The Future of Home-Brewed Medicines and How Researchers Are Pushing Past Original Elixirs

By Karla Lant | May 19, 2015 01:28 PM EDT

Humans have always sought ways to alter their consciousness. Throughout our history as a species we have created and improved techniques for growing, brewing, processing, and, now, synthesizing mind-altering substances. Now, researchers from Concordia University in Quebec and University of California, Berkeley have detailed the steps needed to morphine from scratch from a simple yeast fungus.

The prize that has prompted this research isn't actually morphine, but one of its precursors, an alkaloid called (S)-reticuline. For years researchers have been using poppy DNA with yeast with the goal of turning sugar into precursor substances. (S)-reticuline can produce around 2,500 other compounds-and many can be used to formulate antibiotics, cancer medications, and antispasmodic drugs.

While this is an important accomplishment, the researchers are concerned about the implications of the discovery. This is especially true now that they have succeeded in completing the process in a matter of weeks. Berkeley's John Dueber commented, "We were like, 'Oh wow, this is really happening'. And I don't think people are ready for it yet."

Pharma companies have consistently sought painkillers which could be used with predictable outcomes, and without as much risk of paralysis or addiction. Existing streams of opium come from Australia, Turkey, and India where licensed farmers grow poppies legally; this is all governed by the International Narcotics Control Board. Growers have considerable political power locally.

Pharmaceutical companies already have lab-synthesized opiates like loperamide (Imodium), an antidiarrheal opiate, and Fentanyl, a potent painkiller. Smugglers and dealers of heroin, however, are more reliant on raw materials and local political conditions.

There is no legal provision for this kind of process, via the United States Drug Enforcement Administration (DEA) or from any other source. The DEA handles controlled substances, but not organisms that can produce them. Federal policy governing dual-use research, which involves scientific discoveries that could be exploited, only applies to pathogens and viruses. There is, therefore, a regulatory vacuum.

This led Dueber and Concordia's Vincent Martin to consult with Kenneth Oye, the director of M.I.T.'s Program on Emerging Technologies, and Tania Bubela, a bioethicist. Political scientist Chappell Lawson was also working on this issue. Oye, Bubela, and Lawson have published a comment in Nature this week outlining their concerns.

According to the comment, the risk here is that illicit opiate production could be attainable for many people at a very small scale. Whereas the existing legal opium-poppy industry is well-managed, this development may well make this kind of regulation impossible. And cartels may be outproduced by many smaller shops, resulting in violence and chaos.

"Eventually, this will happen," Duebner says. "I just think we want to be prepared for that eventuality."

So the issue becomes whether to regulate synthetic biology, and in fact, how to do that at all.

Some with expertise in biotechnology disagree about the risk presented by this breakthrough. They believe that the fermentation process is fragile enough to hamper meaningful commercial production by amateurs. Furthermore, even when restrictions are placed on raw ingredients, the effect is not always what is hoped for; witness the various attempts to prevent the sale of precursor chemicals that can be used in the manufacture of methamphetamine.

FBI Supervisory Special Agent Edward You has been watching the progress of these strains of yeast since 2009. "We've learned that the top-down approach doesn't work," says You. "We want the people in the field to be the sentinels, to recognize when someone is trying to abuse or exploit their work and call the F.B.I."

Christina D. Smolke of Stanford is the leader in the race to create a single strain of yeast that is capable of the entire sugar-to-morphine transformation. Her team believes they will publish proof of such a strain by next year. However, she finds the concerns of the critics "inflammatory."

Dr. Oye has indicated that there are ways to prevent abuse of the technology. The DNA of strains for the process could be placed onto watch lists, and government permission could be required of scientists who want to work with them. Strains could be kept in secure locations. Sharing results without permission could be prohibited. Undetectable DNA "watermarks" could be inserted into the DNA of the strains so authorities could trace stolen yeasts. Finally, scientists could alter the strains to ensure they are even more fragile and difficult to grow outside a professional lab setting.

How these issues are resolved remains to be seen, but surely it is notable that the creators of the technology are worried.

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