Research Studies

April 11, 2019

FDA battles sketchy stem cell claims, while big hospitals jump into unproven treatments too

When doctors and regulators crack down on the burgeoning and risky use of purported stem cell therapies, some well-known and respected big hospitals and health systems may have their own practices to explain, too.

As Liz Szabo reported for the nonpartisan Kaiser Health News Service:

Swedish Medical Center, the largest nonprofit health provider in the Seattle area … is one of a growing number of respected hospitals and health systems—including the Mayo Clinic, the Cleveland Clinic and the University of Miami—that have entered the lucrative business of stem cells and related therapies. Typical treatments involve injecting patients’ joints with their own fat or bone marrow cells, or with extracts of platelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the evidence supporting these experimental therapies is thin at best …

April 8, 2019

With costly medical over-testing, causes can be blurry, solutions complex

by Patrick A. Malone

Although experts estimate medical over-testing adds more than $200 billion in wasted spending in the U.S. health care system, reducing it can be hard, as we can see from one example in eye surgery.

Let’s zoom in on cataract surgery, a procedure in which eye surgeons (ophthalmologists) aim to relieve the visual clouding that many patients experience as they age, taking out the natural lens and putting in an artificial replacement. The surgery isn’t without risks, but it goes swiftly and with minor inconvenience for most patients, who get to go home the same day.

For healthy seniors undergoing cataract surgery, the professional consensus has seemed clear for not quite two decades: preoperative testing—which may include a complete blood count, chemical analysis, coagulation studies, urinalysis, electrocardiography, echocardiography, cardiac stress tests, chest radiography, and pulmonary-function tests—is unnecessary. This has been established by rigorous studies (see here and here), as well as by the stringent Cochrane review. The American Academy of Ophthalmology has made this a guideline or clinical statement and spread the word, notably through the public Choosing Wisely initiative that counsels patients on key procedures they need to ask their caregivers about if they’re ordered.

April 3, 2019

$1 billion+ may seem like a lot of money. It still can’t resolve many questions.

by Patrick A. Malone

Although lawsuits can result in needed financial support and welcome recognition of harms suffered by patients seeking medical services, the civil justice system has its limits. They showed in cases in the news in which disputing parties agreed to more than $1 billion in resolutions that left issues unanswered.

What to make of the:

$270-million that Purdue Pharmaceutical will pay to end its part of a fight with Oklahoma over the opioids crisis that has killed hundreds of thousands of Americans

March 31, 2019

5 strikes and you’re not out? Only when you’re sued for bad medical care.

by Patrick A. Malone

Doctors, hospitals, and their malpractice insurers like to demonize lawsuits brought by injured patients, but these legal actions provide a powerful way to identify problem practitioners, and the medical profession should see this truth and use it to better police its own ranks.

That’s one of the recommendations from medical-legal researchers at Stanford University, who examined more than a decade of 60,000 payments for malpractice claims against more than 50,000 doctors. They found a tiny slice of doctors rack up a disproportionate share of repeated malpractice claims. They describe these MDs as “frequent flyers,” a term familiar to the medical community because it often is applied to indigent and homeless patients who rack up big bills for repeated emergency room visits.

Profs. David Studdert and Michelle Melloound found that 2% of physicians accounted for 40% of the paid malpractice claims over a 13-year period. Further, in the report of their study in the New England Journal of Medicine, they offered details on doctors who lose, and keep losing, malpractice cases due to problem care:

March 29, 2019

Doctors retreat on low-dose aspirin advice, underscoring that one size seldom fits all

by Patrick A. Malone

After persuading as many as 7 in 10 American adults to take a daily low dose of a common painkiller to protect against heart disease and cancer, experts now say it is time for more nuanced advice on who should and who shouldn’t take the daily baby aspirin regimen.

Recent studies have shown that the believed protective benefits of low-dose aspirin need to be balanced against the risks of bleeding caused by the drug, the American Heart Association and the American College of Cardiology have declared.

Here is who should NOT go on low-dose daily aspirin:

March 27, 2019

Clinicians are facing up to the preventable harms that ICU’s inflict on many patients in the process of saving lives

by Patrick A. Malone

Doctors and hospitals finally are owning up to and treating mental and physical damages inflicted on some of the sickest and most vulnerable individuals in their care—the 5 million or so patients who get helped in intensive care units, published research shows.

Although ICU patients may get dramatic emergency care that saves them from deadly infections, major disease, and significant accident or injury, experts only recently have begun to recognize and assist them with a condition associated with their stays: post-intensive care syndrome (PICS). A readable new study in the medical journal JAMA says that ICU patients may suffer a “constellation of symptoms” with PICS that hinders their recovery to their pre-hospitalization well-being, including: “muscle weakness, cognitive impairment, depression, anxiety, and post-traumatic stress disorder (PTSD).”

March 25, 2019

Electronic records mess threatens patient safety, investigation finds

by Patrick A. Malone

Tempting though it may be to dismiss doctors’ howls about electronic health records—maybe they’re Luddites or they’re just another group of high-paid workers beefing about their job tools—the persistent and significant nightmare of the complicated computer systems has been this: Do they harm patient care?

The answer now may be: Yes, billions of taxpayer and private dollars spent on EHRs may be reducing patient safety.

That’s the finding of the independent, nonpartisan Kaiser Health News Service, based on its extensive investigation in partnership with Fortune Magazine. The two media operations reported that:

March 17, 2019

A lesson on vaping from sugary drinks of yore: Crack down on Big Tobacco

by Patrick A. Malone

Those who are senior enough to remember the allures of sweet drinks like Tang, Hawaiian Punch, and Kool-Aid also may need to be sage enough to share a deep, evidence-based distrust and disapproval for the nefarious actions of Big Sugar and Big Tobacco. Those suspicions may need to be renewed in regulators’ crackdowns on vaping, its flavorings, and flavored tobacco cigarettes.

Yes, the federal Food and Drug Administration now has formally detailed its plan to curb the soaring youthful purchases and uses of e-cigarettes for vaping, telling merchants that they soon will be required to keep these goods, including flavored liquids that the devices catalyze, in separate walled off areas of stores and away from those age 18 and younger. This will affect not only big retailers like Walgreens and Wal-Marts but also gas stations and convenience stores.

Online vendors soon will be required to have mechanisms, so proof of age becomes part of cyber buys of e-cigarettes and their associated products.

March 8, 2019

Catching up on your sleep this weekend? It doesn’t work, researchers find

by Patrick A. Malone

Americans may put off to the weekend catching up on sports scores, store sales, the latest news and more. But there’s a health essential that new research suggests cannot be put off for the weekend: a good night’s sleep.

The study, conducted at the University of Colorado and published in the science journal “Current Biology,” focused on a small group: three dozen healthy adults, split into three groups, with one allowed to sleep nine hours nightly, another getting just five hours of slumber, and a third with a staggered schedule. The last group, for five days, got five hours of sleep, followed by two days in which they could snooze for as long as they wished. They had to return, though, to the five-day cycle of five-hour slumbers.

Researchers followed their subjects for nine-day spans. The results will be un-welcome for proponents of weekend catch-up sleep, because it didn’t help in the ways that many of us would wish. As the Washington Post reported, those “who were limited to five hours of sleep on weekdays gained nearly three pounds over two weeks and experienced metabolic disruption that would increase their risk for diabetes over the long term. While weekend recovery sleep had some benefits after a single week of insufficient sleep, those gains were wiped out when people plunged right back into their same sleep-deprived schedule the next Monday.”

March 4, 2019

FDA warns surgeons against experimental robot-aided cancer operations

by Patrick A. Malone

The federal Food and Drug Administration finally has pushed back at surgeons and hospitals for experimenting on patients, spending $3 billion a year for surgical robots. The devices should not be used for mastectomies and other cancer-related procedures without caution, regulators warn.

The FDA acted after studies have shown that minimally invasive procedures for early-stage cervical cancer, many robot-aided, were more likely than standard, large-incision surgeries to result in recurrences of the disease and deaths.

Regulators also may have been prodded by their poor history in halting harms to women with so-called keyhole procedures, particularly the nightmares the FDA was slow to react to involving minimally invasive hysterectomies and a tissue-grinding tool called a morcellator.