A Bitter Pill

A Houston inventor says alcohol-free medicines aren't alcohol-free at all, and could harm you

Nothing in Wilson's past suggests that he was destined to become a consumer advocate, unless you count his days as a longhaired, somewhat radical student-body president at Arizona State University in the early '70s. He does, however, descend from a long bloodline of inventive, if somewhat whimsical, imaginations.

Wilson's grandfather, for instance, came to America from Scotland in 1901, and immediately set out on a seven-year quest to find a place where the landscape was rumored to resemble the Island of Skye. Wilson's father was an engineer and an inventor who decided he wanted to live in the Amazon, so he did. Wilson still has no idea why.

After college, Wilson started accumulating a working knowledge of basic chemistry that would come in handy later. He worked for Allied Chemical and as a field representative for Shell Oil, where he learned about surface-acting agents, the backbone of his new technology.

"The human body has hundreds of surfactants," he says. "Surfactants are things that your body makes. The human body does not make alcohol."

A compulsive scribbler, Wilson keeps a little black book for ideas and musings that come to mind during the course of a day. He had it with him in 1981, when, in a hotel room somewhere in Wyoming, he opened his suitcase to find that a bottle of mouthwash had broken, soaking his belongings in a tacky green liquid.

There, amid the sickly sweet odor and his stained boxer shorts, Wilson pondered with some annoyance the rhetorical question, "Why can't you just mix this crap like (powdered) Kool-Aid?"

The answer didn't come until several years later, but it has changed Wilson's life. In 1987, he chucked a promising career with Kidder, Peabody to put all his energy into developing a dry, nonalcoholic mouthwash. He was 36.

"I just started thinking about making a change, about what I could do," he says. "I thought, at my age, if I didn't go for the brass ring then, I never would."

It didn't take much time at the research library to discover that alcohol was everywhere -- in foods, drugs, cosmetics, even on kitchen countertops. The turning point was the day Wilson read an article about a four-year-old girl who was accidentally poisoned by mouthwash. At the time, many mouthwashes contained upward of 60 percent alcohol, and they all lacked childproof caps and warning labels. (Wilson was among a consortium of individuals, physicians and consumer groups that pushed the FDA to require child-resistant caps on mouthwashes in 1995.)

Angry, but imbued with a sudden sense of life-and-death purpose, Wilson spent the next three years at his kitchen table perfecting a nonalcoholic mouthwash. In 1988, he formed Spectrum Consumer Products and filed for his first patent. But even then, he understood there was more to what he'd learned than mouthwash.

"I knew I was going to pursue a drug-delivery company," he says. "I was prepared to bet the ranch from day one, from the day I quit my job. My sense was that we had a pretty good idea and we were going to make it."

But for the FDA, people around the world might now be taking their medicine mixed with water rather than propylene glycol. But, just as the agency was slow to respond to the problems caused by ethanol, the FDA seems reluctant to consider the possibility that propylene glycol might have adverse effects as well.

In fact, the FDA seems opposed to even revealing the substance's presence in medications. The agency has chosen to limit its definition of alcohol to ethanol, which allows drug manufacturers to freely use other alcohols, such as benzyl alcohol and propylene glycol, as solvents and preservatives. While benzyl alcohol pretty much describes itself, you'd almost have to be a chemist to know that propylene glycol is an alcohol. Moreover, thanks to the FDA's narrow definition, a cold medication could be comprised of 15 or 20 percent propylene glycol and still legally be labeled "alcohol-free."

Clouding the issue further, the FDA has classified propylene glycol as an inactive ingredient, which means manufacturers are currently not required to list it on product labels.

All this from an agency that, in 1995, stated that its goal was "to provide important and truthful labeling to consumers who may be interested in total avoidance of alcohol for personal, religious or medical reasons."

Says Andrew Barron: "The issue to me is not that propylene glycol is this horribly toxic chemical; it's not. But it should be labeled for what it is, and if you ask a chemist, propylene glycol is an alcohol. As for truth in advertising, saying something is alcohol-free is wrong if it's got propylene glycol in it."

While the substance is not horribly toxic --it's estimated to be about one-third as potent as ethanol -- studies have shown that propylene glycol can cause significant health problems, particularly because of how it reacts with some active ingredients.

How humans handle the substance hasn't been studied extensively, but when it has been studied, the results haven't been especially encouraging. In 1987, for example, an article in a British publication, Journal of Pharmaceutical Pharmacology, reported that propylene glycol may compromise the human immune system. In concentrations as small as 0.5 percent, researchers found that propylene glycol inhibits cytotoxicity, or the ability of red blood cells to defend themselves. The study concluded that drug manufacturers "would be wise to consider [propylene glycol's] potential immunosuppressive effects in the evaluation of drug formulations."

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