Let's say you're a scientist, and you've invented what you think is a useful treatment for pain. But you have a problem. You don't have the money to go through the regulatory approval process. Should you try to sell it to consumers anyway, and run the risk of being accused of selling snake-oil?
That's the dilemma Ted Price and his colleagues faced. Price is a researcher at the University of Texas, Dallas. His work focuses on solving a vexing question about pain: why does pain persist even after injuries heal?
Price experienced this himself, from basketball injuries that hurt long after the initial swelling and inflammation went away.
To find the answer, Price and his colleagues focused on chemical signals sent inside nerve cells. They found that a lot of chemical pathways used by these signals were activated inside nerves immediately after an injury, but just two pathways remained activated when pain persisted.
"We had this really great idea a long time ago, that was 2009," says Price. "We would inhibit one of these pathways, and that would solve pain."
There was one small problem with this really great idea. "We were completely wrong," he says. Shutting down just one pathway had no effect on pain.
But they eventually found a compound that seemed to shut down both pathways, acting like a kind of fire extinguisher to the persistent pain signals. It was a natural compound called resveratrol.
You may have heard of resveratrol. It's a compound in red wine that was supposed to have all sorts of healthful properties. Wine, however, doesn't have enough resveratrol to provide any real benefits. But Price and his colleagues were able to show that using concentrated resveratrol in a cream applied to the skin relieved pain in animals.
When something appears to work in animals, the next step is typically a clinical trial to test it in people. "The reason we couldn't do that is pretty simple," Price says. Clinical trials are expensive, and "we couldn't raise the money to do it."
Under U.S. Food and Drug Administration rules, Price didn't need to do a clinical trial in order to sell the cream, as long as he didn't make any specific claims that resveratrol would ease pain.
"We just eventually decided that it was better to get this out there than to continue to try to raise the money, and run the risk of never getting it into the hands of people that it can help," he says.
Price decided to manufacture his cream and sell it on the Internet, with no formal proof that it works. It costs $19 for a 3-ounce tube.
So, was that the right decision?
Veteran pain researcher Jon Levine of the University of California, San Francisco isn't bothered by the fact that there's no clinical trial data showing the cream works.
"If something is not harmful — and I think the chance that this could be harmful is incredibly small — and if this is not a financial burden for somebody, and they wanted to try it, then I would certainly see no reason not to," says Levine. "And there is certainly some scientific reason to think that it might help."
For his part, Ted Price would still like to do a clinical trial to prove his pain cream works. He'd be delighted to hear from a clinician who had the inclination and the money to collaborate with Price on such a trial. Until then, consumers are on their own to decide whether Price's cream is right for them.