The IFTF Blog
HH Previews Personalized Medicine World Conference
Health Horizons researchers will be attending the 2013 Personalized Medicine World Conference here in Silicon Valley, January 28-29. In the run-up to the conference, we’ll be talking with some of the scheduled speakers to preview their talks at the event. (For more information on the conference itself, please visit the PMWC 2013 conference website.)
Our first in the series of pre-conference conversations is with Dave Kronlage, Senior Vice President of Marketing at Pamlab, LLC, a biomedical company that specializes in prescription medical foods. His talk, Targeted Bioactive Nutrition for Inherited Metabolic Diseases, will close out the Drug Development and Diagnostics session on the first day. That talk—and this interview—discuss research that indicates biomarkers can be used to anticipate a patients response, or lack thereof, to prescription medical foods (as well as to pharmaceuticals).
During our conversation, one of the things I found particularly interesting was simply the existence of prescription medical foods.
“Medical foods are a distinct category, which are regulated by the FDA differently,” Kronlage explained to IFTF's Health Horizons team. To be considered a medical food by the FDA, he continued, a product needs to meet a number of criteria. For instance:
- its active ingredient must be present in/derived from a food,
- it must be administered enterally (either through the mouth or a feeding tube),
- it has to address distinct nutritional or metabolic requirements of patients with a specific diagnosed disease or condition, and
- it has to be proved safe and effective in peer-reviewed scientific literature.
Many prescription medical foods are covered by many health insurance plans and generics even exist for some products.
The category was created relatively recently (1988) and, to me, is interesting in the context of how food categories and regulation could change in the future. In other countries, there are many government certification systems to verify health claims around foods. And, here in the U.S., we’re seeing some attempts to increase regulation of foods that contribute to chronic diseases. Medical foods point to the viability of creating whole new categories of foods and medicines, as well as to some of the implications of those changes. For instance, being prescribed a “food” has a very different emotional connotation, when compared to being prescribed a "drug."
But even within this very specific industry of medical foods, there are changes on the horizon. Researchers have found that certain medical foods, much like some pharmaceuticals, may be more or less effective for a given patient based on their genetic makeup.
“Some patients with major depression have a genetic mutation that limits the amount of L-methylfolate available from a normal diet,” Kronlage says, explaining that L-methylfolate is a bioactive nutrient helps the brain synthesize monoamines that augment antidepressant response. In short, genomics can identify patients (who do not respond well to anti-depressants naturally) who would have their response to anti-depressants improved by taking l-methylfolate as a prescription medical food.
Genomic testing’s increasing availability has similar implications in medical food as it does in pharmaceuticals. It could lead to a future in which a drug or medical food that is effective for 20 percent of the population is only prescribed to that 20 percent. Such a change would seem, (to much of society), to be a correction to an imbalance. However, for people in the pharmaceutical industry, it's a major disruption.
What’s interesting about Pamlabs is that Kronlage says it is embracing this change.
“You're cutting out a large portion of the market,” Kronlage acknowledges. “But we're willing to give up the percentage of the market that doesn't respond [to our products], because, in exchange, you get results that are far superior to standard care.
“We’re not interested in the traditional trial and error approach [to prescribing treatments],” he said, adding that having to go through multiple rounds of treatment before finding one that’s effective is very difficult for patients. “We'd rather be the first line option for a small group than the third or fourth line in all groups.”