FDA Warns Against Pain Curing Claims Of CBD Industry

January 29, 2020 / Thomas Cohn, MD

cbd oil When it comes to selling healthcare products, companies often try to walk a fine line between marketing their product and making false claims about the true ability of their product. Oftentimes there are a lot of semantics at play and the Food and Drug Administration rarely intervenes over product claims unless they feel that the consumer is being grossly misled about a product. It appears they recently felt that way over claims made in the CBD industry.

We’ve talked about cannabidiol on the blog in the past, and like CBD, medical marijuana or other relatively new products on the healthcare market, our stance has been pretty similar. We want patients to find a solution that works for them, we want further scientific research to better understand these products, and we want patients to pair passive treatment options with active treatments like exercise and physical therapy. Until we can point to the science behind a product, we’re leery to suggest it as a solution other than to say, if it works for you and isn’t compromising your health, go for it.

CBD For Pain, Cancer and More

That’s not exactly the same sentiment felt by Rooted Apothecary LLC, a company based in Naples, Florida, that has been pushing CBD products on its customers. They are legally selling CBD products, but the FDA and the Federal Trade Commission believes the claims they are making about the effectiveness of the products are misleading and even illegal.

Some of the claims made by the company about their CBD products include such unsubstantiated claims as it can be effective for teething pain and earaches in infants, or that “CBD was effective in killing human breast cancer cells.” They also made claims that CBD has been effective in treating Parkinson’s disease, Alzheimer’s disease and can safely be used in conjunction with opioids. Not only are these claims unsubstantiated by science, but they can put the consumer’s health at risk.

“Cannabis and cannabis-derived compounds are subject to the same laws and
requirements as FDA-regulated products that contain any other substance,” said
Acting FDA Commissioner Ned Sharpless, MD, in a press release. “We’ve sent
numerous warning letters that focus on matters of significant public health
concern to CBD companies, and these actions should send a message to the
broader market about complying with FDA requirements. As we examine
potential regulatory pathways for the lawful marketing of cannabis products,
protecting and promoting public health through sound, science-based decision-
making remains our top priority.”

Whether it’s CBD or another health and wellness product, we recommend that you do your own research and consult with your physician if you have any questions, especially if you’re already trying certain treatments for your pain. If something sounds too good to be true, it probably is. CBD is far from snake oil, but it’s not a magic pill either. Do your research, trust your gut and consult a professional for any questions you have.

How Effective Is Low Dose Naltrexone (LDN) for Pain?

January 19, 2020January 16, 2020 / Thomas Cohn, MD

Naltrexone is an old drug with many uses that was first developed in 1963. Its initial use was for treating opioid addiction. The drug is a derivative of the opioid oxymorphone but acts in the opposite way at regular doses to block the opioid receptors in the body. Naltrexone also has an effect to suppress the desire to consume alcohol, and won approval for this in 2006. The normal dose of naltrexone is 50 mg, while low dose Naltrexone ranges between 1.5 mg to 4.5 mg per day. The use of low dose Naltrexone began in the 1980’s and over the last several years some practitioners have been using this for pain care.

How Naltrexone Works

The use of a drug that blocks opioids to treat pain appears to be counter-intuitive. At low doses, many medications have different properties and effects than when given at higher doses. Medications like Naltrexone seem to decrease the inflammatory response of microglia in the central nervous system. Prolonged painful stimuli impairs the nervous system and the body’s ability to regulate endorphins. Resetting the central sensitivity to pain is what Naltrexone may do, but it tends to work in cases only when there is not ongoing tissue damage or stimulation of inflammatory factors. It would not work in degenerative arthritis or spinal issues causing acting nerve stimulation. The best use is in fibromyalgia, migraines and central sensitization of the nervous system.

The important factors related to low dose naltrexone and pain are that it affects the microglia in the central nervous system. The microglia are immune cells in the CNS and produce compounds that are excitatory and inflammatory. These can result in pain sensitivity, fatigue, cognitive disruption, mood disorders, and general malaise. Naltrexone can have a neuroprotective and analgesic effect in the nervous system by suppressing microglia activity. When pain is being produced by an overactive nervous system, then this medication may be helpful.

Low dose naltrexone is experimental. There is no FDA approval for such dosing but it has been approved for treatment of other medical conditions at doses ten times higher than what is recommended for pain. It is a generic compound, and can be made by a pharmacist into a capsule at some pharmacies. The cost is about $40 a month, it likely would not be covered by insurance and could be considered a reasonable option when other treatments have not been effective for chronic pain, fibromyalgia, central pain states and migraine headaches. The side effect profile is very low, the most common are vivid dreams and tiredness. There is limited hard research on Naltrexone at low dose, but the most common dosing is 4.5 mg once a day, lower doses down to 1.5 mg and higher or more frequent dosing have been used as well. Dosing is based on the drug’s activity in the body and its breakdown and metabolism.

At this time, if one has chronic pain with definite central pain sensitivity, the use of low dose Naltrexone is experimental. If conventional treatments are not effective, it may be worthwhile to consider trying this medication. If one of the main problems one suffers is fibromyalgia, migraines or a similar condition, it may be reasonable to trial this medication. It probably will not be approved by insurance, and you may have to travel to a pharmacy that can prepare the capsules. It has a low risk and it may be helpful.

Why Gabepentin Isn’t A Perfect Solution To Opioids

January 6, 2020 / Thomas Cohn, MD

Roughly one in five Americans suffers from chronic pain, and millions of opioid prescriptions were written just last year alone. However, it has become clear that opioids are far from a perfect solution for chronic pain. Overdoses and cases of addiction have skyrocketed as doctors have tried to help patients find a way to reduce their pain. As we’ve learned more about the dangers of opioids, doctors have begun to turn to different solutions to the chronic pain puzzle, one of which being gabapentin.

Gabapentin is an anticonvulsant drug that was originally designed to prevent seizures, but more recently it’s been used to help prevent neuropathic pain. It also won doctors over because it doesn’t present the same addiction threats as traditional opioids. From 2012-2016, presecriptions for gabapentin increased 64 percent, and now it’s the 10th-most-commonly prescribed medication in the US.

Baclofen, a muscle relaxant, has also become popular as an opioid replacement. Both drugs can produce a “boozelike” high in patients and help drown out some pain signals, and while they are safer in larger quantities than opioids, recent data on the drugs prove they also have their pitfalls. A researcher by the name of Kimberly Reynolds at the University of Pittsburgh and co-authors found that from between 2013-2017, people tried to commit suicide using gabapentin nearly 42,000 times, and countless more misused the drug.

Finding A Balance

When used correctly, these drugs can provide the type of assistance that some chronic pain sufferers need. However, their use needs to be carefully monitored and part of a larger care effort. A doctor can’t just write this prescription and send the patient on their way. There needs to be a coordinated care effort alongside the prescription. Patients need to try other forms of treatment in combination with their medications, because simply taking a passive drug isn’t going to solve the root problem.

Eventually, if you just rely on this drug, you’re going to need higher doses in order to achieve the same level of relief. Similarly, you may experience withdrawal symptoms if you stop taking the drug, which can have adverse effects on a person’s health. Even though these drugs are being championed as safer than traditional opioids, they aren’t a magic pill that will solve your pain. You need to be doing more alongside these medications to truly address the underlying problem. That type of care is something we try to provide to every patient because we truly want them to find a cure, not just short-term relief.

We’re not anti-medications, but they can’t be used as a stand alone option if you want to have the best results treating your chronic pain. And as recent studies about gabapentins show, they aren’t a perfect solution either. You need to develop a comprehensive treatment strategy with a pain specialist like Dr. Cohn if you want to have the best chance of putting your pain in the past. For more information, or for assistance with your pain condition, reach out to Dr. Cohn’s office today.

Gut Biomes Could Help Indicate Fibromyalgia

December 16, 2019 / Thomas Cohn, MD

New research out of Canada found that individuals with fibromyalgia have different gut biomes compared to a control population, shining more light on the difficult to treat condition.

Gut biomes are made up of microorganisms in our gastrointestinal tract and help with bodily processes like vitamin and nutrient absorption, our metabolism, enzyme synthesis, the production of short-chain fatty acids and other health functions. According to new research, the bacteria that make up this internal microbiome are different than normal in patients with fibromyalgia, possibly explaining why the condition causes them problems and why symptoms can be so severe.

“The abundance of some of these bacterial species correlates with the severity of fibromyalgia symptoms—pain, fatigue, cognitive symptoms and impaired sleep,” said first author Amir Minerbi, MD, PhD. “The demonstration of objective findings separating fibromyalgia patients from healthy controls provides convincing evidence that fibromyalgia is a real syndrome.”

Gut Study

For their research, patients used artificial intelligence to analyze the microbiomes of 77 women with fibromyalgia and 79 healthy controls. After adjusting for potential variables like medications, diet and physical therapy, researchers found some interesting differences between the two.

“Variance in the composition of the microbiomes was explained by fibromyalgia-related variables more than by any other innate or environmental variable,” researchers wrote in their report.

Now that we’re aware of the differences, the next set is analyzing the microbiomes and parsing out tests on smaller scales to see if we can identify certain biomarkers in biomes that contribute to an onset or increase in fibromyalgia symptoms. Researchers also believe that patients with fibromyalgia can attempt to adjust their nutritional intake to see if certain foods improve or aggravate symptoms. Food alone isn’t the only way to manage fibromyalgia, but nutrient intake and absorption is an avenue to consider if you’re dealing with painful symptoms related to fibromyaglia.

At the end of the day, there’s still plenty we need to learn about how our microbiomes impact our overall health, but there seems to be a clear link between gut health and fibromyalgia onset. At a minimum, it’s a starting point for furthering our understanding of the condition, and if all goes as planned with future studies, we’ll be able to better understand the relationship between the two in order to provide better care for patients dealing with the difficult to treat condition.

Medical Marijuana Approved For Chronic Pain Patients In Minnesota

December 4, 2019 / Thomas Cohn, MD

Earlier this week, Minnesota regulators announced an expansion to the state’s medical marijuana program, as they added chronic pain and age-related macular degeneration to the list of conditions that can make a person eligible for treatment. The state’s Health Department also said they planned to expand to more sites so patients can have easier access to medical marijuana.

This is a large expansion for the relatively young medical cannabis program here in Minnesota, which began back in 2014. Back then, only nine conditions made the original list of approved conditions. Now, the program has expanded to include conditions like:

PTSD
Cancer
Sleep Apnea
Chronic Pain
Macular Degeneration

Health Commissioner Jan Malcolm said the new conditions were added to give individuals more ways to deal with debilitating illnesses.

“Minnesota’s medical cannabis program tracks patient experiences so we can learn about the real-world benefits and downsides of using medical cannabis for various conditions,” she said in a statement. “The bottom line is that people suffering from these serious conditions may be helped by participating in the program, and we felt it was important to give them the opportunity to seek that relief.”

How To Get Medical Marijuana For Chronic Pain

The changes don’t go into effect until August, so you’ll still need to wait until the second half of next year in order to get medical marijuana for chronic pain. Under the program’s regulations, you’ll also need to get a doctor’s diagnosis in order to be eligible for the medical cannabis program. The state believes it will be easier for patients to get medical approval for chronic pain than for intractable pain, which was already on the approved list, because intractable pain is defined as pain that cannot be removed, only managed, and many doctors are hesitant to slap the label of incurable on a patient.

The state’s acting medical cannabis program director believes there will be a sizable boost in the amount of patients in the program once August rolls around.

“We do know that 20 percent of the U.S. adult population suffers from chronic pain, and so we could apply those numbers to Minnesota’s population, and of course it would be a smaller subset of folks that would be even interested in trying our program,” said program director Chris Tholkes.

It’s interesting to note that while chronic pain and age-related macular degeneration made the list of approved conditions, four other conditions were rejected. Those conditions that didn’t make the cut were anxiety, insomnia, psoriasis and traumatic brain injury.

We’ll continue to share news related to this change as August approaches as we get ready for what we expect to be a sizable shift in how certain patients with chronic pain try to manage their condition.