Tuesday, September 01, 2020


Dormition of the Mother of God: Main traditions

The name of the holiday reflects the Christian attitude towards death 
 28 August 2020

Dormition of the Mother of God
Open source
On August 28, Orthodox Christians are celebrating the Dormition of the Mother of God. This day is believed to be the end of the earthly life of the Virgin Mary. People are due /supposed to prepare for this holiday with a two-week fast. The Dormition Fast is as strict as Great Lent.

History and meaning of the holiday


Dormition of the Mother of God
Open source
The holiday is called the Dormition ("falling asleep"), because the Mother of God died quietly without suffering, in a state of spiritual peace, and three days later she was resurrected by the Lord and ascended to heaven.
The name of the holiday reflects the Christian attitude towards death. Death is not the end of existence, but a dream: the deceased leaves the world for a while in order to return to life after the general resurrection.
Once, during a prayer to the Mother of God, the Archangel Gabriel appeared and said that in three days She would go to the Lord. The Blessed Virgin was waiting for this news and used the allotted three days to pray and say goodbye to everyone. The apostles witnessed the blessed end of the Holy Virgin. Christ, surrounded by many angels, appeared to receive the soul of His Mother and lead Her to paradise.
The Mother of God was buried in the tomb, where Her parents Joachim and Anne and husband Joseph had been buried before. The body of the Virgin Mary was carried in a solemn procession through Jerusalem. Saint Thomas the Apostle did not participate in the procession - the Lord did not allow him to come on time. He arrived in Jerusalem on the third day after the funeral. Saddened that he would never see the Virgin Mary again, he began to ask the apostles to give him the opportunity to say goodbye to the body. They agreed, but when the coffin was opened, there was nobody in the cave. On the same day in the evening, the Mother of God, surrounded by angels, appeared at a meal to the apostles and greeted them with the words: "Rejoice! I am with you all days."

What should not be done on the Dormition?


Ukrainian News
If this day falls on Wednesday or Friday, you can eat fish. In this case, breaking the fast is postponed to the next day. But if the Dormition falls on other days of the week, then there is no fast.
The people believe that one must not go barefoot on this day. Dew symbolizes Mary's tears, so getting your feet wet is a sign of trouble and misfortune.
It is undesirable to cook on the feast - this must be done in advance. On this day, you should not pick up piercing and cutting objects. Believers try to break even the bread, instead of cutting it.
One should not work on the day of the feast. The only exception is that work that cannot be postponed, as well as help for others. But if the work started in advance is completed precisely on the Dormition, this is a very good sign that promises good luck.
One should not wear bad shoes - old and uncomfortable. If you neglect this sign, further life will be overshadowed by various difficulties and problems.
An unmarried girl who dreams of finding her betrothed as soon as possible cannot talk to anyone on the morning of the Dormition.
On this day, one should not use foul language, conflict, and quarrel, and also think about bad things.
People do not make a fire in the house so as not to bring trouble to themselves.

What one should do on this day?

From the feast of the Dormition, girls' parents welcomed matchmakers and planned a wedding, which was usually celebrated on October, 14. According to legends, if the parents agree on a wedding, then the young people will live a long life in peace and harmony.
Also, the Orthodox holiday coincided in time with the harvest. At this time of the year, the peasants were busy harvesting. That is why, in the popular consciousness, agricultural customs were superimposed on the Church traditions of the Dormition.
On this holiday, you can salt cabbage and cucumbers.

Folk sayings of the holiday

The Dormition is the end of summer and the division of the seasons; it is popularly believed that autumn begins from that day. Two weeks after the Dormition in the old days was called the Indian summer - it lasted until September 11.
Beliefs
  • A thunderstorm on the Dormition means autumn will be early and rainy.
  • On the Dormition of the Virgin, frogs stop croaking.
  • If a rainbow appears, the autumn will be warm and long.
  • If wildflowers' scent is stronger than usual the weather will be bad.
  • Good weather on the Dormition day means Indian summer will be cool.
  • If there is a fog, prepare a large basket - there will be a lot of mushrooms.
  • Frost means there will be short autumn and long frosty winter.
  • If you did not find betrothed at the Dormition day, then you will not get married for a year.
Historian explains how Trump’s dangerous propaganda is driving people to violence

August 30, 2020 Amy Goodman, Democracy Now!
Kenosha shooter (Twitter)

President Donald Trump formally accepted the Republican Party’s nomination on Thursday before a crowd of about 1,500 on the South Lawn of the White House. In defiance of social distancing guidelines, attendees sat shoulder-to-shoulder with few people wearing masks. Trump spoke as the U.S. death toll from the coronavirus neared 180,000 — by far the highest total in the world — and repeatedly defended his administration’s handling of the pandemic. Trump warned of chaos and violence if Joe Biden becomes president, but made no reference to the police shooting of Jacob Blake in Kenosha, Wisconsin, or the killing of two protesters in Kenosha by a 17-year-old Trump supporter. We speak with historian Rick Perlstein, who says Trump paints a “picture of the world that bears no resemblance to reality” and that he has driven people to act violently


Transcript
This is a rush transcript. Copy may not be in its final form.


AMY GOODMAN: This is Democracy Now! We’re Breaking with Convention. I’m Amy Goodman. President Donald Trump formally accepted the Republican Party’s nomination Thursday night before a crowd of about 1,500 people on the South Lawn of the White House. In defiance of social distancing rules, attendees sat shoulder-to-shoulder. Few wore masks. Trump spoke as the U.S. death toll from the coronavirus neared 180,000, by far the highest total in the world. About the same number of people sat in front of him as die every day in the United States of coronavirus. During his speech, Trump repeatedly defended his administration’s handling of the pandemic.

PRESIDENT DONALD TRUMP: The United States has among the lowest case fatality rates of any major country anywhere in the world. The European Union’s case fatality rate is nearly three times higher than ours but you don’t hear that. They don’t write about that. They don’t want to write about that. They don’t want you to know those things.

AMY GOODMAN: In fact, the U.S. has the highest total death toll in the world. With a little over 4% of the world’s population, the U.S. has about 25% of the world’s coronavirus deaths. One-hundred twenty nations have a lower case fatality rate than the United States. CNN reports this was one of the more than 20 false or misleading statements in Trump’s acceptance speech. Earlier in the day, Democratic vice presidential nominee Kamala Harris delivered a prebuttal to Trump’s speech and attacked his handling of the coronavirus outbreak.

SENATOR KAMALA HARRIS: Donald has failed at the most basic and important job of a president of the United States. He failed to protect the American people. Plain and simple. Trump showed what we in the legal profession would call a reckless disregard for the well-being of the American people. A reckless disregard

AMY GOODMAN: During his acceptance speech, President Trump made no reference to the police shooting of Jacob Blake in Kenosha, Wisconsin, or the killing of the two protesters in Kenosha by a 17-year-old white militia Trump supporter.

PRESIDENT DONALD TRUMP: When there is police misconduct, the justice system must hold wrongdoers fully and completely accountable, and it will. But when we can never have a situation where things are going on, as they are today, we must never allow mob rule. We can never allow mob rule. In the strongest possible terms, the Republican Party condemns the rioting, looting, arson and violence we have seen in Democrat-run cities all, like Kenosha, Minneapolis, Portland, Chicago and New York and many others. Democrat-run. There is violence and danger in the streets of many Democrat-run cities throughout America.

AMY GOODMAN: During her prebuttal, Kamala Harris directly addressed the police shooting of Jacob Blake and other incidents of police violence.

SENATOR KAMALA HARRIS: As Vice President Biden put it, the shots fired at Mr. Blake pierced the soul of our nation. It’s sickening to watch. It’s all too familiar. People are rightfully angry and exhausted. And after the murders of Breonna and George and Ahmaud and so many others, it’s no wonder people are taking to the streets. And I support them. We must always defend peaceful protest and peaceful protesters. We should not confuse them with those looting and committing acts of violence.

AMY GOODMAN: During Trump’s acceptance speech, he mentioned Joe Biden’s name, oh, about 41 times. He attacked him repeatedly, claiming he was a Trojan horse for socialism and a threat to the American dream.

PRESIDENT DONALD TRUMP: Biden is a Trojan horse for socialism. If Joe Biden doesn’t have the strength to stand up to wild-eyed Marxists like Bernie Sanders and his fellow radicals—and there are many—there are many, many—we see them all the time—it’s incredible, actually—then how is he ever going to stand up for you? He’s not. Make no mistake, if you give power to Joe Biden, the radical left will defund police departments all across America. They will pass federal legislation to reduce law enforcement nationwide. They will make every city look like Democrat-run Portland, Oregon. No one will be safe in Biden’s America. My administration will always stand with the men and women of law enforcement.

AMY GOODMAN: To talk more about President Trump’s acceptance speech and the 2020 race, we are joined by historian Rick Perlstein. Over the last 20 years, Perlstein has written a four-volume series on the rise of the modern conservative movement, the final volume just published. It’s titled Reaganland: America’s Right Turn, 1976-1980. Welcome to Democracy Now! It’s great to have you with us, Rick Perlstein. Can you talk about the tropes, the language that President Trump used last night? But go beyond his speech last night and talk about what you see happening to the Republican Party right now. Would you say last night was just a celebration of white supremacy?

RICK PERLSTEIN: Yeah. I think that that’s a very hard conclusion to avoid. Adolf Hitler’s chief propagandist, Joseph Goebbels, used to say it’s easier to get the public to believe a big lie than a small one. And what he meant was, if you create such an all-encompassing completely dominating picture of the world that bears no resemblance to reality, people might think that it’s inconceivable that that could be false, right? And that’s exactly what we’ve seen this week in the Republican Convention.

The idea that this is happening while basically a young man who amounts to a stochastic terrorist, that’s basically a person committing political acts of violence believed to be inspired by the acts and wishes of a leader, has happened, is something that you cannot separate from what we saw on our screens. This young man is an impassioned Trump supporter, an impassioned police supporter. He goes to Trump rallies. He goes online and presents videos, believing himself to be an armed vigilante, protecting the nation against these dark and frightening hordes. He comes to Kenosha. And every terrorist believes or claims to believe that they are protecting something, they are protecting order.

This young gentleman goes around with the support of the police who hand him water from their riot tanks. And he shoots. He is fleeing. People are trying to disarm him. And his first instinct is to shoot another person in the head, acting basically in line with not the things that a white supremacist Nazi writer of pamphlets says, but the things that the president of the United States does. And the picture that we are looking at of course bears careful and thoughtful resemblance to the world that the Republican Party made over the last 40 years. But to understand it, we need to go back to the history of strongmen. You know, going back to a Mussolini, going back to a Hitler.

AMY GOODMAN: Johns Hopkins University Professor Narges Bajoghli wrote on Twitter last night, “Having studied production of propaganda in history and present for years, poring over endless hours dissecting how it works and looking for when it works well, the RNC convention the past three days has been some of the best produced and most effective propaganda I’ve seen.” Rick Perlstein?

RICK PERLSTEIN: Yeah. I think that it’s effective in the sense that it’s going to really motivate people who are within this kind of phony worldview, the one in which the coronavirus is referred to in the past tense and America’s economy is the most awesome dynamo the world has ever seen. But of course in order to win, he needs to reach beyond that and win the majority of electoral votes. But by the same token, I’ve made an absolute commitment not to talk about the election of Donald Trump and his attempt to retain power only by talking about voters and electoral votes. Because he is appealing so adamantly to the kind of people who will take arms, take up arms in the streets if he loses.

One of the things we need to understand when it comes to the history of authoritarian strongmen is they are so lawless and their janissaries and enablers are so lawless that they know that if they lose, they may well be called to account for their breaking of the laws. And that makes it an absolute desperate imperative that they not lose. And that is when you see the most frightening developments. The idea that you cannot allow elections to stand. That’s what we saw in Chile in 1970. They lost an election and that’s when they bombed the presidential palace. That’s in 1973 when they bombed the presidential palace, but that’s when the generals seized power by force of arms because they knew that were they to lose, they would be held responsible for the crimes that they had committed.

AMY GOODMAN: Rick, I wanted go back to the Democratic National Convention last week centering on the voices of anti-Trump Republicans but sidelining progressive Democrats, like AOC, for example—Alexandria Ocasio-Cortez. Yes, she spoke for 60 seconds. She took 90 seconds. But she actually wasn’t invited by the DNC. She was invited by Bernie Sanders to nominate him.

RICK PERLSTEIN: Yeah. I want to give it a mixed review. It is absolutely true that they let the former governor of Ohio, John Kasich, a Republican and someone who did things like sign laws to allow guns in bars and was a very adamant pro-life activist—and they let him bait the left wing of the party, which was an absolute absurdity.

But at the same time, they really kind of went all in on a lot of this, on a lot of those nights, for Black Lives Matter. They had an unbelievably galvanizing segment about the imperative to let Dreamers stay in the United States. They had a great segment about feminism. So it was really this attempt to create this big tent.

But at the same time, does the highlighting of these Republicans cause such a contradiction that the American people say to themselves, “Well, what does this party really believe?” And it’s absolutely scandalous that the younger generation of Democrats who are, after all, organizing quite effectively to push aside very long-term incumbent congressmen, were slighted.

AMY GOODMAN: Rich Perlstein, in this last minute we have, and we’ll have you back to talk more about Reaganland, but take us back. You have been chronicling the rise of the conservative and Republican Party for decades now, wrote four books on it. Take us to Reaganland and the similarities you see—Reagan, Trump, and how Trump has taken it further.

RICK PERLSTEIN: Yeah. I’ve been trying to figure out ways to express these very subtle similarities and differences. One thing I will say right now is that Ronald Reagan would definitely say, “Two plus two equals five.” Right? There’s no question about it. But when he would say things like that, it tended to be the off-the-cuff stuff, not the stuff that his speechwriters had written. Whereas when Donald Trump takes a podium and he is reading a speech, that is when he lies the most adamantly.

And it shows that the kind of lying, deception, propaganda, authoritarianism is qualitatively more systematic than under Ronald Reagan. But at the same time that it would not have been possible without Ronald Reagan and the movement around him kind of priming the Republican electorate and Republican elected officials for this kind of lawlessness and viciousness.

AMY GOODMAN: And you of course say that Reagan was one of the most dangerous presidents in U.S. history.

RICK PERLSTEIN: There is no question. Whether a guy cuts 80% out of the public housing budget in eight years, as Ronald Reagan did, with a smile or a scowl, the effect is the same. One of the most dangerous things that Ronald Reagan did as president was something we saw all over in this Republican Convention, which is that idea that people who criticize America are not quite Americans. That is the Reagan legacy, not only to America, but to the United States. That is something that is completely unquestioned in the Republican Party.

AMY GOODMAN: Rick Perlstein, we want to thank you so much for being with us, author of a four-volume series on the rise of the modern conservative movement, the final book just published, Reaganland: America’s Right Turn, 1976-1980. When we come back, we go to the Gulf Coast. Stay with us.

Telemonitoring may reduce heart attack, stroke rate by 50% for people with high blood pressure

People enrolled in a pharmacist-led telemonitoring program to control high blood pressure were about half as likely to have a heart attack or stroke compared to those who received routine primary care, according to new research published today in Hypertension, an American Heart Association journal.
Researchers, led by study author Karen L. Margolis, M.D., M.P.H., executive director of research at HealthPartners Institute in Minneapolis, Minn., found that a heart attack, stroke, stent placement or heart failure hospitalization occurred in 5.3% of the telemonitoring group vs. 10.4% of the routine primary care group.
Home blood pressure monitoring linked with treatment actions from the health care team delivered remotely (telehealth support) in between office visits has been shown to lower blood pressure more than routine care, and patients really like it. In addition, by avoiding serious cardiovascular events over 5 years, our results indicate significant cost savings."
Karen L. Margolis, M.D., M.P.H., study author, executive director of research at HealthPartners Institute in Minneapolis
Patients reported that they liked having support from a trusted professional, rapid feedback and adjustments to their treatment, and having someone to be accountable to.
Margolis reports that over 5 years, the savings from reduced cardiovascular disease events exceeded the telemonitoring intervention costs by $1,900 per patient.
"The findings were just short of statistical significance," said Margolis, "meaning they could have been due to chance. However, we were surprised that the figures on serious cardiovascular events pointed so strongly to a benefit of the telemonitoring intervention," she said.
Uncontrolled high blood pressure is the largest modifiable risk factor contributing to death from all causes. Nearly half of U.S. adults have high blood pressure, defined as equal to or greater than 130 mm Hg systolic (top number), or 80 mm Hg diastolic (bottom number). However, most adults with high blood pressure don't have their numbers under control.
450 participants with uncontrolled high blood pressure were enrolled in the study, conducted at 16 primary care clinics within the HealthPartners system in Minnesota. Participants were blinded and randomized to two groups: 222 patients were in the routine primary care group, and 228 in the telemonitoring group that also received one year of remote care managed by a pharmacist. In the telemonitoring group, patients were able to measure their blood pressure at home and send it electronically to the pharmacist, who then worked with them to make medication and lifestyle changes in their treatment.
In clinic visits for all participants, researchers monitored blood pressure at enrollment, 6 months, 12 months, 18 months and 5 years; kept track of any heart attacks, strokes, coronary stents, heart failure hospitalizations and heart-related deaths that occurred; and counted all the costs of their blood pressure-related care and cardiovascular event care.
They found:
In the telemonitoring group, there were 15 serious cardiovascular events (5 non-fatal heart attacks, 4 non-fatal strokes, 5 heart failure hospitalizations, 1 CV death) among 10 patients. This group also had 2 stent placements, making the total event rate 5.3%.
In the routine primary care group, there were 26 serious cardiovascular events (11 non-fatal heart attacks, 12 non-fatal strokes, 3 heart failure hospitalizations) among 19 patients. They also had 10 stent placements, making the total event rate 10.4%.
Based on these findings, "widespread adoption of the telemonitoring model might help U.S. adults with uncontrolled high blood pressure avoid serious cardiovascular events and reduce health care costs," according to Margolis and colleagues. They recommend future studies to figure out how to increase the number of patients engaged in home blood pressure monitoring over many years, and to measure cardiovascular risk factors and cardiovascular events over that extended period.
The study's limitations are its relatively small size, and it was at a single medical group's urban and suburban primary care clinics, which may not represent the diversity of patients who receive care in other settings across the country.
Source:
Journal reference:
Margolis, K.L., et al. (2020) Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension. Hypertension: Journal of the American Heart Association. doi.org/10.1161/HYPERTENSIONAHA.120.15492.

Low contribution of antiperspirants to total aluminum burden in humans

Consumers can take up aluminum compounds from various sources, including antiperspirants containing aluminum. As stated in the BfR Opinion of 2019 (045/2019) on an aluminum intake, the total burden resulting from all sources of exposure is too high in some population groups.
This finding is not affected by the current reassessment of the contribution of aluminum chlorohydrate in antiperspirants, a product group that is used daily. Their contribution to the total aluminum burden is significantly lower than previously assumed.
This is the result of the current risk assessment by the German Federal Institute for Risk Assessment (BfR). BfR President Professor Dr. Dr. Andreas Hensel: “Significantly less aluminum is absorbed through skin than previously calculated on the basis of the limited data available at the time.” BfR assessed absorption via the skin, i.e. dermal absorption, of aluminum salts for the first time in 2014. “At that time, we pointed out the substantial scientific uncertainty surrounding the data and drew attention to the urgent need for research,” continued Hensel. In the meantime, two human studies addressing those data gaps were conducted in 2016 and 2019. Only the latter was able to produce findings to support reassessment. Therefore, reliable data became only available five years after the BfR's request for a scientifically reliable skin absorption study.
In this case, our current risk assessment also shows just how dynamic the scientific process can be on certain issues, and that it remains a matter of continuously reducing existing uncertainties by closing data gaps."
Professor Dr. Dr. Andreas Hensel, BfR President
To the BfR-Opinion:
https://www.bfr.bund.de/cm/349/new-studies-on-antiperspirants-containing-aluminum-impairments-to-health-unlikely-as-a-result-of-aluminum-uptake-via-the-skin.pdf
aluminum salts are being used in antiperspirants to block sweating and inhibit malodour. Just how much of the aluminum from antiperspirants is being absorbed through the skin has long been uncertain. There are currently three human studies from 2001, 2016 and 2019 on aluminum absorption via the skin (dermal absorption or bioavailability) from antiperspirants. All three studies are based on measuring the aluminum concentration in blood and/or urine. The scientific conclusion and scientific relevance of the three studies differ considerably.
Only the study from 2019 provides reliable data on which to conclude on the absorption rate/ bioavailability. The BfR used this data as the basis for its risk assessment and from this derived the absorption via the skin in a model calculation. The result was that a significant contribution by antiperspirants to the total aluminum exposure is unlikely based on current data.
Those who wish to protect themselves from excessive aluminum absorption, should make sure that acidic and salty foods and beverages do not come into contact with aluminum, e.g. via bottles, baking trays, grill pans.
According to current scientific knowledge, excessive aluminum levels in the body can have negative effects on the nervous system, the kidneys and bone.

The Legacy of Tuskegee Complicates African Americans’ Feelings About Vaccines

A Black scientist’s plea to lean into the data, even as an unjust health care shadow persists in the U.S.

Photo: Marko Geber/Getty Images
Ibelieve vaccinations are an important part of health maintenance. Every year, I get a flu vaccine and encourage my adult children to do the same. So, I was surprised when some of my friends and family members shared with me that they had no plans to take the vaccine for Covid-19 when and if it becomes available.
At least, they specified, they would not be the first in line.
Though my initial reaction was one of surprise, I realized this reluctance is part of a larger conversation — especially in the Black community. Initially, I was puzzled as to where this reluctance came from. As a scientist with a PhD in pathology who has worked in health care for more than 20 years, I tend to make decisions based on empirical data. However, as an African American woman, I have also come to appreciate the historical context of race and science.
In 1972, the Tuskegee experiment, a 40-year study of 600 African American men untreated for syphilis, came to an end. An article published by Jean Heller of the Associated Press prompted the public outrage. By the time the study was finally shut down, almost 130 included men had died due to syphilis and complications caused by the disease. Many had passed the disease on to their spouses and children.
This U.S. government-run study, executed by the agency known at the time as the United States Public Health Service, was not a secret to many in the health care community. It went on for four decades with physicians, nurses, and others knowingly and willingly monitoring men who they knew would die without treatment for the disease.
As a scientist, I know the importance of clinical studies… But as an African-American woman, I also understand my community’s reluctance to be involved in clinical studies.
The study was never designed to “treat” these men. The true purpose was to observe the disease progression in the human body. To make matters worse, the men did not know they weren’t being treated. These mainly poor sharecroppers were recruited to join the study based on the promise of free health care to treat “bad blood.” The unjust impact of that study reverberates still today.
As a scientist, I know the importance of clinical studies and the pressing need to demonstrate whether a drug is an effective or ineffective treatment for people against a given pathogen. But as an African American woman, I also understand my community’s reluctance to be involved in clinical studies and the historically fueled distrust we have for the American health care system — both public and private.
Against that backdrop here in 2020, as we face down the threat posed by a novel virus and the promise of a vaccine produced in a program called “Operation Warp Speed,” it’s no wonder that hesitancy abounds.
Many Americans, regardless of race, are concerned about being injected with a novel vaccine made in record time, but African Americans have a unique legacy with the U.S. health care system — which makes this an even more challenging decision.
As we face down the threat posed by a novel virus and the promise of a vaccine produced in a program called “Operation Warp Speed,” it’s no wonder that hesitancy abounds.
According to the National Opinion Research Center (NORC), the nonpartisan public research organization at the University of Chicago, 40% of African-Americans surveyed said they would not take a Covid-19 vaccine compared to only 25% who said they would. That’s significantly fewer than the 56% of surveyed whites who said they would take the vaccine.
Hopefully, administering and receiving the Covid-19 vaccine will become as routine and safe as what we experience now with the flu vaccine. Because the Black community is deeply impacted by Covid-19, an effective and safe vaccine could help to save our aunts, uncles, parents, and grandparents from unnecessary illness and possible death.
However, is it realistic to expect we will be the first to stand in line for this vaccine? Before we do that, we should know whether it is safe for us. Given the fact that African Americans are 60% more likely to be diagnosed with diabetes, 40% more likely to have high blood pressure, and 3.5 times more likely to be diagnosed with renal disease, it is vital that scientists establish the safety and efficacy of the vaccine in persons with diabetes and high blood pressure.
The legacy of Tuskegee will sadly always be with us. But rather than hinder us, it should drive us to ask the important questions, trust what is proven, and be informed at all times.
This vaccine should demonstrate that it is safe in the human body. The only way we will know if it is is to study the effects of the vaccine over time. We should continue to monitor the safety data coming from the phase 1 through phase 3 studies. We will need to evaluate demographic information regarding differences in response to the vaccine based on age, race, sex, and comorbid conditions. We should have a full picture of the effectiveness of this vaccine as well as the risk.
I can’t tell you whether to take a vaccine or not — that’s not my purpose in writing this. My aim is to say: Let’s inform ourselves and then make a decision. But to my friends who have decided they will not be the first in line for this vaccine: I sure hope you will continue to do those things which have proven to be effective in reducing risk. I still wear a mask in public, I haven’t been to a party in months, and I visit friends and family only occasionally and make a point to keep my distance (when outside) or wear masks (when inside). I also wash my hands often and keep them out of my face. It’s not always easy, but I know it is necessary.
And I will get my flu shot.
The scientist in me will always look to the data to make smart choices about my health. Gone are the days when we could rely only on our doctor for information. We must all become educated health care consumers. And we must reject terms like “vulnerable” being used to describe African Americans at risk in this pandemic. We are not vulnerable, we are disregarded when it comes to health care in this country. We can do better for ourselves and can call on the health care and research community to be better as well.
The legacy of Tuskegee will sadly always be with us. But rather than hinder us, it should drive us to ask the important questions, trust what is proven, and be informed at all times.

Researchers propose new reforms to improve transparency of drug authorizations

On March 28, the Food and Drug Administration (FDA) exercised its Emergency Use Authorization (EUA) authority to allow the use of hydroxychloroquine for the treatment of COVID-19. On June 15, after a number of studies failed to find positive effects, the agency revoked this authorization.
This chain of events raises questions about the speed, rigor and potential politicization of the authorization process. These actions also may have hurt the FDA's credibility and the public's trust in the agency, which could decrease the public's confidence in and adoption of eventual COVID-19 vaccines.
In a Viewpoint piece published in JAMA: The Journal of the American Medical Association, a research team proposes reforms that the FDA could implement to improve the emergency use authorization process and drug approvals during public health crises, which could increase the FDA's credibility and the public's trust in it.
The recommendations are especially timely given that FDA Commissioner Stephen Hahn has stated that the agency will consider using the EUA process to authorize a COVID-19 vaccine, as well as the potential for full approval of COVID-19 vaccines in late 2020.
The FDA is "responsible for protecting public health," which includes ensuring that drugs are safe and effective.
The FDA entered highly unchartered territory when it came to the approval and revocation of hydroxychloroquine for COVID-19, as emergency use authorizations have typically been used for diagnostics and only rarely for therapeutics."
Herschel Nachlis, Study Co-author, Nelson A. Rockefeller Center for Public Policy and the Social Sciences, Dartmouth College
Nachlis is also a research assistant professor of government and policy fellow
"Through this piece in JAMA, we provide recommendations to help the agency make the authorization process more robust, rigorous and transparent in this pandemic environment," he added.
To improve the accountability and transparency of drug authorizations and approvals, the researchers propose four reforms:
  • The FDA could clarify evidentiary standards for EUAs and could create higher standards for widely used products like vaccines.
  • The FDA could consult with the external experts on its Advisory Committees before issuing EUAs. The committee meetings could be live-streamed and more opportunities for public input could be established.
  • Once COVID-19 vaccines are granted marketing authorization, the FDA could establish extensive adverse event reporting systems, facilitate phase 4 trials to monitor post-approval safety and efficacy, and engage the National Vaccine Injury Compensation Program.
  • As part of the FDA's ongoing efforts to enhance public communication about COVID-19 diagnostics, therapeutics and vaccines, the FDA could launch public education campaigns and utilize communication tools like drug facts boxes to help explain regulatory decisions.
     
"The FDA's regulatory processes are often considered the gold standard for the approval of drugs, and are fundamental to American and global public health," said Nachlis.
"Our entire pharmaceutical and healthcare system depends on this standard. Maintaining credibility and public trust is integral to the FDA's ability to fulfill its mission. Now is the time for the FDA to consider ways to enhance its public support, as our nation and the world waits for effective vaccines to be quickly and safely developed, approved and deployed," he added.
Source:
Journal reference:
Thomson, K & Nachlis, H (2020) Emergency Use Authorizations During the COVID-19 Pandemic. JAMA. doi.org/10.1001/jama.2020.16253