Archive for the ‘Supplements’ Category

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


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 painanxietydepressioncertain 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

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**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.

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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.

Study Says Opioids No Better Than Placebos For Back & Neck Pain

https://www.paintreatmentdirectory.com/posts/opioids-no-better-than-placebos-for-back-and-neck-pain-new-study-says

Opioids No Better Than Placebos For Back and Neck Pain, New Study Says

7/10/23

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 enablers despite 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.

Marijuana is still federally illegal, making it inaccessible for many. The FDA has gone to great lengths to try to ban kratom, a very effective southeast Asian pain-relieving herb, and failing that, has done their best to demonize it. Several states have banned kratom. 

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.

Sign My Petition to Require Insurance Companies to Pay for Alternative Treatments

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.

The physical therapy profession is currently hemorrhaging providers despite increasing demand, with over 22.000 physical therapists leaving the workforce in the last quarter of 2021 alone. Over 15,000 licensed clinical social workers left the workforce during the same time period in professions where there were already significant shortages.

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.

Find the Right Provider

The Placebo Effect and Chronic Pain

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.

Want to try a placebo for yourself or a loved one? Here is a placebo you can order on Amazon:

Conclusion

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.

Cindy Perlin is a Licensed Clinical Social Worker, certified biofeedback practitioner, chronic pain survivor, the author of The Truth About Chronic Pain Treatments: The Best and Worst Strategies for Becoming Pain Free and the founder and CEO of the Alternative Pain Treatment Directory. She has been helping her clients in the Albany, NY area reach their health and wellness goals for over 30 years. She also provides virtual pain consults. See her provider profile HERE

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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:

About Cytokines in Lyme Disease and Related Conditions

https://www.treatlyme.net/guide/cytokines

Updated: 6/27/23

By Dr. Marty Ross

About Cytokines in Lyme Disease and Related Conditions

Lowering inflammatory cytokines made by the immune system is essential for Lyme disease and related conditions recovery. In this article and video, I discuss why this is so and lay out a nutritional support plan using supplements to lower cytokines.

Cytokines are proteins made by various types of white blood cells to turn on the immune system to attack invaders like:

  • bacteria (for example, Lyme germs and the co-infections),
  • intestinal yeast,
  • parasites,
  • viruses,
  • Lyme and mold toxins,
  • environmental toxins, and
  • heavy metals toxins, like lead and mercury.
Cytokines are Good, Right? Well, Yes and No.

In the right amount, cytokines promote healing. In excess, they cause all of the major Lyme disease symptoms and dysregulate the immune system. The problem in chronic Lyme and associated diseases is that they are usually made in excess. Fortunately, there are some great steps you can take to lower cytokines. (See top link for article and video)

For more:

Case Report: Lyme Neuroborreliosis Triggers Multiple Strokes

https://danielcameronmd.com/lyme-neuroborreliosis-triggers-multiple-strokes/

CASE REPORT: LYME NEUROBORRELIOSIS TRIGGERS MULTIPLE STROKES

Lyme disease can trigger neurological complications. But neurovascular manifestations are far less common. In this case report, the authors describe a 58-year-old man who suffered multiple strokes due to Lyme neuroborreliosis.

In their article, “A case report of unilateral cerebral vasculitis in adults: keep in mind Lyme neuroborreliosis,” Riescher and colleagues examine the case of a 58-year-old man “with recurrent strokes in the same vascular territory without CSF pleocytosis, reflecting an unusual first manifestation of [Lyme neuroborreliosis].”¹

The authors point out that cerebral vasculitis is reported in only 0.3–1% of all Lyme neuroborreliosis cases, and unilateral or focal vasculitis have only rarely been described, almost exclusively in children.

In this case report, the patient, who had no medical history or cardiovascular risk factors, was admitted to the hospital with sudden right brachiofacial weakness. According to the authors, “He recovered partially, but facial palsy persisted.”

He was referred to the stroke unit but a neurological and general examination was normal.

“Cervical and intracranial CT angiography did not show any abnormalities such as stenosis, occlusion, or dilatation,” the authors wrote.

The man was diagnosed with cryptogenic stroke and prescribed aspirin (160  mg), atorvastatin (80 mg), and perindopril at 2 mg daily.

Two months later, the man exhibited sudden aphasia.

“Burgdorferi-induced cerebral vasculitis is thought to be a very rare manifestation of [Lyme neuroborreliosis]. But it must nonetheless be considered in the differential diagnosis of unexplained recurrent and/or multiple strokes.”

“MRI revealed a new and recent ischemic lesion in the left MCA territory visible on DWI, and another older lesion in the anterior cerebral artery (ACA) territory,” the authors wrote.

The patient was prescribed an oral anticoagulant and a cardiac monitor was inserted.

Over the next several months, the patient developed new symptoms including paresthesia (tingling sensation) in the right hand and foot, headaches, extreme weakness and lack of energy, psychomotor retardation, and unsteadiness.

Thirteen months after his first symptom appeared, he developed paresis (muscle weakness) in his right leg.

“A brain MRI showed a new recent ischemic lesion in the left cingulate cortex on DWI in the left ACA territory as well as other new lesions in the left MCA territory (in the frontal lobe),” the authors wrote.

Additional neurological testing was normal. However, Lyme disease testing was “highly positive” on ELISA and confirmed by Western blot.

The man was successfully treated with a one-month course of doxycycline.

“The patient experienced no further stroke after four weeks of doxycycline treatment.”

“In the following weeks, the patient reported dramatic improvement, with disappearance of his asthenia, dizziness, and right arm paresthesia,” the authors wrote.

The patient later reported that he had a tick bite 2 years prior to his first stroke, along with an erythema migrans rash but he never developed arthritis or pain.

Authors Conclude:

  • “Our patient stood out because he had recurrent ischemic strokes for more than one year (at least four episodes), without other associated symptoms, involving the ICA territory only, and without CSF pleocytosis, which is thought to be highly suggestive of LNB.”
  • “Burgdorferi-induced cerebral vasculitis is thought to be a very rare manifestation of [Lyme neuroborreliosis]. But it must nonetheless be considered in the differential diagnosis of unexplained recurrent and/or multiple strokes.”
  • “This case report reminds clinicians that it can occur without a history of a clear tick bite or erythema migrans, and cranial or peripheral neuritis and that the CSF examination can be normal.”
References:
  1. Riescher, S., Dos Santos, A., Lecomte, R. et al. A case report of unilateral cerebral vasculitis in adults: keep in mind Lyme neuroborreliosis. BMC Infect Dis 23, 283 (2023). https://doi.org/10.1186/s12879-023-08259-z

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**Comment**

I’ve stated this before but it’s worth repeating: many Lyme/MSIDS patients improve by taking blood thinners or anti-coagulants like heparin, systemic enzymes, and things like serrapeptase, nattokinase & lumbrokinase which have a blood thinning effect.  Considering that many pathogens form biofilm, thinning and thereby cleaning the blood seems a logical step in helping treatment be more effective.

9 Lyme & Tick-borne Disease Hacks & Dr. John Aucott’s Lyme Research Update

https://www.treatlyme.net/guide/lyme-tick-borne-disease-hacks  Video Here (Approx. 35 Min)

Nine Lyme and Tick-borne Disease Hacks

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.

Video Thumbnail
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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.

http://  Approx. 2 hours

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