December 6, 2016
When personal gene tests first started rolling out to the general public, the cost was in the thousands. Early adopters helped bring the price down to the hundreds, then a cool C-note. The promise of learning your personal genetic history was fascinating. Even more tantalizing was using the genetic information as a diagnostic tool to help you plan for—and even prevent—a disease, a kind of road map for hazards ahead.
The poster child here is Angelina Jolie, whose 2013 test revealed a defect in gene BRCA1 that could possibly lead to breast cancer, which was the health condition that seemed to run in her family anyway. The concept of true preventive healthcare, as opposed to the current allopathic model of waiting around for something bad to happen and then treating the symptoms, had its champion.
And then that road map got the details—the off-ramps and forks in the road that offer detours around the road hazards.
Thanks to the mapping of the human genome, the concept of epigenetics is now very real. This means that it’s not the genetic code, per se, that’s responsible for your health outcomes, but whether genes turn on or off, or express themselves.
So epigenetics gave birth to nutrigenomics—the power of nutrition to influence gene expression, especially with regard to the prevention or treatment of disease.
Into this provocative space came companies like 23andMe, WellnessFX and Nutrigenomix.
That’s when the Food and Drug Administration and the Federal Trade Commission stepped in, ready to confiscate all those road maps. The FDA’s mission is to be the gatekeeper of America’s healthcare options. People taking healthcare into their own hands via genetic tests and blood draws did not sit well with the agency. People taking healthcare into their own hands by taking supplements never sat well with the agency. Companies linking these personal tests with supplements was a bridge too far for the agency. Something had to be done.
23andMe was forced to dial back the diagnostic information provided in its gene scans, lest Americans get too creative with their healthy lifestyle choices. Theranos had its home blood draw kit disqualified as an unlawful diagnostic tool.
Slapped but not knocked out, companies continue to jump into the space. NuGenix is a venture between GeneLink and Garden State Nutritionals, which sells supplements. Ingredient supplier DSM has invested in gene testing company, Sciona. WellnessFX and Habit are two companies that are both a sort of digital storefront for health services. Consumers buy blood tests and then get a range of blood markers (the more detailed, the more expensive), and then get a consultation to interpret the results. “Recommendations,” said WellnessFX founder James Kean, “could include supplementation, dietary change, exercise, or further consultation with a doctor about genetic risks or early signs of disease.”
Kean said the company attracted three broad types of consumers: train, pain and gain. That is, athletes, people with health problems, and quantified selfers who are on the cutting edge of the personalized healthcare revolution.
Not ready to be left out of the game, the Federal Trade Commission piggybacked on the FDA’s concerns. In 2013/14, the FTC took aim at GeneLink for violating the FTC Act by claiming their customized supplement recommendations could compensate for an individual’s genetic disadvantages.
The FTC took a dim view of nutrigenomics. In the view of federal agencies, only drugs can help people with disease states—and that counts for preventive health services as well. The FDA and the Centers of Disease Control have said they are not aware of any valid scientific studies showing that genetic tests can be used safely or effectively to recommend nutritional choices or to genetically customize supplements. But their opinion differs when considering pharmaceutical companies that are latching on to the epigenetics conceit. That’s because, at its core, gene tests do indeed offer another view to potential future calamity in individuals. “Pre-symptomatic” is the new darling jargon of the pharma set. And the FDA has approved the Factor V Leiden genetic test kit (owned by Roche), which identifies the genetic target causing blood clots in veins. Of course there’s a pharma drug for that. Meaning the FDA is fine with gene tests as a diagnostic tool, just not so much if people take the results to someone other than an Rx pusher.
The FDA is trying to prevent companies from offering piggybacked services, like blood draws with selling supplements, and to mandate a kind of two-click rule where there has got to be some distance between the companies selling diagnostic test kits and those selling supplements. No integration of medicine allowed! That’s why doctors don’t sell drugs from their offices; you have to leave the doctor’s office and then go to the pharmacy. General healthcare advice to accompany blood and gene tests seems to be fine, but not going commercial with products that align with blood and gene tests.
The FDA is, however, opening the door to so-called “companion diagnostics” where companies can pair diagnostic gene tests with a specific drug so long as it is worked through the FDA’s device center, which evaluates the test to determine whether it may be cleared or approved, and FDA’s drug center, which evaluates the drug to determine whether it may be approved. The companion diagnostic test is used to identify who would benefit from the treatment and sometimes to determine if there are patients who not only would not benefit but could be harmed by use of a certain drug for treatment of their disease.
So, next-gen diagnostic tools paired with pharmaceuticals? Good to go. Next-gen diagnostic tools paired with supplements? You know the answer.
The FTC itself has acknowledged the role of supplements in a health-care regimen. “In most cases,” the FTC stated in an online opinion, “diseases occur as a result of interaction among multiple genes and the environment—for example, a person’s lifestyle, the foods with what they eat, and the substances to which they’re exposed, like sunlight, chemicals, and tobacco. The interactions of these factors in contributing to health and disease can be very complex. Even health care experts are just beginning to understand the relationships among these factors. That’s why it is important to gather and analyze this information with a qualified health care provider so you can be sure genetic data is accurate and correctly used.”
The FTC continued, “Some companies also may claim that a person can protect against serious disease by choosing special foods and nutritional supplements. Consequently, the results of their DTC genetic tests often include dietary advice and sales offers for ‘customized’ dietary supplements and cosmetics.” Of course, the FDA and CDC have already said the evidence doesn’t yet exist to make such recommendations, and the FTC uses that to essentially disqualify the whole model.
The disruption prescription
There’s a chance federal agencies would simply like more studies done to validate the efficacy of supplements for a range of modern conditions, as the DEA requested in its decision to not re-schedule marijuana from Schedule I. That’s the optimistic opinion—they don’t have anything against cannabis, there just aren’t enough studies to make decision. The cynical opinion is that federal agencies will fight tooth and nail against changing their comfy patronage-style system.
What these test kits offer is a new view into an individual’s body and its markers. Then, goes the idea, you get a new blood draw in six months and see if your supplement regime had any influence on it. That makes the crossroads of the quantified self movement with personalized nutrition the new frontier for supplements, which have always been saddled with the “hope in a bottle” conceit in that you didn’t really know if it was working, you just hoped that it was doing something to help you attain a better state of health. Measuring blood markers, then consuming a compound and then re-measuring blood markers is not very far afield from what you might get with your doctor after he prescribes a statin for your cholesterol. Statins are already used to prevent future heart disease via cholesterol counts that are deemed to be off kilter.
This means that even if you believe that supplements and other lifestyle choices can be a preventive tool against future disease—and we have every reason to believe this is so—then gene kits are just another way to measure potential disease risk, on top of the age-old test kits called, “What did grandma die from?” So with these common-sense tool kits, the reasonable approach should probably be multi-faceted. Meaning, get a second opinion. And that’s where the power of companies comes in when they offer not just blood tests, like with Habitat, but also consultations with dieticians and doctors. And then you can go ahead and self-medicate with supplements.
The company of the future will be the one to figure out how to elegantly use diagnostics coupled with supplements to become a health-solutions company. It makes certain kind of sense, which, in a cynic’s view, is why the FDA will never go for it. The question remains, then, whether a tech company will emerge as the Uber equivalent of health and supplements. Old-guard taxis fought back with some success, thanks to their allies in local governments. Big Pharma has pockets a quantum leap deeper than cabs. All supplements have going for them is modern society’s unquenchable appetite for options. That appetite doesn’t just drive disruption. It demands it.
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