The United States Food and Drug Administration (FDA) has announced plans for a “public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products.” The 2 full days of hearings, April 20-21, 2015, are entitled “Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework after a Quarter-Century.” The FDA is seeking written testimony from the general public and is inviting potential presentations. The agency’s Federal Register Notice of the meeting details 8 specific areas of interest. Included are an exploration of other nations’ regulatory frameworks, present attitudes, data sources, and the state of information for consumer decision makers. The FDA’s agenda for the hearing will be published later and a webcast of the proceedings will be available here.
The FDA action follows the recent publication by Australia’s National Health and Medical Research Council (NHMRC) of the Evidence of the Effectiveness of Homeopathy for Treating Health Conditions. The agency’s release on the study is blunt: there is no “good quality evidence that homeopathy is effective in treating health conditions.” The finding was based on 225 papers that met the NHMRC’s controversial inclusion criterion. A total of 1800 papers were assessed. The report was picked up internationally, with some examples from ABC News (“Homeopathy Doesn’t Work”), The Guardian (“Homeopathy Not Effective for Any Condition”) and Al Jazeera (“Ineffective for any health condition”).
The National Center for Homeopathy guides its readers to a critique of the NHMRC report by the Homeopathy Research Institute. They note that they participated in the report’s preparation yet question why their questions about the methods were not included. They suggest it was bogus process. They question decisions of what NHMRC considered useful evidence. Their core concern is methodological: “The inaccuracy of the NHMRCs conclusions stem primarily from one fundamental flaw at the heart of this report—the NHMRC reviewers considered the results of all trials for one condition together as a whole, even though the individual trials were assessing very different types of homeopathic treatment.” In an e-exchange with The Global Integrator, author and homeopath Dana Ullman, MPH, CHC notes one inclusion criterion in particular that he views as deeply biasing the NHMRC’s work. He shares that studies must have “three clinical trials of 150+ subjects, each randomized, double-blind, placebo-controlled, with three separate groups of researchers.” Such criteria would, Ullman opines, likely leave acupuncture, herbal medicine and virtually every other non-pharmacologic treatment in the same boat.
Comment: The fact of homeopathic recognition by the FDA is one of those weird political anomalies that makes one realize how large back doors can be. As one might imagine, organizing by the homeopathic community to protect its FDA status is furiously underway. Imagine what might transpire if the FDA actually allows that community of homeopathic supporters to put forward their very best people and evidence. Most assume that the agency will guarantee that potent homeopathic antagonists are on the agenda. If both bring forward their best, these 2 days of hearings would resemble for the field of homeopathy what the 1550 Valladolid debate was for the future of Spanish and European relationships with the civilizations they encountered in their economic expansionism. World views are once again at stake. In the present case, basic views on science, nanophysics and energy may be on trial. Concern that the FDA will approach this with all of the openness of the 16th century’s Spanish inquisition sharpens the parallel.
It is perhaps instructive that the 1550 view toward indigenous civilizations that best reflects modern respect for diversity was argued by Bartholome de las Casas (pictured). The priest, armed with decades of direct experience among the Mayan peoples, was up against prejudicial thought and enthroned economic interests. Despite his testimony to save lives, captured for us as In Defense of the Indians, he lost. It is hard to imagine the FDA’s intent with the hearings as anything other than a plan to remove what it must feel is the embarrassing scourge of homeopathy from its portfolio.