That Spanking New Drug Factory

… is down the hallway, on the left, next to the pool table.  Michael Le Page reports on home brewing your own opiates for NewScientist:

A growing number of drugs, scents and flavours once obtainable only from plants can now be made using genetically modified organisms. Researchers want to add opiates to that list because they are part of a family of molecules that may have useful medicinal properties (see “The yeast route to new painkillers“). Plant yields of many of these molecules are vanishingly small, and the chemicals are difficult and expensive to make in the lab. Getting yeast to pump them out would be far cheaper.

Yeasts capable of doing this do not exist yet, but all the researchers that New Scientist spoke to had no doubt that they soon will. “The field is moving much faster than we had previous realised,” says John Dueber of the University of California, Berkeley, whose team has just created a yeast that makes the main precursor chemical needed to produce opiates. Until recently, Dueber had thought that the creation of, say, a morphine-making yeast was 10 years away. He now thinks a low-yielding strain could be made in two or three years.

While applauding the disruption, and possible dissolution, of drug gangs, I’m more than a little unsettled at the thought of teen age boys experimenting with the creation of opiates in their own homes.  No doubt, so is the DEA:

“It would be as disruptive to drug enforcement policy as it would be to crime syndicates,” says Tania Bubela, a public health researcher at the University of Alberta in Edmonton, Canada. “It may force the US to rethink its war on drugs.”

Nature elaborates:

Various international conventions and national laws are designed to prevent diversion to illegal markets. Countries that manufacture opiates commonly use large, secure industrial facilities. Australia further enhances security by growing a thebaine-rich poppy variety; thebaine is toxic to ingest and is not easily converted into morphine. It is difficult to predict how the main international body, the International Narcotics Control Board (INCB), would react to a new production system for opiates. The INCB is unlikely to slash current opium-production quotas and disrupt current legal opiate-trade patterns to accommodate yeast-based production. This would limit the ability of new producers to enter the market.

Meanwhile, yeast-based opiate synthesis could have a significant effect on illicit markets. Currently, opiates are sold illegally through two main channels. First, prescription pain medications such as oxycodone and hydrocodone are pilfered, prescribed improperly or prescribed legitimately but then sold on illegally by patients. Second, illegally cultivated opium poppies in countries such as Afghanistan, Myanmar, Laos and Mexico are processed into heroin and distributed by criminal networks that sell them at street prices several dozen times the production costs8.

Nature‘s recommendations?

Engineering. Yeast strains should be designed to make them less appealing to criminals. For example, strains could be engineered to make only opiates with limited street value, such as thebaine. Alternatively, weaker strains could be engineered to make it harder for people to cultivate and harvest opiates outside established laboratory settings. Strains could be engineered with unusual nutrient dependencies, for instance. Such methods of ‘biocontainment’ have been developed in Escherichia coli. Opiate-producing yeast strains could also contain a marker, such as a DNA watermark, that makes them more readily identifiable to law-enforcement agencies.

Screening. Because there is some — albeit low — risk of criminal syndicates synthesizing opiate-producing yeast strains using published DNA sequences, commercial organizations that make stretches of DNA to order should be alerted. The sequences for opiate-producing yeast strains should be added to the screening criteria used by these providers. Overseen by two voluntary consortia, the International Association of Synthetic Biology and the International Gene Synthesis Consortium, these criteria currently cover only pathogens.

Security. Efforts should be made to keep opiate-producing yeast strains in controlled environments that are licensed by regulators. Physical biosecurity measures — including locks, alarms and systems for monitoring the use of laboratories and materials — could help to prevent the theft of yeast samples. Laboratory personnel should be subject to security screening. Similarly, assigning liability and penalties may dissuade researchers from sharing strains with anyone who is not legally authorized to work with them.

Regulation. The current laws covering opiates, such as the US Controlled Substance Act and its worldwide equivalents, should be extended to cover opiate-producing yeast strains, to make their release and distribution illegal.

It does occur to me to wonder if these recommendations would be counter-productive – could the next great painkiller be found by a bio-hacker at the local junior college?  Granted, getting it through the FDA approval process seems unlikely – but there it is, that brand new drug that, rumor has it, will stop that relentless agony you – or a loved one – is going through.  Think about it.

I personally think the sober recommendations of Nature will fail – it only takes one researcher willing to take a risk for desperately needed cash (or whathaveyou) for an export from a lab to occur; and, of course, researchers may actively work for criminal gangs.  However, the opposite is a prickly cactus to hug.  The first dead teenager might sink the project.

This may open up an interesting market opportunity for firms to specialize in running FDA tests for drugs they have not developed.  I suspect they already exist, but I could not come up with any names.  They would supply capital and expertise in exchange for a cut of the profits – if any.  Expensive?  Yes.  However, these expenses may start to come down as we get better and better at evaluating toxicity and efficacy.

The blog at Scientific American also covers the issue.

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About Hue White

Former BBS operator; software engineer; cat lackey.

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