Homeopathy on Trial (Again): Australian Report and Now USFDA April 20-21 Hearings

FDAThe 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.

NAFKAM Launches Website With Regulatory Info on CAM Regulation in 39 EU Countries

Vinjar Magne Fonnebo, MD, recently shared excellent news with The Global Integrator. The National Research Center in Complementary and Alternative Medicine (NAFKAM) in Norway, which Fonnebo directs, has launched “a new website on CAM Regulation.”  Provided there are “details on the regulation of Traditional, Complementary and Alternative Medicine (CAM) in 39 European/EU countries.” The website is open-access and available in English.

The 3 core documents on the site were developed through the now-terminated CAMBrella project. From 2010 to 2012, leaders from 12 EU countries and 16 partner institutions, including NAFKAM, conducted exploration of integrative practices and practitioners. Key topics transferred from their work to the site are legal, regulatory, and reimbursement status for 12 identified CAM practices, plus similar information on natural medicine products. A short version of the most significant report is here. Updates to the regulations will be housed in a News section.

In a brief e-interview with the Global Integrator, Fonnebo spoke of future plans: ”We would like to expand this to a global overview of the regulatory situation.” He shared that NAFKAM is working with WHO on the expansion. Fonnebo further noted that, for the United States, the resource would require state-specific regulation since most medical regulation in the United States is at the state level.

Comment: This is a terrific project and resource, both in its current form and in its future intention. As a person who works on the ground mainly in the United States, I can attest that the challenge of disparate regulations in different jurisdictions is frequently confounding. For instance, a naturopathic doctor is licensed as a primary care physician who can legally run a patient-centered medical home in the states of Vermont and Oregon, yet that profession has no licensing in 32 states. Having these regulations for 39 countries in one place will prove a tremendous, time-saving resource for multiple interests and projects.

NAFKAM’s next phase of work with the WHO will be an especially dynamic process. Partly via the strategic direction from WHO, new regulations of products and practitioners in multiple nations are visible monthly. One can imagine a “News” section for these nations that may quickly become more robust that the original database. Side note for the developers: a set of new federal regulations in the United States governing the inclusion of CAM practitioners and integrative health practices is available here: Sections on CAM and Integrative Health in the Affordable Care Act-HR 3590.

Fonnebo (pictured) is a remarkable player in the global movement for integrative health and medicine. NAFKAM was designated in 2008 as a WHO Collaborating Centre for Traditional Medicine; Fonnebo serves as director. I first encountered his work when I learned of the international rump caucus self-referenced as the “Island Group.” These researchers chose to engage head-on the challenges and necessity of embracing new, whole-systems research models to effectively move whole-person, mind-and-body-and-spirit, multi-agent and typically team-based practices. (See Political-Economic Issues in Whole Systems Research Revealed by JACM Roundtable.) Fine work all around, Dr Fonnebo.

Quick Links to Global News in Traditional, Alternative, and Integrative Health and Medicine for February 2015

This monthly Global Integrator feature highlights links to more than 50 media clips in traditional medicine and alternative and integrative health globally during February 2015. The excitement following India Prime Minister Modi’s declaration of a Department of Ayush is picking up steam as that nation moves toward a health program that better integrates traditional methods. Huge growth in a Singapore integrative medicine concern with 28 offices, a Seattle biotech engineer working on faux rhino horn, natural medicine for Ebola (and an attempted exorcism), and much, much more. For January’s links, click here.

  • President of Malaysian Chinese Medical Association Tan Khai Hee calls for more Malaysian practitioners of Chinese medicine and an end to the consumption tax on them.
  • The website for Modern Muslim Living provides a breezy overview of Muslim contributions to medicine.
  • The University of Kashmir has a project “Assessing Medicinally/Dietary Important Plants of Kashmir Valley Proven To Possible Adulteration Through ‘Quality By Design’ Approach And A Search For Biologically Active Constituents From Them.”
  • The Global Wellness Institute, featured here in the Global Integrator Blog, connected with Scientific American for this symposium on the science of wellness.
  • A Chinese herbal medicine is discovered to be a potent anti-Ebola agent by a Texas research team.
  • A very different traditional medicine–Ebola story from Guinea: an herbal healer Kalifa Lengo returned to perform an exorcism to remove the curse at what many consider “ground zero” for the virus.
  • The Guardian reports that a Nigerian herbal cocktail may be useful in India and elsewhere against the spread of drug-resistant malaria.
  • The WHO’s focus on urging traditional medical means for combatting diarrhea is referenced in this Nigerian article on the use of mango leaves.
  • Singapore’s Eu Yan Sang Integrative Health, now with 28 clinics, reports a 40% increase in business in recent years.
  • A TCM Master and a Malaysian entrepreneur have a business for treating eczema with natural products.
  • In Rwanda, traditional healers in the Aga Rwanda Network are seeking to recruit young people to revive their industry. The president of the network, Daniel Gafaranga, says they are targeting those with science backgrounds and hope to have 300 on board by the end of 2015.
  • A research project looking at the whole system of Chinese medicine to support women undergoing in vitro fertilization found a positive correlation.
  • The deputy director general at the South African Department of Health, Yogan Pillay, and a practicing traditional healer who is president of the South African Traditional Healers Association, Sazi Mhlongo, speak to the challenges when some traditional healers urge people to stop their pharmaceutical HIV medications.
  • A UK regulator has successfully held a case against claims made by Herbalveda on three products.
  • US Public Broadcasting Systems reports that tiger farms are stimulating poaching.
  • While in Nepal there is a conference against illegal poaching, across the globe in Liverpool a mother-son team are running a half-marathon to protest bear bile medicinal use.
  • AYUSH minister Shripad Naik says that the traditional medicine agency is coming up with a whole new health policy that elevates traditional practices. In a related story, Naik calls it “a matter of pride” that the nation boasts “519 AYUSH educational institutions including 191 postgraduate colleges where about 35,000 students are admitted annually.”
  • A strategy for linking 15 Indian hospitals in one state to do research on traditional medicine is urged here.
  • The Indian state of Odisha’s chief minister Naveen Patnaik speaks to his state’s commitment to a system that integrates Ayurveda. Similarly, the Telangana state health minister C. Laxma Reddy called for support to set up more AYUSH centers to expand access to traditional methods. Leaders in Kerala also put in a pitch for their getting Indian federal support for an AYUSH center in their state.
  • This China Daily piece features a talk at UC Davis on how few people in the United States understand the way Chinese use foods as medicine.
  • The return of a USC management consultant to help run his family’s herb business is the feature of this Straits Times story.
  • Good news for pangolins regarding this Global Integrator Blog story: the army in Chang Mai, Thailand seized 150 of the scaly creatures, alive, that were bound for medicinal use.
  • A Seattle biotech engineer (pictured, left) has a startup to make faux rhino horn. He reports 45% of Vietnamese rhino horn medicine users would take it from rhino horn made in a lab. The real stuff runs $100,000 per kilogram on the black market.
  • This article on the killing of rhinos for medicine notes the following believed medicinal applications from the horn: snakebites, hallucinations, typhoid, headaches, carbuncles, vomiting, food poisoning, and “devil possession.”
  • Human hands believed to have been severed for medicinal use were found with traditional medicines by the side of this South African river. The LA Times featured an article on the taking of albino limbs for medicinal purposes in Tanzania.
  • This article in The Hindu focuses on the business of bringing Amway’s Nutrilite products to India.
  • A Malaysian program MamaCare trains workers to integrate traditional and Western methods in postnatal care, following a 2002 WHO program.
  • The West African nation of Burkina Faso reports a survey on the widespread use of local plants in traditional medicine.
  • The head of Agbeve Herbal Hospital made a similar pitch for inclusion of these facilities in the insurance scheme.
  • In Ghana, Christian Kwasi Agyeman (pictured), National Chairman of Universal Ghana Herbal Manufacturers’ Union (UGHEMU) and CEO of Taabea Company expresses concern ”over the seeming neglect of the herbal industry by the government.” The company has received a WHO award.
  • A Lancet Psychiatry article on use of diverse traditions in mental health is described here.
  • The University of Toronto’s new integrative medicine program, run by Linda Balneaves, MD, is featured here.
  • A business is advertising a “Global Equipments of Traditional Chinese Industry Report 2015.”
  • The International Business Times UK version speaks to the use of maggots and leeches medicinally.
  • Musings in Customs Today on efforts to stimulate Vietnam’s traditional medicines.
  • The Greater Accra Chairman of Traditional Medicine Practice Council, Oscar Asamaoh Donkoh, has appealed to government and the national health insurance authority to include traditional herbal medicine in the national health insurance scheme as indicated in the Scheme’s Act.
  • In Angola, the Professional Therapists Chamber of Traditional, Natural, Alternative and Non-Conventional Medicine claim 3600 registrants since December 2014.
  • Professor Emeritus Joseph Okogun of Nigeria’s University of Ibadan urged scientists and clinicians to collaborate with the traditional practitioners to ensure standardization of herbal drugs.
  • A brief audio interview highlights the focus of traditional medicine research in Palau.
  • Uganda herbalists (pictured, with regulator) are asking the government for enforceable standards that will support export of herbal products. The article notes an estimate of one traditional health practitioner for every 200-400 Ugandans; for medical doctors it’s one per 20,000.
  • A call for more research in Botswana on indigenous medicine included notice that the University of Botswana created a Centre for Scientific Research, Indigenous Knowledge and Innovation “which attempts to link scientific research with indigenous knowledge systems.”
  • The troubles over regulating traditional practitioners discussed in this Global Integrator Blog piece on Zanzibar are further explored here.
  • Loss of traditional medicine in the United States’ indigenous culture is mourned in this Indian Country article.
  • The business magazine Forbes puts tongue in cheek in reporting the decision of the US FDA to not regulate devices meant to “increase the flow of Qi.”

World Federation of Chinese Medicine Societies Gains WHO Status After Decade-long Process

On March 11, 2015, the World Federation of Chinese Medicine Societies (WFCMS) established an official relationship with the World Health Organization (WHO). The formal tie consummated a process that began a decade ago. The importance to the Chinese of this relationship for their plans for worldwide dissemination of their medicine was made clear by WFCMS president She Jing (pictured): “The relations embodies that WHO attaches great importance to Chinese medicine, which helps extend international influence of Chinese Medicine.” The recognition, according to the announcement, will be a platform through which the WFCMS anticipates influencing the direction of global health and medicine. Li Zhenji, WFCMS vice president and secretary-general, listed four points in a WFCMS-WHO “2015-2017 cooperation plan.”

The announcement the next day at a press conference (group pictured) was accompanied by a brief comment from Bernhard Schwartlander, WHO representative in China. He was representing Margaret Chan, WHO Director General. Stated Schwartlander: “The WHO recognizes the values and role traditional medicine can play in national health systems, especially in primary care.” He reportedly added, “There is continuing demand for traditional medicine around the world. It is not only used to treat diseases and is widely used for disease prevention, health promotion, and health maintenance.” The same article estimated that traditional Chinese medicine (TCM) is practiced in 164 countries and regions and “includes 300,000 employees.”

Comment: Notably, the announcement immediately provoked a skeptical response from a writer at the Quartz website. The reader is greeted first with a written disclaimer that, while the WHO may recognize the WFCMS, the “Jury’s still out” on TCM. Immediately beneath is a visually delivered, sophomoric follow-up punch: amidst a wall of dark-stained, ancient drawers evoking the multiple ingredients in a Chinese apothecary, a live snake’s tail drapes out of one drawer. The ensuing copy, however, is not utterly biased, noting a recent study that found a Chinese herb useful in warding off the Ebola virus.

The bigger story, however, is the platform that this gives the Chinese government for its significant mission in exporting Chinese culture as TCM. Such a mission will be best served if the WFCMS uses its WHO recognition not just for their own interests but for the effort to find the right relationship between traditional medicines of all kinds and industrial medicine. The WFCMS has an opportunity to be an inclusive voice for the broader values and practices associated with integrative health and medicine. Meantime, the leaders of the robust activity to elevate AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy) in India, who also foresee broadened export of their nation’s medicine, likely see such WHO recognition as a near-term target for their own organizations and global ambition.

Traditional Medicine and the Trade in Animal (and Human) Body Parts

In the course of a monthly review of news stories related to traditional medicine, a half dozen developments appeared regarding conflicts surrounding the use of parts of mammals as traditional medicine. A step in the right direction was made in Vietnam, where traditional healers signed an oath to not use rhino horn medicinally. The action was directed by Nguyen Hoang Son, deputy director of the nation’s Traditional Medicine Administration. The third World Pangolin Day was announced and held on February 21, 2015, to celebrate and preserve a species (pictured) whose scales are treasured as medicines. Long overdue, especially from all anthropocentric observers, was an action in Tanzania: the government has banned traditional doctors who use albino body parts. Yes, human albinos.

The need for such collective actions was more often the theme. In India, for instance, there was a huge seizure of ivory and pangolin scales. In Myanmar, an observer visiting a temple that is a major tourist attraction was dismayed to discover that body parts of endangered species were openly sold as medicines. This writer for a Western blog called Munchies showed great indiscretion by teasing readers with information and pricing about the Chinese practice of drinking “tiger bone wine.” This posting came as a writer on a different site ruminated more holistically on the various forces, including traditional medicines that make it difficult to put a price on protecting tigers. Meantime, nearly 50 monkeys and slow loris (pictured) were found in the back of a car in China’s Guangxi Zhuang province. There, “investigators feared the animals could have been destined for traditional medicine or bush meat.”

Comment: I grew up in a tradition in which such medicines were only a symbolic part of my upbringing or culture. This was the (for me) Protestant communion practice of eating a wafer representing the body of Jesus and drinking wine that represented the blood. As such, terminating the actual practice of having mammals as medicine is not challenging. These bans cut closer to home when I think of times I have experimented with some form of vegetarian diet. Denying the food as medicine of meat from various creatures is certainly as disapproved by many, though without the direct argument of imminent extinction to support it. Still, ending these medicinal practices is much easier to anyone who, like me, was not inculcated with a belief that they are essential.

That said, there was no excuse for the Western writer’s cynical article on tiger wine. The counterpoint blog on challenges to protecting the wild tiger calls fallacious the argument of tiger farm owners that they offer a good, alternative source to poached animals. The argument is that we need a taboo as strong as the one that most probably imagined already existed regarding the use of albino parts. (No, that astonishing piece is not about rhinos but albino humans. The United Nations estimates 74 abductions of albinos for this trade in Tanzania since 2000.) As long as there is a medicinal market, some will view poaching as a livelihood; others, as a less expensive means of product sourcing.

One story during the month in which medicinal use of animal parts did not threaten a species is the reference to deer antler therapy in the emerging medical tourism trade in Kazakhstan. These deer parts are viewed as a potential attractant to a zone where deer are raised as livestock.

Excellent Webcast March 10, 2015 Follows IOM Report in Empowering Women Via Investment in Midwifery and Nursing

On March 10, 2015, the Institute of Medicine (IOM) of the US National Academy of Science will host a global webinar open to all called “A Discussion on Empowering Women and Strengthening Health Systems through Nursing and Midwifery Investment and Enterprise.” This followed the publication of an IOM report on a workshop of the same title. The report and the discussion are both led by Marla Salmon, ScD, RN, FAAN, at the University of Washington. She was stimulated by interest in “the feasibility and desirability of innovative investment in nursing and midwifery education and practice enterprise as avenues of opportunity for women’s empowerment.” One conclusion for those in more industrial countries: “Investment in innovative nursing and midwifery enterprise that is taking place has value to informing developments globally and in the United States.”

The workshop, report, and discussion are joint projects of the IOM Global Forum on Innovation in Health Professional Education and the IOM Forum on Public-Private Partnerships for Global Health and Safety. A key focus was on entrepreneurial models for advancing businesses such as the Well Family Midwife Franchise Clinics, begun in 1997 in the Philippines. It is owned and managed by licensed midwives and backed by a consortia of non-governmental organizations (NGOs). Much dialogue focused on empowerment, business education, “social enterprises,” scaling, and sustainability of models.

Comment: Great topic, for many reasons. One is simply that, as the New York Times recently began to admit, midwifery needs to be elevated in a reformed delivery system focused on bettering health outcomes and lowering cost. In addition, the intersection of public and private drivers, such as “social enterprise” models, so critical here, are also underexplored in the entire integrative health and medicine enterprise. Back in 2001, an interprofessional stakeholder identified this need in a set of Design Principles for Healthcare Renewal as “a partnership between an expanded commitment to the public health and a thriving industry of health creation.”

One unfortunate note: the organizers missed a beat in not including in their meeting at least one representative of an excellent go-between profession between nursing and the world’s traditional midwives: the homebirth-oriented, non-nurse midwives. In truth, the attendee list did not readily reveal any inclusion of direct-entry midwives. In the United States, these are organized as Certified Professional Midwives and have the entire apparatus of accredited education, national certification, and licensing. Most midwives globally are not nurses. Ironically, the leading academic center in the United States for such education is in Salman’s backyard, at the Bastyr University Midwifery Department. An innovation for nurses is to give non-nurse midwives as much respect as they, nurses, would like from medical doctors and that we’d all like to see for the mainly female-run enterprises that are the subject of Salman’s work.

The Global Wellness Institute: Update With CEO Susie Ellis After Launch of Evidence Site

The Global Wellness Institute announced February 12, 2015, that it has launched a robust, open access Wellness Evidence site. The web resource is subtitled Evidence-Based Medicine Portal for Wellness Therapies. The data are organized under 24 separate modalities that are frequently part of wellness efforts, from acupressure to chiropractic, exercise, sleep, sauna, and yoga. Credited as data sources on the user-friendly site are Natural Standard (now Natural Medicines), PubMed, Cochrane Collaboration, and Trip Database.

The Global Integrator contacted Susie Ellis, MBA, cofounder of the portal’s sponsor, Global Wellness Institute: Empowering Wellness Worldwide. Ellis is a long-time leader in the global spa and wellness world. She shared how the evidence initiative began in 2007 as a site for spas when the focus of Ellis’ and her associates’ work was framed around the spas concept. “We started 9 years ago to get together globally and organize the first global spa conference,” recalls Ellis. The invitational gathering of now roughly 500 executives has since met in such places as New York, Bali, Switzerland, India, and the Aspen Institute in the United States. Just last year, “we decided that instead of just meeting once a year, we needed an organization.” Besides the annual gathering and the web portal, the resulting Global Spa Institute also engages research and has a growing focus on workplace wellness. Ellis explains that the term spa proved anathema to employers, so the group shifted to the “wellness” handle.

In 2007, as today, the evidence site has leaned on the expertise of corporate wellness expert Kenneth Pelletier, PhD, MD (hc), founder and director of the Fortune 500 studded Corporate Health Improvement Program (CHIP), and evidence-based medicine (EBM) expert Danny Friedland, MD.  The wellness industry that the evidence portal is meant to serve is huge, as the Institute has reported. The site shares estimates of the following “ten sectors comprising the global wellness market: Beauty & Anti-Aging ($1.03 trillion), Healthy Eating/Nutrition/Weight Loss ($574 billion), Fitness & Mind-Body ($446 billion), Wellness Tourism ($494 billion), Preventative/Personalized Health ($433 billion), Complementary/Alternative Medicine ($187 billion), Wellness Lifestyle Real Estate ($100 billion), Spa Industry ($94 billion), Thermal/Mineral Springs ($50 billion) and Workplace Wellness ($41 billion).”

Comment: Smart that Ellis and her associates showed the agility to make the name change in response to employers. The History of Wellness on the Institute’s site reports that in the 1980s large employers were the stakeholders who first promoted the “wellness” focus. That elevation of wellness was part of a realization of the National Business Group on Health, and others, that “healthcare was too important to be left to doctors.

In fact, another stakeholder was similarly indisposed to leave their health to regular medicine: consumers worldwide who began to explore “alternatives” such as nutrition, mind-body medicine, massage, acupuncture, chiropractic, naturopathic medicine, use of vitamins and herbal medicines, and more. That popular movement was reframed first as “complementary medicine” and in the last few years as “integrative health and medicine.” This is a movement in which Pelletier and Friedland are leaders, the latter as chair of the emerging global player, the Academy of Integrative Health and Medicine (AIHM). (Alignment of interest note: I serve on AIHM’s board.)

This is a terrific time to see this wellness resource appear. As I reported here in the Huffington Post, an innovation leader at the Mayo Clinic, the current president of the American Hospital Association, and other thought leaders in medical delivery are increasingly articulating the need to move from “sick care” to a focus on what some call “health creation.” In December 2013, for instance, the former head of the U.S. Center for Medicare and Medicaid Services Don Berwick, MD devoted an entire keynote to the topic, speaking of health creation – the road to salutogenesis – as a 30 year journey that must begin now.

Perhaps Ellis and the Global Spa Institute, with employers at their side, can support and infuse these health systems so that they can become trusted to lead, as these progressive voices urge, a movement to “health” and not just “medicine.” As the CEO of the multi-hospital Allina Health system in Minnesota (United States) pointed out in this other Huffington Post article, when systems are incentivized to keep their patients healthy, “integrative medicine will be an asset.” The new Wellness Evidence website is a new piece of that asset.