Health

Delta-8 is the ‘Russian Roulette’ of Cannabis

Published

3 years ago

September 7, 2023

Sept. 6, 2023 – A product derived from cannabis, created in laboratories around the country, has led to thousands of calls nationwide to poison control centers and sent hundreds of people to emergency rooms with complaints of vomiting, hallucinations, not being able to stand, and even passing out.

And it’s widely available and legal.

The culprit is called delta-8 tetrahydrocannabinol or, more commonly, delta-8 THC. Last May, the FDA issued a consumer update warning of serious health risks linked to delta-8 after people took it, including unintentional exposures in children.

Commercially available delta-8 products are created in labs from cannabidiol (CBD) and a broad mixture of chemicals, such as pesticides, petroleum, and unknown ingredients. Because the FDA does not regulate CBD, delta-8 THC products are slipping under the radar in terms of oversight. As delta-8 products land on the shelves of local gas stations and convenience stores, what questions should consumers be asking before making a purchase?

What is Delta-8 THC?

Delta-8 THC is a cannabis plant ingredient and a “cousin” of delta-9 THC, which is the psychoactive component of cannabis – what gives users a “high.” In its purest form, it can go head-to-head with delta-9; they bind to similar receptors in the body, and both produce a high. But unlike delta-9, delta-8 only occurs in trace amounts in the plant, which has limited the ability of manufacturers to use it commercially. This means that the delta-8 found in the neighborhood smoke shop is not the delta-8 found in nature.

The history behind the growth of the delta-8 market can be traced back to the 2018 Farm Bill. A clause let growers cultivate industrial hemp, which included extraction of CBD and other things in the plant that contain less than 0.3% THC. A glut of extracted CBD supply led to a cornucopia of altered products that use household and other chemicals to convert hemp-sourced cannabinoids into synthetic delta-8.

“They’re literally atoms that are rearranged into arrangements that were not created in nature,” said Chris Hudalla, PhD, an analytical chemist and founder and chief scientific officer of ProVerde Laboratories, a cannabis testing lab based in Milford, MA. “They don’t even have a name because they have never been seen before; we have no idea of their toxicity.”

Hudalla’s lab has tested close to 5,000 delta-8 samples, and 100% were contaminated, some with up to 30 types of unintentional secondary products of unknown toxicity.

“It’s a bit like Russian roulette: Every chemist has a different recipe, and every recipe creates a contaminant profile,” Hudalla said. “We literally know nothing about them. We don’t know if they cause birth defects … or whether they cause cancer.”

Ethan Russo MD, a neurologist and researcher who studies how drugs affect the mind and behavior, said that research done in the 1970s, and more recently by Johns Hopkins Cannabis Science Laboratory, has shown that delta-8 is about half as potent as delta-9, meaning that you need twice as much to get the same effects.

But a double dose comes with a host of potential issues, including overdose and a syndrome called cannabinoid hyperemesis, where long-term use might result in repeated, severe bouts of vomiting that can land people in the emergency room.

People who take delta-8 “may not notice toxicity immediately, but we have no idea what the long-term implications of having these products in your body could be,” said Russo, the founder and CEO of CReDO Science, an organization that consults with industry to help design and guide medicinal cannabis research and clinical trials.

Incidentally, the Biden administration recently proposed changing how cannabis is treated in the Controlled Substances Act. The administration calls for moving it from Schedule I status to Schedule III, a category that includes drugs like ketamine and certain steroids considered to have “moderate to low potential for physical and psychological dependence.”

The rescheduling would mean that scientists would have greater access to cannabis for research, potentially opening the door to later legalization of marijuana and, therefore, less consumer interest in delta-8.

Buyers’ Regret: A Host of Dangerous Side Effects

The FDA relies on voluntary reports from consumers, patients, doctors, and other health professionals to monitor for side effects of some products like delta-8. Between December 2020 and February 2022, there were 104 reports of adverse reactions from delta-8. Poison control centers also documented over 2,300 calls about exposures to delta-8 THC over the same period.

But when researchers started to track the social media site Reddit for self-reported effects of delta-8 – reports that never reached the FDA – they discovered that the numbers were significantly higher and included more than 2,000 adverse events and more than 400 serious adverse events, finding:

Over 40% were psychiatric/mood-related (for example, anxiety, delusions, panic attacks, or paranoia).
Roughly 30% involved the lungs, chest, or throat (for example, a choking sensation, painful breathing, coughing, or throat tightness).
22% were general (for example, fatigue; feeling abnormal, with symptoms like heat and jitters; or having secretions).
17% were gut-related (for example, stomach pain/discomfort, diarrhea, gas, nausea, or vomiting).
Almost 9% involved accidental overdose, and 7.5% reported an increase in blood pressure, heart rate, and weight.

Hudalla recalled the case of a young father who had been using delta-8 gummies for months but, one day, decided to double his intake.

“He passed out for a while, and when he woke up, he had a psychotic episode; he literally thought that he had murdered his two children who were sleeping upstairs,” Hudalla said.

Before You Buy

Until the FDA and states start to regulate synthetic delta-8, consumers can take a few steps to protect themselves.

Do your homework. Learn how and where the products are made. Search the web for sources, and directly ask about key ingredients used to make the product and the reputation of the laboratory that produced it.
Examine the label. A reputable product will have a certificate of analysis (COA), a document from an accredited laboratory that confirms that the product meets specific standards. This should contain the product name, the company ordering the testing, batch number, and date it was made.
Limit your purchases to regulated dispensaries. This might be a deal-breaker for people intent on trying delta-8 products, since most of these are sold on the internet or in gas stations and convenience stores, and through illegal channels.
Be mindful.

But even with a certificate, delta-8 makers do not have do not have a standard processes for potency testing.

“The big distinction between delta-8 and other THC isomer products is that there are no requirements for testing,” said Tracey Lancaster Miller, executive vice president of the Maryland-based Peake ReLeaf Dispensary.

Not only is potency unclear, but “it hasn’t been tested for contaminants, so you don’t know if there might be molds or heavy metals, or other types,” she said.

“These products should be prohibited,” Russo said. But “if they are going to be sold, they need to be properly analyzed with certificates of analysis, and they need proper and accurate labeling. Lack of information of danger does not equal safety.”

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Health

Putting a Hole in Our World

Published

2 years ago

May 17, 2024

Desk Report

May 10, 2024 – When we’re young, we take our macula for granted. At the center of our retina – the deepest layer of the eye that’s chock-full of photoreceptors and that confers color to our world – the macula is like a high-resolution camera. As light hits our eyes, the retina’s macula recasts our world in a bloom of color with astoundingly high visual sharpness.

But as you age, your vision dulls. What once stood out sharply becomes foggy, like condensation on a windowpane. After some time, a coal-black smudge or cloudy circular area begins to affect your central vision.

This effective blind spot widens over time if left untreated. What remains is a “macular hole” in the center of your retina.

This unfortunate series of events marks the advanced stage of age-related macular degeneration, a dangerous retinal disease that affects about 20 million people in the U.S., and nearly 200 million people worldwide.

And it’s not getting better. Estimates are that by 2040, the disease may affect nearly 300 million people worldwide. We are very limited in our ability to treat or prevent it. Read on for what to know.

First, What Causes Age-Related Macular Degeneration?

AMD’s causes are varied, and whether it will affect you is mostly determined by age and genetics, said Marco Alejandro Gonzalez, MD, an ophthalmologist and vitreoretinal specialist in Delray Beach, FL.

Because of the different cocktails that we have in terms of our genetic makeup, some people’s photoreceptor cells in the macula “basically start to shut down,” he said.

AMD’s development involves over 30 genes, and if you have a first-degree relative – parent, sibling, child – who has the disease, you’re three times more likely to get it, too.

Gonzalez explained how the expected rise to 300 million cases by 2040 is due mostly to improved diagnostic tools, along with the fact that the world is getting older and living longer. (Usually, an optometrist can detect signs of AMD during a routine eye exam.)

Eye experts still struggle to stop AMD’s most harmful sign – the cause of those muddy, milky, or even coal-colored circles in your central vision: geographic atrophy.

Geographic atrophy can occur in either of the two forms of age-related AMD: “dry” AMD and “wet” AMD.

Nearly every case of AMD begins as the dry kind, affecting 80% to 90% of AMD patients.

Retinal disease expert Tiarnán Keenan, MD, PhD, offered a vivid image of geographic atrophy for those who have dry AMD.

“As time passes, the circular patches of GA expand like a brushfire, taking more and more vision with it, often to the point of legal blindness,” he said.

A researcher in the Division of Epidemiology and Clinical Applications at the National Eye Institute, Keenan recently led a study that tested the efficacy of the antibiotic minocycline in slowing geographic atrophy expansion in dry AMD. The study operated on the grounds that the body’s immune system could be at play in developing the disease.

When your body’s immune system is overactive, microglial cells (central nervous system immune cells) can get into the sub-retinal space and possibly eat away at the macula and its sensitive photoreceptors.

Though minocycline had been shown to reduce inflammation and microglial activity in the eye in diabetic retinopathy, it didn’t slow the expansion of geographic atrophy or vision loss in patients with dry AMD during Keenan’s study.

When asked if microglial activity could have very little to do with the atrophy expansion, Keenan said it’s something to consider: “Maybe microglia are just there as bystanders clearing up the debris … so inhibiting them is less likely to slow down progression.”

In future drug trials, “maybe it’s possible the minocycline or another approach to target microglia would be helpful, but it would be needed in combination with some other therapy and be ineffective by itself,” he said.

Two Sides of the Same Disease

In dry AMD, Gonzalez compares macular degeneration to the loss of pixels on a screen. “Some of those pixels burn out … and that’s the way you lose vision classically in the dry form.”

Wet AMD is a more progressive form of the disease. It causes abrupt vision loss due to abnormal blood vessel growth.

“If you don’t treat wet AMD quickly, it’s game over,” warned Gonzalez. “Wet macular degeneration is the quicker process of vision loss because these blood vessels wreak havoc.” These new blood vessels bleed, causing fluid to build in the macula, which ultimately leads to scarring.

Gonzalez shed light on why wet AMD develops. “The wet form, for some reason, is the body’s last-ditch effort to try to kind of ‘help’ a dying macula. … When these blood vessels start to grow under the retina, they quickly destroy the architecture of the macula.”

Stopping the Bleeding in Wet AMD

Though wet AMD is rarer, it’s more treatable than dry AMD. Signs and symptoms can be eased with various therapies injected into the eye.

Putting it simply, Gonzalez said these therapies to treat wet AMD “all basically do the same thing. They make these new blood vessels regress temporarily before they cause damage to the macula.”

The injected medication clears away those blood vessels and restores the architecture of the macula. People can recover some vision in this way, but it’s only a temporary tune-up, and shots must be given as often as once a month.

“Degeneration of the cells is still the main problem. You’re not stopping that. But degeneration itself is a lot slower than actual vision loss associated with these blood vessels.”

The Struggle in Developing New Treatments

According to Keenan, “nobody has been able to stop geographic atrophy from happening” in either form of AMD. “So, that’s the main work in the field with trials.”

In December 2023, the FDA approved two new drugs: Syfovre and Izervay, both of which only slow geographic atrophy. Degeneration still happens, regardless.

Keenan explained how these two new drugs are “complement inhibitors … given by injection into the eye once a month or so.”

“Complement” refers to the body’s complement pathway, a trigger that activates a cascade of proteins in enhancing immune response.

Clinical trials showed Syfovre slowing the rate of geographic atrophy by up to 22% over 2 years, and Izervay up to 14% over 1 year.

Though these drugs are a new weapon against this troublesome affliction, they aren’t without their complications.

“Anytime you give an injection in the eye, there’s always the risk of an infection because you’re introducing something from the outside. So that’s the biggest risk,” explained Gonzalez.

An infection is uncommon, but potentially devastating, as you can lose your eye altogether. There’s also the chance of a damaging reaction to the shot.

“You have to pick and choose your patients,” said Gonzalez. “Not everybody is a good candidate for those new shots … and the patient is never going to see better. … It’s a harder sell than the ones for wet AMD.”

A Common Protective Measure

Keenan and Gonzalez both have a fair degree of confidence in reducing the risk of AMD with vitamin therapy.

As a bit of background on how vitamins were found to act as a sort of preventive measure, Gonzalez said, “In the early and late ‘90s, there were series of studies which were called the age-related eye disease studies.” These are now referred to as AREDS 1 and AREDS 2.

Researchers proved that a certain cocktail of vitamins slowed down degeneration. The most is a combo of antioxidants: vitamins C and E and lutein and zeaxanthin, all of which are in the AREDS 2 formula.

People who took these vitamins had a lower chance of losing their vision over the next 2 to 5 years. “[The combo] seems to be complementary and additive … with a combined treatment effect of 55% to 60%, an excellent safety record, and very low cost,” Keenan said.

Gonzalez recommends the AREDS 2 formula of vitamins to every patient of his. “It’s such an easy thing to take, and the downside is minimal.”

Unfortunately, if your genes make you more likely to have the condition, a change in diet or vitamin use could have no effect.

Dire? Possibly. But not all is lost in this fight.

Vigilance with AMD and What to Do Next if You’re Diagnosed

Gonzalez is adamant in educating his patients before time has run out on treating AMD. Recognition is key. “The most common reason a lot of these people get to me ‘too late’ is they don’t realize there’s a problem.”

He explained a typical scenario: “Let’s say you have macular degeneration in both eyes at different stages. One of your eyes starts developing wet macular degeneration … so the better eye takes over and you may not notice there’s a problem.”

Even after a patient is diagnosed with AMD, they usually see a specialist only twice a year. Gonzalez often tells his patients to cover one of their eyes to make sure their vision is intact in both eyes. “You’ll be able to pick up on subtle differences” in each eye, he said.

This type of self-care and vigilance can be the difference between successfully living with and treating the disease for the rest of your life, and trying to get help when it’s simply too late.

For wet AMD, as mentioned before, a round of injections is basically what everyone does. Without quick, invasive treatment, the point of no return approaches rapidly.

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Health

Federal Experts Talk Bird Flu ‘What Ifs’ in WebMD Live Event

Published

2 years ago

May 17, 2024

Desk Report

May 16, 2024 – Multiple U.S. agencies are working to contain the recent bird flu outbreak among cattle to prevent further spread to humans (beyond one case reported in early April) and use what we learned before, during, and after the COVID-19 pandemic to keep farm workers and the general public safe.

Fingers crossed, the bird flu will be contained and peter out. Or the outbreak could continue to spread among dairy cattle and other animals, threatening the health and livelihoods of farmers and others who work with livestock.

Or the virus could change in a way that makes it easier to infect and spread among people. If this happens, the worst-case scenario could be a new influenza pandemic.

With so many unknowns, WebMD brought together experts from four federal agencies to talk prevention, monitoring, and what the “what ifs” of bird flu might look like.

Communication with the public “about what we know, what we don’t know, and ways you and your family can stay safe is a priority for us at CDC,” said Nirav D. Shah, MD, JD, the CDC’s principal deputy director. “We at the federal level are responding, and we want the public to be following along.”

People should consult the websites for the CDC, FDA, U.S. Department of Agriculture (USDA), and the Administration for Strategic Preparedness and Response (ASPR) for updates.

It is essential to not only stay informed, but to seek trusted sources of information, Shah said during “Bird Flu 2024 – What You Need to Know,” an online briefing jointly sponsored by the CDC and WebMD.

An ‘Experimental Hamburger’

If one take-home message emerged from the event, it was that the threat to the general public remains low.

The retail milk supply is safe, although consuming raw or unpasteurized milk is not recommended. “While commercial milk supply is safe, we strongly advise against drinking raw milk,” said Donald A. Prater, DVM, acting director for the FDA’s Center for Food Safety and Applied Nutrition.

As for other foods, thoroughly cooked eggs are less risky than raw eggs, and the nation’s beef supply remains free of the virus as well.

For years, federal inspectors have purchased and tested meat at retail stores, said Eric Deeble, DVM, USDA deputy assistant secretary for the Office of Congressional Relations. So far, H5N1, the virus behind bird flu, has not been detected in beef.

The USDA took testing a step further and recently cooked ground beef from dairy cows in their lab. Using what Deeble described as an “experimental hamburger,” the agency showed cooking beef to 165 F or higher kills the virus if it ever becomes necessary.

The federal government now requires all cattle be tested and be free of bird flu virus before crossing any state lines. The government is also reimbursing farmers for veterinary care and loss of business related to the outbreak, and supply personal protective equipment (PPE) like gloves, masks, and face shields to workers.

Vaccination Not Recommended Now

Federal scientists know enough about H5N1 virus to create vaccines against it quickly if the need arises. It’s more about planning ahead at this point. “Vaccines are not part of our response right now,” said David Boucher, PhD, director of infectious diseases preparedness and response at the Administration for Strategic Preparedness and Response.

If the virus changes and becomes a bigger threat to people, “we have the building blocks to produce a vaccine,” Boucher added.

An event attendee asked if the seasonal flu shot offers any protection. “Unfortunately, the flu shot you got last year does not provide great protection from the avian flu,” Shah responded. “It might do a little bit … but that is the vaccine for seasonal flu. This is something more novel.”

Treatments Stockpiled and Ready

Antiviral medications, which if given early in the course of bird flu infection could shorten the severity or duration of illness, are available now, Shah said. The dairy farmer who was infected with bird flu earlier this year responded to oseltamivir (Tamiflu) treatment, for example.

When it comes to bird flu symptoms, the fact that the only infected person reported so far this year developed pink eye, also known as conjunctivitis, is interesting, Shah said. Officials would have expected to see more typical seasonal flu symptoms, he added.

“Influenza is not a new virus,” Boucher said. “With this strain of influenza, we are not seeing any genetic markers associated with resistance to antivirals. That means the antivirals we take for seasonal influenza would also be available if needed to treat H5N1.”

ASPR has stockpiled Tamiflu and three other antivirals. “We do have tens of millions of courses that can be distributed around the country if we need them,” he added.

“Influenza is an enemy we know well,” Boucher said. That is why “we have antivirals ready to go now and many types of PPE.”

Science in Action

The feds intend to stay on the case. They will continue to monitor emergency department visits, lab test orders, and wastewater samples for any changes suggesting a human pandemic risk is growing.

“While we’ve learned a great deal, there are still many things we do not know,” Deeble said.

Shah added, “As in any outbreak, this is an evolving situation and things can change. What you are seeing now is science in action.”

For the latest updates on bird flu in the United States, visit the CDC’s H5N1 Bird Flu: Current Situation Summary website.

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Health

Federal Experts Talk Bird Flu ‘What Ifs’ in WebMD Live Event

Published

2 years ago

May 16, 2024

Desk Report

Or the virus could change in a way that makes it easier to infect and spread among people. If this happens, the worst-case scenario could be a new influenza pandemic.

With so many unknowns, WebMD brought together experts from four federal agencies to talk prevention, monitoring, and what the “what ifs” of bird flu might look like.

People should consult the websites for the CDC, FDA, U.S. Department of Agriculture (USDA), and the Administration for Strategic Preparedness and Response (ASPR) for updates.

An ‘Experimental Hamburger’

If one take-home message emerged from the event, it was that the threat to the general public remains low.

As for other foods, thoroughly cooked eggs are less risky than raw eggs, and the nation’s beef supply remains free of the virus as well.

Vaccination Not Recommended Now

If the virus changes and becomes a bigger threat to people, “we have the building blocks to produce a vaccine,” Boucher added.

Treatments Stockpiled and Ready

ASPR has stockpiled Tamiflu and three other antivirals. “We do have tens of millions of courses that can be distributed around the country if we need them,” he added.

“Influenza is an enemy we know well,” Boucher said. That is why “we have antivirals ready to go now and many types of PPE.”

Science in Action

The feds intend to stay on the case. They will continue to monitor emergency department visits, lab test orders, and wastewater samples for any changes suggesting a human pandemic risk is growing.

“While we’ve learned a great deal, there are still many things we do not know,” Deeble said.

Shah added, “As in any outbreak, this is an evolving situation and things can change. What you are seeing now is science in action.”

For the latest updates on bird flu in the United States, visit the CDC’s H5N1 Bird Flu: Current Situation Summary website.

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