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Daily Archives: September 8, 2021
With Time and Without Masks, COVID-19 Vaccines Wane in Protection – UC San Diego Health
Posted: September 8, 2021 at 10:12 am
In a letter to The New England Journal of Medicine, publishing online September 1, 2021, an interdisciplinary team of physicians and public health experts at University of California San Diego measured the effectiveness of COVID-19 mRNA vaccines among health workers at UC San Diego Health, most notably during the emergence of the highly transmissible delta virus variant and coincident with the end of the states mask mandate, allowing fully vaccinated persons to forgo face coverings in most places.
The letters authors report that the effectiveness of both the Pfizer and Moderna mRNA COVID-19 vaccines significantly waned over time. Both vaccines were granted emergency use authorization by the Food and Drug Administration in December 2020, with vaccinations of the UC San Diego Health work force beginning the same month for health care workers with direct, patient-facing duties.
In the letter, the authors note that from March through June 2021 vaccine effectiveness against symptomatic infection was estimated to exceed 90 percent; by July, however, it had fallen to approximately 65 percent.
The decline in effectiveness is not entirely surprising, said co-senior author Francesca Torriani, MD, professor of clinical medicine in the Division of Infectious Diseases and Global Public Health in the UC San Diego School of Medicine and program director of Infection Prevention and Clinical Epidemiology at UC San Diego Health.
Waning effectiveness over time, combined with the more contagious delta variant and the end of masking mandates, have boosted cases of COVID-19 among fully vaccinated health workers.
Clinical trial data suggested decreased effectiveness would occur several months after full vaccination, but our findings indicate that confronted by the delta variant, vaccine effectiveness for mildly symptomatic disease was considerably lower and waned six to eight months after completing vaccination.
UC San Diego Health, with a work force of approximately 19,000, operates a robust SARS-CoV-2 testing program. If an employee reports even one mild symptom of COVID-19 during daily screening or an identified exposure, a test is triggered.
Then and now, UC San Diego Health has maintained rigorous, mandatory masking and transmission mitigation measures throughout its hospitals and clinical facilities. Diagnosed positive cases among health workers have universally been identified as community acquired.
In December 2020, workers at UC San Diego Health, like the population overall, began experiencing a surge of SARS-CoV-2 infections, the virus that causes COVID-19.
The situation improved significantly after UC San Diego Health began to inoculate employees using the Pfizer and Moderna vaccines. By March 2021, 76 percent of workers were fully vaccinated, rising to 83 percent by July 2021.
Concomitant with increased vaccination coverage was a decline between March and June in the number of workers reporting at least one symptom of COVID-19 and a positive PCR test. That number declined to fewer than 30 employees per month.
In July 2021, however, cases among this highly vaccinated population began to rise again, coincident with the emerging dominance of the delta variant in San Diego and the ending of Californias masking mandate on June 15. By July, 125 workers had been diagnosed with SARS-CoV-2 and unlike in previous months when approximately 20 percent of these cases involved vaccinated workers, the percentage had risen to 75 percent.
Notably, the vaccines still provide significant protection from severe infection outcomes, such as hospitalization and death. Among the UC San Diego Health employee cases documented, no hospitalizations were reported in vaccinated individuals and only one among unvaccinated persons.
Unlike what was experienced with other variants, with the delta variant parents are frequently getting infected by their young children, ages 5 to 11, said co-first author Lucy Horton, MD, MPH, an assistant professor of medicine in the Division of Infectious Diseases and director of the UC San Diego Health COVID-19 case investigation and contact tracing team. Unvaccinated people are seven times more likely to test positive for COVID-19 than those who are fully vaccinated. More importantly, while children rarely need medical attention, unvaccinated adults are 32 times more likely to require hospitalization compared to those who are fully vaccinated.
Vaccine effectiveness was linked to the passage of time. For workers diagnosed in July, those who became fully vaccinated in January and February had higher infection rates than those vaccinated later in March through May. The infection rate among unvaccinated persons has remained consistently higher than for any vaccinated group, although the difference in rates between the two groups has decreased over time.
The dramatic change in vaccine effectiveness from June to July is likely due to a combination of factors, said co-author Nancy Binkin, MD, MPH, professor of epidemiology in the UC San Diego School of Medicine and Herbert Wertheim School of Public Health and Human Longevity Science. Its the emergence of the delta variant and waning immunity over time, compounded by the end of broad masking requirements and the resulting greater exposure risk throughout the community.
Co-senior author Shira Abeles, MD, an assistant professor of medicine in the Division of Infectious Diseases who has led the COVID-19 vaccination effort at UC San Diego Health, said the findings underscore the importance of rapidly reinstating key interventions, such as indoor masking and intensive testing strategies, plus continuing efforts to boost vaccination rates.
Similar findings are being reported in other settings in the U.S. and internationally, and it is likely that booster doses will be necessary.
Co-authors include: Jocelyn Keehner (co-first author), Louise C. Laurent, David Pride and Christopher A. Longhurst, all at UC San Diego.
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With Time and Without Masks, COVID-19 Vaccines Wane in Protection - UC San Diego Health
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Human life is not an expendable commodity | Letters To Editor | thesunchronicle.com – The Sun Chronicle
Posted: at 10:12 am
To the editor:
Re: Texas abortion legislation is thoroughly un-American, by The Chicago Tribune editorial board (editorial, Sept. 6):
I guess I missed the occasion when terminating the life of an unborn child, who has no say in whether to live or not, became a positive attribute in America for American citizens to be proud of. WOW!
So now weve graduated to the point that not only do we fight to protect the right to decide if an unborn child should be allowed to live, we also fight for the right to force every American citizen to take the jab which, due to the lack of any long-term studies having been completed, could potentially and detrimentally have an effect on our future health and life expectancy.
After all, is it not the least bit plausible that taking the jab might ultimately prove to be an unwise decision, that could negatively affect our health and longevity given those individuals who agreed to be vaxed and then experienced negative side effects. If something, like the COVID-19 vaccine is so beneficial to protecting our health, why/how would it produce negative side effects in anyone who agreed to take the shot?
Unfortunately, only time will tell if taking the jab actually enhances our health or results in having an opposite impact on it.
Have we, as a Christian nation, fallen so far that human life has become an expendable commodity to be managed and controlled? If so, may God have mercy on all of us. Well need it!
Richard Kieltyka
North Attleboro
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Human life is not an expendable commodity | Letters To Editor | thesunchronicle.com - The Sun Chronicle
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Seeking heart health, brain power, and longevity? Here’s why Salmon is the best fish diet for you – Times Now
Posted: at 10:12 am
Salmon fish diet  |  Photo Credit: iStock Images
Most of us have heard about the goodness of the Mediterranean diet. Based on the traditional cuisines of Greece, Italy and other countries that border the Mediterranean Sea, this way of eating is based on plant-based foods, such as whole grains, vegetables, legumes, fruits, nuts, seeds, herbs and spices, olive oil is the main source of added fat and fish and seafood instead of red meat. Fish, seafood, dairy and poultry are included in moderation. Red meat and sweets are eaten only occasionally.
In a 2013 study, Johns Hopkins researchers and others found that a Mediterranean-style diet combined with regular exercise, a healthy weight, and not smoking protected against earlyheart disease, slowed the build-up of plaque in artery walls, and reduced the risk for early death by 80 per cent.
According to the Mayo Clinic website, interest in the diet began in the 1950s when it was noted that heart disease was not as common in Mediterranean countries as it was in the US. Since then, numerous studies have confirmed that the Mediterranean diet helps prevent heart disease and stroke.
Fish is appreciated for the Omega-3 fatty acids - which are healthy polyunsaturated fats that the body uses to build brain-cell membranes. Though our body needs these essential fats, it cant make them on its own.
Instead, a diet rich in omega-3sfound in fatty fish, like salmon, tuna and mackerel, helps protect against heart disease, stroke, cancer and inflammatory diseases. Omega-3 fatty acids also help decrease triglycerides, reduce blood clotting, and lower the risk of stroke and heart failure. This nutritious type of fish is not only rich in omega-3 fatty acids, but also other essential nutrients. Rich in vitamin B12, salmon is wonderful for hair and skin health.
With so many virtues, the salmon fish diet almost becomes a superfood diet. When vital organs like the heart, brain, bones, muscles benefit, it also leads to longevity. Retention of cognitive abilities till ripe old age enhances the quality of life during ageing. That is why Salmon is the best fish diet for heart, brain, and longevity.
Disclaimer: Tips and suggestions mentioned in the article are for general information purposes only and should not be construed as professional medical advice. Always consult your doctor or a professional healthcare provider if you have any specific questions about any medical matter.
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Seeking heart health, brain power, and longevity? Here's why Salmon is the best fish diet for you - Times Now
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Doctor shares key tip that may ‘reverse’ brain decline and boost your life expectancy – Express
Posted: at 10:12 am
Researchers continue to deepen our understanding of how the body interacts with its environment. This interplay between what happens internally and externally is key to prolonging one's lifespan. It underlines the importance of leading a healthy lifestyle, for example. New research builds on this understanding by demonstrating the longevity benefits associated with improving the health of your gut microbiota.
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"What is remarkable about the findings is that the elderly mice that received a fecal microbiota transplantation from young mice showed a reversal of ageing-associated brain changes," explained Doctor Vincent Pedre, Medical Director of Pedre Integrative Health and author of the bestselling book, HAPPY GUTThe Cleansing Program To Help You Lose Weight, Gain Energy and Eliminate Pain."?
He continued: "They found improvements in brain immunity as well as the production of messenger molecules from the brain's control centre, known as the hippocampus.
"This translated into improvements in cognitive behaviour in the elderly mice."
The benefits of improving gut health extend to humans.
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A recently published study in Nature showed that centenarians have a unique gut microbiome capable of producing novel secondary bile acids (metabolites from our own bile) that prevent the growth of inflammatory intestinal pathogens, reported Doctor Pedre.
"Not all of these centenarians were living in multi-generational households, but the new research findings suggest that elderly living in multigenerational households can get exposed to the younger microbiome of their grandchildren, keeping their microbiome more fit."
"We know several ways to promote a healthy gut microbiome and keep inflammatory markers (which lead to aging) at bay," noted Doctor Pedre.
These include:
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Eating a healthy, balanced diet is an important part of maintaining good health, and can help you feel your best.
"This means eating a wide variety of foods in the right proportions, and consuming the right amount of food and drink to achieve and maintain a healthy body weight," explains the NHS.
The Eatwell Guide shows that to have a healthy, balanced diet, people should try to:
According to the NHS, starchy foods should make up just over a third of everything you eat. This means your meals should be based on these foods.
"Choose wholegrain or wholemeal varieties of starchy foods, such as brown rice, wholewheat pasta, and brown, wholemeal or higher fibre white bread."
As the health body notes, they contain more fibre, and usually more vitamins and minerals, than white varieties.
"Potatoes with the skins on are a great source of fibre and vitamins. For example, when having boiled potatoes or a jacket potato, eat the skin too."
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Doctor shares key tip that may 'reverse' brain decline and boost your life expectancy - Express
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How to live longer: The diet that promotes ‘healthier ageing’ within one year of intake – Daily Express
Posted: at 10:12 am
It has long been established that eating a healthy diet can extend your lifespan but research continues to establish the mechanisms that drive this beneficial effect. A Mediterranean-style diet has been consistently championed for its longevity benefits and a study published in the British Medical Journal (BMJ) has posited a novel explanation for its impact.
Researchers investigated if a one-year Mediterranean-style diet intervention could alter the gut microbiota and reduce frailty.
The gut microbiota is increasingly recognised as an important regulator of host immunity and brain health.
The gut microbiota resides in the intestine and is home to the human body's largest population of microorganisms.
To gather their findings, researchers profiled the gut microbiota in 612 non-frail or pre-frail subjects across five European countries (UK, France, Netherlands, Italy and Poland) before and after the administration of a 12-month long Mediterranean diet intervention tailored to elderly subjects (NU-AGE diet).
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The NU-AGE diet emphasises greater intakes of whole grains, fruits, vegetables, low-fat dairy and cheese, fish, low-fat meat and poultry, nuts, and olive oil, the use of a vitamin D supplement (10 g) and lower intakes of alcohol, sodium and sweets.
The researchers found adherence to the diet was associated with specific microbiome alterations.
Adherence to the diet was "positively associated with several markers of lower frailty and improved cognitive function", the researchers wrote.
What's more, the dietary approach was negatively associated with inflammatory markers including C-reactive protein and interleukin-17, they said.DON'T MISSMichael Schumacher health:Jean Todt visits tragic F1 star[INSIGHT]Covid is surging and there is 'only' one vaccinated symptom[TIPS]Dementia: The 'first' symptom of dementia[ADVICE]
"Collectively, our findings support the feasibility of improving the habitual diet to modulate the gut microbiota which in turn has the potential to promote healthier ageing," the researchers concluded.
A Mediterranean diet incorporates the traditional healthy living habits of people from countries bordering the Mediterranean Sea, including France, Greece, Italy and Spain.
The Mediterranean diet varies by country and region, so it has a range of definitions.
But in general, it's high in vegetables, fruits, legumes, nuts, beans, cereals, grains, fish, and unsaturated fats such as olive oil. It usually includes a low intake of meat and dairy foods.
Exercise is also integral to longevity and should complement a healthy diet.
"Adults should do some type of physical activity every day. Exercise just once or twice a week can reduce the risk of heart disease or stroke," explains the NHS.
The health body continues: "Speak to your GP first if you have not exercised for some time, or if you have medical conditions or concerns.
"Make sure your activity and its intensity are appropriate for your fitness."
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The Main Contradiction of the Modern Era – Inter Press Service
Posted: at 10:12 am
Crime & Justice, Economy & Trade, Global, Global Geopolitics, Headlines, Human Rights, Inequity, Labour, TerraViva United Nations
Opinion
Vladimir Popov Principal Researcher, Central Economics and Mathematics Institute, Russian Academy of Sciences, Ph.D.
BERLIN, Sep 6 2021 (IPS) - The main contradiction of the modern era, and indeed of all human history, is not between capitalism and socialism, and not even between authoritarianism and democracy, but between individualism and collectivism, between public and personal interests. Countries that are getting ahead in the economic race allow themselves the luxury of individualism, prioritizing human rights, which ultimately undermines their political and economic power and causes their decline and the rise of more collectivist civilizations. It is literally the story that is as old, as the world itself
Vladimir Popov
Asian values is the priority of the interests of the community (village, enterprise, nation, world community) over the interests of the individual. As a matter of fact, what is today called Asian values, before the 16th century Protestantism, was a universal principle of all mankind there was no primacy of the interests of the individual over the interests of society before that time.
Collectivist values are often juxtaposed to Western liberal values, which stress the primacy of human rights that cannot be alienated from the individual under any circumstances, even for the sake of achieving the highest public good. John Rawls, political philosopher and an authority on the issue, formulated the principle of precedence of democratic values and human rights: according to him, human rights, including political rights, are not subject to political bargaining or to the calculus of social interests. Defenders of Asian values, whose roots are often sought in Confucianism, believe that, in principle, the political rights of individuals can be sacrificed for the highest public good, for example, for the sake of achieving sustained high rates of growth and social equality.
Values, of course, is largely a vague and subjective concept. Economists like to operate with something more tangible objective and measurable categories, but there are those as well. Social harmony is based on low income and wealth inequality, which are perfectly measurable: in China and East Asia today it is lower than in other countries, if only the comparisons are made properly adjusted for country size and level of development. And oligarch-intensity (the ratio of the wealth of billionaires to GDP), which measures inequality at the very top of the property pyramid, is lower in China than in most other countries.
The share of the state in the economy (government consumption as a percentage of GDP, to be precise) is higher than in states with similar characteristics, the number of violations of law and order and criminal penalties (the crime rate, murder rate and incarceration rate) is lower1. There are other measurable objective indicators lifetime employment and unemployment rate, the ratio of bank credit to the stock market, concentration of control over corporations, etc. There are also differences in subjective preferencesmeasured by the World Value Survey and other polls the degree of trust in the government, the willingness to defend ones country, the importance of family ties, and so on2.
But the most important thing, of course, is the mass understanding that the country and society as a whole are more important than any individual, even the most important. For example, the one child policy, practiced in China since the beginning of reforms in 1979 and until recently, is traditionally considered in the West as a violation of the inalienable reproductive rights of citizens, but in China it was supported by the overwhelming majority of the population and did not raise questions.
Ask not what your country can do for you ask what you can do for your country, this famous phrase of John F. Kennedy made a strong impression in the United States and in the West, but not in China. As if it could be otherwise my Chinese friend plainly noticed.
Competition of civilizations
There was a time, when it seemed that the Wests bet on personal freedom and human rights was paying off as the West overtook all other civilizations both economically and militarily. The universal feeling was that the Rest could only imitate the West in order to achieve the same success. However, the rise of East Asia in the post-war period, and especially the rise of its central state China, makes one think that the end of history is postponed, and it is too early to end the debate on the competition of civilizations. China (and earlier other East Asian countries based on Chinese culture Japan, Korea, Taiwan, ASEAN countries) in the postwar period managed to raise growth rates to 7-10% and maintain these growth rates for several decades. As a result, East Asia in the second half of the 20th century became, in fact, the only large region that managed to narrow the gap in the levels of economic development with the West.
Neither Latin America, nor the Middle East, nor South Asia, nor Africa, nor the former USSR and Eastern Europe have succeeded in doing this. True, in the 1950s and 1970s, the USSR and Eastern Europe, as well as Latin America, narrowed the gap with the West. But then their model of import-substituting development ran into the dead end: Latin America after the debt crisis of the early 1980s experienced a lost decade, Eastern Europe in the 1990s had a transformational recession comparable only to the Great Depression of the 1930s. years.
As a matter of fact, only in East Asia there are countries that have been able to transform themselves from developing into developed Japan, South Korea, Taiwan, Singapore, Hong Kong. There are no other states in the world that have managed to catch up with the West due to high growth rates (and not due to higher prices for resources). The last two cases can be attributed to small scales these are cities, not countries, but there is no way to denounce thefirst three cases. Especially now, when China is following in the footsteps of these countries with a fifth of the worlds population.
The significance of this growth today is difficult to overestimate, and not only because China is the largest country in the world, but also because for the first time in modern history we are dealing with successful catch-up development based on illiberal, if not anti-liberal principles on Asian values , collectivist in their essence institutions. After the collapse of the USSR, the Chinese, or rather, East Asian, development model is gaining more and more adherents in developing countries from Brazil to Fiji. Geopolitics and military potential matter a great deal, of course, but in the end it will be the countries with the highest economic efficiency that will dominate. In the last analysis, productivity of labor is the most important, the principal thing for the victory of the new social system (Lenin).
Comparative economic and social dynamics during the COVID-19 pandemic in 2020-21 is another proof of the advantages of the collectivist model, if such proof is still needed. In China, Japan, South Korea, there was practically no increase in mortality compared to the previous period (2015-19), and life expectancy did not decrease. Of the Western countries, only Australia, Iceland, New Zealand and Norway showed such a result, while in the United States the mortality rate increased roughly by 25% on an annual basis, life expectancy decreased by one and a half years from 78.8 in 2019 to 77.3 years in 2020. This year, 2021, life expectancy in the United States will probably decrease even more, while in China it will increase, so that China canovertake the United States in longevity.
And at the same time, China is leading in economic growth: GDP growth rates in 2020 only slowed down slightly (from 6% in 2019 to 2% in 2020; 8-9% is expected in 2021 to compensate for the previous slowdown), whereas in all other G-20 countries, except for Turkey, there was a drop in production, sometimes significant from 5 to 10% in 20203.
Forecast
Russia stands between East and West for almost its entire history. The modern Russian socio-economic model is partly liberal, but partly collectivist, especially after overcoming the chaos of the 90s.
Losing in the competition with the Chinese economic and social model in many ways, the West will probably try to create a united front of states, regardless of whether these states are liberal and democratic or not, to contain the rise of China and the proliferation of the collectivist model. It can be assumed that all countries that the West considers today authoritarian, from Venezuela to North Korea, will receive an indulgence for the alleged violations of human rights and democracy if only they join the anti-Chinese coalition. The West will probably try to seduce Russia with the lifting of sanctions and even the possibility of joining the Western club of civilized countries.
If Russia and other countries that the West considers authoritarian agree to such a compromise, the rise of China and the spread of the East Asian model may be slowed down, but not stopped. But if Russia ties its fate to China and the new collectivist model, the decline of the West could happen faster than expected.
1 Popov, Vladimir. Why Europe looks so much like China: Big government and low income inequalities. MPRA Paper No. 106326, March 2021.
2 Keun Lee and Vladimir Popov (Eds.) Re-thinking East Asian Model of Economic Development After the Covid-19. Special Issue of Seoul Journal of Economics, 2020, Vol. 33;
Popov, Vladimir. Which economic model is more competitive? The West and the South after the Covid-19 pandemic. Seoul Journal of Economics 2020, Vol. 33, No. 4, pp. 505-538;
Covid-19 pandemic and long-term development trajectories of East Asian and Western economic models. Pathways to Peace and Security ( ), 2020, 2 (59).
3 Popov, Vladimir. Global health care system after coronavirus: Who has responsibility to protect. MPRA Paper No. 100542, May 2020;
Popov, Vladimir. How to Deal with a Coronavirus Economic Recession? MPRA Paper No. 100485, May 2020.
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The Main Contradiction of the Modern Era - Inter Press Service
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FDA to decide fate of vape industry in US this week – fox13now.com
Posted: at 10:11 am
SALT LAKE CITY The Food and Drug Administration is slated to decide Thursday how or if e-cigarette companies can continue selling their products.
The agency is now reviewing millions of premarket tobacco product applications (or PMTAs) from e-cigarette companies.
Essentially, the companies are required to prove to the FDA that their products are safe enough to continue to be sold in the United States.
In recent years, the FDA has been under mounting scrutiny from policymakers and public health leaders after e-cigarettes grew more popular among teens and other youth groups.
Until now, companies have been able to sell and market their products under limited restrictions.
Elite Smoke & Vape In Murray is one business that could be impacted by the FDAs decision.
Owner Ryan Delahuerta speculated what could happen.
We are going to see our wall of e-juice shrink down to probably just a couple of brands, said Delahuerta.
He explained that his vaping inventory makes up 70 percent of his sales.
Delahuerta also told FOX 13 News that this change will reinforce the sale of e-cigarettes through alternative, shadier markets.
Youre already seeing a black market emerge on social media selling these, thats unregulated, and thats where teens can get ahold of them," he said.
Meanwhile, one medical professional told FOX 13 News that he considers this a step in the right direction.
Its a good part of public health strategy because it will probably limit the number of youths from using e-cigarettes, said Sean Callahan, a professor of medicine at the University of Utah.
He adds that some adults could be unhappy with the outcome because these vaping products have helped them with their smoke cessation efforts.
Just last week, CNN reported that the FDA blocked the sale of more than 55,000 flavored e-cigarette products.
It was the first ban on products of that kind since PMTAs had to be submitted in September 2020.
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FDA nears day of reckoning on e-cigarettes – POLITICO
Posted: at 10:11 am
Now FDA is days away from a deadline that could signal how it will approach tobacco regulation for years to come. The agency has already said it is considering major changes. FDA announced in April that it planned to release a proposal within a year to ban menthol cigarettes and flavored cigars products disproportionately used by African Americans and teens. The agency is also reportedly considering whether to seek limits on nicotine levels in cigarettes to reduce their addictive potential. Similar concerns about addictive potential and risks to young people lie at the heart of FDAs imminent verdict on vapes.
FDA really is at a critical juncture, said Matthew Myers, the president of the Campaign for Tobacco-Free Kids. In some critical ways how FDA will be perceived will probably be defined with what it does now with regard to pending applications.
In the meantime, the vaping industry is bracing for the possibility of major changes that could tilt the balance in favor of big tobacco companies who have expanded into the e-cig market.
Many vaping products are produced by smaller companies that dont have the resources to thoroughly answer FDAs scientific questions about safety, said Ken Warner, a professor emeritus of public health and tobacco control at the University of Michigan. Large companies such as Juul only sell a handful of types of e-cigarettes, but have the financial resources to stack their applications to make them more likely to be cleared by the agency.
FDA announced in April that it planned to release a proposal within a year to ban menthol cigarettes and flavored cigars. | Andrew Harnik/AP Photo
FDA, which has said it will likely miss the Sept. 9 deadline for some applications, is prioritizing its review queue based on applicants' market share. Juul alone controls over 40 percent of the e-cigarette market; its majority shareholder is Altria the parent company of Philip Morris USA.
FDA has not yet made decisions on applications submitted by the market's larger players, which account for only a handful of the submissions waiting for review. But the agency has already told some smaller companies to stop selling their products.
In some cases, FDA outright denied applications from these firms due to the nature of the e-cigarettes in question. These products, all of which were flavored, lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products, the agency stated.
In other cases, however, the agency has issued either Refuse to Accept or Refuse to File notices to smaller firms whose applications were incomplete or otherwise not meeting technical requirements. Those companies can refile their applications but cannot continue to sell affected products in the meantime.
Dave Morris, who owns a company called Vape Gravy Brands in Phoenix, Arizona, said that his initial application cost about $7,000 per flavor for 14 of the flavors he sells. Weve spent pretty much every penny we saved up on the last six years for this, he said. And with the uncertainty around FDAs decision, I dont know if Ill have a company in two weeks, he said, referring to the Sept. 9 deadline.
Morris and other small e-cigarette companies argue that their products including flavored ones are designed for adults who are looking to quit smoking cigarettes, not to entice new, young tobacco users.
I started smoking and then quit with vaping, said Victoria Drower, the owner of two small vape shops in southern California. I should be working myself out of a job that is my goal.
Morris said that all of his products are designed to fill the large, tank-style e-cigarettes that teenagers often eschew in favor of vape pens. Even if they are flavored, he argued, that appeals to adult smokers, not only to teens.
A person uses an e-cigarette. | Tony Dejak/AP Photo
The vaping industry and some public health experts also argue that vaping can help wean smokers from cigarettes and other traditional forms of tobacco.
People who are trying to quit use more e-cigarettes than any other product, Warner said. In a recent paper published in the American Journal of Public Health, Warner and others argued that policies to reduce teen vaping may also help adults use e-cigarettes to quit smoking tobacco.
According to a CDC study, roughly 15 percent of adult smokers successfully quit smoking using e-cigarettes, compared to 3.3 percent who rely on non-cigarette tobacco products such as cigars or cigarillos. A study in the New England Journal of Medicine found that among smokers who quit, 18 percent remained cigarette-free after a year, compared to 9.9 percent who used nicotine-replacement therapies.
But e-cigarettes have still undoubtedly harmed public health. The focal point for most lawmakers and several public health advocacy groups has been vapes appeal to teens and even children. A 2020 CDC study found that nearly 20 percent of high school students and 5 percent of middle school students had vaped regularly, and mostly used flavored products.
Several lawmakers and state attorneys general have urged the FDA to ban all flavors of e-cigarettes, including menthol, because of their appeal to teens. Already, the agency has banned the sale of reusable flavored e-cigarettes, such as those once sold by Juul. But it still allows the sale of disposable flavored products.
But anti-vaping advocates argue that flavors are totally unnecessary to sell products to adults. Smokers are accustomed to tobacco-flavored products, said Dennis Henigan, the vice president for legal and regulatory affairs at the Campaign for Tobacco-Free Kids. Why in the world do they need strawberry-flavored e-liquids as opposed to tobacco-flavored products?
Others argue that even the smaller players in the e-cigarette industry arent as altruistic as they seem. It's hard to have sympathy for businesses that haven't even attempted to play by the rules, said Desmond Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law who focuses on commercial tobacco policy.
No one has attempted to file applications or legally market these products [before now], no one has filed applications to make modified risk claims legally, he added. The whole idea that e-cigs are a cessation device why has no company filed a drug application to say it's a cessation device?
Still, most public health experts agree that there should be some kinds of e-cigarettes on the market to help wean adults from cigarettes, pipes and other smoked forms of tobacco.
If you have e-cigarettes on the market, that gives smokers a legal option to go to, said Eric Lindblom, a former official at FDA's Center for Tobacco Products who is now a senior scholar at the Georgetown University Law Center.
I personally would like to see more alternatives approved on the market for many different companies, said Mike Cummings, a professor of psychiatry at the Medical University of South Carolina. Alternatives that are acceptable for current smokers to use to stop smoking could be a public health tool. But, he said, you cant have willy-nilly [FDA] clearances.
No matter what FDAs ultimate decision is on e-cigarettes, some parties are going to be angry. I can't in my mind see the FDA threading a needle here that doesn't result in litigation from someone, Jenson said. It's kind of impossible.
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Rubiner & Mendonca: Schools and Parents Alone Can’t Stop Kids from Vaping. To Head Off This Epidemic, the FDA Must Ban All Flavored E-Cigarettes -…
Posted: at 10:11 am
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After more than a year of online learning and social distancing from friends and peers, many teens are finally returning to school and their social circles this fall. But as students make plans for the new school year, we could also see the resurgence of another health crisis that was bad even before the COVID-19 shutdown: the youth e-cigarette epidemic.
In the early months of 2020, teen vaping was rampant in schools; 3.6 million kids, including 1 in 5 high school students, used e-cigarettes. Now, as students head back to school, they could again face the conditions that caused the vaping epidemic in the first place:the powerful influence of peer pressure and the widespread availability of e-cigarette products that lure kids with fun flavors and can quickly addict them with massive doses of nicotine. The industry knows full well that 83 percent of youth vapers use flavored products.
The return to school coincides with another critical date on the calendar: The Food and Drug Administration faces a Sept. 9 deadline for deciding which e-cigarette products can remain on the market. To truly protect kids and end the youth e-cigarette epidemic, the FDA must eliminate the flavored and high-nicotine products including the popular menthol flavor that have driven this crisis. Parents, educators and health advocates are counting on the FDA to take them off the shelves.
The evidence is clear that as long as any flavored e-cigarettes remain on the market, kids will get their hands on them. Last year, the FDA banned flavors other than menthol in cartridge-based products like Juul but left other flavored e-cigarettes widely available. What happened next was completely predictable: Kids migrated to the flavored products that were left. Use of disposable e-cigarettes like Puff Bar soared by an alarming 1,000 percent among high school students, and there was also a notable shift to menthol products, with over 1 million kids using them in 2020.
Those of us working in schools and caring for students health and well-being remember what it was before classrooms were shuttered. Juul and other e-cigarettes were everywhere, and traces of mint- and fruit-scented aerosol lingered in hallways and bathrooms as teens attempted to discreetly satisfy their dangerous nicotine addictions. Educators even smelled it in classrooms. Nurses, teachers and administrators were constantly confiscating devices, with piles of Juuls filling their desk drawers. Some schools had to take the doors off bathroom stalls to stop kids from trying to vape in secret. The percentage of high school e-cigarette users reporting frequent or daily use has risen steadily, to a high of nearly 39 percent in 2020. Thats not surprising, because e-cigs like Juul contain as much nicotine as a whole pack of cigarettes.
The U.S. Surgeon General has found that nicotine use in any form by young people is unsafe, causes addiction and can harm the developing adolescent brain, impacting learning, memory and attention. Studies indicate that young people who use e-cigarettes are more likely to go on to smoke regular cigarettes, and nicotine use during adolescence can increase risk for future addiction to other drugs.
With COVID-19 cases surging once again because of the Delta variant, it is more important than ever to keep kids lungs healthy by preventing young people from smoking or vaping. For school nurses, that means this academic year will bring even more challenges. On top of navigating COVID-19 and the mental health fallout from the pandemic, they will have to redouble their efforts to educate teens about the risks of vaping.
Teachers and parents will also need to learn anew how to recognize the signs of e-cigarette use and addiction. E-cigs can be hard to identify because of their sleek and inconspicuous designs that resemble flash drives or pens. If teens are spending more time alone than usual, coming up with excuses to step away frequently or have a sweet smell on their clothes or in their rooms, these could be signs of vaping. Others include an unexplained cough or increased thirst, increased irritability and mood swings.
But nurses, educators and parents alone cannot combat youth vaping. More than anything, we need the support of the FDA and other policymakers, who are the only ones with the power to eliminate the flavored products driving this epidemic.
As the new school year begins, wed all like to start fresh. But until the FDA takes action, we will face more of the same. Its time for the agency to stop playing whack-a-mole and eliminate all flavored e-cigarettes.
Laurie Rubiner is executive vice president, domestic programs, at the Campaign for Tobacco-Free Kids. Linda Mendonca is president of the National Association of School Nurses and an assistant professor at the Rhode Island College School of Nursing. She was a school nurse for two decades.
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From October, it will be all but impossible for most Australians to vape largely because of the homework police – ABC News
Posted: at 10:11 am
After a misstep, it's about to become illegal to import e-cigarettes without a prescription, which means that, for most Australians, it'll become all but impossible to vape from October 1.
The misstep tells us a lot about how the Australian government works behind the scenes most of it good.
Mid last year, Health Minister Greg Hunt announced plans to ban the import of nicotine-containing e-cigarettes and refills without a doctor's prescription. Border Force would be checking parcels.
To Hunt, the decision made sense. It was already illegal to buy and sell such products without a prescription in every Australian state and territory, and it was illegal to possess them without a prescription in every state but South Australia.
All Hunt was doing was closing a (very wide) loophole.
Government backbenchers revolted, Hunt pointed to a doubling of nicotine poisonings over the past year and the death of a toddler, the Prime Minister offered less than complete support, saying he was keeping an "open mind", and Hunt put the idea on the backburner.
That's the way it played out in public.
But beneath the surface, something impressive was swinging into gear. It's called the Office of Best Practice Regulation OBPR, an apolitical body nestled within the prime minister's department.
ABC News
So what did this little-known part of the government do that will effectively stamp out vaping from next month? Its executive director, Jason Lange, revealed the back story at an Economic Society of Australia meeting in Canberra earlier this year.
Set up during the 1980s to ensure government decisions didn't needlessly tie up business in red tape, the office gradually was given other things to consider, including the effect of government decisions on citizens, on the environment and on the distribution of burdens throughout society.
Then in 2013 Prime Minister Tony Abbott moved it out of the Department of Finance into his own department: Prime Minister and Cabinet.
Prime Minister and Cabinet is the traffic cop: it decides what gets put forward for cabinet to decide, and when. So suddenly the office was working at the centre of government decisions, getting to view every one of the 1,800 or so things put to senior ministers to decide each year.
For the few hundred proposals it thinks might have significant unintended impacts, the office demands an impact statement.
It doesn't tell the department or authority putting forward the idea what to put in the statement. But as Lange explained, it "marks the homework". The proposals behind any statements that aren't good enough are harder to bring to cabinet.
Hunt's decision on e-cigarettes wasn't accompanied by an impact statement the first time around. Lange's office made sure it was on the second.
Each OBPR analysis has to address seven questions.
The first is what problem the agency is trying to solve. Maybe it's not really a problem. Merely working that out puts what follows into focus.
The second is why government action is needed. Maybe the problem isn't very big, or maybe it will solve itself.
The third is what options the agency is considering. The agency has to put forward at least three options, including one that isn't a regulation. In the case of e-cigarettes, that option was a public awareness campaign.
Then it has to estimate the likely benefits and costs of each option, including the costs to people the option wasn't intended to hit, such as under-the-counter retailers and people using vaping to give up smoking.
The fifth question is the range of people and organisations to be consulted (which is a way of making sure it happens). The sixth is to identify the best option from the list, which includes making no regulation whatsoever.
The seventh is the means by which the measure would be implemented and (importantly) later evaluated.
Once in, and usually after being sent back for further work, the analysis is graded on a scale from "insufficient" to "adequate" to "good practice" to "exemplary".
Very few are graded exemplary, and very few that we know about are graded inadequate, because if such a proposal does get adopted by cabinet, the impact statement gets published along with the grade and a statement that describes its failings a "nuclear option" Lange says can be deeply embarrassing.
All impact statements attached to proposals the government adopts get published along with its OBPR rating. It is often the best opportunity the public has to read about the thinking behind the proposal.
Tellingly, only about 80 of the hundreds of impact statements started each year get to decision makers, which means the process itself knocks out poorly thought out proposals.
But if an idea has merit, as did the ban on importing nicotine-containing e-cigarettes without a prescription, the 180-page impact statement can make all the difference.
It sets out the problem clearly, sets out a number of possible solutions and identifies the winners and losers from each, and shows how they were consulted.
It demonstrates someone in the government has thought it through clearly, and provides material for the government to use when selling its decision.
On the Office of Best Practice Regulation website are hundreds of impact analyses on topics as diverse as food standards, protection for car dealers, and the redress scheme for child sexual abuse.
That's why from October 1 it will become illegal to import without a prescription nicotine-containing e-cigarettes, and illegal to supply any liquid nicotine that isn't in child-resistant packaging.
Behind the scenes, the government got it right.
Peter Martin is visiting fellow at the Crawford School of Public Policy, Australian National University. This article originally appeared on The Conversation.
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