Articles Posted in Testing

aduhelm-300x250Taxpayers and patients are suffering the rising negative consequences of the federal Food and Drug Administration’s dubious decision to overrule its own independent expert advisors and to approve on scant evidence Aduhelm. It is a prescription drug targeting Alzheimer’s disease, and concerns are rising about the medication’s safety and costs, not to mention whether it really works.

FDA advisors had argued against the drug, cautioning  that it carries significant potential side effects including swelling and bleeding in the brain. Those taking Aduhelm have been warned to undergo frequent, regular, and pricey brain scans as safeguards.

Still, experts have been startled by a much-discussed death of a 75-year-old Canadian woman, who was taking the drug as part of a clinical trial. She suffered seizures, was hospitalized, had brain scans, and was diagnosed with brain swelling shortly before she died.

covidpic-300x247Americans’ Thanksgiving holiday traveling, socializing, and  shopping resumed with vigor, near pre-pandemic norms. And yet:

needles-300x152With studies showing that as many as half of patients infected with the coronavirus suffer physical and psychological problems for six months or more after they thought they first recovered, wise people may want to take every precaution they can against the disease.

They may wish to heed new federal recommendations calling for vaccine boosters, now approved for all Americans 18 and older and strongly encouraged for those older than 50.

The building data on “long Covid” is disconcerting, the Washington Post reported, noting:

bowserbooster-300x225The coronavirus pandemic continues to kill an average of 1,200 Americans each day and the disease infects more than 76,000 people daily — unwavering numbers that have led public health officials — wary of what the hectic holidays will bring — to double down on their campaign for vaccinations against the virus.

This is especially true for kids, and with boosters, perhaps now for almost all.

The drug maker Pfizer, which already had presented federal regulators with data on how its vaccine wanes in effectiveness over time, has asked for approval to give all patients who have completed its two-shot regimen a third dose for increased protection.

cnncovidicu-300x242When hospitals too often fail to disclose and to adequately deal with their problems, patients and their loved ones suffer. That’s what happened during the coronavirus pandemic, when individuals admitted for other reasons were infected in hospitals and died of Covid-19 at alarming rates.

The federal government, separately, also is stepping up its efforts to get hospitals to comply with U.S. regulations to foster greater transparency in institutions’ pricing of medical goods and services.

The independent, nonpartisan Kaiser Health News (KHN) service, to its credit, has dug into publicly available data to show how Covid-19 became the latest problem pathogen spread in hospitals — part of the menace long known as HAIs or hospital acquired infections.

dcvaxmayorbowsernbcwashington-300x229Even as the coronavirus batters parts of the country, notably the Mountain West, public health officials are pointing to key ways in which Americans could safely and effectively further quell the pandemic that has claimed hundreds of thousands of lives and infected tens of millions.

Children ages 5 to 12 have been approved for emergency use for a lower-dose Pfizer vaccine, and a third of parents who told pollsters they were eager to get their youngsters vaccinated have begun to do so at pediatricians’ offices, clinics, schools, pharmacies, and other at-the-ready sites.

Experts say vaccinating young children, atop of already approved shots for kids ages 12 and older, will provide an important safeguard to a vulnerable population of millions as well as helping to ensure they will not spread the coronavirus.

kidvax-300x195The coronavirus pandemic’s fourth, lethal Delta-variant surge keeps receding from its scary September peaks, with “fewer than half as many cases … being identified each day, and tens of thousands of fewer coronavirus patients … hospitalized.”

Still, as the New York Times also has reported, “trouble spots continue to emerge in parts of the West. Alaska leads the country in recent cases per capita, while Colorado has the fastest rate of case growth.”

The pandemic’s grim toll also is lessening but still takes an unacceptable 1,400 lives daily (versus 2,000/day in September).

covidshotcloseup-260x300Don’t doubt the central role that vaccines are playing in the battle against the coronavirus pandemic.

Federal officials — even as the Delta-variant surge is easing — have dominated the news by approving yet more boosters for those who have gotten the Moderna or Johnson & Johnson shots and announcing preparations to vaccinate kids ages 5 to 12.

Experts now have endorsed boosters for the millions who have gotten Pfizer, Moderna, and J&J shots. They also approved proposals to mix and match vaccines, an approach especially advised two months after those 18 and older receive the one-shot J&J product.

cdcoct2021covidcasesreported-300x154As the summer’s deadly Delta variant surge slowly seems to be receding, questions are rising anew as to what further harms the coronavirus pandemic may inflict on a nation that already has suffered greatly.

The infection still is creating major problems in Alaska, as well as parts of the West and Upper Midwest, notably Minnesota. There, hospitals and health care systems are struggling to care for not only their regular populations of patients but also big numbers of unvaccinated patients requiring intensive treatment for Covid-19.

An unacceptable 1,700 Americans still are dying on average each day from the virus, even as medical scientists and doctors now can muster a growing arsenal to prevent and battle the illness — with free, widely available vaccinations, new monoclonal antibody therapies, and public health measures like face covering, distancing, testing, and quarantines.

cdcflushot-300x199The battle to quell the coronavirus pandemic and especially its deadly Delta variant surge soon may extend to the nation’s children.

A drug maker has submitted required data and formally requested from federal regulators an emergency approval for a vaccine for youngsters ages 5 to 12. Officials say they will take up this request, pronto, with the possibility that parents by Halloween or early November can start to see the great relief of strong, safe protection for their children from the debilitating and deadly virus.

It already has taken a stark toll on youngsters, with an estimated 140,000 of them losing their main caregivers — parents or grandparents — between April 1, 2020, and June 30 of this year, a newly published study estimates.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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