My Comments To The FDA

On April 20-21, the FDA will be accepting public comments regarding their proposed changes to the regulation of homeopathic drugs in the United States.  I assume that they will move to make OTC homeopathic drugs LESS available to the American consumer. The following are my comments that I have submitted to the FDA today: IN DEFENSE OF HOMEOPATHY

Homeopathy was founded by German physician Samuel Hahnemann in 1796. This traditional healing art is founded on the concept that there exists a homeostatic principle in all living things called the vital force or Dynamis.   In China, this force is called Chi, in Japan it is called Ki, and in India it is known as Prana.  So far, it has not been possible to directly measure this force; we only know it indirectly through its action on living tissue or biological systems.

After a detailed and intensive study and analysis of the patient's signs and symptoms, the homeopathic physician prescribes a homeopathic drug whose characteristics most closely match those of the patient's symptom complex.  The patient symptoms act as guide to the drug selection and the homeopathic drug is thought to somehow interact with the vital force and stimulate generalized healing,  not simply elimination of the guiding symptoms.

The symptoms associated with each drug are derived from homeopathic provings, namely, single or double blind experiments on normal, healthy individuals. Additional sources of information for each drug come from cured cases and toxicological data. Together all the data points constitute the materia medica of that particular homeopathic drug.

The homeopathic method of detailed symptom elicitation and analysis has been validated by continuous practice for over 200 years. After administration of the drug, follow up visits are used to assess the correct action of the drug, if another dose is required or if a different drug should be prescribed. Homeopathy has been used to treat acute or chronic conditions with the goal to cure the patient.   In the case of incurable patients, homeopathy has been use to palliate.

Homeopathy arrived in American in 1824, in the Hudson valley of New York State. Within 20 years, the American Institute of Homeopathy was founded in New York City. It was the first national physician’s organization in the United States. Three years later, partly in response to the competitive threat from homeopathic physicians, the American Medical Association was founded in 1847. In the 1890s, there were 23 homeopathic medical schools, 175 homeopathic hospitals, and about 15,000 homeopathic physicians in the United States.  In the beginning of the 20th century, there were 4 schools of medicine that competed in the healthcare marketplace: homeopathic physicians, allopathic physicians, osteopathic physicians and eclectic physicians (naturopathic).  This was long before the development of the medical industrial complex in this country when physicians survived by their results and not by their inclusion in insurance networks.  Some of these medical schools still remain but they have long ago changed to allopathic institutions: Boston University School of Medicine, University of Michigan School of Medicine, New York Homeopathic Medical College, and Hahnemann Medical School in Philadelphia. In NYC where I practice, Flower & Fifth Avenue Hospital, Metropolitan Hospital and New York Ophthalmic Hospital were all homeopathic institutions. New York Homeopathic Medical College is now known as New York Medical College where I occasionally deliver lectures on homeopathy for an elective course on Complementary and Alternative Medicine.

Homeopathy, then, is a healing art from a vitalist perspective, utilizing a descriptive method to arrive at a drug prescription.  The homeopathic physician does concern him or herself with the pathophysiology involved in each patient's case, however, the most important data used for drug selection is always the patient's experience of their illness.  So, if 50 patients with asthma show up at a homeopath's office,  they may each very well receive a different prescription. The name of the disease is the same but the individual's manifestation of the disease may be different in each of the 50 asthma patients. The changes that homeopathic patients experience are real and documentable; they are not merely  changes in functional symptoms. Chest x-rays change, blood counts change; pulmonary function tests change and reliance on conventional medications is reduced or eliminated.

The field of medicine is no stranger to the use of therapeutic interventions for which there is no mechanism of action or little proof of efficacy.  Aspirin was first produced in 1853 and first marketed by Bayer in 1899. It wasn't until the 1970s that prostaglandins were explored as a mechanism of action for the aspirin molecule. Should we now retroactively state that until the mechanism of action was found that all responses to the drug were based on the placebo effect?

What should we say about the countless tonsils and adenoids that were routinely removed by surgeons for many decades during the 20th century?  Before the 1980s breast cancer was treated with a radical mastectomy mostly because it seemed to "make sense" to remove lymph nodes and the pectoralis major and minor muscles as well as the breast tissue itself. This went unchallenged and un-researched mostly because of the reputation of the surgeon who developed the technique (Halstead). In the 1990s we learned that lumpectomy would work better and could be combined with chemo and radiation based on the individual's case.  Every time a physician writes a prescription for a drug to be used “off label” he or she is using an unproven therapy. Should we prosecute these physicians?

I am an Adjunct Assistant Clinical Professor at an osteopathic medical school. Our main textbook runs over 1100 pages and provides, in part, the scientific basis for osteopathic manipulation. However, there are many clinical manipulative techniques that have not been exhaustively researched. Medicare pays for osteopathic manipulation. The federal government supports osteopathic medical schools and hospitals – shall we remove funding and close these institutions for the use of unproven therapies?  To be consistent, I suppose we should outlaw acupuncture, psychoanalysis, psychotherapy, hypnosis, occupational therapy, physical therapy, speech therapy, therapeutic touch, and all surgical procedures without a double blinded, placebo controlled study supporting its use. Should we withdraw funding from the institutions that offer these services to patients?  By the way, we may have to add psychiatry to the list. To this day, there are no objective tests for most psychiatric conditions. What we have is a Diagnostic and Statistical Manual which is nothing more than an expert panel’s opinion of which behaviors constitute a particular illness (see discussion below on antidepressants and placebo).

Sometimes studies are done but as a society and as policy makers, we ignore them anyway. When in 2009, the US Preventative Services Task Force recommended against the routine use of mammography in asymptomatic women age 40-49 this advice was loudly criticized by the news media and various “experts”. We were shown interviews with asymptomatic women whose cancers were detected by such mammograms. The new recommendation was based on better research methods and is consistent with the WHO recommendation.  But we ignore the statistics and focused on a handful of individual cases.

Since the late 1990s, researcher Irving Kirsh, PhD (now at Harvard University) has conducted multiple meta- analyses of research conducted on antidepressants. These studies showed that with the exception of severely depressed patients in hospitals, the effects of modern antidepressant drugs were no better than placebo. He reviewed both published and unpublished studies (the studies the drug companies didn’t publish but submitted to the FDA). The FDA itself duplicated his studies and came to the same conclusion. The ongoing saga of these studies is documented in this article: Antidepressants and the Placebo Effect, Zeitschrift Fur Psychologie, 2014: 222(3) 128-134.  Below is the abstract from that article:

“Antidepressants are supposed to work by fixing a chemical imbalance, specifically, a lack of serotonin in the brain. Indeed, their supposed effectiveness is the primary evidence for the chemical imbalance theory. But analyses of the published data and the unpublished data that were hidden by drug companies reveals that most (if not all) of the benefits are due to the placebo effect. Some antidepressants increase serotonin levels, some decrease it, and some have no effect at all on serotonin. Nevertheless, they all show the same therapeutic benefit. Even the small statistical difference between antidepressants and placebos may be an enhanced placebo effect, due to the fact that most patients and doctors in clinical trials successfully break blind. The serotonin theory is as close as any theory in the history of science to having been proved wrong. Instead of curing depression, popular antidepressants may induce a biological vulnerability making people more likely to become depressed in the future.”

IMS Health reported in 2012 that there were over 270 million prescriptions written for antidepressants in the US.  Industry reports (as reported on the Statista website) indicate that the 2013 market for antidepressants in the US was 9.4 billion dollars.

Universally, the most frequent argument against homeopathy is that the reason people say it works is because of the placebo effect. Anyone who practices homeopathy knows that this is not true. Homeopathic drugs work in new born babies, in infants, in patients in a coma, in animals and with plants. To have a placebo effect, you must have awareness. People in a coma are not conscious like the patient I treated with high potency Hypericum (I asked her mother to apply it to her daughter’s skin while she was unconscious in an ICU on a respirator).  In 2010, Frenkel, et al published an article in the International Journal of Oncology entitled, Cytotoxic Effects of ultra- diluted remedies on breast cancer cells, which showed that human breast cancer cells in a petri dish were killed in response to two of the four homeopathic drugs tested. Do isolated human cancer cells in a petri dish have consciousness? About this seemingly powerful and universal argument against homeopathy (and all things inexplicable) one is compelled to ask, what is the placebo effect anyway? What neural pathways are involved? What neurotransmitters are involved? When does this effect develop? What about its close cousin, the nocebo effect? (Subjects have side-effects but no improvement).  How do you research the placebo effect with a double blinded, placebo controlled protocol? The placebo effect itself has not been completely explained so we are in the position of essentially using one unknown phenomenon (placebo) to explain another unknown phenomenon (homeopathy), not especially logical.

If, we permit some therapeutic modalities without exhaustive research but not others, isn’t that a violation of the Equal Protection Clause of the 14th Amendment and the Due Process Clause of the 5th Amendment? If we permit some drugs that work only by placebo effect and not others, don’t we also violate these constitutional amendments?

Critics readily point out that efficacy of homeopathic drugs has not been proven by clinical research. They point out methodological flaws in some studies and have used meta-analyses to show that homeopathy doesn’t work. Meta-analysis of data is the same method used by Kirsh, et al in the antidepressant studies. Ignored in the case of Kirsh but upheld as a strong argument against homeopathy?  There is a very good reason why research studies frequently show that homeopathy is ineffective – the research method used is terribly flawed. Clinical trials using double blinded, placebo controlled, cross over protocols can NEVER show a therapeutic effect for a homeopathic drug because this methodology defies the very nature of the homeopathic process. Clinically, the homeopathic prescription is not based on a statistical model testing pathophysiology but a qualitative, descriptive, case study model based on cure.

For example, if one was conducting a clinical trial for a new drug for rheumatoid arthritis, you would have a control group and an experimental group. The control group gets placebo and the experiment group gets the drug. The subjects take their pills for a set amount of time and the results are measured by acceptable parameters. The two groups are then switched and results are again measured after a set amount of time. A statistical analysis is done to see if the results are simply due to chance.  To conduct this study homeopathically you would have one or more homeopathic physicians interview each experimental subject using standard homeopathic interview techniques aimed at eliciting each patient’s unique experience of their arthritic symptoms. This interview could take up to two hours for each subject. Then the symptoms would be analyzed using a standard homeopathic computer program and each subject would be given the homeopathic drug most likely to stimulate healing in the subject. The experiment would have to run several months to a year to allow time for follow up assessment and possible change of medication. Improvement would be assessed using the same parameters used in conventional research. Most likely each subject would receive a different homeopathic drug because of their individual presentation of their disease. The subjects in the control group would have a two hour, non-homeopathic talk with the homeopathic physician and meet periodically for “follow ups”. After a year of this process, the results (using the same standard parameters) would be compiled and a statistical analysis would be performed on the results. Now, have any of the studies you have reviewed used this protocol? I suspect not. You simply can’t use a research method that can’t assess a phenomenon, and then declare the phenomenon fake when that method shows no effect.

Homeopathy is based on treating the patient, not the disease and so conventional research attempts will always be futile. However, there is one notable exception to this principle and that is the homeopathic treatment of epidemic infectious diseases. Only in this case can one expect that virtually all patients will require the same homeopathic drug and this phenomenon is NEVER studied with conventional methods. So, the one situation in which you could actually study a homeopathic drug with a placebo controlled, double blinded study is exactly the kind of study that is NEVER done. It would be easy to do. Take the disease caused by the Ebola virus. Now I know that the CDC and the WHO would be against it and that Doctors without Borders has said that it would be unethical to use homeopathy in the treatment of Ebola, but this is simply absurd!  Here you have a disease that is 50% fatal and for which we can only offer supportive care. Most believe that homeopathy is fake, that there is only water in the bottle, so if the only thing you are doing for these patients is supportive care which includes hydration, then how is it unethical to put a few drops of nothing into the patient’s drinking water?  What are these agencies afraid of?  Fund a pilot study that would pay for a group of board certified homeopathic physicians to observe and interview the patients and let them come up with several possible homeopathic drugs and treat several groups of patients. The control is supportive care. The experimental group is supportive care plus the homeopathic “nothing”. How does this harm the patients? Due to the nature of the disease, you would have the answer within less than a month. And by the way, should the epidemic drug be found by this process, you could then use it to treat ALL Ebola patients in Africa for a few hundred dollars.

And now I must move to the other major argument against homeopathy made by anyone in the blogosphere who ever took a high school or college chemistry course – the Avogadro limit. Homeopathic drugs are usually made in either an X potency or a C potency. X potencies are serially diluted, one part in ten and the C potency drugs are diluted serially one part in a hundred.  When the X potency serial dilution reaches the 24th step or the C potency dilution reaches the 12th step, you have exceeded Avogardo’s number and the probability of finding one molecule or atom of the staring material is zero. So this is the final argument, no possible way there can be anything there, ergo homeopathy is a fraud. Except - it works anyway. If you are all troubled by this number, then make legal, for OTC consumption, homeopathic drugs under this numerical limit. Nothing more dilute than 24 X or 12C. End. Done.  Just keep in mind that a 1X is 10%, a 2X is 1%, a 3X is .1% and a 4X is .01%.  Albuterol by inhalation is .083% and cyclosporine ophthalmic is .05% so we are already using allopathic drugs in tiny amounts. Also keep in mind that highest dilution desensitization solutions for allergy are also in the 4X range and that the human nose can smell down to one part per trillion.

Recall, also, that the Frenkel experiment on human breast cancer cells used homeopathic drugs that were 30C (10-60) and 200C (10-400). How is that possible? We do not know. We don’t yet have a theory. What should we do? I emailed an emeritus physics professor recently after having finished reading his physics text for non- science majors. I explained to him my interest in in ultra-dilutions beyond the Avogadro limit and proposed a couple of thought experiments. He said that quantum chemistry should be able to answer the question and he would trust experimental results more than theory in this area. He also mentioned that there may already be work published in this area but he himself wasn’t aware of any.

I think it is pretty clear that we are not going to find an answer using 19th century chemistry and Newtonian mechanics. These approaches are fine for our work-a-day world in which Newton’s laws always apply, however, when you begin to examine things that are very big like a galaxy, that move very fast and approach the speed of light or look at things very small like one atom or a subatomic particle, then it seems to me that you need to employ quantum field theory. Maybe we can try to “look” at a 22X or 23X homeopathic solution with a tunneling scanning electron microscope? What if we made a homeopathic drug out of a radioactive substance? Knowing the half-life of the substance we could possibly learn something about the interaction between solute and solvent as the radioactive substance was diluted using the homeopathic protocol. What happens as the substance decays to zero? What happens to the solvent? What is happening beyond Avogadro’s number that may explain a homeopathic drug’s effect?

Well, we are not going to know the answer to these questions unless we look. So, I propose the following: A 3% federal sales tax on all homeopathic drugs sold in the United States, the Homeopathic Research Tax. This would be for basic science research only. As sales of homeopathic OTC drugs have already reached the one billion dollar mark, this should yield 30 million dollars per year. The tax would sunset after we discover how something beyond the Avogadro limit is possible. A commission composed of board certified homeopathic physicians, experimental and theoretical quantum physicists and chemists and a historian and philosopher of science would help select the studies worthy of the grants. There should also be a two million dollar contest so undergraduate and graduate students can participate as well.

Solving the Avogadro limit problem is the first part of the issue but that should at least quiet some critics who talk about fraud and engage in ad hominem attacks against homeopaths and homeopathic manufacturers. The bigger issue is how does the drug interact with a biological system?  Exploring this much more difficult issue will yield results not only for the homeopathic industry but for the study of human physiology itself. That knowledge would benefit everyone because it will potentially lead to a paradigm shift in medicine. It could potentially be the basis of a 23rd century medicine with economic implications far beyond the tiny homeopathic industry in this country.

The other issue that the FDA should consider before contemplating restricting the sale of OTC homeopathic drugs is the issue of Prohibition. These drugs are so dilute that they are very easy to make and market illegally. I have enough stock solutions, pellets and tablets in my office to medicate the entire population of NYC ten times over. People will be making this stuff in their kitchens and selling it on the internet. Homeopathic drugs will enter the US from Canada, Mexico, South America and India. Take a few active pellets of a drug add one drop of cheap vodka and then add 500 blank pellets and you now have 500 pellets of a new batch of the drug. How will you stop it?  When you seize an illegal shipment of a 200C potency homeopathic drug, how will you test it to prove that you have seized a homeopathic drug and not a bunch of blank sugar pellets?  What will the Justice Department charge the violators with – illegal possession of sugar? Are you going to send DEA agents to arrest a grandmother who needed some relief from her arthritis pain? Are you going to seize a mother’s stash of teething tablets? Should she instead continually give her infant child more and more Tylenol? Are we going to live in an America where I can give myself lung cancer by smoking as much tobacco as I want, get high every day smoking pot but not be able to  get some Arnica gel to rub on my sore shoulder? REALLY ?  I guarantee you that there will never be any patients in rehabilitation for abuse of Arnica.

Finally, I think you should consider the nature of science itself. It is like all human endeavors – it happens in a social, cultural, economic, political and religious context. It doesn’t drop as “objective” from the sky; we make science happen and it continually renews itself, it evolves. In 3000 B.C, mankind believed that the sun and all the planets revolved around the earth. In 300 B.C. Greek philosopher Aristarchus proposed a theory which placed the sun at the center of the solar system. It was immediately rejected by the Greeks. It would take 2000 years before a sun-centered solar system would again be considered. First, we had to try to fit the earth centered universe to an increasing larger list of exceptions and problems. Detailed quantitative measurements didn’t fit and the apparent retrograde motion of some planets couldn’t be explained with the epicycle theory of Ptolemy. The earth centered universe couldn’t be properly challenged because church fathers St. Augustine and Thomas Aquinas had linked Christian theology to Greek thought. What was known, what could be known had to comply with Church authority.  By the mid- 1500s we had Copernicus, a sun centered solar system, the end of the Middle Ages and the beginnings of the Renaissance. This Enlightenment paved the way for Kepler’s theory of the elliptical shape of planetary orbits and the beginning of modern science with Galileo’s telescopic observations and measurements which disproved the earth-centered theories.  This willingness for brave souls to challenge Church authority was part of an intellectual age, an age of freedom, which made the founding of this great country possible.

The world changed again in 1687 with the publication of Newton’s classic work, Mathematical Principles of Natural Philosophy. The laws of motion and gravity that he articulated created an entire new world, a Newtonian world which remained unchallenged for the next 200 years. These laws explained everything that humans experienced in their day to day lives but as research continued to improve it became clear by the dawn of the 20th century that Newton’s laws could not explain nature in 4 extreme situations: high speeds, enormous gravitation fields, huge distances and tiny distances. Changes were well underway for another paradigm shift at the close of the 19th century. The 20th century would bring us Special Relativity Theory, General Relativity Theory and Quantum Physics, despite the reluctance of physicists to supersede Newton’s Laws.  The simple solar system atomic model is gone. Particles are gone; waves are gone as is particle/wave duality. We have quantum fields now and quarks and gluons and matter and anti-matter and entanglement and non-locality and gravitons and bosons and on and on and on.  In the twenty first century we learned that all that we have been studying for the past 5000 years is but 5% of everything. Everything else is dark matter and dark energy about which we know absolutely NOTHING.

All of this is driven by our human consciousness, the nature of who and how we are. It is driven by things like symmetry in theories and the roundness of numbers and of experimental data fitting nicely into theories and the search for the holy grail of someday finding a theory that unites all of the forces in the universe. Let me quote from Physics: Concepts and Connections by Art Hobson:

“On a deeper level, modern physics teaches us that the processes of the universe are not simply mechanical motions of matter, but are more appropriately viewed as transformations of energy. Energy, not matter, is the “stuff” of the universe. Energy itself is the ability to do work and so bring about change, and it takes the form of motion and interactions. Ultimately, the universe is made of fields, fields that have energy and even fill the “empty space” of the universe. The significance of post-Newtonian physics touches deeply upon the cultural roots of industrial civilization. Modern culture still assumes that the Newtonian clockwork universe represents science’s view of reality. This materialist world-view leaves little room for freedom, chance, creativity, or spiritual values.  Modern physics paints a non-Newtonian picture of fields and energy structured by relativity and quantum theory. Many non-mechanical forms of energy operate in this post-Newtonian universe, and reality emerges not as predictable clockwork but as a dynamic and unpredictable network of energy. This is nearly the opposite of a clock. Many have suggested that if we are to use metaphors at all, the universe is like a living organism rather than a clock”

Let stand the current regulatory framework for homeopathic drugs. Help seek funding for basic science research. Give this country time. I believe that with the proper funding, Americans can figure this out within 10 years. We certainly don’t need any help from Australia!

It is said that during the Inquisition, after the Italian scientist, Galileo Galilei was forced to recant his claim that the earth moved around the sun, he said, “ EPPUR SI MUOVE” ( and yet it moves). I am sure that my deceased Italian parents would want me to say to you, “ EPPUR SI CURA” (and yet it cures).

 

 

Domenick J Masiello