Can the FDA Follow Basic Health Care Principles on Natural Agents for Compounding Pharmacies?

Can the FDA Follow Basic Health Care Principles on Natural Agents for Compounding Pharmacies?

Two health care principles surfaced while listening to a webinar in which longtime integrative medicine attorney Alan Dumoff, JD, MSW, described the current status of the work of the American Association for Naturopathic Physicians (AANP) and the Integrative Medicine Consortium to protect natural agents that the US Food and Drug Administration is threatening to ban from compounding pharmacies.¹ One is the Hippocratic principle familiar to all practitioners as “first do no harm.” In the integrative health world, this is taken to its logical extension: When possible, use less-invasive modalities with fewer adverse effects. The second principle is a modern one worn on the forehead of every medical delivery organization that has been marketing itself for the last 25 years since it became commonplace for hospitals to engage in marketing: “patient-centered care.” Each, according to Dumoff’s presentation, might as well have been run over by a tractor given their abuse by the FDA’s Pharmacy Compounding Advisory Committee (PCAC).

A key factor for PCAC on whether a natural substance should be maintained as an approved compounding agent is whether the PCAC members think a synthetic drug is available for the condition for which the compounded natural agent would be used. If available, PCAC presumes that the natural agent is not necessary. This is regardless of differences in the 2 agents’ adverse event profiles. One example of the peculiar logic behind this principle that Dumoff shared is methysulphonylmethane (MSM). Four reports of relatively minor adverse events for MSM led to a PCAC recommendation for delisting MSM, despite the fact that the pharmaceutical comparator, COX-2 inhibitors, carry a black box warning for increased risk of heart attack and stroke. Another is 5-HTP (5-hydroxytriptophan), which is recommended by PCAC for banning because it might have the adverse effects of a synthetic drug that is known to have multiple adverse effects. Patient choice goes out with this bathwater. In an interview,² Dumoff shares also that PCAC is blind to patient centeredness in its refusal to examine data on functionality. Patients tend to care about such outcomes.

Dumoff was given a platform³ by the United Natural Products Alliance (UNPA) to talk about the threat he believes the FDA’s work is potentially building toward attack on public access to dietary supplements. Thus far, neither consumers nor industry have paid much notice. The situation surprises UNPA vice president Frank Lampe: “UNPA believes this should concern everyone in the dietary supplement industry.” The AANP has a GoFundMe site⁴ that has drawn $46 000 from practitioners. More funds will be needed if a planned Citizen’s Petition to the FDA can go forward to protect these efforts to follow basic health care principles and keep these agents available.

Yoga and Mindfulness: National Survey Finds US Citizens Are Learning To Chill Out

The first report on adult complementary and integrative medicine use from the most recent National Health Information Survey (NHIS) suggests that in an insane world, the sane are turning to yoga and meditation. The report⁵ from a team lead by Tainya Clarke, PhD, MPH, of the Centers for Disease Control and Prevention and Richard Nahin, PhD, of the National Center for Complementary and Integrative Health highlighted that from only 2012 to 2017 meditation use jumped from 4% to 14% and yoga use from 9.5% to 14% of adults. Unlike past reports on NHIS surveys that included long lists of complementary medicine modalities and compared use to previous years, this initial paper focused only these areas and in chiropractic, which was up from 9% to 10%. There is nothing on acupuncture or massage, for instance.

An examination of the questions in the actual survey⁶ suggests that additional reports may be coming. The surveyors also gathered use data relative to naturopathy, chelation, homeopathy, progressive relaxation, guided imagery, spiritual meditation, centering meditation, mindfulness meditation, Qi gong, and traditional medicine use. The questions of mind-body modalities also probed whether both the mind and body were engaged. The surveyors also broke with past surveys with questions that may better reach new populations. Date is anticipated to eventually by reported that will share uses of traditional medical practitioners such as Shaman, Curandero, Yerbero, Hierbista, Sobador, Native American Healer, and Medicine Man. This is the first time that the survey has shown this level of cultural sensitivity. Notably, the integrative health movement in general as poorly connected to indigenous medical practices.

ShortTakes.

• Earl Bakken, the founder of Medtronic who was a powerfully influential figure in integrative medicine philanthropy, died in his Big Island home in Hawaii at age 94 years.⁷

• A campaign in parts of the integrative health community for the new World Health Organization (WHO) definition of primary care to include traditional, complementary and integrative components was not successful. The ultimate Astana Declaration version only has a very minor mention of “traditional.”⁸

• The Southwest College of Naturopathic Medicine & Health Sciences cut the ribbon for the opening of the new Neil Riordan Center for Regenerative Medicine on November 15, 2018. Riordan is a stem cell expert.⁹

• The Top 10 medical stories for Cleveland Clinic list “alternative therapies for pain management” as No. 1.¹⁰

• A study from the American Massage Therapy Association estimates that optimal use of massage in US health care will save $24.9 billion annually.¹¹

• Multiple members of the Academic Consortium for Integrative Medicine and Health contributed to a recent white paper from the National Institutes of Health on “emotional well-being.”¹²

• Integrative health publisher, author, and educator Bonnie Horrigan has died at 68 years old. In the mid-1990s, Horrigan was the visionary publisher of Alternative Therapies in Health and Medicine, a sister publication to IMCJ, and most recently served in a similar capacity at Explore: The Journal of Science and Healing.¹³

• To help address a long-standing challenge in the public face of its profession, the Association of Accredited Naturopathic Medical Colleges has posted info distinguishing “naturopathic doctors” (who attend accredited institutions) from “naturopaths” (who, among other distinguishing features, don’t).¹⁴

• The new integrative oncology center at Seattle’s Fred Hutchinson Cancer Research Center is led by naturopathic physicians Heather Greenlee, ND, PhD, a past president of the Society for Integrative Oncology who was formerly at Columbia Medical Center, New York City.¹⁵

• Prince Charles, homeopathy’s most significant backer during the past 3 decades—and also a strong supporter for the integrative model and for environmentalism—has said he’ll stop “spouting of” on such things if he becomes king.¹⁶

Shocking Findings on Consumer Beliefs in Alternative Medicine Cures for Cancer

An American Society for Clinical Oncology (ASCO)-Harris poll¹⁷ recently discovered that 40% of US adults in a recent believe that “cancer can be solely cured through alternative remedies.” These beliefs are in shocking contrast to a 2017 study that found that choosing alternatives increases risk of death 2.5 times.¹⁸ The belief was especially strong among the young. For those aged 18 to 35 years, the percentage pushes up to nearly half, at 47%. Remarkably, 38% of family members and other caregivers to people with cancer agree. And 22% of cancer survivors do. The media jumped on the news. In one account, John Wayne Cancer Institute oncology specialist Jose Carillo, MD, was asked to hazard a guess on why there is this level of unfounded belief: “If I had to speculate, I think that there may be a skepticism of medicine and pharmaceutical industries that play a role in increasing [people’s] willingness to look at alternative therapies in spite of a lack of scientific data.” The strategic director of pathology research at the American Cancer Society Ted Gansler, MD, supported Carillo’s view.

This chasm of mistrust between belief and evidence—if this is what it is—suggests a bridging role for health care professionals who are open to complementary and integrative approaches and can also help patients find their way to conventional treatment when that is where the evidence points. ASCO’s chief medical officer Richard L. Schilsky, MD, FACP, FASCO was asked whether he thought that this predicament might suggest value in an elevated role for integrative oncology. Schilsky responded without fully addressing the question: “Any treatment provided to cancer patients should be grounded in evidence derived from well-designed research studies. If there’s solid evidence indicating that a complementary therapy provides a benefit, oncologists should discuss the research with their patients.” Given the public health-level of concern suggested by these survey findings, a better framed response might be: If there is solid evidence that the public does not trust the cancer establishment, perhaps oncologists should actively engage an optimal future for cancer care that is a partnership with their integrative oncology colleagues.

In a Major Medical System’s Group Acupuncture Leads to Great Access and Higher Income

Revenue enhancement in a major medical delivery organization was found in a surprising quarter, according to experience data from North Carolina’s Levine Cancer Institute. In a presentation¹⁹ by Susan Yaguda, BSN, MSN, for an Academic Consortium for Integrative Medicine and Health webinar, listeners also learned that the same method enhanced access. The method? Move more acupuncture treatment to a group model. Yaguda compared Levine’s first quarter 2015 with that from a year earlier. Although increasing awareness of the services were thought to account for part of the growth, data are compelling: visits increased 275%, income jumped by 180%, and income per hour worked by the acupuncturist more than doubled. And this was in a schedule in which the available hours for acupuncturist services increased by only 36%.

In a follow-up interview,²⁰ Yaguda said Levine has since decided to move all their acupuncture to a group model. The choice was facilitated by the availability of individual acupuncture appointments elsewhere inside the Atrium delivery organization of which Levine is part. Were patients sorry to see the individual visits taken away? Yaguda recalled only one person who was against the group format: “It was someone with a lot of anxiety.” Then she noted a benefit that individual clinicians may not expect: “Usually they tell us that they like the group—they like being all in the same boat.” Yaguda shared that Levine began with 1/2 day per week of an acupuncturist’s time, doubled that to a full day, then added another half day. They presently offer the group acupuncture services 2 full days per week, treating from 10 to 28 patients per shift. She expects the group-delivered acupuncture services to continue to grow.

“Healing” from Patients’ Perspectives: An IFM/Institute for Health and Healing Project

It was not too many years ago—essentially prior to the past 20 years that coincide with the integrative era—that the idea of healing could hardly be spoken above a whisper in the context of regular medicine. Yet even through the past 20 years, most examinations of what healing means have come through the voices of practitioners. In a project²¹ that involved David Jones, MD, the former medical director of the Institute for Functional Medicine and 3 scholars at the Institute for Health and Healing (one of whom is Jones), long-time integrative medicine leader at the University of Michigan, Sara Warber, MD, and others, intensive interviews with 23 patients were engaged and analyzed to discover what healing means from a patient’s perspective. The participants were selected for having been through self-described healing experiences.

The results are intriguing. The authors developed a model of healing based on a definition of healing as “recovering a sense of integrity and wholeness after experiencing illness and suffering.” The model typically began with an initiating trauma or “wounding event.” Those who heal tend to engage “an erratic, long-term process, experienced uniquely by each person” based on their circumstances. Community was identified as the key factor in healing: “Through persistence, the suffering person forms safe, trusting relationships with helpers, who in turn, enable the person to gain resources, such as positivity. The cycle of acquiring relationships and resources repeats indefinitely, fostering beneficial attributes, such as self-acceptance. These contribute to a restored sense of wholeness and integrity, which constitutes healing.” The interviewees made clear that their healing—a “recursive, not step-wise” process—did not lead to the absence of illness. Rather, each, in the context of community, found ways to live with their conditions.

In a media release on the paper,²² University of Vanderbilt professor of ethics Larry Churchill, PhD, calls the model advanced by the researchers “the best, brief phenomenological portrait of healing we have available.” The open access study, published in BMJ Open, is believed to be the first of its kind. The authors entitled it Healing Journey: A Qualitative Analysis of the Healing Experiences of Americans Suffering From Trauma and Illness. Study coauthor Kurt Stange, MD, MPH, strikes a hopeful note in speaking to the study’s potential impact: “Greater understanding of patients’ journeys may positively inform the way health professionals, caregivers, and communities support those who are ill.”