Posted on Leave a comment

White House Blocks New Coronavirus Vaccine Guidelines

1dimitri-houtteman-unsplash Shidonna Raven Garden and Cook

Source: The New York Times
The F.D.A. proposed stricter guidelines for emergency approval of a coronavirus vaccine, but the White House chief of staff objected to provisions that would push approval past Election Day.

Sharon LaFraniere
Noah Weiland

By Sharon LaFraniere and Noah Weiland

WASHINGTON — Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process.

Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.

The struggle over the guidelines is part of a monthslong tug of war between the White House and federal agencies on the front lines of the pandemic response. White House officials have repeatedly intervened to shape decisions and public announcements in ways that paint the administration’s response to the pandemic in a positive light.

That pattern has dismayed a growing number of career officials and political appointees involved in the administration’s fight against a virus that has claimed more than 209,000 lives in the United States.

The vaccine guidelines carry special significance: By refusing to allow the Food and Drug Administration to release them, the White House is undercutting the government’s effort to reassure the public that any vaccine will be safe and effective, health experts fear.

“The public must have full faith in the scientific process and the rigor of F.D.A.’s regulatory oversight if we are to end the pandemic,” the biotech industry’s trade association pleaded on Thursday, in a letter to President Trump’s health secretary, Alex M. Azar II, asking for release of the guidelines.

The Food and Drug Administration submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in the office of Mark Meadows, the White House chief of staff. Their approval is now seen as highly unlikely.

A main sticking point has been the recommendation that volunteers who have participated in vaccine clinical trials be followed for a median of two months after the final dose before any authorization is granted, according to a senior administration official and others familiar with the situation, who spoke on the condition of anonymity. Given where the clinical trials stand, that two-month follow-up period would all but preclude any emergency clearance before Election Day.

The conflict began almost as soon as the Food and Drug Administration submitted the guidelines to the White House budget office on Monday, Sept. 21. The next day, Dr. Stephen M. Hahn, the F.D.A. commissioner, briefed Mr. Azar on the matter.

That Wednesday, Mr. Meadows raised a series of concerns, a senior administration official said. He questioned the need for two months of follow-up data, said that stricter recommendations would change the rules in the middle of clinical trials and suggested that Dr. Hahn was overly influenced by his agency’s career scientists. The White House on Monday did not respond to a request for comment.

Speaking to reporters on Sept. 23, Mr. Trump publicly cast doubt on whether the guidance would be approved. “We may or may not approve it,” he said, suggesting that the regulatory action “was a political move more than anything else.”

F.D.A. officials later provided additional justification to the White House, explaining that the two-month follow-up was necessary to identify possible side effects and ensure that a vaccine’s protection against Covid-19, the disease caused by the coronavirus, was not short-lived. But they have been unable to break the stalemate.

The White House has the authority to intervene in such nonbinding guidance documents — a step below enforceable regulations — at least partly because of an October 2019 executive order that tightened restrictions over the issuance of such documents. That order asserted that “agencies have sometimes used this authority inappropriately in attempts to regulate the public.” White House officials have cited it to force the Food and Drug Administration and other agencies to submit pandemic-related guidelines to the White House budget office for review before public release.

Staff members at the budget office scrutinize the documents for statements that could undercut the president’s public message that the administration either has the pandemic under control or will soon, according to former and current federal officials.

The testing and release of a vaccine is an issue that has gained wide national attention. Mr. Trump has repeatedly misrepresented how quickly a vaccine might be available to most Americans, promising a major breakthrough in vaccine development as early as this month. No clinical trial in the United States has yet advanced far enough to prove that any vaccine is safe and effective, although Pfizer, one vaccine developer, is hoping for interim results soon from its trial.

The Food and Drug Administration’s new guidelines were intended to assure companies developing vaccines that they were being held to a common standard and to reassure the public. Polls suggest that Americans are increasingly wary about taking a coronavirus vaccine: A survey published last month by the Pew Research Center found that 51 percent of Americans would either probably or definitely take one, down from 72 percent in May.

Dr. Peter Marks, the F.D.A.’s top regulator for vaccines, said last week in an event organized by Friends of Cancer Research that the government had to be transparent about the standards it was using to evaluate experimental vaccines in order to build public trust. He and other health officials have stressed that the companies developing vaccines are already fully aware of the agency’s expectations for products seeking authorization for emergency use.

Mr. Azar on Friday played down the conflict with the White House, telling a House panel that those concerned about its involvement in the guidelines were making “a mountain out of a molehill.”

“What the commissioner is proposing to put out is public emergency use authorization guidance on a vaccine that would be consistent with letters already sent to the manufacturers,” Mr. Azar said. “The F.D.A. has already told the manufacturers what they’re going to look for.”

Some vaccine makers, including Johnson & Johnson, have publicly indicated that they will follow the agency’s recommendations, regardless of the White House’s actions.

At a recent meeting with F.D.A. staff members, Dr. Marks said the agency “may hear more noise in the press” about trouble with the guidance but added that the “goal isn’t to get into fights,” according to people familiar with his comments. He said at the Friends of Cancer Research event that there was no reason “to get all excited” because “we are going to have a transparent advisory committee meeting for each and every emergency use authorization that comes through.”

Privately, Dr. Marks has told colleagues that an angry tweet from Mr. Trump attacking F.D.A. scientists over the guidelines could damage public confidence in a coronavirus vaccine.

The guidance laid out more specific criteria for clinical trial data and recommended that it be reviewed by the advisory committee of independent experts. It is expected to be included in the briefing papers for the committee’s next meeting, scheduled for Oct. 22.

Food and Drug Administration officials hope the committee will consider those standards before giving its blessing to any emergency use authorization for a vaccine. The most likely recipients of any vaccine that wins that authorization will be high-risk populations such as health care workers.

In addition to the two-month follow-up period, the guidelines stated that there should be at least five cases of severe infection in the placebo group as evidence that a vaccine is effective in preventing more than just mild to moderate illness. About 10 percent of Covid-19 cases are considered severe.

The guidelines also laid out the agency’s expectation that vaccine makers would continue to assess the long-term safety and efficacy of the drug, if granted emergency use authorization.

Katie Thomas contributed reporting from Chicago. Kitty Bennett contributed research.

How do you feel about a coronavirus vaccine? What do you think the guidelines will be? Will you take a coronavirus vaccine?

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.

Posted on Leave a comment

Interfacing Humans and Technology – Elon Musk

Elon Musk – Cyborgs
Shidonna Raven Garden and Cook

Elon Musk is the CEO of Space X and Tesla Motors. Space X has begun commercial space travel transportation and recently returned a group of Astronauts from space splashing them into the Gulf of Mexico. He is by far one of the people on the cutting edge of space and technology not to mention engineering and other talents. Musk also began many successful and well known companies such as PayPal. As one thinks about medical devices and the concept of cyborgs, one can see how the current science and medical trend of interfacing humans and technology. How do we see this in our everyday lives? How do we see this occurring in our doctors offices? How do we see this in our interactions with technology and technological advances? What if you became too slow to compete with robots or Ai (artificial technology) on a job? Would you interface with technology to become more competitive? What are the health implications of doing so? Share your comments with the community by positing your comments 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.

Posted on Leave a comment

Medications & Substance Abuse

burdock seeds shidonna raven garden and cook

There is nothing more sensational than a star and their story of substance abuse. The questions is how do they get there. Indeed COVID 19 has highlighted the pharmaceutical industry as the world waits on the edge of its seat for a cure. In the mist of the pandemic many companies have gone under; others have faced tough times and decisions and yet others have re-invited themselves: namely Kodak. Kodak, famous for photo production, has now decided to get into the pharmaceutical business. Indeed there are many medicines, typically derived from nature, that have made a world of difference. There is no denying that the pharmaceutical industry makes several millions annually and often repackage a drug already on the market so they can circumvent clinical trails. The purpose of clinical trails is to confirm the medicine works and does what it claims to do.

Several times we have been offered medicines or a procedure that could be avoided by making changes in our diet, i.e. dialysis in place of increasing iron intake and taking a dietary supplement. In fact the medicines can add up quickly during one hospital visit. In some cases the symptoms produced by one medicine lead to the prescription of another medicine to address conditions one would not have if they did not take the medicine. In fact many doctors report that their patience soon suffer substance abuse. But many medicines are some type of drug. Its easy to see how multiple drug prescriptions can lead to substance abuse if one is not careful.

How many medicines do you take? What are they for? What are their sources in nature? Share your posts 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.

Posted on Leave a comment

How to buy food

vitamin d sun shidonna raven garden and cook

The New Organic Grower by Eliot Coleman has been essential to us in understanding how to buy food. It also helped us understand what our food should look, how it should be produced, processed and labeled. It also left us with concerns regarding transparency in the food industry and how our foods are labeled. In this day in age where scientists seem to be making more contributions to food production and processing than farmers, Eliot’s book reminds us that the growth, not production, of food is a biological process that begins in the soil not a scientific process that begins in a lab. When we look at many of our foods and the additives as well as preservatives in them, we can see there is a reason to be concerned about the things we are knowingly or unknowingly consuming. Eliot’s book is the beginning of understanding and knowledge of food and how science has taken food production away from this biological process.

To understand how to buy food appropriately we must first begin by reading our food labels and asking questions regarding the foods we buy. How were they grown and processed? Where do they come from? How far do they come? Coleman helps us understand what organically grown food means, looks like and how it is processed. It was one of our most helpful reads and can be found below. Where do you buy your foods? Are they organic? Are they locally grown? Share your comments 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.

scroll up and down

Posted on Leave a comment

Food Additives & the FDA

Food Additives & the FDA
Shidonna Raven Garden and Cook

An interesting point to note is that farmers typically grow food in the ground while scientists often create “food” in laboratories. Food products that you find on the shelf can include “foods” created in a science lab rather than on a farm or garden naturally. During this Organic journey it has been important to know how the food that ends up on our table is produced. The interesting thing about food production is how transparent it is not when you are looking at your food and their labels in the grocery store. What is also interesting are the standards of the government agencies that regulate the food industry and the many loop holes around these regulating bodies. Do you think companies who manufacture food additives in labs should determine whether a food is safe for consumption or not? Would you rather eat food manufactured in a lab or grown on a farm? Would you rather eat food produced by a scientist or by a 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.

Posted on Leave a comment

GMO & your Health

GMO and Your Health
Shidonna Raven Garden and Cook

Scientist are often responsible for creating GMOs and ‘food products’. Food occurs in nature naturally and can be cultivated from seeds. If all the food we eat are GMOs, food will cease to be grown in nature but looked at as products. This has health, financial and economical implications. Scientist created chemical pesticides that Organic Farmers state they do not need and are detrimental to food and food nutrition. Further Organic Farmers state that scientist are always pushing products farmers do not need making farming unsustainable and economically impossible unless farmers become industrial farmers. Industrial farmers are known for focusing on quantity and not quality: nutrition. The lack of nutrition in food is said to be the source of many health problems and concerns today. These very food production practices have Organic Farmers returning to the strength, health and nutrition found in food that focuses more on biology rather than science or medicine.

What do you think the profit is in GMOs? Do you think GMOs should be put on the market for sale before they know the effects of GMOs on humans? Do you think they should disclose the effects of GMOs to people similar to cigarette labels? 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.

Posted on Leave a comment

The Organic Movement

Real Organic Project
Shidonna Raven Garden and Cook

My Agricultural Grandparents by Eliot Coleman | Real Organic Project

Eliot Coleman believes that food is more of a function of biology than science. He also believes that the USDA could go further in regulating and understanding what true Organic growing means. Do you think the USDA goes far enough? Do you think the USDA is transparent enough? What questions do you have about Organic food? Do you think non Organic food can give your body the nutrients it needs to be healthy and to function properly? Share your comments below with the community by posting it 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.

Posted on Leave a comment

Rethink: Organic

burdock seeds shidonna raven garden and cook

When I picked up “The New Organic Grower” by Eliot Coleman within the first couple of pages and throughout the book, it was purposefully stated that the writer wanted to change the way you think about food growing and consumption. As you would imagine many organic growers have similar ways of thinking and philosophies. And when I read it, it changed the way I thought about growing food, consuming food and the balance of nature all around me. I came to value birds and bees even more now that I could so how important they are to the growth of my own foods through pollination. It is a simple concept we learn as children. But, how much do we value the work they do? How much do we value the role they play in food growth?

For some it is easy to choose organic. For others it takes looking at things in a whole new light. So, maybe on this journey you may come to see some things in a new light. Probably since its inception, science has been imitating nature. In fact Oxford Dictionary defines science as “the intellectual and practical activity encompassing the systematic study of the structure and behavior of the physical and natural world through observation and experiment.” 

How much science borrows from nature really stood out to me when I learned how Velcro was invented. George de Mestral observed the burdock seeds in nature and how they stuck to his clothes during walks. From there he invented Velcro. It begs the question whenever I see an invention or namely a chemical: where in nature did they get this one from? Perhaps next time we reach for a food or a medical remedy, we will ask where in nature did this come from? And why not go to the source of nature for my remedy rather than a chemical or invented imitation of the original? Why not take Echinacea from my garden to boost my immune system rather than waiting for the onset of a cold to take cough medicine, whose ingredients I can hardly pronounce and would need a degree in medicine to even identify. What inventions or common remedies do you know the sources of in nature? How has this journey changed the way you think about the foods you eat? How could changing your diet change your health?   As always you are the best part of what we do. Keep growing! 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.

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