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The following articles were submitted by Dr. Deborah Tracy: (posted December 16, 2020)
In a recent scientific brief, the CDC examined the community use of cloth masks to mitigate SARS-CoV-2 transmission risk. Cloth masks protect the community both by limiting potentially infectious droplets exhaled by the wearer and by filtering droplets from air inhaled by the wearer. The CDC also stated that mask use is particularly important considering that asymptomatic or presymptomatic individuals are responsible for more than 50% of all transmission. A recent study conducted in Kansas found that counties that imposed a mask mandate exhibited a decrease in transmission, while counties that did not experienced an increase. The counties with mask mandates reported a 6% decrease in daily incidence, while without a mandate reported a 100% increase over the same period. The study findings are consistent with similar studies conducted in other states that did and did not have mask mandates.
Good news and bad news today. First, the bad news. The U.S. continues to report new single-day records for daily incidence of new coronavirus cases with 194,610 reported on Friday. This is 36% more cases than the previous record, which was reported on the previous day. Since November 4, the average daily incidence has increased by 65%, and it appears to still be increasing exponentially. This surge is being called the “third wave,” and the reality is that for frontline healthcare workers, this is just the ever growing peak of a single wave that began in March. The U.S. never successfully contained the “first wave” so healthcare workers have not gotten a reprieve since the pandemic began. The upcoming Thanksgiving holidays is scaring public health leaders, in part fueled by a study that found a very high probability that at least one person will be carrying the coronavirus in holiday gatherings of 10 or more.
Now, the good news. Moderna Therapeutics issued a series of press releases over the past several days regarding the progress for the Phase 3 clinical trials for its candidate SARS-CoV-2 vaccine. Last week, Moderna announced that it identified enough cases among study participants—i.e., at least 53—to conduct the first interim analysis on the vaccine’s efficacy. The study completed enrollment of 30,000 participants in late October, and the primary metric is preventing symptomatic COVID-19 disease, with secondary aims of preventing severe disease and preventing infection. Last Friday, Moderna announced that Swiss regulatory officials began reviewing the trial’s safety and efficacy data to evaluate the possibility of authorizing its use in Switzerland. The review will occur on a rolling basis, as new data become available, as opposed to waiting until all data are collected, in hopes of accelerating the review process compared to traditional timelines. The most noteworthy news, however, was today’s announcement that interim analysis of the data indicates that the candidate vaccine could be nearly 95% effective. Like Pfizer’s announcement last week, this update was provided in a press release, and the actual data still need to be published and reviewed; however, the news is promising that multiple highly efficacious vaccines could be available in 2021. The Moderna interim analysis involved 95 participants with confirmed COVID-19 (90 of which were in the placebo group). Notably, 11 severe COVID-19 cases were reported among trial participants, and all were among the placebo group. Among the 95 cases, 15 are aged 65 years or older and 20 are racial or ethnic minorities—12 Hispanic or LatinX, 4 Black or African American, 3 Asian, and 1 multiracial. Moderna estimates the vaccine to be 94.5% efficacious based on the preliminary data, which would be comparable to the Pfizer vaccine. The vaccine also appears to have an acceptable safety profile, with no serious adverse events reported thus far.
Moderna also announced that the vaccine has demonstrated longer shelf life and greater stability at refrigeration temperatures than initially anticipated. According to the press release, “remains stable at 2° to 8°C (36° to 46°F)...for 30 days” and “at -20° C (-4°F) for up to six months.” The Moderna vaccine could be stored temporarily in standard refrigerators or freezers. Additionally, the Moderna vaccine can remain at room temperature for up to 12 hours and does not require onsite dilution or additional handling at the vaccination site, which could reduce the logistical burden required for mass vaccination. Both Pfizer and Moderna are expected to file for Emergency Use Authorization (EUA) with the FDA, and regulatory authorities in other countries. The news about both vaccine candidates has been received positively and with relief, especially as initial expectations about the efficacy of mRNA vaccines were somewhat low. Neither company has released the full interim analysis or the data analyzed in a journal, however, and the long-term safety and efficacy of these candidates remains to be assessed. By the way, if you would like to participate in a COVID vaccine research trial you may contact Headlands Research.
The CDC’s Advisory Council on Immunization Practices met yesterday and recommended the phasing for COVID vaccine distribution. The initial doses purchased by the U.S. government will be allocated to the states based on population and each state will determine how to allocate their doses. In a call yesterday, Florida’s Surgeon General stated that nursing home and long term care residents and staff as well as first responders will be in the first phase. That will be followed by healthcare workers at higher risk for exposure (ICU, ER, COVID units, and COVID testing) although the state has asked us to identify those workers who are over 55 years old or with underlying medical conditions so that they can be prioritized.
What we know about the vaccines:
Note: Both vaccines are expected to receive approval for EUA within the next 2 weeks, and become available shortly thereafter.
--------------------This is an interesting article from the International Journal of Infectious Disease that described a study that found that patients with COVID-19 had significantly low zinc levels compared to healthy controls and zinc deficient patients developed more complications and had a prolonged length of hospital stay.
September 9, 2020
RE: Open Public Testimony September 10-11, 2020 joint meeting of the Drug Safety and Risk Management Advisory Committee (DSARM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). The committees will discuss the results of required post marketing studies (Post marketing Requirements 3051-1, 3051-2, 3051-3, and 3051-4). FDA-2020-N-0982
posted May 29, 2020
updated letter to Govenor DeSantis from FSIPP
The FSIPP 2021 Conference, now in the planning stages.
Details are posted on the FSIPP-CONFEREONCE.com website.
February 2020 Help Us Protect Your Patients
FMA News Link
CLICK HERE FOR the complete FMA Newsletter.
Harold Cordner, MD
The use of opioids to treat acute and chronic nonmalignant and malignant pain has steadily increased since the late 1990s. With this increase in opioid use, prescription opioid abuse increased to epidemic proportions. In 2012, an estimated 2.1 million Americans suffered through substance-abuse problems related to prescription opioid pain relievers. Florida was the epicenter of prescription-drug abuse, overdose deaths and "pill mills."
Since 2010, the state of Florida has drastically reduced the accidental deaths due to prescription opioid abuse through legislation, the enactment of the Prescription Drug Monitoring Program, the crackdown on pill mills and other means.
here is you quick link to the
FSIPP/FSPMR 2020 Virtual Conference Home Page
Past webinars are posted on the PAST-EVENTS page
FSIPP has been a leader in promoting fair legislation, access to care and protecting reimbursement. We continue to educate payors, state officials and organizations regarding our area of expertise. We must take ownership of our speciality, promote well developed research and continue to expand our mission in the public and political arena.
To promote the development and practice of safe, high quality, cost-effective interventional pain management techniques for the diagnosis and treatment of pain and related disorders, and to ensure patient access to interventional pain medicine (or management) doctors and these treatments in the State of Florida.
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Articles on Genetics Testing in Pain Management
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Our parent organization is ASIPP, the American Society of Interventional Pain Physicians. Visit ASIPPs website, for a bountiful resource for pain practitioners, and to review a list of ASIPPs accomplishments which have greatly benefited both pain patients and pain physicians.