Here Is How the FDA Made the RSV Wave More Dangerous
Forget Covid-19 and Monkeypox. Respiratory syncytial virus (often shortened to RSV) may be the biggest public health threat this season. RSV is a virus that often results in mild cold-like symptoms for many infected adults. However, it can be deadly for children. RSV is estimated to be responsible for 1 out of 50 children’s deaths globally and 1 out of 56 deaths for children in developed countries.
RSV is rapidly spreading across the US and threatens our youth. The Center for Infectious Disease Research and Policy at the University of Minnesota reports the highest hospitalization rates for flu (including RSV) in a decade—with children and seniors most affected. California recently reported its first RSV complications-related death for a child. Fearing the worst is yet to come, Colorado Governor Jared Polis signed an order extending the Covid-19 emergency declaration to include RSV and other respiratory viruses. Governors in other states could follow his lead.
The younger the patient, the more difficult RSV is to treat. Infants with RSV cannot safely use most medications to treat the virus’s symptoms. Because infants are particularly susceptible to developing bronchitis or pneumonia from RSV, carefully monitoring breathing patterns is vital.
There are very few devices that effectively monitor an infant’s oxygen levels, and many of them are only found in hospitals. There used to be one widely available to parents until the Food and Drug Administration ordered it off the market.
Nearly a year ago, the FDA sent a warning letter to Owlet regarding its Smart Sock—a product that monitored an infant’s pulse and oxygen intake. The letter stated the FDA determined the Smart Sock is a medical device that needed to undergo the agency’s approval process before reaching the market. At the time, Smart Socks had been on the market for five years, boasted a 90 percent accuracy rating according to peer-reviewed research, and helped over 600,000 parents care for their children.
Unable to undergo the time-consuming and expensive process, Owlet released a version of the Smart Sock this January. But the latest version no longer monitors an infant’s heart or lungs. Consequently, the FDA drove parents’ best option to carefully monitor their baby’s vital organ function off the market.
In an article I wrote for the American Institute for Economic Research shortly before the Smart Sock was pulled from store shelves, I warned, “The cost of the agency’s decision is hundreds of thousands of infants going without a highly reliable monitoring device and countless sleepless nights for parents fearing for their children’s health or life.” As RSV sweeps across the country, there will be tragically more of both.
https://blog.independent.org/2022/12/06/rsv-wave/
**************************************************Could COVID hold key to curing cancer? Virus' notorious spike protein kills hard-to-treat lung tumors in lab studies
The virus has claimed the lives of six million people and caused unprecedented global disruption — but Covid might actually hold clues to curing cancer.
In lab studies, a modified version of Covid's spike protein killed the most treatment-resistant and deadliest form of lung cancer.
The spike protein is the unique part of Covid that is used to infect people as it is the structure that binds to human cells in the first instance.
It could also infect and kill lung cancer cells, as when combined with other cells, the protein can set in motion the process of cells dying.
Kalipada Pahan, professor of neurology at RUSH Medical College in Chicago and lead investigator of the study, said: 'If these results are replicated in lung cancer patients, it would uncover a promising avenue of this devastating disease.
'Intranasal spike S1 protein could be used for late-stage lung cancer when there’s no other therapy to stop the progression.'
The researchers said there have been anecdotal cases of people with lung cancer whose conditions improved after being infected with Covid, which bolsters their theory.
In the study, published in the journal Cancers, the team took a cloned version of the spike protein that is available to buy for scientists.
They then exposed it to non-small cell lung cancer cells from humans in a petri dish. They found that when the protein was added, it sparked the death of the cancer cells.
Next they gave the protein to the mice with established lung cancer by spraying it up their nose every other day, and gave another group of mice a saline solution as a control.
After four weeks, they examined the mice's tumors and found that the number and size of tumors had decreased in the group given the Covid spike.
Lung cancer is the main cause of cancer related deaths in the world, and has quite a low five-year survival rate.
Rates have not improved despite a multitude of therapies for lung cancer.
According to the American Cancer Society, there will be around 236,740 new cases of lung cancer in this year alone.
Non-small cell lung cancer makes up around 84 percent of all lung cancers, found a study.
*******************************************************
Sex, Racial, and Ethnic Representation in COVID-19 Clinical Trials. A Systematic Review and Meta-analysis
Hong Xiao et al.
Key Points
Question: Compared with their representation in the US population with COVID-19, are female participants and racial and ethnic minority persons underenrolled in COVID-19 prevention and treatment trials?
Findings: In this systematic review and meta-analysis of 122 US-based COVID-19 clinical trials with 176 654 participants, female participants were underrepresented in treatment trials, Asian and Black participants were underrepresented in prevention trials, and Hispanic or Latino participants were overrepresented in treatment trials.
Meaning: These findings show systemwide differences in representation for several key demographic groups in COVID-19 prevention and treatment trials in the US.
Abstract
Importance: Since the onset of the COVID-19 pandemic, there have been calls for COVID-19 clinical trials to be fully representative of all demographic groups. However, limited evidence is available about the sex, racial, and ethnic representation among COVID-19 prevention and treatment trials.
Objective: To investigate whether female participants and racial and ethnic minority individuals are adequately represented in COVID-19 prevention and treatment trials in the US.
Data Sources: Identified studies were registered on ClinicalTrials.gov or published in the PubMed database from October 2019 to February 2022.
Study Selection: Included studies must have provided the number of enrolled participants by sex, race, or ethnicity. Only interventional studies conducted in the US for the primary purpose of the diagnosis, prevention, or treatment of (or supportive care for) COVID-19 conditions were included.
Data Extraction and Synthesis: Data on counts of enrollments by demographic variables (sex, race, and ethnicity) and location (country and state) were abstracted. Studies were broadly categorized by primary purpose as prevention (including vaccine and diagnosis studies) vs treatment (including supportive care studies). A random effects model for single proportions was used. Trial estimates were compared with corresponding estimates of representation in the US population with COVID-19.
Main Outcomes and Measures: Sex, racial, and ethnic representation in COVID-19 clinical trials compared with their representation in the US population with COVID-19.
Results: Overall, 122 US-based COVID-19 clinical trials comprising 176 654 participants were analyzed. Studies were predominantly randomized trials (n = 95) for treatment of COVID-19 (n = 103). Sex, race, and ethnicity were reported in 109 (89.3%), 95 (77.9%), and 87 (71.3%) trials, respectively. Estimated representation in prevention and treatment trials vs the US population with COVID-19 was 48.9% and 44.6% vs 52.4% for female participants; 23.0% and 36.6% vs 17.7% for Hispanic or Latino participants; 7.2% and 16.5% vs 14.1% for Black participants; 3.8% and 4.6% vs 3.7% for Asian participants; 0.2% and 0.9% vs 0.2% for Native Hawaiian or Other Pacific Islander participants; and 1.3% and 1.4% vs 1.1% for American Indian or Alaska Native participants. Compared with expected rates in the COVID-19 reference population, female participants were underrepresented in treatment trials (85.1% of expected; P < .001), Black participants (53.7% of expected; P = .003) and Asian participants (64.4% of expected; P = .003) were underrepresented in prevention trials, and Hispanic or Latino participants were overrepresented in treatment trials (206.8% of expected; P < .001).
Conclusions and Relevance: In this systematic review and meta-analysis, aggregate differences in representation for several demographic groups in COVID-19 prevention and treatment trials in the US were found.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2799224
**************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
**************************************************
No comments:
Post a Comment