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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!

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White House Blocks New Coronavirus Vaccine Guidelines

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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!

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Health Fraud: FDA

FDA – Health Fraud Scams
Shidonna Raven Garden and Cook

Unfortunately health fraud scams are prevalent and many fall prey to them besides the elderly. I have personally been misdiagnosed, which included fraudulently signing my name to several medical documents and applications without my consent. Like many who are misdiagnosed to charge higher or unnecessary fees to insurance companies, medicare and medicaid, my health deteriorated to the worst condition I have ever experienced during my life. Some medical professionals will misdiagnose you based on a voting system based on no scientific evidence often handing out prescriptions to legitimize their diagnosis. The FDA is correct: these activities can and have put peoples lives in danger and have cost some their lives. Be well informed. As those who seek medical care the red flags do not always seem as obvious as you think. Undercover Epicenter Nurse: How Fraud, Negligence, and Greed Led to Unnecessary Deaths at Elmhurst Hospital reveals just how easy and how many lives have and can be lost.

What do you know about your doctor? What do you know about the history of the medical professionals and facilities that serve you? Have any reports or complaints been placed against these individuals or their facilities? 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.

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COVID 19 and Climate Change

COVID-19 Mitigation Leads to Reduced Pollution Associated with Decreased Fossil Fuel Use
Source: NASA
Shidonna Raven Garden and Cook

Many people have commented on the not so unusual phenomena of the planet healing itself as the world halted to a stop. In deed climate change such as extreme temperatures of heat: we have seen 102 Degrees Fahrenheit in Norfolk, VA, USA this summer (2020) alone. Extreme heat can leave people exposed to stroke and heat exhaustion landing them in the hospital. So, as one might imagine people are thrilled to see the positive change in the environment. We have definitely felt the heat and experienced the flood waters here in Norfolk, VA, USA.

We know that COVID 19 remains at the forefront of people’s minds as we wait at the edge of our seats for a cure. While you wait read COVID-19: How to Prevent Getting Infected.

What measures have you and yours taken to stay COVID 19 free? There is so much we still do not know about COVID 19. Have any of your precautions included organic or natural remedies? Do you know of anyone who has tested positive for COVID? 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.

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Too much and never enough!

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Pharma drew a line in the sand over Covid-19 vaccine readiness — because someone had to

By ED SILVERMAN @Pharmalot – Source: Stat News

SEPTEMBER 7, 2020

Talk about a rebuke.

President Trump may want a Covid-19 vaccine to ship in time to boost his reelection chances, but the pharmaceutical industry doesn’t appear ready to cooperate — at least, not on his terms.

In a highly unusual turn of events, nine vaccine makers — including some of the world’s biggest companies — plan to issue their own public pledge not to seek government approval without extensive safety and effectiveness data on Tuesday. This follows a fairly similar open letter the BIO trade group released last week warning any vaccine or therapy should only become available with the same sort of “rigorously considered” data.

These are only words, but right now, these are the words that Trump needs to hear.

After Trump has brazenly and transparently bullied members of his own team — most notably, Food and Drug Administration Commissioner Stephen Hahn — someone has to draw a line in the sand and push back against him.

Get the revealing book Trump’s niece wrote about him. Trumps presidency has been far reaching as his decisions have highly impacted us all via COVID 19. Do you know who is in the Whitehouse? Hear what his niece has to say:

There’s good reason. As we move closer to Nov. 3, vaccine makers are still testing their shots. Yet at a Friday press conference, Trump said a vaccine might be ready “maybe even before Nov. 1” or “sometime in the month of October.”

The vaccine makers that are signing this pledge — Pfizer, Merck, AstraZeneca, Sanofi, GlaxoSmithKline, BioNTech, Johnson & Johnson, Moderna, and Novavax — are rushing to complete clinical trials. But only Pfizer has indicated it may have late-stage results in October, and that’s not a given.

Yet any move by the FDA to greenlight a Covid-19 vaccine without late-stage results will be interpreted as an effort to boost Trump — and rightly so.

Consider Trump’s erratic and selfish remarks. He recently accused the FDA of slowing the vaccine approval process and being part of a “deep state.” No wonder there is concern he may lean on Hahn to authorize emergency use prematurely. For his part, Hahn has insisted he won’t buckle to political pressure, but he also said emergency use may be authorized based on preliminary data.

“It’s unprecedented in my experience that industry would do something like this,” said Ira Loss of Washington Analysis, who tracks pharmaceutical regulatory and legislative matters for investors. “But we’ve experienced unprecedented events since the beginning of Covid-19, starting with the FDA, where the commissioner has proven to be malleable, to be kind, at the foot of the president.”

Remember, we’ve seen this movie before.

Amid criticism of his handling of the pandemic, Trump touted hydroxychloroquine, a decades-old malaria tablet, as a salve and the FDA authorized emergency use. Two weeks ago, he touted convalescent blood plasma as a medical breakthrough, but evidence of its effectiveness against the coronavirus is inconclusive. And Hahn initially overstated study results.

Most Americans seem to be catching on. A STAT-Harris poll released last week found that 78% of the public believes the vaccine approval process is driven by politics, not science. This goes for a majority of Democrats and Republicans.

Poll: Most Americans believe the Covid-19 vaccine approval process is driven by politics, not science

The pharmaceutical industry has to be vocal, though.

Why? The FDA has long been seen as the global gold standard among regulators. No government agency is perfect, but Trump is sadly undermining its credibility. If he keeps this up, it will only make it harder for companies to later point to the FDA as validation for the safety and effectiveness of their products.

This explains why the biotech executives used such pointed phrases as “FDA should maintain its historic independence” and “political considerations should be put aside.” The vaccine makers, however, avoided using any language that might appear confrontational and further provoke Trump. Instead, they underscored a need to “adhere to high scientific and ethical standards.”

Let’s be clear, though. These public pronunciations are not simply altruistic attempts to take the moral high ground. With each tweet and off-the-cuff remark about the vaccine timeline, Trump is eroding whatever confidence the public may have in vaccine makers, which is already questionable as far as some people are concerned.

“The companies are aware that, on a good day, they have trouble selling vaccines to 25% of the country that is suspicious about safety. So the last thing they need is to have Trump pull a stunt and push through a vaccine ahead of its time,” Loss said. “In many ways, the industry is doing a defensive move to ensure they’re not going to have to defend any approval because the president is doing a dance.”

The pharmaceutical industry is keenly aware that its reputation is also at stake as the pandemic becomes more and more politicized.

And simply put, that’s not good for business.

Will you vote on November 3rd? Is it important for the politicians to know you will cast a vote? Do you have questions? Contact your local office of elections. 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.

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True to the Journey

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Moderna’s coronavirus vaccine deal with the U.S., announced last week with a $1.525 billion price tag, would be worth far more if all options are exercised—and if the mRNA biotech meets an aggressive timeline for the shot’s arrival.

The company stands to gain up to a whopping $8.125 billion, according to a Moderna securities filing that details the price for follow-up doses and the windfall for an early FDA approval.

The base agreement calls for 100 million doses of the company’s COVID-19 vaccine candidate, mRNA-1273, for $1.225 billion. But the drugmaker is eligible for a $300 million bonus if it’s able to score an FDA emergency use authorization or full approval by Jan. 31, the filing shows. 

Source: Fierce Pharma

As we get information regarding COVID 19 and on the many companies working on the vaccine, I am reminded of something my supervisor once said “the medical industry is a business like any other business”. A family friend recently shared that she tested positive for COVID 19. We prayed for her and offered her all the information we had about COVID 19. She was grateful, yet she stated that she would be seeking natural means for recovering from COVID 19. In the midst of a global pandemic it is easy to seek out the quickest solutions. She reminds us that through it all it is important to stay true to the ‘Organic Journey’. It is true in gardening and true with health. It may seem easier and quicker to grab the nearest chemical or drug for a solution. But, in our Organic Journey we have learned to first ask “what is the Organic Remedy to this problem. Who do you know that has been impacted by COVID 19? How has your family been impacted? How has your ability to work been impacted? 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!

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Wireless Medical Devices

Wireless Medical Devices
Shidonna Raven Garden and Cook

One thing we know about the FDA is that its board of medical professionals (often with unreported conflicting relations) are often too quick to push drugs and medical devices onto the market. Often they have financial incentives that encourage them to get these drugs and devices on the market fast, which is why we often see recalls. When a drug and device is not properly tested, it brings clinical trails to the unknowing public who become tests subjects. The FDA is this not proactive but reactive in dealing with things that people often spend years complaining about. Indeed these complaints are often made by thousands upon thousands of people.

The question is, should we just because we can? Are we ready for this level of technology? Do we know all the risks or are we the test subjects? Many people eat GMOs (genetically modified organisms) without knowing it. The results are still out on the impact of GMOs on the public and environment. In fact many people do not even know what GMOs are. Share your comments with the community by positing them below. Share the wealth of healthy 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!

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Hackable Devices and Dick Chaney

Dick Chaney – Hackable Medical Devices
Shidonna Raven Garden and Cook

Medical devices are becoming increasingly prevalent. Many products or medical devices are rushed to market or pass through loop holes created by the medical professionals who sit on the FDA board with a host of conflicting relationships they conveniently fail to report. As those in the medical profession say “that is what we do for each other”. Do you or someone you know have a medical device? Do you know of anyone who has had a device hacked? Do you think the FDA should be overhauled to serve the public rather than the medical industry? 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 you know. 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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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.

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The Industry

The Pharmaceutical Industry
Source: Top Documentary Films
Shidonna Raven Garden and Cook

While this documentary focuses on one medical profession, it gives insight into the medical and pharmaceutical industry as well as the FDA, the government agency responsible for approving the drugs on the market today. Read our article “Oh Baby!” to learn more about diet and health. What did you learn after watching this film? How has it changed the way you look at the medicines you take? How has it changed the way you look at your health? How has it changed the way you look at your diet? How has it changed the way you view and choose medical professionals? As always you are the best part of what we do. Stay healthy and 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.

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