30 of this year, a newly published study estimates.

October 8, 2021

Ex-president’s buddies schemed to exploit VA patients’ data, records show

by Patrick A. Malone

A trio of former President Trump’s country club friends planned to use the clout he gave them over the Department of Veteran Affairs to set up a potentially enriching scheme to exploit the confidential, personal medical records of millions of U.S. veterans and their families, documents show.

Congressional Democrats, now leading key House committees, have rebuked the three for even suggesting the plan. They were Trump acquaintances from his country club who were given sweeping influence over the VA and were known to lawful government officials as “the Mar-a-Lago crowd.”

The trio — Ike Perlmutter, Bruce Moskowitz (shown above), and Marc Sherman — never served in the U.S. military. They’re not veterans. Perlmutter and Sherman had zero experience in health care. And Moskowitz, while a doctor, is a primary care practitioner — not someone known for his direct experience in running big, complex operations.

October 6, 2021

Fake pills, laced with lethal fentanyl, are circulating widely, U.S. warns consumers

by Patrick A. Malone

Federal officials have sharply escalated their battle with opioid painkiller abuse and overdoses, issuing an urgent public warning that street drugs of many different varieties may be tainted with tiny but lethal doses of the synthetic painkiller fentanyl.

The U.S. Drug Enforcement Administration and the Justice Department also provided stark evidence of the risks involved, announcing a bust involving 810 people and the seizure of “8,843 pounds of methamphetamine, 1,440 pounds of cocaine and 158 weapons,” CBS News reported. Officials asserted that the seizure contained enough illicit materials to “kill more than 700,000 people and to potentially make tens of millions more lethal pills.”

The DEA said it has recorded a scary spike in cases involving pills sold in illicit fashion, fake medications of many different kinds, that are tainted with fentanyl, which pushers say provides a powerful high but which doctors and law enforcement warns can kill in minute doses:

October 5, 2021

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

by Patrick A. Malone

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.”

October 3, 2021

Another milestone of lives lost needlessly

by Patrick A. Malone

It’s one thing when toddlers in their terrible twos react to common sense directions for their own good, throwing themselves to the floor, declaring, “I won’t, I won’t — and you can’t make me …” When grownups behave in, basically, the same way, the results can be catastrophic.

The estimated death toll of the coronavirus pandemic in this country — a figure likely to be far understated — has hit 700,000.

That’s like wiping out the equivalent or more of the population of cities like Boston, Nashville, or Las Vegas.

October 1, 2021

Experts call for end to a race-based adjustment in a key kidney function test

by Patrick A. Malone

Medical 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.”

September 29, 2021

MDs urged to better police their own, as health disinformation runs amok

by Patrick A. Malone

Doctors 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 as “the 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.