Archive for the ‘Pain Management’ Category

Chronic Pain Reprograms Our Immune Systems & Our Brains

https://popularrationalism.substack.com/p/chronic-pain-reprograms-our-immune?

Chronic Pain Reprograms Our Immune Systems and Our Brains

A fascinating study from McGill University suggests that parallel changes methylation occur in both our brains and in our T-cells

James Lyons-Weiler

Oct. 13, 2023

A study from McGill University, titled “Chronic pain changes our immune systems,”, published in the journal Scientific Reports, reveals that chronic pain can alter the way genes function in the immune system. Specifically, the research found that chronic pain changes the DNA marking not only in the brain but also in T cells, which are a type of white blood cell essential for immunity.

The study used rat models and examined DNA from their brains and white blood cells. The researchers mapped DNA marking by a chemical called a methyl group, which is crucial for regulating gene function. This area of study falls under the growing field of epigenetics, which involves modifications that turn genes ‘on’ or ‘off,’ effectively reprogramming how they work.

The researchers were surprised by the extensive number of genes that were marked by chronic pain, ranging from hundreds to thousands. These findings could have implications for other systems in the body that are not normally associated with pain. The study suggests that understanding these epigenetic changes could open new avenues for diagnosing and treating chronic pain.  (See link for article)

_____________

Important excerpt from the study:

This study supports the plausibility of DNA methylation involvement in chronic pain and demonstrates the potential feasibility of DNA methylation markers in T cells as noninvasive biomarkers of chronic pain susceptibility.

For more:

Category:

Pain Management, research

Lyme Pain

https://danielcameronmd.com/lyme-pain/

LYME PAIN

Lyme pain

Welcome to another selection from my book “An Expert’s Guide on Navigating Lyme disease.” The books highlights the findings of my first 600 Lyme disease Science blogs.  In this episode, I will discuss Lyme pain.

By 

Reported pain associated with Lyme disease includes headaches, eye pain, neck pain, chest pain, abdominal pain, bladder pain, joint pain, and neuropathy. More recently, central sensitization syndrome (CSS) has been described. Pain medication may not be as effective as when used for other illnesses. Thankfully, pain often improves upon successfully treating Lyme disease.

CENTRAL SENSITIZATION SYNDROME AND LYME DISEASE.

Chronic pain, debilitating fatigue, and heightened sensory disturbances are common in Lyme disease patients. In the article “Post-Treatment Lyme Syndrome and Central Sensitization,” it is suggested that in some cases, such symptoms may be due to central sensitization syndrome (CSS) (Batheja et al., 2013). Central sensitization syndrome (CSS) involves changes in the central nervous system, particularly the brain and spinal cord. This syndrome “is thought to involve hyperactivation of central neurons, leading to various synaptic and neurotransmitter/ neuromodulator changes” (Batheja et al., 2013).

“Notably, in relation to Lyme disease, infections, in general, are known to activate central sensitization in some patients, possibly through the release of inflammatory cytokines,” Batheja points out. Read more.

LYME PRESENTING AS ABDOMINAL PAIN IN A BOY.

At age 8, a boy was hospitalized for severe abdominal pain and underwent extensive testing, but the results were negative. His abdominal pain remitted over the next two months (Savasta et al., 2020).

One year later, the boy was admitted with learning difficulties including attention deficit, difficulty speaking, irritability, and difficulty walking due to an ataxic gait.

He was diagnosed with abdominal neuroradiculopathy. Additional laboratory and radiological findings confirmed the diagnosis of late Lyme disease.

He was treated with six weeks of oral and IV antibiotics. Three months after treatment, the boy’s gait and scholastic performance had improved and entirely resolved after one year. Read more.

A WOMAN WITH A HISTORY OF LYME WITH PAIN REFRACTORY TO TREATMENT.

Lyme disease patients often suffer from ongoing illness following treatment. A study found that 31% of patients remained in significant pain for months after a three-week course of doxycycline to treat an erythema migrans rash (Bechtold et al., 2017).

Researchers describe a 31-year-old woman with Post-Treatment Lyme disease Syndrome (PTLDS) “whose pain was refractory to treatment options such as radiofrequency ablation, vitamin infusion therapy, opioid analgesics, and other pharmacotherapies.” Her pain began gradually, three years prior and a short time after being diagnosed and treated for Lyme disease. “The patient complained of diffuse body pain (6–7/10), fatigue, headache, and brain fog (7–8/10)” (Hanna et al. 2017).

The patient was prescribed off-label Ketamine for pain, reducing her pain by 71%. Read more.

BREAST CANCER PATIENT DEVELOPS LYME DISEASE.

A 61-year-old woman was diagnosed with stage II breast cancer with lymph node metastasis. She underwent a lumpectomy, followed by chemotherapy, radiation, and anti-estrogen treatment, letrozole.

One year later, the woman complained of radicular leg and back pain followed by a foot drop on one foot and right-sided facial palsy in two weeks. Moreover, she was in severe pain despite narcotics.

A spinal tap was performed due to unexplained neurologic findings. Lyme disease tests by blood and spinal fluid were positive.

She was diagnosed with Lyme disease and treated with intravenous ceftriaxone for 14 days. As a result, she became pain-free despite her history of severe pain despite narcotics. Read more.

LYME PRESENTING WITH SEVERE NEUROPATHIC PAIN.

A 36-year-old man suffered from a chronic pain syndrome associated with Post-Treatment Lyme Disease Syndrome (PTLDS) (Karri and Bruel, 2020). The doctors did not offer antibiotic treatment.

The patient described severe neuropathic pain in both feet and categorized the pain at a level 10 out of 10 despite treatment with methadone 5 mg every 4 hours as needed. The doctors assumed that the tick-borne infection had resolved, and elected not to treat it with antibiotics.

Instead, they treated the patient’s symptoms. The pain remained severe despite trials of gabapentin, duloxetine, bupropion, and narcotics. Two surgical procedures were performed, which improved the patient’s pain.

Author’s note: I might have retreated with an antibiotic. Read more.

LYME DISEASE CASE WITH SEVERE PAIN FOR 9 YEARS.

In an article published in Saudi Journal of Anaesthesia, doctors describe the case of a 23-year-old woman who suffered from severe chronic pain for 9 years due to post-treatment Lyme disease syndrome (PTLDS). Her pain intensified and became more difficult to manage after she underwent dental extractions and required hospitalization.

Out of 19 symptoms associated with Post-Treatment Lyme Disease Syndrome (PTLDS), 9 were especially significant and included fatigue, joint pain,  focusing/concentration, muscle pain, memory, finding words, sleep, neck pain, and irritability. The remaining symptoms were paresthesias (tingling sensations), low back pain, headache, photophobia, dizziness, visual clarity, chills, coordination, sweats, fasciculations (muscle twitches), breathing difficulties, urination changes, and nausea (Rebman et al., 2017).

Two participants met the criteria for postural orthostatic tachycardia syndrome (POTS). Results from the physical exam and laboratory testing of our sample of patients with PTLDS did not show a pattern of significant objective abnormalities.” However, “the most notable exception was the higher rate of diminished vibratory sensation on physical exam among participants with PTLDS. Read more.

LYME DISEASE PAIN AFTER DENTAL SURGERY.

Despite an uneventful extraction of four molars, a woman complained of severe widespread pain. Her pain medication list was extensive. The woman’s oral pain was minor, while her main issue was overall body pain (Lim and Kinjo Lim 2018).

Although the physicians used a multimodal pain regimen during surgery, they could not prevent her Lyme disease symptoms from recurring after surgery. Finally, the patient’s pain became so severe that she was transferred to the Intensive Care Unit (ICU). “A multimodal pain regimen was used for two days that include ketamine infusion, acetaminophen, ketorolac, oxycodone, and hydromorphone” (Lim and Kinjo Lim 2018).

Author’s note: It would be reasonable to revisit the woman’s PTLDS clinical history to determine whether she was adequately treated for her infection. Read more.

COMPLEX REGIONAL PAIN SYNDROME (CPRS) FROM LYME.

A review from Raigmore Hospital in the UK discussed autonomic dysfunction due to infectious diseases. “Complex regional pain syndromes [CRPS] and reflex sympathetic dystrophy (RSD) with regional sympathetic hyperactivity have also been reported in some patients with Lyme disease” (Artal 2017). CRPS is characterized by considerable pain (allodynia, hyperalgesia), edema, trophic changes of the skin and muscles, and sudomotor disorders.

Artal discussed a case first described by Sibanc et al. (2002). A 46-year-old man reported increasing pain and swelling in his left foot. The pain eventually caused his leg to become dysfunctional. “Even the slightest contact with the skin of the affected area caused the patient unbearable pain” (Sibanc and Lesnicar, 2002). The man improved after four weeks of intravenous ceftriaxone. Read more.

FATIGUE AND COGNITION FROM CENTRAL SENSITIZATION SYNDROME?

Fatigue and cognitive impairments are prominent features of central sensitization syndrome. Patients with Post-treatment Lyme disease Syndrome or chronic Lyme disease often have persistent insomnia and fatigue. While fatigue can have a central or peripheral origin, “central fatigue often has the significant correlate of cognitive impairment” (Batheja et al., 2013).

Studies of patients with Post-treatment Lyme disease Syndrome “have shown that problems with memory, working memory, processing speed, and verbal fluency are common” (Batheja et al., 2013).

Central sensitization syndrome has been described in several illnesses characterized by fatigue with similar presentations to Lyme disease, including fibromyalgia and chronic fatigue syndrome (Batheja et al., 2013). Read more.

For more:

Category:

Activism, Lyme, Pain Management, Treatment

Link Between Chronic Pain & Suicide

https://www.paintreatmentdirectory.com/posts/the-link-between-chronic-pain-and-suicide-understanding-and-prevention

The Link Between Chronic Pain and Suicide: Understanding and Prevention

The Link Between Chronic Pain and Suicide: Understanding and Prevention

By: Cindy Perlin, LCSW

Chronic pain not only leads to physical suffering but can also have severe psychological and emotional consequences. One of the most concerning correlations is the connection between chronic pain and suicide. Chronic pain patients are at least twice as likely to commit suicide as the general population. This article aims to shed light on this link, its underlying causes, and provide valuable prevention strategies.

Understanding the Link

Chronic pain and suicide are intertwined in a complex relationship that involves both physical and psychological factors.

Individuals living with chronic pain often experience a significant reduction in their overall quality of life. This can lead to feelings of hopelessness, despair, and isolation, which can contribute to the development of suicidal thoughts and attempts.

Key Factors Contributing to the Link:

  1. Psychological Impact: Chronic pain can lead to depression, anxiety, and feelings of hopelessness which increase the risk of suicide.
  2. Loss of Functionality: Many individuals with chronic pain find it challenging to engage in daily activities, work, or hobbies they once enjoyed. This loss of functionality can lead to feelings of inadequacy and a sense of purposelessness.
  3. Social Isolation: Chronic pain often limits an individual’s ability to socialize, leading to isolation and feelings of loneliness. Lack of social support can contribute significantly to the risk of suicide.
  4. Inadequate Pain Management: Poorly managed pain can exacerbate all the above factors. In some cases, individuals may turn to substances or risky behaviors in an attempt to alleviate their suffering, further compounding the risk.
  5. Stigma and Misunderstanding: People with chronic pain often face skepticism or disbelief from others, including family, friends, coworkers and healthcare providers. This can lead to a sense of invalidation and make it even more challenging to seek help.

The Connection Between Opioids and Suicide Risk

“The relationship between opioid prescribing and suicide risk is a complex one. This is particularly the case when people have their opioids tapered,” says Mark Olfson, MD, MPH, professor of epidemiology at Columbia School of Public Health. People can become desperate if their pain is not well controlled. Yet opioids also pose a greater risk of overdose than any other drug class and approximately 40 percent of overdose suicide deaths in the U.S. involve opioids. At a population level, the national decline in opioid prescribing over the last several years appears to have
reduced the number of people who died of suicide.”

The Truth about Chronic Pain TreatmentsOrder now!

“If opioid prescribing per capita had held constant from 2009 to 2017, there would have been an estimated 10.5 percent more suicide deaths involving opioids in 2017,” noted Olfson. In the U.S., geographic regions with the greatest declines in people filling opioid prescriptions also tended to have the greatest declines in total suicide deaths.

People who abuse opioids are 14 times more likely to die by suicide compared to the general population, a statistic that shows the very strong link between mental distress, chronic pain, opioids and suicide.

Prevention Strategies

  1. Seek Professional Help: If you or someone you know is struggling with chronic pain and experiencing thoughts of suicide, it is crucial to seek help from a healthcare professional. They can provide a comprehensive evaluation, recommend appropriate treatments, and connect individuals with mental health resources.
  2. Comprehensive Pain Management: Effective pain management is essential in reducing the risk of suicide in individuals with chronic pain. Often pain patients lose hope when the limited options offered by conventional medicine don’t help. There are many little-known alternative pain treatments that can provide safe and effective pain relief. Search the Alternative Pain Treatment Directory for helpful information, products and alternative healthcare providers.
  3. Address Mental Health Concerns: It is vital to address any co-occurring mental health conditions, such as depression or anxiety, as part of a comprehensive treatment plan.
  4. Build a Support System: Establishing a strong support network is crucial. Friends, family, and support groups can provide emotional support and a sense of belonging, which can significantly improve an individual’s outlook and resilience.
  5. Education and Awareness: Raising awareness about the link between chronic pain and suicide is essential in reducing stigma and fostering understanding. Education can help individuals recognize the signs of distress in themselves or others and encourage seeking help.
Cindy explains how to quickly reduce stress and pain naturally!

Resources for Prevention

  1. National Suicide Prevention Lifeline (USA): 1-800-273-TALK (1-800-273-8255) – Provides free, confidential support 24/7.
  2. Crisis Text Line (USA): Text “HOME” to 741741 – A free, confidential texting service for individuals in crisis.
  3. International Suicide Hotlines: For a comprehensive list of suicide hotlines around the world, visit https://www.suicide.org/international-suicide-hotlines.html.
  4. National Alliance on Mental Illness (NAMI): Provides resources, support, and education for individuals and families dealing with mental health conditions. Website: https://www.nami.org/.

Conclusion

The link between chronic pain and suicide is a serious concern that requires attention and intervention. By understanding the complex factors contributing to this connection and implementing prevention strategies and effective pain relief, we lessen the suffering that drives pain patients to want to end their lives.

Remember, seeking help is a sign of strength, and there are resources available to assist individuals in their journey towards improved mental and physical well-being.

For more:

Category:

Activism, Pain Management, Psychological Aspects, Treatment

Kratom : A Safer Opioid Alternative

https://www.paintreatmentdirectory.com/posts/kratom-as-an-opioid-alternative

Kratom as an Opioid Alternative

Kratom as an Opioid Alternative

By: Cindy Perlin, LCSW

Richard states, “I have suffered immense pain from fibromyalgia for 25 years, to the point of disability & early medical retirement from my job in government healthcare as a licensed psychiatric clinician at a county facility. I tried many medications to relieve my pain to no avail. I have also been a practicing herbalist for 22 years. It was recommended I try Kratom from another herbalist friend. I cannot begin to tell you of the immense relief immediately felt from the first dose of this amazing plant. I have been using kratom for several months now. I have no adverse effects, no withdrawal if not used, nor noticeable side effects. I can now go through the day with absolutely no pain! Period! This is one of the most valuable herbal remedies I have ever used.”

When Jason was 18 years old he broke his wrist and knuckles. He was given Vicodin and became addicted. He graduated to methadone and heroin. He had never used anything before but pot and alcohol occasionally. For the next seven years he was in and out of detox. All his plans went downhill. He had wanted to be a pro baseball player. He had trouble getting and keeping a job. He got a D.U.I. He watched eight of his friends die from heroin overdoses and he still couldn’t stop using. Then one day a friend posted on Facebook about kratom. Jason ordered a sample pack of a red vein strain, the most calming strain of Kratom. Since he started using kratom, he has not had the urge to use opioids again. Jason’s life is now back on track. He’s been clean for over eight months and is going to school to get a machinist certificate. He uses kratom for pain management,  anxiety, and depression. He doses twice a day and reports that it costs him $30-$40 a month. He’s now confident about his future. 

Millions of Americans now use kratom as an alternative to opioids. Many have similar stories.

Read other inspiring stories

What is Kratom?

Kratom is an herb that is native to tropical Southeast Asia and is part of the coffee family. Its scientific name is Mitragyna speciosa. The American Kratom Association says kratom is “more akin to tea and coffee than any other substances”. It has been used medicinally by the people of Southeast Asia for hundreds of years. More recently, millions of Americans have begun using kratom for pain management, anxiety, insomnia, as an energy booster, and to ease withdrawal from opioids. Many pain patients insist kratom has significantly improved their  quality of life and others, like Jason, say it has literally saved their lives.

The Johns Hopkins Kratom Study

The study, published online in the journal Drug and Alcohol Dependence in 2020, was an anonymous, online survey of 2798 kratom users. 59% of users reported taking kratom daily and the most common dosages were 1-3 grams.

Kratom was used by 91% of respondents for pain management, 67% for anxiety and 65% for depression, “with high ratings of effectiveness”. 41% reported using kratom as an opioid alternative. About a third of those using kratom for opioid withdrawal reported they were abstinent from opioids for over a year due to their kratom use.

About one third of respondents said they had adverse effects from kratom such as constipation, upset stomach or lethargy. They rated their adverse effects as mostly mild in severity and lasting less than 24 hours. A very small minority, .6%, sought treatment for adverse effects.

According to researchers, 2% of respondents met the diagnostic criteria for kratom-related substance abuse disorder. When asked how troubled they felt about their kratom use, the mean rating was 3.2 on a scale of 0 to 100.

A previous kratom study showed similar results

The results of this survey are similar to the 2016 online survey of 6150 kratom users by Pain News Network and the American Kratom Association. Nine out of ten respondents said kratom was “very effective” for pain management, depression, anxiety, insomnia, opioid addiction and alcoholism. Less than one percent said it didn’t help. The percentage of patients who rated kratom “very effective” for their pain condition:

  • Irritable bowel syndrome 94%
  • Migraine 93%
  • Fibromyalgia 93%
  • Rheumatoid arthritis 92%
  • Back pain 92%
  • Acute pain 92%
  • Lupus and other autoimmune diseases 91%
  • Osteoarthritis 90%
  • Neuropathy 90%
  • Trigeminal neuralgia 88%
  • CRPS 79% (Complex Regional Pain Syndrome)
  • Ehlers Danlos syndrome 76%

Is there any evidence that kratom has a high potential for abuse so that it would not be a good opioid alternative?

According to Dr. Jack Henningfield, a highly respected addiction specialist at Johns Hopkins, kratom is no more addictive than caffeine and “the factors that appear important in sustaining kratom consumption appear more similar to those that sustain dietary caffeine consumption, namely to better manage fatigue and daily life demands and provide mild effects considered enhancing to quality of life” including pain relief and enhanced work performance.

According to the National Institute on Drug Abuse, “Compared to deaths from other drugs, a very small number of deaths have been linked to kratom products and nearly all cases involved other drugs or contaminants.”

The federal government’s efforts to ban kratom

In 2016, the Drug Enforcement Administration proposed temporarily classifying kratom  as a Schedule I drug under the Controlled Substances Act, a drug with no known medical uses and a high potential for abuse. This would have made the use of kratom illegal. But the agency backtracked after a public outcry and pressure from some members of Congress. The DEA then asked the FDA to expedite scientific and medical evaluation instead.

In November 2017 the FDA issued a warning to consumers against using kratom, saying that there had been 36 deaths related to the herb. Scott Gottlieb, FDA Commissioner at the time, stated that kratom has similar risks of abuse, addiction, and death as opioids. This statement was ludicrous because the purported deaths from kratom occurred over a period of several years and were fewer than occurs in one day as a result of opioid overdoses. The National Institutes on Drug Abuse (NIDA) tested the FDA claims that kratom is associated with deaths, and they concluded those claimed deaths were actually caused by poly-drug users who abuse dangerous drugs or were caused by people who used an adulterated kratom product.

In 2018, the FDA published a report claiming that FDA scientists had “analyzed the chemical structures of the 25 most common compounds in kratom and concluded that all of the compounds share structural characteristics with controlled opioid analgesics, such as morphine derivatives. They also found that compounds in kratom that “bind strongly to mu-opioid receptors, comparable to opioid drugs”. This study and its conclusions have been widely criticized as misleading and unscientific. Other substances, such as Imodium, an over-the-counter remedy for diarrhea, also bind to opioid receptors but are not classified as opioids.

About 95% of kratom comes from Indonesia. The FDA reportedly played a role in the Indonesian government’s 2019 decision to ban the export of kratom as of 2022. Kratom advocates in Indonesia and the U.S. have convinced the Indonesian government to delay the export ban at least until 2024. There have been some restrictions placed on export by the Indonesian government that are negatively affecting supply and cost and hurting Indonesian farmers who were earning their living growing kratom.

In 2021, the FDA went to the World Health Organization and asked them for an international ban on kratom. In response, the WHO’s Executive Committee on Drug Dependency (ECDD) voted 11-1 to simply continue to monitor data on health impacts of kratom over the next two to three years, rather than institute strict controls. Members found “insufficient evidence” to warrant any action at the time. The committee based its decision on a scientific review of the benefits and risks of kratom. 80,000 people also submitted comments to the committee about their experiences with the herbal remedy.

The FDA continues to seize shipments of kratom to the United States  with no rationale other than that it is kratom.  The FDA’s continuous attempts to demonize kratom have also caused six states to criminalize kratom: Alabama, Arkansas, Indiana, Rhode Island, Vermont and Wisconsin.

These actions by the federal government and states have caused many consumers to be fearful of trying kratom. In my humble opinion, the FDA and DEA are more concerned about protecting pharmaceutical profits than protecting public health.

Conclusion: Kratom is a safe and effective alternative to opioids

Although extensive research is lacking on kratom, all indicators are that kratom is much safer than opioids and provides better pain relief, making it an excellent opioid alternative.

The author, Cindy Perlin, is a Licensed Clinical Social Worker, certified biofeedback practitioner and chronic pain survivor. She is the founder and CEO of the Alternative Pain Treatment Directory and the author of The Truth About Chronic Pain Treatments: The Best and Worst Strategies for Becoming Pain Free. She’s located in the Albany, NY area, where she has been helping people improve their health and emotional well-being for over 30 years. See her provider profile HERE. She is available for both in-office and virtual consultations.

_________________

**Comment**

Another perfect example of corrupt health “authorities’ banning anything that is considered a threat to Big Pharma and the medical monopoly.

For more:

Category:

Activism, Pain Management, research, Supplements, Treatment

ACTION ALERT: FDA Trying to Ban CBD

https://www.paintreatmentdirectory.com/posts/the-fda-is-trying-to-ban-cbd-supplements

The FDA is Trying to Ban CBD Supplements

The FDA is Trying to Ban CBD Supplements

By: ANH-USA

Editor’s note: The following article and call to action about the FDA’s efforts to ban CBD supplements is being reprinted from the Alliance for Natural Health website. This is not the first time the FDA has tried banning natural treatments relied on by millions of Americans, but part of a long and corrupt history. The FDA has also been trying for several years to ban kratom, an herb being successfully used by millions of Americans to treat pain, opioid addiction and withdrawal, anxiety and more. Recently, the FDA has also taken action against homeopathy, a safe, natural system of medicine used worldwide since its development in 1810. The FDA has been trying to get stronger regulatory authority to take vitamins and other supplements off the market. It seems the FDA is leaving no stone unturned in its efforts to protect the profits of the pharmaceutical industry instead of protecting the health of the public.

The FDA Misleads on CBD Safety

…providing further evidence that the agency is trying to engineer a ban on affordable CBD to protect drug industry profits. Action Alert!

As the evidence of CBD’s myriad health benefits continues to pile up, it increasingly looks to us like the FDA is preparing to issue a ban on CBD supplements. We must support bills in Congress that take the issue out of the FDA’s hands by allowing the sale of CBD in supplement form.

Lawmakers do appear to be taking this issue seriously. In addition to the bill introduced by Representative Morgan Griffith (R-VA), another similar bill has just been introduced by Senators Ron Wyden (D-OR), Rand Paul (R-KY), Jeff Merkley (D-OR), and Representative Earl Blumenauer (D-OR) to allow the sale of CBD in supplements. Additionally, Congress is holding a hearing on July 27 during which members will formally scrutinize the impact of the FDA’s failure to develop a regulatory pathway for the sale of CBD in supplements and food. Let’s show the FDA the scale of our opposition to its unjustified plan and demonstrate the huge level of grassroots support for CBD supplements ahead of the hearing.

We want to make it crystal clear what we face if we don’t stop the FDA in its tracks. CBD, or cannabidiol, is one of over 100 natural compounds called cannabinoids found in a wide range of plants, most notably the hemp plant. The cells of our bodies are laced with cannabinoid receptors that form part of the endocannabinoid system that is essential to life and to robust health. We produce cannabinoids internally (endocannabinoids) and we also consume them in some foods (exocannabinoids). Most of these cannabinoids, including CBD, are not psychoactive – THC being an exception – but they all offer profound benefits. CBD is one of the most well researched non-psychoactive cannabinoids and it has an incredible array of health benefits, with evidence showing that has profound anti-inflammatory and immune modulating effects and can help with pain, anxiety, depression, certain cancers, and even heart health.

Let that sink in for a moment. The opioid epidemic is killing an astonishing number of Americans every year; rates of anxiety and depression are reaching new highs, particularly among young people; heart disease is the leading cause of death for adults in the US. CBD has been found to help with all of these conditions, but instead of working to make this compound more widely available as a supplement, which is the way it should be sold according to the Dietary Supplement and Health Education Act of 1994 (DSHEA), the FDA wants to stop all supplement sales of CBD. The FDA’s justification is the protection of the profits of one pharmaceutical company that has a CBD drug that will cost patients a stunning $32,500 per year. It will also mean citizens who have been benefiting from low-cost health support from CBD supplements since they became widely available a few years ago will have no further access to the supplements they have relied on. There is something deeply wrong with this picture.

How did we get here? For starters, the FDA says that CBD can’t be a supplement because it has approved a drug version of CBD called Epidiolex that is used to treat two rare forms of epileptic seizure, Lennox-Gastaut syndrome (LGS) or Dravet syndrome, in children over 2 years. This ability for FDA to rule in favor of drug companies has to do with the FDA back-channel that we’ve written about many times before. In short, if a substance is studied as a drug (i.e. a drug company has made an Investigational New Drug application) before there is evidence it was sold as a supplement (i.e. evidenced by a supplement company’s New Dietary Ingredient notification), then the drug company can ask the FDA to ban the supplement form of that compound.

Yet, as pressure mounts from Congress and a variety of stakeholders to make CBD more widely available, the FDA has been reviewing scientific information on CBD. Earlier this year, the agency released a statement explaining that the “existing regulatory framework” for foods and supplements is not appropriate for CBD and that a new regulatory pathway is needed.

One of the main issues raised by the FDA is that of safety. The agency claims that CBD presents various safety concerns, specifically the potential for harm to the liver and the reproductive system and concerns for vulnerable populations such as children and pregnant women.

These views are articulated in a review article authored in part by FDA staff. To support the assertion that CBD can pose threats to the male reproductive system, the authors cite a 1981 animal study in which monkeys were administered 30, 100, or 300 milligrams per kilogram of body weight per day (mg per kg bw/day) of CBD orally. But consider that 300 mg per kg bw/day for a human weighing 154 pounds would be 21,000 mg, or 21g, of CBD—far, far more than anyone would ever take as a supplement!

This is emblematic of a larger problem we’ve discussed before: the deeply flawed risk assessment models used by federal bureaucrats to prevent us from utilizing natural medicines to stay healthy. These types of models have been used by European regulators to set absurd limits on supplement dosages (known as tolerable upper limits, or ULs). ANH’s founder and Executive and Scientific Director, Robert Verkerk, PhD, has published several papers critiquing this approach that was originally developed by the Institute of Medicine (now the National Academy of Medicine), pointing to a fundamental flaw: in trying to restrict vitamin or other micronutrient dosages in this way, regulators completely ignore the fact that risks vary greatly depending on the form and dose of a nutrient used, and for most populations you’ll find overlap in the doses that cause health benefits for the majority and risks for a few. So if you then create a law that aims to eliminate a potential risk for everyone, you actually deprive the vast majority access to the micronutrient and all the benefits it offers.

Bringing it back to CBD: the fact that the FDA is, in part, using a decades-old animal study in which an absurdly high CBD dose was used to demonstrate that CBD has safety concerns once again demonstrates that the federal approach to assessing risk and benefit is fundamentally broken. It’s based on a defunct toxicological model that should have no place in modern day food or supplement law-making. The agency is also not giving proper weight to the incredibly favorable safety record of CBD used as a supplement or the multitude of benefits we can get from using CBD as a supplement. Instead, the FDA has chosen to focus on old evidence of harm that was only found when absurdly high doses were taken experimentally. To us, it seems like the agency is simply grasping at any information it can to demonstrate harm so it can justify its proposed ban on CBD supplements. The driver? Nothing less than preventing competition for the pharmaceutical drug version of CBD, given its the drug companies that are the FDA’s principal paymasters.

And, indeed, the FDA’s view on CBD’s safety is not supported by experts in the industry and elsewhere. A 2020 meta-analysis looked at human trials to assess CBD efficacy and safety. The authors concluded that most studies reported no adverse events with acute administration of CBD and mild to moderate effects with chronic administration, with the most common side effects being tiredness, diarrhea and changes of appetite/weight. Again, these side effects must be weighed against the benefits of CBD use for combatting opioid misuse, heart disease, anxiety, and depression. Harvard Health Publishing, the publication of the Harvard Medical School, states simply that, for adults, “CBD appears to be very safe.”

We cannot allow the FDA to cater to the drug industry at the expense of public health.

Action Alert! Write to Congress in support of bills that allow the legal sale of CBD in supplements. Please send your message immediately.

The FDA has said that they will not be allowing CBD to be in food or supplements, explaining that the “existing regulatory framework” for foods and supplements are not appropriate for CBD. The agency denied three Citizens Petitions requesting the agency issue a regulation that would allow CBD to be sold as a supplement. Clearly the FDA is more interested in protecting Big Pharma profits than with promoting consumer access to a product that can benefit their health. We need Congress to take the issue out of the FDA’s hands to create a legal pathway for CBD supplements.

Write to Congress and tell them to support the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 and the Hemp Access and Consumer Safety Act to protect access to CBD supplements.

Sign the Petition Here

_________________

**Comment**

The FDA wants patients between a rock and a hard place.  On one hand they state extended antibiotics are not to be used for Lyme/MSIDS because they are unsafe, and then they also want to remove important supplements that help us, but when the agency is alerted to the fact doctors have never witnessed so many “vaccine”-related injuries and VAERS reports are higher than any other vaccine in its history, after the mRNA gene therapy injections……crickets.

Something doesn’t smell right.

If the FDA had their way we’d just all die already.

For more:

The FDA has a long & sordid history of attempting to ban anything it views as competition to its lucrative drugs & vaccines due to its vested interests with Big Pharma.

Category:

Activism, Herbs, Inflammation, Pain Management, Sleep, Supplements, Treatment