Shocking DEA Position On Meth-Resistant Pseudoephedrine

Do you remember all the buzz last year around this new generation of meth-deterring pseudoephedrine, based on a new formulation that makes it impossible to convert into meth? If not, just have a look here and there.

Best News For Ephedrine So Far

For us these promising new products were the best news for ephedrine since years because it could give full access to ephedrine over the counter and at the same time prevent local meth production: a real win-win for honest patients who don’t need a doctor’s prescription and for drug agents who don’t have to clean dangerous meth labs.

The condition for this win-win is to pass state laws that require a doctor’s prescription with an exemption for pseudoephedrine that cannot be converted into meth. In fact these new products Zephrex-D and Nexafed make only sense if the companies get exemption to the federal Combat Methamphetamine Epidemic Act of 2005 (CMEA) that keeps ephedrine behind the counter.

Considering all consequences we were quite sure that officials would take their time before giving a positive answer to the exemption request ;)

Political Tricks

– In March 2012 already, Westport applied for an exemption to CMEA

– In December 2012 the DEA informed them that the exemption was denied.

– In May 2013 six Missouri congressmen urged the DEA to reconsider their position and to allow “unrestricted access” to Zephrex-D, in other words an OTC status, calling the new meth-resistant products “a huge advancement in our fight against this scourge.” It was signed by five Republican Reps. and one Democratic Rep.

– Boom! In a letter dated May 6, James Shroba, the DEA’s acting special agent in charge of the St. Louis office, notified Westport Pharmaceuticals in these terms: claims that Zephrex-D is meth-resistant are wrong since DEA chemists were able to product meth from it.

What about that? Seriously, how could expect such position? And how to explain it?

A US pharmaceutical company is coming with a potential solution to the epidemic meth problem fought by law since decades and what do they get in return? A slap in the face.

Emilie Dolan, director of marketing and media relations for Westport Pharmaceuticals, politely said that the DEA’s message was unexpected and that they have had a good relationship with the agency, working together to try and come up with a solution.

Paul Hemings, vice president at Westport, reacted in a less political way :) saying that the DEA’s letter came as an “absolute shock”.

Our Point of View

This dispute shoes what powerful political stakes are in play here. Remember what we like to say: “politicians care about power, companies care about money and doctors care about people”. With exceptions of course but true most of the time.

– Drug agents want to get rid of cleaning meth labs because it’s dangerous for them. They push prescrition laws for ephedrine (hard lobbying) because they think it’s the best way to achieve their goal. Now the good question: would they stick to their point if it was proven that a prescription law would not decrease meth abuse (it will come from Mexico) and that it would also put a burden on law abiding citizens? In other words, how much do they value their own interest when conflicting with other people’s interest?

– Wesport Pharmaceuticals are confident: recent independent laboratory tests of Zephrex-D demonstrate that meth cannot be produced from Zephrex-D using the famous One Pot method and extraction/conversion manufacturing methods convert less than 0.5% of the pseudoephedrine into meth. It means that instead of 11 tablets of standard pseudoephedrine (30mg) needed to manufacture one dose of meth, you would need almost 1800 pills of Zephrex-D. The cost would be $450 instead of $2.30! Meth cooks are not that stupid ;)  The more advanced techniques achieve a less than 2% production of meth out of Zephrex-D but in that case this small amount of meth produced is still locked in excipients that cannot be smoked, injected or snorted. So what?

Again, what could explain this DEA position? It’s just guess work from our side but for us it has more to do with the lobbying still done by law enforcement for prescription laws for ephedrine, and also with the competitive advantage given to Wesport that probably has pushed other pharmaceutical companies to react.  Somebody in our group even mentioned that maybe the DEA did not like the fact that Wesport was communicating so much on crime protection (see below a screenshot from zephrex-d.com) and also anticipating on the decision about exemption.

DEA denies Zephrex ad slogan as meth-resistant ephedrine

Anyway. Here is the DEA Letter to Westport Pharmaceuticals

Conclusion

Read all these official messages between the lines, with one focus: what is their primary goal here and what is the driving force? And then make your own mind.

Mike Budd.

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