Comments Off on Big Pharma Won’t Embrace Drug Designed to Prevent Methamphetamine Production

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.

As flu season approaches, Westport and Acura are pushing to get their products in as many pharmacies as possible. Zephrex-D and Acura are now both available across the country. As of last month, Zephrex-D was being sold in more than 15,000 pharmacies including Walmart, Nexafed in at least 2,600 pharmacies.

But for customers who hope they can now buy pseudoephedrine products off the shelf and not have to show their ID — as is the case for cold and allergy medicines that don’t contain pseudoephedrine — that day has yet to come. Under the Federal Combat Methamphetamine Act of 2005, all pseudoephedrine has to be kept behind the counter. Purchasers must also show ID and are limited in how much they can buy per month and per year without a prescription.

Westport requested an exemption from this regulation on the grounds that its product’s built-in protections made it unlikely to be diverted, but the DEA denied this request.

In a written response to questions about the regulation of Zephrex-D, the DEA said it “welcomes the efforts of companies to develop products that deter the production of illicit drugs. While this particular company claims that their ‘drug delivery system provides a new and unconventional approach to combat drug misuse,’ this product can still be utilized to manufacture methamphetamine. As such, controls on this product cannot be relaxed as this product does not meet the exemption criteria under the Controlled Substances Act.”

Jason Grellner explains that under federal law if any pseudoephedrine can be extracted from a drug, no matter how little or how or impractical for the manufacture of methamphetamine, it must be regulated like any other pseudoephedrine product.

While Grellner doesn’t expect these new tamper-resistant products to be turning up at meth lab sites, he thinks the DEA’s caution is not a bad idea. Over the years, meth cooks have been nothing if not resourceful. The spread of the now dominant Shake ‘n’ Bake or one-pot method, which requires little pseudoephedrine, was itself an adaption to the sales limits imposed by the Combat Methamphetamine Act.

How the large pharmaceutical companies which dominate the more than half a billion dollar a year pseudoephedrine business will respond to these upstarts is not yet clear. Between them, Pfizer, Johnson & Johnson, and Merck produce 13 of the 15 name-brand pseudoephedrine products sold in the United States.

Johnson & Johnson’s McNeil Consumer Care said in a written statement, “we are concerned about methamphetamine abuse and continue to work with others in our industry to find ways to help law enforcement control the sale of pseudoephedrine for illicit purposes while also ensuring those who rely on our products can have access to them.”

The company said it has followed research into efforts to prevent the extraction of pseudoephdrine to make methamphetamine but was “aware of no technology that has proven effective in doing so,” noting that the DEA had yet to recognize a sufficiently conversion resistant technology.

The company noted its support for the National Precursor Log Exchange (NPLEx) — which alerts retailers and allows them refuse an illegal sale of pseudoephedrine. Pfizer, in a written statement, also emphasized its support for NPLEx as evidence of its commitment to prevent diversion of pseudoephedrine.

But there are signs that makers of regular pseudoephedrine products are concerned that these new tamper-resistant formulations may present a threat to their market share as pressure continues for the greater regulation of pseudoephedrine.

Half the states in the country have considered making pseudoephedrine available only by prescription as a means of preventing the spread of meth labs. In large part, through the lobbying efforts of the Consumer Healthcare Products Association (CHPA), which represents makers of over-the counter medicines, drug companies have been successful at stopping all but two states from passing these laws.

Most states which have had NPLEx in place for over a year, have continued to see rising numbers of meth labs. In light of this fact, and the defeat of pseudoephedrine prescription bills at the state level, cities and counties are passing their own laws. Over 70 cities and counties, mostly in Missouri, have adopted local ordinances making pseudoephedrine a prescription drug in the last four years.

In Franklin and Jefferson Counties in Missouri, the new prescription laws allow for the exemption of tamper-resistant pseudoephedrine products such as Nexafed and Zephrex-D. That has got the Consumer Healthcare Products Association crying foul. Speaking at a hearing on prescription legislation in West Virginia this week, CHPA’s Senior Director of State Governmental Affairs, Carlos Gutierrez argued against any exemptions saying they amounted to a “government-sponsored monopoly.”

Jason Grellner, who has lobbied extensively for pseudoephedrine prescription laws, supports these exemptions and battled with CHPA over this issue at the state level last year. “Why would the Missouri state legislative body not want to end meth labs and allow patient access, especially when the company that has come up with this idea is a Missouri company,” says Grellner.



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