Brainstorm Health: Marijuana Cancer Claims, Alnylam RNAi Drug, Teva…

Greetings, readers! This is Sy.

The Food and Drug Administration (FDA) has a message for companies trying to hawk marijuana-based products as ones that can “prevent, diagnose, treat, or cure cancer” with zero evidence supporting that assertion: Knock it off, immediately.

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” said FDA Commissioner Dr. Scott Gottlieb in a statement.

The FDA sent warning letters to four companies—Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC—for claiming various products they sell online containing cannabidiol (CBD), a non-psychoactive cannabis component (i.e., the part that doesn’t get you high), can thwart the biological processes that cause cancerous cells to spread.

As medical and fully legal recreational marijuana become increasingly common in America, claims about cannabis’ health effects have finally been getting serious scrutiny. The medical literature to date paints a mixed picture of marijuana’s effect on health. For instance, while there’s no real evidence it can treat cancer, it is fairly clear that marijuana can treat nausea in cancer patients undergoing chemotherapy. Cannabis can also be used to soothe chronic pain, mollify muscle issues in people with multiple sclerosis, and improve sleep for people with certain disorders in the short term, according to a review of more than 10,000 individual studies published by the National Academies of Sciences, Engineering, and Medicine earlier this year.

FDA chief Gottlieb notes that there aren’t any marijuana-derived products approved the FDA. But there are several going through later-stage clinical trials, including an experimental epilepsy treatment from GW Pharmaceuticals and Zynerba Pharmaceuticals’ cannabis-based gel for a rare autism spectrum disorder called Fragile X syndrome.

Read on for the day’s news.

Sy Mukherjee

@the_sy_guy

[email protected]

DIGITAL HEALTH

Alnylam shares shoot up on RNAi rare disease drug study. Alnylam stock rose 11% in Thursday afternoon trading after a late-stage trial of its experimental treatment patisiran showed promising results in a rare disease. What's intriguing about Alnylam's therapy is that it's a so-called "RNA interference." This is a fledgling and experimental drug space with big implications for the future of gene-based therapy; it involves "silencing" certain gene from being expressed by using the body's RNA pathway. That could hold big promise for many genetic diseases if drug companies keep getting encouraging results since, theoretically, the production of disease-causing proteins could be shut down entirely. (Nasdaq)

INDICATIONS

Teva continues its brutal decline. Beleaguered drug giant Teva saw its stock plunge 19% in Thursday trading after announcing that it would miss its 2017 profit forecasts. The generic drug maker has been bleeding sales to competitors and been grappling with small profit margins on its products, as well as a mountain of debt. Kare Schultz took over as the company's new CEO just this week amid a major executive restructuring. (Reuters)

THE BIG PICTURE

Heart stent study sends shock waves across medical industry. A small trial could have huge repercussions for the use of "percutaneous coronary intervention" (PCI)—or the non-surgical, non-invasive method of using catheters, balloons, and stents to open up narrowing arteries rather than doing a bypass surgery. The ORBITA trial found that, for patients with stable coronary disease, PCI was no better than a placebo (the study involved conducting both real and sham procedures in these patients). "Although there are a number of necessary caveats and cautions, the trial will likely force the cardiology community to consider and debate the possibility that throughout its 40 year history many of the benefits of PCI, at least in the population with stable disease, have been the result of a placebo effect both in patients and in their cardiologists," writes medical journalist Larry Husten, who focuses on heart health issues. (Cardio Brief)