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Brainstorm Health: FDA Marijuana-Based Drug Approval, Pharma Innovation, GSK Shingles Vaccine

June 25, 2018, 8:40 PM UTC

Happy Monday, readers—This is Sy.

I was going to focus today’s essay on a striking statement from China on the opioid crisis—specifically, this one, from Liu Yuejin, deputy head of China’s National Narcotics Commission—pointing the finger straight at the United States over the following President Trump’s assertion that “cheap and deadly” opioid forms manufactured in China are flooding the U.S.:

“China’s drug control agencies, now and in the years to come, will place greater emphasis on drug control cooperation between China and the United States. But I believe that to resolve this the more important issue is for the United States to strive to reduce and compress the great demand and drug consumption markets of opioids.”

Those are some fighting words worth exploring, especially since Liu went on to point out that China hasn’t experienced the same kind of opioid abuse and trafficking seen in America.

But there’s another bit of major headline news today: The Food and Drug Administration (FDA) approved the first-ever marijuana based prescription drug in the U.S., a treatment from the U.K.’s GW Pharmaceuticals to tackle debilitating childhood epileptic disorders. The FDA cleared the drug, meant to treat Lennox-Gastaut syndrome and Dravet syndrome, for patients two years of age and older.

This isn’t a surprise given the overwhelming recommendation for Epidiolex by the FDA’s own expert advisers in April. The question is whether the floodgates will now open for companies seeking drug approvals that involve marijuana derivatives, whether to treat neurological conditions or movement disorders or even chronic pain.

Much will depend on the actual substances at play. After all, Epidiolex’s main ingredient is cannabidiol (CBD)—which is different from the psychoactive, high-producing THC component of marijuana. But another intriguing question is what will happen to the overall legal status of CBD now that a federal agency has officially designated it a drug with proven medical benefits.

Read on for the day’s news.

Sy Mukherjee


Another gene-editing mice. CRISPR-Cas9, the gene-editing technology that's been at the heart of many a digital health-focused press release, is in the news once again. This time, the process has shown promise (in mice) in reducing some types of repetitive behaviors that are associated with autism spectrum disorders, specifically Fragile X syndrome. To repeat: The results are extremely preliminary and were demonstrated in mice. But on the human level, there are currently ongoing CRISPR trials for cancer.


Parsing innovation in the drug development world. The Economist Intelligence Unit and contract research giant PAREXEL are out with an expansive new look at the state of biopharmaceutical innovation and its effect on overall drug development. It's a deep dive that's well worth exploring in full—but one part caught my eye in particular. "Most innovations improve efficiency in clinical trials, while precision medicine trials are associated with slower recruitment overall. Adaptive, patient-centric and real-world data (RWD) trials had the shortest time to recruit 100 participants (3, 4 and 6 months respectively), all shorter than our benchmark of 7 months," wrote the authors. In this case, innovation refers to metrics such as how a trial is conducted and ultimately executed; given the low numbers of patient enrollment in many clinical studies, and the abject failure rate of big pharma trials, this is a critical issue for companies to get right. And as it turns out, certain forms of these studies attract far more participation than others, especially if they put a lower burden on the patient. (Economist Intelligence Unit)

Glaxo's shingles vaccine in short supply. GlaxoSmithKline's shingles vaccine Shingrix is such a runaway hit that U.S. patients are on the waiting list for the shot, which is meant to inoculate against a reactivation of the chickenpox that can present as a painful rash. Shingrix is one of very few products available to vaccinate against shingles (the other being Merck's Zostavax), and uptake of the GSK competitor has been rapid, fostering a temporary backlog. But that also means that the shot may have significantly higher sales than analysts originally expected. (Reuters)


Food as medicine? Kaiser Health News is out with a fascinating report on a local Medicaid project that offers healthy food as a kind of treatment. "The Metropolitan Area Neighborhood Nutrition Alliance (MANNA), a Philadelphia-based nonprofit organization that provides medically appropriate food for people with serious illnesses, prepares and delivers the meals," the outlet reports. According to the nonprofit Health Partners, the experiment is going surprisingly well. “We wanted to see how this would work out and we are quite pleased that with the cooperation of our members we did see a dramatic reduction in their costs" in addition to improved health outcomes, says Health Partners CEO William George. (Kaiser Health News)


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Produced by Sy Mukherjee

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