Testing Category Archives — DC Medical Malpractice & Patient Safety Blog Published by Washington, D.C. Personal Injury Lawyers

December 3, 2021

FDA under renewed fire over dubious approval of Alzheimer’s drug

Taxpayers 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.

November 28, 2021

Not so fast, Omicron variant says, as U.S. races for holiday normalcy

by Patrick A. Malone

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

Public health, political, and financial leaders expressed increasing concern about B.1.1.529, a new variant detected in South Africa, Israel, and elsewhere. The World Health Organization dubbed this coronavirus strain Omicron, the next alphabetic-derived Greek name in the group’s list. WHO said the variant shows many mutations, especially in the spike the virus uses to invade human cells, and is of high concern — an official designation that caused worldwide markets to plunge, as well as travel bans to go up temporarily between a half dozen nations and southern Africa and Europe and the United States. Experts cautioned that further research will be needed to establish Omicron’s infectiousness, the severity of the disease it causes, and whether existing vaccines are effective and safe against it.
A fifth likely coronavirus surge appeared to be gaining ground, with deaths declining or holding static from peaks set during a summer of sickness and fatalities, mostly in the South and Pacific Northwest. Now, cases and hospitalizations are increasing, notably in the Midwest and Northeast. Hospitals and health systems in Michigan are reporting they are getting overwhelmed with serious coronavirus cases, most of them afflicting the unvaccinated.

November 23, 2021

U.S. urges booster shots for all 18 and older and especially the 50+

by Patrick A. Malone

With 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:

November 16, 2021

Pandemic battles focus on boosters for all and more shots for kids

by Patrick A. Malone

The 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.

November 9, 2021

Thousands admitted to hospitals for other reasons ended up with Covid-19

by Patrick A. Malone

When 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.

November 7, 2021

Kids now can get Covid shots. Will they? And what about the new anti-Covid pills?

by Patrick A. Malone

Even 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.

October 31, 2021

U.S. pandemic deaths climb toward 750,000 as shots for kids near

by Patrick A. Malone

The 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).

October 24, 2021

U.S. has three approved boosters and is prepped to vaccinate kids

by Patrick A. Malone

Don’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.

October 17, 2021

As Delta surge eases, what’s next with this pandemic?

by Patrick A. Malone

As 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.

October 10, 2021

As experts ponder vaccinating our kids, Covid orphans tens of thousands

by Patrick A. Malone

The 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.