John Waters Reflects on ‘Pink Flamingo’ and ‘Liarmouth’ – AARP

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Happy 50th birthday,Pink Flamingos. Director John Waters, 76, is enjoying theonce-shocking films newfound respectability acceptance last year into the National Film Registry, alongside Casablanca andCitizen Kane, and itsnew Criterion 4K restoration. And hes also making news for the release of his recent novel, Liarmouth, andtheThe Pope of Trash,a major exhibition coming next year to the new Academy Museum of Motion Pictures in Los Angeles.In fact, Waters is moderately shocked at trading notoriety for mainstream adoration at this stage in the game.

The nattily dressed so-called Pope of Trash (aka Duke of Dirt and Prince of Puke) told AARP all about it during Massachusetts Provincetown International Film Festival, which showcased the still shockingPink Flamingos, a tale of murderous Baltimore mayhem starring the legendary late drag queen Divine. His reaction to his new respectability is bemused, considering that the film is probably worse than its ever been, in todays standards.

While its wonderful to be considered the elder statesman of filth, Waters is genuinely moved. Im greatly honored that all these things have happened with no irony. But the movie itself with all of todays political correctness and everybody being so touchy about everything is probably even more hideous than it ever was. Hes been touring with the film, where the audience is the youngest its ever been, he says. He often asks: How many people here are seeing it for the first time? More than half always raise their hands.

Divine stars in "Pink Flamingos."

Courtesy Everett Collection

Waters finds this and the fact that the movie still plays to an audience amazing in a good way. Pink Flamingoswasnt ever supposed to just shock. It was supposed to make you shocked and to make you laugh about it. And people still do laugh.

Although it may sometimes feel that the movie rose out of the 1970s pop cultural ooze, like Venus from her shell, the filmmaker says he was influenced by art films and, because they broke all the censorship laws, by Federico Fellini and Ingmar Bergman and all that. And by underground movies like those of Andy Warhol. I made exploitation films for art theaters. Thats what mine were, and they still are.

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John Waters Reflects on 'Pink Flamingo' and 'Liarmouth' - AARP

From the Land of Oz: An Aussie-Born US Citizen Explains Why It’s Important to Teach Kids to Love Their Country – The Epoch Times

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An Australian-born naturalized citizen is determined to teach American youth how to love their country

From sea to shining sea, the greatness of the United States of America has been seen in gleaming alabaster cities, purple mountain majesties, fruited plains, and waves of grain for over two centuries. The sacrifices of everyday heroes, whose engraved names mark monuments and tombstones, have enriched the greatness of this nation since before the Revolutionary War. Yet still today, there are patriotic citizens pledging allegiance every day as Old Glory waves in the wind at sports events, corporate offices, city streets, front porches, or flagpoles.

American flags are everywhere. You have to hunt to find the flag in Germany or Australia. Thats not the case here; it is omnipresent!

Coming from a perspective of deep respect, admiration, and appreciation, naturalized citizen Nick Adams speaks as one of the many thousands of legal immigrants who arrive on Americas shores ready to make good on their personal dreams of success.

He believes the United States is considered the most patriotic country in the world.

Adams, who legally immigrated from Australia in 2016, sought citizenship in a land of best opportunity. Though his journey through the system was arduous, his American dream had only begun. His garage, in fact, helped set the stage for todays booming educational, patriotic enterprise, which brings civic-centric programming to American youth through FLAG, or the Foundation for Liberty and American Greatness.

What we do resonates with donors who share a concern for the direction of the country and a frustration that civics isnt being taught anymore, said Adams. We want every young American to tie their personal dreams to love of country. We see that as the answer to the increasing lack of patriotic pride in our youth.

FLAGs mission helps students build upon fundamental civic knowledge and understand their role as active citizens. Adams founded the nonprofit; his dream is gaining momentum as parents and educators embrace his efforts to re-educate children in a system that no longer teaches civics effectively, if at all, in the classroom.

Adamss own success reverberates in the classroom. With a craft for storytelling, he tells young Americans of his journey to becoming a citizen, how he overcame stage 4 cancer, how he became a presidential appointee for the Wilson Center, how he wrote best-selling books, and how he lives out the American dream as a motivational speaker and television commentator.

With a $2 million budget, Adamss 100 percent non-political organization aspires and inspires, he said, through passion that energizes schoolchildren.

Patriotism requires passion. Through amplifying the voices of legal immigrants and capturing the hearts and minds of young Americans, we are successfully showing them how to appreciate the American opportunity.

His presentations have a three-fold mission: to rally against socialism and preserve the American way of life, to fight the false narrative that paints a picture of America as a terrible country, and to teach the foundations of civics to young Americans.

With infectious enthusiasm, Adams projects continued rising demand for his organizations resources and seminars. Testimonials from students and staff flood FLAGs headquarters, The Andrew Adamopoulos Logistics Center, named after Adamss father, in Tarpon Springs, Florida. Depending on the grade and emphasis, presentations cover Americas founding and U.S. Constitution, the U.S. immigration system, and Entrepreneurship 101. Certified FLAG ambassadors, including Adams himself, introduce live, engaging historical content in a way that reignites childrens enthusiasm at all grade levels on campuses across the country.

In modern America, there are Americans who truly remember what patriotism was and is. However, he added, there are younger Americans who have a different idea of what it means to be patriotic.

In fact, FLAGs Patriotism Study conducted just a few years ago found that younger citizens are losing the American spirit. It confirms Adamss reason for founding the organization. As stated in the study: Americans ages 1437 are less likely to consider themselves American patriots, less likely to aspire to entrepreneurship, and less aware of the inalienable rights enshrined in the Constitution.

From a grassroots level, educators welcome visits from the FLAG team but also extend learning through lesson plans, professional development, and student-friendly versions of the U.S. Constitution, the Declaration of Independence, and the Federalist Papers.

When Adams introduces the idea of civics at a school or youth gathering, he asks students what makes the United States Constitution so special. The typical answer, he said, is freedom.

And then I ask if the United States is the only country that has a constitution. It is the greatest document ever written! It is because every single time any other country or government or people have attempted to write and pass a constitution, it has always laid out powers of government and the limits of the people. The United States Constitution gives us the opposite, stating the powers of the individual and the limits of the government. This is why American exceptionalism is so great!

With just over 1 million students served since FLAGs inception, the impassioned founder plans to pivot with extended outreach of FLAGs pilot programming in 2022.

The 21st century is the American century, he said. And with the launch of his new vision, 2076 Project, his goal is to help preserve America and celebrate its 300th birthday. The best way to do this, he said, is to combat critical race theory, teach Americanism, promote the American dream to future generations, and celebrate 300 years as the freest country in the world.

The projects details were still under wraps at the time of the interview, but Adams noted that the lack of true patriotism can be linked to a cultural mindset.

There is a widespread war against patriotism through political correctness doctrines. We cannot have confidence to say, America is great!

He emphasizes the fact that true patriotism requires an opinion in order to protect America.

Patriotism is a love of country and is one of the most understated and wrongly defamed virtues that we have. Patriotism got the wrong wrap following the world wars in the 20th century in that patriotism was blamed for the atrocities caused by war. It is easier to blame patriotism than it is to blame evil. But they got it wrong.

Where FLAG gets it right is to encourage citizens at the early levels, giving them an appreciation for Americas values and important documents through patriotic messaging.

No other resource on the market, he said, has been as effective at reaching hearts and minds and sharing the greatness of this nation. It helps that the messenger is very grateful to live the American dream with opportunities that abound. The happy warrior plans to instill an appreciation for Americas greatness in younger generations, hopefully beyond 2076 and the anniversary of this countrys founding.

Thats if the all-natural patriot can continue helping his country from sea to shining sea.

This article was originally published in American Essence magazine.

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From the Land of Oz: An Aussie-Born US Citizen Explains Why It's Important to Teach Kids to Love Their Country - The Epoch Times

Transhumanism: The Evil Force Behind the New World Order Jonathan …

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When one goes to Hararis official website (https://www.ynharari.com), one immediately sees this quote on the home page, History began when humans invented gods, and will end when humans become gods.

Leo Hohmann also wrote the following quote concerning Harari from his interview with Patrick Wood, editor in chief at Technocracy News and Trends. Not only is Harari the key advisor to the head of the WEF, he has millions of devoted followers.

He is your model transhumanist who thinks he can become god, Wood told me. He is the chief philosophical adviser to the World Economic Forum and one of the premiere authorities in WEF circles. They just hang on his every word. (quote from Patrick Wood)

The level of evil we are dealing with here is so intense that most Christians and conservatives have no idea how deep it goes and will frankly have trouble believing it. No politician is going to be able to save us from this evil, only Jesus Christ.

Another thing worth noting is that Harari is not only tied in with Schwab. He has a large following among Western elites. One of Hararis admirers is Barack Obama, the man who has the ear of Joe Biden. In fact, Obama has called Harari his favorite author.[ii]

Yuval Noah Harari is the man behind the curtain. Hes the driving force behind transhumanism, a key component of Schwabs Great Reset.

The elite regard transhumanism as the next step in the human evolutionary process. While all the other development advancements happened to us, they say, now we get to have a say in the future enhancements of our race. The combining of humans with machines is but another step in the continuing evolutionary progression of mankind.

Transhumanists are avid atheists who see themselves as aiding the evolution of humanity.

Do not let the proponents of the NWO or the Great Reset deceive you; they all accept transhumanism is an essential step to convince people of the need for world governance. Some of these globalists may profess a belief in God or allegiance to a church, but they are lying. They are all staunch atheists who reject all that Scripture says about creation, especially Genesis 1:27, God created man in his own image.

If there is one verse to keep in mind when thinking about the transhumanists, its John 8:44. In this verse, Jesus is confronting the Jews who opposed Him:

You are of your father the devil, and your will is to do your father's desires. He was a murderer from the beginning, and does not stand in the truth, because there is no truth in him. When he lies, he speaks out of his own character, for he is a liar and the father of lies.

The proponents of the NWO are all Luciferian transhumanists that lack all respect for human life. They have already deceived a great many people with their lies.

Here are some quotes from Yuval Noah Harari that I took from interview clips Jan Markells bi-monthly Understanding the Times conference in Minneapolis on April 21, 2022. This event also featured Pastor Brandon Holthaus and Pastor Mark Henry. In these videos we watched Harari say the following:

Humans are now hackable animals that will be re-engineered.

Previously, government surveillance was above the skin, now its going under the skin.

The free will to choose who we vote for or what we buy in the supermarket, human free will, Thats over! (my emphasis)

Can you see the devaluation of human life bubbling to the top in these quotes? Previously, I have written at length about how we see this in abortion, infanticide, and the war in Ukraine. Now with Harari, we see the same murderous agenda and deception that Jesus talked about in John 8:44.

The transhumanists see us as hackable animals that they hope to enslave and totally control.

Harari also said this, which at first seems contradictory to his other declarations:

Humans are acquiring divine powers . . . and the power to re-engineer life.

So yes, he says that humans are acquiring divine powers, but perhaps its only for those in power rather than those that the elite hope to control. Transhumanism is about the masses worshipping them as gods. Is this not preparing the world for the coming man of lawlessness that Paul wrote about in 2 Thessalonians 2:3-4?

Let no one deceive you in any way. For that day will not come, unless the rebellion comes first, and the man of lawlessness is revealed, the son of destruction, who opposes and exalts himself against every so-called god or object of worship, so that he takes his seat in the temple of God, proclaiming himself to be God.

The spirit of the antichrist is alive and well in Harari. In one of the interviews that I referenced earlier, Harari referred to Jesus resurrection from the dead and His claim to be the Son of God as fake news.

Leo Hohmann is correct, we are dealing with a force thats far more evil, and I might add deadlier, than anything we can imagine. Jesus is our only hope for the time in which we live.

The Luciferian globalists are far along in their plans to bring about the NWO. It does not matter what the majority of people want, they have the power necessary to assert their control over our will. This happened with 2020 Presidential Election in America. It happened in 2021 with vaccine mandates that resulted in the deaths of a great many people. The riots that took place all through Paris on April 24, 2022, were in response to the reelection of Emanuel Macron, who many Parisians did not believe really won the election.

Once the elite put digital currencies in place across the world, it will be game over. They will have the control they need to begin tightening their stranglehold on humanity, which will lead to the beast government of the Tribulation period. As Harari stated as the goal of transhumanism, the will of the people no longer matters, thats over!

Now for the good news, the future tense of the Gospel: Scripture assures us that Jesus is coming to take us home to heaven before Gods wrath falls on this evil Christ-rejecting world (2 Thessalonians 5:1-11). We will be out of here long before the antichrist exerts his control over the coming NWO.

In contrast to what the world tells us is fake news, we indeed serve a risen Savior whose words are true and certain. He is the true Son of God and Hes coming very soon to take us to the place Hes preparing for us (John 14:2-3). We can be absolutely certain of this.

Our hope rests on a sure foundation: Jesus!!

If you desire greater confidence regarding the pretribulation Rapture, please consider purchasing my book, The Triumph of the Redeemed-An eternal Perspective that Calms Our Fears in Perilous Times. I spent over a thousand hours studying and researching the basis for our imminent hope so I could present a solid, biblical case for the pretribulation Rapture. You can find my book on Amazon. Thanks!!

Never forget: Jesus imminent appearing to take us home is the solid foundation of our hope in these perilous times.

Jonathan C. Brentner

Website: Our Journey Home

[i] Leo Hohmann, Klaus Schwabs puppet Young Global Leaders revealed Trudeau in Canada, Buttigieg in U.S., Macron in France, and many more, on his blog @ https://leohohmann.com/2022/02/10/klaus-schwabs-puppet-young-global-leaders-revealed-trudeau-in-canada-buttigieg-in-u-s-macron-in-france-and-many-more/#more-8956

[ii] Leo Hohmann, Who influences the influencers? Meet Klaus Schwabs chief adviser, March 15, 2022 on His blog.

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Transhumanism: The Evil Force Behind the New World Order Jonathan ...

Complementary and Alternative Medicine (CAM) – NCI

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Complementary and alternative medicine includes practices such as massage, acupuncture, tai chi, and drinking green tea.

Credit: iStock

Complementary and alternative medicine (CAM) is the term for medical products and practices that are not part of standard medical care. People with cancer may use CAM to

Integrative medicine is an approach to medical care that combines conventional medicine with CAM practices that have shown through science to be safe and effective. This approach often stresses thepatient's preferences, and it attempts to address the mental, physical, and spiritual aspects of health.

Conventional medicineis a system in which health professionals who hold an M.D. (medical doctor) or D.O. (doctor of osteopathy) degree treat symptoms and diseases using drugs, radiation, or surgery. It is also practiced by other health professionals, such as nurses, pharmacists, physician assistants, and therapists. Itmay also be called allopathic medicine,biomedicine, Western, mainstream, or orthodox medicine. Some conventional medical care practitioners are also practitioners of CAM.

Standard medical careis treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals. Also called best practice, standard of care, and standard therapy.

Complementary medicine is used along with standard medical treatmentbut isnot considered by itself to be standard treatment.One example is using acupuncture to help lessen some side effects of cancer treatment.Less research has been done for most types of complementary medicine.

Alternative medicine is used instead of standard medical treatment. One example is using a special diet to treat cancer instead of cancer drugs that are prescribed by an oncologist. Less research has been done for most types of alternative medicine.

For details about specific CAM therapies, NCI provides evidence-based Physician Data Query (PDQ) information for many CAM therapies in versions for both the patient and health professional.

Scientists learn about CAM therapies every day, but there is still more to learn. This list is meant to be an introduction to what types of CAM are practiced, not an endorsement.Some of the therapies listed below still need more research to prove that they can be helpful. If you have cancer, youshould discuss yourthoughts about using CAM with yourhealth care provider before using the therapies listed below.

People may use the term "natural," "holistic," "home remedy," or "Eastern Medicine" to refer to CAM. However, experts often use five categories to describe it. These are listed below with examples for each.

These combine mental focus, breathing, and body movements to help relax the body and mind. Some examples are

This type of CAM uses things found in nature. Some examples are

These are based on working with one ormore parts of the body. Some examples are

Energy healing is based on the belief that a vital energy flows through the body. The goal is to balance the energy flow in the patient. There's not enough evidence to support the existence of energy fields. However, there are no harmful effects in using these approaches. Some examples are

These are healing systems and beliefs that have evolved over time in different cultures and parts of the world. Some examples are

Some CAM therapies have undergone careful evaluation and have been found to be generally safe and effective. These include acupuncture, yoga, and meditation to name a few. However, there are others that do not work, may be harmful, or could interactnegativelywith your medicines.

CAM therapies include a wide variety of botanicals and nutritional products, such as herbal and dietary supplements,and vitamins. These products do not have to be approved by the Food and Drug Administration (FDA) before being sold to the public. Also, a prescription isn't needed to buy them. Therefore, it's up to you to decide what's best for you. Some tips to keep in mind are below.

It's always important for you to have a healthy diet, but especially now. Do the best you can to have a well-rounded approach, eating a variety of foods that are good for you. For advice about eating during and after cancer treatment, see the NCI booklet, Eating Hints.

Cancer patients who want to use CAM should talk with their doctor or nurse. This is an important step because things that seem safe could be harmful or even interfere with your cancer treatment. It's also a good idea to learn if the therapy you're thinking about has been proven to do what it claims to do. Examples of questions to ask are below.

What types of CAM therapies might help me

Don't be afraid to ask questions.It's okay to feel hesitant when asking about using CAM. But doctors want to know what concerns you have so they can give you the best possible care. Let them know that you would like to use CAM methods and want their input.

NCI and the National Center for Complementary and Integrative Health (NCCIH) are currently sponsoring or cosponsoringclinical trials that test CAM treatments and therapies in people. Some study the effects of complementary approaches used in addition to conventional treatments, and some compare alternative therapies with conventional treatments. You can find a list of all cancer CAM clinical trialshere.

Lifelines: Complementary and Alternative Medicine

Dr. Jeffrey D. White, OCCAM Director, explains the use of complementary and alternative medicine in cancer.

Patients, their families, and their health care providers can learn about CAM therapies and practitioners from the following government agencies:

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Complementary and Alternative Medicine (CAM) - NCI

Benefits of Alternative Medicine – Everglades University

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Alternative medicine has been playing a large role in the healing industry for centuries and its popularity is showing no sign of slowing down.

The numerous benefits directly linked with alternative or natural medicine has created a wave of interest, especially in the western world, that seems to continue to grow at a rapid rate.

Alternative medicine includes a range of treatments that, while considered unorthodox, have various advantages that many modern forms of medicine simply cannot achieve.

Due to its practices being generally not accepted as a traditional or standard approach in the medical field, alternative medicine consistently receives criticism and backlash for being backwards and unreliable.

Unfortunately natural medicine is also commonly associated as a remedy that is only used by those who are unable to afford modern treatment despite the countless studies focused on the subject that say otherwise.

One study, for example, found that majority of individuals who use alternative medicine use it because they find these health care alternatives to be more congruent with their own values, beliefs, and philosophical orientations toward health and life says the Jama Network.

There is no denying the substantial difference between a standard hospital room with sophisticated tools and equipment and an acupuncture table where needles are inserted into specific points of the body to help cure ailments such as depression or anxiety.

Just because the former is considered superior doesnt mean the latter isnt as effective.

There are several common forms and their benefits of alternative medicine are extraordinary and have been helping people in need for hundreds of years. Lets take a look.

An extremely popular form of alternative medicine, acupuncture has helped millions of Americans with its use of needles and/or electric stimulation and is even used by licensed physicians who say it has increased success in treating problems that often resist Western medicine, such as female sexual dysfunction.

This ancient Chinese technique has been tested with case-controlled clinical studies and has shown that acupuncture can successfully help cure illnesses such as:

Herbal medicine is tailored around the use of plants, roots, berries, and leaves and is utilized to employ the bodys natural healing capabilities.

This technique has not only been around for thousands of years but it has also been known to help cure conditions such as heart problems, skin rashes, chronic fatigue, and premenstrual cycle, obesity and more.

There are about four billion people (80% of the worlds population) who are currently using herbal medication treatment as their primary health care further proving the benefits of alternative medicine.

Similar to acupuncture, acupressure therapists use their feet, hands and elbows to focus on the pressure points of the bodys meridians or channels of the body instead of needles.

Meridians are believed to be the invisible channels that carries the flow of energy, or chi, that connects all parts of your body and acts as a passageway for communication between your vital organs.

The theory goes that when one of these meridians is blocked or out of balance, illness can occur according to WebMD.

Acupressure has been known to relieve anxiety for individuals who are about to endure surgery and nausea for those are in the process of chemotherapy. Acupressure also helps those dealing with motion sickness and sickness from pregnancy.

Generally referred more as a complementary medicine as opposed to alternative due to its wider range of acceptance, chiropractic is constantly used to help develop strong bones and healthy surrounding muscles.

Chiropractors focus on manipulating the spinal cord with force exerted from their hands to realign and ensure proper form in regards to the spine.

They focus on the direct relationship between the nervous system and the spine to reduce pain in the lower back or neck. It also helps headaches, joint pain and high blood pressure.

Alternative medicine has helped people for hundreds of years and will continue to help people for years to come.

Prices for modern medicine are skyrocketing and there are countless cases of people finding help and relief from alternative medicine.

Alternative medicine works to find the core of the problem and takes a different route than most are used to.

With so many countless benefits of alternative medicine it only makes sense that we offer a degree program that specializes in the teaching and preparation for entry-level careers in the respected field as we understand and recognize the unlimited potential.

If youre interested in learning more about our degree with a Major in Alternative Medicine do not hesitate to reach out to Request More Information.

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Benefits of Alternative Medicine - Everglades University

Dangerous herbal abortion misinformation is thriving on WitchTok – Input

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Katy Willis grew up in a witchcraft-friendly home. Her mother is an ancestral medicine practitioner and Reiki master, and Willis inherited her moms talents for spiritual practices like energy healing, tarot reading, and spell work.

The 24-year-old Willis, who lives in small-town Ohio, deepened her practice by traveling to Mexico in 2021, where she learned about herbalism from an expert, drinking different teas designed to help her with ailments like period cramps. Needless to say, shes no stranger to the benefits of alternative medicine.

Willis passion for herbs and magic led her to TikTok, where there is a thriving witchcraft culture. (Hashtags like #witch, #witchcraft, and #witchtok have amassed more than 100 billion views total.) I know theres some people who do this for the aesthetic its definitely trendy, says Willis, who has 123,000 followers on her TikTok account, @amidnightwitch.

I think TikTok really intrigued people to learn more about how witchcraft works, she continues, and I do believe the majority of people practicing witchcraft believe in it.

This belief, it turns out, could be putting people with uteruses in danger. The Supreme Courts recent ruling revoking the landmark abortion rights decision Roe v. Wade left many people who can get pregnant scrambling for resources and aid as abortion was effectively outlawed in large parts of the U.S. Willis observed many people turning to WitchTok. And she was horrified when she saw the advice on offer.

I don't know a whole lot about how to make teas or medicine or any of the sorts, but I am educated enough to know whats harmful, says Willis. There's a lot of misinformation going on about how to use herbs as an abortion [method]. That can be extremely harmful to people and their health.

Willis is one of several creators who has raised the alarm about herbal abortions, which are going viral on TikTok. Videos published since the high courts June 24 decision which offer advice about using herbs like mugwort, cinnamon, feverfew, and papaya seeds as alternatives to medical abortions have been viewed hundreds of thousands of times, and more are appearing on the platform each day.

Onlookers and medical professionals are worried that such misinformation could do more harm than good, putting pregnant people at risk by endangering their lives or leading them away from resources that could help them.

According to herbalists and witches who are active on TikTok, the spread of misinformation about herbal abortions can be traced back to last falls SB8 ruling in Texas, when concerns about the sanctity of Roe v. Wade were raised by women across the U.S. One of the more recent videos which gave recommended doses of papaya seeds, goji berries, black cohosh, chamomile tea, evening primrose oil, and mugwort as DIY abortifacients has been viewed over one million times since it was published on May 4.

I noticed it about that time, and it kind of died out very quickly, says Shawna Bynum, a 41-year-old community herbalist and apothecary owner from Texas who has more than 21,000 followers on her TikTok account, @livingearthherbology. The videos began to spread again when the high courts draft decision was leaked. It was a bombardment of misinformation, and it hasnt really stopped since then, Bynum says.

Medical practitioners echo Bynums concerns. [Herbal abortions] are only partially effective, and theres no accurate data about how effective they are. The only effective methods are the abortion pill or surgical termination, says Dr. Adeeti Gupta, a New York City-based OBGYN and founder of the walk-in womens health center group Walk In GYN Care.

I would strongly recommend against them, Gupta adds. Even if its in early pregnancy, it can lead to heavy bleeding, infection, and death. Every abortion procedure should be supervised by a trained medical provider.

Bynum has noticed many of the videos are published by new witches and self-taught herbalists, who are often under the age of 25 and their videos have been so successful that, as an expert herbalist, shes been inundated with questions about abortifacient herbs.

The last couple of days, Ive gotten a couple hundred emails asking for more information. Im like, This is not the time to fuck around and find out if these herbs are going to work, says Bynum, who has posted warnings on her own TikTok page about the dangers of such practices.

Although she understands that TikTok witches are trying to help, she stresses that they are hurting their followers. The kneejerk reaction is to try and be a helper, she says. But its more detrimental than helpful.

Willis is concerned many TikTokers are creating these videos to rack up views, without recognizing the damage they could do. I feel like a lot of people do it for clickbait or clout, and they dont understand the harm that it could bring. Theres so many young, naive women watching these videos and saving them for later, she says.

Willis has been combating misinformation as far back as May by amplifying videos that outline why abortifacient herbs dont work. After all, shes seen the damage they can do IRL. I had a friend who went through a herbal abortion. She took advice through someone she met on TikTok, and she went through two weeks of hell, Willis says. It worked, but its a one in a million chance.

Of course, not everyone believes that distributing this information is a bad thing. I saw people werent talking about some of the herbs I knew about, and not every video hits everyones For You page. So I thought if I also made a video, more people would be able to see them, says Lauren Blosser, a 26-year-old nursing student from Michigan with 12,600 followers on her TikTok account, @ahobbitgrandma.

Her video of herbs you should not look up if you dont want to have a miscarriage a tongue-in-cheek way of distributing information about abortifacients in which Blosser winks at the camera has been viewed over 300,000 times since she published it in 2020. I tried to make it easy to digest, so women could research it themselves, she says. Obviously, you shouldnt make a decision based on TikTok.

Lauren BlosserLauren Blosser

Shes seen her video gaining more traction in the wake of the Roe v. Wade ruling. Im still getting likes. Im glad people are still seeing it, says Blosser, who tells Input that she is not an herbalist and based her video on her own research. Ive definitely noticed more people duetting, commenting, and sharing it.

Willis says that many videos like the one Blosser has produced are rife with misinformation and dangerous recommendations. Ive seen people recommend herbs that are poisonous. Its just like, Yeah, itll kill your child thats in your womb, 100 percent. But its also going to cause all these other issues that could lead to your own death, she says.

She points to pennyroyal, a herb often recommended on TikTok as an abortifacient, which can cause damage to a persons liver and kidneys. I don't think people think about that, Willis says. Its really insane how much these videos get normalized and popularized.

Bynum knows these videos often find women when they are in a desperate position and wants them to recognize that modern medicine exists for a reason. There was a time when your only option was herbal medicine, so thats what people used. At the same time, lets be real: Women died, or it was unsuccessful, and babies were born with birth defects, she says.

The most likely thing thats going to happen is people will get go sick theyll need to see a doctor, she continues. And then, with mandatory reporting, theyll be arrested for attempted murder.

Blosser, meanwhile, has a different point of view. I dont believe everything should just be straight-up Western medicine, she says. Women have been using these herbs for centuries. Its an important tool to have in your belt like, better safe than sorry if it came down to it. I couldnt tell someone how much to go out and consume. But I think I can plant that seed of knowledge.

Medical professionals wish users like Blosser wouldnt go around planting their seeds of knowledge. Dr. Meera Shah, chief medical officer of Planned Parenthood Hudson Peconic in New York State, tells Input that herbal treatments are ineffective methods of abortion and urges people considering them to pursue proper medical care.

People in need of abortion can contact their local Planned Parenthood health center to discuss safe and legal options with a trained healthcare professional, she says. Plan C has more information about the difference between getting an abortion from a doctor or nurse and a self-managed abortion, including legal considerations.

Both Willis and Bynum are firmly on the side of the doctors who condemn herbal abortion treatments, and they are trying their best to amplify the work of content creators who advise against such practices. Since the courts decision, Willis has reposted videos about deleting period-tracking app data and finding local protests in favor of abortion rights.

My hope is that people really just get that message: Lets focus more on whats actually helpful, Willis says, rather than taking the risk of something that might end your life.

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Dangerous herbal abortion misinformation is thriving on WitchTok - Input

Great Huts to host Wellness Day in Portland this Saturday – Jamaica Observer

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Great Huts' Wellness Day will feature wellness practitioners sharing ancient wisdom and healing practices at various locations of the resorts picturesque cliffside property in Portland.

PORTLAND, Jamaica Great Huts will host its Wellness Day in Portland on Saturday, July 2, featuring an array of wellness practitioners sharing ancient wisdom and healing practices at various locations of the resorts picturesque cliffside property.

Our objective is to help Jamaicans and visitors alike heal by sharing traditional knowledge and supporting patrons on their own individual health journey. It is of tremendous benefit to our bodies, mind and spirits to immerse in nature, which makes this unique experience so incredible and why we are making it easy to travel to Portland with transport included as an option, said Vivene Levison, Managing Partner of the resort, in a press release.

Dubbed A celebration of body mind and spirit, the wellness day begins with yin yoga on the Great Huts beach with African trained Sky Barrett at 10 am followed by Learn the Fundamentals of Ayurveda; Ancient Science of Life with Dr Anjali Talcherkar.

The release stated that Ayurveda is one of the worlds oldest holistic healing systems and heavily practiced in Nepal and India where over 80 per cent of the population report using it, according to Wikipedia.

Patrons are encouraged to learn more from lead speaker Anjali who holds a doctorate in integrative medicine and a master's degree in psychology. Her focus is in the area of complementary and alternative medicine (CAM) in mental health, combining Eastern medicine and breath-based, yogic practices with traditional interventions, the release added.

The next workshop that follows is entitled Cultivating your Auric Field featuring Paula Hurlock, Covenor of Wellness Experience Jamaica, a consortium of practitioners.

Jamaica is home to over 80 per cent of the planets healing herbs. We share, endorse and validate ancestral wisdom and traditional Jamaican remedies. We believe that there is a knowledge gap and it is their hope that this platform will assist in sharing vital information for our population. But the average millenial or city dweller do not know the herbs our grandmothers used to heal the family, Hurlock said.

The days wraps up with a Tea Time Meditation with Usui Reiki Master Deanna Thomas.

Transportation is being offered from the Jamaica Pegasus in Kingston to Portland and back. The scheduled pick up at Jamaica Pegasus is at 7:30 am Saturday.

The days activities including the yoga, workshops, vegan lunch and Tea Time Meditation with transport cost J$13,500.

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Great Huts to host Wellness Day in Portland this Saturday - Jamaica Observer

Why Your Pain Happens, and What the Future of Alternative Pain Relief Really Looks Like in the Opioid Crisis – Prevention Magazine

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Lets talk about what pain is, exactly. You know its an uncomfortable physical feeling, but its actually much more than that. In fact, the International Association for the Study of Pain (IASP) defines pain as an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage. The IASP goes on to point out that the lived feeling of pain is shaped by biological, psychological, and social factors, so your version of pain will always be different from that of your spouse or siblinga sensation you describe as merely annoying could have them reeling in agony.

As, well, painful as it may be, though, pain does serve a purpose. Pain is fundamentally our harm alarm, says Sean Mackey, M.D., Ph.D., a professor and chief of the Stanford Division of Pain Medicine in Palo Alto, CA. It is an experience that keeps us out of danger. Pain is an incredibly wonderful thing when its working correctly. The problem, of course, is that it doesnt always. Lets say you break your arm. In a healthy scenario, pain signals travel from the injury site through your spinal cord to your brain to let you know that you need care and you probably shouldnt repeat whatever behavior led to the fracture. But if theres a kink in that pain-perception system, the pain could become chronic, lasting long after the wound has healeda mystery researchers are trying to untangle.

Theres a bit of controversy over the nature of chronic pain and how it evolves, says Dr. Mackey. One theory, he says, is that after an injury like that broken arm, signals get rewired in the brain to perpetuate the experience of pain even though the original pain stimulus is gone. Another theory posits that after an injury, low-grade pain signals continue to travel to your spinal cord and brain, but its as if an amplifier has been installedyour brain interprets the signals to be more intense than they are.

Because so much is unknown about the mechanisms behind chronic pain, it can be difficult to treat. For acute pain like that of a headache or a broken arm, you might take acetaminophen or a nonsteroidal anti-inflammatory (NSAID) like ibuprofen, both of which are non-opioid analgesics that decrease the production of painful mediators called prostaglandins, says Anuj Malhotra, M.D., assistant director of the Pain Management Division at the Hospital for Special Surgery in New York City.

What causes chronic pain, though, is sometimes completely different, so the same treatments may not work. You dont have the same responsiveness to those medications, or they may become less safe in certain patient populations with longer-term use, says Dr. Malhotra. For instance, too much acetaminophen can lead to liver damage, while overusing NSAIDs can put you at risk for digestive problems, kidney damage, and bleeding.

Thats why scientists are constantly searching for innovative treatments for chronic pain. Consider this: Research shows that an estimated 20% of U.S. adults (about 50 million people) have chronic pain, and 8% struggle with high-impact chronic pain (pain that has lasted three months or longer and is accompanied by at least one major activity restriction). For those with high-impact chronic pain, it can be hard to move, work, sleep, socialize, get dressed, or bathe, says Mary Driscoll, Ph.D., an assistant professor of psychiatry and a research psychologist at Yale School of Medicine in New Haven, CT. And when people have pain, theres rarely a reprieve, so it may get better or worse, but its always there.

That physical stress can have emotional effects as well, she says: It can prompt people to become socially isolated or challenge their sense of self. It can also perpetuate fears of injury or disability and elicit feelings of helplessness, anger, and frustrationand contribute to things like depression and avoidance of activity. On top of all that, chronic pain is invisible to those around the sufferer, which makes it hard for others to understand and often leads people in pain to feel stigmatized. Its no wonder sufferers may try anything to get relief.

In the late 1990s and early 2000s, when Purdue Pharma sent sales reps all over the country claiming that its new opioid, OxyContin, was effective at treating pain and had a low risk of addiction, physicians and patients were desperate to believe it. Twenty years later, opioids are still causing harmand driving the news. In September, a settlement between Purdue Pharma and thousands of state, local, and tribal governments was approved by a bankruptcy judge, then unraveled by a federal judge. In October, Hulu launched its popular drama series Dopesick, inspired by real investigations into OxyContins deceptive marketing. Finally, in November, a report from the CDCs National Center for Health Statistics declared that the number of annual deaths related to drug overdoses topped 100,000 for the first time in 2021and 75% of those were linked to opioids.

The OxyContin saga is complicated, involving failures of government oversight and accusations of greed and lies, but the upshot for patients is that even though people didnt think they would become addicted, many did. Opioids cover pain regardless of the source, but they dont treat the cause of the pain, explains Dr. Malhotra. With no way to address the pain trigger, he says, your body gets used to the medication, so youre going to need a higher dose in order to get the same results. With a higher dose come more side effects and the potential for overdose or addiction, he adds. Indeed, research has long shown that taking opioids for chronic pain increases the chances of addiction.

Pain specialists and researchers have been consumed with the aftermath of the opioid epidemic, but the solution isnt as simple as no longer prescribing them. There was abuse, but as doctors attempted to restrict access, pain patients who were doing well on opioids found themselves forcefully tapered and accused of being addicts, says Dr. Mackey. On the other hand, theres a greater awareness that physicians were prescribing, in general, too many opioids, he says. As clinicians, we needed to reevaluate for whom we were prescribing opioids and in what circumstances and recognize that in most cases, opioids are not a first-line treatment for chronic pain.

If theres a silver lining to the opioid epidemic, its that it brought greater attention to innovative and non-pharmacological treatments. Physicians are having more conversations with patients about alternative options, for which insurance coverage is increasing, and new treatments are being studied.

One that looks promising is spinal cord stimulation, in which a small insulated wire or lead is placed along the spinal cord above the area where the pain is generated. For example, if you have pain in your legs, those signals come into the lumbar spine, so the leads are placed in the thoracic spine and you can modulate the signal before it gets to your brain, where you process it, says Dr. Malhotra. In some cases, he says, the modulation could be something you would feel, like warmth or a buzzing sensation that replaces the pain, or it could be at a high frequency that blocked the pain signal, meaning you wouldnt feel anything.

Another option thats gaining steam is virtual reality (VR). In one study, when hospitalized patients used VR goggles to access relaxation experiences, they reported less pain than patients who watched yoga and meditation videos on their hospital televisions. Other research suggests that VR therapy could help relieve the phantom-limb pain from which amputees often suffer. With the therapy, you could be skiing down a mountain and doing activities using your legs even after an amputation, tricking your brain to suppress symptoms of pain, explains Leena Mathew, M.D., a professor of anesthesiology and director of the Pain Medicine Fellowship at Columbia University Medical Center in New York City.

New medications are in the works too, one of which was inspired by congenital insensitivity to pain (CIPA), a condition that prevents people from feeling pain (not a good thingif you cant feel that a stove is hot, you might rest your arm on it). In people with CIPA, says Dr. Malhotra, often there is a mutation in a particular sodium channel throughout the body, so there are some medications that are targeted toward purposely inactivating this channel more specifically to treat painful areas. Another subset of medicines is aimed at a protein involved in pain transmission and inflammation in the brain and spinal cord.

Of course, these are just a few treatment optionsthere are plenty of other procedures, medications, and alternative therapies out there. But no matter what path you decide to take, remember that chronic pain is similar to conditions like diabetes and asthma: It often cant be cured, but there are tools to help mitigate it. Go in with a mindset that you need to work hand in hand with your clinician, and the solution may involve a degree of management of your pain to help you be more functional and have a better quality of life, Dr. Mackey says.

As much progress as weve made with pain treatment, not everyone has equal access to it. Not only is good insurance coverage a luxury in the U.S., but insurance is not the only barrier. People cant always afford to take time away from work or caregiving to go to physical therapy twice a week or cook healthy meals regularly. Plus, research shows that women are more likely than men to report having painful conditions, but women and people of color are less likely to have their pain taken seriously by health care providers than are men or white people. These issues are the result of an incredibly complex and unfair health care system, but by raising concerns with doctors, we can start to move the needle. At the very least, we all have to acknowledge that disparities exist, says Dr. Mathew. Try using the strategies below to advocate for yourself.

Seeking pain care can be a frustrating endeavor, admits Driscoll. But the more you can pinpoint how pain affects you and what aspects of your life you want to improve, she says, the easier it is to identify treatments. For example, if pain has led you to give up activities or dampens your mood, an intervention like CBT may help. If its affecting your ability to walk, then PT, yoga, or even a treatment such as pain injections might be key. Some literature suggests that when a woman comes in with fibromyalgia, providers may assume whats bothering her most is painand that may be true for some women, but in many cases its fatigue, says Driscoll. So if the provider is treating the pain or thinks pain is the biggest problem, then the woman walks out with a treatment plan thats not really addressing whats bothering her the most. Being clear with providers about how pain interferes with your life is essential.

If you have a diagnosis, reach out to patient advocacy organizations that focus on the condition and see if they have educational resources. Im not asking people to try to train to be doctorsthats not the message, says Dr. Mackey. But learn as much as you can, because that will make you more empowered to advocate for yourself.

This can be tough, especially if you live in a rural area or have an insurance plan with few in-network providers, but its impor tant. You need to find a clinician with whom you can establish a good partnership, somebody whos going to validate whats going on, says Dr. Mackey. If theres no one nearby, he suggests asking whether your insurance covers telemedicine.

A lot of my success in practice with patients is actually when theyre patient, so to speak, says Trahan. Healing takes time. Be willing to work with your doctor to try different approaches and put in the time to let them be effective.

Try these drug-free strategies for combating common pain points.

If neck tension or bad posture is causing your pain, try to sit up straight and gently bring your chin toward your chest. Slowly bring your chin back up and repeat several times. This lubricates the facet joints in the neck, which can help decrease stiffness and reduce pain, Trahan explains. You can also put a drop of lavender essential oil on each thumb, then use your thumbs to massage the soft tissue behind your ears. The combo of aromatherapy and massage should relax your neck muscles.

With pain in this area, you have to look at what youre doing throughout the day, says Trahan. Instead of crossing your legs when you sit, keep your knees hip-width apart. Rather than leaning on one hip when you stand, put equal weight on both legs. It might feel unnatural at first, but you get used to that posture and then start experiencing less hip pain because youre not overusing the muscles and tendons and ligaments of that joint, Trahan says. If you have osteoarthritis in your hips, she also suggests that you perform hip stretches, such as lying on your back with your knees bent and windshield-wipering your legs from side to side a few times a day. This motion helps wash out inflammatory proteins and the extra fluid in the hips while stretching and expanding the ligaments, she says.

Not sure whats causing your back to ache? Trahan suggests strengthening your core, because it works in tandem with and supports back muscles. A few exercises established by back expert Stuart McGill, Ph.D., can help you build a strong core for injury prevention and rehabilitation, including curl-ups: Lie on your back with one leg out straight and the other knee bent, foot on the floor. Place one or both hands under the curve of your low back and slowly raise your shoulders, chest, neck, and head a couple of inches off the floor in a straight line. Pause for a few deep breaths, then lower your body again.

Depending on the source of your pain, you may want to mention to your doc these science-backed non-pharmacological options.

During acupuncture, very thin needles are inserted into certain parts of the body. It can be viewed through the Eastern lens, which considers meridians or pathways in the body, says Dr. Malhotra, or the Western lens, which theorizes that the needles activate new nerve endings, taking your attention away from the original pain and telling your brain it was a false signal.

Physical therapy is a movement-based intervention in which a practitioner guides a person through specific exercises that can, when done repeatedly, help lessen pain. One 2021 study found that patients with lower-back pain who were prescribed PT in the emergency room had greater improvement in functioning and used fewer high-risk medications in the following three months compared with those with similar pain who received the usual care in the ER.

The idea of this therapy is not to imply that the pain is all in your headit is very real. But since pain can influence your emotional well-being (and vice versa), psychological treatments like cognitive behavioral therapy for chronic pain (CBT-CP) can help. CBT-CP gives you tools to recognize pain and cope with it in a more useful way. For example, pain is a stressor, which can lead to muscle tension, and when muscles are tight, that can make the underlying pain worse, says Driscoll. CBT-CP teaches people to recognize that this process is going on in the body and encourages use of a relaxation strategy like deep breathing or visualization to reduce the pain. Learning to pace yourself is another tool Driscoll says is often taught during CBT-CP, to help you recognize the impulse to push through activities that may lead to pain flares. Once youre aware of these impulses, CBT-CP helps you identify ways to accomplish tasks with less pain.

Yoga combines the benefits of movement with the perks of a mindfulness and relaxation practice. The key is to find an instructor who has experience and training in working with your conditionstart with one-on-one sessions if youre new to yoga. The instructor can give you modifications and tips on how to adapt the poses to your needs.

Your body cant function well if you dont provide it with all the nutrients it needs to do its job, preferably through a healthy, well-rounded eating plan. If your diet is deficient in certain nutrients, you might need to supplement, says Sarah Trahan, N.M.D., a staff physician at Southwest College of Naturopathic Medicine & Health Sciences in Tempe, AZ, who focuses on acute and chronic pain management using regenerative medicine. Common vitamins and minerals can be helpful in preventing or reducing pain, but research also supports the use of turmeric, omega-3 fatty acids, and cannabidiol (CBD). Therapeutic doses of these supplements can be just as effective as some analgesic meds, but make sure to talk to your doctor before taking any.

Studies have linked various lifestyle factorsincluding a high-fat diet, unmanaged stress, inadequate sleep, and smokingto increased pain. That means regardless of the approach to pain relief you and your physician decide on, its going to be a lot harder to feel a difference if you have a foundation of unhealthy habits. As Trahan says, You can fertilize the garden, but if you never water it, the fertilizer was just wasted money.

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Why Your Pain Happens, and What the Future of Alternative Pain Relief Really Looks Like in the Opioid Crisis - Prevention Magazine

What Is Infrared Sauna Therapy? – Everyday Health

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Infrared saunas have been studied for a variety of problems, such as cardiovascular disease, diabetes, chronic pain syndromes, and injuries, says Melinda Ring, MD, the executive director of the Osher Center for Integrative Health at Northwestern University in Chicago. Its important to keep in mind that currently, research on infrared therapy is limited and more is needed to explore exactly what benefits it may provide, she explains. Whats more, much of the existing body of literature on the health benefits of sauna bathing is on traditional Finnish saunas and is not specific to infrared therapy. While the studies below speak to infrared sauna bathing specifically, they are, as a whole, based on small groups of people.

Heres a look at what more recent research suggests infrared sauna may be able to do for your health.

Another research review, published in August 2018 in Mayo Clinic Proceedings, explains the potential connection between saunas and heart health. The authors concluded that sauna bathing, including infrared sauna use, may reduce blood pressure, improve blood vessel function, reduce inflammation, and calm the nervous system, among other changes. Whats more, the hearts reaction to sauna bathing may also be akin to walking, something that strengthens the heart and is recommended for people who have heart failure.

Studies on the use of infrared sauna and exercise recovery are not consistent across the board. Other past research found that well-trained runners who performed a simulated trail-running race recovered better and faster when they used cryotherapy (cold therapy) than with far-infrared or no therapy.

Theres no doubt that stepping into an infrared sauna feels good for most people. And for certain groups of people, it may also do more.

A smallpast study looked at mildly depressed people who were treated for 15 minutes once a day for five days in a far-infrared sauna and then told to lie in bed for 30 minutes. Over four weeks they reported fewer physical complaints (such as discomfort and pain thats viewed as mentally distressing), more relaxation, and an improvement in appetite compared with the control group. The authors theorized that thermal therapy is sedating (boosting relaxation) and may have an effect on the nervous system, triggering the chill and calm parasympathetic nervous system. A change in appetite is one symptom of depression, and this study also indicates that infrared sauna use may impact hunger hormones in a positive way.

Another small study, published in September 2020 in the Korean Journal of Family Medicine, concluded that infrared sauna use among 38 obese individuals improved their quality of life (something that other research has shown is lower in folks with a higher BMI). In the study, participants sat in an infrared sauna for 15 minutes and rested in room temp air for 30 minutes twice a day for four consecutive days. After the four days, those taking infrared saunas reported less pain and discomfort, as well as less anxiety and depression.

An infrared sauna is a warm, quiet space with nothing to distract you, which could also potentially be a factor in its therapeutic benefits, in addition to the actual infrared exposure. It can trigger your relaxation response to decrease stress, says Simms. One caveat, says Simms: You wont get this benefit if you go in there and scroll social media or answer emails on your phone. As a review published in April 2018 in Evidence-Based Alternative and Complementary Medicine points out, sauna bathing might release endorphins, strongly support you to stop and practice mindfulness, reduce stress and improve relaxation, and can simply give you a break in your day for self-care thats psychologically beneficial. People come out feeling really energized. An infrared sauna session can be invigorating, says Simms.

A small amount of research has suggested that those with inflammatory conditions, such as rheumatoid arthritis, may benefit from infrared sauna therapy, which has been found to lessen pain and stiffness, concludes the aforementioned review in Evidence-Based Complementary and Alternative Medicine, which looked at the results of four studies specific to rheumatological diseases.

One of these past studies, published in Clinical Rheumatology, concluded that people with rheumatoid arthritis and ankylosing spondylitis who used infrared therapy eight times over a four-week period had less pain, stiffness, and fatigue over the short-term, though these differences were small.

In addition, that same review looked at two randomized controlled trials of people with chronic pain disorders who used infrared therapy. One randomized controlled trial published in the Journal of Alternative and Complementary Medicine found that using the sauna for eight weeks helped people with chronic tension headaches reduce headache intensity by 44 percent. The authors theorized that some of the effect could be from the relaxation response, which may decrease activity of the sympathetic nervous system, responsible for the fight-or-flight response. Another small past trial with 46 participants found that people with a chronic pain disorder had improvements in mood and were more likely to return to work after practicing sauna bathing.

Finally, a pilot study published in Internal Medicine evaluated 10 people with chronic fatigue syndrome who sat in a far-infrared sauna for 15 minutes and then lay in a bed under a blanket for 30 minutes once a day, five days a week for four weeks found that the therapy helped reduce pain after treatment and improved mood. The authors theorized that this therapy may have worked by reducing the oxidative stress that may play a role in symptoms; the warmth was also likely relaxing, contributing to a boost in mood.

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What Is Infrared Sauna Therapy? - Everyday Health

FDA Regulatory News and Trends – Lexology

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Welcome to the inaugural issue of FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal and regulatory world.

FDA Warning Letter focuses on GMP failures at 503B compounding outsourcing facility. After a brief hiatus from the string of Warning Letters sent to 503B outsourcing facilities in mid- to late 2021, on June 7, 2022, FDA issued a Warning Letter to Hybrid Pharma, LLC based on an inspection ending in September 2021. FDA appears to be coming back with a vengeance, as the same Hybrid Pharma facility received a previous Warning Letter in November 2018. Read more.

Guidance coming to supplements industry on new dietary ingredients. The FDA intends to release multiple draft guidance documents to the dietary supplements industry in the form of relatively small, discrete topics related to New Dietary Ingredients, an FDA executive said on May 26. Betsy Jean Yakes, acting director of the agencys Division of Research & Evaluation, made those comments at the IPA World Congress + Probiota Americas conference in Washington, DC. An FDA spokesperson elaborated that the agency has announced its intent to finalize the NDI Notification Procedures and Timeframes sections of its guidance in its Foods Program Guidance Under Development. Under the law governing NDIs, a manufacturer that wishes to introduce a new ingredient in a supplement must file a notification with the FDA 75 days before marketing the ingredient.

FDA says it now has the staff to review pre-submissions for non-COVID-19 products. The FDA said in a May 31 blog post that it now has the staff it needs to review pre-submissions for medical devices that arent related to the COVID-19 pandemic. In the post, Jeff Shuren, director of the agencys Center for Devices and Radiological Health (CDRH), and William Maisel, director of its Office of Product Evaluation and Quality (OPEQ), noted that since the beginning of the pandemic, the demand for medical devices has far exceeded the demand in any previous public health emergency. This, they said, had significantly overloaded the agencys ability to review requests for Emergency Use Authorization (EUAs) as well as conventional requests. The post also noted that in December 2021, the agency had highlighted that it was prioritizing work in this area that is related to COVID-19 and that it had a limited ability at that time to accept non-COVID pre-submissions. In the May 31 post, the agency said that things have changed and that it is pleased to announce that, as of June 1, 2022, CDRH plans to accept all non-COVID IVD pre-submissions and that due to the continued elevated workload related to COVID, its likely these IVD pre-submissions will initially be reviewed under an extended timeline.

FDA withdraws COVID-era guidance on marketing submissions and applications. On June 7, the FDA announced it is withdrawing a guidance document entitled Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical DevicesQuestions and Answers (Revised). This document was originally issued in June 2020 and updated in December 2020, during the height of the COVID-19 pandemic. The agency said it is withdrawing this guidance document because it recognizes that the conditions that created the need for these policies have evolved and that they are no longer needed essentially, that the pandemic has decreased in scope and severity. The effective date of the withdrawal of the guidance is July 7, 2022. A key aspect of the withdrawal is that the agency said it has determined it is in the interest of the public health to return to pre-pandemic policies regarding hold times for marketing submissions and applications to the FDA. Reverting to policies regarding hold times described in the preexisting guidance documents should facilitate more timely premarket review of innovative and potentially lifesaving devices, the agency said.

FDA issues industry guidance on tropical disease priority review vouchers. On June 13, the FDA issued a guidance for industry entitled Tropical Disease Priority Review Vouchers. The guidance explains how the agency implements provisions of section 524 of the Food, Drug, and Cosmetic Act and how sponsors may qualify for a priority review voucher based on eligibility criteria set forth in the statute. It also discusses how to use priority review vouchers and how priority review vouchers may be transferred to other sponsors. The idea behind section 524 is to stimulate research into possible drugs for certain tropical diseases that affect millions of people and to create a way to give priority review vouchers to sponsors of diseases that can treat those diseases. Priority review means that applications for those drugs take priority over any other type of drug application.

Ex-Eli Lilly employee files suit claiming she was fired for making allegations about the manufacture of Trulicity. Amrit Mula, a former senior human resources employee at Eli Lilly & Co., filed a federal lawsuit on June 6 claiming that she was fired after reporting manufacturing and data falsification issues related to the pharmaceutical companys products, including its blockbuster diabetes drug Trulicity. The suit was filed in the US District Court for the District of New Jersey. Mula, who was an associate director of employee relations at Eli Lilly in Branchburg, New Jersey, contends in the lawsuit that she repeatedly asked her superiors, starting in 2018, to remedy manufacturing violations involving several biologic drugs, including Trulicity. Lilly executives responded by marginalizing, harassing and eventually terminating her position under false pretenses, she said in the lawsuit. The US Department of Justice last year launched a criminal investigation into alleged manufacturing irregularities at the plant.

Guidance for small businesses on importation rule. On May 25, the FDA issued a nonbinding Industry Guidance document concerning the implementation of its 2020 rule on the importation of prescription drugs from Canada. The guidance document is specifically designed, the FDA said, to aid small businesses in their efforts to comply with the rule. The document reviews the structure of the importation program. It points out that the program, under section 804 of the Food, Drug and Cosmetic Act, will be implemented through time-limited Section 804 Importation Programs (SIPs), which will be reviewed and authorized by the agency and managed by states or Indian tribes, or in certain future circumstances by pharmacists or wholesale distributors. The purpose of the final rule, the guidance notes, is to achieve a significant reduction in the cost of covered products to the American consumer while posing no additional risk to public health and safety.

FDA rescinds approval for a drug being used against lymphoma. On June 1, the FDA withdrew for safety and health reasons -- its February 5, 2021 accelerated approval for a new cancer drug, Ukoniq or umbralisib. Ukoniq had been approved to treat two types of lymphoma, marginal zone lymphoma and follicular lymphoma. However, findings from a post-market clinical trial continued to show a possible increased risk of death in patients receiving the drug, leading the agency to determine that the risks of treatment with Ukoniq outweigh its benefits. Based on this determination, the drugs manufacturer, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq from the market for the approved uses in these two types of lymphoma. The FDA told doctors to stop prescribing Ukoniq and to switch to alternative treatments for patients who were taking it. The drug had been approved in February 2021. The pending user fee legislative proposals contains additional authorities for FDA to require additional clinical studies for accelerated approvals and take enforcement action based on those results.

Appeals court rejects challenge to FDA ban on sale of raw butter. On June 10, the US Court of Appeals for the DC Circuit, affirming the ruling of a US district judge, found against a farmer who had asserted that the FDAs regulation banning the interstate sale of raw butter violates the federal Food, Drug, and Cosmetic Act. The appeals court found that the FDA acted reasonably when it concluded that raw butter was too dangerous to be sold interstate. The court pointed out that when Congress set a standard of identity for butter, it explicitly prevented the FDA from altering that definition. The plaintiff in the case, the court noted, contended that the pasteurization requirement for butter does alter that definition in violation of the law. But, the court concluded, That is incorrect: The pasteurization rule did not amend the statutory standard of identity for butter, either formally or functionally. Raw-cream butter, though unpasteurized, is still butter, notwithstanding the FDAs determination that its interstate sale would threaten public health.

FDA provides guidance on risk management for the pharma industry. On June 14, the FDA released a new guidance document titled Quality Risk Management that is intended to offer to pharmaceutical companies a systematic approach to quality risk management for better, more informed, and timely decisions. The agency, recognizing that the manufacture and use of pharmaceuticals necessarily entails some risk, said that the document specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle. The FDA noted that the guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products.

Program to help device makers find new ways to sterilize their devices. On June 7, the FDA announced it is considering a master file pilot program for premarket approval holders whose approved medical devices are sterilized using radiation. The FDA is doing this because of global supply chain constraints and the need to support sterilization supply chain resiliency. If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources. The FDA is working with sterilization experts, medical device manufacturers, and other government agencies to advance alternative ways to sterilize medical devices while maintaining device safety and effectiveness. Sterilization master file pilot programs are often used to encourage new ways to sterilize medical devices that reduce the potential impact of ethylene oxide on the environment and on public health. Ethylene oxide is used to sterilize about 50 percent of all sterilized medical devices, but long-term exposure to it is linked to certain cancers.

New FDA guidance points to priority in finding drugs to treat serious bacterial diseases. On May 24, the FDA issued a nonbinding Industry Guidance document titled Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases Questions and Answers (Revision 1). A major purpose of the guidance document is to emphasize that since many serious cases of bacterial disease persist in hospitals and other settings especially cases that cannot be treated by currently available drugs it is important to prioritize efforts to find new appropriate drugs. The guidance quotes a previous FDA statement noting that it is appropriate to exercise the broadest flexibility in applying the statutory standards, while preserving appropriate guarantees for safety and effectiveness. These procedures reflect the recognition that physicians and patients are generally willing to accept greater risks or side effects from products that treat life-threatening and severely debilitating illnesses, than they would accept from products that treat less serious illnesses. These procedures also reflect the recognition that the benefits of the drug need to be evaluated in light of the severity of the disease being treated.

Warning Letter sent to maker of hand-sanitizing products. On May 23, the FDA sent a Warning Letter to Missouri-based Aire-Master of America, telling the company that it is engaging in significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. Because of these violations, the agency said, its drug products are to be considered adulterated under federal law. The company manufactures hand-sanitizing products. The FDA also noted several other violations and told the company that its products are unapproved new drugs because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from the FDA, the agency said in the Warning Letter. The FDA also strongly recommended that the company hire a consultant to help it meet the requirements of CGMP.

The future of diagnostic regulation. DLA Piper Partner Bethany J. Hills joined Dr. Timothy Stenzel, Director, Office of In Vitro Diagnostics and Radiological Health, CDRH, William G. Morice, Chair, Department of Laboratory Medicine and Pathology, Mayo Clinic and Mike Dobias, Officer, Health Care Products, The Pew Charitable Trusts to discuss important trends in diagnostic regulation at the Food Drug Law Institute Annual conference in Washington, DC on June 15, 2022. Dr. Stenzel provided a deep overview of the lessons learned by CDRH from the COVID pandemic, touching on important innovations in over-the-counter and home testing technologies. A key takeaway is that technologies that are well understood by the FDA can benefit from more efficient regulatory authorization review, while novel technologies take longer and Dr. Stenzel encouraged continued development of novel technologies. Dr. Morice spoke on topics of addressing health access disparities and the infrastructure issues that require updating and restructuring for the future success of deploying diagnostic technologies rapidly. Dr. Stenzel described a number of programs where government supported test validation was very effective and allowed for rapid deployment of tests that would have otherwise been inaccessible. Finally, Mike Dobias and Dr. Morice discussed in depth the pending legislation, the VALID Act, embedded in the proposed user fee bills, that will fundamentally change the way diagnostics are categories and regulated. Mr. Dobias provided an overview of the classification framework, the technology certification program for testing modifications and the available exemptions from pre-market authorization, while Dr. Morice focused on the need for clarity and predictability in the delivery and innovation of diagnostics and the ways the legislation could address those concerns. Key other topics included addressing cost barriers to diagnostic testing and dealing with large data and delivery gaps as tests become more available to consumers directly in their homes.

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FDA Regulatory News and Trends - Lexology

Where is the best place to get treated for cancer? – Yahoo News

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Where is the best place to get treated for cancer?

Mexico has become the first tourist destination for Americans when it comes to health matters. Several factors contribute to Americans decision to get their health issues treated in cities such as Tijuana and Mexicali.One of these factors, and perhaps the most relevant one to understand this social phenomenon, is the excellent quality of specialized doctors when it comes to treating cancer or malignant tumors. Also, patients can find breakthroughs in laparoscopy and robotic surgery in Tijuana.Economy is another important factor. Medical treatment costs are 30% to 70% cheaper in Mexico than in the United States. One can add to this relevant fact another one: geographical position. There is a symbiotic relation between both countries. For example, Mexico offers high-quality medical services and very affordable prices, while American patients play a tourist role. Every year, the number of foreigners who are looking for a medical center to treat their diseases in Mexico increases.According to an article published by the BBC, Tijuana received around 1,2 million people for medical tourism in 2018. This year, this number reached 2,5 million people. This has already been noticed by investors who are working to offer better lodging facilities not only for patients, but also their companions.

The low cost of treatments, consultations, and medications, as well as the prestige that doctors in the border have, have made Tijuana the first medical destination for Americans. In addition, there are a lot of Americans who are looking for alternative cancer treatments, which means they focus even more on this border city.If you want to find out more information about alternative cancer treatments, call MedBaja services at (619) 333-6066 or leave your information in the form down below:

Many patients are looking for alternative treatments because conventional ones such as chemotherapy tend to have a lot of side effects with hair loss in different parts of the body (known as alopecia) as the best known. However, it is a long list: anemia, changes in skin and nails, fertility problems in women and men, deliriums, diarrhea, edema, nausea, and vomiting are some of these side effects.Chemotherapy is a chemical process that acts directly on active human cells, stopping their multiplication and destroying them. Unfortunately, it not only destroys cancer cells, but also healthy cells.In an investigation titled Toxicity of oncological treatments, Doctor Christina Caballero writes that the most affected cells during chemotherapy are healthy cells, and the side effects, or toxic effects, have a direct consequence when it comes to quality of life, causing fear in some patients. She, however, adds at the end that the effects are bearable.

Despite the variety of medications that exist nowadays to treat cancerous conditions, side effects or toxic effects continue to appear. In the words of Doctor Caballero, despite the great number of selectivity with these directed therapies, a series of collateral effects, sometimes unpredictable, emerges.Physical wear caused by side effects makes patients look for other types of treatments, for example, alternative medicine.If you wish to combat your condition with more natural and less invasive treatments, ITC has the answer. Call MedBaja services at (619) 333-6066 or leave your information in the form down below:

Complementary or alternative medicine, instead of a conventional procedure as it is often done under the scientific method, consists of healing the body through therapies unrelated to the use of medications.In Tijuana, the capital of medical tourism, you will find Immunity Therapy Center, Cancer Tutor certified center to treat cancer. It offers a second point of view against traditional medicine and its difficult side effects. Immunity Therapy Center holds itself to account through strict assessment and evaluation processes that ratify it as a high-quality option, capable of assisting and treating cancer problems.

They also have around 28 alternative treatments to fight cancer. Some of these are: Vaccine Against Specific Killer Cells, Intravenous Curcumin Treatment, Viral Vaccination Cancer Treatment, Enzyme Therapy, Biomagnetic Therapy, among others.Get treated by the best professionals. Find out all about the ideal cancer treatment for you with MedBaja services at (619) 333-6066 or leave your information in the form down below:

Learn More about Immunity Therapy Center

Types of alternative cancer treatmentsMore than 21 alternative therapies and natural treatments for cancer are combined with traditional treatments. Some of the options are:

Enzyme therapy Vitamin and mineral therapies Oxygen therapy biomagnetic therapy Laser therapy HALO therapy Hyperthermia

It is important to note that most stays are for six weeks, but depending on the patient and the progress of their condition, this period may be longer or shorter. Instructions are provided so that the patient can continue their treatment at home after leaving the center.

This type of treatment is unique because of its use of alternative therapy, and therefore not covered by medical insurance, so each patient must pay for his or her own expenses. Patients can contact the center for help finding the best payment option.

Most patients come to the center accompanied by a loved one, so that they have the support and company of someone they trust, which is crucial when undergoing treatment for disease.

To learn more about the center and its therapies, visit the following link. This could be the life opportunity youve been looking for.

Get in contact with a specialist and learn about Alternative Cancer Treatments in Tijuana, fill-out the contact form below:

Alternative Cancer Treatment in Mexico | Survivor Testimonials

Call us at MedBaja Services on (619)333-6066 to find out more about this cheap, revolutionary, and holistic approach to cancer treatment, or fill out the form below so we may contact you immediately.

INDEX: CANCER TREATMENTS IN MEXICOIs it safe to travel to Tijuana to receive cancer treatment?What to expect from an Alternative Cancer Treatment in Mexico?What makes Tijuana a leader in alternative cancer treatments?Viral anti-cancer vaccine, an innovative alternative treatment in TijuanaWhy is cancer treatment significantly more affordable in tijuana?How to choose a cancer center in Mexico?Where can I find a Cancer Tutor Verified Center in Tijuana?ITC: The best level of healthcare for cancer patients is in TijuanaTestimonial from a Cancer Survivor Treated in Tijuana, MexicoGuanabana: Why Fly to Tijuana, Mexico, For This Alternative Treatment?Anticancer Uses of Turmeric: Why Travel to Tijuana For This Asian Cuisine?5 Safer Natural Alternatives to Chemotherapy Available in Tijuana, MexicoWhat is the Cost of Cancer Treatment in Mexico?5 groundbreaking alternative cancer treatments in MexicoViral anti-cancer vaccine, an innovative alternative treatment in Tijuana

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Where is the best place to get treated for cancer? - Yahoo News

Nasal washing for hay fever – how to reduce symptoms with alternative therapies – The Mirror

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Avoiding pollen is next to impossible for most, and when it does strike the consequence to sufferers means a whole host of unpleasant symptoms. But there are a number of ways, some lesser-known, to help relieve hay fever

Image: Getty)

Hay fever patients across the UK are facing worsened symptoms as the summer gets underway and pollen count soars.

As the Met Office warned in June, very high pollen levels will affect the more than 10 million people who experience seasonal allergies.

And experts have noted that June has already seen the highest pollen levels in England and Wales so far this year.

Max Wiseberg, airborne allergens expert and creator of HayMax organic allergen barrier balms, said sufferers "need to be well prepared and do everything they can to lessen their hay fever symptoms".

Pharmaceutical remedies are generally based on either antihistamines or steroid nasal sprays, whilst natural remedies are based on physical preventative measures, immune boosters or natural antihistamines," Max explained.

"The interesting thing about this is that many of these remedies can be complementary to each other.

So, if one helps, but doesnt do the whole job, you may be able to try other remedies at the same time and get a better result.

In other words, you can create your own, bespoke hay fever first aid kit that suits your specific needs.

Popular treatments for hay fever sufferers include:

Nasal washing, or nasal sinus irrigation, is basically just pouring a saltwater solution into one nostril and letting it drain out the other.

The ancient Indian practice can help rinse out mucus, bacteria, and allergens like dust and pollen.

That means you may need less allergy medicine or nasal decongestants.

According to Head and Neck surgeons, nasal washing can be done following these steps:

Any container with a spout should work, but you can buy a specialist neti pot to help.

You can also buy natural eye drops which contain a herb called Euphrasia (more commonly known as Eyebright), adds Wiseberg.

Butterbur is a herbal extract believed to have an antihistamine-like effect on hay fever symptoms, and is widely available in capsules.

Quercetin is thought to limit the release of histamine. As well as being found naturally in many foods, it can also be taken in a capsule.

Turmeric is another lesser-known solution according to Wiseberg and has been shown to have anti-allergy properties.

Most often used in dried form, it can also be bought fresh and is available in tablet and capsule form, he advised.

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Nasal washing for hay fever - how to reduce symptoms with alternative therapies - The Mirror

Contrast-enhanced mammography vs. MRI: Neoadjuvant therapy response in breast cancer – EurekAlert

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image:A, CC (left) and MLO (right) low-energy images from pre-NAT CEM performed on 25th day of luteal phase show a 60-mm architectural distortion (line on CC) in the central portion of the right breast. B, CC (left) and MLO (right) recombined images from pre-NAT CEM show marked background parenchymal enhancement, hindering lesion evaluation; 90-mm non-mass regional enhancement (line) was described. C, Axial fat-saturated T1-weighted unenhanced MR image shows a 70-mm hypointense irregular mass (line) with not circumscribed margins in the central portion of right breast. D, Axial fat-saturated T1-weighted post-contrast MR images shows corresponding fast initial enhancement (line) with delayed plateau. view more

Credit: American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR)

Leesburg, VA, June 22, 2022According to ARRS American Journal of Roentgenology (AJR), contrast-enhanced mammography (CEM) may be a useful alternative test for neoadjuvant therapy (NAT) response assessment in patients with breast cancer who are unable to undergo MRI.

After NAT for breast cancer, CEM and MRI yielded comparable assessments of lesion size (both slightly overestimated vs pathology) and RECIST categories, and no significant difference in specificity for pathologic complete response, wrote corresponding author Rubina Manuela Trimboli of IRCCS Humanitas Research Hospital in Milan, Italy. Noting that MRI had higher sensitivity for pathologic complete response, delayed CEM acquisition may help detect residual ductal carcinoma in situ (DCIS).

Trimboli and teams prospective study included 51 patients (mean age, 46 years) with biopsy-proven breast cancer from May 2015 to April 2018, who were candidates for NAT. Patients underwent both CEM and MRI before, during, and after NAT: pre-NAT, mid-NAT, and post-NAT, respectively. Post-NAT CEM included a 6-minute delayed acquisition. One breast radiologist with experience in CEM reviewed CEM examinations; one breast radiologist with experience in MRI reviewed MRI examinations.

Compared with pathology, post-NAT CEM, MRI, and delayed CEM systematically overestimated residual tumor size by 0.8 mm, 1.9 mm, and 1.2 mm, respectively. For detecting pathologic complete response by post-NAT imaging, sensitivity and specificity were 81% and 83% for CEM, 100% and 86% for MRI, and 81% and 89% for delayed CEM.

While MRI remains the preferred test for NAT monitoring, the authors of this AJR article concluded, the findings support CEM as a useful alternative when MRI is contraindicated or not tolerated.

North Americas first radiological society, theAmerican Roentgen Ray Society (ARRS) remains dedicated to the advancement of medicine through the profession of medical imaging and its allied sciences. An international forum for progress in radiology since the discovery of the x-ray, ARRS maintains its mission of improving health through a community committed to advancing knowledge and skills with the worlds longest continuously published radiology journalAmerican Journal of Roentgenologythe ARRS Annual Meeting, InPractice magazine, topical symposia, myriad multimedia educational materials, as well as awarding scholarships via The Roentgen Fund.

MEDIA CONTACT:

Logan K. Young, PIO

44211 Slatestone Court

Leesburg, VA 20176

703-858-4332

lyoung@arrs.org

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Contrast-Enhanced Mammography Versus MRI in the Evaluation of Neoadjuvant Therapy Response in Patients With Breast Cancer: A Prospective Study

22-Jun-2022

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Contrast-enhanced mammography vs. MRI: Neoadjuvant therapy response in breast cancer - EurekAlert

Malone Testifies on Inadequacy and Illegality of Federal Pandemic Response at State Hearing – The Epoch Times

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Dr. Robert Malone will present testimony before the Texas Senate Health and Human Services Committee hearing on Monday June 27th.

In stating his qualifications, Dr. Malone explained why he is in a unique position to provide an opinion regarding federal pandemic responses, I have been deeply involved in multiple prior outbreak responses including AIDS, the Post Anthrax/Smallpox scare, Pandemic Influenza, Ebola, Zika, and now SARS-CoV-2.

He explained how in all prior pandemic responses, the role of the Centers for Disease Control and Prevention (CDC) was to provide impartial and accurate data to advise state public health authorities who, according to the U.S. Constitution, have the right and duty to manage their own public health policy as well as the practice of medicine.

In the United States, each state has its own public health department and licensing board for medical doctors. Additionally, during the COVID-19 pandemic, the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Disease (NIAID) took a lead role over the CDC. This had never happened before.

Malone also related how, In my professional experience, during all prior outbreaks and vaccine development programs, risks and benefits have always been evaluated and stratified by risk group, and public health recommendations have been tailored to account for differences in risk/benefit ratios.

Rather than following tried and true methods, new protocols were developed by Drs. Anthony Fauci and Deborah Birx in a non-transparent way without public hearings, comment, or input from treating physicians.

These new protocols involved the rapid development of vaccines with inadequate safety trials and the aggressive blocking and suppression of the use of effective repurposed drugs and treatment regimes. None of the vaccines could have received Emergency Use Authorization if there existed an alternative efficacious treatment.

Since the COVID-19 vaccine role outs began, the CDC has purposefully withheld data that it thought would contribute to vaccine hesitancy and admitted that it did not monitor or analyze vaccine safety data, included cases reported to the Vaccine Adverse Event Reporting System (VAERS).

Malone said, This has compromised the informed consent process. Instead, the CDC has actively promoted and marketed vaccination with unlicensed (emergency use authorized) products, with over $1 Billion USD in federal funding expended to both market the products and to censor those who have raised concerns regarding vaccine safety and effectiveness.

He continued, [the] FDA, NIH, and CDC (together with WHO) have cooperated to actively restrict, demean, and deprecate use of multiple currently available licensed drugs for treatment of COVID-19 by licensed practicing physicians, and have facilitated retaliation against physicians who do not follow the treatment guidelines established and promoted by the NIH which has neither mandate nor significant prior experience in developing and implementing universal treatment guidance and protocols, and which has done so in a unilateral manner without seeking meaningful input from practicing physicians. He provided the example of the retaliation experienced by the highly qualified physician and scientist authors of the Great Barrington Declaration.

Both the NIH and CCD have promoted federal policies across the entire United States with no respect for state autonomy and evidence suggests they have gone so far as to withhold monoclonal antibody treatment from the state of Florida because Governor Desantis COVID management policies did not align with federal ones.

He stated, It is my professional opinion that in the case of the COVID crisis, we have seen an unprecedented weaponization of public health policies to advance political and economic agendas, which are not directly related to public health.

It is also my opinion that the federal government has incrementally usurped the constitutional rights of states to regulate health care and the practice of medicine, and that this has been accomplished using a variety of coercive tactics.

He urged Texas senators to develop their own state drug manufacturing not only for business and economic development but to also protect the health and safety of the citizens of Texas as, in his opinion, outsourcing drug development and manufacturing to places like China and India represents a threat to national security and public health.

Dr. Malone concluded, In sum, during the COVID crisis, I believe that we have seen an unprecedented encroachment of the U.S. Federal Government into the practice of medicine, the circumventing of both bioethical and regulatory norms that have been developed over decades, and heavy handed and politicized federal implementation of a wide range of interventions in our communities, businesses, churches, government, monetary policy and general commerce.

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Malone Testifies on Inadequacy and Illegality of Federal Pandemic Response at State Hearing - The Epoch Times

India and US went pro-choice around the same time. Only one strengthened its abortion laws – ThePrint

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PastForward is a deep research offering from ThePrint on issues from Indias modern history that continue to guide the present and determine the future. As William Faulkner famously said, The past is never dead. Its not even past. Indians are now hungrier and curiouser to know what brought us to key issues of the day. Here is the link to the previous editions of PastForward on Indian history, Green Revolution, 1962 India-China war, J&K accession, caste census and Pokhran nuclear tests.

In a judgment that will have far reaching consequences, the US Supreme Court last week overturnedits own 1973 Roe vs Wade judgment against state restriction on abortion, setting womens sexual and reproductive health rights back by many decades.

Roe vs Wade was a landmark when it was originally passed; but what is less known is that Indian womens right to abortion predated that seminal case when Norma McCorvey, a Texas resident, challenged Henry Wade district attorney of Dallas county, demanding the right to abort her baby. Although, by the time the right to abort came, McCorvey had already delivered her baby. Jane Roe was the alias used to protect her identity.

Two years before the US Supreme Court judgment, in India, womens right to seek an abortion was established by the Medical Termination of Pregnancy Act, 1971. Much water has flown under the bridge since then. In 2021, the revised MTP Act took into account changed social realities and also the advancements made in medical field, which expanded the safe abortion window considerably. The most important change that the 2021 law brought was not the expansion of permissible limit for abortion from 20 weeks of gestation to 24 weeks. It was in its recognition of the need to make abortions accessible for all women irrespective of their marital status.

ThePrint takes a look at how Indias abortion law evolved.

Also read: Who was Jane Roe of Roe v Wade? What overturning of the 1973 judgment means for American women

The MTP Act of 1971 allowed abortions up to 20 weeks provided two registered medical practitioners agreed that continuing the pregnancy involved a risk to the life of the pregnant woman or the unborn child, including mental or physical abnormalities. For a pregnancy caused by rape, the law allows abortion, holding that pregnancy in such a case presumed to constitute a grave injury to the mental health of the pregnant woman. Contraceptive failure was also an acceptable ground for abortion in case of a married woman as per this law.

The genesis of the law lay in a government committee that was constituted in 1964, much before Roe vs Wades initiation date of 1970. Until then, Indian law had a provision for an imprisonment of up to three years for the provider of abortion services and of up to seven years for the woman seeking those services. Exception was allowed in the case of miscarriage to save the life of the pregnant woman in good faith.

In its report submitted in 1966, the committee headed by then-minister of public health, law and judiciary Shantilal Shah said: The committee considers the above provision too restrictive; and therefore recommends that it should be liberalised to allow termination of pregnancy by a qualified medical practitioner acting in good faith However, the committee was clear that abortion was unviable as a method to control population growth.

A 2016 article in the journal Indian Law Institute Law Review noted that the MTP Act was implemented in the month of April, 1972 and again revised in the year of 1975 to eliminate time consuming procedures for the approval of the place and to make services more readily available. This Act was amended in the year 2002 and again in 2005.

Also read: How changes to pregnancy termination bill give women better options for abortion

Throughout the amendments in the MTP Act, there was one constant abortions were legally allowed in the country only till 20 weeks of pregnancy. This had to do with the available medical facilities and the assessment at those points of time about what constitutes a safe window for abortion without jeopardising the life of the mother. But with the advent of advanced medical equipment, it became possible for doctors to detect foetal abnormalities well beyond the 20-week deadline, making the decision of carrying pregnancy through a fraught question for the would-be parents.

One such instance came in 2008 when Mumbai couple Haresh and Niketa Mehta approached the Bombay High Court for permission to abort their baby, which doctors said would be born with a congenital heart block. Their application was turned down and Niketa eventually miscarried. The case became one of the landmarks in the long journey of the Indian abortion law in allowing abortions beyond the 20-week barrier.

There have been cases where courts have granted permission beyond the permissible time limit. In 2015, a 14-year-old rape victim from Gujarat was permitted by the Supreme Court to abort after 20 weeks as a special case. The court, however, asserted that this case could not be used as a precedent to grant permission in another similar case.

On the other hand, in 2020, the Kerala High Court denied permission to a couple to abort their 35-week foetus.

The longstanding need to review the limit in gestation age, which doctors and patients have been arguing in favour of for years, was finally met in 2021 when a new MTP Act came into force that allowed abortion up to 24 weeks. The upper gestation limit, the law says, will not apply in cases of substantial foetal abnormalities diagnosed by a medical board. The board will include one paediatrician, one gynaecologist and one radiologist or sonologist. But why that law marked a shift in mindset lies in a paragraph which says: For the purposes of clause (that is when the pregnancy is less than 20 weeks old), where any pregnancy occurs as a result of failure of any device or method used by any woman or her partner for the purpose of limiting the number of children or preventing pregnancy, the anguish caused by such pregnancy may be presumed to constitute a grave injury to the mental health of the pregnant woman.

This was a major shift from the earlier law when contraceptive failure was an acceptable reason for abortion only for married women, leaving many unmarried pregnant women at the mercy of quacks and illegal service providers. The original draft of the Bill had included the contraceptive failure clause only for married women but the ministry of health pushed for a more inclusive language to ensure better access to safe abortion services. According to a 2018 study by the Guttmacher Institute, 50% of pregnancies in six of the largest Indian states Assam, Bihar, Gujarat, Madhya Pradesh, Tamil Nadu and Uttar Pradesh are unintended. According to United Nations Population Fund (UNFPA)s State of the World Population Report 2022, 67 per cent of all abortions that happened in India between 2007-2011 were unsafe.

Also read: Why Indias law on abortion does not use the word abortion

The two thorny questions in the abortion law have always been: who can deliver the essential health service and who can seek it the latter being more of a social nature but one that requires a legal framework. Indias position on this question has evolved with time, taking into account social realities so that the question of who needs an abortion is now looked at through the prism of individual rights rather than societal norms. But in a country where doctors are chronically in short supply even the 1966 report mentioned this problem the question of who is qualified to provide abortion services is complicated as well. So, around 2014-15, the ministry of health and family welfare proposed an amendment to the MTP Act, 1971 to allow ayurveda, naturopathy, and homeopathy practitioners to perform medical abortions that is, abortions that did not require any surgical intervention.

The proposal caused a backlash, particularly from the Indian Medical Association (IMA), the largest body of allopathic doctors in the country. But what put paid to the plan was not the uproar but the death of a woman in Maharashtras Sangli district in 2017, allegedly after she sought an abortion from an unqualified person. Ahomoeopathy doctor was later caught allegedly running an illegal sex-selective abortion racket. Following the incident, the MTP Act, despite being included in the agenda of the Union Cabinet, was not taken up for several months. The PMO stepped in and askedthe health ministry to ensure better implementation of the MTP Act, 1971 and the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, 1994 before trying to amend either. The PCPNDT Act is meant to stop sex selective abortions. The Sangli incident also caused concerns in the highest levels of the government about the implications of increasing the provider base in a country where regulations tend to fall repeatedly short.

The plan to allow practitioners of alternative medicine to perform abortions was dropped and eventually when the MTP Act, 2021 came into effect, the status of a provider was limited only to qualified allopathic practitioners.

The MTP Act, 2021 was hailed by the World Health Organization (WHO) as a progressive step towards equitable access to abortion services. In a historic move to provide universal access reproductive health services, India amended the Medical Termination of Pregnancy (MTP) Act 1971 to further empower women by providing comprehensive abortion care to all. The new Medical Termination of Pregnancy (Amendment) Act 2021 expands the access to safe and legal abortion services on therapeutic, eugenic, humanitarian and social grounds to ensure universal access to comprehensive care. The new law, which came into force from 25 March 2021, will contribute towards ending preventable maternal mortality to help meet the Sustainable Development Goals (SDGs) 3.1, 3.7 and 5.6, WHO said in a statement in April 2021.

(Edited by Prashant)

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India and US went pro-choice around the same time. Only one strengthened its abortion laws - ThePrint

Donating to help women get abortions is a First Amendment right protected by Supreme Court precedents – The Conversation

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Several Texas abortion funds which are charities that help people who cant afford to get an abortion pay for their travel, lodging and medical bills paused disbursements on June 24, 2022, after the Supreme Court ruled that Americans have no constitutional right to the procedure.

The Lilith, Equal Access, Frontera and other funds said they were taking this step to assess the legal consequences of the courts ruling in Texas, which already had some of the nations strictest abortion laws. Abortion funds in some other states, including Oklahoma, were also reportedly halting their work.

Some funds active in Texas made this decision based on concerns that their financial assistance to women seeking abortions may now be illegal in that state, as well as fears that their donors could also be sued for violating Texas law.

But as an expert on reproductive rights and First Amendment law who has argued before the Supreme Court, I believe that donating to abortion funds even in places where helping people get abortions is illegal is protected by the U.S. Constitution.

The Supreme Court has ruled on several occasions that fundraising, whether its by charitable organizations or political candidates, is a form of speech protected by the First Amendment.

The court handed down the first relevant ruling in 1980, with its Schaumburg v. Citizens for a Better Environment decision. The court struck down an Illinois city ordinance that had prohibited charitable organizations from soliciting contributions unless 75% or more of their revenue was used directly for charitable purposes, rather than for salaries, administration and overhead costs.

The city of Schaumburg had defended that ordinance by contending it regulated conduct involving commercial transactions and was necessary to prevent fundraising for fraudulent causes. The Supreme Court rejected this characterization, asserting that fundraising is a form of protected speech because it is intertwined with informative and perhaps persuasive speech seeking support for particular causes or for particular views on economic, political, or social issues.

The court further noted that without the right to seek and receive donations, the flow of information and advocacy would likely cease.

Several campaign finance rulings have reinforced the Schaumberg ruling.

The best-known among them is Citizens United v. Federal Election Commission. Two other key rulings are Buckley v. Valeo, which preceded the Schaumberg case, and McCutcheon v. Federal Election Commission. All three established that contributions to political candidates, and spending by those candidates, is a form of speech protected by the First Amendment.

In the eyes of the law, seeking donations and making contributions are two sides of the same coin. The Supreme Court has said that both are important ways to show support for political preferences, advance ideas and advocate for policy changes.

The First Amendment right to solicit or give funds is not limited to charitable organizations or candidates. Simply panhandling on the street, the most basic form of soliciting funds, is entitled to First Amendment protection, according to several lower federal courts.

The Supreme Court has also held that the freedom of association principle embodied in the First Amendment protects the right to support a cause by making donations or paying dues.

Based on the freedom of association, which includes the right to join together with others for social or political purposes, the court has been very protective of the right of donors to remain anonymous. That has especially been the case for donors who support controversial causes and when revealing their identity might subject them to harassment, threats, public hostility or other forms of reprisal.

In 1958, the Supreme Court ruled in NAACP v. Alabama that the First Amendment barred Alabama from forcing the NAACP to disclose the names of its members or donors who resided in the state. The court pragmatically recognized that compelling disclosure of supporters of a civil rights group in Alabama in the 1950s could endanger the donors.

This First Amendment principle of protecting the speech and the rights of donors to fund charitable causes guards both sides of the political spectrum.

In July 2021, for example, the Supreme Court decided a case brought by two organizations considered to be conservative: the Americans for Prosperity Foundation and the Thomas More Law Center. The two organizations challenged a California law that required them to disclose the names of their donors who gave more than $5,000.

California tried to justify this law as necessary to prevent fraud by registered charities the same preventing fraud rationale that Schaumburg had unsuccessfully asserted as the reason it needed to restrict charitable solicitation.

Relying on the NAACP case among others, the Court held in Americans for Prosperity Foundation v. Bonta that the compelled disclosure requirement violated the donors right to freedom of association.

Based on this body of law, the First Amendment protects the right of abortion funds to seek contributions and to make contributions to individuals in Texas and other states where abortion is illegal to support their activities. The First Amendment also protects the right of people to make donations to abortion funds.

A 2021 Texas law known as Senate Bill 8 prohibits aiding and abetting an abortion after six weeks into pregnancy. The measure specifically mentions providing financial assistance as a form of aiding and abetting.

The law authorizes any person in the world to bring a civil damages lawsuit against anyone who aids and abets an abortion, and to recover attorneys fees in addition to at least $10,000.

One reason why abortion funds might be leery right now is that Texas law permits someone to seek a court order to force others to hand over information that might provide a basis for suing them.

Two individuals have already sought such an order to require the Lilith Fund to disclose information about its funding and donors in order to determine if they violated the 2021 restriction on aiding and abetting an abortion by giving money.

The Thomas More Law Society the same organization that successfully asked the Supreme Court to protect it from having to disclose its donors is representing the people seeking donor information from the Lilith Fund, and tweeted that Lilith Fund donors could face legal action for violating the Texas abortion laws aiding and abetting prohibition.

A Texas trial court judge has found that the provisions authorizing anyone to sue someone who provides or aids and abets an abortion likely violate the Texas Constitution, and has temporarily enjoined the law, meaning that it is on hold pending appeal.

The case is likely to go to the Texas Supreme Court. How that court rules will have a great impact on the liability risk faced by the Lilith Fund for providing financial assistance to women to help them get an abortion. While the legal process is playing out, the Lilith Fund is trying to minimize its legal risk by suspending the distribution of money to women.

If the Texas appellate courts eventually uphold S.B.8, the ban on providing financial assistance to Texas women could be enforced. In that event, the Lilith Fund would be able to make a strong case that they dont need to reveal any information because of First Amendment protections.

If states try to punish abortion funds or individuals for providing a woman with financial assistance to get an abortion in another state where it remains legal, including the money required to travel there, that would likely violate the Constitution.

Giving money to people who want to obtain a legal abortion would not be aiding and abetting a crime. Moreover, the Constitution protects the right to interstate travel. The freedom to cross state lines is a right deeply embedded in U.S. history dating to the Articles of Confederation, prior to the Bill of Rights.

Assisting someone with obtaining a legal abortion by giving them money also could be protected as a form of free speech because it can be one aspect of advocating for and supporting the right to legal abortion. Disbursing these funds could also be protected under the Constitution as an aspect of the freedom to associate with women who seek legal abortions by giving them financial support.

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Donating to help women get abortions is a First Amendment right protected by Supreme Court precedents - The Conversation

Trumpists Call on Supreme Court to Let States Establish Religion Within Their Borders – Rolling Stone

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America First Legal (AFL), a right-wing group whose team includes several former Trump administration officials, is urging the Supreme Court to do even more to shatter whats left of the wall between church and state.

On Tuesday, June 28, the group issued a statement essentially calling for a total overhaul of the First Amendments establishment clause, a key provision separating church and state. The statement arrived one day after the Supreme Court cracked part of the clauses foundation with its ruling in Kennedy v. Bremerton. In that case, the courts far-right majority ruled that public school officials in Bremerton, Washington, violated the First Amendment rights of high school football coach Joseph Kennedy when they fired him following a controversy stemming from his ritual of praying at the 50-yard line during football games. The 6-3 decision effectively overruled a 1971 precedent for interpreting the First Amendments establishment clause.

While the establishment clause exists to keep the government from establishing an official religion in the United States, or doing anything that might favor one religion over another, the AFL is now hopeful that the Supreme Court will eventually disincorporate the establishment clause in a future case. Doing so, the AFL suggests, would allow states to decide whether and to what extent they will establish religion within their borders.

The AFLs vice president and general counsel Gene Hamilton a former Trump official in the Departments of Justice and Homeland Security, whose hits include axing DACA and helping create the infamous family separation policy argued in a statement that the original intent of the establishment clause was to let the states decide just how much they want to separate church and state.

We are pleased that the Supreme Court decided in Coach Kennedys favor, Hamilton said. Perhaps the Court will, in a future case, finally restore the original meaning of the Establishment Clause and disincorporate it as to the states. But for today, we celebrate with Coach Kennedy and all Americans who value religious freedom.

Allowing individual states to establish their own official religions is just one possible tidal wave-sized ripple that could follow Kennedy v. Bremerton. Considering the current Courts apparent disdain for established precedent, it could also pave the way for overturning the landmark 1962 case that ruled prayer in public schools was unconstitutional.

Kennedy v. Bremerton is also just one of two major SCOTUS rulings this term to take a crack at the long-established boundaries between church and state. Earlier in June, the right-wing majority ruled in Carson v. Makin that taxpayer money from a tuition assistance program in Maine could be used to send kids to private religious schools.

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Trumpists Call on Supreme Court to Let States Establish Religion Within Their Borders - Rolling Stone

First Amendment to the Constitution | Community | hometownsource.com – ECM Publishers

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Do Not Expect Section 230 And The 1st Amendment To Save Antitrust Bills From Abuse – Techdirt

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from the fix-the-damn-bill dept

Over the last few weeks, weve written quite a bit about the American Innovation and Choice Online Act (AICOA), which has become the central push by a bunch of folks in Congress to create a special antitrust bill for big tech. There are some good ideas in the bill, but, as weve been highlighting, a major problem is that the language in the bill is such that it could be abused by politically motivated politicians and law enforcement to go after perfectly reasonable content moderation decisions.

Indeed, Republicans have made it clear that they very much believe this bill will enable them to go after tech companies over content moderation decisions they dislike. Most recently, theyve said that if the bill is clarified to say that it should not impact content moderation, that they will walk away from supporting the bill. That should, at the very least, give pause to everyone who keeps insisting that the bill cant be abused to go after content moderation decisions.

We recently wrote about four Senators, led by Brian Schatz (with Ron Wyden, Tammy Baldwin, and Ben Ray Lujan), suggesting a very, very slight amendment to the bill, which would just make it explicit that the law shouldnt be read to impact regular content moderation decisions.

In response to that Schatz letter, Rep. David Cicilline (who is spearheading the House version of the bill, while Senator Amy Klobuchar is handling the Senate side), sent back a letter insisting that Section 230 and the 1st Amendment already would prevent AICOA from being abused this way. Heres a snippet of his letter.

Moreover, even if a covered platforms discriminatory application of its terms of servicematerially harmed competition, the Act preserves platforms content-moderation-relateddefenses under current law. Section 5 of S. 2992 states expressly that [n]othing in this Act maybe construed to limit ... the application of any law.

One such law is Section 230(c) of the Communications Decency Act. Under thatprovision, social-media platforms may not be treated as the publisher or speaker of anyinformation provided by another information content provider. They also may not be heldcivilly liable on account of any action voluntarily taken in good faith to restrict access to oravailability of material that the provider or user considers to be obscene, lewd, lascivious, filthy,excessively violent, harassing, or otherwise objectionable, whether or not such material isconstitutionally protected. Accordingly, as with other liability statutes enacted since thepassage of Section 230, Section 230 provides an affirmative defense to liability under [the Act]for ... the narrow set of defendants and conduct to which Section 230 applies. Another stillapplicable law is the First Amendment to the U.S. Constitution, which the Act does notandindeed, cannotabrogate.

He then goes on in more detail as to why he believes the bill really cannot be abused. And while he does note that that he remains committed to doing what is necessary to strengthen and improve the bill and that he is happy to keep working with these Senators on it, the very clear message from his letter is that hes pretty sure the bill is just fine as is, and that Section 230 and the 1st Amendment already protect against abuse.

Finally, your proposed language for the Actalthough well intentionedis alreadyreflected in the base text of the bill. As detailed above, among other things, section 5 of S. 2992preserves the continued applicability of current laws, including 47 U.S.C. 230(c), that protectsocial-media platforms from liability for good-faith content moderation. Although I agree thatlegislation is necessary to address concerns with misinformation and content-moderationpractices by dominant social-media platforms, I have consistently said that this legislation is notthe avenue for doing so. As such, this legislation is narrowly tailored to address specificanticompetitive practices by dominant technology firms online. And as the Department of Justicehas noted, it is a complement to and clarification of the antitrust laws as they apply to digitalmarkets. As such, it does not supersede other laws.

Except Cicilline is wrong. Very wrong. We at the Copia Institute this week signed onto a letter from TechFreedom and Free Press (two organizations that rarely agree with each other on policy issues) along with some expert academics explaining why.

The letter explains why Cicillines faith in Section 230 and the 1st Amendment is misplaced. It walks through, step by step, ways in which motivated state AGs (or even the DOJ) might get around those concerns, by claiming that moderation decisions were not actually content-based decisions, but business conduct, focused on anti-competitive behavior.

We dont have to look far to see how that played out: the Malwarebytes case was an example of that in action. That was a case where a company was able to avoid Section 230 by claiming that a moderation decision (calling an app malware), was actually done for anti-competitive reasons. But with AICOA, we could get that on steroids. As the letter notes:

There is a substantial risk that courts will extend the Malwarebytes reasoning to exclude AICOA claims from Section 230 protectionincluding politically motivated claims aimed at content moderation. Specifically, courts may try to harmonize the two statutesi.e., strive to give effect to bothby accepting some showing of anticompetitive results as sufficient to circumvent Section 230(c)(2)(A) in non-discrimination claims.

Anticompetitive animus is not required by the plain text of AICOA 3(a)(3). Allowing only AICOA claims that allege (and, ultimately, prove) anticompetitive motivation to bypass Section 230s protection would infer an intent requirement where Congress chose not to include one. While courts do sometimes infer intent requirements, they may reasonably conclude that doing so here would effectively read Section 3(a)(3) out of the statute. How could a platform with no direct stake in the market where competitive harm is alleged ever have an anticompetitive intent? Thus, how could any plaintiff ever bring a Section 3(a)(3) claim regarding harm to competition between downstream business users that would survive Section 230(c)(2)(A)? For Rep. Cicillines presumptions about Section 230 to be correct, courts would have to effectively render Section 3(a)(3) a nullity by holding that only claims of self-preferencingbut not discrimination between other business usersare actionable. This is an implausible reading that clearly contradicts what the present draft of AICOA says.

The Malwarebytes court relied heavily on Section 230s history and purpose as evincing Congressional intent to protect competition. Here, there is explicit statutory language and legislative history from which a court could conclude that AICOAs purpose is to prohibit anticompetitive results, regardless of motiveand thus to carve those claims out from Section 230. This result would apparently be statutorily required if another bill co-sponsored by Sen. Klobuchar becomes law: The SAFE TECH Act (S. 299) would amend Section 230 to exempt any action brought under Federal or State antitrust law.

Theres a lot more in the letter, but the point is clear. The idea that 230 will magically stop the abuse of this bill seems contradicted by the way the law is currently drafted, and actual cases on the books.

Filed Under: 1st amendment, aicoa, amy klobuchar, ben ray lujan, brian schatz, content moderation, david cicilline, ron wyden, section 230, tammy baldwin

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Do Not Expect Section 230 And The 1st Amendment To Save Antitrust Bills From Abuse - Techdirt

Did George Washington Violate the First Amendment?, by Terence P. Jeffrey – Creators Syndicate

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Did George Washington in his first act as president violate the first principle soon to be enshrined in the First Amendment?

Did the Congress that approved the First Amendment compel him to do so?

On April 7, 1789, three weeks before Washington was inaugurated, the Journal of the Senate reported that the Senate had ordered "a committee ... to take under consideration the manner of electing Chaplains, and to confer thereupon with a committee of the House of Representatives."

On April 15, 1789, the committee reported back: "That two Chaplains, of different denominations, be appointed to Congress, for the present session, the Senate to appoint one, and give notice thereof to the House of Representatives, who shall, thereupon, appoint the other; which Chaplains shall commence their services in the Houses that appoint them, but shall interchange weekly."

Two days later, the House concurred.

Then, on April 25, 1789, the Journal of the Senate reported: "The Senate proceeded to the appointment of a Chaplain, in the manner agreed upon the 15th of April; and (t)he right reverend Samuel Provoost was elected."

Two days after that, the House resolved: "That this House will, on Friday next, proceed by ballot to the appointment of a Chaplain to Congress on the part of this House."

Two days after that, the House agreed to a resolution, already adopted by the Senate, that said: "That after the oath shall have been administered to the President, the Vice-President and members of the Senate, the Speaker and members of the House of Representatives, will accompany him to St. Paul's Chapel to hear divine service performed by the Chaplains of Congress."

The Congress was then meeting at Federal Hall in New York City.

On April 30, 1789, Washington stood on the balcony of that hall and was sworn in as this nation's first president.

"Washington took the oath with his hand on the Bible, and kissed the Bible after taking the oath," says the Mount Vernon website.

The Journal of the Senate includes the text of his inaugural address.

"(I)t would be peculiarly improper to omit, in this first official act," said Washington, "my fervent supplications to that Almighty Being who rules over the universe who presides in the councils of nations and whose providential aids can supply every human defect, that his benediction may consecrate to the liberties and happiness of the people of the United States, a government instituted by themselves for these essential purposes: and may enable every instrument employed in its administration to execute with success, the functions allotted to his charge.

"In tendering this homage to the Great Author of every public and private good, I assure myself that it expresses your sentiments not less than my own; nor those of my fellow citizens at large, less than either," Washington continued.

"No people can be bound to acknowledge and adore the invisible hand, which conducts the affairs of men, more than the people of the United States," he said.

Washington then followed through on the resolution Congress had passed earlier that week.

"The President, the Vice President, the Senate, and House of Representatives," reports the Journal of the Senate, "then proceeded to St. Paul's Chapel, where divine service was performed by the Chaplain of Congress, after which the President was reconducted to his house by the committee appointed for that purpose."

In 1983, the Supreme Court heard the case of Marsh v. Chambers. The issue then was whether the Nebraska state legislature had violated the First Amendment and established a religion by having a chaplain begin its sessions with a prayer.

The court voted 6-3 that it had not. Chief Justice Warren Burger wrote the opinion for the majority. In this opinion, Burger pointed to the historical fact that the House and Senate first elected their chaplains in April 1789 and voted later that same year to pay them a salary.

"A statute providing for the payment of these chaplains was enacted into law on September 22, 1789," he noted.

"On September 25, 1789, three days after Congress authorized the appointment of paid chaplains, final agreement was reached on the language of the Bill of Rights," said Burger. "Clearly the men who wrote the First Amendment Religion Clauses did not view paid legislative chaplains and opening prayers as a violation of that Amendment, for the practice of opening sessions with prayer has continued without interruption ever since that early session of Congress."

Burger noted that James Madison personally supported the payment of congressional chaplains.

"It bears note," said Burger, "that James Madison, one of the principal advocates of religious freedom in the Colonies and a drafter of the Establishment Clause ... voted for the bill authorizing payment of the chaplains."

The Establishment Clause says: "Congress shall make no law respecting an establishment of religion."

If the men who wrote the Establishment Clause also voted to pay for a chaplain to work for the very Congress in which they served, how can an assistant football coach at a public school violate the Establishment Clause by personally saying a prayer after a game?

He cannot.

The Supreme Court this week decided this question correctly. But three justices Sonia Sotomayor, Elena Kagan and the retiring Stephen Breyer voted the wrong way.

Which side would incoming Justice Ketanji Brown Jackson have taken?

We now live in a nation where fundamental rights remain just two or three votes shy of cancellation.

Terence P. Jeffrey is the editor-in-chief of CNSnews.com. To find out more about him, visit the Creators Syndicate webpage at http://www.creators.com.

Photo credit: MikeGoad at Pixabay

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Did George Washington Violate the First Amendment?, by Terence P. Jeffrey - Creators Syndicate