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© 28 Nov 2016 GreenMedInfo LLC. This work is reproduced and distributed with the permission of GreenMedInfo LLC.

www.greenmedinfo.com/blog/extreme-bias-ftc-s-ruling-homeopathic-medicine

by Dana Ullman MPH CCH

In an ongoing effort to undermine homeopathy, the FTC disregards hundreds of peer-reviewed studies and suggests that there is no scientific evidence for these safe, effective therapies.

Extreme Bias in FTC’s Ruling on Homeopathic Medicine

Despite the fact that there are over 300 clinical trials published in peer review medical journals, the US government’s Federal Trade Commission (FTC) has deemed homeopathic medicine to be unproven scientifically.  This governmental agency will now require manufacturers of homeopathic medicines to provide the following two statements in their marketing of over-the-counter homeopathic medicines: (1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.

Obvious evidence of the FTC’s bias in this ruling is that the word “homeopathy” was not even coined until 1805, and the founder of homeopathy, Samuel Hahnemann MD did not write his first book on the subject until 1810.  The first homeopath to come to the USA wasn’t until 1825.  And yet, the FTC asserts that homeopathy is based on theories from the 1700s?

The fact that the FTC is not being honest or accurate on historical facts will lead anyone to question whether they are honest or accurate in their assessment of homeopathic research. In actual fact, research showing the efficacy of homeopathic medicines have been published in many of the most respected medical journals in the world, including The Lancet 1, BMJ (British Medical Journal, 1, 2), Chest (the publication of the American College of Chest Physicians), Rheumatology (the publication of the British Society for Rheumatology), Pediatrics (publication of the American Academy of Pediatrics), Cancer (journal of the American Cancer Society), Journal of Clinical Oncology, Pediatrics Infectious Disease Journal (publication of the European Society of Pediatric Infectious Diseases), European Journal of Pediatrics (publication of the Swiss Society of Pediatrics and the Belgium Society of Pediatrics), and numerous others. And yet, the FTC insists that there is “no scientific evidence” that homeopathy works? Really, none?

It should also be noted that the prestigious World Health Organization (W.H.O.) has deemed France to have the BEST health care in the world. It is therefore important to note that according to a recent survey published in the respected medical journal, Family Practice, 95% of French paediatricians, dermatologists, and general practitioners use homeopathic medicines. Further, 43% of all health and medical professionals prescribed at least one homeopathic medicine in a 12-month period. And ALL of these statistics were gathered from the government’s prescription records, making this data precise and accurate. The practice and usage of homeopathic medicine is also substantial in Germany, Italy, Netherlands, India, Pakistan, Mexico, Brazil, and Argentina. And yet, homeopathy is “not accepted by most modern experts?”  Is there absolutely no respect for minority schools of thought in medicine for the first time in medical history?  Is conventional medicine so perfect that it can only allow for medical treatments that a majority of medical experts accept?  Or…are there efforts influenced by Big Pharma to reduce competition in health care?

To be clear, the work of the FTC is vital for consumer protection, but it is clear that this governmental agency is ignoring important scientific evidence, and one must wonder if they are protecting Big Pharma from competition more than protecting the consumer.

To understand how and why the FTC has such obvious bias against homeopathy (and various alternatives to Big Pharma), it is helpful to know something about history…and then, to learn something about the body of scientific evidence that presently exists for homeopathic medicines.

History of Attacks Against Homeopathy

Due to the impressive successes that physicians found from homeopathic medicines in the treatment of severe infectious disease epidemics in the 19^th century, homeopathy grew so rapidly that the American Institute of Homeopathy was established as this country’s first national medical organization in 1844.  A rival medical organization was formed just two years later asserting that one of the reasons for their formation was to slow the growth of homeopathy.  That organization called itself the American Medical Association.

Homeopathy continued to grow in America in the 19^th century and was called “the new school,” while conventional medicine was deemed to be “the old school.”  By the early 20^th century, there were 20 homeopathic medical schools in America, including Boston University, University of Michigan, Ohio State University, University of Minnesota, Hahnemann Medical College, and even the University of Iowa.  

At the turn into the 20^th century, George Simmons became the new President of the American Medical Association, and he devised a brilliant plan to make the AMA rich and powerful.  Simmons created the AMA’s “Seal of Approval on Drugs.”  To get this award, drug manufacturers did not require ANY evidence on safety or efficacy of drugs.  Instead, the drug-maker simply needed to divulge the ingredients of their drug (an important consumer protection) AND, more importantly, they were required to pay for advertisements in EVERY local, regional, and national AMA publications (a legal form of bribery).  This “collaboration” between the AMA and Big Pharma led to a significant increase in membership in the increasingly rich AMA, growing from 8,000 members in 1900 to over 70,000 members in 1910.

The “collaboration” between Big Pharma and government has been substantial in the 20^th century and even more so in the 21^st century.  In fact, for the past couple of decades, Big Pharma has spent almost 50% more (!) in lobbying politicians than the closest industry (the Insurance industry). When you take this fact into account and then realize that Big Pharma spends its greatest amounts of advertising dollars for TV news programs, you can see and understand Big Pharma’s strategy to “own” the news and politicians.  This strategy has worked too well. 

Evidence of serious corporate shenanigans on health products is just beginning to be uncovered. According to the British Medical Journal, recently uncovered evidence has verified the extraordinary extent to which key public health experts at the Center for Disease Control (CDC) have been influenced by big money given by the sugar industry to take any blame away from sugar for today’s obesity epidemic.

Verifying additional problems at the CDC, Dr William Thompson, a senior scientist at the CDC has obtained whistleblower status after he admitted to falsifying research to show that there is no correlation between vaccination and autism when, in fact, his research actually showed that there was a correlation between vaccination and the autism rate in all children and was found to be 250% higher in black children than those children not vaccinated.  Yet, CDC Director Tom Frieden has attempted to block Thompson from testifying in a civil hearing asserting, "Dr William Thompson's deposition testimony would not substantially promote the objectives of CDC or HHS [Health and Human Services]."

According to Robert Kennedy Jr. one of the key people in this cover-up at the CDC is Dr Colleen Boyle who is the Director of the National Center on Birth Defects and Developmental Disabilities, one of the CDC’s centres that evaluate autism rates.  This same scientist who was previously found to have orchestrated the cover-up of Agent Orange and dioxin toxicity in the 1970s, and rather than punish her, she was rewarded with a plum position that enabled her to cover-up the vaccine-autism connection.

Needless to say, the media has repeatedly asserted that there is “no connection between vaccines and autism,” and yet, the media has carefully avoided reporting on this whistleblower case.  Recent reports about serious levels of anxiety from employees at the CDC are well-founded because the Trump administration may be more forthright in investigating corporate and scientific fraud.  Trump has expressed his support for vaccines, but has also expressed direct concern about the inadequacy of safety studies on them. 

The additional reason that issue of vaccines is discussed here is that Americans do not know that there are virtually no double-blind and placebo controlled studies that show that vaccines are safe.  The few times that vaccine research has used a “placebo,” they do not place pathogens in the placebo but they actually still insert mercury or aluminium adjuvants in the placebo, thereby destroying the ability for real scientific evaluation of safety from these neurotoxins.  Even one of the most prestigious medical journals in the world, the Cochrane Collaboration, has acknowledged that the measles, mumps, and rubella vaccine research on safety is “largely inadequate.”  And yet, Big Pharma spins the fact that there are so few real tests for safety to mean that “vaccines are safe” (when you don’t really test with a real placebo, you cannot evaluate safety issues).  To make matters worse, not only are vaccines allowed to be marketed despite the paucity of safety evidence, several states are now making them mandatory for children who wish to attend public or private schools.

As important as regulatory agencies are for consumer protection, it is disturbing how much corporate involvement has influenced these governmental agencies.  Instead of providing consumer protection, there seems to be much more corporate protection, and it seems obvious that Americans want a serious change from this corporate swamp.

This discussion about the swamp surround vaccine research and governmental agencies is provided here because there is also a swamp surrounding homeopathic and natural medicines and regulatory agencies. 

Homeopathic Research

Additional obvious bias was evidence when the FTC’s ruling cited old and incorrect information asserting that homeopathic medicine are “so diluted that no single molecule of the original substance remains.”  In actual fact, an important study in 2010 was published in the famed journal, Langmuir (published by the American Chemistry Society), that verified that six different homeopathic medicine were found to have nanoparticles of the original medicinal agents even after they were diluted 1:100 two-hundred times and this fact was confirmed by three different types of spectroscopy.  Further, the nanodoses that remained in water were, according to Archives in Internal Medicine, comparable to the nanodoses to which many common hormones and cell-signalling agents are known to operate. Based on this research, anyone who says that there are “no active ingredients” or “no molecules” in homeopathic medicines are basing such assertions on disproven theories, not scientifically verified facts.

Unless the FTC wishes to proclaim that our body’s hormones are placebos, 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, 1, 2, 3, 4.  Even the highly prestigious Nature magazine edition in India published an important news report about one of these studies that showed these effects from a homeopathic medicine.  Ultimately, at least a dozen laboratories have confirmed the persistence of nanomedicines in water made with homeopathic medicines, including labs at the University of Arizona, 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.  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 medicine 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 favour 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 medicine 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, 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. 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. 

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 practising 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 kit 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.

The 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 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.  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 homeopathy 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 effect 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 U.S. 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, they 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 year (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.  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 but instead more commonly result from powerful economic forces at play.

Further Information

For evidence-based research on homeopathic treatments, visit the GreenMedInfo.com Research  Dashboard.

Acknowledgement Citation

© 28 Nov 2016 GreenMedInfo LLC. This work is reproduced and distributed with the permission of GreenMedInfo LLC.

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