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Psilocybin Designated As A “Breakthrough Therapy” For Major Depressive Disorder (MDD)

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In Brief

  • The Facts:

    Numerous studies have proven the efficacy of treatment using psilocybin for various mental health disorders including depression. It has now been labelled as a "breakthrough therapy" by the FDA. More research is underway.

  • Reflect On:

    Early research is promising, but is still in it's infancy. At the end of the day, people still need to do the inner work and not be completely reliant on substances outside of themselves, although they can be a good source of assistance.

The US Food and Drug Administration (FDA) has recently granted psilocybin treatment (the active component of magic mushrooms) a Breakthrough Therapy classification for the second time this year. They are hoping to accelerate trials that will test its efficacy in treating major depressive disorder (MDD).

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According to the FDA, a breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.

This new designation of psilocybin as a Breakthrough Therapy for MDD recognizes the hugely unmet medical need in the large population of those who suffer as well as the potential for improvements to the current treatments and therapies. This is being coordinated by a non-profit research organization, the Usona Institue.

“The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients, which Usona is now seeking to confirm in its own clinical trials. What is truly groundbreaking is FDA’s rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies,” says Charles Raison, MD, Director of Clinical and Translational Research at Usona. “Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices.”

The Multidisciplinary Association for Psychedelic Studies (MAPS) has done numerous studies over the years involving psilocybin for treating various disorders including addiction, depression and use in palliative care.

The new status given to psilocybin follows the launch of Usona’s Phase 2 clinical trial, which will involve 80 participants and seven study sites across the US. 2 of the 7 sites are recruiting and the rest should be active within the first quarter of 2020.

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The methodology is comparable to other therapeutic studies involving psilocybin — preparatory psychotherapy sessions before the active psychedelic dose is administered, followed by a number of integrative psychotherapy sessions after.

The trial will investigate the effects of a single dose of psilocybin and its efficacy in treating general depressive episodes.

The current Phase 2 trial should be completed by the beginning of 2021 and with the assistance of the Breakthrough Therapy classification from the FDA, it should be able to move into much larger Phase 3 trials, if the results from Phase 2 are positive.

“Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices,” says Raison.

Previous Research

In an attempt to treat depression, researchers from Imperial College, London gave 12 patients psilocybin. The 12 patients who were chosen had been clinically depressed for an average of about 18 years and the results were actually quite remarkable. The results from the psilocybin treatment actually succeeded the typical pharmaceuticals that are prescribed to treat depression like selective serotonin reuptake inhibitors (SSRIs) and electroconclusive therapy. Just 1 week after taking the magic mushrooms, all 12 patients from the study reported feeling better, and checking in 3 months later, 5 of them were in complete remission. Quite impressive from only one dose.

“That is pretty remarkable in the context of currently available treatments,” says Robin Carhart-Harris, a neuropsychopharmacologist at Imperial College, London and first author of the latest study, which is published in The Lancet Psychiatry.

A Step In The Right Direction

Although many people may oppose regulation of this treatment by the FDA, we have to applaud how far this research has come in such a short time. If psilocybin assisted psychotherapy becomes legal, this has the potential to benefit millions who have not benefited from traditional methods of treatment for depression. This groundbreaking research has the ability to save lives.

Of course, many have benefited from doing their own research with themselves as guinea pigs, myself included. I am not suggesting anyone try this, as these treatments should be implemented under the guidance of professionals who have the proper tools to assist you through the process.

But speaking from experience, there is a tremendous opportunity available here, to help those who are suffering as the experience helps to take you outside of yourself. It often causes a major perspective shift and deep insights into ones life. Of course this isn’t always the case and it is very important to note that psychedelic therapies are not a one size fits all approach and they are not recommended for everyone. Furthermore, it’s simply a tool to be used and perhaps shouldn’t be looked at as a ‘cure.’ Ultimately, we all have to do the inner work in order to feel better instead of constantly relying on something outside of ourselves.

Once these laws are passed than this treatment will be more accessible and can be administered responsibly with the assistance of trained professionals.

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Awareness

Alcohol Is Killing More People Than The Opioid Epidemic. So Why Aren’t We Talking About It?

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In Brief

  • The Facts:

    Alcohol related deaths are the third leading cause of preventable deaths in the US.

  • Reflect On:

    Should we be glamorizing the consumption of alcohol in the media and in advertisements? Is it time to get real about the potentially life threatening risks of this drug?

In recent years, we have been hearing a lot about the opioid epidemic that is sweeping the nation. The Center for Disease Control reported that over 47,000 people died in the United States alone from an opiate overdose in 2017, that is almost 5 times the amount of deaths caused by opiates in 1999. This is important, and yes it is good this is getting the attention that it deserves. However, in the same year, an estimated 88,000 people died from alcohol related causes — Did anyone hear about that?

Alcohol is the third leading cause of preventable death in the United States, the first is tobacco and the second is poor diet and minimal physical activity. Given this, why aren’t we talking about it? And why don’t we see warning labels on alcoholic beverages? Why are we promoting such a harmful substance? We certainly don’t see huge billboards with people in bikinis popping oxycontin or injecting heroin, because we are well aware that these substances are addictive and can cause harm, so again, why are we openly promoting alcohol? Especially to young people?

Is It Because It’s Legal?

Is it possible that alcohol related deaths do not garner as much of a cause for concern because it is legal, easily available and socially acceptable? Most likely. Alcohol sales reached $253.8 billion in the US in 2018 — this might also have something to do with it.

I’m not suggesting that criminalizing alcohol is a solution to this issue or anything, the same way I don’t see how it’s still against the law to use any drugs at all, regardless of how bad they are for you. I believe that we should have the say in how we treat ourselves and what we put into our bodies, not the government or a legal system. But instead of being portrayed as a harmful substance, like opiates, crystel meth, and crack are — alcohol is glamorized by the media; often being portrayed as sophisticated, fun, sexy and generally just the cool thing to do.

Alcohol Is Basically Encouraged In Our Society

There is no doubt about it, the use of alcohol is deeply ingrained in our culture. So much so, that choosing not to drink is often the more odd thing to do. People will always ask, oh, how come you’re not drinking? As opposed to other drugs, people won’t typically ask, oh why aren’t you smoking meth tonight? Or whatever it may be.

Binge drinking is practically expected on the weekends, and for many people it is a way to unwind, let loose and have fun after a long workweek. Many people justify their consumption this way insisting that it’s fine, because, I don’t drink every day. The thing about alcohol abuse is that it doesn’t have to be every day to be considered a problem or for the person to be considered an alcoholic.

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There are many ways we tend to justify our use, because the thought of giving it up entirely or admitting that we even have a problem can be extremely overwhelming — especially if our entire livelihoods are centered on it.

How Much Is Too Much?

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) created a web site called “Rethinking Drinking” to highlight the amount of misconceptions about what is considered “low-risk” and “high-risk” alcohol consumption. It turns out, more than three drinks in a day or more than seven drinks per week for women and four drinks per day or 14 drinks per week for men are considered “high-risk,” and these patterns can be detrimental both in the short and long-term.

Some people might have an attitude of, I don’t drink at all during the week, so I have all of my allotted alcoholic beverages on the weekend — however, for men consuming 5 or more drinks and for women consuming 4 or more drinks in about a 2 hour period is considered binge drinking.

Is It Time To ‘Rethink That Drink’?

Should we have more campaigns aimed to raise awareness about the potential harm caused by alcohol? Because it is legal it seems to have this view of also being safe, because our government officials and lawmakers always have our best interest at heart, right? 😉 But if we aren’t educating young people effectively on the potential risks associated with alcohol consumption, then perhaps there should be more of an effort to make the risks known on the packaging and even eliminating ads. In my opinion, it simply does not make sense to be legally allowed to advertise something that is so harmful — especially in such a glamorized way.

I don’t know what it’s like now for teens and if it is still considered “cool” to drink and if there is a ton of peer pressure around the whole thing. My hope is that this view will shift, young people will be made more aware of the risks and more people will find the courage to step away from what is no longer serving them or what’s not in their best interest.

Many health advocates and people that are very cautious with regards to what they are putting into their body are still completely overlooking alcohol as a harmful substance. Now, there is no judgment to anyone who chooses to drink, but I think it’s time to take a good hard look at these things and at least have the awareness behind it. Surely, it can be fun from time to time to relax, to loosen up, to be silly, but when we are relying on it to escape our unhappiness from our current situation, well then maybe it’s time to face these situations head on, rather than escape them and change whatever is encouraging us to reach for that glass of wine, whiskey or beer in the first place.

How Can We Support Others?

The fact of the matter remains, many people who drink can do so sparingly, not in excess and not very often. They have a handle on it and it doesn’t interfere with their lives in a negative way. However, for the ones who have struggled — with drinking too much, too frequently, with black outs, it can be difficult to even know if it’s a problem because of how acceptable it is in our society.

If someone says, no thanks I’m not drinking, don’t ask why, and instead try, right on! And no peer pressure. I’ve had problems with drinking, have quit and relapsed twice, currently I’m sober. Before I stopped drinking this time around I would open up to some people about it, questioning my use and whether or not it was harmful, many people would tell me, ahh don’t be so hard on yourself! We are allowed to enjoy life, or shut down from time to time if we need to. If someone is expressing to you that they are concerned they might have a drinking problem, don’t make them second guess themselves, if they are opening up about it please try to support them. We don’t always know what others are going through — apparently even if they flat out tell us. This may also challenge our own relationship with alcohol, but if you can keep that separate.

Do You Have A Problem?

If you are concerned that you might have a drinking problem, you probably do. Keeping in mind that having a problem with alcohol doesn’t necessarily make you an alcoholic. You may have a problem with alcohol if you can identify with any of the following scenarios:

  1. Spending a lot of time obtaining, using, and recovering from the effects of alcohol.
  2. Cravings, or a strong desire to use alcohol.
  3. Being unable to cut down on alcohol use despite a desire to do so.
  4. Continuing to abuse alcohol despite negative interpersonal or social problems that are likely due to alcohol use.
  5. Using alcohol in physically dangerous situations (such as driving or operating machinery).
  6. Drinking more or for a longer time than originally intended.
  7. Continuing to abuse alcohol despite the presence of a psychological or physical problem that is probably due to alcohol use.
  8. Being unable to fulfill major obligations at home, work, or school because of alcohol use.
  9. Giving up previously enjoyed social, occupational, or recreational activities because of alcohol use.
  10. Having a tolerance (i.e. needing to drink increasingly large or more frequent amounts of alcohol to achieve the desired effect).
  11. Developing symptoms of withdrawal when efforts are made to stop using alcohol.

A great way to get things in check is to commit to a period of time without any alcohol consumption and monitor how you feel, what you accomplish, and if you feel uplifted. You may need to ask your friends to support you during this time and have some sober activities prepared! Board games, cards, movies, sports, hiking — all these things can be great sober fun!

If your problem is more severe than this, or you are needing help in any way, reach out to a trusted friend or family member or you may benefit from your local Alcoholics Anonymous meetings for a whole slough of support and resources. If that’s not your jam, check out Hello Sunday Morning for assistance in moderating your use.

My hope is that in the near future it will be more common not to drink and doing so will be more like taking a drug, or having an experience that is typically out of the ordinary.

It is never too late to make a change, first step is to get really honest with yourself…

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Alternative News

Joe Rogan May Take Down The Original Criticism Of “The Game Changers” Documentary

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In Brief

  • The Facts:

    Joe Rogan recently had James Wilks, the maker of "The Game Changers" documentary on to discuss the benefits of a plant base diet and to refute a previous episode where Chris Kresser debunked it.

  • Reflect On:

    When it comes to health, it's important sometimes to suspend what we believe and have been made to believe, and simply look at the information from a neutral perspective.

Joe Rogan has long ‘criticized’ vegans in various ways, and has also emphasized his belief that one cannot be optimally healthy on a vegan diet. He’s done this a number of times, which was hard for some onlookers to watch and listen to who have educated themselves on plant-based diets. Until recently, Rogan mainly focused on guests that were geared towards promoting meat-eating as optimal, and there’s nothing wrong with that, but a balance of understanding and information can go a long way to educating people.

One of the most recent examples of Joe Rogan and his guest ‘”debunking” a plant-based diet came from a critique of a recent documentary that is now airing on Netflix, called “The Game Changers,” made by filmmaker, James Wilks – a retired English mixed martial artist. The film was executively produced by James Cameron, and features interviews with the top scientists and doctors in their field who present an abundance of research and publications showing the benefits of a plant-based diet.

Not long ago, health coach and author Chris Kresser came on the “Joe Rogan Experience” after the documentary received a lot of attention, and the title of the podcast was titled: “Chris Kresser Debunks ‘The Game Changers Documentary.’

For someone like my self who has done a lot of research into the topic, it was frustrating to listen to it given the fact that it was quite clear, for me and others who had actually done thorough research from a neutral standpoint, that Kresser wasn’t really addressing all the facts, and was simply a big believer in what he was saying without even examining the information on the other side.

The challenge is, Rogan’s podcast was listened to by millions of people, and many came away actually believing the information that was said in the original debunking episode – information we later find out was completely incorrect. These types of episodes that massively mislead people are not just an issue with people who have large followings discussing vegan diets and health, but it’s a big issue with many other topics. This is why it was great that Rogan decided to have James Wilks on for a chance to defend his documentary, and the truth is he absolutely destroyed Kresser’s claims that were presented as facts in the previous podcast with Rogan. The best part was Kresser was on the show as well so he had a chance to truly make sure everyone was on the same page.

Wilks addressed every single criticism made by Kresser in the previous episode, from topics such as B12, protein amount, and protein quality, among many others. He also brought up the fact that we shouldn’t be listening to people like Kresser on such topics, but should be relying on properly published peer reviewed research that’s repeatable, non-industry conflicting research, as well as information that comes from the world’s leading scientists in the field of biology and nutrition, many of whom were presented in the Game Changers documentary. Or, people like Wilks, who have throughout done their research.  This episode really exposes how Kresser is not accurate or factual in his position on this topic, an important note for his followers.

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It’s important to keep in mind that not everything Kresser said previously had time to be addressed in this podcast, but it could have been. 100 percent of Kresser’s criticisms that were addressed were 100 percent completely debunked by Wilks, so much so that this is what Joe Rogan had to say via an Instagram post:

If interested, you can watch The Game Changers documentary on Netflix, and check out the podcast in question below.

Some Quotes From The Game Changers Documentary

One of these experts is Dr. Christina Warinner, who earned her Ph.D. from Harvard University in 2010 and received her postdoctoral training at the University of Zurich (2010-2012) and the University of Oklahoma (2012-2014). She became a Presidential Research Professor and Assistant Professor of Anthropology at the University of Oklahoma in 2014, and is currently a Leader in Microbiome Sciences at the Max Planck Institute for the Science of Human History.

Her work has led to some very interesting findings and conclusions:

“Humans do not have any specialized genetic anatomical or physiological adaptations to meat consumption. By contrast, we have many adaptations to plant consumption.” (The Game Changers documentary)

She goes deeper in her presentation at the 2016 International Conference on Nutrition in Medicine, and in this TEDX talk she gave a number of years ago.

Gradual increases in brain sizes of early humans have also been attributed to meat, but research is showing that “because there is not a very strong match between meat consumption and gradual increases in brain size, scientists have looked to other options. And given that plant foods are such an important part of modern humans that hunt and gather foods, the money is on plant foods and shift in the kinds of plant foods as being the major driving factor in increasing brain size.” – Nathaniel J. Dominy

“We have a brain, that just is desperate for glucose. It’s such a fussy organ, that’s the only thing it really takes in for energy. Well, meat is not a very good source of glucose, to have a big brain like this you need to eat something different. And the most efficient way to get glucose is to eat carbohydrates.” – Dr. Mark Thomas, geneticist, University College, London (The Game Changers documentary)

With overwhelming scientific evidence to many of the most common deadly diseases, I discovered that the meat, egg, and dairy industries have been engaged in a covert response, funding studies that deny this evidence while burying their involvement in the fine print. One of the hired guns paid to conduct these studies is Exponent, INC. A company whose research was used by the Tobacco industry to deny the connection between second hand smoke and cancer. For more than 50 years, Exponent has generated studies that challenge the health-risks of everything from asbestos, arsenic and and mercury, to animal foods.” – James Wilks,  “The Game Changers” documentary

“The formula, works beautifully for people selling food, it works beautifully for people selling drugs to treat the diseases that bad food causes, and it works beautifully for the media, which can give us a new story about diet, everyday. But despite the appearance in our media of confusion, there’s massive global consensus about the fundamentals of a health-promoting, and it’s a diet that every time… In every population, every kind of research, it’s a plant food predominant diet, every time.” – Dr. David Katz, Founding Director of Yale University Prevention Research Center (The Game Changers documentary)

A Related CE Articles With More Information: 

Humans Are Not Designed To Eat Meat – Leading Microbiome Scientist Explains

12,000 Doctors Urge The FDA to put Cancer Warnings on Cheese 

Scientist: Milk From Cows Has “The Most Relevant Carcinogen Ever Identified” & “Turns on Cancer”

Scientist Explains How Cow’s Milk Leeches Calcium From Your Bones & Makes Them Weaker

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Awareness

Half of All Commonly Used Drugs Seriously Affect The Gut Microbiome, Scientists Warn

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In Brief

  • The Facts:

    Many commonly prescribed medications have been found to have a drastic affect on the "good bacteria" in our gut.

  • Reflect On:

    It is important to be aware of all potential side effects before taking a new drug to decide whether or not it's worth it for you.

The link between a healthy gut microbiome and overall well-being has been established in recent years as we are learning that around 95% of the serotonin (commonly referred to as the “happy hormone”) produced in our bodies actually comes from our gut! This is one of many reasons why it is important to take care of our health, be mindful of the foods we are eating and be aware of adverse reactions from any drugs we are taking.

A recent study presented at UEG Week 2019 (United European Gastroenterology) has found that 18 commonly prescribed prescription drugs extensively affect the taxonomic structure and metabolic potential of the gut microbiome. Another eight drugs from different categories were also found to increase antimicrobial resistance mechanisms in study participants, and that’s not good.

According to the official press release regarding the findings of the study,

“Researchers at the University Medical Center Groningen and the Maastricht University Medical Center looked at 41 commonly used drug categories and assessed 1883 faecal samples from a population-based cohort, patients with IBD and patients with IBS intermixed with healthy controls. The researchers compared the taxonomic and metabolic functions profiles of drug users to non-drug users, looking at the effect of single medication use and then combined medication use. The changes observed could increase the risk of intestinal infections, obesity and other serious conditions and disorders linked to the gut microbiome.”

In a healthy gut, we all have a microbe population living inside our intestines. This microbe population consists of tens of trillions of microorganisms, which include over 1000 various species of bacteria. There are many different factors that can affect the microbiota population in the human gut, including various forms of medication.

The drug categories that were concluded in the study to have the biggest impact on the gut microbiome are as follows:

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  • Proton pump inhibitors (PPIs) – used to treat dyspepsia which affects between 11% and 24% of the European population. PPIs are also used to treat peptic ulcer, H. Pylori eradication, Gastro reflux and Barrett’s oesophagus.
  • Metformin – used as a treatment for Type 2 diabetes, affecting 10% of European adults
  • Antibiotics – used to treat bacterial infections, taken by 34% of the European population each year
  • Laxatives – used to treat and prevent constipation, affecting 17% of European adults

More Important Findings

The study also showed that the gut microbiota of PPI users resulted in an increased level of upper gastrointestinal tract bacteria as well as increased fatty acid production. Metformin users showed higher levels of bacteria Escherichia coli (E.coli).

The research also showed that seven more categories of drugs were linked to significant changes to the levels of bacteria populations found in the gut. Oral steroids were related to higher levels of methanogenic bacteria, which has is associated with an increased BMI and obesity. Also, certain antidepressant drugs (known as SSRIs) used by those who also suffer from IBS was linked to an abundance of a bacteria species called Eubacterium ramulus, which can be harmful.

Lead-researcher of the study, Arnau Vich Vila said: “We already know that the efficiency and the toxicity of certain drugs are influenced by the bacterial composition of the gastrointestinal tract and that the gut microbiota has been related to multiple health conditions; therefore, it is crucial to understand which are the consequences of medication use in the gut microbiome. Our work highlights the importance of considering the role of the gut microbiota when designing treatments and also points to new hypotheses that could explain certain side-effects associated with medication use.”

Final Thoughts

It is important to understand all potential side effects when deciding on introducing a new drug into our system. The bacteria in our gut is there for a reason and it assists our bodies with many functions and if they are killed off or thrown off-balance it could result in more serious issues down the road.

If you are experiencing any of these issues and taking any of these medications it may be worthwhile to talk to your doctor about it and see if there are any alternative methods for treatment.

Our health is our greatest wealth!

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