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Coronavirus clinical trials are pausing over safety concerns – here’s what that means

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Source: CNBC
PUBLISHED THU, OCT 15 2020 6:00 AM EDT UPDATED THU, OCT 15 20209:02 PM EDT
Berkeley Lovelace Jr.@BERKELEYJR

  • J&J said Monday it paused the late-stage trial of its coronavirus vaccine candidate after a participant reported an “adverse event.”
  • Less than 24 hours later, Eli Lilly said its late-stage trial of its leading monoclonal antibody treatment for the coronavirus had been paused by U.S. health regulators over potential safety concerns.
  • Pauses to clinical trials are not uncommon, and the delays should reassure the public that the systems in place intended to protect volunteers are working, medical experts say.

Coronavirus clinical trials from drug giants Johnson & Johnson and Eli Lilly hit a snag this week after safety monitors halted them over bad reactions from participants.

J&J said Monday it paused the late-stage trial of its coronavirus vaccine candidate after a participant reported an “adverse event.” Less than 24 hours later, Eli Lilly said its late-stage trial of its leading monoclonal antibody treatment for the coronavirus had been paused by U.S. health regulators over potential safety concerns. The pauses are likely to add to concerns about the safeness of potential Covid-19 vaccines or treatments.

But pauses to clinical trials are not uncommon, and the delays should reassure the public that the systems in place intended to protect volunteers are working, medical experts said in phone interviews with CNBC.WATCH NOWVIDEO04:02Jim Cramer: Eli Lilly pausing antibody trial isn’t a big setback

The data and safety monitoring board, an independent group of experts who oversee U.S. clinical trials to ensure the safety of participants, recommends a pause to a clinical trial any time there is an “adverse event,” said Isaac Bogoch, an infectious disease specialist and professor at the University of Toronto. The pause will take as long as needed to gather all information and does not necessarily mean there is a problem with the vaccine or treatment, he said.

“The DSMB will say let’s push pause on this,” said Bogoch, who is also a member of the group and is overseeing other clinical drug trials. “They will say, ‘we need more data and let’s see if this person was in the vaccine group or in a placebo group.’ They’ll say, ‘let’s see what the actual illness is and use all the data at our disposal to determine whether this was a true side effect from the vaccine and if so, decide if it is safe to proceed with this study.’”

Pauses happen all the time, especially in large clinical trials with older adults, according to Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Offit, a past member of the CDC’s Advisory Committee on Immunization Practices, said “adults get sick” and sometimes “they are going to get sick in the same period of time” of getting a vaccine or treatment.

“Johnson & Johnson’s vaccine is designed to prevent Covid-19. It is not designed to prevent everything else that happens in life,” he said. “You’re always going to be sorting out those temporal associations. Strokes, heart attacks, neurological problems. Always. You always err on the side of caution and make sure that this isn’t a problem and then continue again.”

Bogoch echoed those remarks, adding, “no one before Covid-19 cared when there was a pause on a clinical trial for an antibiotic or heart medication.”

“Never have we been in a scenario where you truly have 7 billion people watching intently and following every single bit of progress under a microscope,” he said. “You know, it’s fascinating and it’s good. It creates a more health literate community. There is only good that can come of it.”

He added a pause isn’t the same as a regulatory hold, sometimes referred to as a “clinical hold.”  A clinical hold is imposed by a health authority, like the Food and Drug Administration, he said.

“It’s a little more serious when you get to a regulatory hold,” he said. “That’s actually when the FDA steps in and say we’re concerned about a particular event and we’re going to stop this trial because we don’t think it’s safe to proceed with the data that we have available at this point in time.”

The FDA still has a late-stage clinical trial from AstraZeneca, a front-runner in the Covid-19 vaccine race, on hold in the United States. That means the company is unable to administer second doses of its two-dose vaccine regimen to U.S. participants.

The company announced on Sept. 8 that its trial had been put on hold due to an unexplained illness in a patient in the United Kingdom. The patient is believed to have developed inflammation of the spinal cord, known as transverse myelitis. The trial has since resumed in the U.K. and other countries but is still on hold in the U.S.

It remains unknown what reactions the participants in J&J’s and Eli Lilly’s trials had.

Offit said companies will sometimes claim they are protecting the confidentiality of the patient, but he disagreed with the behavior. “As long as you can’t identify the person, they can give you a fair amount of information about the person, but they don’t,” he said.

Dr. Mathai Mammen, global head of research and development at J&J’s Janssen arm, told investors on a conference call Tuesday that the company still had “very little information” on the reason for the holdup, including if the patient received the vaccine or the placebo. “It’ll be a few days at minimum for the right information to be gathered,” he added.

Dr. Ezekiel Emanuel, a former health advisor in the Obama administration, said it would “raise serious questions” if the participant received the vaccine.

“One adverse event is serious, especially when you’re considering a vaccine that you’re going to roll out to tens, hundreds of millions of people, maybe even billions,” he said Tuesday on CNBC’s “Squawk Box.” “That’s the ultimate concern.”

Eli Lilly and the National Institutes of Health did not disclose what the “safety” concern was either, but Eli Lilly said it was “supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” spokeswoman Molly McCully told CNBC. 

Indeed, the whole world is on edge for the first time in “modern” history with over 1 Million dead global (as reported by Wikipedia) from COVID 19 and even more cases. People are waiting for a solution and the end of the pandemic. How important is a vaccine to you and yours? Is a safe and effective vaccine more important to you than simply a vaccine? Will you take the vaccine once it is here?

Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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Norfolk Botanical Gardens

Pumpkin Plant
The Norfolk Botanical Gardens
Shidonna Raven Garden and Cook

We have personally been to Norfolk VA Botanical Gardens several times for several occasions as well as just to go! The Botanical Gardens are beautiful every time. No time is like the other because there is always something beautifully different in bloom in the garden not to mention its beautiful statues and fountains. To learn more about the Botanical Gardens or to plan your next visit: click here. The garden is a stones throw from the Norfolk International Airport and are especially nice in the Spring and Summer as one might imagine. Take plenty of photos, as if you could resist, and share them with the community by emailing them to us and we will post them. Tell us all about your trip by posting here and sharing it with the community. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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African American Farm

African American Farmers
Source: Clemmons Family Farm
Shidonna Raven Garden and Cook

How far are the local farms from where you live? Do you know your local farmers? Do you know that some farms allow second gleaning for free? My family and I visited a farm in New England when we lived there and picked apples (second gleaning) at a local orchard in the northern part of Massachusetts. The orchard was about an hour away from where we lived. We purchased some apple cider from the farm and got the apples for free. It made a delicious apple pie. Have you considered visiting your local farmer?

Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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Dick Gregory: Health

Dick Gregory, Food and Health
Shidonna Raven Garden and Cook

How do you choose a healthier diet when you feel that you can not afford it? How do you make the switch from more medicine to more healthier foods? What do you think about eating more fruits and vegetables than meats? Share your comments with the community by positing them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing.

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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Soul Fire Farm

Soul Fire Farm
Shidonna Raven Garden and Cook

Who are the Organic Growers in your community? How are you apart of the Organic Farms and Gardens in your community? If you are not a farmer or gardener, are you an organic consumer? How can you get to know the farmers who grow your food? Don’t know, Ask. Share your comments with the community by positing them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing.

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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African Americans & Organic Farming

Do you think that organic foods are for only the rich and famous? Is what we call organic farming today just the way people farmed before scientists begin selling farming products and chemicals? Is organic farming not just not industrial farming? Share your comments with the community by positing them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing.

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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Diabetes & Diet

diabetes shidonna raven garden and cook

As I shared my own health concerns with family and friends, so too they shared their concerns with me. In some cases we discovered that we had similar health concerns and we begin to share notes on our own individual journeys with our health concerns. What worked. What did not work. What we did not like. Things that just did not seem to add up and be viable options for a real solution nor good health. A few of these conversations surrounded diabetes or the danger of becoming a diabetic.

As the data from the CDC shows us from 2018 African Americans have relatively high percentages as it relates to other racial groups in the data set they provided. As you might have guessed one of the things they (family, friends and their health professionals) wanted to tackle in order to avoid becoming diabetic was to change their diets. In this case Help Guide states there are some common myths about diabetes that we should consider. They state that their is no special diet needed for diabetics. Specifically they stated “As with any healthy eating program, a diabetic diet is more about your overall dietary pattern rather than obsessing over specific foods. Aim to eat more natural, unprocessed food and less packaged and convenience foods.”

We agree that more natural or organic as well as unprocessed foods such as packaged and convenience foods do not promote good health and are not the cornerstones of a proper diet. Again we have another source confirming this belief. Here are a couple beliefs about diabetes they (Health Guide) say are myths:

Source: CDC 2019. Summary Health Statistics: National Health Interview Survey: 2018. Table A-4a.
Shidonna Raven Garden and Cook

Myth: You must avoid sugar at all costs.

Fact: You can enjoy your favorite treats as long as you plan properly and limit hidden sugars. Dessert doesn’t have to be off limits, as long as it’s a part of a healthy meal plan.

Myth: You have to cut way down on carbs.

Fact: The type of carbohydrates you eat as well as serving size is key. Focus on whole grain carbs instead of starchy carbs since they’re high in fiber and digested slowly, keeping blood sugar levels more even.

Myth: You’ll need special diabetic meals.

Fact: The principles of healthy eating are the same—whether or not you’re diabetic. Expensive diabetic foods generally offer no special benefit.

Myth: A high-protein diet is best.

Fact: Studies have shown that eating too much protein, especially animal protein, may actually cause insulin resistance, a key factor in diabetes. A healthy diet includes protein, carbohydrates, and fats. Our bodies need all three to function properly. The key is a balanced diet.

Were any of your myths dispelled? How has your diet affected your health or how you feel day to day? What are your health concerns? What did you think of the CDC data? Share your comments with the community by posting them below. Share the wealth and health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Stay healthy.

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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How to Celebrate Memorial Day

As COVID 19 lingered on, it left many of us with more questions than answers. Finally we could see the number of deaths begin to slow. While COVID 19 seemed to sweep the world in a matter of weeks brining things to a halt in the United States, we finally began to receive reports that we were effectively slowing the spread of COVID 19. While there is neither vaccine nor cure in sight yet, we could gather some satisfaction from the fact that things were beginning to work in slowing the spread of the virus. As we entered phase one of reopening and things seem to be returning to normal, in the back of our minds we know that things will inevitable not be the same. COVID 19 has caused us to rethink many things. How we work, socialize, shop and celebrate just to name a few. Many of us are sporting hair styles and facial hair that was totally different a few months ago because barber shops and salons are closed to the public.

As things reopen, we wonder what the new normal will be. We believe healthy will be the new normal. While many communities such as the African American and elderly communities got hit the hardest because of pre existing health conditions, many are left grappling with the fact that preexisting health conditions make them susceptible to disease and illness. So, one must reconsider having preexisting conditions at all and rethink how they define healthy. Preexisting health conditions cannot simply be left to linger. If we allow illness to linger, than we are not the fittest and many of them did not survive this pandemic.

Memorial Day is a day to celebrate those who have fallen in the line out duty. It is a time to gather and often eat. Many people have cookouts during this time. With Memorial Day just around the corner many of us are wondering just how to celebrate Memorial Day. The Military is huge in a town home to the largest Naval Base in the United States (Norfolk, Virginia), so is Memorial Day. While we are still in phase one of reopening, gatherings are still limited to just 10 people and we still have to be cognizant of the fact that COVID 19 can remain on surfaces for hours to days.

While we highly recommend following all the recommended and enforced guidelines, we recently had a cook out without any issue. Our gathering was about seven people and we were highly organized and clean when we cooked out. So, we believe that you can still celebrate Memorial Day with a traditional cookout but just on a small or smaller scale. You might have to forgo any traditions of fireworks or events with large gatherings as they are still being discouraged.

COVID 19 has caused many people to rethink how they stay connected and socialize with many people making use of software such as zoom and Google hangout. What are ways that you can celebrate and acknowledge Memorial Day here with us? What is your favorite salad recipe? Submit it via a comment or email it to us. Share your recipe with the community. How can you make your favorite recipes organic recipes? Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep growing.

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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Corona: Healthy is the New Normal

covid 19 shidonna raven garden and cook

As a state official stated, Corona brought everything to a screeching halt with in a matter of weeks. Having spent the last several weeks at home and some not able to work, many people are eager to see things get back to normal and to get back to work. Social distancing has heighten the importance of our connection to those people we consider friends and family as well as those we associate with on nearly a daily basis. All of us across the globe have suffered similar issues together. Loved ones on the front lines and those lost alone in hospitals to die without a final proper burial. No single event in modern history has been more galvanizing than Corona. As many of us are eager to get back to normal, we are revealed to see things opening back up slowly but surely. We are reminded and cautioned by leaders such as Governor Northam and T.D. Jakes that Corona is still indeed with us. We have simply slowed the spread of it. So as we begin to venture back out into our communities and return to work, we must be reminded that Corona is without a cure and remains in our midst.

Some of the hardest hit communities have been the elderly, African American and Hispanic communities. The CDC (Center for Disease Control) stated that 30 % of the African American population are Corona patients while they make up only 13% of the US population. There are many factors that contribute to these numbers. Population density is one. That can include a densely populated home or an urban environment that tends to be densely populated. Lack of paid sick leave and insurance is another factor the CDC is saying contributes to these numbers. Preexisting health conditions or concerns is another contributing factor and is why we write to you today. While we are passionate about gardening and cooking, it is because doing these things properly can lead to good health. With Corona in our midst and a matter of good practice, being healthy has become the new normal. Get hit hard by a pandemic and you will begin to refocus your health goals and what is important in life. As we can see from the CDC statistics being in good health is one way to combat Corona.

Stay Masked Up
Shidonna Raven Garden and Cook
  • Do an honest assessment of your current state of health
  • Do everything possible to be as healthy as possible that includes eating right (a diet appropriate to your specific needs)
  • Stay informed and follow the guidelines of each re opening phase
  • If you do not know where to get correct information, start with the CDC

This gives us pause to think critically about the social economical issues that minority populations face daily. The CDC numbers are alarming and illuminating to social economic issues which can neither be ignored nor accepted. How has Corona impacted you and your loved ones? What will you do differently since Corona? What re 3 things you will do today to improve your health? What questions do you have about the foods you consume daily? Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. You are at the center of our thoughts and prayers.

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.