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Is The FDA Trying to Ban Over-The-Counter Homeopathy?

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This article is from Greenmedinfo.com, printed here with their permission. It was written by Larry Malerba, DO, DHt,  a classical homeopath, osteopathic physician.  For more from Greenmedinfo, sign up for their newsletter here.

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Is the FDA acting out of malicious intent or willful ignorance in publishing a new draft guidance on homeopathics which would effectively treat them like pharmaceutical drugs, with similar regulatory requirements? 

FDA’s Regulatory Overreach Reflects Poor Understanding of Homeopathy

When FDA announced a “draft guidance” in December 2017 stating its latest intentions regarding the regulation of homeopathic products, it became clear that the agency had paid little attention to the concerns of the homeopathic community of practitioners, consumers, patients, and manufacturers. It turns out that the FDA’s public hearing held in 2015—during which numerous representatives of homeopathic interests from across the U.S and around the globe gave overwhelmingly positive testimony as to the safety, efficacy, and unique nature of homeopathic medicines—was just a pretense designed to give the appearance that it was taking the public’s concerns into account.

Hiding behind rhetoric emphasizing concerns for the safety of consumers—“FDA is proposing a new, risk-based enforcement approach to homeopathic drug products that have the greatest potential to cause risk to patients”—FDA is intending to launch a two-pronged initiative that exaggerates the risks associated with homeopathic products and denies the existing evidence in support of their safety and effectiveness.

Regarding the Safety of Homeopathic Medicines

FDA has chosen to use a very small number of unsubstantiated accounts of adverse events supposedly associated with homeopathic products in order to justify overregulation of the industry as a whole. Failing to acknowledge that the current regulatory framework, Compliance Policy Guide 400.400 (adopted in 1988), is more than sufficient to accomplish its stated goal of protecting the public from potential harm, FDA appears bent on tearing that policy down in favor of either a new and unnecessarily stringent policy or no replacement policy at all.

No policy at all would likely result in confusion about FDA’s expectations of homeopathic manufacturers and could provide opportunity for FDA to exploit the lack of clear regulatory bounds. Ronald Whitmont, MD, President of the American Institute of Homeopathy (AIH), echoes this sentiment:

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“What is clear is that FDA has ignored the homeopathic community’s requests to update this guidance. By withdrawing CPG 400.400 the FDA is removing the only clear guidelines that have served to help the FDA, the homeopathic manufacturers, and the public to understand the policies surrounding the marketing and labeling of homeopathic products.  

The AIH is very concerned that the withdrawal of this document will create a situation where anything can be labeled “homeopathic” and muddy the waters around what actually is homeopathic. The AIH is also concerned that withdrawal of the guidance would allow the FDA to act capriciously and to interpret the new guidelines more broadly than they should be.

If the FDA is unhappy with the current CPG 400.400 we advise that they amend it to make it a better, more comprehensive guideline, not one with less clear instructions that could result in abuses from both manufacturers and regulators. Only the public will suffer when this happens.”

I have written previously about FDA’s trumped-up scare tactics regarding homeopathic teething tablets. For decades, homeopathic medicines have been subject to unrelenting criticism from mainstream science and conventional medicine. Critics contend that the quantities of ingredients used are too small to have any physiological effects and, all observed effects must, therefore, be written off as placebo effects. In other words, the predominating belief is that homeopathic doses are too small to be of any health concern.

Astonishingly, we are witnessing a suspicious about-face whereby homeopathic medicines have apparently morphed overnight in the minds of FDA officials from useless placebos to dangerous toxins. Although the scientific community is talking out of both sides of its mouth, it can’t have it both ways. Truth be told, any qualified homeopathic doctor will tell you that neither assertion is the case. While homeopathic medicines are clearly not placebos, they are also nothing like conventional pharmaceuticals.

Homeopathic medicines are in a class completely on their own, which is why when homeopathic physician and New York State Senator, Royal Copeland, MD, sponsored legislation creating the Food, Drug and Cosmetic Act of 1938, it was abundantly clear to the U.S. Congress that homeopathic products did not pose a risk and did not warrant the type of scrutiny that the modern-day FDA now claims it deserves.

Although the safety profiles of homeopathic medicines are unparalleled, FDA wants you to believe otherwise. A handful of isolated and unproven cases of seizures supposedly caused by homeopathic Belladonna elicited a “warning against the use” of teething tablets and a thorough review of FDA’s oversight of the entire homeopathic industry.

By contrast, here is a list of 200 drugs admittedly known to be able to produce seizures as possible side effects. I don’t see FDA clamoring to warn people against using these drugs. And I certainly don’t see them undertaking an audit of the entire pharmaceutical industry. When the safety of homeopathic products is compared against the track records of almost all conventional pharmaceuticals, FDA’s egregious double standard becomes unavoidably apparent.

If you understand homeopathy and you’ve seen it work, you know that safety is a virtual non-issue. If a remedy is manufactured according to standards of the Homeopathic Pharmacopeia of the United States (HPUS), there is no reason for concern and no need for FDA to think it would need greater oversight. Therefore, the only way a homeopathic medicine can cause harm is if it has been manufactured recklessly in a manner that does not follow proper protocol. A properly made homeopathic dilution, by definition, cannot be toxic because the degree of dilution is too great. For FDA to believe otherwise is unscientific and disingenuous.

Another completely specious contention that FDA makes in its draft guidance is that homeopathic treatment “may cause users to delay or discontinue medical treatments that have been found safe and effective.” This is a classic anti-homeopathy activist talking point, one that makes a number of bogus assumptions, and one that is inherently defamatory of the homeopathic medical profession. It implies that homeopathic treatment is inferior, that it does not constitute safe and effective treatment, and that turning to conventional allopathic drug therapy is always the superior, safe, and effective thing to do.

There is no possible justification for such a statement given that one Johns Hopkins study concluded that medical error is the third leading cause of death in the U.S., a number that represents more than 250,000 deaths per year. And FDA wants to ratchet up regulation of homeopathy due to a few uncorroborated case of seizures from one homeopathic product? Something smells very fishy, indeed.

The Homeopathic Industry Agrees That Safety Standards Are Needed

Now, it is true that unscrupulous parties have been known to market so-called homeopathic products that don’t follow proper manufacturing guidelines as set out by the HPUS or don’t adhere to “current good manufacturing practices” (cGMP). If and when that happens, FDA already has the regulatory authority to effectively handle such infractions. As such, there is no need to make any changes in regulatory policies regarding homeopathic products. Nevertheless, FDA appears ready to jump the shark, giving the clear but erroneous impression that homeopathic products have suddenly become a safety concern.

The homeopathic industry does not disagree with FDA regarding the need for safety standards. However, it objects to the need for revised standards that place homeopathic products at risk for overzealous and punitive regulatory actions. Current FDA policy as stated in Compliance Policy Guide 400.400 is both adequate and effective. Eric L. Foxman, R.Ph., Secretary of the American Association of Homeopathic Pharmacists, is rightfully concerned, and has this to say about FDA’s proposed actions:

“In its apparent zeal to address problematic products, the FDA has decided to do away with the existing regulatory framework under which the industry and the agency have worked together for over 25 years. This is poorly considered and ill advised. In fact, without some of the aspects of the existing Compliance Policy Guide, many more problematic homeopathic products could conceivably be brought to market. This could lead to the marketing of more adulterated, misbranded or fraudulent products masquerading as homeopathic. That would be an abdication of FDA’s role as a public heath agency, and would be a giant step backwards for homeopathy and, especially, the American consumer.”

Although the homeopathic manufacturing industry has tried to maintain a good faith relationship with FDA, the agency, in my opinion, has not acted in kind. Historically speaking, the two parties once did have a good working relationship, but this has not been the case for decades.

Regarding the Purported Lack of Evidence in Support of Homeopathy

FDA’s announcement and its new draft guidance statement make repeated references to the “unproven” nature of homeopathic medicines. Emboldened by another agency that also has little knowledge of homeopathic medicines, FDA makes reference to FTC’s claim that, “companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions.”

Here, in direct violation of the spirit of an act of Congress that created the Food, Drug and Cosmetic Act, the modern FDA appears to be setting the stage for the possibility of removing the special status of homeopathic medicines. This would give them the same status as conventional drugs, potentially subjecting them to the same regulatory approval process.

This would likely bankrupt the industry, since homeopathic drugs would not be able to command the same outlandish prices that conventional pharmaceuticals have used to gouge the public and to pay for the exorbitant costs of the drug approval process. It amounts to a form of organized governmental crime that only the most obscenely wealthy companies can afford.

(I would like to make clear that this is not the opinion of the homeopathic manufacturers. They do not interpret FDA’s intent in the same conspiratorial way as do I and some others. They are of the opinion that FDA is looking to do its job to protect the public, and not out to undermine homeopathy. It is also important to note that while FDA’s actions could impact the manufacture and marketing of certain homeopathic products, it has no jurisdiction over those who practice homeopathic medicine.)

This brings us to the critically important issue of what it is that actually constitutes scientific evidence. First and foremost, I must state with unequivocal certainty that any claim that there is a lack of research evidence to support homeopathy is an absolute falsehood. Those who make such claims are either deliberately lying, are repeating bogus talking points that they have read or heard elsewhere, or do so out of pure ignorance. There are literally thousands of research trials, many of which shine favorably upon homeopathy. To examine the evidence and then deny its existence is to be deliberately obtuse.

Dr. Samuel Hahnemann developed his system of treatment by similars 200 years ago by studying the effects of his diluted medicines on healthy test subjects. FDA acknowledges this methodology, which Hahnemann called “proving.” It is an inherently safe process that involves using highly diluted medicines that are incapable of producing toxic effects. Diluted medicines are made, they are proven on test subjects, and the resulting information is used as a guide to treat people with symptoms that match the symptom patterns of the remedy provings. There is good reason to believe that it was Hahnemann himself who conducted the very first placebo-controlled, blinded research trials.

In addition to provings and modern research trials, homeopathy also has a vast body of clinical literature that dates back 200 years. Included in the literature, which was written almost exclusively by experienced physicians, are thousands upon thousands of clinical case studies. Physicians painstakingly documented the patients they encountered, the symptomatic presentation of their complaints, the remedies administered to them, and the short and long term outcomes of treatment. This process continues to this day, with countless case histories having been published in numerous international homeopathic journals both new and old.

What happens when we try to evaluate homeopathic products according to conventional pharmaceutical research standards? What all homeopathic practitioners understand—and FDA does not—is that successful homeopathic treatment is critically dependent upon context. It is not possible to get reliable results by choosing a target symptom or two to treat in isolation from all other symptoms of the patient. This type of symptomatic focus is the very thing that defines allopathic medicine. In contrast to a conventional cough suppressant drug, for example, there is no such thing as a homeopathic remedy that can be used to treat coughs in general. Each cough is unique and must be treated accordingly.

For example, Drosera is a well-known remedy for coughs of a specific type. It is especially suited to violent coughing paroxysms that can result in vomiting and even nosebleeds. The attacks are more likely to flare up after midnight. Pulsatilla, on the other hand, suits coughs that are much less aggressive. The cough gets worse when lying down, forcing the person to sit up to get relief. The person who needs Pulsatilla also complains of feeling worse in a warm room, needs fresh air to feel better, and experiences a noticeable decrease in thirst. Spongia is a remedy suited for hoarse, dry coughs. There is often tickling in the throat, which can be quieted by drinking warm drinks.

This is just a small sample of potential homeopathic cough remedies and their unique characteristics. While these types of details have little to no bearing on conventional drug therapy choices, they are crucial factors that determine successful homeopathic prescriptions.

Now imagine what would happen if FDA required a study to “prove” the value of Drosera in treating coughs. Of 100 test subjects, how many do you think would fit the criteria to justify a prescription of this particular homeopathic medicine? Very few, indeed. How long would it take to find 100 test subjects that do have symptom patterns that match Drosera? I suspect it would take years even under the best of circumstances.

Furthermore, although Pulsatilla is well-indicated for certain types of coughs, it can also be used it to successfully treat a wide spectrum of health problems, including hot flashesear infectionsgallbladder attackseczemadepression, and many more. Unlike most pharmaceutical drugs, homeopathic medicines do not have single indications. They have many uses. This basic truth adds even further confusion to FDA’s already poor understanding of homeopathic products.

So when FDA demands proof of homeopathic effectiveness according to conventional medical standards, the deck is already stacked against any prospect of success. Conventional drug trials are very poorly suited to understanding the benefits of homeopathic medicines. Each homeopathic medicine has many potential therapeutic indications, and there are many potential homeopathic remedies that can help the various individuals diagnosed with the same illness.

The irony here is that FDA requires a homeopathic label to include a specific indication for its use, and then asks for proof that it can help that condition. FDA is under the false impression that it can treat homeopathic products as if they are no different from allopathic drugs. Furthermore, FDA’s latest draft guidance states the following:

Generally, a drug, including a homeopathic drug, is considered a “new drug” if it is not generally recognized as safe and effective (GRAS/E) by qualified experts for use under the conditions prescribed.

Although this guidance clearly implies that FDA should consult qualified experts when making judgments regarding homeopathic medicines and their uses, there are no such experts on FDA’s staff. Neither does FDA have any ongoing official working relationships with outside experts in spite of requests from the homeopathic community that FDA fulfill this obligation. FDA lives in an allopathic bubble with no conception of the true nature of homeopathic products, how they work, or how they should be regarded. It is clear that FDA just doesn’t get it; it has little understanding of how homeopathy works or how it should be evaluated.

There are only two plausible explanations for FDA’s misguided attitude toward homeopathy. One is that it is acting with malicious intent to undermine the homeopathic industry, and to subvert an act of Congress, in which case it would not be far-fetched to assume that they are being encouraged to do so by Big Pharma, which is the one party that stands the most to gain from this fiasco. Given FDA’s multiple references to the recent growth of the homeopathic market, this is not an unreasonable conclusion.

The other explanation is that FDA is acting out of willful ignorance. They act like they are listening but their minds are closed. Notwithstanding the possibility of good intentions to guard the public safety, FDA’s actions reveal that it has a very poor grasp of homeopathy, and it does not seem interested in learning from true homeopathic experts.

So what is the best way to study the effects of homeopathic medicines? In terms of conventional research methodology, the protocol most suited to studying homeopathy is one that treats each individual according to his or her unique symptom pattern. It would involve treating a particular disease category, such as ear infections for example, with as many different remedies as are needed to treat the various individuals involved in the study. Each case of ear infection would receive the single remedy that best matches its symptomatic expression. It might require 10, 15, 20 or more different remedies in order to properly treat all of of kids in the study. Of course, this does not satisfy FDA’s conception of a properly conducted research trial. Nevertheless, it is the only way to give homeopathy a fair shake.

As far as homeopaths are concerned, the types of evidence best suited to homeopathy are provings and case studies as previously described. Ironically, and perhaps conveniently for disbelievers, this is the type of evidence that modern medicine now derisively calls “anecdotal.” Medical science has devolved to a point where it trusts the statistical trickery of research trials that evaluate only a few limited parameters (such as the ability to suppress a cough) more than it trusts the first-hand experiences of patients and their doctors (case studies).

Modern standards of medical evidence are badly out of kilter. The first step in rectifying the imbalance will be for medicine to acknowledge the truth of the safety and effectiveness of homeopathy and the many lessons that it has to teach about health and healing.

We Must Continue to Stand for Freedom of Medical Choice

Here’s what you can do…

1. One way to help right now is to submit positive comments (not criticisms of FDA) to FDA in support of homeopathy. Tell FDA that its current regulatory guidelines (Compliance Policy Guide 400.400) for homeopathic products are more than adequate and that any further changes place your right to choose in jeopardy. The period for public comment before FDA makes its final decisions about this critically important policy closes on March 20, 2018. (Comment here)

2. The Homeopathic Pharmacists of the United States also urge those who live in certain states (CO, NM, PA, TN, WA, UT) to urge their legislators to tell FDA not to scrap the current guidelines regarding the regulation of homeopathic products. All you have to do is sign your name to the letter. Even better if you add your own personal story of homeopathic success. (Take Action Here)

About the author:

Larry Malerba, DO, DHt is a classical homeopath, osteopathic physician, and educator whose mission is to build bridges between holistic healing, conventional medicine, and spirituality. He is the author of Green Medicine and Metaphysics & Medicine. His new book, Dynamic Medicine: The World According to Homeopathy, offers an insightful introduction to the best kept secret in the holistic health world. Dr. Malerba is board certified in Homeotherapeutics and past president of the Homeopathic Medical Society of the State of New York.
www.DrMHomeopathy.com
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Long-Term Consequences of Mumps Vaccination: Many Unanswered Questions

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This is Part II of a two-part series on mumps. Part I discussed how mumps vaccination and the flawed mumps component of Merck’s MMR vaccine are fostering dangerous mumps outbreaks in adolescents and young adults.

It has been about five decades since the U.S. Food and Drug Administration (FDA) approved Merck’s first mumps vaccine. The company began launching combination MMR (measles, mumps and rubella) vaccines in the 1970s. Coincidentally—or not—an infertility crisis has been brewing over roughly the same time period, with dramatic declines in sperm counts and record-lowfertility levels. However, few investigators seem interested in assessing whether mumps outbreaks in highly vaccinated populations of teens and young adults could be having long-termeffects on fertility or other health indicators.

As described in Part I, childhood MMR vaccination has been an unmitigated disaster where mumps is concerned, deferring mumps infection to older ages and leaving adolescents and young adults vulnerable to serious reproductive complications. Public health reports show that the vast majority of mumps cases and outbreaks occur in youth who have been fully vaccinatedwith the prescribed two-dose MMR series, supporting a hypothesis of “waning immunity after the second dose.” FDA and Centers for Disease Control and Prevention (CDC) officials even admitthat mumps outbreaks in the post-vaccination era “typically involve young adults,” and that vaccination is failing to protect those who are college-age and above.

Myopically, many vaccine experts have called for a third MMR dose—or even “booster dosing throughout adulthood”—even though the FDA’s and CDC’s own research shows that MMR boosters in college-age youth barely last one year. As alleged in whistleblower lawsuits wending their way through the courts over the past eight years, Merck presented the FDA with a “falsely inflated efficacy rate” for the MMR’s mumps component, using animal antibodies and other fraudulent tactics to fool FDA—and the public—into believing that the vaccine was effective.

When infection arises after puberty, however, mumps is no laughing matter, presenting an increased risk of complications such as hearing loss, encephalitis and inflammation of the reproductive organs.

Mumps after puberty is no laughing matter

Around the time that the first mumps vaccine came on the market, the 1967 children’s classic The Great Brain humorously depicted mumps infection in childhood as a mere nuisance. The book’s young protagonist goes out of his way to intentionally infect himself with mumps so that he can beat his two brothers to the recovery finish line—and he experiences no adverse consequences other than his siblings’ annoyance.

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When infection arises after puberty, however, mumps is no laughing matter, presenting an increased risk of complications such as hearing loss, encephalitis and inflammation of the reproductive organs. About one in three postpubertal men with mumps develops orchitis(inflammation of the testes), which can damage sperm, affect testosterone production and contribute to subfertility and infertility. During a mumps outbreak in England in the mid-2000s, mumps orchitis accounted for 42% of all hospitalized mumps cases; the researchers attributed this outcome—which was the most common reason for hospitalization—to “the high attack rates in adolescents and young adults” that occurred “despite high coverage with two-dose MMR.” An analysis of a 2006 mumps outbreak in the U.S. reported that male patients were over three times more likely than female patients to experience complications, “due primarily to orchitis.”

An estimated 5% to 10% of postpubertal women will develop oophoritis (swelling of the ovaries) following mumps infection. Oophoritis is associated with premature menopause and infertility, but mumps-related oophoritis has garnered little notice.

Mumps infections are often asymptomatic or produce nonspecific symptoms such as fever, while cases of orchitis may present with no other mumps symptoms. Nonetheless, public health officials advise clinicians that orchitis is an instant cue to test for mumps virus, and testing often reveals elevated mumps antibodies. In a case report of MMR failure, British clinicians isolated a novel genetic strain of mumps virus from the patient’s semen two weeks after the onset of orchitis and found mumps RNA in the semen 40 days later; they also noted “the appearance of anti-sperm antibodies,” with “potential long-term adverse effects on the patient’s fertility.”

In 2017, researchers who reviewed 185 studies conducted in Western nations found that sperm counts had plummeted by 50% to 60% between 1973 and 2011—an average decrease of 1.4% annually. Commenting on this work, one analyst estimated that 20% to 30% of young men in Europe and North America have sperm concentrations associated with a reduced ability to father a child. Given estimates that as much as 40% of reproductive problems have to do with the male partner, there is agreement on the importance of “finding and eliminating [the] hidden culprits in the environment” that most researchers believe are to blame.

An estimated 5% to 10% of postpubertal women will develop oophoritis (swelling of the ovaries) following mumps infection. Oophoritis is associated with premature menopause and infertility, but mumps-related oophoritis has garnered little notice.

MMR’s and MMRV’s potential to impair fertility never studied

Merck has not evaluated either of its two MMR vaccines—the MMR-II and the MMR-plus-varicella (MMRV) vaccine—for their potential to impair fertility. Whether such testing would unearth direct effects on fertility (as appears to be possible with HPV vaccination in women) is thus unknown. However, mumps vaccination undeniably increases reproductive-age individuals’ risk of mumps infection and, in the process, increases the risk of fertility-altering complications. These facts alone should be attracting far more attention.

Unfortunately, because clinicians already tend to underdiagnose mumps infection and underestimate mumps complications, it is likely that they are failing to recognize possible vaccine-induced reproductive health consequences of mumps infection in their adolescent and young adult patients. In one university outbreak, “most physicians…did not suspect mumps,” and even when they became aware of the outbreak, “diagnosing mumps was not always straightforward.” Moreover, although differentiating between vaccine strains of mumps virus and wild types could provide valuable information, few clinicians have the capacity or inclination to perform testing of this type. A Japanese study of cerebrospinal fluid and saliva from patients with mumps complications found vaccine strain in nearly all of the samples and noted the information’s importance in helping determine whether the complications were vaccine-related.

Those who have sought to understand mumps vaccines’ poor performance point to a mixture of explanatory factors. These include waning immunity, the high population density and close quarters encountered in settings such as college campuses, incomplete vaccine-induced immunity to wild virus as well as viral evolution such that “the vaccine triggers a less potent reaction against today’s mumps viruses than those of 50 years ago.” However, some also quietly admit that individuals with “mild vaccine-modified disease” could be perpetuating the chain of transmission. This latter point ought to be raising questions about the logic and wisdom of administering further rounds of MMR boosters during outbreaks while ignoring the problems created by the doses already given.

… some individuals respond poorly to mumps vaccination and vaccine-induced antibody levels correlate poorly with protection from mumps infection, irrespective of the number of additional doses of mumps-containing vaccine they receive.

Most scientists appear to be either resigned to ongoing mumps outbreaks in vaccinated populations or actually accept periodic outbreaks as the cost of doing business. Publications by FDA and CDC researchers reveal these agencies’ awareness that some individuals respond poorly to mumps vaccination and that vaccine-induced antibody levels correlate poorly with protection from mumps infection, “irrespective of the number of additional doses of mumps-containing vaccine they receive.” Considering the effects on fertility, the generally abysmal track record of mumps vaccination and Merck’s fraudulent claims about efficacy, it is hard to fathom medical and public health experts’ complacency about current mumps vaccines and vaccine policies.


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Legal Challenge Against Forced Vaccination Filed in New York City

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On April 15, 2019, a legal challenge was filed in the New York State Trial Court by Robert Krakow, Robert F. Kennedy, Jr. and Patricia Finn against the New York City Department of Health and Human Hygiene for their forced Measles-Mumps-Rubella vaccination. The legal team asked for a temporary restraining order against the mandate that the Judge will likely review and provide an ex parte decision. Children’s Health Defense is supporting these efforts.

Last week, Children’s Health Defense reported that the NYC Commissioner of Health declared a public health emergency, ordering all people who live, work or reside in four Brooklyn zip codes to be vaccinated with the Measles-Mumps-Rubella vaccine. Non-compliance with the order is a misdemeanor subject to criminal and civil fines, including imprisonment. Only those with documented immunity, medical contraindications or infants under six months are exempt from the vaccine mandate.

READ THE PETITION
READ THE MEMORANDUM OF LAW
READ THE AFFIRMATION

Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Your support is essential to CHD’s successful mission.

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Magnesium Puts Psychiatric Drugs to Shame for Depression

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In Brief

  • The Facts:

    This article was written by Sayer Ji, Founder of Greenmedinfo.com where this article first appeared. Posted here with permission.

  • Reflect On:

    Is the priority of our federal health regulatory agencies and pharmaceutical companies human health, or profit? If there are more effective ways to treat several illnesses, why do they never mention them?

Depression is one of the most widely diagnosed conditions of our time, with over 3 million cases in the U.S. every year, and 350 million believed affected worldwide.1 Conventional medicine considers antidepressant drugs first-line treatments, including the newly approved injected postpartum drug costing $34,000 a treatment, to the tune of a 16 billion dollars in global sales by 2023. Despite their widespread use, these drugs are fraught with a battery of serious side effects, including suicidal ideation and completion — the last two things you would hope to see in a condition that already has suicidality as a co-morbidity. For this reason alone, natural, safe, and effective alternatives are needed more than ever before.

While research into natural alternatives for depression is growing daily — GreenMedInfo.com’s Depression database contains 647 studies on over 100 natural substances that have been studied to prevent or treat depression — it is rare to find quality human clinical research on the topic published in well-respected journals. That’s why a powerful study published in PLOS One titled, “Role of magnesium supplementation in the treatment of depression: A randomized clinical trial,” is so promising. Not only is magnesium safe, affordable, and easily accessible, but according to this recent study, effective in treating mild-to moderate symptoms of depression.

While previous studies have looked at the association between magnesium and depression,2-7 this is the first placebo-controlled clinical study to evaluate whether the use of over-the-counter magnesium chloride (248 mg elemental magnesium a day for 6 weeks) improves symptoms of depression.

The study design was a follows:

“ An open-label, blocked, randomized, cross-over trial was carried out in outpatient primary care clinics on 126 adults (mean age 52; 38% male) diagnosed with and currently experiencing mild-to-moderate symptoms with Patient Health Questionnaire-9 (PHQ-9) scores of 5–19. The intervention was 6 weeks of active treatment (248 mg of elemental magnesium per day) compared to 6 weeks of control (no treatment). Assessments of depression symptoms were completed at bi-weekly phone calls. The primary outcome was the net difference in the change in depression symptoms from baseline to the end of each treatment period. Secondary outcomes included changes in anxiety symptoms as well as adherence to the supplement regimen, appearance of adverse effects, and intention to use magnesium supplements in the future. Between June 2015 and May 2016, 112 participants provided analyzable data.”

The study results were as follows:

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“Consumption of magnesium chloride for 6 weeks resulted in a clinically significant net improvement in PHQ-9 scores of -6.0 points (CI -7.9, -4.2; P<0.001) and net improvement in Generalized Anxiety Disorders-7 scores of -4.5 points (CI -6.6, -2.4; P<0.001). Average adherence was 83% by pill count. The supplements were well tolerated and 61% of participants reported they would use magnesium in the future. Similar effects were observed regardless of age, gender, baseline severity of depression, baseline magnesium level, or use of antidepressant treatments. Effects were observed within two weeks. Magnesium is effective for mild-to-moderate depression in adults. It works quickly and is well tolerated without the need for close monitoring for toxicity.”

 For perspective, conventional antidepressant drugs are considering to generate an “adequate or complete treatment response” with a PHQ-9 score “decrease of 5 points or more from baseline.” At this level of efficacy, their recommended action is: “Do not change treatment; conduct periodic follow-up.” The magnesium’s score of -6.0 therefore represents the height of success within conventional expectations for a complete response, which is sometimes termed “remission.” In contradistinction, conventional antidepressant drugs result in nearly half of patients discontinuing treatment during the first month, usually due to their powerful and sometimes debilitating side effects.8

To summarize the main study outcomes:

  • There was a clinically significant improvement in both Depression and Anxiety scores.
  • 61% of patients reported they would use magnesium in the future.
  • Similar effects occurred across age, gender, severity of depression, baseline magnesium levels, or use of antidepressant treatments.
  • Effects were observed within two weeks.

 The study authors concluded:

“Magnesium is effective for mild-to-moderate depression in adults. It works quickly and is well tolerated without the need for close monitoring for toxicity.”

Beyond Depression: Magnesium’s Many Health Benefits & Where To Source It

Magnesium is a central player in your body’s energy production, as its found within 300 enzymes in the human body, including within the biologically active form of ATP known as MG-ATP. In fact, there have been over 3,751 magnesium binding sites identified within human proteins, indicating that it’s central nutritional importance has been greatly underappreciated.

Research relevant to magnesium has been accumulating for the past 40 years at a steady rate of approximately 2,000 new studies a year. Our database project has indexed well over 100 health benefits of magnesium thus far.  For the sake of brevity, we will address seven key therapeutic applications for magnesium as follows:

  • Fibromyalgia: Not only is magnesium deficiency common in those diagnosed with fibromyalgia, 9,10 but relatively low doses of magnesium (50 mg), combined with malic acid in the form of magnesium malate, has been clinically demonstrated to improve pain and tenderness in those to which it was administered.11
  • Atrial Fibrillation: A number of studies now exist showing that magnesium supplementation reduce atrial fibrillation, either by itself, or in combination with conventional drug agents.12
  • Diabetes, Type 2: Magnesium deficiency is common in type 2 diabetics, at an incidence of 13.5 to 47.7% according to a 2007 study. 13 Research has also shown that type 2 diabetics with peripheral neuropathy and coronary artery disease have lower intracellular magnesium levels. 14 Oral magnesium supplementation has been shown to reduce plasma fasting glucose and raising HDL cholesterol in patients with type 2 diabetes.15 It has also been shown to improve insulin sensitivity and metabolic control in type 2 diabetic subjects.16
  • Premenstrual Syndrome: Magnesium deficiency has been observed in women affected by premenstrual syndrome.17 It is no surprise therefore  that it has been found to alleviate premenstrual symptoms of fluid retention, 18 as well as broadly reducing associated symptoms by approximately 34% in women, aged 18-45, given 250 mg tablets for a 3-month observational period.20 When combined with B6, magnesium supplementation has been found to improve anxiety-related premenstrual symptoms.19
  • Cardiovascular Disease and Mortality: Low serum magnesium concentrations predict cardiovascular and all-cause mortality.21 There are a wide range of ways that magnesium may confer its protective effects. It may act like a calcium channel blocker,22it is hypotensive,23 it is antispasmodic (which may protect against coronary artery spasm),24 and anti-thrombotic.25 Also, the heart muscle cells are exceedingly dense in mitochondria (as high as 100 times more per cell than skeletal muscle), the “powerhouses” of the cell,” which require adequate magnesium to produce ATP via the citric acid cycle.
  • Migraine Disorders: Blood magnesium levels have been found to be significantly lower in those who suffer from migraine attacks.26,27 A recent Journal of Neural Transmission article titled, “Why all migraine patients should be treated with magnesium,” pointed out that routine blood tests do not accurately convey the true body magnesium stores since less than 2% is in the measurable, extracellular space, “67% is in the bone and 31% is located intracellularly.”28The authors argued that since “routine blood tests are not indicative of magnesium status, empiric treatment with at least oral magnesium is warranted in all migraine sufferers.” Indeed, oral magnesium supplementation has been found to reduce the number of headache days in children experiencing frequent migranous headaches,29and when combined with l-carnitine, is effective at reducing migraine frequency in adults, as well.30
  • Aging: While natural aging is a healthy process, accelerated aging has been noted to be a feature of magnesium deficiency,31especially evident in the context of long space-flight missions where low magnesium levels are associated with cardiovascular aging over 10 times faster than occurs on earth.32 Magnesium supplementation has been shown to reverse age-related neuroendocrine and sleep EEG changes in humans.33 One of the possible mechanisms behind magnesium deficiency associated aging is that magnesium is needed to stabilize DNA and promotes DNA replication. It is also involved in healing up of the ends of the chromosomes after they are divided in mitosis.34

 It is quite amazing to consider the afformentioned side benefits of magnesium consumption or supplementation within the context of the well-known side effects of pharmaceutical approaches to symptom

management of disease. On average, conventional drugs have 75 side effects associated with their use, including lethal ones (albeit sometimes rare). When considering magnesium’s many side benefits

and extremely low toxicity, clearly this fundamental mineral intervention (and dietary requirement) puts pharmaceutical approaches to depression to shame.

Best Sources of Magnesium In The Diet

The best source of magnesium is from food, and one way to identify magnesium-containing foods are those which are green, i.e. chlorophyll rich. Chlorophyll, which enable plants to capture solar energy and convert it into metabolic energy, has a magnesium atom at its center. Without magnesium, in fact, plants could not utilize the sun’s light energy.

Magnesium, however, in its elemental form is colorless, and many foods that are not green contain it as well. The point is that when found complexed with food cofactors, it is absorbed and utilized more efficiently than in its elemental form, say, extracted from limestone in the form of magnesium oxide.

 The following foods contain exceptionally high amounts of magnesium. The portions described are 100 grams, or a little over three ounces.

  • Rice bran, crude (781 mg)
  • Seaweed, agar, dried (770 mg)
  • Chives, freeze-dried (640 mg)
  • Spice, coriander leaf, dried (694 mg)
  • Seeds, pumpkin, dried (535 mg)
  • Cocoa, dry powder, unsweetened (499 mg)
  • Spices, basil, dried (422 mg)
  • Seeds, flaxseed (392 mg)
  • Spices, cumin seed (366 mg)
  • Nuts, brazilnuts, dried (376 mg)
  • Parsley, freeze-dried (372 mg)
  • Seeds, sesame meal (346 mg)
  • Nut, almond butter (303 mg)
  • Nuts, cashew nuts, roasted (273 mg)
  • Soy flour, defatted (290 mg)
  • Whey, sweet, dried (176 mg)
  • Bananas, dehydrated (108 mg)
  • Millet, puffed (106 mg)
  • Shallots, freeze-dried (104 mg)
  • Leeks, freeze-dried (156 mg)
  • Fish, salmon, raw (95 mg)
  • Onions, dehydrated flakes (92 mg)
  • Kale, scotch, raw (88 mg)

 Fortunately, for those who need higher doses, or are not inclined to consume magnesium rich foods, there are supplemental forms commonly available on the market. Keep in mind, for those who wish to take advantage of the side benefit of magnesium therapy, namely, its stool softening and laxative properties, magnesium citrate or oxide will provide this additional feature.

For those looking to maximize absorption and bioavailability magnesium glycinate is ideal, as glycine is the smallest amino acid commonly found chelated to magnesium, and therefore highly absorbable.

For more information on natural solutions to resolving depression, download our free e-book on the topic “21st Century Solutions to Depression.” 

References:

1) World Health Organization. Depression fact sheet no. 369 2012 [cited 2016 December 20]. Available from: http://www.who.int/mediacentre/factsheets/fs369/en/.

2) Jacka FN, Overland S, Stewart R, Tell GS, Bjelland I, Mykletun A. Association between magnesium intake and depression and anxiety in community-dwelling adults: the Hordaland Health Study. Aust N Z J Psychiatry. 2009;43(1):45–52. Pmid:19085527.

3) Huang JH, Lu YF, Cheng FC, Lee JN, Tsai LC. Correlation of magnesium intake with metabolic parameters, depression and physical activity in elderly type 2 diabetes patients: a cross-sectional study. Nutrition J. 2012;11(1):41. pmid:22695027; PubMed Central PMCID: PMC3439347.

4) Tarleton EK, Littenberg B. Magnesium intake and depression in adults. J Am Board Fam Med. 2015;28(2):249–56. Pmid:25748766

5) Yary T, Lehto SM, Tolmunen T, Tuomainen T-P, Kauhanen J, Voutilainen S, et al. Dietary magnesium intake and the incidence of depression: a 20-year follow-up study. J Affect Disord. 2016;193:94–8. Pmid:26771950

6) Eby GA, Eby KL. Rapid recovery from major depression using magnesium treatment. Med Hypotheses. 2006;67(2):362–70. pmid:16542786

7) N Engl J Med. 2000 Dec 28;343(26):1942-50. Managing depression in medical outpatients.

8)  Damiano Piovesan, Giuseppe Profiti, Pier Luigi Martelli, Rita Casadio. 3,751 magnesium binding sites have been detected on human proteins. BMC Bioinformatics. 2012 ;13 Suppl 14:S10. Epub 2012 Sep 7. PMID: 23095498

9) G Moorkens, B Manuel y Keenoy, J Vertommen, S Meludu, M Noe, I De Leeuw. Magnesium deficit in a sample of the Belgian population presenting with chronic fatigue. Magnes Res. 1997 Dec;10(4):329-37. PMID: 9513929

10)  J Eisinger, A Plantamura, P A Marie, T Ayavou. Selenium and magnesium status in fibromyalgia. Magnes Res. 1994 Dec;7(3-4):285-8. PMID: 7786692

11)  I J Russell, J E Michalek, J D Flechas, G E Abraham. Treatment of fibromyalgia syndrome with Super Malic: a randomized, double blind, placebo controlled, crossover pilot study. J Rheumatol. 1995 May;22(5):953-8. PMID: 8587088

12) GreenMedInfo.com, Atrial Fibrillation and Magnesium (5 studies)

13)  Phuong-Chi T Pham, Phuong-Mai T Pham, Son V Pham, Jeffrey M Miller, Phuong-Thu T Pham . Hypomagnesemia in patients with type 2 diabetes. Clin J Am Soc Nephrol. 2007 Mar;2(2):366-73. Epub 2007 Jan 3. PMID: 17699436

14)  M de Lordes Lima, T Cruz, J C Pousada, L E Rodrigues, K Barbosa, V Canguçu. The effect of magnesium supplementation in increasing doses on the control of type 2 diabetes. Diabetes Care. 1998 May;21(5):682-6. PMID: 9589224

15) Y Song, K He, E B Levitan, J E Manson, S Liu. Effects of oral magnesium supplementation on glycaemic control in Type 2 diabetes: a meta-analysis of randomized double-blind controlled trials. Cardiovasc Toxicol. 2008;8(3):115-25. Epub 2008 Jul 8. PMID: 16978367

16)  Martha Rodríguez-Morán, Fernando Guerrero-Romero. Oral magnesium supplementation improves insulin sensitivity and metabolic control in type 2 diabetic subjects: a randomized double-blind controlled trial. Diabetes Care. 2003 Apr;26(4):1147-52. PMID: 12663588

17)  F Facchinetti, P Borella, G Sances, L Fioroni, R E Nappi, A R Genazzani. Oral magnesium successfully relieves premenstrual mood changes. Obstet Gynecol. 1991 Aug;78(2):177-81. PMID: 2067759

18)  A F Walker, M C De Souza, M F Vickers, S Abeyasekera, M L Collins, L A Trinca. Magnesium supplementation alleviates premenstrual symptoms of fluid retention. J Womens Health. 1998 Nov;7(9):1157-65. PMID: 9861593

19)  S Quaranta, M A Buscaglia, M G Meroni, E Colombo, S Cella. Pilot study of the efficacy and safety of a modified-release magnesium 250 mg tablet (Sincromag) for the treatment of premenstrual syndrome. Am J Gastroenterol. 2008 Dec;103(12):2972-6. PMID: 17177579

20) M C De Souza, A F Walker, P A Robinson, K Bolland. A synergistic effect of a daily supplement for 1 month of 200 mg magnesium plus 50 mg vitamin B6 for the relief of anxiety-related premenstrual symptoms: a randomized, double-blind, crossover study. J Womens Health Gend Based Med. 2000 Mar;9(2):131-9. PMID: 10746516

21) Thorsten Reffelmann, Till Ittermann, Marcus Dörr, Henry Völzke, Markus Reinthaler, Astrid Petersmann, Stephan B Felix. Low serum magnesium concentrations predict cardiovascular and all-cause mortality. Atherosclerosis. 2011 Jun 12. Epub 2011 Jun 12. PMID: 21703623

22) Andrea Rosanoff, Mildred S Seelig. Comparison of mechanism and functional effects of magnesium and statin pharmaceuticals. J Am Coll Nutr. 2004 Oct;23(5):501S-505S. PMID: 15466951

23)  GreenMedInfo.com, Magnesium’s Hypotensive Properties.

24) GreenMedInfo.com, Magnesium’s Antispasmodic Properties.

25) Joen R Sheu, George Hsiao, Ming Y Shen, Yen M Lee, Mao H Yen . Antithrombotic effects of magnesium sulfate in in vivo experiments. Int J Hematol. 2003 May;77(4):414-9. PMID: 12774935

26) Afshin Samaie, Nabiollah Asghari, Raheb Ghorbani, Jafar Arda. Blood Magnesium levels in migraineurs within and between the headache attacks: a case control study. Pan Afr Med J. 2012 ;11:46. Epub 2012 Mar 15. PMID: 22593782

27) Mahnaz Talebi, Dariush Savadi-Oskouei, Mehdi Farhoudi, Solmaz Mohammadzade, Seyyedjamal Ghaemmaghamihezaveh, Akbar Hasani, Amir Hamdi. Relation between serum magnesium level and migraine attacks. Neurosciences (Riyadh). 2011 Oct ;16(4):320-3. PMID: 21983373

28) Alexander Mauskop, Jasmine Varughese. Why all migraine patients should be treated with magnesium. J Neural Transm. 2012 May ;119(5):575-9. Epub 2012 Mar 18. PMID: 22426836

29)  Fong Wang, Stephen K Van Den Eeden, Lynn M Ackerson, Susan E Salk, Robyn H Reince, Ronald J Elin. Oral magnesium oxide prophylaxis of frequent migrainous headache in children: a randomized, double-blind, placebo-controlled trial. Eur J Endocrinol. 2009 Apr;160(4):611-7. Epub 2009 Jan 29. PMID: 12786918

30) Ali Tarighat Esfanjani, Reza Mahdavi, Mehrangiz Ebrahimi Mameghani, Mahnaz Talebi, Zeinab Nikniaz, Abdolrasool Safaiyan. The effects of magnesium, L-carnitine, and concurrent magnesium-L-carnitine supplementation in migraine prophylaxis. Biol Trace Elem Res. 2012 Dec ;150(1-3):42-8. Epub 2012 Aug 17. PMID: 22895810

31) David W Killilea, Jeanette A M Maier. A connection between magnesium deficiency and aging: new insights from cellular studies. Magnes Res. 2008 Jun;21(2):77-82. PMID: 18705534

32) GreenMedInfo.com, What We Learned From The Accelerated Aging of Astronauts

33) Katja Held, I A Antonijevic, H Künzel, M Uhr, T C Wetter, I C Golly, A Steiger, H Murck. Oral Mg(2+) supplementation reverses age-related neuroendocrine and sleep EEG changes in humans. Pharmacopsychiatry. 2002 Jul;35(4):135-43. PMID: 12163983

34) William J Rowe. Correcting magnesium deficiencies may prolong life. Clin Interv Aging. 2012 ;7:51-4. Epub 2012 Feb 16. PMID: 22379366


Sayer Ji is founder of Greenmedinfo.com, a reviewer at the International Journal of Human Nutrition and Functional Medicine, Co-founder and CEO of Systome Biomed, Vice Chairman of the Board of the National Health Federation, Steering Committee Member of the Global Non-GMO Foundation.


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