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    Columns

    The DSHEA Disconnect: What Doctors Don’t Know Can Hurt Us

    Will the industry step up to build better connections with the healthcare community, while the opportunity is at hand?

    The DSHEA Disconnect: What Doctors Don’t Know Can Hurt Us
    Practitioners garner a high level of trust with the public and legislators.
    Erik Goldman, Holistic Primary Care05.02.16
    Nearly 60% of healthcare professionals do not know what DSHEA is.

    Let me repeat that: nearly 60% of a cohort of primary care practitioners have no idea what DSHEA means, what it does, how it affects you, or how it affects them.

    And we’re not talking about old-school, dyed-in-the-wool allopathic specialists here. This is among a sampling of self-identified holistic, functional, and integrative medicine practitioners—64% of whom are currently selling supplements in their practices, and 93% of whom regularly recommend supplements to their patients.

    Yet more than half do not recognize the core piece of legislation that essentially created the supplements industry, that governs it, and that to some extent determines the legal use of these products.

    The data came from Holistic Primary Care’s 2016 Practitioner Survey, fielded in March, which garnered responses from more than 850 practicing healthcare professionals, 31% of whom are conventionally trained MDs and DOs.

    Among the 44 questions was one that asked respondents, “What is your view on DSHEA?”

    The acronym was deliberately not spelled out, because we wanted to find out to what extent this term—so widely used in industry circles—had currency with clinicians.

    Respondents had to choose from four answers: 1) DSHEA is fully adequate and effective; 2) DSHEA would be adequate and effective if properly enforced; 3) DSHEA is inadequate and needs major revision; or 4) I do not know what DSHEA is.

    The latter was by far the most commonly chosen answer.

    Only 6% of respondents considered DSHEA to be fully adequate and effective. Nineteen percent said the law is inadequate and needs significant revision. A nearly equal number, 18%, said DSHEA just needs better enforcement. But the largest proportion of respondents did not even recognize the term.

    As one doctor put it in the write-in verbatim comments: “Is that the same as DHEA?”
    Let that sink in for a moment.

    Opportunity for Obvious Allies
    The Dietary Supplement Health & Education Act (DSHEA) has been the law of the land for more than 20 years. Whatever its flaws—and there are many—it remains a landmark in the history of the natural products industry, one that divides time in to pre- and post- eras.

    DSHEA affects almost every aspect of the supplement world, which, despite all the negative press it receives, continues to be a rapidly growing and increasingly important segment of healthcare.

    And yet, the term means nothing to 57% of the most supplement-friendly healthcare professionals anyone could ask to meet. I’m sure if we exclusively surveyed MDs in conventional hospital or managed care settings the level of unknowing would have been even higher.

    That should be deeply troubling to anyone concerned about the future of DSHEA and, by extension, the future of the industry.

    I’ve written in this column before about the glaring lack of practitioner involvement in the regulatory discussion. Few practitioners participated in the initial drafting of DSHEA or the political efforts to push it through Congress. That absence was somewhat excusable—or at least understandable—in 1994. At that time, few practitioners outside of naturopathic physicians or chiropractors used supplements in their day-to-day patient care.

    It’s a very different picture now. Our surveys have shown steady and consistent growth in the number of practitioners who sell supplements in their clinics, who discuss supplements with their patients, and who recommend them for the management of a wide range of health conditions.

    The industry has certainly benefitted from practitioner buy-in; for more than a decade, the professional channel has remained one of the fastest growing and most lucrative segments of the entire industry. But by and large, we have failed to engage the medical community as political allies.

    And the industry is going to need allies.

    Envisioning DSHEA 2.0
    If the attorneys general actions and the Fed’s “coordinated sweep” of 2015 made manufacturers sweat, just wait until after the election. Whoever wins in November, it’s a safe bet that after the dust settles, the rioting quiets down, and the wrangling over cabinet positions is over and done, sooner or later someone’s going to come back to the question of what to do with that unruly supplements industry.

    There are plenty of people on both ends of the political spectrum who’d like to see this industry brought to heel. And our list of high-level political champions has grown very, very short.

    If the companies that comprise this industry hope to enjoy continued growth, expansion, and mainstream acceptance in the coming decades, they need to face the reality that the regulatory system as defined by DSHEA is in need of a rewrite. And sooner or later, it’s going to get one, whether we like it or not.

    Even with increased enforcement, DSHEA leaves too many gaps through which unscrupulous, poorly made products reach the market. And by its very nature, the law prevents ethical, committed companies from communicating truthfully about what their science really shows, and what their products can really do.

    I do not know what “DSHEA 2.0” could or should look like. But I am convinced that the industry needs to be proactive—very proactive—in facing that question, and in engaging healthcare professionals in the process.

    The fact is that supplements are part of healthcare these days. Many of the major medical centers—including the renowned Cleveland Clinic—now have integrative or functional medicine departments, wherein clinicians are using nutraceuticals and herbs as adjuncts to or substitutions for drug therapies.

    Those practitioner communities need to be a part of the regulatory discussion. For one, the laws governing supplement manufacture and marketing affect their practices by influencing what products are available to them, and how they learn about these products.

    Secondly, their perspective as caregivers is extremely valuable. Practitioners are well positioned to see and to champion the benefits of well-made nutritional and herbal products used properly. They’re also acutely aware of the dangers that arise when people unknowingly ingest garbage, or misuse nutraceutical products.

    Thirdly, practitioners still garner a high level of trust with the public and with legislators. Though they do not carry quite the level of undisputed clout that they wielded several decades ago, doctors and nurses are still viewed as authorities on health matters. When they do speak up with conviction and critical mass, they command respect.

    Opening Dialogue
    As startling as our survey responses were on the matter of DSHEA recognition, the verbatim comments offer some measure of hope.

    Respondents are definitely concerned about the proliferation of poor quality products, but they are equally wary of federal regulators. As one practitioner put it, “There are too many low quality supplements on the market giving good ones a bad name. However, I am not sure I want government regulating supplements.”

    Another said: “I believe there need to be better quality controls to ensure a product is what it says it is, but to add requirements for formal evidence of effectiveness through official studies or other strictures would hinder the ability to introduce new products.”

    Some practitioners view the FDA as a tool of Big Pharma—an industry that many physicians hold in disdain.

    “FDA always protects the big pharmaceutical industry and commonly disagrees with natural remedies.”

    The most promising signals, I believe, came from the clinicians who lament the fact that practitioners are not involved in the regulatory process.

    “Those who oversee the creation of this act are not well-versed in herbs, supplements etc., and therefore cannot pinpoint those who are qualified to dispense and advise. There needs to be an open dialogue with those of us who are qualified to advise and dispense.”

    Another one said, “There needs to be properly trained nutritionists on the DSHEA board. Currently they are one step from clueless.”

    Time To Bridge The Gap
    Nothing major is likely to happen on the regulatory front for a couple of years. The three-ring freak show that is the current presidential election cycle, coupled with global economic and political stability, are pushing all non-essential legislative issues to the margins.

    This means the industry has a precious time window to begin the arduous but vital process of re-envisioning the regulatory framework, and building a deep and committed network of healthcare allies.

    There’s no excuse for the fact that in 2016 nearly two-thirds of supplement-savvy practitioners do not recognize the name of the statute that governs how supplements are made and marketed.

    Despite robust growth for more than 10 years, the practitioner channel companies have invested very little time, energy or war chest resources in building a more enduring relationship with the clinical community—a relationship that goes beyond the transactional.

    Our survey shows the gap. It also shows that there are many willing practitioners out there. The question is, will the industry step up now, while the opportunity is at hand, or wait until it’s too late? I surely hope we choose the former. 

    Holistic Primary Care’s 2016 Practitioner Survey report is available for purchase at www.TPCForum.com. You can also sign up for the free monthly Practitioner Channel Update newsletter to stay on top of issues and developments.


    Erik Goldman is co-founder and editor of Holistic Primary Care: News for Health & Healing, a quarterly medical publication reaching about 60,000 physicians and other heathcare professionals nationwide. He is also co-producer of the Practitioner Channel Forum, an annual executive level gathering focused on challenges and opportunities in the health practitioner channel. For more information: www.TPCForum.com.
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