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From the Townsend Letter
April 2017

Extreme Bias in FTC's Ruling on Homeopathic Medicine
by Dana Ullman, MPH, CCH
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Unless the FTC wishes to proclaim that our body's hormones are placeboes, it can and should accept and recognize that the nanodoses used in homeopathic medicines have physiological action.
Further, modern evidence for the physiological effects from homeopathic medicines is provided by a growing body of basic research that has shown up- and down-regulation of genetic expression from homeopathic medicines, including in these studies.22-25  Even the highly prestigious Nature magazine edition in India26 published an important news report about one of these studies that showed these effects from a homeopathic medicine.  Ultimately, at least a dozen laboratories27 have confirmed the persistence of nanomedicines in water made with homeopathic medicines, including labs at the University of Arizona,28 Northwestern University, University of California at Davis, University of Mumbai, Russian Academy of Science, and India Institute of Technology.
Ultimately, homeopathy is the "original nanomedicine," and the entire field of nanomedicine is so hot that some reports estimate that it will be a $130 billion industry this year.29  It is hard to avoid the possibility that Big Pharma is pressuring the FTC to rid itself of any competition, even though homeopathy itself is only $1 billion industry in the US. 
The FTC report on homeopathy carefully avoided reference to the largest review of research on homeopathy that has ever taken place. The Swiss government's "Health Technology Assessment" on homeopathic medicine30 is much more comprehensive than any previous governmental report written on this subject to date. Not only did this report carefully and comprehensively review the body of evidence from randomized double-blind and placebo-controlled clinical trials testing homeopathic medicines, they also evaluated the "real world effectiveness" with observational studies (discussed below) as well as safety and cost-effectiveness. The report also conducted a highly-comprehensive review of the wide body of preclinical research (fundamental physio-chemical research, botanical studies, animal studies, and in vitro studies with human cells) as well as epidemiological studies and cost-effectiveness studies.
After assessing basic research and the high-quality clinical studies, the Swiss report affirmed that homeopathic high-potencies seem to induce regulatory effects (e.g., balancing or normalizing effects) and specific changes in cells or living organisms. The report also reported that 20 of the 22 systematic reviews of clinical research testing homeopathic medicines detected at least a trend in favor of homeopathy.  To date, this report on homeopathy was the only review of research to ever to be published in a peer-review medical journal. 
The newest meta-analysis (a systematic review of research) on homeopathic medicine31 chose to evaluate only those clinical trials that provided individualized treatment. In reviewing the "highest quality studies," the researchers found that homeopathic patients were almost twice as likely to experience a therapeutic benefit as those given a placebo. Further, in reviewing a total of 22 clinical trials, the homeopathic patients experienced greater than 50% likelihood to have benefited from the homeopathic treatment than those given a placebo.
Perhaps one of the strongest statements in this article was the confirmation that four of the five-leading previous systematic reviews of homeopathic research also found a benefit from homeopathic treatment over that of placebo: 

Five systematic reviews have examined the RCT research literature on homeopathy as a whole, including the broad spectrum of medical conditions that have been researched and by all forms of homeopathy: four of these 'global' systematic reviews reached the conclusion that, with important caveats, the homeopathic intervention probably differs from placebo.     

The ultimate observation of this significant review of homeopathic research is that there IS a difference between homeopathy and placebo, despite what skeptics and the media tend to assume and assert.
To date, there are at least 300 clinical studies that have been published in peer-review medical journals. Although ALL of the meta-analyses conducted on homeopathy deem that "good quality studies" must be randomized, double-blind and placebo-controlled, these same guidelines are not expected of vaccines, nor are any surgical procedures required to have these standards for evaluating safety or efficacy. A double standard persists, and attacking and bullying the little guy (homeopathy) has become the order of the day.
According to the most prestigious medical journal in the world, The New England Journal of Medicine,32 randomized double-blind and placebo-controlled trials are not the only way to evaluate therapeutic benefits from a treatment.  In fact, this medical journal has published numerous articles that assert that observational trials are just as reliable. One author asserted emphatically, "The popular belief that only randomized, controlled trials produce trustworthy results and that all observational studies are misleading does a disservice to patient care, clinical investigation, and the education of health care professionals." 
Observational trials provide information on "real world" use and practice, and there is a considerable body of evidence that homeopathic treatment provides "real world benefits.33 It is very common for conventional drugs to be found seemingly effective in randomized double-blind and placebo-controlled trials but not really work in "real world medicine." In comparison, homeopathic medicine has consistently been found to be effective in real world medicine.33 

Implications of Ruling on Homeopathy Today
The FTC ruling will require the above described statements asserting that there is no scientific evidence for the efficacy of a homeopathic medicine.  However, the vast majority of homeopathic medicines are single-ingredient homeopathic medicines that are not prescribed for specific diseases but for the unique syndrome of symptoms that every person has.  And because the vast majority of practicing homeopaths use these single ingredient homeopathic medicines, the practice of homeopathy itself will not be influenced much by this FTC ruling. 
In fact, some homeopaths actually appreciate this ruling because it'll encourage people to understand homeopathy and the homeopathic approach to healing better.  Further, the ruling will lead more people who are seeking safer alternatives to conventional drug treatment to purchase homeopathic guidebooks, such as those that this author has written, that teach people how to select the right homeopathic medicine for their own, their family's, or their friend's health care problem. Therefore, books such as Everybody's Guide to Homeopathic Medicines and Homeopathic Medicines for Children and Infants may be in greater demand.  And people who want to learn to use a homeopathic medicine kit34 to treat their families will be encouraged to access such courses or e-courses. 
This ruling will have its primary impact on the various homeopathic formulas on the market today that make figuring out which medicine to get more "user-friendly."  Homeopathic formulas are mixtures of homeopathic medicines that include ingredients that are known to benefit people with specific ailments, but each ingredient is thought to only have benefits for the limited group of people whose symptoms match those that each substance is known to cause (if given in overdose).  Therefore, a homeopathic pharmacy creates a mixture with ingredients that will have a more broad-spectrum effect beyond that of a single remedy.
It is these homeopathic formulas that the FTC ruling will impact.  However, because there are now over 300 clinical trials published in peer-review medical journals, there are a surprising number of studies that show that homeopathic formulas do provide therapeutic benefits. The FTC ruling, therefore, will have some benefits for those homeopathic medicines that have had such research. Certain books or ebooks that reference such research will probably increase in demand. And courses and e-courses that teach people how to use a homeopathic medicine kit and that provide evidence from peer-review medical journals will also be more popular.
Ther-BioticThe bad news about the FTC. ruling is that poor people who cannot afford going to a professional homeopath and those people who are not motivated to learn how to use homeopathic medicines will be unable to get the benefits from homeopathy like 500 million people across the world do. 
It is additionally intriguing to know that every one of the dozens of surveys ever conducted on who uses homeopathic medicines has discovered that these homeopathy users are more educated than those who don't.35  Therefore, it seems that it is common for more educated people to go out of their way to choose homeopathy. 

Closing Thoughts
The FTC report on homeopathy36 noted a survey of users of homeopathic medicine found that 60% to 73% were satisfied with the performance of the homeopathic treatment they used and half of the people who used a homeopathic medication for one condition went on to use a homeopathic treatment for other conditions.
The report then noted that a representative of the homeopathic industry remarked that such levels of satisfaction would not be explained by the placebo effect37 based on his assertion that the "placebo effect … is probably around 30%" (see p. 5)  When one considers the widely recognized fact that homeopathic medicines are considerably safer than conventional drugs, one would think that this system of medicine would be embraced and encouraged by federal regulatory agencies, especially for pregnant and lactating women and for infants and children.  However, this FTC ruling suggests that there is no scientific evidence that homeopathy works. 
Even though other constituencies of the "natural health movement" have not had a collaborative relationship with the FDA (Food and Drug Administration) in the 20th and 21st centuries, homeopathy and advocates for this system of medicine have had a long-time collaborative relationship with this governmental agency ever since this health agency was first empowered with regulatory controls as a result of the famed Federal Food Drugs and Cosmetics Act of 1938. 
In fact, this 1938 law was written by a senator from New York who was a medical doctor as well as homeopathic physician by the name of Royal Copeland, MD. This three-term US senator was so highly respected that Franklin D. Roosevelt was his campaign manager when he first ran for the US Senate. This 1938 law not only empowered the FDA, it also gave formal federal recognition to homeopathy and homeopathic medicines as a different and separate system of medicine and pharmacology.
The bottom line here is that the US Congress passed this important consumer protection law in 1938, and it granted formal recognition of the US Homeopathic Pharmacopeia as a DIFFERENT compendium of drugs than the US Pharmacopeia. This law did not seek to merge these two different schools of thought in medical practice; but, instead, it sought to respect them as different and complementary. It is, therefore, questionable if homeopathic drugs should be understood or regulated in the same manner as conventional drugs.
One would hope that the FTC would have a good working relationship with the homeopathic community as the FDA has, but the fact remains that the new FTC ruling now requires marketing information on homeopathic medicines to include statements that there is "no scientific evidence that the product works" and the product's claims "are not accepted by most modern medical experts." The intent of this article was to show the extreme bias in their recent ruling, in their evidence from history, and their interpretation of homeopathic research.
Ultimately, the FTC is staffed by lawyers, not by physicians or scientists or experts on homeopathy and natural medicine. Clearly, this FTC report has numerous significant errors of fact and has obvious biases. One would hope that these problems will be rectified.
Whether the FTC corrects its report and changes its ruling or not, it will be curious to watch if the FTC and health and medical regulatory agencies continue to protect Big Pharma and Big Corporations or if they will truly seek to protect consumers. 
It will also be important, even vitally important, to observe what priority the FTC grants this new ruling on homeopathy. In this day and age in which the average American is prescribed 13 prescription drugs per year38 (not counting any of the over-the-counter drugs they are prescribed or that people take on their own), there are very few studies that confirm the safety or efficacy of this common practice of "poly-pharmacy."  If regulatory agencies are truly interested in protecting the health of Americans, it would be prudent if they focused their attention on the real and significant dangers to American's health that exist in our use and over-use of conventional medications, not on homeopathic medicines that has an impeccable 200-year history of safety.
Finally, the FTC chose to issue these rulings after Donald Trump has been elected President. Trump has asserted that he plans to eliminate two regulations for every new regulation.39 Is this new regulation really worthy of keeping when two other regulations will be eliminated? Considering the long-time safety history of homeopathic medicines, it is surprising and even shocking that the FTC would consider proposing new regulations now. One cannot help but wonder who or what is pulling their strings. Only the naïve think that policies result in a vacuum; more commonly, they result from powerful economic forces at play.

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