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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Is the FDA acting out of malicious intent or willful ignorance in publishing a new draft guidance on homeopathics which would effectively treat them like pharmaceutical drugs, with similar regulatory requirements?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When FDA announced a “draft guidance” in December 2017 stating its latest intentions regarding the regulation of homeopathic products, it became clear that the agency had paid little attention to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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Awareness

Half of All Commonly Used Drugs Seriously Affect The Gut Microbiome, Scientists Warn

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In Brief

  • The Facts:

    Many commonly prescribed medications have been found to have a drastic affect on the "good bacteria" in our gut.

  • Reflect On:

    It is important to be aware of all potential side effects before taking a new drug to decide whether or not it's worth it for you.

The link between a healthy gut microbiome and overall well-being has been established in recent years as we are learning that around 95% of the serotonin (commonly referred to as the “happy hormone”) produced in our bodies actually comes from our gut! This is one of many reasons why it is important to take care of our health, be mindful of the foods we are eating and be aware of adverse reactions from any drugs we are taking.

A recent study presented at UEG Week 2019 (United European Gastroenterology) has found that 18 commonly prescribed prescription drugs extensively affect the taxonomic structure and metabolic potential of the gut microbiome. Another eight drugs from different categories were also found to increase antimicrobial resistance mechanisms in study participants, and that’s not good.

According to the official press release regarding the findings of the study,

“Researchers at the University Medical Center Groningen and the Maastricht University Medical Center looked at 41 commonly used drug categories and assessed 1883 faecal samples from a population-based cohort, patients with IBD and patients with IBS intermixed with healthy controls. The researchers compared the taxonomic and metabolic functions profiles of drug users to non-drug users, looking at the effect of single medication use and then combined medication use. The changes observed could increase the risk of intestinal infections, obesity and other serious conditions and disorders linked to the gut microbiome.”

In a healthy gut, we all have a microbe population living inside our intestines. This microbe population consists of tens of trillions of microorganisms, which include over 1000 various species of bacteria. There are many different factors that can affect the microbiota population in the human gut, including various forms of medication.

The drug categories that were concluded in the study to have the biggest impact on the gut microbiome are as follows:

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  • Proton pump inhibitors (PPIs) – used to treat dyspepsia which affects between 11% and 24% of the European population. PPIs are also used to treat peptic ulcer, H. Pylori eradication, Gastro reflux and Barrett’s oesophagus.
  • Metformin – used as a treatment for Type 2 diabetes, affecting 10% of European adults
  • Antibiotics – used to treat bacterial infections, taken by 34% of the European population each year
  • Laxatives – used to treat and prevent constipation, affecting 17% of European adults

More Important Findings

The study also showed that the gut microbiota of PPI users resulted in an increased level of upper gastrointestinal tract bacteria as well as increased fatty acid production. Metformin users showed higher levels of bacteria Escherichia coli (E.coli).

The research also showed that seven more categories of drugs were linked to significant changes to the levels of bacteria populations found in the gut. Oral steroids were related to higher levels of methanogenic bacteria, which has is associated with an increased BMI and obesity. Also, certain antidepressant drugs (known as SSRIs) used by those who also suffer from IBS was linked to an abundance of a bacteria species called Eubacterium ramulus, which can be harmful.

Lead-researcher of the study, Arnau Vich Vila said: “We already know that the efficiency and the toxicity of certain drugs are influenced by the bacterial composition of the gastrointestinal tract and that the gut microbiota has been related to multiple health conditions; therefore, it is crucial to understand which are the consequences of medication use in the gut microbiome. Our work highlights the importance of considering the role of the gut microbiota when designing treatments and also points to new hypotheses that could explain certain side-effects associated with medication use.”

Final Thoughts

It is important to understand all potential side effects when deciding on introducing a new drug into our system. The bacteria in our gut is there for a reason and it assists our bodies with many functions and if they are killed off or thrown off-balance it could result in more serious issues down the road.

If you are experiencing any of these issues and taking any of these medications it may be worthwhile to talk to your doctor about it and see if there are any alternative methods for treatment.

Our health is our greatest wealth!

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Awareness

The Health Benefits Of Reading Books Compared To Reading From Screens

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In Brief

  • The Facts:

    Numerous studies show the scientific benefits of reading. These benefits tend to increase when reading from actual books rather than screens.

  • Reflect On:

    Do screens consume the majority of your time? When was the last time you read a book? Reading is akin to exercise for your brain.

In the age of information we are being bombarded left, right and center with quick facts, fake news, censored information, video images and so much more. This is greatly affecting the span of our attention. To many the idea of picking up a book, when we could just as easily listen to it, or read segments on our phones is completely absurd. However, there are many benefits that come along with reading books that just might make it worth it to you.

Consider just the very act of reading a book in itself, holding it, turning the pages, seeing your progress in the development of the story, it’s almost as if you are a part of it.

Benefits Of Reading Books

Reading requires patience and diligence, which is not something required from a glance and a click on a quick headline. Reading a book  is almost a kin to running a marathon for your brain, I mean if you can finish a whole book!

Reading stimulates imagination and creativity.

Research has shown that reading helps with comprehension and emotional intelligence as well as fluid intelligence — meaning the ability to reason and have flexible thinking. This leads to smarter decision-making regarding yourself and others.

As we age, our memory will decline, but regular reading can help keep minds sharper longer according to research published in Neurology. Frequently exercising your mind was also proven in that same study to lower mental decline by 32 percent.

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“Our study suggests that exercising your brain by taking part in activities such as these across a person’s lifetime, from childhood through old age, is important for brain health in old age,” study author Robert. S. Wilson of the Rush University Medical Center in Chicago said in a statement. “Based on this, we shouldn’t underestimate the effects of everyday activities, such as reading and writing, on our children, ourselves and our parents or grandparents.”

Reading can help make you more empathetic — researchers from the Netherlands designed two experiments showing that people who were “emotionally transported” by a work of fiction experienced boosts in empathy,

“In two experimental studies, we were able to show that self-reported empathic skills significantly changed over the course of one week for readers of a fictional story by fiction authors Arthur Conan Doyle and José Saramago,” they wrote in their findings. “More specifically, highly transported readers of Doyle became more empathic, while non-transported readers of both Doyle and Saramago became less empathic.”

Even More Reasons Read Books

Aside from these deeper reasons to read books, here are some more basic ones:

Books are a lot easier on the eyes than screens, which will provide a nice break for many of us as we are spending an increasing amount of time staring at screens at work, at home, on our smartphones while watching Netflix — your eyes could use the break.

One survey of 429 university students revealed that nearly half had complained of strained eyes after reading digitally. Electronic books can cause screen fatigue, which may lead to blurred vision, redness, dryness, and irritation. With print books, you don’t have to worry about any of that.

If you are reading an actual book, there is less of a chance that you will be distracted compared to reading on your phone. A book has no notification pings, buzzes or pop-ups, and you can ensure this distraction free time by leaving your phone in another room or putting it on silent or on airplane mode while reading.

Another great thing about books and the wonderful byproduct of less screen time is less exposure to electromagnetic frequencies, if you don’t have your phone on you, and perhaps you even have your Wi-Fi turned off while not in use you are giving your body a bit of a break from the constant bombardment of these frequencies.

Reading books before bed can help you sleep better, the main reason being — they do not emit blue light, or any kind of light at all actually, which has been shown to interfere with a good night’s rest. Not only that, but personally I find in general, reading a book tends to make me sleepy, so I enjoy reading a few chapters before putting my head down for the night.

Who doesn’t love the smell of a good book? You know that lovely, kind of musty smell old books give off? Or the fresh, crisp paper smell of a brand new book?

Final Thoughts To Consider?

Will reading books become an outdated thing of the past? Or will we be able to stand by the benefits of books and keep collecting them for generations to come? Only time will tell! To finish off, I’ll leave you with some words of wisdom from the late, great, Dr. Seuss,

“The more that you read, the more things you will know. The more that you learn, the more places you’ll go.” — Dr. Seuss

Much Love

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Alternative News

Research Suggests Many Diagnosed With ADHD May Not Actually Have A “Disorder”

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In Brief

  • The Facts:

    The fact that ADHD is diagnosed strictly on behavioural characteristics and not brain imaging or other science means that many who have this label don't formally have a neurodevelopmental disorder.

  • Reflect On:

    Why is medication the only resort to combating the symptoms of ADHD? Why are other interventions, like meditation, dietary changes, a change in lifestyle/environment never really discussed or emphasized?

Attention Deficit Hyperactivity Disorder, commonly known as ADHD, has become an epidemic. According to the Centres for Disease Control (CDC), ADHD is one of the most common neurodevelopmental disorders of childhood. It is usually first diagnosed in childhood and often lasts into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviours (may act without thinking about what the result will be), or be overly active.

They go on to state that it’s normal for children to have trouble focusing and behaving at one time or another. “However, children with ADHD do not just grow out of these behaviours. The symptoms continue, can be severe, and can cause difficulty at school, at home, or with friends.”

The CDC claims that children with ADHD might daydream a lot, forget or lose things a lot, squirm or fidget, talk too much, have a hard time resisting temptation, have trouble taking turns, and make carless mistakes or take unnecessary risks. But are these really symptoms of a serious “neurodevelopmental disorder?”

Is This Science-Based?

It’s not as if children are taken into the lab and have their brains scanned to determine if serious brain abnormalities exist. ADHD is diagnosed purely off of behaviour, and there may be something very wrong with diagnosing someone with neurological abnormalities simply baed on observation, instead of actual science. Who is to say that the behaviours listed above are not those of a normal child, or even a normal adult, especially within a school or work environment that does not seem to be foster a human being’s natural state? Perhaps the person or child in question doesn’t actually have neurodevelopmental problems, but is simply responding appropriately to the environmental that they find themselves in?

There is hardly any evidence suggesting that there is a neurological problem, as is often expressed by the medical industry. There are studies, however, that do show differences. For example, one of the largest imaging studies of ADHD to date recently identified differences in five regions of the brain, with the greatest differences seen in children rather than adults.

It’s important to note here the the brain of a child is still developing, and that the structure is not permanent and continues to develop until early adulthood.  More than 3,000 people diagnosed with ADHD had an MRI compared to controls, to measure the volume and the size of seven regions of the brain that were thought to be linked to ADHD–the pallidum, thalamus, caudate nucleus, putamen, nucleus accumbens, amygdala, and hippocampus. The study found that overall brain volume and five of the regional volumes were smaller in people with ADHD — the caudate nucleus, putamen, nucleus accumbens, amygdala and hippocampus.

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“These differences are very small — in the range of a few percent — so the unprecedented size of our study was crucial to help identify these. Similar differences in brain volume are also seen in other psychiatric disorders, especially major depressive disorders.”–Dr Martine Hoogman, Radboud University Medical Center, Nijmegen, The Netherlands.(source)

Smaller brain regions do not equate to a neurodevelopmental disorder or a lack of brain functioning though. This is simply an assumption. As with depression, where 6 decades of research that serotonin (or norepinephrine, or dopamine) deficiency is the cause of depression and anxiety, scientific credibility has not been achieved. This is well known. A New England Journal of Medicine review on major depression stated:

” … numerous studies of norepinephrine and serotonin metabolites in plasma, urine, and cerebrospinal fluid as well as postmortem studies of the brains of patients with depression, have yet to identify the purported deficiency reliably.”

Despite this fact, drugs are being prescribed that alter brain chemistry based on the prevailing unsubstantiated ‘theories’ regarding several ‘mental disorders.’ Here is an eye opening quote regarding the Diagnostic and Statistical Manual of Mental Disorders:

“[DSM-V] is a wholesale imperial medicalization of normality that will trivialize mental disorder and lead to a deluge of unneeded medication treatment – a bonanza for the pharmaceutical industry but at a huge cost to the new false positive patients caught in the excessively wide DSM-V net.”–Allen Frances, DSMIV Taskforce Chair (source)

Financial Ties With Big Pharma

Speaking of the DSM, American psychologist Lisa Cosgrove and researchers have investigated financial ties between the DSM panel members and the pharmaceutical industry. She published her research in the journal Plos OneThe study found that, of the 170 DSM members who sat on panels of ‘mood disorders,’ ‘schizophrenia’ and other psychotic disorders, most of them had financial ties to drug companies. The connections were especially strong in those diagnostic areas where drugs are the first line of treatment for mental disorders:

The revised Diagnostic and Statistical Manual of Mental Disorders (DSM), scheduled for publication in May 2013 by the American Psychiatric Association (APA), has created a firestorm of controversy because of questions about undue industry influence. Some have questioned whether the inclusion of new disorders (e.g., Attenuated Psychotic Risk Syndrome) and widening of the boundaries of current disorders (e.g., Adjustment Disorder Related to Bereavement) reflects corporate interests. These concerns have been raised because the nomenclature, criteria, and standardization of psychiatric disorders codified in the DSM have a large public impact in a diverse set of areas ranging from insurance claims to jurisprudence. Moreover, through its relationship to the International Classification of Diseases, the system used for classification by many countries around the world, the DSM has a global reach.

Psychiatrist Dr. Daniel Carlat has said:

“And where there is a scientific vacuum, drug companies are happy to insert a marketing message and call it science. As a result, psychiatry has become a proving ground for outrageous manipulations of science in the service of profit.”

Questioning The System

Dr. Marcia Angell, a physician and longtime Editor-in-Chief of the New England Medical Journal (NEMJ), also considered one of the most prestigious peer-reviewed medical journals in the world, said the following:

It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine. (source)

Here is another great quote:

“The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful.”–Arnold Seymour Relman (1923-2014), Harvard professor of medicine and former Editor-in-Chief of The New England Medical Journal  (source)

A very interesting and uncharacteristic article in the New York times titled The Selling of Attention Deficit Disorder raised awareness about this issue in 2013. The article discusses efforts to expose the manufacturing of a “profit driven machine into which our children are being fed.”

Centers for Disease Control and Prevention show that the diagnosis had been made in 15 percent of high school-age children, and that the number of children on medication for the disorder had soared to 3.5 million from 600,000 in 1990.

Behind that growth has been drug company marketing that has stretched the image of classic A.D.H.D. to include relatively normal behavior like carelessness and impatience, and has often overstated the pills’ benefits.

According to Kelly Brogan, MD, psychiatrist:

Psychiatric studies funded by pharma are 4x more likely to be published if they are positive, and only 18% of psychiatrists disclose their conflicts of interests when they publish data.

Psychiatry is particularly susceptible to industry corruption because of the highly subjective, non-biological, impressionistic nature of diagnostic criteria. With our “governing body” the American Psychiatric Association heavily funded by pharmaceutical companies, the temptation is all too great to open the diagnostic umbrella to encompass behavioral criteria like “makes careless mistakes” or “often has difficulty waiting his or her turn.”

Looking At ADHD Differently

What about other aspects of ‘ADHD’ that are never really emphasized? Recent work in cognitive neuroscience shows that people with an ADHD diagnosis and creative thinkers have difficulty suppressing brain activity that comes from the “Imagination Network.” This suggests people with ADHD might have differences in parts of the brain that actually makes them ‘superior’ in many ways, but it’s information that pharmaceutical companies can’t make a profit off of.

Currently, there are no school assessments to evaluate creativity and imagination. The fact remains,  people who show characteristics of ADHD are more likely to reach higher levels of creative thought and achievement compared to those who don’t show these characteristics.

“By automatically treating ADHD characteristics as a disability– as we so often do in an educational context– we are unnecessarily letting too many competent and creative kids fall through the cracks.”–Scott Barry Kaufman, Scientific Director of The Imagination Institute in the Positive Psychology Center at the University of Pennsylvania. (source)

Scrutinizing ADHD Treatment

A longitudinal NIMH study, the only one of its kind, demonstrated that after an initial decrease in ADHD symptoms, at three years, there was deterioration in the medicated group, and by six, worse attentional and behavioral symptoms than unmedicated controls, and increased functional impairment. Despite claims that stimulant side effects are “generally mild,” data accumulated by psychiatrist Dr. Peter Breggin has demonstrated quite the opposite. He cites studies that demonstrate concerning risks for:

  • Motor and vocal tics
  • Addiction, withdrawal and rebound
  • Growth suppression
  • Adverse cardiovascular effects
  • Mania, suicidality, psychosis

A study by Nasrallah et al in which more than 50% of young adults treated with ADHD medication experienced PET-confirmed brain atrophy, concluding “cortical atrophy may be a long-term adverse effect of this treatment.” In rhesus monkeys, Wagner et al demonstrated long-term changes to dopamine levels and receptor density, related to compensatory changes the brain undergoes in the setting of chronic intoxication. Subjects abstinent from stimulants for three years were found to have persistent dopamine-related brain changes on PET scans, related to Parkinsonian pathology.

That being said, many people have reported success with medications, but could this be placebo?

Alternatives

Dr. Kelly Brogan sees pharmaceutical intervention for symptoms of ADHD as very harmful for a child’s development:

When we interfere with behavior and brain growth, when we force children to conform to our needs as busy, distracted, and often chronically ill adults, we may be fundamentally compromising their expression of self, as Breggin cites Greenough et al.

Spontaneous or self-generated activities–play, mastery, exploration, novelty seeking, curiosity, and zestful socialization-are central to the growth and development of animals and humans and necessary for the full elaboration of CNS synaptic connections. (source)

She looks at other ways to treat these symptoms, and feels the first line of defense is dietary solutions. 

Some studies have, indeed, emerged that show a link between a gluten/casein free diet and improvement in autistic symptoms, and some parents have already seen the benefits of implementing this research.

The Mayo Clinic claims that certain food preservatives and colourings could increase hyperactive behaviour in some children. It would be best to avoid these, regardless of whether they are linked to ADHD or not.

It has also been suggested that EEG biofeedback (electroencephalographic) could help. It’s a type of neurotherapy that measures brainwaves. You can read more about that here.

In 2003, a study published in the journal Adolescence looked at how regular massages for 20 minutes twice a week could improve behaviour in the classroom. This is interesting because studies have also suggested that tai chi and yoga may also help improve ADHD symptoms. According to the studies, children with ADHD that practiced tai chi became less anxious or hyperactive. (source)

Other safe interventions are out there, you just have to look for them.

The Takeaway

I hope this article provides insight for people as well as parents who are considering using medications if their child is labeled as having ‘ADHD’. This article is not meant ignore symptoms of ADHD, but the idea of administering drugs so someone can better fit into a regimented environment should be questioned.

A challenge to convention like this can often be vilified, and that’s ok. We are going through a period of time where it’s best to keep an open mind, as new information is emerging in various areas that challenge our long-held belief systems.

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