By Craig Malisow
By Jeff Balke
By Angelica Leicht
By Jeff Balke
By Sean Pendergast
By Sean Pendergast
By Jeff Balke
By Ben DuBose
Houston entrepreneur Mark Wilson is on a crusade to let the world in on what he calls the Food and Drug Administration's "dirty little secret" -- namely, that so-called alcohol-free medicines aren't alcohol-free at all. He's invested his time, money and career in proving that two inventions of his are truly alcohol-free ways to deliver cold medications, mouthwash and cough medicine.
So far, the FDA isn't listening, and until it does, the drug manufacturers see no reason to change their ways.
Alcohol -- specifically, ethyl alcohol or ethanol -- has been a key ingredient in nonprescription drugs since before the temperance movement, when snake-oil salesmen went from dry town to dry town, peddling Lydia Pinkams and other "magic elixirs" with a wink and a nod. But ethanol has a practical purpose as well: It does what water cannot -- dissolve active ingredients and disperse them uniformly throughout a mixture that can be taken orally. The alcohol also dissolves the flavoring oils that make liquid medications taste better.
In 1990, Wilson was awarded two patents that would render obsolete the use of ethanol or any other liquid solvent in mouthwashes and drugs. The technology incorporates surface-acting agents, or surfactants. Explained in the simplest terms possible, these surfactants allow the blending of water and oil -- or in the case of drugs, water and active ingredients that are otherwise soluble only in alcohol. Wilson has, indeed, found a way for mouthwash, as well as just about any medication, to be carried about in powdered form and then mixed with water like Kool-Aid.
To say the invention is revolutionary is something of an understatement. Imagine never having to swallow another pill or foul-tasting concoction. Imagine encouraging your children to take their medicine by mixing it with a few ounces of water and telling them it's fruit punch.
"We can give you a drug and make it taste like fresh-squeezed orange juice," says Wilson, a 46-year-old former investment banker whose first patent was for a dry, nonalcoholic mouthwash flavored with essential oils from fruits and flowers. "A lot of people, especially the elderly, take multiple drugs -- big pills, nasty-tasting liquids. Why do they have to have a bad experience reinforced every day?"
And, Wilson asks, why should they risk their health by taking medication laced with alcohol? In the past decade, the hazards of consuming alcohol with nonprescription pain relievers such as acetaminophen have been well documented. The federal Food and Drug Administration has acknowledged as much by ordering drug manufacturers to reduce the level of ethanol in their over-the-counter, or OTC, products and by mandating stronger warning labels on ethanol-based medications.
So, it would seem that a so-called "drug-delivery system" that eschews alcohol is an idea whose time has come.
Not so, at least according to the FDA. The agency's "dirty little secret," says Wilson, is that drug manufacturers have replaced the ethanol in their OTC medications with another solvent, propylene glycol, a substance that was banned from use in cat foods by the FDA in May 1996.
Moreover, the FDA has apparently refused to acknowledge what is taught in any high school chemistry class: Propylene glycol is an alcohol. In what may come as a shock to parents who are careful about what nonprescription drugs they administer to their children, the agency has allowed OTC medications loaded with propylene glycol to be sold as "alcohol-free."
"It's a bait and switch, a canard," Wilson argues. "The FDA says that for something to be called sugar-free, it has to be sugar-free, and it is. But the drug manufacturers just took out one alcohol and replaced it with another."
Wilson readily acknowledges that he has a vested interest in the propylene glycol issue. As long as the FDA continues to allow its use, drug manufacturers will see no reason to switch to a nonalcoholic process, for which his company, Argyll Scientific, owns worldwide patents.
There are, however, questions about how much propylene glycol -- which is also prominent in foods and cosmetics, as well as being the central ingredient in aircraft deicing fluid -- can safely be consumed. Interestingly, for propylene glycol, unlike many FDA-approved food and drug additives, the agency has no scientific research that proves it safe.
"If you give me an ounce of ethylene glycol, or antifreeze, I will go into kidney failure," says Wayne Snodgrass, a pediatrician and toxicologist who is medical director of the Texas State Poison Center at the University of Texas Medical Branch in Galveston. "But the government hasn't put a number on how much propylene glycol, per body weight, per day, the general population can take without a problem. If that number exists, I'm not aware of it."
Meanwhile, the FDA has ignored studies that suggest propylene glycol may cause seizures, central nervous system depression and severe metabolic acidosis. Several of these studies have concluded that the substance should be re-examined for use as a drug solvent.
Yet, Ivy Kupec, an FDA spokesperson, says the agency's position is that propylene glycol is not an alcohol and that "there is no safety concern at this time that warrants any further review on its use as an inactive ingredient in OTC drugs."