Prize pHight

Who says the natural products industry should decry drugs with OTC status?The opportunity for exploiting underappreciated weaknesses in the digestive health category, au naturel, is explosive.

ByAnthony Almada, B.Sc., M. Sc.

The hallowed status that over-the-counter (OTC) drugs have enjoyed over the past several decades—ostensibly confidence-inspiring first line remedies for what ails many —is under siege. From pediatric to digestive meds, regulatory waves of resistance have been leveled. One “revelation” that continues to be “revealed” is that many of these OTC drugs lack substantial evidence of efficacy, as defined by randomized controlled trials (RCTs). Their approval came under the scrutiny of safety and NOT efficacy. Hmmm. Could a regulatory hole in the bulletproof vest adorning “drugs” create an opportunity for exploitation using natural bioactives?

One category of OTC drugs that is a bellwether of the U.S. population’s health status is digestive health, specifically antacids and laxatives. Examination of the drug monographs that exist for this class of drugs reveals a notable overlap with many “active” dietary ingredients found in both conventional foods/food processing and dietary supplements. Ingredients like calcium carbonate, metal hydroxides, sennosides (as a standardized plant extract), and methylcellulose abound. Think of your favorite brand and call the customer service line, then ask to receive a copy of ANY RCTs that have been conducted on their actual OTC antacid or laxative product offered for sale. Prepare to wait for the ozone layer to be rendered intact.

The advent of acid suppressant agents making the prescription (Rx) to OTC switch has created a new category of “antacids,” which work through biologically reducing the stomach’s production of acid rather than chemically through acid neutralization. This was pioneered by cimetidine (Tagamet). A most recent iteration has yielded a combination, “tag team” OTC that offers an acid suppressant and an acid neutralizer e.g. Pepcid Complete. Notably, this combination has been subjected to clinical trials. However, these acid suppressant agents that work through “silencing” a certain type of histamine receptor in the stomach lining, are all synthetic children, never before seen in Nature or likely in the universe. The au naturel path still has appeal.

What of these OTC drugs lacking substantial evidence of efficacy (and “FDA approved” evidence of only safety)? They are built solidly around a brand axis, and a regulatory advantage that enables them to expressly claim a symptom-reducing or condition-alleviating benefit or consumer experience. The “science” is almost all test tube or “pirated,” a rare example of one’s pioneering efforts fostering the growth of an industry segment of Herculean proportions, without violation of the federal law known as the Lanham Act (the Lanham Act allows a plaintiff to sue—in federal court—a defendant that is allegedly engaging in false attribution: marking a garment that is made in the Maldives as “Made in Italy” or attributing another entity’s scientific data to their own product, which is NOT chemically identical).

With brand power, financial resources, and distribution being the only competitive weapons this class of OTC drugs can access, the threat posed by an evidence-based, robustly branded, and craftily messaged (read strategic media campaign that secures editorial placement in high and top tier media vehicles) all-natural counterpart warrants a business case assessment.

Imagine crafting an antacid that enjoys one or more RCTs, ideally with BOTH a placebo and a positive control drug (pick your favorite OTC category leader), demonstrating superior acid indigestion/heartburn symptom relief (intelligent design would suggest using a crossover element, with each subject trying each treatment at three adequately spaced intervals … .) Dream up the composition to be completely devoid of labeled inactive ingredients that read like a chemical warfare recipe book, a great sensory (taste, scent) profile, and a certain “twist” that stays within the monograph for the active ingredient e.g. calcium carbonate, but also erects a barrier to duplication that is above sea level. Viral marketing, a vigorous sampling program, social network-linked community creation, and biomedical community-birthed dissemination of the data from the RCT could create enough buzz that BuzzMetrics or TMZ.com would tout you as a meteor in training.

The full ticket price for entry and
entertainment is surprisingly low:

Regulatory guidance in registering as an OTC drug: $2-4,000
Contract manufacturing facility that is OTC drug cGMP: $0 (just need to qualify one)
Pilot crossover RCT of merit with a placebo and active control group: Under $40,000
Aggressive strategic media campaign, linked to a medical meeting presentation: $10,000
Addition to top and bottom line, and to brand equity: Invaluable
Experience of hearing your brand name be cursed by big pharma: PRICELESSNW