Decongestant and Ventilation Problem, in the middle ERAS (tour) to be (disaster) ERIS (coronavirus)
DC 11.54pm
The leading decongestant used by millions of Americans looking for relief from a stuffy nose is likely no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient. At the same time, CDC experts recommend new coronavirus XBB boosters for everyone ages 6 months and older. The Covid pandemic of 2019-23 ranks among our greatest tragedies in modern times. 15-20 million deaths or more, threats to our global security.
As the temperatures soar and Covid is on the rise, there is an obvious solution that would keep students & educators learning & healthy: invest in and upgrade school ventilation systems.
"We accept respiratory diseases right now, like colds and flu, as a way of life — but maybe we don't have to" Linsey Marr, Engineering Professor from Virginia Polytechnic Institute and State University said. "Maybe if we start paying more attention to cleaning our indoor air, we could really reduce the burden on our health & society"
Along with Virginia Tech, the $8.8 million project also involves researchers at the University of Michigan, University of Pittsburgh, Emory University and Georgetown University — all working to get a definitive answer as to how the flu spreads.
"Conventional wisdom about the flu is that it's transmitted when people cough or sneeze in your face, and it's these large wet droplets that carry the virus. It lands on you and you get the flu," Marr said, "but it turns out there's not a lot of direct evidence that supports that idea."
So, researchers set out to see what might actually be happening when the flu starts to circulate in a community, including looking at how well masks may be able to mitigate its spread.
"What's new about this research is that we're bringing a really interdisciplinary approach to it," Marr said. "It's not just medical doctors — it's virologists, it's engineers who understand how viruses can move around in the environment, in the air and on surfaces."
Researchers say one possibility is that the flu is actually transmitted not just by large wet droplets, but by fine particles that can remain suspended in the air for a long time.
"People get the flu when they're close to others who are infected," Marr said. "And I think we didn't realize that, 'Oh, maybe people are also getting it when they're at a distance and they're just sharing air in the same room.'"
Doctors say that's why it's critical to make sure as many people as possible get the flu vaccine every year, which they say could have added benefits.
"It's kind of like keeping your immune system at its best, in peak condition – so, another good reason to get your yearly flu shot, because it might reduce those common respiratory infections," said Dr. Scott Joy, chief medical officer for HealthONE Physician Services Group.
Back at the MITIGATE FLU project, whatever the findings end up showing could potentially be used to bring about structural changes to how indoor air is handled in buildings, which is something that got a lot of attention during the pandemic.
"We kind of accept respiratory diseases right now, like colds and flu, as a way of life — but maybe we don't have to," Marr said. "Maybe if we do start paying more attention to cleaning our indoor air, we could really reduce the burden that it places on our health and society."
Advisors voted 13-1. While the benefits appear to be greatest for the oldest and youngest people, the benefits exceed the risks for everyone, according to CDC analysis. FDA okays new coronavirus vaccine as respiratory illness season nears. Good news for the majority. Sadly, can't save or help those who have been radicalized by disinformation.
The Covid Study Group (non-partisan, scientists/doctors/policy ppl) used Western Europe as a comparable baseline and estimates the U.S. suffered an extra half *million* deaths, at least. As one member of the group said: "Trump was a comorbidity." I've never doubted it — people are suffering," says Dr Harlan Krumholz, cardiologist at Yale involved in Long Covid research. "But we're now seeing imaging evidence, biopsy evidence, physiologic testing evidence of derangements in people who have long COVID." In a study evaluating deaths in people >25 yo in Florida and Ohio between March 2020 and Dec 2021, excess mortality was sign higher for Republican voters than Democratic voters after COVID-19 vaccines were available to all adults.
Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the ingredient found in popular versions of Sudafed, Allegra, Dayquil and other medications sold on pharmacy shelves.
"Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine," said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine.
The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine — were moved behind pharmacy counters. A 2006 law had forced the move because pseudoephedrine can be illegally processed into methamphetamine.
Those original versions of Sudafed and other medicines remain available without a prescription, but they account for about one-fifth of the $2.2 billion market for oral decongestants. Phenylephrine versions — sometimes labeled "PE" on packaging — make up the rest.
If the FDA follows through on the panel's recommendations, Johnson & Johnson, Bayer and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves. That would likely force consumers to switch to the behind-the-counter versions of the pills or to nasal sprays and drops that contain phenylephrine, which are not under review.
This week's two-day meeting was prompted by researchers at the University of Florida, who petitioned the FDA to remove phenylephrine products based on recent studies showing they failed to outperform placebo pills in patients with cold and allergy congestion. The same researchers also challenged the drug's effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.
That was also the recommendation of FDA's outside experts at the time, who met for a similar meeting on the drug in 2007.
This time, the 16 members of the FDA panel unanimously agreed that current evidence doesn't show a benefit for the drug.
"I feel this drug in this oral dose should have been removed from the market a long time ago," said Jennifer Schwartzott, the patient representative on the panel. "Patients require and deserve medications that treat their symptoms safely and effectively and I don't believe that this medication does that."
The advisers essentially backed the conclusions of an FDA scientific review published ahead of this week's meeting, which found numerous flaws with the 1960s and 1970s studies originally used to support phenylephrine's approval. The studies were "extremely small" and used statistical and research techniques no longer accepted by the agency, regulators said.
"The bottom line is that none of the original studies stand up to modern standards of study design or conduct," said Dr. Peter Starke, the agency's lead medical reviewer.
Additionally, three larger, rigorously conducted studies published since 2016 showed no difference between phenylephrine medications and placebos for relieving congestion. Those studies were conducted by Merck and Johnson & Johnson and enrolled hundreds of patients.
A trade group representing nonprescription drugmakers, the Consumer Healthcare Products Association, argued that the new studies had limitations and that consumers should continue to have "easy access" to phenylephrine.
Like many other over-the-counter ingredients, phenylephrine was essentially grandfathered into use during a sweeping FDA review begun in the 1972. It has been sold in various forms for more than 75 years, predating the agency's own regulations on drug effectiveness.
"Any time a product has been on the market that long, it's human nature to make assumptions about what we think we know about the product," said Dr. Theresa Michele, who leads the FDA's office of nonprescription drugs.
But FDA reviewers said their latest assessment reflects new testing insights into how quickly phenylephrine is metabolized when taken by mouth, leaving only trace levels that reach nasal passages to relieve congestion. The drug appears more effective when applied directly to the nose, in sprays and drops.
There's unlikely to be any immediate impact from Tuesday's panel vote, which is not binding.
The group's negative opinion opens the door for the FDA to pull phenylephrine from a federal list of decongestants deemed effective for over-the-counter pills and liquids. The FDA said removing the products would eliminate "unnecessary costs and delay in care of taking a drug that has no benefit."
The FDA's nasal decongestants drug list, or monograph, has not been updated since 1995. The process for changing a monograph has traditionally taken years or decades, requiring multiple rounds of review and public comment. But a 2020 law passed by Congress streamlines the process, which should allow the FDA to accelerate the publication of new standards, doses and labeling for nonprescription ingredients.
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-prada- Adi Mulia Pradana is a Helper. Former adviser (President Indonesia) Jokowi for mapping 2-times election. I used to get paid to catch all these blunders—now I do it for free. Trying to work out what's going on, what happens next. Arch enemies of the tobacco industry, (still) survive after getting doxed. Now figure out, or, prevent catastrophic situations in the Indonesian administration from outside the government. After his mom was nearly killed by a syndicate, now I do it (catch all these blunders, especially blunders by an asshole syndicates) for free. Writer actually facing 12 years attack-simultaneously (physically terror, cyberattack terror) by his (ex) friend in IR UGM / HI UGM (all of them actually indebted to me, at least get a very cheap book). 2 times, my mom nearly got assassinated by my friend with “komplotan” / weird syndicate. Once assassin, forever is assassin, that I was facing in years. I push myself to be (keep) dovish, pacifist, and you can read my pacifist tone in every note I write. A framing that myself propagated for years.
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