Articles Posted in Quality outcome measures

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.

chartnytnhomedeaths-300x213Nursing home owners and operators have pleaded “poor us” through a lethal 2020. But profit-seeking players in the industry clearly still see rapacious opportunity in long-term care facilities — with residents suffering the consequences.

NPR and the Washington Post both have dug into the results when investment groups or chains acquire and operate nursing homes, and, as the media organizations reported, resident care declined.

The newspaper focused one of its deep digs on long-term care on New Jersey-based Portopiccolo Group, and how it “buys troubled nursing homes and tries to make them profitable,” paying “hundreds of millions of dollars to acquire facilities in Maryland, Virginia and elsewhere,” with little federal, state, or local oversight of its acquisitions.

cdcinoculate-300x240The “warp speed” race to develop a Covid-19 vaccine has gotten hit with a yellow flag.

It could be a good thing that the product’s makers — Oxford University and AstraZeneca — followed medical-scientific protocols and paused their Phase III clinical trial due to a participant’s unexplained illness.

Officially, the company offered spare information about the occurrence, especially because it affects the private medical information of a single individual.

vaccination-300x199As the novel coronavirus infections and deaths keep skyrocketing, Americans more and more have been forced into tough risk analyses, and frankly, too often thinking like gamblers. They are, for example, looking a lot at the much-promoted possibility of a Covid-19 vaccine in desperate poker ways — “betting on the come” and playing “river, river …”

Experts are asking just how savvy this health care approach is, putting in high stakes in the hopes the deck is dealt just so, or believing in a cliff’s edge rescue when the last cards on the table are flopped over to reveal a winner? Is it reality check time? And is there is a Plan B?

Vaccine makers around the world are racing to produce a viable response to Covid-19. U.S. infections have skyrocketed past 4 million and the disease is heading toward killing 150,000 Americans. Politicians and public health officials continue to speak optimistically about “Operation Warp Speed” and other campaigns globally to develop a vaccine that experts say will play a vital role in blunting Covid-19’s sickening and lethal spree through humanity.

silence-300x192Historian Doris Kearns Goodwin highlighted a crucial strength of the 16th U.S. president as he led the nation through one of its most divisive times: Abraham Lincoln encouraged dissent and welcomed opposing points of view, going so far as to appoint three better-known political rivals to top positions in his administration.

That extraordinary lesson in crisis leadership seems to be getting lost in the nation’s battle with the novel coronavirus.

Too many doctors, nurses, and experts in science and medicine have been censored, disciplined, and dismissed for speaking truth to power, warning, for example, about unacceptable conditions for health workers treating Covid-19 infections, news organizations have reported.

drugsinhand-201x300Whoa, Nelly. For Americans stuffing their heads with vague data about potential drugs to treat Covid-19 — including chloroquine, hydroxychloroquine, azithromycin, remdesivir, ritonavir, lopinavair, Actemra, Oseltamivir, Ribavirin, Umifenovir, interferon, baricitinib, imatinib, dasatinib, nitazoxanide, camostat mesylate, tocilizumab, sarilumab, bevacizumab, fingolimod, and eculizumab — let’s get a little perspective, please.

Let’s put things simply, especially for most ordinary folks who have no desire to play at being pharmaceutical experts: As of this writing, as noted online in a meta-review by the respected Journal of the American Medical Association, this is the reality about drugs for the novel coronavirus:

 “No proven effective therapies for this virus currently exist.”

covidtestinggapnyt-300x185Public health experts and many politicians agree that the pursuit of any next steps in dealing with the Covid-19 pandemic will rely on testing, testing, testing. The nation will need significantly more tests, with faster and better results, that show who is infected now. Further, many, many more people will need to take blood antibody tests to determine who was infected with the disease and may have some level of immunity from it.

This is the problem: Weeks after the novel coronavirus swept the nation, infecting hundreds of thousands and killing thousands, the testing available is too scant, takes too long, and — despite much bloviating and promises — is mired in unacceptable ways.

The gulf between the needed level of testing and what is occurring is Grand Canyon sized (see NYT graphic, based on Harvard University research, above), and this is a giant problem in potentially relaxing Covid-19 restrictions now in place.

covidstayhome-sharonmccutcheon-200x300With President Trump, members of his administration, and other politicians shoving back against public health officials’ recommendations on when to get Americans out of their homes and returning to work, the ultimate decision may be up to individuals: Do we give up the existing physical-distancing guidance? Or not?

The data on Covid-19 infections and deaths is still building, but it may be worth reviewing what is known about the disease, whom it afflicts, and how.

Based on the deaths of those diagnosed with the novel coronavirus, it has been deadlier for men than women. It is taking a terrible and disproportionate toll among African Americans, with Latinos afflicted at high rates, too.

ACAsigning-300x176As the coronavirus pandemic causes Americans sky-high anxiety about their health and how they might access and afford extensive medical treatment if infected, the nation slid with only modest public attention into the second decade of one of its landmark health care experiments — the Affordable Care Act.

Obamacare became the law of the land on March 23, 2010, when the 45th president signed the 2,000-page bill for which he had campaigned long and hard. Republicans in the White House and Congress have attacked the ACA relentlessly ever since.

Researchers have spent a decade scrutinizing the ambitious act’s outcomes with zeal. The New York Times summarized some of the independent, nonpartisan evaluations, finding key areas that the public may wish to recognize in how Obamacare changed the complex U.S. health care system, on which Americans spend more than $3.5 trillion annually. In brief, as a result of the ACA, the newspaper reported (with boldface emphases mine):

AAMedals-300x156Although federal experts estimate that alcohol abuse leads to 88,000 Americans’ deaths annually and economic costs of almost $250 billion, one of the nation’s oldest and best-known programs to deal with this problematic behavior has long been surrounded by doubts.

Critics have questioned its effectiveness, criticized its “irrationality,” and focused on its stepped regimen, desperate and self-enrolling participants, and core tenets, including its spiritual appeals to higher and external powers.

But after a deep dig into the building and rigorous evidence about it — including scrutiny of 27 studies, (some of them randomized clinical trials) with more than 10,000 participants — researchers from Harvard, Stanford, and Europe have concluded in a published, research review for the respected Cochrane Collaboration that Alcoholics Anonymous, indeed, can be beneficial for many but not all excessive alcohol users.

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