…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 Epidiolexthat 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 agencyreleased 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 severalpapers 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.
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.
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.
Division of Immunology, Tulane National Primate Research Center, Tulane University Health Sciences, Covington, LA, United States
Lyme disease, caused by the spirochete Borrelia burgdorferi, is the most common vector-borne illness in the United States. Many aspects of the disease are still topics of controversy within the scientific and medical communities. One particular point of debate is the etiology behind antibiotic treatment failure of a significant portion (10–30%) of Lyme disease patients. The condition in which patients with Lyme disease continue to experience a variety of symptoms months to years after the recommended antibiotic treatment is most recently referred to in the literature as post treatment Lyme disease syndrome (PTLDS) or just simply post treatment Lyme disease (PTLD). The most commonly proposed mechanisms behind treatment failure include host autoimmune responses, long-term sequelae from the initial Borrelia infection, and persistence of the spirochete. The aims of this review will focus on the in vitro, in vivo, and clinical evidence that either validates or challenges these mechanisms, particularly with regard to the role of the immune response in disease and resolution of the infection. Next generation treatments and research into identifying biomarkers to predict treatment responses and outcomes for Lyme disease patients are also discussed. It is essential that definitions and guidelines for Lyme disease evolve with the research to translate diagnostic and therapeutic advances to patient care.
_________________
Translation: TIME FOR CHANGE!
Thankfully the study authors point out the following:
Without intervention, Bb establishes a persistent/chronic infection in both its reservoir and non-reservoir hosts.
Controversy regarding chronic infection revolves around whether Bb can persist after antibiotics and whether they are capable of causing the symptoms patients experience.
There are many bacterial species associated with persistent infections in humans including: Mycobacterium tuberculosis, Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, and B. burgdorferi (109).
Bacterial tolerance is different from resistance in that bacteria are not actively growing in the presence of the antibiotic and there is no heritable genetic change in the persistent bacteria’s genome (110, 111).
The stress response and other mechanisms allow bacteria, including Borrelia, to survive lethal conditions such as limited nutrients, extreme pH levels, and the presence of certain antibiotics.
Drug-induced bacterial persisters show a biphasic killing curve and the regrown persister cells have the same minimum inhibitory concentration (MIC) to the administered antibiotic as the original population but a higher minimum bactericidal concentration (MBC) (112).
Several independent studies have demonstrated that Bb can form drug-tolerant persister cell in vitro.
In vivo studies of Bb antibiotic persistence often use different parameters that can make comparisons between two or more studies difficult.
It is likely that lack of consensus of definitions and diagnosis lead to the treatment controversy.
Despite treatment controversy, a biostatistical review of the literature found that retreatment of LD with antibiotics may be beneficial in certain cases (163).
Since research for PTLD revolves around autoimmunity, immune-mediated factors, and/or persistent infection, most drugs fit into one of three categories: immune therapies, pathogen specific inhibitors, or antibiotics.
Studies screening drug libraries have revealed:
disulfiram has demonstrated borreliacidal activity both in vitro and in vivo (174–176)
vancomycin may have efficacy against stationary Bb based upon cultures and evaluation in SCID mice (177)
hygromycin A has shown efficacy against Bb, without disturbing the gut microbiome like so many broad-spectrum antibiotics, in vitro and in an in vivo mouse assay, but it’s use in preventing persistent infections was not determined (178)
drug combinations such as daptomycin or artemisinin, cefoperazone, and doxycycline as well as the combination sulfachlorpyridazine, daptomycin, and doxycycline have shown evidence of in vitro activity against Bb persisters and round bodied forms (117, 172). Azlocillin and cefotaxime are effective in in vitro killing against Bb persisters induced by doxycycline, which appear to be more tolerant to other antibiotics (179).
daptomycin or daunomycin, doxycycline, and cefuroxime have had success in sterilizing in vitro Bb biofilm-like microcolonies (180, 181).
dapsone, used in treatment of leprosy, has had success when combined with other antibiotics in killing biofilm-like Bb (182), and dapsone has had positive effects in a small PTLD and co-infection clinical study (183).
oregano, cinnamon bark, clove, and various flowers, grasses, and berries, as well as natural compounds such as those found in bee venom and its component melittin have demonstrated potential in vitro growth inhibition against Bb and its various forms (184–188) but need further research to determine the safety and efficacy of, and the composition and activity of the exact compounds found.
Curative treatment during early LD stages is a key to solving the current PTLD public health problem.
It is likely that more than one mechanism is involved in antibiotic treatment failure that leads to PTLD.
The current treatment guidelines are dependent upon the immune system’s ability to clear persistent spirochetes and conditional to the surviving spirochetes being non-viable and not enough to sustain a prolonged immune response.
In order to make PTLD a thing of the past, personalized medicine is required as well as the need to evolve and progress with scientific discoveries and innovations.
A new study just published in The Lancet, a highly respected mainstream journal, reported that patients with low back pain and neck pain who were prescribed opioids did no better than patients given a placebo. The randomized, controlled study of 347 patients found that there was no significant difference in pain scores between the two groups at six weeks. A year later, the placebo group had slightly lower pain scores,1.81 compared to 2.37 for the opioid group. The average age of participants in the study was 44.7 years and they all had lower back pain, neck pain or both for 12 weeks or less.
According to the National Institute for Drug Abuse (NIDA), 10-12% of those prescribed opioids develop an addiction. Despite the fact that over a million Americans have died of opioid overdoses to date, opioids continue to be widely prescribed as noted by the CDC. After peaking in 2012 at 81.3 prescriptions per 100 persons nationwide, the prescription opioid rate was 43.3 per 100 persons in 2020. However, some counties had rates that were nine times higher than that. This study indicates that many pain patients are being unnecessarily exposed to devastating and potentially fatal risks for absolutely no benefit.
I believe that the reason that opioids continue to be so widely prescribed despite the risks is that healthcare providers and patients have heard so often that “opioids are the best treatment we have for pain”. This statement has been repeated so often by pharmaceutical interests and their enablersdespite the lack of evidence that most people believe it. Will this study be enough to change these beliefs? I doubt it.
Besides patients’ and healthcare providers’ frequently reinforced beliefs that “opioids are the best treatment we have for pain”, there are several other barriers that get in the way of change. These include:
Healthcare providers are not educated about safer and more effective alternatives.
One survey of medical school curriculum in the U.S. found that physicians were receiving less than two hours of education about pain during their four years of medical school. Post-graduate education is largely sponsored by the drug companies, who fund the medical journals through advertising, sponsor most of the continuing education courses and conferences that physicians attend and send sales reps to physicians’ offices to peddle their wares on an almost daily basis. There are no comparable platforms for educating physicians about alternatives to pharmaceuticals for the treatment of pain.
Insurance companies won’t pay for alternative treatments or severely underfund them.
They do not pay for acupuncture, biofeedback, massage, nutritional counseling or supplements, exercise programs, herbal treatments, light therapy or other proven pain treatments. They have not raised fees for chiropractors, mental health providers or physical therapists in over 40 years.
Government policy often blocks access to alternative treatments.
The FDA has also recently declared homeopathy illegal, classifying all remedies as unapproved drugs, despite significant evidence that homeopathy is safe and effective and a long tradition of its use being legal.
No federal or state laws require insurance coverage for most alternatives or adequate fees for the treatments, like physical therapy, psychotherapy and chiropractic, that are covered.
The supply of alternative service providers cannot currently meet increased demand.
For instance, while the demand for chiropractic services has been increasing, the U.S. Small Business Administration reports that the five-year survival rate of chiropractic practices is only 48.9%. This is most likely due to low fees and excessive paperwork demands by insurance companies.
There are already shortages of massage therapists and demand for acupuncturists is already increasing compared to supply. These shortages will be even more severe if insurance coverage is made available.
The placebo effect refers to the improvement in a patient’s condition, despite receiving a treatment with no active pharmacological properties, for example: a sugar pill. Research has consistently shown that when patients genuinely believe they are receiving an effective treatment, their bodies often respond accordingly, producing measurable improvements.
The power of placebos extends beyond a mere psychological response; it can lead to actual physiological changes in the body. Studies have shown that the placebo effect can trigger the release of endorphins (the body’s natural opioids), dopamine (the body’s natural mood elevators) and other neurotransmitters associated with pain relief and improved mood. This indicates that the mind possesses an innate ability to activate the body’s self-healing mechanisms.
Placebo-controlled clinical trials are now standard practice in drug development, enabling researchers to evaluate the true effectiveness of new medications, or in the case of the above-described study, older medications.
While placebos have the potential to produce positive outcomes, some have raised ethical concerns about their use. They claim that deceiving patients by prescribing placebos without their knowledge undermines the principle of informed consent. However, I would counter that by pointing out that prescribing potentially dangerous drugs without warning patients of the full range of risks or the fact that a safer alternative exists is a much higher order ethical violation.
Researchers are exploring ethical ways to use placebos. Some studies have shown that even if you tell patients they are getting a placebo for their condition, it still seems to have the desired effect.
Placebos and the Power of the Mind/Body Connection
Placebos are an indicator of the power of the mind-body connection to influence our well-being. The effectiveness of placebos in pain management has been observed for both acute and chronic pain. Placebos have shown significant analgesic effects in conditions such as migraines, osteoarthritis, and even post-surgical pain. They have been proven to reduce pain intensity, increase pain tolerance, and enhance overall well-being. Placebos have also been shown to reduce anxiety and depression and to improve sleep.
Many safer treatments for back pain, neck pain and other types of pain exist and should be offered to patients instead of misinforming patients that “opioids are the best treatment we have for pain”. A “best” treatment doesn’t have the potential to kill people.
BTW, in the effort of staying real: The Lancet and other journals have been caught numerous times publishing fraudulent studies and pushing politics rather than science:
Marty Ross MD presents nine hacks for Lyme and tick borne disease. Watch this video and Powerpoint presentation to find real ways to improve your health.
This is a second recording of a video Powerpoint presentation first delivered to the Canadian Lyme Disease Research Network Virtual 2023 Awareness Event on May 23, 2023.
Watch Dr. John Aucott’s update on latest Lyme disease research
Dr. John Aucott, Director of the Johns Hopkins Lyme Disease Research Center, recently delivered an overview of Lyme and other tick-borne disease research. You can watch a replay of his presentation below.
What follows is the introduction to Dr. Aucott by Shireen Rusby, one of the founders of Maryland’s Lyme Care Resource Center.
May is Lyme disease awareness month. Like any “awareness” effort, the intent is to increase the attention to and appreciation for the subject. In the case of Lyme disease there is a particularly powerful irony to the concept of awareness. Lyme disease is an illness that is often hidden and its symptoms unrecognized, yet the patient can be so overwhelmed that there is little reprieve from the self-awareness that dominates each day.
Those of us living with Lyme disease, as well as those living with many other long-term, hidden health conditions, have experienced very similar scenarios – the body’s natural inclination toward homeostasis is challenged.
Balance becomes harder to achieve and maintain. Lyme has imbalanced us, COVID has imbalanced us, ME/CFS has imbalanced us, dysautonomia and POTS have imbalanced us. So while our bodies, minds and spirits are making constant efforts to balance and rebalance physically, mentally and emotionally, what is the impact of stressors on a system that is already experiencing overload?
Well, that’s a whole thesis in and of itself and we’re not going to cover it tonight. But there is one stressor that we can increase “awareness” of this evening. For members of the Lyme community and those of other hidden illnesses, the challenges of dysfunctional homeostasis are compounded by the emotional strain of invalidation.
What interferes with healing
When we then begin to doubt our own reality, we make efforts to normalize the abnormal state of our being and that in turn leads to an even greater maladaptive response and further interferes with healing.
In his book, Conquering Lyme Disease, Dr. Brian Fallon states: “The experience of being disbelieved and misrepresented over and over is inherently traumatizing. Some patients…have identified this atmosphere of disbelief (and the resulting social isolation and self-doubt) as the single most stressful aspect of their illness experience.”
Some of you may have seen the movie Avatar. It is a futuristic story of human beings landing on another planet and attempting to conquer the native people of that land. When greeting each other, these natives to whom we are supposedly superior, look each other in the eye and say, “I see you.”
This simple phrase encapsulates much of our ongoing struggle in the medical world. It speaks to a fundamentally necessary component of the practitioner-patient relationship that is at times absent in this journey with invisible illness.
Many medical professionals may not know where to turn when blood work looks normal and verifiable analytical tools fail to provide objective evidence. The simple truth, however, is that an absence of evidence is not evidence of absence. That quote, often attributed to the astrophysicist Carl Sagan, can serve as an incredibly powerful guiding principle when it comes to illnesses like Lyme disease.
The art of inquiry
Our lack of comprehensive and neatly packaged scientific proof need not preclude our awareness and acknowledgement of the situation. Rather, this is an opportunity for us to practice the art of inquiry as the necessary first step on the path of healing.
And certainly, there is no one path of healing in illnesses as complex as Lyme disease, and that adds to the challenge for both the patient and the practitioner. The fractured Western paradigm of medicine, in its tendency to compartmentalize and classify health as black or white, present or absent, positive or negative often fails to recognize the holistic nature of human suffering.
But the path of healing is first paved with recognition of and respect for the imbalanced body, mind and spirit.
Our journey to regain and retain balance begins again each day. In paving this path let us remember to turn toward the light especially when it seems dark, and let us use the tools of compassion and understanding to help one another.
Fostering awareness of this hidden yet ever-growing health pandemic will increase the opportunities for healing, and will turn the tide against the history of glaring invisibility and deafening silence.
We have as our guest speaker tonight someone who has made it his mission to foster the awareness of Lyme disease. He has paved the path of healing for countless Lyme warriors with sound practices and with stellar science.
John Aucott and his amazing team at the Lyme Disease Research Center, have partnered with many, first and foremost with the patients they serve, to produce the scientific evidence necessary to authenticate many of our struggles – struggles which we have experienced for months, years or even decades, while seeking out the rare practitioner like him who looks at us and says “I see you.”
For your endless support, for your validation of what we endure, and for your ongoing efforts to find the evidence that may have once seemed absent –we offer our endless gratitude.
LCRC May 2023: Advances in Lyme Disease and Tickborne Disease Research
Dr. Aucott will be discussing research advances in Lyme Disease and Tickborne Diseases, including an update on diagnostics, potential biomarkers, advanced neuroimaging, and future treatments.
Madison Area Lyme Support Group 