Critique of Proposed Regulations of Homeopathic Medicines and Alternative Proposals (4)
Read the third part of the article
Medical history shows that homeopathy gained its greatest popularity in Europe and America due to its impressive results during infectious-disease epidemics, including typhoid, cholera, yellow fever, scarlet fever, pneumonia and influenza. A book titled The Logic of Figures compared the death rate from various infectious diseases in the 19th century in conventional versus homeopathic hospitals. The death rate in the conventional hospitals was between two and eight times greater.
In 1855, a governmental report on the London cholera epidemic of 1854 “just happened” to omit the mortality figures of the London Homeopathic Hospital. This epidemic was made famous because Dr. John Snow took the matter into his own hands by removing the handle of the pump from which Londoners were getting their tainted water. Because the homeopathic hospital was the closest hospital to this pump, many people who developed cholera went there for treatment.
The mortality rate at this hospital was only 19 percent as compared with 33 percent to 53 percent at all other London hospitals. When the authors of this report were challenged in the House of Lords, a representative of the Board of Health disingenuously proclaimed that inclusion of these statistics would give “an unjustifiable sanction to the empirical practice alike opposed to the maintenance of truth and to the progress of science”.
In 1988, the FDA adopted CPG 400.400 to eliminate the confusion over what could and could not be sold as a homeopathic drug. The recent FDA guidelines seek to eliminate this guidance and replace it with vague guidelines that will create confusion for the homeopathic industry and for consumers. It makes more sense to maintain the CPG 400.400 guidelines and to simply add more specificity to them rather than abolish them.
In some European countries, a medicinal agent can only be considered homeopathic if it is in at least a 3X dilution. A change in this definition would help differentiate herbal doses from homeopathic ones. Further, this change in regulation would make it more difficult for new medicinal agents to be marketed under the “homeopathic” banner that tend to work by conventional pharmacological means.
The FDA could make it clear to manufacturers and consumers that a homeopathic ingredient cannot be mixed with a nutritional supplement (which the FDA deems to be a “food”). Such “formulas” would constitute mixing a “drug” and a “food”. Present FDA regulation already doesn’t allow mixing drugs and foods.
The new FDA guidelines are exploring whether to prohibit the marketing of mixed-ingredient homeopathic medicines. These “homeopathic formula products” have a long history of usage and safety throughout the world, and studies have found them effective for many conditions, especially respiratory allergies.
For example, a randomized, double-blind and placebo-controlled trial has been published in The Lancet in the treatment of people with hay fever and a high-quality study published in the British Medical Journal confirmed homeopathic doses of various allergens were found effective for respiratory allergies to that allergen.
The small group of homeopathic medicines made from diseased tissue, bacteria or viruses are called “nosodes” and, at present, the vast majority of them are available only by prescription by certain health and medical professionals. No new regulation of homeopathic nosodes is necessary unless the FDA has some new toxicological or epidemiological evidence.
Most single-ingredient homeopathic medicines are regulated as over-the-counter drugs and, as such, the FDA requires that manufacturers list a specific ailment for which each drug is indicated.
Because single-ingredient recommendations are based on a pattern of symptoms, not a specific disease diagnosis, it behooves the FDA to consider withdrawing the requirement for an “indication for treatment” for single-ingredient homeopathic drugs, except when adequate research confirms the efficacy of that homeopathic medicine.
Even if an extremely small number of people may be hypersensitive to exceedingly small doses of a medicinal agent in a homeopathic medicine, our society doesn’t outlaw common foods that are known allergens (milk, peanuts, wheat, strawberries), nor does it make them available only upon prescription by a physician, even though some can cause significant distress, anaphylactic shock or death.
Therefore, the remote possibility that this might occur does not justify restricting the availability of homeopathic medicines that benefit many others.
Intellectual Dishonesty Has Continued Into the 21st Century
In 2010, the U.K. House of Commons’ science and technology committee report on homeopathy was highly critical of this subject. However, any rational person should be suspicious of this “report”. The Science and Technology Committee normally consists of 14 members of Parliament, yet this report was approved and signed by only three members, with one vote against the report (most members of the committee did not take this investigation seriously).
Of the three votes in favor, two members were so newly appointed that they did not attend any of the hearings. The remaining “yes” vote was from Evan Harris, a medical doctor and devout antagonist to homeopathy. Ironically, shortly after this vote, Harris was voted out of office from a general election by a twenty-something-year-old candidate who had no previous political experience.
More recently, the Australian National Health and Medical Research Council (NHMRC) published a report on homeopathy that concluded there is “no reliable evidence that homeopathy is effective for any condition”.
However, the definition of “reliable evidence” was so high that only between 2 to 5 percent of conventional medical practices would be deemed to have reliable evidence, despite the billions of dollars on medical research conducted yearly (after reviewing over 3,000 treatments, the British Medical Journal only found 11% of medical treatments are “beneficial” IF the minimum reliable study size was just 20 patients; this number would be considerably less IF the minimum reliable study was 150 patients).
Even more problematic about the Australian report was the fact that this governmental agency hid evidence of the existence of this first report. This previous review found homeopathic medicines effective. In other words, not only has there been “intellectual dishonesty” in the attacks on homeopathy but also serious breaches of ethics in evaluating it.
Stifling Homeopathic Medicines Could Have Detrimental Effects
Brian Josephson, Ph.D., is a British physicist who won a Nobel Prize in Physics in 1973 for work he completed when he was only 22 years old. He is currently a professor at the University of Cambridge. Responding to an article in New Scientist, Josephson wrote:
“Regarding your comments on claims made for homeopathy: criticisms centered around the vanishingly small number of solute molecules present in a solution after it has been repeatedly diluted are beside the point, since advocates of homeopathic remedies attribute their effects not to molecules present in the water, but to modifications of the water’s structure.
Simple-minded analysis may suggest that water, being a fluid, cannot have a structure of the kind that such a picture would demand. But cases such as that of liquid crystals, which while flowing like an ordinary fluid can maintain an ordered structure over macroscopic distances, show the limitations of such ways of thinking. There have not, to the best of my knowledge, been any refutations of homeopathy that remain valid after this particular point is taken into account.
A related topic is the phenomenon, claimed by Jacques Benveniste’s colleague Yolène Thomas and by others to be well established experimentally, known as ‘memory of water.’ If valid, this would be of greater significance than homeopathy itself, and it attests to the limited vision of the modern scientific community that, far from hastening to test such claims, the only response has been to dismiss them out of hand.”
Josephson’s remarks on the structure of water have been confirmed by more recent research. The American Chemistry Society’s journal, Langmuir, published a series of studies that confirmed using three different types of spectroscopy that nanodoses of six different homeopathic medicines persist in water solutions even after dilutions of 1-to-100, six times, 30 times and 200 times.
Of special importance, the dosages remaining in water were similar in size as doses to which our bodies’ hormones and cell-signaling agents are known to operate. Josephson went on to describe how many scientists today suffer from “pathological disbelief” that is, they maintain an unscientific attitude that is embodied by the statement “even if it were true I wouldn’t believe it”.
Ultimately, homeopathic medicine is the “original nanopharmacology” and any new regulations that stifle this important system of medicine just as new and strong evidence is emerging to verify its mechanism of action and its efficacy could have detrimental effects on the future of health and medical care. Because some of the testimony given to the FDA repeats a historic bias against homeopathy, it is important to understand the origins of this misinformation and not let it be accepted without verifiable evidence.
Is America a pluralist society or a homogenous one – and should regulation reflect our society? This is not just an academic question but a practical one, and the way it is answered will play an important role in how the FDA should regulate homeopathic medicine (as well as other systems of healing).
The founding of the U.S. placed a special value on personal freedoms and cultural diversity. America was temporarily thought to be a “melting pot” country, but today, it is much more clear that they are a cultural mosaic or, if you will, a “salad bowl” with diverse ingredients, each with its own value.
Likewise, there has never been just one school of thought and practice in medicine and in healing, both historically and internationally. The appreciation for diversity in medicine and healing was canonized in the federal Food, Drug and Cosmetic Act of 1938. This important legislation gave recognition to the Homeopathic Pharmacopeia of the United States as an equal, but different, body of medicinal agents to the U.S. Pharmacopeia.
The fact that U.S. law recognizes both of these compendiums of drugs means that there are two different standards for drugs in America. They are not a homogenized culture where there is just one school of thought and practice in medicine. They are a pluralist society and therefore need pluralist laws that respect this diversity.
In 1988, the FDA issued the Compliance Policy Act 400-400 titled Conditions Under Which Homeopathic Drugs May Be Marketed, and this document has established clear, measurable and enforceable standards for the manufacture and sale of homeopathic drugs in the U.S.
These guidelines contribute significantly to improving cost, quality and access to safe homeopathic drug products. There may be certain challenges to respecting different schools of thought and practice in medicine, but Thomas Jefferson, the US third president, reminded of the importance of American liberty and of the necessity to work to educate the population how to make the best of their freedoms. He said: “I know no safe depository of the ultimate powers of the society but the people themselves; and if we think them not enlightened enough to exercise their control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education.”
1.The American Association of Homeopathic Pharmacists is encouraging those who live in certain states (Colorado, New Mexico, Pennsylvania, Tennessee, Washington, Utah) to urge their legislators to tell FDA not to scrap the current guidelines regarding the regulation of homeopathic products. These representatives work on committees that have oversight on the FDA. The citizens are simply asked to sign the letter written by the Association.
You may wish to do one additional, simple thing and that is to add some type of personal statement about your experiences with the safety and efficacy of homeopathic medicines. Click here or here to access more information and to access the political representatives (please note that there are certain senators and other congresspersons to contact).
2. The homeopathic community is NOT encouraging everyone to write to the FDA. Now is not the time to express fear about the FDA’s potential actions or to condemn them. Consider submitting short positive comments to the FDA in support of homeopathy.
You might tell the FDA that its current regulatory guidelines (Compliance Policy Guide 400-400) for homeopathic products provide much consumer protection 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 important policy closed on March 20, 2018.
3. Consider supporting homeopathic organizations, pharmacies and resource centers that work to provide useful, practical information about homeopathy so that you can optimize your usage of these natural medicines. Becoming a member of the National Center for Homeopathy is particularly important because they will keep you informed about developments with the FDA and about future suggested actions to consider. For details, go to www.HomeopathyCenter.org. Put your wallet where your heart is and where your health is!
February 7, 2019
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