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    Columns

    Genetics, Nutrition & The Battle Over Health Freedom

    Nutrigenomics, like all disruptive technologies, faces many unanswered questions, and has encountered some regulatory obstacles recently.

    Genetics, Nutrition & The Battle Over Health Freedom
    Genetics, Nutrition & The Battle Over Health Freedom
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    Erik Goldman, Holistic Primary Care03.03.14
    To find ways of rationally guiding nutritional recommendations has been something of a Grail Quest within the nutraceuticals industry for some time now, particularly among companies marketing products to and through healthcare practitioners.

    Over the last decade, the fulfillment of that quest has been closer than ever, with the decoding of the human genome, the emergence of early biomarkers for a host of serious disorders, and major advances in the ability to measure hormones, antibodies and markers of inflammation.

    Nutrigenomics—the study of the ways in which foods and nutrients modulate gene expression—has sparked something of a revolution at the leading edge of our industry. In the last 10 years, several practitioner-channel companies have formed partnerships with labs that provide a dizzying variety of blood, urine and saliva tests that can be used to tailor individualized diet and supplementation protocols.

    Unlike conventional diagnostic tests that detect signs of already established diseases, these emerging genetic and immunologic tests indicate predispositions for physiologic imbalances that, left unchecked, could ultimately lead to serious disorders down the road.

    In principle, these emerging nutrigenomic partnerships are an ideal business model for all involved. Practitioners win because they have a new set of tools with potential to improve their ability to prevent disease and help restore health. There’s also potential for a nice new cash revenue stream into the physicians’ practices.

    Labs have a new channel in which to market tests, and the nutraceutical companies now have the basis for creating entirely new premium lines of products targeted toward measurable physiological outcomes.

    Patients win because they have new opportunities to avert major disorders long before they cause loss of life and limb, something they can accomplish—at least in theory—with food and supplements. They can also—again in theory—do away with the hit-or-miss, trial-and-error that characterizes a lot of supplement use.

    But, like all disruptive technologies—and nutrigenomics is highly disruptive—there are many unanswered questions, and recently, some unexpected developments.

    Quelling the Genomics Revolution?
    Late last November, FDA issued a widely publicized warning letter against 23andMe, a Silicon Valley-based company that took DNA testing out of academia and into America’s living room, very much like what America Online did for the Internet back in the early 1990s.

    With its $99 saliva test kits, colorful commercials (“It’s like a self-portrait”), and sophisticated yet simple redux of genome science, 23andMe offered easy access to complete DNA profiles, as well as Personal Genome Service—explanations in lay terms of an individual’s predisposition to 254 common disorders, carrier status for known genetic diseases and likely responses to common drugs.

    By all accounts, the company was on a roll. Upward of 400,000 consumers had their genomes profiled by the time FDA issued what amounts to a cease-and-desist order. The agency is prohibiting 23andMe from offering the Personal Genome Service (PGS), an injunction the company promptly obeyed.

    According to FDA, 23andMe’s tests amount to an “unapproved diagnostic device. Regulators said the company has not provided sufficient data to support its gene-based health risk assessments. The agency also expressed concern that without competent practitioner guidance people could misuse genetic information.

    According to FDA spokeswoman Susan Laine, regulators consider the 23andMe Saliva Collection Kit and Personal Genome Service a medical device, based on its intended uses: the test package provides assessments for the BRCA-related genetic risk of breast cancer, and predicts an individual’s drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity), which puts it in the realm of diagnostics.

    “FDA has serious concerns about the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these.” The agency stated it has repeatedly called on the company to supply data to support its claims.

    Ms. Laine stressed that FDA is not singling out 23andMe. “FDA has been working with many other direct-to-consumer genetic testing companies, to be sure that those selling medical devices are moving toward appropriate regulatory compliance. The agency uses the same evidentiary bar for all companies that make similar claims.”

    23andMe’s troubles were compounded by a $5 million class action lawsuit filed on behalf of a San Diego woman who claimed that PGS results are “meaningless,” and that 23andMe, “falsely and misleadingly” promotes its tests.

    The complaint challenges the veracity of 23andMe’s tests, also noting that 23andMe is amassing customers’ DNA information with the long-term goal of marketing data to researchers. “It seems to me to be a very thinly disguised way of getting people to pay them to build a DNA database,” Mark Ankcorn, the attorney filing the suit, said in an Associated Press interview.

    Many advocates of healthcare alternatives view FDA’s move as a direct attack on personal health freedom. Others, however, agree that the realm of genetic testing harbors much potential for abuse—both medical and fiscal. Opinions from healthcare practitioners have been highly variable, but most agree that people seeking gene tests would benefit from guidance from well-trained clinicians.

    Double Helix Meets Dollar Signs
    23andMe—whose major investors include Google and Genentech, and whose co-founder Anne Wojcicki was married to Google founder Sergey Brin—succeeded because it made genetics seem fun. In an age when healthcare issues trigger intense rancor, 23andMe rang a populist bell that resonated with many.

    In 2008, the company and its test kit was named “Invention of the Year” by TIME magazine. Initially priced at $395, it generated buzz but not much revenue. Consumer engagement grew rapidly once the price dropped to $99.

    A Silicon Valley darling, 23andMe gathered seed money from Google, Genentech, New Enterprise Associates and Mohr Davidow Ventures, with Google’s portion alone totaling $3.9 million. In 2012, the company raised another $50 million to augment its existing capital of $52.6 million.

    While revenue from its nearly half a million customers was significant, the company’s future growth was predicated on mining its DNA library.

    In an interview with Bloomberg News, just weeks before FDA’s action, Ms. Wojcicki said, “We will hit a million people, probably within first quarter of next year. And I think with a million people, you start to really become disruptive. One, you have so much data—by far and away the largest data set—and two, you have all these people running around town asking their physicians and telling their friends and family about their genome. With a million people, you start to get into meaningful Big Data.”

    A Landmark Case
    There are many yet-to-be answered questions, including whether 23andMe will step up and meet FDA’s demand for validation, and if so, whether the agency will green-light reintroduction of the PGS tests.

    “Although we cannot speculate on any outcomes, we certainly hope we can work with 23andMe to get tests to market that have demonstrated validity,” said Ms. Laine. 

    But deeper questions lie beneath the surface—questions about the validity of making disease risk determinations based on analysis of single nucleotide polymorphisms (SNPs), the basis of most consumer-facing genome tests, including 23andMe’s.

    In a recent New York Times article, Kira Peikoff, a healthy 28-year-old reporter chronicled her experience of getting her genome read by three different testing companies, including 23andMe. The three reports showed marked discrepancies on key disease risk assessments including rheumatoid arthritis and psoriasis.

    Ms. Peikoff’s article underscores the divergent methodologies used by commercial genome test companies, and the lack of consensus on how to translate SNP data into meaningful risk prediction.

    FDA’s letter, issued by Alberto Gutierrez, director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health, took 23andMe to task for, essentially, ignoring requests for more data.

    The communication breakdown has triggered much speculation. Some observers believe it reflects an “above the law” mentality among 23andMe’s executives; others question whether the company really has the science.

    23andMe has insisted its tests are legit. In a recent blog, Anne Wojcicki noted that, “We have worked extensively with our lab partner to make sure that the results we return are accurate,” and added that, “We stand behind the data that we return to our customers.”

    Empowerment or Recklessness?
    However it pans out, the 23andMe case will likely have far-reaching implications. FDA’s letter included language that seems to challenge the very notion of direct-to-consumer genomics.

    Dr. Gutierrez wrote in FDA’s warning letter: “Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments.”

    In short, FDA is worried that some people might seek unwarranted surgeries based on genomic signals of cancer risk, or that others might discontinue medications or change doses on their own, without practitioner guidance, based on what their 23andMe results tell them.

    At the heart of the matter is the question of self-management of significant health matters: are people capable of making sound and safe decisions without practitioner guidance based on results obtained from a commercial gene test?

    FDA’s stated concerns echo similar contentions that followed other disruptive medical technologies like home pregnancy testing when first introduced in the mid-1970s, or home HIV testing in the 1990s.

    FDA’s fear that women will get prophylactic mastectomies based on erroneous 23andMe results—the so-called “Angelina (Jolie) effect”—seems far-fetched. As some health freedom advocates quickly pointed out, in order to get such a procedure, a woman would have to go through multiple physician consultations. Presumably, impulsive decisions would be tempered by good medical judgment.

    The notion that people will self-tailor drug therapies based on gene findings is harder to dismiss.

    Empowered and individualized self-management is one of the core tenets of holistic and functional medicine. Yet, organizations representing functional and personalized medicine practitioners have been quiet about the 23andMe case.

    A spokeswoman for the Institute for Functional Medicine said the group’s leadership, “doesn’t want to offer an opinion until the issue with the FDA is resolved. But we all agree that this is a hot topic and one that IFM will want to weigh in on in the near future.”

    The Personalized Lifestyle Medicine Institute (PLMI)—which has been active in promoting the concept of mitigating genetic risk through lifestyle change—has been similarly cautious, though the group’s founder, Jeffrey Bland, PhD, voiced general support for genomic testing in a video posted on the group’s website.

    Who Owns the Book of Life?
    “The most important asset we own is the information encoded in our DNA, the 23 chapters of our Book of Life—our chromosomes, our genomes. It’s very intimate. It’s the River of Life that’s confluent down to us. It doesn’t tell us how we’re going to die, it doesn’t tell us how we’re sick. It’s going to tell us how we live, it’s going to tell us how to adjust our lifestyle, environment, principles of living so that we can maximize our life experience and our function,” said Dr. Bland in the video.

    “This concept of a negative view of this information, that it’s all about disease risk, about how we will get sick is totally off-center. It’s really information that alerts the person as to how they should design their lifestyle to live optimally healthy. It’s a functional component, not a dysfunctional component.”

    Dr. Bland views the current controversy as a reflection of the nation’s “death and disease-centered culture.” Given that only 30% of chronic diseases have a direct genetic linkage, there’s tremendous opportunity to influence the factors that regulate gene expression. “Wouldn’t you want to know how to modify that environment to create an outcome called health rather than disease?”

    David & Goliath? Not Quite!
    Libertarian commentators on the 23andMe case see the strangling hand of “the government” trying to kill off innovation and stifle personal liberty. Others argue FDA is acting in the interests of big insurance and pharmaceutical corporations wishing to protect their disease-based revenues and/or gain control over the world’s largest gene library.

    Those who smell a corporate conspiracy point to a March 2012 report by UnitedHealth Group—the nation’s largest publicly traded health insurer—that questioned the accuracy and affordability of consumer-facing genetic tests and called for greater regulation. UHG estimated that gene testing was already a $5 billion business, and could become a $25 billion industry by decade’s end.
    A number of 23andMe’s supporters portray the company as an innovative and well-meaning “David” being trampled by the “Goliath” of a paternalistic and greedy medical establishment.

    It’s an appealing narrative, except that with a $100 million war chest, the world’s biggest Internet company in its corner and a massive cache of highly marketable data already in it’s possession, 23andMe is hardly an underdog.

    Nor is FDA necessarily bent on squelching genomics. Just weeks after its injunction against 23andMe, the agency announced marketing authorization of Illumina’s MiSeqDx, the world’s first high-throughput genomic sequencer, which will enable faster and cheaper DNA analysis and ultimately enable clinicians to identify nearly unlimited numbers of genetic variations.

    The Future of Genome-Guided Nutrition
    Loren Israelsen, founder and president of the United Natural Products Alliance, said interest in genomics is high among natural products executives. In an interview, Mr. Israelsen said he is following the 23andMe story closely, in part out of direct personal interest in the subject.

    “My sense is that people who want to know about their genetics really have a passion for this. They want all the details.” He said his organization made 23andMe test kits available to attendees at a recent industry gathering focused on nutrigenomics and personalized medicine, which was held one month before FDA’s action.

    “A number of people couldn’t get into those boxes fast enough. Others were really unsure. Still others did not want to know—they gave the kits away to someone else.”

    He believes that some data provided by companies like 23andMe make sense for everyone to know, including the capacity to metabolize common drugs, and inter-ethnic metabolic differences and predispositions for various disorders. Knowing these things can lead to better decision-making and improved self-care.

    That said, he acknowledged that, “in the wrong hands, ill can come from this.”

    In the rush to commercialization, there’s plenty of incentive for testing companies as well as the supplement and drug makers to over-promise, under-deliver and wittingly or unwittingly misguide consumers. The question is whether it is necessary to curtail peoples’ unfettered access to genomic testing in order to protect them from these abuses. It’s a question with big implications for our industry.

    Nutrigenomics and its impact on the supplement and natural products industry will be a key focus during this year’s upcoming Health Practitioner Marketing Forum, April 2-4 at the Hotel Maya, Long Beach, CA. For more information visit www.hpmforum.com.    


    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 healthcare professionals nationwide. He is also co-producer, with Greg Stephens of Windrose Partners, of the upcoming Health Practitioner Marketing Forum. Mr. Goldman and Holistic Primary Care recently conducted a survey involving 2,000 primary care doctors and exploring their engagement with and use of nutraceuticals and natural products. The survey report, and proceedings from the Practitioner Marketing Forum are available at www.HPMForum.com.
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