Yesterday, the FDA completed a two-day hearing to solicit opinions on whether and how to adjust their current enforcement policies to reflect the growth in the homeopathic marketplace over the last 25 years. As we reported three weeks ago, the agency appears poised to address the obsolete codification of homeopathy in the 1930s to rein in what many call the deceptive ruse of a belief system masquerading as medicine.
In planning the meeting at their White Oak campus in Maryland, the agency appears to have catered to the homeopathic industry. An overwhelming majority of on-site presentations were homeopathy advocates, including representatives from the official U.S. compendium organization, practitioners, manufacturers, and societies representing homeopathic and physicians. Only three of the two dozen presenters were from science-based critics of homeopathy; one was representative from Health Canada, where homeopathic remedies are lumped in with all natural health products (NHP).
Homeopathy is NOT herbal medicine
Homeopathic remedies are often conflated with herbal remedies – those that have the potential to contain biologically-active molecules whose effects are more pronounced as the dose increases. In contrast, homeopathic remedies are primarily diluted solutions of some of the same plants and other chemicals including arsenic and heavy metals such as mercury.
The bizarre contention of homeopaths is that the preparation is a medicinal product despite the fact that no molecules of the original material remains in the final solution. In fact, practitioners of homeopathy claims that it is an entirely different system of medicine than that practiced in the majority of the world.
But despite the formalization of homeopathy as a system of alleged medical practice, with authoritative sounding societies and training programs, one must suspend the laws of physics, biology, and chemistry to even propose that homeopathic products are capable of any therapeutic benefit beyond a placebo. If anything, homeopathy is an elaborate placebo dressed up in labeling guidelines drafted in the 1930s and treatment settings where practitioners listen to their clients longer than in authentic medical practice.
“The evidence for homeopathy’s effectiveness is between scant and nil”
No convincing evidence exists for the effectiveness of homeopathic products. Even the NIH arm for the study of alternative medicine, the National Center for Complementary and Integrative Health, has concluded that “there is little evidence to support homeopathy as an effective treatment for any specific condition.”
The most interesting testimony came from Adriane Fugh-Berman, MD, a pharmacology professor at Georgetown University who embraces some aspects of alternative medicine and is a vocal critic of the pharmaceutical industry. Fugh-Berman co-authored a highly-cited 2007 paper that excoriated the practice of pharmaceutical sales representatives and their influence on the medical profession (the grant supporting the work was derived from settlement fund from Warner Lambert’s inappropriate marketing of gabapentin). Fugh-Berman’s testimony is highly relevant because homeopathy supporters’ general claim is that the pharmaceutical industry is behind the suppression of their practice.
In the section of her testimony carrying the subheading, “Clinical Evidence is Lacking,” Fugh-Berman wrote,
“Lastly, the evidence for homeopathy’s effectiveness is between scant and nil; this picture has become much more clear over the past 20 years. Although Kleijnen’s 1991 BMJ paper found that the majority of 105 homeopathy trials were positive, it noted that most trials were of poor methodological quality. Shang’s 2005 Lancet analysis compared 110 homeopathy trials with matched trials of conventional medicine, and found only a weak effect of homeopathy, compared to a strong effect of conventional medicine. Benefits attributed to homeopathy‐‐ but not conventional medicine‐‐ disappeared when the analysis was restricted to high‐quality trials. And just this year, an assessment of 176 studies in 57 systematic reviews from Australia’s National Health and Medical Research Council concluded that “that there are no health conditions for which there is reliable evidence that homeopathy is effective.”
In addition to lacking any relevant biological activity, homeopathy shares with dietary supplements the self- medication concern that serious conditions may go untreated and increasingly complicated by a consumer’s avoidance of legitimate medical care.
This photo taken on Feb. 6, 2009 shows a collection of homeopathic treatments in the office of homeopathic practicioner Begabati Lennihan, in Cambridge, Mass., including preparations made with robinia, castor bean, silver phosphate, and clippings of Wintergreen and rosemary. But consumers and even health care professionals become confused when such photos imply that the products still contain some of the plant medicine, thereby conflating homeopathy with herbal medicine. (AP Photo/Josh Reynolds)
Of course it’s safe — mostly
The homeopathic presenters at the hearings repeatedly cited the safety of the remedies. That seems logical for products that are essentially wildly overpriced vials of water or dried balls of sugar. And, of course, if something has no therapeutic activity, it cannot have side effects. All drugs have side effects but their risk-benefit profile plays into whether they are approved for specific indications.
But one reason for the FDA hearings was that some manufacturers have exploited the standards of the Homeopathic Pharmacopeia of the United States (HPUS) to produce medicines that contain real, biologically active doses of some chemicals. (The HPUS is a non-governmental, non-profit organization that establishes standards for product quality.)
For example, products with zinc, such as Cold-Eeze lozenges and Zicam nasal spray are sold as homeopathic remedies, without pre-approval demonstration of safety or effectiveness. Three Zicam-branded products were recalled in 2009 after 130 users reported a loss of their sense of smell.
Last year, Terra-Medica recalled several products that FDA pointed out had the potential to contain penicillin at levels that might trigger a harmful immune response in susceptible individuals.
Homeopathic has also snuck into veterinary practice and retail pet stores. The chemist and science writer Yvette D’Entremont, known most recently for her critique of consumer advocate Vani Hari (Food Babe), raised attention to homeopathic “calming” remedies that contained 13% ethyl alcohol, the same concentration as in a typical bottle of wine. The dose suggested for the pets were enough to make them drunk, but ethyl alcohol is a permitted diluent under the HPUS, listed as an “inactive ingredient.” In fact, these products could be purchased from pet stores without showing proof of age. Her Change.org petition, complete with a video of her getting intoxicated by the product, led Petco to remove the “Good Dog” homeopathic remedy from store shelves.
Retail pharmacy is complicit in the ruse
Fugh-Berman also raised another issue with which I have concurred since starting as a school of pharmacy faculty member back in 1992: Homeopathic remedies are sold in stores beside over-the-counter remedies that contain actual medicine. Again, from Fugh-Berman’s published testimony:
“It is misleading to sell homeopathic remedies alongside conventional OTC drugs
Allowing homeopathic remedies to sit side‐by‐side with conventional drugs that have undergone FDA scrutiny as over‐the‐counter drugs is inherently misleading [Ed.: Some OTC drugs have been grandfathered in, such as aspirin and acetaminophen]. Many consumers have no idea what homeopathy is, and may assume that homeopathic products are phytomedicines or dietary supplements. Not only do homeopathic remedies undergo none of the FDA review that conventional drugs are subject to, but they are not regulated even to the degree that dietary supplements are. Disease claims are disallowed for dietary supplements, but homeopathic remedies can make the same disease treatment claims as conventional drugs!
I consider the selling of homeopathic remedies in pharmacies to be an ethical breach and I have raised this point repeatedly with independent pharmacists and pharmacy chains. Only CVS, which recently removed tobacco products from their stores, has indicated that they may be examining the appropriateness of other product categories.
FDA playing catch-up
It’s anyone’s guess as to how the FDA will use the testimony and public comments to guide their next steps. As one might expect, dozens of public comments came in that were verbatim cut-and-pasted from a statement drafted by purveyors of homeopathic products. But we’re at a time where the FDA is playing catch-up on decisions made or deferred since the 1960s when the modern framework of clinical trials was instituted and received grandfathered approval. Not only are herbal medicines and homeopathic remedies under renewed scrutiny by the agency but too are marketers of unapproved drugs: old drugs that have since been repackaged in new dosage forms that have not met the modern burden of safety and effectiveness testing.
So while homeopathic purveyors and clients may object that their medical misrepresentation is under attack by the government, pharmaceutical companies, academicians, journalists, or medical organizations that fear competition with their safe and gentle remedies, the truth is that the tide is turning in the U.S. against pseudoscience and the idea that freedom to make health decisions does not authorize medical chicanery.
Article : Forbes