Articles Posted in Product Safety

berenson-223x300Moderation matters with health issues, so skepticism about marijuana and its widening use may be welcome. But let’s see how much of recent wariness about this intoxicant is just a puff of smoke — or does it catch fire and become something more?

Author Alex Berenson has become the latest advocate for tamping down the national exuberance for pot. It has in recent days become legal for recreational use in 10 states and the District of Columbia and has been broadly legalized for medical purposes in 19 other states. Cannabis products have become trendy, and stocks in pot-selling enterprises have become a hot investment topic.

But Berenson — in Opinion pieces in both the Wall Street Journal and the New York Times, as well as in a new, well-selling book — paints a more ominous picture of weed. He’s not harkening back to risible scare campaigns, ala the  movie classic Reefer Madness. Berenson says his concern about dope started in a casual mention by his wife, a psychiatrist, that the criminal patients she specializes in treating shared a commonality: They all smoked grass.

cancerdeathrates2018-271x300Cancer hasn’t gotten knocked out of its spot as Americans’ No. 2 killer, but health officials have delivered some good news about the disease that once was considered irreversible in its lethal course: Cancer deaths rates have fallen now for a quarter of a century.

The American Cancer Society, pointing to 1991 as a peak year, says that death rates from the disease declined by 27 percent, “meaning more than 2.6 million deaths [were] avoided between 1991 and 2016.”

Still, 1.7 million Americans likely will be diagnosed with cancer this year, and the disease will kill more than 600,000 patients — meaning 1,666 people per day in this country will die of cancer.

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…

jeanne_lenzerbrownlee-150x150Medical devices race onto the market with little or no effective testing or regulatory safeguards, and a proposed “reform” of the oversight system of products that are implanted in tens of millions of Americans is a sham, safety advocates say.

That’s because there are gaping flaws in the proposal to alter the so-called 510(k) procedure under which the federal Food and Drug Administration clears medical devices for sale, say medical journalist Jeanne Lenzer (right) and health care activist Shannon Brownlee (left).

Their Op-Ed in the Washington Post is the latest salvo against FDA Commissioner Scott Gottlieb’s claims of “transformative” changes in medical device regulation by his agency. News organizations around the world in recent weeks have published investigations of how poorly such products are tested, reviewed, and then released on markets, killing and injuring patients as a result.

knees-300x81With a graying nation projected to see millions of patients undergoing knee replacements each year at an annual cost to taxpayers running in the billions of dollars, it may be past time to ask if surgeons and hospitals promote and perform these popular procedures to excess.

Liz Szabo, in a story written for the nonprofit, nonpartisan Kaiser Health News Service (KHN) and published in the Washington Post, reported that knee surgeries have their “risks and limitations,” and “doctors are increasingly concerned that the procedure is overused and that its benefits have been oversold.”

As she wrote:

When doctors, hospitals, insurers, and their captive lawmakers howl about how unfair malpractice lawsuits allegedly can be for modern medicine, patients who have suffered harms while seeking medical services should require loved ones, friends, and members of their community to view Bleed Out.

This new HBO documentary details the decade-long quest by comedian Steve Burrows and his family for justice for his mother, Judie. She was an energetic, retired teacher when she fell from her bike and needed emergency hip surgery. Before she had recovered, she fell again and needed a second operation. But this time, something went wrong: She lost more than half her blood, fell into a coma, and suffered irreversible brain damage that meant that she would spend the rest of her life in institutional care in rural Wisconsin.

drunkdriving-300x122Don’t be tempted over the next few days of new year’s revelry to drive while distracted or intoxicated — whether under the influence of alcohol, marijuana, or prescription drugs.

It’s a myth that the start of the year is the deadliest time for motorists across the country. But Jan. 1, statistically and without great explanation, has been most lethal for pedestrians nationwide. Pedestrians also are in greater harm’s way than they should be here in Washington, D.C.

Drunk driving poses significant problems in the nation’s capital, where alcohol-related fatalities increased 33 percent in 2017. Officials in the District of Columbia need to crack down even more on an issue that puts motorists, pedestrians, and cyclists alike in peril.

juulcig-300x159When the reviews of 2018 get written, here’s hoping that health experts castigate the federal Food and Drug Administration and Scott Gottlieb, its chief, for a major blunder that continues to harm the well-being of the nation’s teenagers and young adults.

That’s because Gottlieb and his agency held a regulatory door wide open as the maker of the e-cigarette device Juul stormed through, campaigning to hook teen-agers and collegians on vaping. That’s the practice of using e-cigarettes to catalyze commercially prepared solutions to get a high, typically from nicotine, a powerfully addictive substance that carries a range of risks, especially for the young.

Big Tobacco loves Juul so much that, as a holiday gift, Altria, a major player in the industry, has cut a $12.8 billion deal with the e-cigarette maker that includes a $2 billion bonus to be split by the company’s 1,500 employees.

davincirobot-300x176When surgeons insist on cutting on patients using the million-dollar da Vinci robot system, patients should demand to know why — and to be skeptical to the nth degree whether the device-based operation will be beneficial to them, or if it is yet another way for doctors and hospitals to make medical care exorbitantly expensive and to boost their profits.

NBC News, as part of a global investigation of medical devices and their harms, deserves credit for adding yet more disturbing disclosures with a detailed story about the da Vinci. The report clearly seeks to be balanced and doesn’t deliver as hard-hitting a point of view as The Bleeding Edge, a recent and important HBO documentary on the surgical robot system.

Still, there are plenty of disturbing items that ought to stop lawmakers, regulators, safety advocates, and patients, and force a hard re-thinking about da Vinci:

chickenwash-300x107Here’s hoping the season stays merry for all and that holidays are relaxing, restful, and healthful. A few tips to stay on the right side of health and safety:

  • Be sure to follow best practices when it comes to food hygiene and safety. Do wash fruits and vegetables to rid them of surface contaminants, including dirt and pesticides. This isn’t foolproof and doesn’t clear these products of all bacteria that can cause foodborne illness — far from it. But washing does help. As for raw meat and poultry, don’t for cleanliness’ sake rinse it, then pat it dry. This just spreads contaminants all around the kitchen, food scientists have found. And, tempting though it may be, don’t eat that cookie or cake dough, and don’t think that baking recalled products might make them safe.
  • Don’t give necklaces, bracelets, or anklets to ease the tooth discomfort experienced by babies or children with special needs: The federal Food and Drug Administration has warned this jewelry can be risky for the vulnerable, noting instances in which they have experienced “choking, strangulation, injury to the mouth and infection.” The agency also cautioned that amber teething necklaces contain “succinic acid, which allegedly may be released into an infant’s blood stream in unknown quantities. Manufacturers of these products often claim succinic acid acts as an anti-inflammatory and relieves teething and joint pain. The FDA has not evaluated these claims for safety or effectiveness and recommends parents not use these products.” The agency issued its warning after a 7-month old choked to death on a wooden teething bracelet while under parental supervision, and an 18-month old was fatally strangled by his amber teething necklace during a nap. The FDA also reminded that it urges caregivers to “avoid using teething creams, benzocaine gels, sprays, ointments, solutions and lozenges for mouth and gum pain. Benzocaine and other local anesthetics can cause methemoglobinemia, a serious condition in which the amount of oxygen carried through the blood is reduced. This condition is life-threatening and can result in death.” Pediatricians say that discomfort to teething can be eased with adults offering a gentle gum massage with a clean finger or by giving babies a hard rubber ring to chew.

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