Articles Posted in Testing

cbdThe federal Food and Drug Administration has waded into its potential oversight of a substance that already is becoming wildly popular. The process of figuring government rules for cannabidiol, aka CBD, well could be called Confusion By Design.

The New York Times and Washington Post both reported on the parade of dozens of parties, pared from hundreds of aspirants, wanting to influence the FDA’s path with the agency’s first hearing on CBD. It already is sold in thousands of products on the market now. These include pet foods, soft drinks, bath salts, and oils and solutions that users add to food and rub on themselves.

Of great concern to the FDA are the extreme and proliferating claims that vendors are making for unproven health-related benefits of use of CBD, which is a nonintoxicating extract that can be derived from hemp and marijuana. As the popular health information WebMD site reported:

Spending’s askew when billions go for unproven surgical robots while lack of affordable care leads thousands of poor, black, and brown patients to need diabetic amputations

amputations-300x171If U.S. health care leaders look ahead to 2020 and wonder why their sector of the economy will be one of the key concerns of presidential candidates and voters, they can only blame themselves for allowing the public to conclude that the industry’s big money and big profit drives have gone haywire.

eyefocus-300x278Although 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.

breastimplantUncle Sam has paid what critics have called long overdue attention to women’s breasts and how surgeons and diagnosticians treat them.

In an angry and emotional public hearing, women ripped the federal Food and Drug Administration for lax oversight of implants that surgeons use to augment and reconstruct breasts, even as the agency proposed its first changes in 15 years to guidelines about mammograms for patients with dense breast tissue.

The FDA has been under fire for decades over breast implants, mostly banned in 1992 but allowed anew in 2005. Experts long have debated whether materials in the implants, notably silicone and not necessarily saline fillings, may be injurious to women’s health. New concerns have developed over surface texturing on the devices, which are supposed to help in the surgery but may affect tissues around and near the breast, leading to spikes in reported cases of rare cancers.

vamps-300x169Funny the mischief that can happen with a little blood and spit. Seemingly unrelated medical stories last week brought home the lesson of the law of unintended consequences. Those consequences abound everywhere, in health care most especially. So with blood, we’re learning about a bizarre new fountain-of-youth treatment, with echoes of vampires, for seniors who ought to know better.   And with spit, we’re learning how seemingly harmless genetic tests can raise from the dead some disturbing revelations about our deceased family members.

Bunk about blood transfusions

The federal Food and Drug Administration has warned older Americans about a new kind of anti-aging bunk flying out of the Silicon Valley: blood transfusions. Companies, dancing on a fine legal line, have hinted that seniors could benefit by getting transfusions of young people’s blood and blood products.

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.

dirtydrugs-300x143Even as Big Pharma launched the new year with yet another round of profiteering price hikes for prescription medications, a new investigation has uncovered how drug makers get away with nasty manufacturing practices, which, combined with lax oversight, send billions of doses of tainted products to market each year,  imperiling patients’ health.

Sydney Lupkin, writing for the independent, nonpartisan Kaiser Health News Service (KHN), has done the public a service in exposing the weak, irregular, and risky oversight of drug making by the federal Food and Drug Administration. This is a significant problem, Lupkin reported:

Since the start of 2013, pharmaceutical companies based in the U.S. or abroad have recalled about 8,000 medicines, comprising billions of tablets, bottles and vials that have entered the U.S. drug supply and made their way to patients’ medicine cabinets, hospital supply closets and IV drips, a Kaiser Health News investigation shows. The recalls represent a fraction of the medicines shipped each year. But the flawed products contained everything from dangerous bacteria or tiny glass particles to mold — or too much or too little of the drug’s active ingredient. Over the same period, 65 drug-making facilities recalled nearly 300 products within 12 months of passing a Food and Drug Administration inspection…

holick-214x300Media coverage of diet and nutrition topics, for their abundance of hype and sheer bunk, may take the cake. Some recent, solid reports not only offer examples of the scope and scale of this public tomfoolery and its costs but also the reasons why it persists.

Let’s start with reporter Liz Szabo’s deep, detailed take-down of Michael Holick, a Boston University endocrinologist and unabashed pusher of a widespread medical myth that many of us may be deficient of Vitamin D, the so-called sunshine supplement.

Szabo, investigating for the independent, nonpartisan Kaiser Health News Service and the New York Times, reported that Holick has advocated for Vitamin D sufficiency guidelines that created in 2017 alone a $936 million market for its supplementation, with Americans spending another $365 million for more than 10 million vitamin deficiency tests paid for by Medicare.

hennepin-300x200Big Pharma howls often about the federal Food and Drug Administration path to get prescription drugs approved for markets, complaining current regulatory processes take too long and, with their requirement for rigorous clinical trials, are too tough.

Even as drug makers seem to be finding sympathetic officials to make these regimens faster and laxer, some voices want the FDA to consider costlier and what they say is more realistic and useful scrutiny of drugs that goes beyond current attempts  to find if they are safe and effective.

Shouldn’t regulators — at the FDA or elsewhere in the federal bureaucracy — help consumers much more to know the answers to “two crucial questions: How do … new therapies compare with already known ones? What are the relative benefits and harms in a particular situation, for a person like you?”

kaisertavr-300x175When big hospitals and their doctors jostle with competitors in smaller and medium-sized facilities over who gets to perform an important and booming kind of surgery, it’s not a pretty sight — nor might it be obvious with which institutions patients ought to side.

Phil Galewitz of the independent, nonpartisan Kaiser Health News Service does consumers a service with his reporting on recent bureaucratic brawling in Baltimore before federal regulators charged with determining where surgeons may replace leaky valves without open heart procedures.

As Galewitz explains, surgeons and medical device makers for a few years now have worked together to develop a new way to fix defective valves for tens of thousands of patients too frail to undergo open heart operations that, among other things, involve getting their chests cracked open. Surgeons, instead, can snake a catheter through patients’ blood vessels, into their heart, and shove aside the leaking valve, replacing it with a new model.

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