Walgreens pharmacy manager Sarah Freedman stands in her store in Washington, Tuesday, June 26, 2012.
(CBS NEWS) -- In 2006, President George W. Bush signed into law a ban on
the over-the-counter sale of Sudafed and other medications that contain
the decongestant pseudoephedrine. The law was designed to make it
harder for drug dealers to use the drug, which is effective in fighting
nasal congestion, as the basis for manufacturing crystal meth - a
devastating and highly-addictive stimulant that the National Institutes
of Health reports nearly 5 percent of Americans over age 12 have used in
The law made it harder for meth cooks
to get their hands on pseudoephedrine - it mandated that an individual
present an identification to purchase Sudafed and similar products and
limited how much they could buy each month - but it did not stop them.
Indeed, the legislation gave rise to a practice known as "smurfing," in
which multiple individuals purchase as many pseudoephedrine-based
products as they can each month and then sell them to meth cooks.
As lawmakers grappled with the problem, a pair of pharmaceuticals
companies were developing what it hoped would be a better solution.
Their approach was grounded in this question: What if instead of making
it harder for drug dealers to get their hands on pseudoephedrine-based
drugs, you make it harder, or even impossible, for them to convert those
drugs into methamphetamine?
That's the concept behind
Acura Pharmaceuticals' Nexafed and Westport Pharmaceuticals' Zephrex-D,
both of which are designed to offer all of the benefits of Sudafed while
also disrupting efforts to convert pseudoephedrine into meth.
products are not a panacea: The DEA estimated last year that meth from
Mexico accounts for 80 percent of the meth supply in the United States.
While Mexico has outlawed pseudoephedrine, cartels there have turned to a
chemically-intensive production method to produce crystal meth on a
What the new formulations could do, however, is reduce the negative impact of small meth labs in American communities.
Mexican meth-production process is "not easily replicable" by a
small-scale American meth producer, notes Detective Sgt. Jason "Jake"
Grellner of the Franklin County (Missouri) Narcotics Task Force, a Vice
President of the National Narcotic Officers Association and an expert on
methamphetamine. "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 being
pulled into "smurfing" and the meth industry as a whole, the product
will have an important impact. "The burns and explosions and all of the
problems associated with these one-pot meth labs are just a scourge on
communities," he said.
Nexafed has become available in
1,400 pharmacies across the country since it was put on the market seven
months ago, according to the company, with the highest concentration in
high-meth states like Missouri, Kentucky, Tennessee, Georgia and
Florida. (The company estimates that there are 65,000 pharmacies in the
United States, which means that the product is in roughly 2.2 percent of
them overall.) In West Virginia, the Fruth Pharmacy chain is in the
process of removing other pseudoephedrine-based products in favor of
"It is somewhat of a risky move by us as a
retailer considering other large chains such as CVS, Walgreens, Rite
Aid, and Wal Mart continue to stock the standard formulations," said
Craig Kimble, Director of Pharmacy and Clinical Services at Fruth, in an
email. But, he added, "[w]e think it is the right thing to do for our
communities and to aid law enforcement."
The version of
Nexafed now available can still be used to make meth, though the yield
is far smaller than what a meth cook can get from Sudafed and similar
products. Two weeks ago, the company announced an
improved formulation that it said initial testing showed could not be
used to make meth at all. The current version of Nexafed has already
gone through FDA-level bioequivalence testing to demonstrate that it is
just as effective as Sudafed, though the new version has yet to be
submitted for such testing. The company hopes to bring it to market by
the end of the year.
Zephrex-D, meanwhile, is on store
shelves in the Saint Louis area, including at some major chains like CVS
and Walgreens. In May, Westport Pharmaceuticals announced that
independent testing had found that meth makers would have to spend $450
on Zephrex-D to get enough pseudoephedrine to convert it into one dose
of meth, which sells on the street for about $30.
science behind how all this works is a little complicated, but the
simple explanation is this: When the tablets are dissolved, they turn
into a thick gel or gummy-like substance that effectively traps the
pseudoephedrine, making it difficult or impossible to isolate it for
The new products will only be effective in fighting meth production,
of course, if they lead to the reduction or disappearance of the
traditional formulations from pharmacy shelves. There are two ways this
could happen: one, Nexafed and Zephrex-D replace those products, or two,
the new technology is integrated into them.
appears more likely, in no small part because existing pseudoephedrine
products generate hundreds of millions of dollars in sales each year.
Pfizer, which owned Sudafed until 2006, previously spent $15 to $25
million in an effort to make pseudoephedrine extraction impossible
before it gave up. "The tough lesson that we learned is, as fast as we
could do things, following all of the rules -- the FDA guidelines and
things that make drugs appropriately safe -- well, the meth cooks could
move a lot more quickly," Pfizer executive Steven Robins told Frontline in
2005. "So every time we would try to create an enhancement that would
block them, they changed their process so they could extract it."
CEO Bob Jones acknowledged that meth cooks will do everything they can
to find a way to extract pseudoephedrine if Nexafed technology takes
hold. He said the company monitors websites where meth cooks publish
workarounds for efforts to disrupt extractions.
average meth cook probably is not trying to figure this out - they're
simply following a recipe," he said. "But the true innovators in this
industry are some very smart chemists. It wouldn't be a surprise if they
were already working on this."
Rivet, the VP of
marketing said his company is "in dialogue" with "several" large
pharmaceutical companies about Nexafed, though the conversations appear
to be preliminary. According to Jones, those companies are taking a
"wait and see" approach to see how meth cooks respond to the product.
the new formulation survives scrutiny, he said, "I think they're going
to be forced to either add similar technologies to their products or
think about removing their product from the market." (Pfizer has already
licensed another Acura product, Oxecta, which is being marketed as an
abuse-deterrent alternative to OxyContin.) Representatives for Johnson
and Johnson, the parent of the company that manufactures Sudafed, did
not respond to requests for comment.
Grellner, an advocate for requiring a prescription for
pseudoephedrine in its current form, sees the new products as
potentially bringing the era of homemade meth labs to an end.
is 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."