Articles Posted in Clinical guidelines

Kaiserexempt-300x205If a surgical staple gun malfunctioned so seriously that it generated not a few dozen formal complaints but more than 10,000 reported incidents, shouldn’t patients, doctors, and hospitals have the right to know that information from the federal agency overseeing the safety of medical devices?

Apparently not. Or maybe not without a big kick in the pants from journalists.

Instead, the staff at the federal Food and Drug Administration turned a move to ease paperwork and bureaucracy into a giant and little-known system that lets medical device makers hide serious and significant numbers of reports about failures and flaws with at least 100 products, a Kaiser Health News Service investigation found.

dialysis-300x198Diabetics and those with failing kidneys may have gotten a glimmer of relief from the staggering costs of caring for their conditions, as Big Pharma relented a tad with news it will put out a less-costly insulin product and federal officials suggesting Uncle Sam soon may be upsetting the flush profits of the dialysis industry.

DaVita Inc. and Fresenius Medical Care AG run more than 5,000 U.S. dialysis clinics and control around 70 percent of the market, Reuters news service reported in a story describing how Alex Azar, the powerful head of the federal Health and Human Services department, wants “a new payment approach for treating kidney disease that favors lower cost care at home and transplants.”

Why? As Reuters explains, “The goal is to reduce the $114 billion paid by the U.S. government each year to treat chronic kidney disease and end-stage renal disease, a top area of spending.”

davincirobot-300x176The 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.

teenstress-300x168Recent news reports underscore how the nation’s youth are struggling more than had been believed with stress, anxiety, and depression.

The New York Times, based on nationwide polling by the respected Pew Research Center, reported that 70 percent of teenagers surveyed cited mental health concerns as a top issue for them. It ranked ahead of bullying, drugs, gangs, alcohol, and teen pregnancy.

As the newspaper reported, dealing with stress, anxiety, and depression hits teens hard these days, for a lot of good reasons:

mdepressionRoughly 1 in 7 moms, who, during or after pregnancy, suffer debilitating depression — losses of energy or concentration, changes in sleeping and eating patterns, feelings of worthlessness or suicidal thoughts — now may get counseling that has proven helpful to women and their babies.

Preventive health experts have called on medical providers to guide women to this specialized care that could benefit 180,000 to 800,000 mothers each year. Because this treatment has been put forward this way, women also can get help affording it. As the New York Times reported, the recommendation for maternal depression counseling, by the United States Preventive Services Task Force, means insurers must cover the services — with no co-payments — under the Affordable Care Act.

Experts told the newspaper the USPSTF action was an important step on perinatal depression, noting:

measlesnhs-300x200The 44th President implored the members of his staff that a key aspect of their collective success could be summarized by a simple notion: Don’t do stupid stuff. If only many more parents nationwide would concur — and shun the anti-scientific nonsense peddled by anti-vaxxers.  As the new year advances, public health officials across the country are battling measles outbreaks, dozens of reported cases in the Pacific Northwest (Washington and Oregon) and in New York City.

The concern is rising because disease carriers are increasing in their number and mobility in areas where populations may be especially vulnerable due to low vaccination rates. Public health officials have likened the situation to “tossing a match into a can of gasoline,” or a disease spread “like a wildfire.”

As the New York Times reported of the risks this childhood infection poses: “Measles can cause permanent neurological damage, deafness and in relatively rare cases, death.”

With the nation fast graying, a long-term care crisis looms, and too many Americans may not realize that not only will nursing home care be tough to find and afford, it also may be less than ideal. But what happens if seniors themselves — especially the frail old — are asked how care-giving services might best serve them, so they not only can stay in their homes but also enjoy their lives more?

That’s the experimental approach taken by a health care team in Denver, working in the long-titled program, “Community Aging in Place — Advancing Better Living for Elders.” CAPABLE staff intervene with the aged, asking them how, even with disability and debilitation, to improve their lives. The program offers them six visits by an occupational therapist, four visits by a registered nurse, and home repair and modification services worth up to $1,300.

headmri-300x300When patients experience bad headaches, severe chest pain, back or neck aches, or even when kids come in with gut pain that likely is appendicitis, doctors too readily push them into and through what may be hospitals’ over-sized cash-generating machines. It’s past time to end wasteful use of high-powered imaging systems, experts from the Mayo Clinic and Stanford University say.

Drs. Ohad Oren, Electron Kebebew, and John Ioannidis have called out their medical colleagues in an opinion piece published in the medical journal JAMA over excess computed tomography (CT) and magnetic resonance imaging (MRI), saying conditions can’t justify why Americans undergo these costly scans at many times the rate, for example, that Finns do.

Research shows diagnoses don’t improve with many more MRIs and CTs. Instead, they may lead to yet more costly, invasive, and unnecessary tests and procedures, some of which can harm patients.

abraarkaranmdWell, just because.

That isn’t a great answer for cranky toddlers with too many questions. It’s also an unacceptable but real reason why too many hospitalized patients get woken up in the middle of the night and subjected 24/7 to expensive, invasive, and often unnecessary tests and procedures.

Abraar Karan (right), an internal medicine resident at the Brigham and Women’s Hospital/ Harvard Medical School, has blogged with welcome candor about doctors’ casual acceptance of medical routines that not only discomfit but also can harm patients. As he wrote online for BMJ (aka the British Medical Journal): “The reality of medicine is that there are many things we as doctors do for absolutely no reason. That is to say, there is no evidence (randomized controlled trial or otherwise) for doing them, other than ‘that’s the way we’ve always done it.’”

diabetesteststrips-300x200Doctors, hospitals, health officials, and disease advocacy groups race to warn about diabetes’ risks, harms, and increasing prevalence. But why, then, doesn’t modern medicine also do much more to help diabetics with the skyrocketing costs of their care, whether with insulin at excessive prices or with  expensive medical aids?

Ted Alcorn of the New York Times drilled down on one slice of diabetes care to capture how medical profiteering distorts what ought to be a more direct, simple, and less pricey treatment for a disease that afflicts as many as 100 million Americans in varying degree.

He reported on the “strange marketplace” for the chemical-imbued plastic strips diabetics use to test their blood sugar, inserting them into specialized meters for glucose readings. Before diabetics adjust their diet or take insulin, they may test themselves with strips and meters as many as 10 times a day. The costs add up. Diabetics can pay thousands of dollars annually to get test strips over the counter.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information