Archive for the ‘Supplements’ Category

FDA’s Suspicious Timing on ‘Wanting More Information’ on NAC – Which Helps COVID & Lyme/MSIDS

https://articles.mercola.com/sites/articles/archive/2021/12/15/fda-wants-more-information-on-nac

FDA Wants More Info on NAC

Analysis by Dr. Joseph Mercola Fact Checked
n acetylcysteine

Story at-a-glance

  • The Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have filed separate citizen petitions with the FDA requesting that the agency reverse their position on NAC; the agency is now asking for more information on the 58-year-old supplement
  • According to some legal experts, the actions taken by the FDA are not legal under U.S. code Title 21. The FDA has used the exclusion provision three other times, all of which financially benefited the pharmaceutical industry
  • While past actions may have opened the door to the most recent attack against NAC, it is not difficult to understand why the FDA chooses now to target NAC, when it has demonstrated effective action against COVID-19
  • Evidence suggests those with a glutathione deficiency have worse outcomes with COVID-19. NAC is a precursor to glutathione and may help lower the risk of severe disease
  • NAC can be part of your early at-home treatment that is crucial to lowering the severity of the illness and reducing the risk of long-haul symptoms

N-acetylcysteine (NAC) is a powerful antioxidant that was approved as a drug in September 1963.1 Since that time it’s been used as a nutritional supplement that is not found in natural sources.2 NAC contains the amino acid cysteine, which is a precursor to glutathione, also called “the master antioxidant.”3

Glutathione is made of three amino acids — glutamic acid, glycine and cysteine.4 However, NAC is only available in supplement form. The precursors to NAC can be found in foods that are high in cysteine, which include pork, beef, chicken, eggs, dates and sunflower seeds.5

NAC is used in prescription form as an antidote for acetaminophen-induced hepatotoxicity.6 It is also a powerful mucolytic agent for use in upper respiratory conditions. Memorial Sloan-Kettering7 also lists uses in the treatment of depression, precancers, HIV and AIDS, and to alleviate cancer treatment side effects.

In 2020, NAC made the news when the FDA decided over-the-counter sales of this compound, which at that time had been available for 57 years, should require a physician’s prescription going forward. The FDA issued warning letters8 to seven companies the agency said were illegally selling hangover products. By May 2021, Amazon, which also owns Whole Foods, decided to remove any supplements containing NAC.9

FDA Requests More Information on NAC

As Natural Products Insider reports, the letters warned that NAC could not be “lawfully marketed in dietary supplements because it was first studied as a drug in 1963.”10 The Council for Responsible Nutrition (CRN) sent a letter in December 2020 to the FDA’s Office of Dietary Supplement Programs describing the position as “legally invalid.”11

The CRN and the Natural Products Association (NPA) filed separate citizen petitions with the FDA. The CRN letter in December 2020 challenged the FDA’s determination that NAC should be precluded from supplementary use.12 They then filed a citizen position petition June 1, 2021, requesting the FDA reverse their position and outlining why this sudden policy change is “legally invalid on multiple grounds.”13

The NPA filed a separate citizen petition with the FDA14 requesting that the agency not exclude NAC as a dietary supplement or, alternatively, that the Department of Health and Human Services (HHS) issue a regulation finding NAC is lawful in supplements. While the HHS has the authority, it has not been used in the 27 years since the law giving the HHS such power was enacted in 1994.

November 24, 2021, the FDA announced they were requesting more information about how NAC has been marketed as a dietary supplement.15 Natural Products Insider reports that this was encouraging to some in the industry as it signaled the FDA was open to the idea of issuing the regulation that NAC is a lawful ingredient in supplements.16 The FDA called this:17

“… tentative responses to both citizen petitions, requesting additional information from the petitioners … and noting that the agency needs additional time to carefully and thoroughly review the complex questions posed in these petitions.”

The FDA18 also requested information and data on the date that NAC was first marketed as a dietary supplement, reports of adverse events and details on how the products are marketed and sold. The data are requested by January 25, 2022. Steve Mister, president and CEO of CRN said in a statement:19

“The provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA) may not be interpreted retroactively to remove ingredients that were lawfully marketed in 1994 and have enjoyed a long history of safe use since then. The delay in clearing up the status of NAC by asking for more data and refusing to admit its error disregards the law and disserves consumers who use NAC.

This is not a complicated determination for the FDA to make. DSHEA makes clear that ingredients in use as dietary supplement ingredients prior to its enactment are grandfathered into the supplement marketplace. Thus, pharmaceutical manufacturers could not have had any expectation of exclusivity in the years prior to the creation of this provision of the law.

Given the long history of safe use of NAC, FDA cannot now try to establish a safety concern in order to award this ingredient exclusively to drug makers.”

FDA First Used Legally Questionable Drug Exclusion Provision

U.S. code Title 21,20 specifically defines what a dietary supplement is and is not. According to experts, the actions of the FDA in banning the sale of NAC and finding it a “medication” is illegal under the law. Attorney Stan Soper21 writes that under Title 21 §321 paragraph (ff)(3)(b)10 the actions of the FDA do not meet the Drug Exclusion Provision.

According to Soper,22 the exclusion provision has only been invoked a few times, specifically when used to keep red yeast rice, vitamin B6 and cannabidiol (CBD) from being sold as supplements. In each of these cases there was a potential pharmaceutical financial loss that triggered the assertion the supplement was illegal.

In the case of red yeast rice, it contains a naturally occurring substance that acts in a similar manner to Lovastatin, a statin medication.23 In 2005, drug manufacturer Biostratum filed an investigational new drug (IND) application with the FDA to use vitamin B6 in the treatment of diabetic kidney disease.

Their argument was there was “no evidence that it was marketed as a dietary supplement or food prior to its IND and Phase II investigations.”24 In 2009 the FDA declared vitamin B6 was not a dietary supplement despite documentation that it had been sold as such before the IND application.

The FDA has also invoked the Drug Exclusion Provision against CBD, warning that it is not a legal dietary supplement since there was no meaningful evidence it was marketed as such before drug investigations were approved for Sativex and Epidiolex, which are drugs that contain CBD.

After the 2018 Farm Bill was signed legalizing hemp, then-FDA secretary Dr. Scott Gottlieb made the statement that it was illegal to introduce CBD into the food supply or market it as a supplement.25 Soper postulates26 that the use of the Drug Exclusion Provision against CBD may have opened the door for the FDA to use it against NAC.

Why Take Aim at NAC?

In the citizen petition27 sent to the FDA June 1, 2021, CRN argued that the FDA failed to sufficiently explain this sudden change in policy on NAC, thus “rendering it arbitrary and capricious.” According to CRN, before the seven warning letters in July 2020, “it was FDA’s longstanding policy to permit the marketing of dietary supplements containing NAC.”

Even though the agency had reviewed more than 100 notification structure/function claims for NAC-containing supplements over the years, they never raised the drug exclusion clause. In one response to a petition for a qualified health claim, the FDA had even stated that NAC was considered a dietary supplement.

While the Drug Exclusion Provision on CBD may have opened the door, it still raises the question of why the FDA chose now to target NAC. Historically the provision was used inappropriately to protect the finances of pharmaceutical companies. That is also likely the root of the motivation to ban NAC as a supplement.

As pulmonologist Dr. Roger Seheult succinctly explains in the MedCram video below, NAC is a crucial chemical compound necessary to reduce the oxidative stress associated with severe COVID-19 infections and thus may significantly impact the sales of antiviral drugs. And, as I and other health experts have pointed out in the past, without severe disease, is there truly a need for a vaccine?

Glutathione Depletion Worsens COVID-19 Outcomes

Researchers have been studying NAC since it was discovered. In 2010,28 researchers found that it could inhibit the expression of proinflammatory cytokines in cells that were infected with highly pathogenic H5N1 influenza virus. These same proinflammatory cytokines play a crucial role in severe COVID-19.

Researchers have confirmed that in severe cases, cytokine levels are elevated and once they reach excessive levels it triggers a cytokine storm.29 This causes significant tissue damage that NAC may be able to inhibit. In one 2020 paper,30 the authors describe a case of COVID-19 in a patient with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

This is a genetic disorder that can lead to hemolytic anemia31 and depletes glutathione,32 increasing the risk for human coronavirus infections such as the common cold. NAC was given to the G6PD-deficient patient and nine other COVID patients on ventilators. The NAC “elicited clinical improvement and markedly reduced CRP in all patients.”33

Other published papers have since demonstrated there is a potential use of NAC in the treatment of COVID-19.34,35,36 One 2021 study37 compared consecutive patients hospitalized with moderate or severe COVID-19 pneumonia.

One group received only standard care and the other group received 600 mg of NAC twice daily for 14 days. There were 42 in the NAC group and 40 in the control group. Treatment with NAC led to lower rates of severe respiratory failure and significantly lower mortality rates.

Early at Home Treatment Is Crucial

NAC is only one in a line of treatment modalities that have proven to be successful but have been vilified by governmental agencies. Since the start of this pandemic, it seems global and national health authorities have done everything in their power to discourage and prevent people from accessing treatments, such as ivermectin38,39,40 and hydroxychloroquine,41,42,43,44 that compete with the COVID jab.

The actions around NAC appear to be yet another shameful attempt to prevent patients from helping themselves. By limiting access to nutritional supplements that have demonstrated the capability of reducing severity of the infection, agencies are essentially boosting the risk that infections progress into more serious cases.

Should you come down with symptoms of COVID-19, early treatment is crucial. Not only can it significantly reduce the length of time that you’re sick, but early treatment will also minimize your risk of long-hauler syndrome,45 which can include symptoms that last much longer than the original infection.46 This can include cough, body aches, difficulty sleeping, headaches and brain fog.

There is also scientific evidence that NAC can improve a variety of lung problems, including pneumonia and acute respiratory distress syndrome (ARDS), common characteristics of COVID-19. For example:

  • Research47 published in 2018 found NAC reduces oxidative and inflammatory damage in patients with community-acquired pneumonia.
  • Another 2018 study48 found NAC improves postoperative lung function in patients undergoing liver transplantation.
  • A 2017 meta-analysis49 found a significant reduction in ICU stays among ARDS patients treated with NAC.
  • NAC is also a well-known mucolytic used to help clear mucus out of the airways of cystic fibrosis patients.50 Some studies also suggest NAC can help reduce symptoms of COPD and prevent exacerbation of the condition.51
– Sources and References

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**UPDATE**

Dr. José Luis Sevillano proposes a preventive treatment for Panamanian colleagues who at a conference were very interested in treating patients with zinc, glutathione, and N-acetylcysteine (NAC).  These antioxidants have been found to help the body detoxify graphene, which experts have discovered in the PCR swabs, face masks, and the COVID injections.  

**Comment**

On a personal note: my husband, infected with Lyme/MSIDS since 2010 or so has struggled with bizarre blood issues including low ferritin, small and too many red blood cells, hypercoagulation, and anemia at one point requiring iron sucrose infusions.  We were both infected with Babesia as well, which is known blood to affect and change blood cells.

Eventually the iron came up and leveled, the hypercoagulation went away (after years of heparin) but the cell count has always been strange, and he has always struggled with fatigue since becoming infected, whereas I have not.  I suspect a glutathione issue and wonder if glutathione IV wouldn’t have helped his severe COVID case as well.  Where IV C, blood ozone, and 4 doses of only 12 mg of ivermectin completely turned me around, he continued to languish while on much higher doses and even HCQ in the mix, and had many symptoms I did not have (severe headaches, skin eruptions, and horrific cough without end).   While I take NAC daily, he does not (which is going to change today!).

NAC and Lyme/MSIDS

This article shows that glutathione metabolism is the most important target of B. burgdorferi infection and is essential for cytokine production, likely through glutathionylation.

This article discusses how Dr. Horowitz, a well-known Lyme literate doctor, published the first study of two COVID patients treated with three natural supplements, hydroxychloroquine, and an antibiotic. At 9 and 11 days into treatment, with both patients seeing gradual but incomplete improvement, a corner turned.  **Horowitz has now substituted ivermectin for HCQ**

The breakthrough came after he increased the dose of glutathione.  Within an hour, both patients were breathing better. “I definitely felt like the edge was taken off my symptoms,” said one of them, David Roth, 53. “I felt it fairly quickly.”

Although anecdotal,” Horowitz said, “I have heard from patients who were on NAC and glutathione when they were exposed to COVID-19, that they did not get sick or test positive for the virus, when others around them did.”  Source

Horowitz protocol for prevention

Top tier:
Glutathione, 250 to 500 mg twice a day
N-acetylcysteine (NAC), 600 mg twice a day
Second tier but makes above even better:
Alpha lipoic acid, 600 mg once to twice a day
Zinc, 40 to 50 mg a day
Icing on the cake:
Curcumin, 1000 mg twice a day
Sulforaphane glucosinolate (broccoli seed extract), 100 mg twice a day
3, 6 Beta glucan, 500 mg to 1000 mg once a day

To treat the infection, Horowitz uses the same supplements as in the prevention protocol but in higher doses. He further adds high-dose Vitamin C and ivermectin, which shows promise for COVID and would have to be prescribed by a physician. (Please read article in full as there are many great suggestions)

I have spoken with other COVID patients, some infected with tick-borne illness and some not, and ALL have responded a bit differently to ivermectin.  I now wonder if the IV C and blood ozone didn’t help me more than I first believed as those things were not used by the other patients.  While I still believe ivermectin to be effective, results will vary from person to person and sometimes it’s a combination of things that support your individual Achilles heel that work best. Once again, independent Lyme literate doctors are going to be a better choice (or independent functional medicine practitioners and the like who actually think for themselves) as mainstream medicine doesn’t have time and doesn’t care about these issues.  They treat everyone with an archaic “one size fits all” approach that hasn’t worked since the beginning of allopathic medicine.

This goes to show that cases will very considerably, just like with Lyme/MSIDS.

How to Get Unstuck With the Lyme Recovery Roadmap

https://rawlsmd.com/health-articles/how-to-get-unstuck-with-the-lyme-recovery-roadmap

How to Get Unstuck with the Lyme Recovery Roadmap

by Dr. Bill Rawls
Updated 10/15/21

During your Lyme disease recovery, it’s not unusual to find yourself stuck from time to time, not knowing what to do to further heal and reduce undesirable symptoms. To overcome this all too common circumstance and experience progress again, you’ll want to pay careful attention to potential obstacles that can impede wellness and remove them.

While eliminating microbes and reducing symptoms are crucial pieces of the recovery puzzle, there’s always more to the story. The biggest reasons symptoms occur in the first place are because our bodies’ cells aren’t getting enough nutrients, oxygen, or water, and the waste and toxin removal mechanisms are compromised. Ultimately, getting well is a matter of minimizing the factors that are disrupting the health of your cells to the best of your ability.

Building a Strong Foundation of Natural Support

So then, what direction do you go in if you need to get unstuck? Start by building a strong foundation in your Lyme disease recovery.

key steps in building your foundation: suppress microbes, protect cells, inhibit inflammation, cellular connectivity, good flow

The bedrock of any comprehensive natural protocol should contain these three critical elements: antimicrobial herbs, immune-modulating herbs, and methylation and cellular support.

antimicrobial, immune-modulating, and methylation and cellular support

While many herbs have the potential to be of benefit to your recovery from chronic Lyme disease, certain ones rise to the top because they tackle the myriad of cellular stress factors you endure, helping to quell an environment where chronic illness flourishes.

My preferred herbs and supplements from the 3 categories above include:

1. Antimicrobial Herbs to Suppress Microbes

Many herbs have antimicrobial effects against borrelia, bartonella, babesia, mycoplasma, and more. In fact, recent research from Johns Hopkins University has shown that herbal therapy may be more effective at combating borrelia and babesia than medications. The following is a list of herbs to help form the basis of your Lyme protocol.

antimicrobial herbs andrographis, berberine, cats claw, sarsaparilla, garlic, and more

2. Immune-Modulating Herbs

Herbs with immune-modulating properties help to normalize the functions of the immune system, inhibiting dysfunctional chemical messengers called cytokines and restoring the immune system’s communication pathways.

Medicinal mushrooms, in particular, are a great way to modulate the immune system, but other herbs are helpful as well.

immune-modulating herbs reishi mushroom, cordyceps, rehmannia extract, and chinese skullcap

3. Methylation + Cellular Support

Finally, combining herbs with supplements that address methylation — the body’s biochemical process that switches on and off genes, regulates metabolism, mood, detoxification, and more — will amp up the cellular protection.

methylation and cellular support: activated b vitamins, glutathione, alpha lipoic acid, and more

Removing the Obstacles to Healing

When trying to remove obstacles to healing, it’s vital to understand this: It’s generally not one factor but multiple factors that set the stage for chronic immune dysfunction associated with stealth infections and chronic illness. Besides microbes, other stress factors compounding the problem include:

  • Unnatural diet
  • Toxic environment
  • Chronic Stress
  • Sedentary lifestyle

Let’s take a look at each of these obstacles, how they impact healing, and what we can do about them:

1. Poor Diet

The foods you eat equate to fuel for the body so that you have the energy you need to repair tissues and curb inflammation. Without sufficient nutrients, the opposite is true: your body is starved of the nourishment it needs to restore itself. And while the occasional slip-up might not be enough to through your recovery completely off track, repeatedly consuming foods devoid of nutrients presents significant challenges for the body.

excess carbohydrates leads to increased insulin levels, insulin resistance, immune suppression, and more

evaluate your diet with the self-assessment tool to determine if it's an obstacle to healing
answering no to one or more items in the diet assessment suggests diet is an obstacle to healing

General Diet Guidelines

To keep your diet as nutrient-dense as possible, consider the following guidelines.

general diet guidelines cook your vegetables, avoid fried foods, minimize carbohydrates, and chew your food

Some foods are problematic for many people because they contribute to food allergies, sensitivities, digestive issues, or increase the body’s toxic burden. Foods to consider nixing from your diet altogether are as follows:

foods to eliminate include lectins, dairy, alcohol, artificial preservatives, and artificial sweeteners

2. Toxins

Toxins are present in the foods you eat, the air you breathe, personal care products, household cleaners, and more. Toxins can have a profound influence on the body.

toxins compromise cellular energy production, disrupt hormones, promote inflammation, and more

evaluate your environment with the self-assessment tool to determine if it's an obstacle to healing
answering no to one or more items in the toxin assessment suggests toxins are an obstacle to healing

Although toxins can come from a variety of sources, you’re probably most familiar with mold and its mycotoxins. Unfortunately, mold exposure can curtail your efforts to get well — regardless of whether it’s “toxic” or even whether you’re allergic to mold. More than 50% of homes and more than 85% of commercial buildings in the U.S. have water damage and mold, even if you can’t see or smell it outright. Symptoms can range from mildly disruptive to serious and truly life-threatening. To clean up mold and your environment, put these tips into action:

eliminate mold by removing visible signs of it and cleaning heating units and air conditioners
eat organic food, filter your water, replace HVAC filters, and quit smoking to minimize other toxins

3. Stress

Chronic stress is very pervasive in modern life. Often people suffering from stress don’t realize that their symptoms are stress-related. Stress has the potential to disrupt all normal functions of the body and mind.

stress disrupts functions of the body like digestion, immune system, daily maintenance, and tissue repair

evaluate your stress levels with the self-assessment tool to determine if it is an obstacle to healing
answering no to one or more items in the stress assessment suggests stress is an obstacle to healing

Stress sends the sympathetic nervous system — the part of the nervous system associated with the “fight or flight” response — into overdrive, leading to issues like poor sleep, feelings of irritability or anxiousness, increased pain levels, among others. Since you can’t outrun stress, learning to manage it is one of the best steps you can take for your health.

dedicate time to stress relief by mediating, gardening, walking, or using herbs to support the stress response

dedicate time to improving sleep by taking a hot bath, blocking out excess light, and sleeping in a cool room

4. Inactivity

If you’re highly symptomatic or experiencing a relapse, moving your body might be the last thing you want to do. But even gentle, restorative exercise (restorative yoga, qigong, taking a stroll, doing leisurely laps in the pool) can help counter the pitfalls of being too sedentary.

inactivity decreases blood flow, increases toxin retention, disrupts immune function, and zaps energy

evaluate your activity level with the self-assessment tool to determine if it's an obstacle to healing
answering no to one or more items in the activity assessment suggests inactivity is an obstacle to healing

if you have limited activity levels, consider gentle exercises like restorative yoga, pilates, or qigong

if you are bedridden, avoid exercise until you feel ready or consider using an infrared sauna

What if Symptoms Persist?

Sometimes, you can do all the right things and still wind up perplexed as to what’s going on or what to do next. The good news, however, is there are still several options to consider.

First, do you need to add additional herbal support to combat coinfections? Some herbs to think about include:

if symptoms persist, try additional herbal support like cryptolepis, black walnut, neem, or red root

Second, do you need the assistance of a heroic therapy — more potent interventions for when you feel like nothing else is moving the needle? For Lyme disease, the ones you’re most apt to be prescribed or recommended are:

heroic therapies are more potent interventions like antibiotics, rife machines, ozone, and hyperthermia therapy

Wellness is Within Reach

Treating Lyme disease requires persistence as you slowly chip away at layers of dysfunction and cellular stress factors. While it can be overwhelming, whenever you get stuck, go back to the basics and look for the areas where you might have gotten off track.

self check-ins are crucial each week to make sure you're staying on track toward your goal of healing

Review this recovery roadmap, and do weekly self check-ins. Remain consistent with your protocol and celebrate all of your healing milestones — no matter how big or small they are. Soon, you’ll find yourself turning the corner.

Dr. Rawls is a physician who overcame Lyme disease through natural herbal therapy. You can learn more about Lyme disease in Dr. Rawls’ new best selling book, Unlocking Lyme.
You can also learn about Dr. Rawls’ personal journey in overcoming Lyme disease and fibromyalgia in his popular blog post, My Chronic Lyme Journey.

________________

**Comment**

If you are a newbie, or even an “advanced” patient, this article may really stress you out as there’s so much to learn, consider, and address.  The intent is never to overwhelm, but to enlighten as this is probably the toughest thing to treat and encompasses every bodily system.  Please, just learn what you can and take one thing at a time.  Most things cost money and time and patients are typically short on both so don’t beat up on yourself. 

The Manufacturing of Bone Diseases & 8 Natural Osteoprotectives

https://www.greenmedinfo.com/blog/osteoporosis-myth-dangers-high-bone-mineral-density

The Manufacturing of Bone Diseases: The Story of Osteoporosis and Osteopenia

The present-day definitions of osteopenia and osteoporosis were arbitrarily conceived by the World Health Organization (WHO) in the early ’90s and then projected upon millions of women’s bodies seemingly in order to convince them they had a drug-treatable, though symptomless, disease

Osteopenia (1992)[i] and osteoporosis (1994)[ii] were formally identified as skeletal diseases by the World Health Organization (WHO) as bone mineral densities (BMD) 1 and 2.5 standard deviations, respectively, below the peak bone mass of an average young adult Caucasian female, as measured by an X-ray device known as dual energy X-ray absorptiometry (DXA, or DEXA). This technical definition, now used widely around the world as the gold standard, is disturbingly inept, and as you shall see, likely conceals an agenda that has nothing to do with the promotion of health.

Deviant Standards: Aging Transformed Into a Disease

A “standard deviation” is simply a quantity calculated to indicate the extent of deviation for a group as a whole, i.e., within any natural population there will be folks with higher and lower biological values, e.g., height, weight, bone mineral density, cholesterol levels. The choice of an average young adult female (approximately 30 years old) at peak bone mass in the human lifecycle as the new standard of normality for all women 30 or older, was, of course, not only completely arbitrary but also highly illogical. After all, why should an 80-year-old’s bones be defined as “abnormal” if they are less dense than a 30-year-old’s?

Within the WHO’s new BMD definitions the aging process is redefined as a disease, and these definitions targeted women, much in the same way that menopause was once redefined as a “disease” that needed to be treated with synthetic hormone replacement therapies (HRT); that is, before the whole house of cards collapsed with the realization that by “treating” menopause as a disease the medical establishment was causing far more harm than good, e.g., heart disease, stroke and cancer.

As if to fill the void left by the HRT debacle and the disillusionment of millions of women, the WHO’s new definitions resulted in the diagnosis, and subsequent labeling, of millions of healthy middle-aged and older women with what they were now being made to believe was another “health condition,” serious enough to justify the use of expensive and extremely dangerous bone drugs (and equally dangerous mega-doses of elemental calcium) in the pursuit of increasing bone density by any means necessary. 

One thing that cannot be debated, as it is now a matter of history, is that this sudden transformation of healthy women, who suffered no symptoms of “low bone mineral density,” into an at-risk, treatment-appropriate group, served to generate billions of dollars of revenue for DXA device manufacturers, doctor visits and drug prescriptions around the world.The Manufacture of a Disease

WHO Are They Kidding?

Osteopenia is, in fact, a medical and diagnostic non-entity. The term itself describes nothing more than a statistical deviation from an arbitrarily determined numerical value or norm. According to the osteoporosis epidemiologist Dr. L. Joseph Melton at the Mayo Clinic who participated in setting the original WHO criteria in 1992, “[osteopenia] was just meant to indicate the emergence of a problem,” and he noted, “It didn’t have any particular diagnostic or therapeutic significance. It was just meant to show a huge group who looked like they might be at risk.[iii] Another expert, Dr. Michael McClung, director of the Oregon Osteoporosis Center, criticized the newly adopted disease category osteopenia by saying, ”We have medicalized a nonproblem.”[iv]

In reality, the WHO definitions violate both commonsense and fundamental facts of biological science — sadly, an increasingly prevalent phenomenon within drug-company-funded science. After all, anyone over 30 years of age should have lower bone density than a 30-year-old, as this is consistent with the normal and natural healthy aging process. And yet, according to the WHO definition of osteopenia, the eons-old programming of your body to gradually shed bone density as you age, is to be considered a faulty design and/or pathology in need of medical intervention.

How the WHO, or any other organization that purports to be a science-based “medical authority,” can make an ostensibly educated public believe that the natural thinning of bones is not normal, or more absurdly, a disease, is astounding. In defense of the public, the cryptic manner in which these definitions and diagnoses have been cloaked in obscure mathematical and clinical language makes it rather difficult for the layperson to discern just how outright insane the logic they are employing really is.

So, let’s look closer at the definitions now, which are brilliantly elucidated by Washington.edu’s published online course on Bone Densitometry, which can be viewed in its entirety here.

The Manufacture of a Disease Through Categorical Sleight-of-Hand

bone mineral density loss

The image above shows the natural decrease in hip bone density occurring with age, with variations in race and gender depicted. Observe that loss of bone mineral density with age is a normal process.

Bell Curve Bones

Next is the classical bell-shaped curve, from which T- and Z-scores are based. T-sores are based on the young adult standard (30-year-old) bone density as being normal for everyone, regardless of age, whereas the much more logical Z-score compares your bone mineral density to that of your age group, as well as sex and ethnic background. Now here’s where it gets disturbingly clear how ridiculous the T-score really system is:

WHO definitions osteoporosis

Above is an image showing how within the population of women used to determine “normal” bone mineral density, e.g., 30-year-olds, 16% of them already “have” osteopenia, according to the WHO definitions, and 3% already “have” osteoporosis! According to Washington.edu’s online course, “One standard deviation is at the 16th percentile, so by definition, 16% of young women have osteopenia! As shown below, by the time women reach age 80, very few are considered normal.”

Osteopenia and Osteoporosis Rates with Age

Above you will see what happens when the WHO definitions of “normal bone density” are applied to aging populations. Whereas at age 25, 15% of the population will “have” osteopenia, by age 50 the number grows to 33%. And by age 65, 60% will be told they have either osteopenia (40%) or osteoporosis (20%).

On the other hand, if one uses the Z-score, which compares your bones to that of your age group, something remarkable happens: a huge burden of “disease” disappears! In a review on the topic published in 2009 in the Journal of Clinical Densitometry, 30% to 39% of the subjects who had been diagnosed with osteoporosis with two different DXA machine models were reclassified as either normal or “osteopenic” when the Z- score was used instead of the T-score. The table, therefore, can be turned on the magician-like sleight-of-hand used to convert healthy people into diseased ones, as long as an age-appropriate standard of measurement is applied, which presently it is not.

Bone Scans or Scams? How Dense Bones Can Harm Your Health

Bone Mineral Density Is NOT Equivalent to Bone Strength

As you can see there are a number of insurmountable problems with the WHO’s definitions, but perhaps the most fatal flaw is the fact that the DXA is only capable of revealing the mineral density of the bone, and this is not the same thing as bone quality/strength.

While there is a correlation between bone mineral density and bone quality/strength — that is to say, they overlap in places — they are not equivalent. In other words, density, while an excellent indicator of compressive strength (resisting breaking when being crushed by a static weight), is not an accurate indicator of tensile strength (resisting breaking when being pulled or stretched).

Indeed, in some cases having higher bone density indicates that the bone is actually weaker. Glass, for instance, has high density and compressive strength, but it is extremely brittle and lacks the tensile strength required to withstand easily shattering in a fall. Wood, on the other hand, which is closer in nature to human bone than glass or stone, is less dense relative to these materials, but also extremely strong relative to them, capable of bending and stretching to withstand the very same forces that the bone is faced with during a fall. Or, take spider web. It has infinitely greater strength and virtually no density. Given these facts, having “high” bone density (and thereby not having osteoporosis) may actually increase the risk of fracture in a real-life scenario like a fall.

Essentially, the WHO definitions distract from key issues surrounding bone quality and real world bone fracture risks, such as gait and vision disorders.[v] In other words, if you are able to see and move correctly in your body, you are less likely to fall, which means you are less prone to fracture. Keep in mind also that the quality of human bone depends entirely on dietary and lifestyle patterns and choices, and unlike X-ray based measurements, bone quality is not decomposable to strictly numerical values, e.g., mineral density scores.

Vitamin K2 and soy isoflavones, for instance, significantly reduce bone fracture rates without increasing bone density. Scoring high on bone density tests may save a woman from being intimidated into taking dangerous drugs or swallowing massive doses of elemetal calcium, but it may not translate into preventing “osteoporosis,” which to the layperson means the risk of breaking a bone. But high bone mineral density may result in far worse problems.

High Bone Mineral Density & Breast Cancer

High Bone Mineral Density & Breast Cancer

One of the most important facts about bone mineral density, conspicuously absent from discussion, is that having higher-than-normal bone density in middle-aged and older women actually INCREASES their risk of breast cancer by 200% to 300%, and this is according to research published in some of the world’s most well-respected and authoritative journals, e.g., Lancet, JAMA, NCI. (see citations below).

While it has been known for at least 15 years that high bone density profoundly increases the risk of breast cancer — and particularly malignant breast cancer — the issue has been given little to no attention, likely because it contradicts the propaganda expounded by mainstream women’s health advocacy organizations. Breast cancer awareness programs focus on X-ray based breast screenings as a form of “early detection,” and the National Osteoporosis Foundation’s entire platform is based on expounding the belief that increasing bone mineral density for osteoporosis prevention translates into improved quality and length of life for women.

The research, however, is not going away, and eventually these organizations will have to acknowledge it or risk losing credibility.

High Bone Density: More Harm Than Good

The present-day fixation within the global medical community on “osteoporosis prevention” as a top women’s health concern is simply not supported by the facts. The No. 1 cause of death in women today is heart disease, and the No. 2 cause of death is cancer, particularly breast cancer, and not death from complications associated with a bone fracture or break. In fact, in the grand scheme of things osteoporosis or low bone mineral density does not even make the CDC’s top 10 list of causes of female mortality. So, why is it given such a high place within the hierarchy of women’s health concerns? Is it a business decision or a medical one?

Regardless of the reason or motive, the obsessive fixation on bone mineral density is severely undermining the overall health of women. For example, the mega-dose calcium supplements being taken by millions of women to “increase bone mineral density” are known to increase the risk of heart attack by 24% to 27%, according to two 2011 meta-analyses published in Lancet, and 86% according to a more recent meta-analysis published in the journal Heart. Given the overwhelming evidence, the 1,200+ milligrams of elemental calcium the National Osteoporosis Foundation (NOF) recommends women 50 and older take to “protect their bones” may very well be inducing coronary artery spasms, heart attacks and calcified arterial plaque in millions of women. Considering that the NOF named calcium supplement manufacturers Citrical and Oscal as corporate sponsors, it is unlikely their message will change anytime soon.

Now, when you consider the case of increased breast cancer risk linked to high bone mineral density, being diagnosed with osteopenia or osteoporosis would actually indicate a significantly reduced risk of developing the disease. What is more concerning to women: breaking a bone (from which you can heal) or developing breast cancer? If it is the latter, a low BMD reading could be considered cause for celebration and not depression, fear and the continued ingestion of inappropriate medications or supplements, which is usually the case following a diagnosis of osteopenia or osteoporosis.

I hope this article will put to rest any doubts that the WHO’s fixation on high bone density was designed not to protect or improve the health of women, but rather to convert the natural aging process into a blockbuster disease, capable of generating billions of dollars of revenue.

Learn more on the GreenMedInfo.com database:


References

[i] WHO Scientific Group on the Prevention and Management of Osteoporosis (2000 : Geneva, Switzerland) (2003). “Prevention and management of osteoporosis : report of a WHO scientific group” (PDF). Retrieved 2007-05-31.

[ii] WHO (1994). “Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. Report of a WHO Study Group”. World Health Organization technical report series 843: 1-129. PMID 7941614.

[iii] Kolata, Gina (September 28, 2003). “Bone Diagnosis Gives New Data But No Answers”New York Times.

[iv] Ibid

[v] P Dargent-Molina, F Favier, H Grandjean, C Baudoin, A M Schott, E Hausherr, P J Meunier, G Bréart Fall-related factors and risk of hip fracture: the EPIDOS prospective study. Lancet. 1996 Jul 20;348(9021):145-9. PMID: 8684153

Probiotics Types & Functions

https://www.treatlyme.net/guide/probiotics-lyme-disease  Video Here

By Dr. Marty Ross

Probiotics in Lyme Disease Image by Marty Ross MD

Probiotics Types and Functions

Probiotics are healthy germs which a person takes to improve intestinal and overall health. According to the World Health Organization definition from 2001, probiotics are “live micro-organisms which, when administered in adequate amounts, confer a health benefit on the host.”

Current probiotic products fall into three categories:

  • human intestinal bacteria
  • soil-based spore-forming bacteria
  • human intestinal yeast.

The health benefits of probiotics may include:

  • stimulating the immune system
  • removing toxins,
  • balancing inflammation caused by infections and allergies
  • controlling food and environmental allergies
  • keeping Candida Albicans intestinal yeast under control
  • fighting and controlling unhealthy intestinal bacteria like Clostridium Difficile (C. Diff)
  • maintaining the good balance of normal intestinal bacteria, viruses and parasites
  • preventing intestinal bacteria, viral, and yeast (from Candida) infections
  • aiding food digestion

(See link for article and video)

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Can LDN Or Gabapentin Improve Sleep?

https://rawlsmd.com/health-articles/can-low-dose-naltrexone-or-gabapentin-improve-sleep?

Can Low-Dose Naltrexone or Gabapentin Improve Sleep?

by Dr. Bill Rawls
Posted 10/1/21

If you experience the symptoms of poor sleep or sleeplessness that often accompany people with Lyme disease, fibromyalgia, and other chronic illnesses, you’re probably desperate for some help. Can medications like low-dose naltrexone (LDN) and low-dose gabapentin provide relief for those wired but tired nights? Watch as Dr. Bill Rawls discusses the use of LDN and low-dose gabapentin and the ways in which they might be of benefit to you. Read more about Lyme disease and sleep here.

Video Transcript

Question: Can low-dose Naltrexone or Gabapentin improve sleep?

Tim Yarborough: Our next question here is asking about LDN (low-dose naltrexone). I heard that low-dose, as well as low-dose gabapentin for helping with better sleep. Have you heard anything about that, Dr. Rawls?

Dr. Rawls: Well, there are two different things. Of course, low-dose naltrexone is an opioid blocker and gabapentin is a drug that mimics GABA in the brain. So, low-dose naltrexone was a drug developed back in the 70’s, I believe, to help opioid heroin addicts get off heroin. So it blocks opioid receptors in the body. So if you’re taking heroin or a narcotic, you just don’t feel any of the effects.

It didn’t work out very well because it didn’t have any effects for controlling pain or other kinds of things, so people just wouldn’t take it. But somebody along the way found that if you use 10% of the dose, then it had this interesting effect of very briefly blocking opioid receptors and the body responded by making lots of endorphins, and so we’ve been using that for some years. It has to be compounded. So they have to take the drug and drop the dose down to 1.5 to 4.5 milligrams, which is a fraction, about 10% of the normal prescribed dose, that you would use for a narcotic addiction.

So it really doesn’t have that much in the way of side effects in most people, and a lot of people do get a boost of endorphins, so it can be very valuable. I used it in my practice. I found that it was about 50/50, honestly. About 50% of people noticed a significant difference. About 50% of people got nothing from it. And at either end of the spectrum, I had some people with terrible side effects, and other people that it just was a wonder drug, so I think it’s worth trying.

The safety profile with it is very high. It is not habituating. It does not have any opioid effects, whatsoever, and it will not really, it directly in itself, help with pain. You cannot be on any kind of narcotic and use it. So you have to be off of all narcotics to use it, and it can be valuable for decreasing pain. Some people actually do sleep better on it, so it is worth trying.

Though CBD does some of those things, CBD boosts endorphins also, and you can use them together because they work completely differently. It’s fine to use CBD and low-dose naltrexone together.

Gabapentin is another drug that affects GABA receptors, and it does cross over into the brain a bit, but it’s more affecting the peripheral nervous system. So you have different types of GABA receptors all through your nervous system, in your brain, and in your peripheral nervous system. So gabapentin, it was more designed for paresthesia and irritated nerves peripherally, but some people find that they do get a central GABA effect from it. It does help with sleep a little bit.

They will tell you, at least they told that the thing with the drug is, they said it’s not directly metabolized by the liver, and it’s not crossing into the brain, so it’s not habituating at all. It turned out that that was completely false. It’s not as habituating as a benzodiazepine, but it is habituating. So the longer you take it, the more of it you’ll need and sometimes you do have withdrawal symptoms getting off of it, when you decide you want to get off of it.

So it can be a drug that is valuable. It can work something like a sleeping pill. It’s not quite as addictive as a sleeping pill, but it’s still habituating. You’re still going to pay some price with it.

Problem with these things though, is that once you get habituated to it, you need more and more of a dose, and eventually you get to a dose that it just doesn’t work anymore and then you have to go to a stronger drug to sleep, and that’s the issue with the drugs.

Dr. Rawls is a physician who overcame Lyme disease through natural herbal therapy. You can learn more about Lyme disease in Dr. Rawls’ new best selling book, Unlocking Lyme.   You can also learn about Dr. Rawls’ personal journey in overcoming Lyme disease and fibromyalgia in his popular blog post, My Chronic Lyme Journey.

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