The FDA Just Approved a New Drug Application for Cocaine-Based Nasal Spray

By John Vibes

In a shocking drug approval last year, the U.S. Food and Drug Administration (FDA) approved a ketamine-based nasal spray for treating depression. The news was surprising considering the history that the substance has as a snortable club drug and the strict policy of drug prohibition and regulation in the United States. However, in the short time since, ketamine is slowly becoming more respected as a legitimate treatment for depression in clinical settings.

Meanwhile, other nasal sprays for drugs that were once considered illicit are beginning to reach the market as well.

As the Mind Unleashed reported last month, a pharmaceutical company called Silo Wellness announced that they were developing a nasal spray for psilocybin, the active ingredient in many of the most popular “magic mushrooms.” The psilocybin-based spray is also intended to be used as a treatment for depression.

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Now, in the most shocking FDA approval yet, the agency has approved a cocaine-based nasal spray for use as an anesthetic.

In a January 13 press release, Lannett Company Inc. announced that the FDA approved a New Drug Application (NDA) for the cocaine-based nasal spray which is intended to be used as a local anesthetic for surgeries in the nose cavities.

The drug is called NUMBRINO and is comprised of a patented nasal solution which contains cocaine.

Lannett CEO Tim Crew says that the company is planning full clinical trials to prove the effectiveness of the drug.

“The FDA’s approval of our Cocaine HCl product, the first NDA approval to include full clinical trials in the company’s history, marks a major milestone in Lannett’s 70+ years of operations. We believe the product has the potential to be an excellent option for the labeled indication. We expect to launch the product shortly, under the brand name NUMBRINO®,” Crew said in the press release.

Variations of the cocaine-based solution were tested on 159 patients during the interventional clinical trial. In the treatment of these patients the investigators tested a placebo topical solution against cocaine hydrochloride 4% or 10% as an aesthetic prior to a diagnostic procedure, according to MDMag.

There are certainly many more regulatory challenges that Lannett will need to face in order to bring this drug to market, but the FDA approval of their NDA shows that the drug meets all of the agency’s requirements in the process thus far and that they have a good chance of full market approval.

By John Vibes | Creative Commons |

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Australian Fires Biggest In The World And 5 Times Larger Than Amazon Fires

By John Vibes

The wildfires that are current ripping across Australia have gotten only passing mention in the global media, but they are actually far more serious than similar events in recent years. Very few people around the world are aware of the magnitude of these fires, even when compared to the recent and ongoing fire crisis in the Amazon.

To put the current situation into perspective, about 12 million acres have burned so far in the Australian fires. Meanwhile, just over 2 million acres of land have been burned so far during this year’s fires in the Amazon. 2 million acres is certainly still significant, but it is one part of a wider problem that is impacting ecosystems all over the world.

The graphic above created by Statista, with information provided by the BBC, the New York Times, as well as local fire and rescue organizations, gives a visual illustration of just how big the fires in Australia are. The graphic also notes that 6.7 million acres of land were burned in Siberia.

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The fires have become so large that the resulting smoke has disrupted weather patterns across the continent, and has even caused the glaciers of neighboring New Zealand to turn brown.

As Truth Theory reported in early January, nearly a half-billion animals are estimated to have been killed in the fires since they began in September.

Heavy rains last week gave emergency crews a bit of help in some areas, but over 100 fires are still burning across the country. So far, up to 17 people have died in the fires and an incalculable amount of property damage has occurred.

As Truth Theory reported last month, the fires in New South Wales could be responsible for wiping out all of the koalas in the region, who were already experiencing dangerously low population levels.

According to a report published last year by WWF Australia and the Nature Conservation Council (NCC), koalas were already on their way to becoming extinct in New South Wales due to deforestation, and this was before the fires even began.

John Vibes is an author and journalist who takes a special interest in the counter culture, and focuses solutions-oriented approaches to social problems. He is also a host of The Free Your Mind Conference and The Free Thought Project Podcast. Read More stories by John Vibes

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Trump Administration Announces Nationwide Ban on Most Flavored Vaping Products

By John Vibes

This week, the Trump administration and the U.S. Department of Health and Human Services (HHS) announced that flavored vaping products will be banned across the country.

The measure stopped short of banning all vaping products, and as a result there will still be some openings for consumers who are looking for a flavored nicotine option.

Open tank systems, which allow vape users to refill the fluid with whatever type of liquid they wish, will act as a loophole. Consumers will be able to manually fill their tanks with flavored juice.

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Menthol vaping products, and those that taste similar to cigarettes, will not be affected by the ban.

In a statement announcing the ban, Alex Azar, HHS secretary, said that the measure was aimed at keeping nicotine products away from children:

By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth.

Still, many vape shop owners and others in the industry are concerned that they won’t be able to last through the current regulatory environment. Many activists in the industry have suggested that this change in policy will only make vaping products more dangerous, by pushing them onto the black market.

The Center for Disease Control and Prevention (CDC) published a report in the midst of the vaping scare, saying that black market products, particularly black market THC cartridges, were behind a large number of the vaping related illnesses that were reported in the news.

A statement from the CDC said:

We do know that THC is present in most of the samples tested by the [Food and Drug Administration] to date, and most patients report a history of using THC-containing products. The latest national and state findings suggest products containing THC, particularly those obtained off the street or from other informal sources (e.g. friends, family members, illicit dealers), are linked to most of the cases and play a major role in the outbreak.

The Food and Drug Administration (FDA) also eventually agreed that it was black market products that were responsible for the string of illnesses that caused the scare earlier this year.

Despite the evidence that has been discovered since the initial vaping hysteria began, the U.S. government has still gone forward with banning products that have been shown to play no significant role, if any, in the recent deaths.

In fact, the evidence has shown that bans such as the one to pass this week are what make this kind of product more dangerous.

By John Vibes | Creative Commons |

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Scientists Say Babies Will Grow In Artificial Wombs Within Ten Years

By John Vibes

The abortion debate is once again taking center stage in US politics, and the prospect of artificial wombs is slowly becoming a part of the conversation, as the technology is actually starting to become a reality. According to some experts in the field, we are just a decade away from this type of technology reaching the public.

Dr. Carlo Bulletti, associate professor at Yale University’s obstetrics, gynecology, and reproductive science department, has predicted that a fully functioning artificial womb could be used in the medical field in the next ten years.

Scientists call this Ectogenesis, which is an artificial pregnancy outside of the body. Numerous experiments have tested this process with animals and have been slowly advancing the success rates of the procedure. In the most notable of these experiments, a premature lamb was kept alive for weeks in an artificial womb.

Study: Artificial womb technology and the frontiers of human reproduction: conceptual differences and potential implications

There are still concerns about how a pregnancy like this would impact the health and mental development of the baby, considering the importance of bonding, but many experts insist that artificial births are the future.

In a recent interview with Metro, Dr. Anna Smajdor, associate professor of practical philosophy at the University of Oslo, explained that bonding can happen mentally, but did not address whether or not this could cause developmental issues for the baby.

“Many arguments have been made about the necessity of gestation and childbirth for bonding. Although it may be true that the physical closeness between mother and baby facilitate bonding, it is certainly not true that it is necessary for bonding. If it were, fathers would have no claim to be bonded with their children. Not just this, but it is becoming increasingly clear that traumatic births actually impede maternal bonding, rather than the other way round,” Smajdor said.

“With developments in technology, increasingly, parents describe the moments of special bonding as being when they see the first scans. So this seems to imply that it is a visual connection that is regarded as being important rather than the physical one per se. Ectogenesis could actually facilitate this kind of visual bonding,” she added.

In an article for Wired, Tech writer Matt Chessen said that people in the future will find traditional pregnancy unappealing.

“Most future folk will find pregnancy – especially the delivery of an infant through a birth canal – messy and risky,’ technologist and author Matt Chessen wrote in Wired. ‘Creating a baby inside another human being is hazardous. The child’s health is dependent on the mother’s physical security as she navigates the world, and the fetus is susceptible to infections, poor nutrition, and other threats.” Chessen said.

Some researchers in the field have been even bolder than Bulletti with their predictions.

Last year, academic Elizabeth Chloe Romanis wrote in the BMJ’s Journal Of Medical Ethics that, “It seems probable that we are only several years away from testing on human subjects.”

Dr. Alan Flake, of the Children’s Hospital of Philadelphia, which carried out the most famous Ectogenesis experiment, believes that we could be just a year or two away from seeing this technology in FDA trials.

“We’re in the process of interacting with the [US Food And Drug Administration] FDA, so it’s not impossible that we could be doing a clinical trial one to two years from now,” Flake said.

This strange technology seems like something out of a dystopian film, but it could possibly provide a solution for women with health problems who still want to have children, and it could also make the abortion debate much more interesting in years to come. Although, even if there was an artificial way to continue a pregnancy outside of the body, this would not guarantee that there would be enough qualified parents to raise the children that resulted from all of these additional pregnancies.

IMAGE CREDIT: Matrix Movie

John Vibes is an author and journalist who takes a special interest in the counter culture, and focuses solutions-oriented approaches to social problems. He is also a host of The Free Your Mind Conference and The Free Thought Project Podcast. Read More stories by John Vibes

This article was sourced from Truth Theory.

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Multiple Studies Show That Alcohol Is The Real “Gateway Drug” For Teens

By John Vibes

According to a series of studies that have been conducted by researchers at the University of Florida over the past several years, alcohol is the real “gateway drug” for teens in the United States. This research finally gives some scientific opposition to the popular myth that cannabis is a gateway drug for young people, that supposedly leads them towards more dangerous drugs like meth or heroin.

The first study was conducted in 2012 and was titled, “Alcohol as a Gateway Drug: A Study of US 12th Graders.” In this study, researchers examined surveys of high school students to determine their interest in specific drugs and see how they got involved in the lifestyle. The results showed that a vast majority of the teens tried alcohol before anything else, and that alcohol was the drug that was causing the most trouble for young people.

“The findings from this investigation support that alcohol should receive primary attention in school‐based substance abuse prevention programming, as the use of other substances could be impacted by delaying or preventing alcohol use,” the study concluded.

The second study, which expanded upon these findings was titled “Prioritizing Alcohol Prevention: Establishing Alcohol as the Gateway Drug and Linking Age of First Drink With Illicit Drug Use.”

This new study picked up right where the conclusion of the previous research left off, by seeking to show that an increased focus on the dangers of alcohol in drug education programs would reduce the likelihood that a teenager would start down a path of drug addiction.

The researchers concluded that “Alcohol is the most commonly used substance, and the majority of polysubstance-using respondents consumed alcohol prior to tobacco or marijuana initiation. Respondents initiating alcohol use in sixth grade reported significantly greater lifetime illicit substance use (M = 1.9, standard deviation [SD] = 1.7, p < .001) and more frequent illicit substance use (M = 6.0, SD = 6.5, p < .001) than those initiating alcohol use in ninth grade or later. Overall, effect sizes for these differences were large (eta squared = 0.30 and 0.28, respectively).”

According to the study’s co-author, Adam E. Barry, the later in life that a person consumes alcohol, the less likely they are to abuse drugs. Also, it seems that in most cases, alcohol and tobacco use comes earlier in life than the use of marijuana.

“By delaying the onset of alcohol initiation, rates of both licit substance abuse like tobacco and illicit substance use like marijuana and other drugs will be positively affected, and they’ll hopefully go down,”  Barry said in an interview with Raw Story after the first study.

Barry said that his studies were intended to correct some of the propaganda that has infected American culture since the Reefer Madness era.

“Some of these earlier iterations needed to be fleshed out, that’s why we wanted to study this. The latest form of the gateway theory is that it begins with [marijuana] and moves on finally to what laypeople often call ‘harder drugs.’ As you can see from the findings of our study, it confirmed this gateway hypothesis, but it follows progression from licit substances, specifically alcohol, and moves on to illicit substances,” Barry said.

“So, basically, if we know what someone says with regards to their alcohol use, then we should be able to predict what they respond to with other [drugs]. Another way to say it is, if we know someone has done [the least prevalent drug] heroin, then we can assume they have tried all the others. I think [these results] have to do with level of access children have to alcohol, and that alcohol is viewed as less harmful than some of these other substances,” Barry added.

Is alcohol the real gateway drug for teenagers? One recovered addict thinks so. Hear more from him tonight on News 2 at 6. #TeensAndDrugs

Posted by WKRN-TV Nashville on Thursday, September 28, 2017

It is important to note that in the conclusion of the most recent study, the researchers also seem to advocate for drug testing teenagers and even elementary school students.

“Findings underscore the importance of screening for substance use, even among youth enrolled in elementary/middle school. In addition, school prevention programs should begin in elementary school (third grade) and target alcohol use,” the text of the study said.

While this research is certainly informative, the very idea of a “gateway drug” could be entirely flawed to begin with. Perhaps our society has a “gateway drug effect” because we have a very rudimentary and immature perspective on drugs. As we grow, we are taught that “drugs are bad” and to “stay away from drugs,” which gives the impression that all drugs are on equal ground in terms of danger and physical harm.

Obviously, this is not the case, some drugs are very safe while others are very harmful. To make matters even more confusing, illegal drugs are often less harmful than the legal ones. Perhaps it is this mentality that creates the “gateway drug effect.” According to David Nutt’s breakthrough study “Development of a rational scale to assess the harm of drugs of potential misuse,” alcohol is more dangerous than crack or heroin, while psychedelics and cannabis are some of the safest psychoactive substances in popular use. / David Nutt

IMAGE CREDIT: lacamerachiara

John Vibes is an author and journalist who takes a special interest in the counter culture, and focuses solutions-oriented approaches to social problems. He is also a host of The Free Your Mind Conference and The Free Thought Project Podcast. Read More stories by John Vibes

This article was sourced from Truth Theory.


How To Make A Bee Waterer In Just A Few Minutes For Under 5$

By John Vibes

Bees are an extremely important part of the global ecosystem because they are responsible for pollinating 80% of the flowering crops on the planet, which obviously has a significant impact on the human food supply and all life on the planet.

Beekeeping is a great way to help maintain and regrow bee populations, but that can be an overwhelming investment for many people. Luckily, there is another very easy way that you can help bees, and the supplies will only cost you a few dollars, you may even be able to find most of them around your house.

Bees are always in search of fresh water sources, but there are predators in creeks and rivers, and in deep areas like pools or birdbaths they risk drowning.

Kim Flottum, the editor of the Bee Culture magazine, writes in his book The Backyard Beekeeper: An Absolute Beginner’s Guide to Keeping Bees in Your Yard and Garden:

Water is used to dissolve crystallized honey, to dilute honey when producing larval food, for evaporation cooling during warm weather, and for a cool drink on a hot day.

There are a variety of different ways that you can create a bee waterer, and you can be as creative as possible, but today we will discuss the cheapest and most simple design for people with busy schedules.

All that you will need is a shallow bowl or pan, and a few handfuls of marbles or pebbles. As shown in the video below, just fill the pan with the marbles or pebbles and then fill with water. Make sure that you don’t entirely submerge the marbles, this way the bees will have a surface to stand on.

Next, place the device outside in a shady location, at least a few feet off the ground so they can get their water in peace without fear of predators. To avoid attracting mosquitoes to the area, it is important to change the water often, every day if you can, and clean the bowl and its contents at least once every week.

Experts have warned not to add sugar or honey to the water, because it can cause numerous problems for bee populations, including decreased pollination and even disease.

Last month, Truth Theory reported that actor Morgan Freeman turned his 124-acre ranch in Mississippi into a sanctuary for bees. Freeman said that the bees seem to appreciate his help. He has never been stung while working with the bees, and he doesn’t even wear any protective gear.

John Vibes is an author and journalist who takes a special interest in the counter culture, and focuses solutions-oriented approaches to social problems. He is also a host of The Free Your Mind Conference and The Free Thought Project Podcast. Read More stories by John Vibes

Photo: Intelligent Living

This article was sourced from Truth Theory