06Jun

COVID-19 has had at least one positive effect on health: Vaping, the use of e-cigarettes, among teens and young adults has decreased markedly since the beginning of the pandemic.

A survey reported Dec. 3 on the JAMA Network Open says almost a third — 32.8% — of young adult users 13-24 that changed their e-cigarette use since the beginning of the COVID-19 pandemic quit vaping. Another 35.3% reduced their use of e-cigarettes. Not all e-cigarette users changed their smoking habit, but 56.4% of the survey participants did.

One of the two researchers, Bonnie Halpern-Felsher, a developmental psychologist and professor of pediatrics at Stanford University, told HealthDay, “One of the main reasons they quit is that they were worried about lung health, and we think that’s important, that they thought they could hurt their lungs.”

Vaping already was on the decline according to a CDC and FDA survey conducted just before the COVID shutdown in March. The report published in September found 20% of high school students and 5% of middle school students were vaping in early 2020, compared with 28% of high school students and 11% of middle school students in 2019.

The just published survey said who quit or decreased their use out of concern for their health accounted for 25% of the total. Because they were at home and their parents would know caused 15.2% to quit or cut back. Another 19.5% said it was because they couldn’t get the products. Almost a third (32.1%) said a combination of those factors were responsible.

There’s good reason for youthful vapers to quit. Research has revealed that 13-24 year-old cigarette and e-cigarette users were much more likely than non-smokers to be diagnosed with COVID-19. Dual-users who vaped and smoked cigarettes were 7 times more likely to get a COVID diagnosis. Those who vaped only were 5 times more likely.

The newest survey also found those adhering to the stay-at-home orders were 1.5 times more likely to have reduced or quit e-cigarettes, a consequence of access being limited, a lack of socializing with other users or worries about parents or a combination.

“In this study, sheltering-in-place policies that may have limited access to retail store purchases may have helped facilitate quitting or reduced use among both underage youth and young adults,” the researchers noted.

However, they also found that “that vape shops and online platforms are routinely selling to underage youth during this pandemic.”

Photo by Chiara Summer on Unsplash

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Jun 6, 2023

Thank You to Doctors Everywhere

When Eudora Brown Elmond founded the first National Doctor’s Day in a small Georgia town in 1933, no one could have predicted the significance it holds today for all of us.

She simply wanted to celebrate her husband’s career.

Today, we celebrate the heroic work of doctors who risked their health and their very life to treat those infected by the SARS-CoV-2 virus.

Most nations honor the work of medical doctors with a special day of recognition. In the US, we celebrate National Doctor’s Day on March 30, chosen because it marks the day in 1842 that anesthesia was first used. 68 years after Elmond’s first doctor’s day, Congress made it an official day of recognition.

The red carnation doctors may wear today was a tradition Elmond started.

We at Green Key Resources join with all Americans to say “Thank you” to doctors everywhere. Thank you for being there when your country needed you most. Thank you for your courage, your long hours and your caring.

Thank you for being a doctor!

Photo by JAFAR AHMED on Unsplash

Jun 6, 2023

COVID-19 Puts Spotlight On Adaptive Clinical Trials

One of the lasting effects of the COVID-19 pandemic is likely to be the accelerated acceptance of adaptive clinical trials.

Dr. Anthony Fauci endorsed adaptive trials when he announced the effectiveness of redelivering in treating COVID-19 patients.

“The data shows that remdesivir has a clear-cut, significant positive effect in diminishing the time to recover,” Fauci said in a White House briefing April 29.

The data came from a unique type of clinical trial launched in February and sponsored by the National Institute of Allergy and Infectious Diseases where Fauci is director. The Adaptive COVID-19 Treatment Trial (ACTT) is different from classical clinical trials in that researchers can make changes in dosing, patients and other parts of the study as the data accumulates.

That’s why, not quite two months into the study, Fauci was able to declare remdesivir effective in reducing recovery time for COVID-19 patients. Discussing the trial findings up to that point, Fauci said, “What [the trial] has proven is that a drug can block this virus.”

Adaptive clinical trial design is common in testing medical devices, but much less so in testing drugs and new therapies. Those tests are almost exclusively designed as randomized clinical trials (RCT) in which subjects are divided into at least two groups, with one receiving the new drug and a second a placebo. It’s a double-blind test meaning neither the patient nor the clinical researchers know who is getting what. Once underway, only in the rarest of situations can the process depart from the trial’s original design.

Though considered the gold standard for testing the efficacy and safety of new drugs, the RCT design has been criticized for its cost, duration and inflexibility. As long ago as 2004 the Food and Drug Administration announced a Critical Path Initiative to accelerate drug development. “Modernizing Clinical Trial Designs and Strategies” was one of the programs.

At the end of last year, the FDA issued an industry guidance for pharmaceutical and bioscience firms “on the appropriate use of adaptive designs for clinical trials.”

The guidance notes,

“Adaptive designs can provide a variety of advantages over non-adaptive designs. These advantages arise from the fundamental property of clinical trials with an adaptive design: they allow the trial to adjust to information that was not available when the trial began.

While the ACTT, first launched at the University of Nebraska Medical Center and now involving 68 sites, and other adaptive COVID-19 trials now underway are showing they can deliver results, adaptive trials are unlikely to any time soon – or ever — become the new standard for drug testing.

Dr. Adams Dudley, a drug safety expert at UC San Francisco, told the Los Angeles Times, it’s risky to allow companies with a financial stake in the outcome to change study rules during a trial. However, in a crisis like the current COVID-19 pandemic, Dudley said randomized clinical trials take too long.

Noted the Times, “With thousands of people dying every day of COVID-19, the deliberate pace of this gold standard research may not be the best way to end the crisis quickly.”

Photo by Viki Mohamad on Unsplash

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