(CBS NEWS) -- In 2006, President George W. Bush signed into law abanonthe over-the-counter sale of Sudafed and other medications that containthe decongestant pseudoephedrine. The law was designed to make itharder for drug dealers to use the drug, which is effective in fightingnasal congestion, as the basis for manufacturing crystal meth - adevastating and highly-addictive stimulant that the National Institutesof Health reports nearly 5 percent of Americans over age 12 have used intheir lifetime.
The law made it harder for meth cooksto get their hands on pseudoephedrine - it mandated that an individualpresent an identification to purchase Sudafed and similar products andlimited how much they could buy each month - but it did not stop them.Indeed, the legislation gave rise to a practice known as "smurfing," inwhich multiple individuals purchase as many pseudoephedrine-basedproducts as they can each month and then sell them to meth cooks.
As lawmakers grappled with the problem, a pair of pharmaceuticalscompanies were developing what it hoped would be a better solution.Their approach was grounded in this question: What if instead of makingit harder for drug dealers to get their hands on pseudoephedrine-baseddrugs, you make it harder, or even impossible, for them to convert thosedrugs into methamphetamine?
That's the concept behindAcura Pharmaceuticals' Nexafed and Westport Pharmaceuticals' Zephrex-D,both of which are designed to offer all of the benefits of Sudafed whilealso disrupting efforts to convert pseudoephedrine into meth.
Theproducts are not a panacea: The DEA estimated last year that meth fromMexico accounts for 80 percent of the meth supply in the United States.While Mexico has outlawed pseudoephedrine, cartels there have turned to achemically-intensive production method to produce crystal meth on alarge scale.
What the new formulations could do, however, is reduce the negative impact of small meth labs in American communities.
TheMexican meth-production process is "not easily replicable" by asmall-scale American meth producer, notes Detective Sgt. Jason "Jake"Grellner of the Franklin County (Missouri) Narcotics Task Force, aVicePresident of the National Narcotic Officers Associationand an expert onmethamphetamine. "It's time intensive, it's chemical intensive."
Brad Rivet, vice president of marketing at Acura Pharmaceuticals,said that if Nexafed can help keep high-school students from beingpulled into "smurfing" and the meth industry as a whole, the productwill have an important impact. "The burns and explosions and all of theproblems associated with these one-pot meth labs are just a scourge oncommunities," he said.
Nexafed has become available in1,400 pharmacies across the country since it was put on the market sevenmonths ago, according to the company, with the highest concentration inhigh-meth states like Missouri, Kentucky, Tennessee, Georgia andFlorida. (The company estimates that there are 65,000 pharmacies in theUnited States, which means that the product is in roughly 2.2 percent ofthem overall.) In West Virginia, the Fruth Pharmacy chain is in theprocess of removing other pseudoephedrine-based products in favor ofNexafed.
"It is somewhat of a risky move by us as aretailer considering other large chains such as CVS, Walgreens, RiteAid, and Wal Mart continue to stock the standard formulations," saidCraig Kimble, Director of Pharmacy and Clinical Services at Fruth, in anemail. But, he added, "[w]e think it is the right thing to do for ourcommunities and to aid law enforcement."
The version ofNexafed now available can still be used to make meth, though the yieldis far smaller than what a meth cook can get from Sudafed and similarproducts. Two weeks ago, the companyannouncedanimproved formulation that it said initial testing showed could not beused to make meth at all. The current version of Nexafed has alreadygone through FDA-level bioequivalence testing to demonstrate that it isjust as effective as Sudafed, though the new version has yet to besubmitted for such testing. The company hopes to bring it to market bythe end of the year.
Zephrex-D, meanwhile, is on storeshelves in the Saint Louis area, including at some major chains like CVSand Walgreens. In May,Westport Pharmaceuticalsannouncedthatindependent testing had found that meth makers would have to spend $450on Zephrex-D to get enoughpseudoephedrineto convert it into one doseof meth, which sells on the street for about $30.
Thescience behind how all this works is a little complicated, but thesimple explanation is this: When the tablets are dissolved, they turninto a thick gel or gummy-like substance that effectively traps thepseudoephedrine, making it difficult or impossible to isolate it formeth production.
The new products will only be effective in fighting meth production,of course, if they lead to the reduction or disappearance of thetraditional formulations from pharmacy shelves. There are two ways thiscould happen: one, Nexafed and Zephrex-D replace those products, or two,the new technology is integrated into them.
The latterappears more likely, in no small part because existing pseudoephedrineproducts generate hundreds of millions of dollars in sales each year.Pfizer, which owned Sudafed until 2006, previously spent $15 to $25million in an effort to make pseudoephedrine extraction impossiblebefore it gave up. "The tough lesson that we learned is, as fast as wecould do things, following all of the rules -- the FDA guidelines andthings that make drugs appropriately safe -- well, the meth cooks couldmove a lot more quickly," Pfizer executive Steven Robinstold Frontlinein2005. "So every time we would try to create an enhancement that wouldblock them, they changed their process so they could extract it."
AcuraCEO Bob Jones acknowledged that meth cooks will do everything they canto find a way to extract pseudoephedrine if Nexafed technology takeshold. He said the company monitors websites where meth cooks publishworkarounds for efforts to disrupt extractions.
"Youraverage meth cook probably is not trying to figure this out - they'resimply following a recipe," he said. "But the true innovators in thisindustry are some very smart chemists. It wouldn't be a surprise if theywere already working on this."
Rivet, the VP ofmarketing said his company is "in dialogue" with "several" largepharmaceutical companies about Nexafed, though the conversations appearto be preliminary. According to Jones, those companies are taking a"wait and see" approach to see how meth cooks respond to the product.
Ifthe new formulation survives scrutiny, he said, "I think they're goingto be forced to either add similar technologies to their products orthink about removing their product from the market." (Pfizer has alreadylicensed another Acura product, Oxecta, which is being marketed as anabuse-deterrent alternative to OxyContin.) Representatives for Johnsonand Johnson, the parent of the company that manufactures Sudafed, didnot respond to requests for comment.
Grellner, an advocate for requiring a prescription forpseudoephedrine in its current form, sees the new products aspotentially bringing the era of homemade meth labs to an end.
"Pseudophedrineis the key to ending the meth lab problem here in the United States,"he said. "It is not the key to ending the methamphetamine problem.That's a problem of addiction."