Articles Posted in Product Safety

aduhelm-150x150The federal Food and Drug Administration has created an instant medical and regulatory morass by giving an accelerated approval to Biogen’s costly prescription medication targeted at patients with Alzheimer’s disease.

This is the first drug to win the precious official nod from the FDA in almost two decades.

But the agency’s OK to market aducanumab (pronounced “add-yoo-CAN-yoo-mab”), which will go by the brand name Aduhelm, may go in the books as one of the sketchiest and most ferociously contested in recent times. The drug somehow overcame Everest-sized reasons why, at best, it needed further study — which it is supposed to get. And it faces Himalayan-sized criticisms that it will raise false hopes for those afflicted with a condition that is spiking in a fast-graying nation, and for which no effective medical remedy has been found.

cnnhoustonvaxprotest-300x169In the crunch to quell the coronavirus pandemic and to do so by getting as many people as possible their protective shots, public health officials consistently have stressed a big V in the national vaccination campaign: Voluntary.

But as hundreds of millions of people around the globe have willingly gotten them and the vaccines have shown to be overwhelmingly safe and effective, the unvaccinated may get leaned on with more than pleas, nudges, and incentives.

They may notice this quiet push in the workplace, especially if they hold health-related jobs, and at schools. The result may be to resurface the fiery and counter-factual anti-vaccination extremism in the country.

donutstoon-300x206With the Fourth of July just weeks away, federal officials have ramped up their campaign to hit President Biden’s announced goal of having 70% of adults in this country vaccinated against the coronavirus. The aim is for the rapidly opening nation to safely and fully declare its independence from the deadly pandemic.

Biden, while thanking those who already have gotten their shots, has pressed the 20 million or so unvaccinated among us to get on board, asap. The administration will try multiple ways to increase the 63% or so of adults vaccinated, including by:

  • relaunching outreach efforts with a national tour featuring Vice President Kamala Harris in the South and Midwest

babysleepers-300x217One of the federal government’s top consumer watchdogs has roused itself from its torpor and, finally, moved to ban what a leading independent group calls “dangerous infant sleepers and other products that do not align with expert medical recommendations for safe sleep.”

As Consumer Reports said of the new orders by the federal Consumer Product Safety Commission (CPSC) regarding devices linked to the deaths of dozens of babies:

“The ruling, which was approved by three of four CPSC commissioners, was years in the making — and was prompted in part by an ongoing CR investigation that has linked inclined sleepers, such as the Fisher-Price Rock ’n Play Sleeper, to at least 94 infant deaths. CR has also tied in-bed sleepers, such as the DockATot and the Baby Delight Snuggle Nest, to at least 12 fatalities. The CPSC has separately tied unregulated ‘flat sleepers’ —such as baby boxes, soft-sided travel beds, and bassinets with no stand —to 11 deaths. All told, that amounts to close to 120 infant deaths connected to one of these hazardous infant sleep products.”

debbiedingell-150x150Just because myriad drugs and supplements are sold over the counter does not mean these pills are safe. They can pose serious health risks and cause major damage, a prominent Midwestern congressman has reminded by sharing her own near-disaster with a well-known OTC drug.

Debbie Dingell, a Michigan Democrat, told the Washington Post that she recently awoke with great pain and a feeling of bloating. Her symptoms were so severe and unrelenting that she called her doctor and was rushed into emergency surgery for a perforated ulcer. She was hospitalized for a week to recuperate.

The likely cause for her serious problems, her doctors told her: Her extended taking of high doses of an over-the-counter pain reliever found in many people’s medicine cabinets — Motrin, or ibuprofen. As she told the newspaper, she took it to ease her pain after dental implants and jaw surgery:

summerfun-221x300In these uncertain times, the start of summer — marked unofficially by the just-passed, long Memorial Day weekend — may have caught more than a few of us by surprise. Seasonal health and safety precautions, however, should be well considered and carefully carried out, especially by parents.

All of us, for example, must step up our safeguards against damages caused by exposure to the sun, reported Jane Brody, the longtime health and wellness columnist for the New York Times. She noted that she, like many people, talked a good game about avoiding peak burn times of the day and slathering on sunscreen. She didn’t always follow through, though she has recommitted to doing so for a reason, she wrote:

“I hereby pledge to do better this yearalbeit late in the game. A new report from a dermatology team at Kaiser Permanente health care centers in California has prompted me to reform. The team, headed by the epidemiologist Lisa Herrinton in Oakland, followed nearly half a million patients seen at the centers for up to 10 years. Half had already developed one or more actinic keratosis, a precancerous rough, scaly skin lesion caused by years of unprotected sun exposure. As you might expect, these lesions most often form on the face, ears, back of the hands, forearms, scalp and neck and are — or should be — routinely removed when found by dermatologists to prevent progression to cancer. The lesions are markers of sun damage and can serve as an early warning system for people at risk of developing cancer somewhere on sun-exposed skin. While the hazard is greatest for people with light skin, blue eyes, freckles, or red hair, having a dark complexion is not a free pass. Tanning, not just burning, is a form of sun damage.”

While Big Pharma wages an expensive behind-the-scenes battle to prevent federal lawmakers from cracking down on soaring prescription drug prices, industry officials have sought to take advantage of a sudden, positive shift in public perceptions about their industry due to the great outcomes of the coronavirus vaccines.

Drug makers are hitting hard their argument that the high prices for their products, including vaccines and top-selling treatments for cancer and other serious conditions, can be attributed to factors like the huge expense of scientific research and development of breakthrough therapies.

comparesite-300x126Hospitals in the Washington, D.C., area got generally lackluster ratings for quality and safety of health care in the latest reviews by federal and independent groups. Two well-known D.C. hospitals got one star, the lowest ranking, in a federal survey, while a nonprofit rater gave another D.C. hospital a flunking grade of F.

The reviewers, due to the coronavirus, suspended their 2020 ratings, so the new measurements were the first in many months and they showed, to a degree, how institutions held up during the pandemic. The rankings also underscored the urgency of local officials’ announced plans to revamp hospital care, including helping to fund two new facilities.

The stars awarded by the federal Centers for Medicare and Medicaid Services (CMS) reflected criteria revised to deal with criticisms from hospitals themselves and others. The CMS rankings, as described by the industry publication Becker’s Hospital Review, were launched in 2016 and “assigns stars based on 48 measures in the following five categories: mortality, safety of care, readmission, patient experience, and timely and effective care. This differs from CMS’ previous method, which included 65 measures across seven groups.”

cigsmenthols-300x227The Biden Administration will ban menthol cigarettes and flavored cigars with new regulations to be issued within the next year — actions that Big Tobacco is expected to battle but which proponents say could have big health benefits for those who have been targeted to buy and use these products.

Smoking is a leading cause of death in this country, and especially among African Americans, with critics saying cigarette makers have exploited communities of color, the poor, and LGBTQ people with flavorings to popularize damaging goods. As the Washington Post reported of the announced plans of the federal Food and Drug Administration:

“[Its] menthol ban would reduce health disparities between white and black smokers. About 85% of African American smokers use menthol cigarettes, three times the rate of white smokers, and their rate of quitting smoking has not declined as quickly as it has for whites. As a result, black smokers suffer disproportionate rates of disease and death. Similarly … the effort to remove menthol and flavorings from small cigars [is] a way to prevent young people from starting the smoking habit and helping them quit. The small cigars are increasingly popular with young smokers; more high school smokers now use small cigars than cigarettes.”

bupe-300x188Health workers with legal prescribing privileges have gotten newly revised federal guidelines — once again — making it easier for them to help those addicted to powerful opioid painkillers by prescribing buprenorphine, another powerful medication.

This action could be beneficial in battling the opioid abuse and drug overdose crisis that ebbed in recent times and then worsened during the coronavirus pandemic, overall killing hundreds of thousands of Americans.

As the Washington Post reported of regulators’ latest decisions:

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