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Scientists: Government’s only pot farm has moldy samples/no federal testing standards

http://www.pbs.org/newshour/updates/scientists-say-governments-pot-farm-moldy-samples-no-guidelines/

Scientists say the government’s only pot farm has moldy samples — and no federal testing standards

Sue Sisley, a primary care physician in Scottsdale, Arizona, recalls the moment she picked up the carefully wrapped package fresh from the delivery truck. Nearly two years after Sisley and her colleagues were awarded a grant to study marijuana as a treatment for 76 military veterans suffering from chronic post-traumatic stress disorder, her shipment of the drug was finally in hand.

But minutes later, as she opened the packets to weigh the drug – as required by the federal Drug Enforcement Administration – her enthusiasm turned to dismay. It didn’t look like marijuana. Most of it looked like green talcum powder.

“It didn’t resemble cannabis. It didn’t smell like cannabis,” Sisley says. What’s more, laboratory testing found that some of the samples were contaminated with mold, while others didn’t match the chemical potency Sisley had requested for the study.

There’s only one source of marijuana for clinical research in the United States. And “they weren’t able to produce what we were asking for,” Sisley says.

Rick Doblin, MAPS’ director, says this recent episode “shows that NIDA is completely inadequate as a source of marijuana for drug development research.”

“They’re in no way capable of assuming the rights and responsibilities for handling a drug that we’re hoping to be approved by the FDA as prescription medicine,” he says.

It’s unclear whether mold, lead or discrepancies in potency has been a problem in prior cannabis studies, because until now, it appears that no one looked.

NIDA says this is the first time researchers have expressed concern about mold or potency testing. Neither the agency nor the University of Mississippi tests samples for mold before they’re shipped.

Sisley says researchers have taken too much for granted. “There’s no telling how many subjects in past studies were exposed,” she says.

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Beyond quality control issues, some critics say the Mississippi farm doesn’t provide researchers with enough options. For example, the potency of marijuana in NIDA’s collection tops out at 13 percent THC. That’s less than half the level in the most potent strains sold in states where the drug is legal and regularly tested.

That means “if you’re trying to do a study where you imitate what patients do in the real world, you can’t,” Sisley says.

Van Dyke echoes her concern. “It’s an important issue. The products in Colorado are different from the products produced by NIDA, and there’s untapped demand to study those products that people are really using.”

Another criticism stems from NIDA’s practice of achieving higher THC concentrations by mixing different strains together, rather than growing new plants.

In its April 2016 letter, the agency told Warren the Mississippi facility has “approximately 185” batches of cannabis, at varying concentrations of THC and CBD. Different varieties, the letter says, “may be blended to achieve specific cannabinoid concentrations of interest to researchers.”

Critics, including Sisley, say that mixing strains is a lost opportunity. Every cannabis plant contains several hundred unique compounds, which some believe may significantly alter the drug’s effects. If different plants are mixed together, scientists have a harder time tracking those effects.

For the people wondering why there aren't more marijuana studies done: it's a gigantic and expensive licensing issue with the DEA and, if you get approved, you were limited to this one exclusive source of marijuana for studying.
 
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