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On the hunt for personalized medicine

On the hunt for personalized medicine
Nutrition-centered integrative care is the final pillar for delivering on the promise of genomics & deep diagnostics.

In June of this year, the Supreme Court issued a controversial ruling affirming the constitutionality of the Affordable Care Act. Chief Justice John Roberts cast the deciding vote in a 5-4 majority that found President Obama’s central provision of healthcare reform—the individual mandate requiring insurance coverage for every citizen—legal as a tax, though not as expected under Congressional authority through the commerce clause. Regardless, score one for integrative medicine.

As NBJ reported two years ago, “Obamacare” opens the door in minor but meaningful ways to integrative practitioners in pursuit of preventive options. Even dietary supplements have a perch for larger relevance on the conventional healthcare stage through individual wellness plans inclusive of nutritional counseling and supplements with an approved health claim.

Since that reporting two years ago, the integrative medicine industry has—you guessed it—grown. According to NBJ data, service revenues for practitioners grew 4% in 2011 to reach $50.6 billion. The strongest growth came from osteopaths ($530 million in 2011 revenue), ayurvedic practitioners ($200 million), homeopaths ($1.1 billion), and massage therapists ($16.2 billion).

In terms of market share, chiropractic continues to wane as the dominant voice of integrative medicine with largely flat revenues of $18 billion, nearly matched by massage therapy.

Sales of dietary supplements through integrative practitioners saw 9% growth in 2011 to reach $2.5 billion. Specialty formulations, base vitamins and herbs & botanicals remain the strongest product categories, while MDs ($320 million in 2011 supplement sales), massage therapy ($130 million), Ayurveda ($30 million) and osteopathy ($60 million) saw the fastest channel growth. By total sales volume, the big three—chiropractic, TCM and naturopathy—began to separate themselves a bit from a tight cluster around $450 million two years back. Naturopaths now represent 22% of practitioner supplement market sales at $540 million, approximately $70 million more than TCM and $90 million more than chiropractic.

For deeper dives into the current sales landscapes of integrative medicine, see our overviews of the ten major modalities tracked by NBJ [pages 18-21] and the trends informing leading practitioner supplement manufacturers [pages 7-9]. The discussion continues there, while this story takes a hard pivot toward the future and a look at the burgeoning field of personalized medicine.

Personalized medicine is …

“In the past, it was good for the average to eat less salt, more fiber,” says Dr. Jeffrey Bland, the recognized father of functional medicine and recent founder of the Personalized Lifestyle Medicine Institute (PLMI). “If you’re trying to treat the average through generalized principles, you can end up with regression to the mean. If you don’t personalize, you miss your mark. Nutrition is for real people. We learn in medicine how to treat statistical people.”

According to Bland and the consensus of voices interviewed for this issue, we’re squarely on the front edge of this curve. The history of medicine is rife with examples—the electrocardiogram, for one—of a 50-year lag between a discovery and its implementation in common practice. While Moore’s law and the accelerations of technology compress that learning curve, the 50 years fall to 10 perhaps. “This is the start of the learning curve for a new biology,” says Bland.

Accordingly, the terminology of personalized medicine is fluid and its definition still largely intuitive, but the impetus for all this excitement begins, rather than ends, with genomics. “Genomics in a vacuum has very little value,” says Bland. “Personalized medicine needs to be more about networked thinking over siloed thinking. The Human Genome Project was a truly revolutionary step, but we’re in the early stages of transitioning that knowledge out of the realm of the specialist. The average doctor still wants to know what to do with this, what disease you get out of that genetic data.”

“I call it lifestyle systems biology,” says Tim Avila, president of Systems Bioscience. “We can call it personalized or lifestyle medicine. We can measure genetic variation and approach it that way. The point is that the old approach to nutritional medicine has long since passed.” This raises an important point for this indeterminate new world of medicine and nutrition—the science is here, and genomics is but one entry into the discussion. There are entirely new industries being born around genomics, diagnostics and lifestyle medicine—the three pillars of personalization to date—but it takes all three to produce the breakthrough.

“This is the secret sauce of personalized medicine,” says Bland. “No system works in isolation, so only by putting this together as a system—genomics with biomarkers with lifestyle-based therapeutics—does it become truly valuable. You start off with a nodal event like the Genome Project, and that becomes weblike with multiple points of connection. Then you have an industry. Each of the pillars as a commercial entity unto itself is misguided.”

“Draw the circle of a lifestyle medicine world,” says Avila, “then cut it in half. One half is prevention. We can learn early on through genetic variation what to avoid for an individual before the presentation of full-on disease. The other half is illness, learning how to individualize medicines and therapies using the principles of functional medicine. It’s more about optimal diets and lifestyle inputs.”

Again, we have the three pillars working together. Genomics decode our hardware, phenomics assess the software through a dizzying array of more affordable biomarkers and deeper diagnostics, and lifestyle medicine provides a smarter, therapeutic approach to prevention before disease even sets in. Few major companies have proven willing to foray into this brave new world—Nestlé comes to mind with its significant commitment to medical foods, as does Metagenics now with its unrestricted grant to PLMI—but that world is verily crawling with upstarts and startups.

The genomics pillar

Take 23andMe. For $299, this consumer-friendly DNA analysis company will send you a spit kit in the mail. Two weeks after you mail it back, let the genotyping commence with test results clustered in two buckets—ancestry and health. Ancestry findings point you toward unknown relatives—on average 100—as well as lineage derivations from mitochondria, Y-chromosome and reference points in your autosomal DNA. The health indicators make things really interesting, with carrier status determinations for 48 mutations (cystic fibrosis, sickle cell anemia, Tay-Sachs), predisposing risk for 119 diseases (diabetes, macular degeneration, breast cancer), and 20 indicated drug responses (clopidogrel interference, statin side effects, warfarin sensitivity). Somewhere in the gray area between ancestry, health and an Orwellian dystopia lie the included analytics on early research tied to 57 genetic traits, including hair color, lactose intolerance and male pattern baldness. NBJ could not reach 23andMe in time for comment in this story.

This is genotyping—the quest for common genetic variants in a cost-effective approach—rather than full sequencing, and the company does have its critics. Some argue against the quality and value of SNP testing in general, while others raise obvious alarms over leaping from genetic indicators to disease prediction. Case in point: Single-gene mutations like cystic fibrosis provide much clearer cause and effect than prostate cancer, an interplay of perhaps 75 SNPs that together account for maybe 20% of ultimate disease risk. Note the “perhaps” and “maybe.”

23andMe uses array technology from Illumina, a market leader in computational biology with an estimated 1,500 sequencers in the field and $1 billion in annual revenues. Roche launched a hostile—and as of yet unsuccessful—$6.7 billion bid for Illumina back in January. Other key players here include Life Technologies, a $3.8 billion company whose Ion Torrent division recently launched an affordable benchtop sequencer; Knome, with an upper hand in software and interpretation of genetic data; and Navigenomics with analytical services targeting clinicians—the professional’s 23andMe—that caught the eye of Life Technologies for a July acquisition.

This is the hotbed of medicine meeting technology—the data backbone of the industry—but it’s doubtful to serve as the final key to health and immortality. “Genomics—even with all its potential—really tells you nothing about the individual performance of a person,” says Dr. Bland. “The most remarkable thing we’ve learned from genomics is this—we have 20,000-25,000 genes in our human library, but hundreds of thousands of proteins. How does that work? It’s not one-to-one any more. The way we transition from genotype to phenotype is a major a-ha discovery still in the making.”

The biomarkers pillar

“Biometric measurement merged with expert opinions is the killer app for the future of medicine, and the prize is $1 billion in health spending by consumers and employees.” That’s Jim Kean, founder and CEO of WellnessFX, a diagnostics provider whose baseline package at $199 delivers twice the biomarkers of a typical physical and web time with doctors and practitioners of your choosing. The bloodwork runs from traditional measures of cholesterol like HDL, LDL and triglycerides to ApoB and LP(a), markers that begin to capture the undiagnosed risk in otherwise healthy lipid panels.

It’s deeper than you’re used to going, and it requires a new vernacular to understand and manage a host of data. It comes as no surprise then that WellnessFX is also a data visualization company, democratizing healthcare through actionable presentation of rich data at price points—they hope—that encourage you to measure and re-measure yourself. Supplement companies should take note: Given sufficient scale, platforms like WellnessFX become desirable fulfillment platforms, as well as de facto population samples for research and development.

“There’s huge focus on the pathogenic potential of gene concentrations and less about how efficient your body is working as a machine,” says Kean. “For nutrition, we see genotyping as a tool that points to generalized propensity for an individual. Since we’re focused as a company on immediate actionability, we’re more interested right now in quickly and easily breaking down the barriers to better blood chemistry diagnostics. From the areas we picked for our baseline plan, you roll over your blood chemistry every 90 to 120 days to see how biomarkers moved. That’s why nutrition and supplements matter, and that’s why we’re so trend-oriented.”

While the company sells 30 biomarkers and 20 minutes of practitioner time for $199 to consumers, it’s also active with corporations willing to offer smarter, preventive benefits to employees. “We finished a pilot program at a tech company really illustrative of the power of predictive medicine,” says Kean. Through onsite blood draws and two-week turnaround of results, WellnessFX is now able to represent that company as a biological entity and tailor messages to employee groups based on tiered results without crossing privacy lines. “Of the 100-plus employees we measured, the most recommended supplement was vitamin D, followed by omega-3s, multis and B complex vitamins,” says Kean. “Folks also reported lots of stress so the company is looking at investments in yoga and mindfulness, as well as adjustments to the cafeteria.” Consider the implications here for the capital markets and local government when Company A proves healthier than Company B. Who gets the better debt rating? Who gets the subsidy?

When it comes to phenotyping, RNA expression and the detailed measurement of real bodies inside real lives and environments, passive monitoring is also gaining traction via the smartphone world. “The data logger industry is fascinating,” says Kean, “but we’ll let those guys slug it out as we cheer them on from the sidelines.” The world is your oyster for data loggers, but leading companies in the space now include Fitbit—focusing on activity, sleep, diet and weight—and Azumio—sleep, stress and heart rate. Other players of note include Jawbone, RunKeeper and Withings. The big win for a quantified self lies in the ability of these wireless devices and apps to slip into the background for constant, innocuous monitoring fed seamlessly to the cloud and, ultimately, your practitioner.

“Genes have very little to do at any given moment with an individual being,” says Avila. “That’s just potentiality expressed through environment. Each one of us is a systems biology experiment, but we’re going through a toxic world. Give people a chance to manage their toxic burden.” Or as Bland puts it: “The toolkit is as broad as we want to cast the net.

It’s every bit of information we take in from the outside world—everything we can see and feel, our exposure to radiation and pollution, the whole environment.” There are upwards of 25,000 health apps available for smart phones, with data now available to people in real time. All of this creates a “motive force” for patients to interact with caregivers and manage their own health in new and unpredictable ways, according to Bland.

The lifestyle pillar

geneME is a supplement manufacturer based in Lexington, Kentucky, which offers “DNA customized nutrients” and “genetically customized supplements.” The company asks for a cheek swab, tests for 12 genes, and then builds personalized supplement formulations off a common base. “All of our products require knowledge of only these 12 genes,” says Dany Sfeir, geneME’s chief marketing officer. “We explain every single SNP and color code the information for our customers. We then formulate the right boosts to replenish what their bodies are missing according to the DNA tests.”

This means 511,000 possible combinations of ingredients, according to Sfeir, receptivity), NQO1 ( for optimizing CoQ10 as ubiquinone versus ubiquinol) and MTHFR ( for processing folic acid and clearing homocysteine). “We believe in personalization and customization of the product,” says Sfeir. “Our DNA testing is not conducted to explore medical flaws. It’s just enough to produce better product recommendations.

geneME operates as a direct seller of dietary supplements and skincare products, with no immediate plans to broach retail. “This industry is brand new,” says Sfeir. “We need to educate before we get into the retail space. We also need to address the privacy concerns raised for consumers by genetic testing.” Sfeir believes that these privacy concerns and the challenges of life as a first mover are the biggest roadblocks to success, even more than cost—geneME charges $175 for the one-time DNA assessment, and $129 for an average monthly supply of product. “Cost is a roadblock, but there is so much interest,” says Sfeir. “I would argue that cost is lower on our list of priorities than education, consumer acceptance and managing an ever-changing regulatory environment.”

Far removed from the world of direct-to-consumer, Pamlab—tagline: Natural Personalized Medicine—is working hard on medical foods targeting metabolic disorders and neuroscience. Based in Covington, Louisiana, Pamlab offers products like Metanx for diabetic peripheral neuropathy, Deplin for depression and schizophrenia, NeevoDHA for high-risk pregnancies, and CerefolinNAC for cognitive impairment and memory loss. “All of the science we invest in has a battery of biomarkers where we can predict a greater treatment effect,” says David Kronage, senior vice president of commercialization. “We are very interested in nutragenomics—genomics provides one marker we evaluate in disease states. Some of these genes are fairly common in 20% to 50% of the general population, and they can predict metabolic imbalances. Our depression trial has probably been the most rewarding here. Genetic and blood markers predicted a greater treatment effect for our product, and if patients tested negative for the markers, there was no effect.” Genomics plus biomarkers plus a nutritional therapy—that’s all three pillars working together.

“We are taking our model of successful products with strong clinical merit and a personalized medicine angle driven by biomarkers to begin drug discovery,” says Kronage. “We’re not large enough to market a drug effectively, so we would need to partner there.” The desire to move upstream toward drugs—and not downstream toward supplements—ties directly to greater credibility, greater access through more universal insurance coverage, and protections from the higher barriers to entry around pharmaceuticals.

According to Kronage, the big win for personalized medicine looks something like this: You indentify biomarkers in an individual, communicate that information back to a physician, and promote interaction through the distribution arm of a pharmacy that allows for personalized feedback about both the condition and the product. Perhaps this is a more practical, near-term path to success for personalization within the confines of conventional care. “It’s not unforeseeable to get the labs caught up to the science, but there’s a lot of work to be done," says Kronage. "Maybe we give away the diagnostic to find viable patients for our medical foods under insurance plans? We’re not there yet, but we know the biomarkers to look for and we can help the labs commercialize that knowledge.”

Where does all of this personalized science leave the supplement industry? Far removed from where the industry stands today, that’s for sure. Forget about shotgunning dumb combination products targeting the average. “Think of the rich array of secondary metabolites in plants that were traditionally neglected and thought to be so much flotsam and jetsam,” says Bland. “We now recognize these phytochemicals as symphony orchestrators that open up opportunities for nutrition products far more complex than what we thought possible in the ‘70s, ‘80s and ‘90s. Resveratrol, curcumin—these are phytochemicals found to have unique effects in modulating gene expression. It’s nothing like vitamins and essential fatty acids.”

And it’s not just supplements rife for disruption. “Right now we form camps and tribes—hard orthodoxies—around diet,” says Avila. “You find a trend and you ride it—raw this, paleo that—until consumers realize that it’s not optimal for them. These broad swaths of trends and fads are less useful inside an individualized systems biology. Most of our variation comes from diet and the foods that are toxic to us specifically—take gluten, or a true allergy to the full spectrum of grain protein molecules. This type of complexity rattles markets. Systems biology really helps us begin to understand what’s toxic information to each person and what’s not.”

Personalization will prove rattling to supplement manufacturers—consider the challenges of inventory management to come as single-nutrient, single-dose formulas are indentified—and regulators alike—consider the antiquation of FDA as the lines between food and drug blur. This is what happens when paradigms shift. Everything starts to rattle.

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