Despite Addiction Concerns, FDA Approves Potent New Opioid Painkiller 1,000x Stronger Than Morphine

The Food and Drug Administration has approved a new opioid medication that’s up to 10 times more powerful than fentanyl. Critics say the drug will contribute to the opioid crisis.

The new drug is called Dsuvia. It’s produced by a company called AcelRx Pharmaceuticals Inc. The company says that their opioid is a 3-millimeter-wide tablet of sufentanil designed to be administered under the tongue where it will dissolve. The effects happen fast. The company sees use for acute physical pain in hospitals, surgical centers, emergency rooms, and in battlefield situations.

There are very tight restrictions being placed on the distribution and use of this product. We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia.” – FDA Commissioner Scott Gottlieb

Opioid addiction is often considered to be the biggest crisis in the U.S. More people die from opioid overdoses than breast cancer.

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The company says that DSUVIA will not be sold in retail pharmacies or available for outpatient use. The FDA says that it cannot be used for more than 72 hours at a time. This same drug with the chemical name sufentanil is already available as IV medication and is administered to patients with acute pain who cannot swallow a pill, but this new drug can be used for people who cannot swallow or take an IV. The company

Projected annual sales for the drug are said to be at 1.1 billion dollars. DSUVIA is expected to be available in the first quarter of next year.

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Sperm Counts Keep Declining in U.S. and Europe, New Studies Say

They might have used different methodology and measurements, but two recent studies have come to the same conclusion – male fertility is on the decline. Both studies were premiered at the Scientific Congress of the American Society for Reproductive Medicine (ASRM) in Denver.

The first study is a collaborative effort between private fertility centers in New Jersey and Spain. This study looked at 120,000 men struggling with infertility and found that the percentage of men with a total motile sperm count (TMSC) of more than 15 million declined from 85 percent in 2002-05 to 79 percent in 2014-17. A TMSC under 15 million is considered low, and this study also found that the number of men with an extremely low TMSC (0 to 5 million) increased from 9 to more than 11.5 percent.

The second study comes from researchers at Mount Sinai’s Icahn School of Medicine in conjunction with the California Cryobank and Reproductive Medicine Associates of New York. They looked at 124,000 sperm samples from 2,600 donors between 19-38 from various locations, including Los Angeles, Palo Alto, Houston, Boston, Indianapolis, and New York City. Testing sperm count, sperm concentration, and TMSC, researchers discovered that these numbers declined in almost every location from 2007 to 2017 (New York City was an exception for all three factors, while sperm counts in Boston showed no change).

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This is not news. Scientists from Hebrew University in Jerusalem found last year that sperm counts in the west have more than halved over the last forty years. The average rate of yearly decline is 1.4 percent. At this point, the real news would be the discovery of why. Why are men in the developed world experiencing this loss of fertility? Science still don’t know.

What We Need to Know

There are some theories as to how sperm counts and male fertility are declining in the western world. Some say the lack of exercise and increasing obesity play a part in decreased sperm numbers. Others point to the standard American diet, laced with sugar, soy, and other health-disrupting substances. Chemicals found in everyday items like Bis-Phenol A (BPA) are another common reason floated for the decline of male fertility. Add in smoking, stress, and drinking, and the causes of male infertility look like the textbook definition of an unhealthy lifestyle. Scientists haven’t found the official link between infertility and this kind of lifestyle. This suggests there isn’t one cause for the decline, though.  All of these options are valid and correct. Together they form the conditions needed to effectively slow men’s fertility in its tracks.

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Is This A Bad Thing?

As an environmentalist, I would love this news if the decrease in fertility wasn’t caused by environmental toxicity. Fewer people means less strain on resources, and 2017 study found that potential parents lower carbon emissions equivalent to 58.6 tonnes of CO2 emissions every year by having one fewer child. But lower sperm counts and decreased male fertility negatively affect the lives of the men dealing with them. Individuals struggling with infertility are more likely to develop diabetes, substance abuse disorders, or heart conditions. In a way that strains resources as well, especially in the U.S., where health care costs are a heavy burden on the population. Maybe we should treat infertility as a lifestyle problem, rather than a medical one. Let’s see that study.

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Groundskeeper Accepts Reduced $78 Million Award From Monsanto Cancer Suit

Dewayne “Lee” Johnson, the groundskeeper who was awarded $289 million in a civil suit against Bayer’s Monsanto, has agreed to accept the reduced award of $78 million. Dewayne went to trial on the grounds that the weedkiller Roundup caused his cancer. The jury awarded him $39 million in compensatory damages and $250 million in punitive damages. Superior Court Judge Suzanne Bolanos cut the award by $211 million, stating that punitive damages at more than seven times the size of the compensatory award are not legally justified.

In enforcing due process limits, the Court does not sit as a replacement for a jury but only as a check on arbitrary awards.”

Johnson could have demanded a new trial, but instead, he accepted the reduced award of $78 million. Doctors report he has very little time left to live. Johnson accepted the lower amount in a desire to reach “a final resolution within his lifetime,” spokeswoman Robin McCall told The Associated Press.

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Dewayne “Lee” Johnson, was 42, working as a groundskeeper and pest-control manager in Northern California, when he developed a rash that led to a diagnosis of non-Hodgkin’s lymphoma in August 2014. Court records say duties at work included mixing and spraying hundreds of gallons of Roundup, Monsanto’s glyphosate-based weedkiller.

His attorney disagreed with the judge’s settlement reduction, but Johnson will accept the lower amount in hopes of achieving “a final resolution within his lifetime,” spokeswoman Robin McCall told The Associated Press.

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Bayer acquired Monsanto in June. In an emailed statement Bayer spokesperson Charla Lord told NPR:

The Court’s decision to reduce the punitive damage award by more than $200 million is a step in the right direction, but we continue to believe that the liability verdict and damage awards are not supported by the evidence at trial or the law and plan to file an appeal with the California Court of Appeal.

There is an extensive body of research on glyphosate and glyphosate-based herbicides, including more than 800 rigorous registration studies required by EPA, European and other regulators, that confirms that these products are safe when used as directed.”

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Glyphosate is one of the most widely used and well-known herbicides in the U.S. Reuters reports that Bayer faces about 8,000 more lawsuits on the herbicide.




How To Reverse Climate Change – We Need Grazing Animals For Regenerative Agriculture

Meat consumption is not the problem. It’s how we farm the animals. A Regenerative Secret is a short documentary video that that shows the benefits of regenerative agriculture and exposes how concentrated animal feeding operations are detrimental to our ecosystem. The video is sponsored by Joyce Farms, produced by Finian Makepeace of Kiss the Ground and featuring Dr. Allen Williams, Ph.D, Joyce Farms’ Chief Ranching Officer and a leading expert in soil health and regenerative agriculture.

We need grazing animals. Proper, truly sustainable animal farming methods are what we need to regenerate our soil, and I don’t see this happening if everyone became vegans. The soil needs their dung. Regenerative farming practices can completely restore soil health, and at a rate most do not even know is possible.

If we continue using industrial and even sustainable organic farming methods, we are threatening both the long-term availability of the land to farm as well as our overall health. Regenerative agriculture practices can quite literally regenerate the land by rebuilding the soil, leaving it far better than our generations found it.” – Joyce Farms

Of course, we should radically reduce our meat consumption, which we would have to do if we stopped factory farming. But this is exactly what we need to do to be able to feed the estimated 12 billion people that will inhabit the earth before human population numbers stabilize. We need a lot more soil to grow produce and grains, and that soil needs to be very healthy.

Also, check out this video below for a more indepth explanation. “Desertification is a fancy word for land that is turning to desert,” begins Allan Savory. He reports that “desertification is happening to about two-thirds of the world’s grasslands, accelerating climate change and causing traditional grazing societies to descend into social chaos. Savory has devoted his life to stopping it.”

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Probiotic Bacteria Could the Solution to Antibiotic-Resistant Bacteria

The National Institutes of Health (NIH) has released a new study that confirms the awesome powers of a bacteria commonly found in probiotic supplements: Bacillus. Testing a variety of Bacillus microbes against Staphylococcus aureus, a common cause of antibiotic-resistant infections, scientists found that the beneficial bacteria stopped the S. aureus bacteria from colonizing the gut. Dr. Anthony S. Fauci, M.D. leads the National Institute of Allergy and Infectious Diseases (NIAID), the NIH division responsible for the study.

Probiotics frequently are recommended as dietary supplements to improve digestive health…This is one of the first studies to describe precisely how they may work to provide health benefits. The possibility that oral Bacillus might be an effective alternative to antibiotic treatment for some conditions is scientifically intriguing and definitely worthy of further exploration.”

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Drawing Conclusions

This study came in two parts. The first part examined the behavior of S. aureus in healthy subjects and the second used a mouse model to explain bacillus’ influence on the harmful bacteria. In both cases, researchers found that more bacillus equals less S. aureus. In the initial section of the study, scientists found 200 volunteers in rural Thailand. They first tested them for Bacillus, and then tested for S. aureus. Of the 101 subjects who tested positive for Bacillus, none of them tested positive for S. aureus.

The second portion of the experiment was a mouse study, based on the volunteer findings. The guts of the mice were deliberately colonized with S. aureus. These mice were then fed probiotics every two days, which eliminated the S. aureus colonization. Researchers identified fengycins, a lipopeptide (a molecule that’s part peptide and part lipid), as the reason S. aureus was no longer able to colonize. The lipopeptide shuts down the sensing system the potentially harmful bacteria need to proliferate.

How to Use This News

This information makes a fantastic case for probiotics and more specifically bacillus. Even potentially dangerous bacteria like Methicillin-resistant Staphylococcus aureus (MRSA) are susceptible to those supplements. Bacillus is a widespread bacteria, with more than 200 species found in the air and water. More than half of the rural Thai volunteers from the first portion of the study had bacillus in their guts, and the likelihood that they have an every other day probiotic regimen is very low. People can get bacillus from eating raw, vegetable foods.

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If you want a probiotic though, there are a few things to look for. First, the probiotic does you no good if it doesn’t make it past the stomach acid and bile to make it to the intestinal tract. There are a couple of ways around that. The American Nutrition Association found that Lactobacillus, Bifidobacterium, and Streptococcus are the bacteria most likely to make it past the stomach acid. Another strategy is to find a probiotic with an acid resistant-capsule. That can increase the chances the probiotic will be able to balance the gut and do some good.

Beneath the Surface

We often talk about bacteria in terms of “good” and “bad.” Bacillus, found in most probiotics, is considered a good bacteria. E. coli and S. aureus are considered bad bacteria. Yet E. coli produce vitamin K2 and is a crucial part of a healthy digestive system. Meanwhile, two strains of Bacillus (B. anthracis and B. cereus) cause anthrax and food poisoning, respectively. Scientists have barely discovered what bacteria are capable individually, much less how they work holistically. This study suggests that thinking about how our microbes work together could be a positive, necessary shift…especially with the threat antibiotic-resistant bacteria pose. Antibiotics have been easy and lucrative. But those drugs might not be viable much longer. Are probiotics the best solution?

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Microplastics are In Your Poop

According to a recent study presented at the 26th United European Gastroenterology (UEG) Week, the plastics surrounding the food we eat has now made it into our gut. Researchers from the Medical University of Vienna and the Environment Agency Austria tested eight volunteers from a variety of countries, including Finland, Italy, Japan, the Netherlands, Poland, Russia, the U.K., and Austria. These volunteers were asked to keep a food diary for a week leading up to having a stool sample taken. Of the 8 volunteers, none of them were vegetarian, and six reported eating sea fish. After analyzing the samples they collected, researchers confirmed that every single volunteer had microplastics in their stool. Scientists identified nine different kinds of plastics, including polypropylene (PP), polyethylene-terephthalate (PET), and others. Dr. Philipp Schwabl is the lead researcher who presented the findings at the 26th UEG Week.

This is the first study of its kind and confirms what we have long suspected, that plastics ultimately reach the human gut. Of particular concern is what this means to us, and especially patients with gastrointestinal diseases. While the highest plastic concentrations in animal studies have been found in the gut, the smallest microplastic particles are capable of entering the blood stream, lymphatic system and may even reach the liver. Now that we have first evidence for microplastics inside humans, we need further research to understand what this means for human health.”

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Where Is It From?

The researchers of this study chose to focus on food packaging. Plastic food packaging is everywhere. In 2013, the plastic industry produced 78 million metric tons of packaging and only 28 percent of that was recycled. The amount of non-bottle plastic packaging containers (dairy tubs, deli containers, lids, etc.)  recycled in the U.S. reached nearly 1.3 billion pounds in 2015. If that number is 28 percent of all of the non-bottle plastic in the U.S., the total amount of plastics directly touching deli meats, dips, spreads, sandwiches, and other popular foodstuffs is roughly 4.6 billion pounds. How do you avoid that?

It’s possible to limit your exposure to plastics through the food you eat. Shopping at the farmer’s market, bringing your own packaging to stores, and choosing items packaged in paper or glass are all potential options. That’s not the only way a person is exposed to microplastics, though. Water is another avenue of exposure. An analysis of popular bottled water brands found that 90 percent of them contained microplastics. The actual water bottle could be the source of those pieces, but a study of the water in major metropolitan areas found that 83 percent of samples contained plastic microfibers.

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We Are the Fish Now

Microplastics enter our environment through a myriad of ways, like cosmetics, manufacturing processes, fishing gear, and packaging. Once microplastics are in the water, they are impossible for fish and other marine life (including coral) to avoid and can sometimes even get stuck in gills. These plastics are more than an irritant. They also contain BPA and other similar substances and can disrupt the endocrine system and cause serious health concerns.

We’ve known about plastics pollution in the oceans since the 1960s and 70s. Our use of it has increased dramatically since then. Four years ago, it was estimated there were between 15 and 50 trillion pieces of plastics in the oceans, and scientists have been discovering significant amounts of plastic in whales, birds, and fish. This study is confirmation that we are no different.

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Organic Foods May Lower Cancer Risk According to New Study

JAMA Internal Medicine reported a French study where nearly 69,000 adults completed web-based questionnaires about their diets over three 24-hour periods. People who reported eating more organic foods were less likely to develop certain cancers, compared to people who consumed the least amount of organic foods. Organic consumers were 25 percent less likely to develop cancer during the study. Specifically, organic consumers were 73% less likely to develop non-Hodgkin lymphoma and 21% less likely to develop postmenopausal breast cancer.

After the surveys were completed follow-up time varied but averaged about four and a half years. Participants developed 1,340 cancers. Common cancers included breast cancers, prostate cancers, skin cancers, colorectal cancers and lymphomas.

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People who ate more organic foods were more likely to be married and had higher income and education levels. These participants also consumed less processed meat and alcohol. More than three-quarters of the volunteers were women with average ages in their mid-40s.

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