For millions of Americans, pseudoephedrine provides relief from the discomfort of congestion when pollen counts soar or the flu virus spreads. But thousands of others prize the drug for its role in the relief of other symptoms — the decongestant is the one ingredient found at virtually all meth labs in the United States. Easy access to pseudeophedrine and refinements in meth production have put the drug’s manufacture in the hands of addicts, and led to a 63 percent increase in the number of meth labs over the past five years.
These highly toxic and volatile labs are turning up everywhere from homes, to motel rooms, to cars and state parks. They have left a trail of destruction in their wake, overwhelming law enforcement agencies that are left with the costly and hazardous cleanup of these labs. In some counties, hospital burn units and jails are filling up with meth cooks, while across the country, thousands of children have been pulled out of homes were meth is made.
For over 25 years, law enforcement and the large pharmaceutical companies that market pseudoephedrine have battled over how to regulate the drug. Narcotics enforcement organizations have fought for greater restrictions on pseudoephedrine, which the pharmaceutical industry has opposed, arguing that this punishes law-abiding consumers while failing to foil meth cooks.
But now, two small Midwestern pharmaceutical companies have come up with a product they say promises to solve this problem.
Westport Pharmaceutical’s Zephrex-D and Acura Pharmaceutical’s Nexafed are both formulated to allow the normal release of pseudoephedrine when the product is used as directed, but make it next to impossible for meth cooks to extract it and turn it into methamphetamine.
The new products were launched last December; Zephrex-D in independent and chain pharmacies in Missouri, while Acura focused its launch in the Midwest and Southeast where meth labs are concentrated.
The genesis of Zephrex-D owes something to the location of Westport’s headquarters in a suburb of St. Louis, Missouri. Several years ago, the company was working on a formula to prevent prescription painkillers from being crushed and either smoked, snorted or injected to get high. The recreational use of these drugs has become an epidemic according to the Centers for Disease Control, and every year far more Americans die from prescription opioid overdoses than from all illegal drugs combined.
Westport’s Vice President and General Manager, Paul Hemings, says one day, the company’s patent attorney suggested they take the tamper-proof technology they were developing for opioids and apply it to pseudoephedrine. “Where we are is meth central within the United States and Missouri,” says Hemings. Last year, Missouri reported nearly 2000 meth labs and the state consistently ranks first or second for the number of meth labs in the country.
“She said, you know what, you’ve got a technology here that could do a lot of good and take care of a problem right in our backyard,” says Hemings, “and the idea was born out of that.”
Switching to pseudoephedrine also allowed Westport to get its product to market faster because of the longer federal approval process for prescription drugs. Acura, for its part, had already marketed a product to prevent tampering with an immediate release oxycodone product. The prescription painkiller is licensed to Pfizer and marketed as Oxecta.
“That similar technology was applied to pseudoephedrine to try to make it very, very difficult to make into meth,” explains Acura’s Vice President of marketing Brad Rivet, who notes that it took four to five years of research and development.
Few people in America are more knowledgeable about the problem of meth labs than detective sergeant Jason Grellner. The commander of the Franklin County Narcotics Unit came upon his first lab in 1997, and since then, Grellner, who until last year directed Missouri’s Narcotics Officers’ Association, estimates he’s participated in or supervised the cleanup of over 2,000 meth labs. He was among several senior narcotics enforcement officers that Acura and Westport presented their products to at a meeting in California three years ago.
Grellner was highly skeptical. “We have been told by Big Pharma since the late nineties that their scientists had looked at this problem and could find no way to chemically or physically lock the pseudoephedrine in their product so that it would be bioavailable, but not useful in manufacturing methamphetamine,” says Grellner. “So it was hard to believe companies as small as Acura and Westport had come up with a solution.”
Westport’s headquarters in Maryland Heights are adjacent to Franklin County. The company gave Grellner a challenge; try to extract pseudoephedrine from our product and turn it into methamphetamine.
Grellner agreed. To be safe, he went over to the local fire department training grounds, suited up in protective gear, and had firemen on standby. First, Grellner used a regular pseudoephedrine product and was able to make meth easily. Then he tried using Zephrex-D. “Right off the bat, I noticed you can’t grind it,” says Grellner. “It clumps together and holds and the other thing was that it floated in our one-pot bottle. No matter what solvent we used, it wouldn’t mix. It would not do what other pseudoephedrine does.” Westport offers Zephrex-D free of charge to any police department that wants to test its product.
The company says in tests by an independent lab, between 0.5 and less 2 percent of the pseudoephedrine was extracted and converted into meth. At these yields, cooking meth becomes uneconomical, says Grellner. He notes that no boxes of Zephrex-D have been found at meth lab sites in Missouri since the product was launched.
Making these products useless to meth cooks is only half the goal, however. “It’s quite a fine balance that you have to strike,” says Brad Rivet of Acura. “First and foremost we have to make sure we’ve got a product that is absolutely as effective as the consumers expect, and secondarily try to make it as meth-resistant as possible.”
The extent to which the therapeutic ingredients of a drug are released when it is used as directed is called “bioavailability.” A study of Acura’s pseudoephedrine product, Nexafed, published in the American Journal of Drug and Alcohol Abuse found its effectiveness as a decongestant was comparable to Sudafed. Westport’s Paul Hemings says independent bioavailability tests have found that well over 90 percent of the pseudoephedrine contained in Zephrex-D is released when consumed.
This is the first in a two-part series. Read part two here.