A neuroscientist and some grape skins vs. the pharmaceutical industry.

To prescribe or not to prescribe

In late 2017, NPR aired a two-minute segment on the science behind our new pain cream. It became such a popular segment that it left our customers hungry for more detail. So by popular demand and for the first time ever, here’s part 6 of an 11-part story on the discovery and creation of Ted’s Pain Cream. To read from the beginning, click here.

Now our subversive professor heroes had a tough decision to make: how to take it to market. They could pursue clinical trials and hope to get their cream approved for use as a prescription drug, which as data-driven scientists was their preference. That’s how you prove efficacy to the skeptics. But after trying to find financial backing, they realized there was an unfortunate business flaw in that approach. Investor types were quick to point out that even though resveratrol has never been used to treat pain, it’s already on the market as a supplement, which means it would not have the same kind of legal protection that a truly new drug would. Even if it ended up being the most effective prescription pain treatment of all time, it would be tough for any single company to own it for long. Making it far, far less attractive for investors.

So Ted and Greg had to consider other options. Interestingly, the same attribute that made resveratrol less investor-friendly for clinical trials also opened another door entirely. Since resveratrol is already on the natural market, it can be used in any herbal product. If they listed resveratrol as an herbal “other ingredient” and not as an active ingredient, they could put it in any product they wanted. The question was, “Should they?”

Opening that door had some obvious downsides. Some advisors cautioned them against it altogether. Without clinical trials, they said, you put your product on the same shelves as snake oils, you risk losing credibility with the scientific establishment, and make yourselves, in the eyes of many, no different than the homeopathy peddlers of the world.

A crisis in need of more solutions

So they deliberated. They put it out of their minds. They continued teaching their classes and running their pain lab. Then they deliberated some more. During those deliberations, it slowly dawned on them how much time they were spending in the lab making cream for the people who kept asking for more. “We very literally couldn’t keep up with demand,” laughs Greg. In the end, after much discussion, they decided they had to risk the backlash and go full steam into plan B.

 

If resveratrol is so great, why is it so far down the ingredient list?

Find out why

Ted explains their thinking like this: “The more feedback we got from our experiment, the more we realized that for a large percentage of testers, this stuff really, really worked. Our preclinical studies strongly supported what we were seeing, for this group, resveratrol clearly had a strong effect on pain.” They knew the risks, and they were willing to go for it. “We still get challenged on that decision today,” admits Ted. “But for us, the bottom line continues to be, we’re in an opioid crisis, here is something new that is helping people now. Had we gone the clinical-trial-first road, we’d still be waiting on the next phase. If this can help one person avoid opiates, avoid addiction, avoid overdose, then in our book, it’s worth the occasional criticism.”

It was also about that time they realized they may be able to carve out a middle road, one that could allow them to avoid the homeopathy aisle entirely, and sport an FDA approved label in the process. All they had to do was add another ingredient, one already approved by the FDA for pain relief. The question was, which one? They quickly stumbled on the answer: wintergreen oil. Also known as methyl salicylate. Why? Well, like resveratrol, it’s also natural and has also been in use by humans for thousands of years. But more importantly, its mechanism of action is well understood. And given their understanding of how resveratrol seems to work, Ted and Greg had sound neuroscience-backed reasons for believing that it would work very well in concert with resveratrol, helping to magnify its effects.

 

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