he winter of 2006-2007 may be the worst cold and flu season in a hundred years, but not because colds and flu will be more frequent or more severe. The suffering and misery will be due to FDA regulations and lawmakers’ meddling that has caused manufacturers to replace safe and effective cold meds with safe but ineffective cold meds!

There is near universal agreement that phenylephrine (PE), the decongestant that has replaced pseudoephedrine (PSE) in most OTC cold remedies, is almost 100% ineffective at relieving nasal congestion. I say “near” universal agreement because drug companies that make the ineffective cold remedies stand as the lone voice of disagreement with university researchers; pharmacist organizations in the U.S., Canada, and Australia; the FDA’s own pulmonary advisory committee; and published findings in the Journal of Allergy and Clinical Immunology.

In 1976 the FDA deemed a 10 mg dose of phenylephrine to be “safe and effective” for relieving nasal congestion. Immediately upon approval, it was ignored. From 1976 until 2005 the ingredient was rarely used in OTC meds, because other ingredients worked much better.

What works: ephedrine. Ephedra is an herb that has been used for centuries as a nasal decongestant. Ephedrine, the active principle of ephedra, was first extracted from ephedra, then later synthesized in the lab as ephedrine HCl. Synthetic ephedrine was both cheap to produce and highly effective at relieving nasal congestion. It was the decongestant of choice until the late 1990s, when “back-alley chemists” found that it could be used to make methamphetamine. As meth production and use increased, the FDA banned the herb ephedra from health food stores. Most people don’t know that synthetic ephedrine HCl was not banned from OTC cold remedies, but most manufacturers switched their formulas anyway.

What works: pseudoephedrine. Drug makers quickly switched their OTC cold remedies from ephedrine to pseudoephedrine (“false ephedrine”), a close chemical relative. Although it took a higher dose of pseudoephedrine to achieve the same efficacy as ephedrine, the bottom line was that OTC products with pseudoephedrine worked just as well at relieving nasal congestion.

It wasn’t long before illegal meth producers found that they could make meth from pseudoephedrine, but by a longer and more dangerous process. Most people have heard news accounts of “meth labs” blowing up or starting a roaring fire that took out an entire apartment building. Those tragedies occurred because of the extra step necessary to first turn pseudoephedrine into ephedrine, before the actual meth production could even begin.

As a reaction to the escalating meth crisis, lawmakers did what lawmakers always do — they made laws. In this case, some local yokel lawmakers — whose successful political campaigns made them eminently qualified to evaluate the safety and efficacy of pharmaceutical substances and render medical decisions — passed laws to get cold remedies with pseudoephedrine off the shelf and behind pharmacists’ counters.

What doesn’t work: phenylephrine. Drug companies realized that most consumers don’t consider cold remedies equivalent to hand guns, and therefore wouldn’t put up with producing ID and being registered in some government database just to relieve the sniffles. So many manufacturers of OTC cold remedies switched their formula again — this time from pseudoephedrine to phenylephrine. It really didn’t matter that they rejected phenylephrine 30 years ago as being ineffective; when all the effective ingredients are banned or restricted, they have to put something in their product to keep it on the market, even if they know it doesn’t work!

The cheapest and most effective decongestants available were now being treated like street drugs, and for what reason? To prevent “kitchen meth labs” from flooding the market with cheap, home-grown meth?

Wal-Mart is not the source. The dirty little secret the government doesn’t want you to know is that most meth has never been made from cold remedies found on the shelves of your local Wal-Mart or Rite-Aid pharmacy. Sure, there were some biker gangs and dopers who cooked up batches of meth for personal use or to distribute to friends, but only a miniscule amount of meth was cooked up in kitchen meth labs. The meth epidemic is not home-grown — it was imported from Mexico!

Beginning in the 1980s, Mexican “superlabs” took the place of clandestine mom-and-pop labs. Each superlab can produce 10 lbs. of meth every 24 hours (1 oz. makes 120 “hits”). That’s 1500 times the amount a single user can make for himself. By last year (2005), superlabs in Mexico supplied 65% of the meth on American streets. Another 12% came from Mexican-run superlabs in the U.S., meaning that over 3/4 of the meth used in America comes from the Mexican drug cartels! And that doesn't even count the meth coming in from Columbia, Argentina, and Indonesia.

Six of the major Mexican drug cartels have been linked, by Mexican or U.S. authorities, to methamphetamine production and importation into the U.S. As strange as it may seem to clueless lawmakers in the U.S., the Mexican cartels’ superlabs did not get their ephedrine and pseudoephedrine from U.S. drug stores. In fact, they weren't getting it from Mexican drug stores or from manufactured cold remedies at all. They were buying the raw ingredients from the chemical wholesalers and manufacturers in India, Germany, and China that supplied those same ingredients to major drug companies.

Always one step behind. U.S. officials discovered the Mexican cartels’ supply line when one drug cartel, the Amezcua brothers, inadvertently shipped several tons of ephedrine through the Dallas/Fort Worth airport. Until then, U.S. authorities were not aware of the scope of the problem. After the FDA banned ephedra, the U.S. DEA pressured international ephedrine manufacturers to stop mass production of the drug, which they did. (Nothing like threatening to cut off U.S. purchases of all their products to make them toe the line.) The Dallas/Fort Worth bust also alerted authorities on both sides of the border that Mexican superlabs were major source of meth in the U.S.

As soon as ephedrine manufacture stopped, pseudoephedrine purchases skyrocketed as drug companies switched the formulas of their OTC cold remedies. Without missing a beat, Mexican drug cartels also switched their meth production from ephedrine to pseudoephedrine. But since the spotlight was now on drug labs in Mexico, Mexican-run superlabs started scattering to other parts of the world.

Overnight, pseudoephedrine imports to Canada went from 30 tons per year to over 100 tons per year. Argentina’s annual import of bulk pseudoephedrine doubled, Columbia’s tripled, and Indonesia’s rose tenfold.

In an attempt to cut off the sale of bulk pseudoephedrine to meth labs, various governments began restricting sales to licensed laboratories. Some licensed Canadian labs began pressing pure pseudoephedrine into pill form, and shipping them by the pallet-load into the U.S. (Most legitimate cold remedies are not a pure decongestant, but a combination of a decongestant, an antihistamine, an expectorant, etc.) Truckloads of pseudoephedrine, either as bulk powder or pressed into pills, are routinely “stolen” from licensed pharmaceutical companies in Mexico. Each truckload contains 3 tons of pseudoephedrine, enough to make 18 million “hits” of meth. And while authorities in Mexico scrutinize importers, wholesalers, and manufacturers, they have little or no oversight of retail drug stores. So cartel members simply opened “drug stores” in storefronts and back alleys that sell only one product — pseudoephedrine pills. Their business is booming, with some selling 50 or 100 cases of pills containing the pure decongestant to each customer.

The U.S. consumer is punished. Almost none of the pseudoephedrine that makes its way into methamphetamine production comes from retail pharmacies in the U.S. And yet, in U.S. communities large and small, lawmakers are responding to pressure from the misguided public and special-interest groups to “do something” about the meth epidemic sweeping the nation. When pressured to “do something,” the only thing lawmakers can possibly “do” is make laws. (When the only tool you have is a hammer, everything looks like a nail!) Since lawmakers either 1) don’t have a clue about the world-wide source of the epidemic or 2) lack the backbone to stand up to the special-interest groups that don’t have a clue, they make laws to regulate people in their miniscule part of the world.

Lacking the authority to ban pseudoephedrine outright, local yokel lawmakers control their constituents’ behavior by constructing barriers to its sale — limiting quantities, registering purchasers, and so forth. And while each meth superlab continues to crank out nearly 20,000 hits each day, local lawmakers proudly claim they’re “fighting the meth epidemic” by keeping you and me from effectively fighting a cold.

What’s a consumer to do? As I said above, there is near universal agreement that phenylephrine is almost 100% ineffective at relieving nasal congestion. Fortunately, effective decongestants can still be obtained. OTC medications that contain ephedrine HCl are still available, but because they’re difficult to find locally, you’ll probably have to buy them on the Internet. OTC medications that contain pseudoephedrine (HCl, sulfate, tannate, etc.) are still available at your local pharmacy. In most jurisdictions they’re no longer available “over the counter,” but instead are “behind the counter,” meaning that you must ask for them. If you’re okay with forfeiting your privacy, you can buy them anywhere; otherwise, opt to buy them in jurisdictions that limit quantities but do not require you to register like a sex offender. Or buy them on the Internet, where most sellers will limit the quantity but not require you to “produce your papers.”

And one more thing... Don’t be part of the hand-wringing public that demands lawmakers “do something” about problems that are impossible to fix through legislation. After several generations of an ever-escalating “war on drugs,” study after study has found that more laws and more cops do not stop or even decrease drug abuse in the long term. In fact, the only proven method of permanently reducing drug abuse is through treatment programs and rehabilitation.

UPDATE! Be sure to read my followup article, written for the 2007-2008 cold season.

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