Poisoning babies is bad

Homeopathy is based on the idea that you can treat sick people with diluted versions of substances that would cause the sick person’s symptoms in a healthy person. So, we guess it’s something like building up an immunity to iocane powder, except without any clinical evidence. In the US, homeopathy is a multibillion dollar industry and the FDA has taken notice. They’ve kind of let homeopathic solutions do their own thing for years now but homeopathic teething products, recently implicated in 400 adverse events, including the deaths of 10 children, have the FDA a bit more ready to take action. The agency is getting serious about getting the most dangerous homeopathic products off the market, which will hopefully help to avert these tragedies in the future.

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Swab, Spit, or Blood

We’ve all seen the Ancestry.com ads for DNA tests that reveal your ethnic mix. Harmless enough. But what if a similar test indicated you had a low risk for coronary heart disease? Would you start swallowing these 2,000+ calorie bombs at every meal? Not harmless. Consumers are increasingly embracing genetic health risk (GHR) testing to understand their individual risk for developing diseases and the FDA recently released an update to streamline the development and review pathway for GHR tests. These tests can be valuable for drug development (see how Novartis is using genetic testing in an Alzheimer’s trial) and treatment decisions and the CDC has some thoughts on the topic.

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We Insys on bringing you an opioid crisis update

Early last week, the founder of Insys Therapeutics resigned from his company’s board after being hit with racketeering and fraud charges. Essentially, the feds are alleging he and other Insys execs participated in a bribe scheme to get doctors to prescribe more of their synthetic opioid Subsys. This comes after President Trump did finally follow through on his declaration of an impending declaration of a state of emergency for the crisis. That means the US government is getting serious about a crackdown—here are some ways that could take shape. The FDA certainly didn’t mince words about getting serious either, with Commissioner Scott Gottlieb saying it would be taking actions that could be “disruptive” and “uncomfortable” for drug makers.

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Tragic news – Weed doesn’t cure cancer

We hate to be the news source to break it to you, but you can’t use “it’s curing my cancer” as the reason for your marijuana consumption. With the loosening of US laws that prosecute marijuana sales and consumption has come the upstart of many businesses and products, some of which, the FDA finds, are making claims that would classify them as “new drugs.” And of course, if it’s a new drug, the FDA will have something to say about it. According to NBC News, the regulators are putting the kibosh on 4 companies in particular that market products with pot or hemp claiming to treat cancer. Culprits include: CW Botanicals; Natural Alchemist; Greenroads Health; and That’s Natural Marketing and Consulting. They responded—probably—with a collective, “Stop bringing me down, bro.”

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FDA, kickin’ butt and taking orphan names

A recent blog by FDA commissioner Scott Gottlieb outlines the progress FDA has made eliminating the backlog of ~200 orphan drug designation requests. Recall, an orphan or rare disease is one that “generally affects fewer than 200,000 people in the United States.” But these orphans aren’t cute. They are big business. According to EvaluatePharma “worldwide orphan drug sales are forecasted to total $209bn in 2022.” According to Gottlieb, the number of orphan designation requests more than doubled between 2012 and 2016, rising to 568 new requests. FDA plans to “close a loophole that allows sponsors to avoid an obligation to study drugs in pediatric indications.” The Pediatric Research Equity Act (PREA) was enacted to promote more pediatric studies. Hasn’t happened but Dr. G. plans to change that. Bravo.

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It’s aliiive! And it’s approved!

Last week, the FDA approved Novartis’ Kymriah—a “living drug” that works by making immune cells realize they should get rid of those pesky leukemia cells making a mess of things. We’ve been following this story since June, because it’s really cool for a couple reasons. First, it marks the first time a gene therapy has been approved for use in the US, although more CAR-T treatments are in the pipeline. Second, the treatment is designated for the most prevalent form of childhood cancer in the US—acute lymphoblastic leukemia (ALL). There is a bit of worry that the treatment is prohibitively expensive, which is what sunk the first gene therapy approved in the EU, but maybe competition will help drop prices.

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Regulators gonna regulate

This writer is confused. Is the government in the business of deregulating drug use (i.e., marijuana, i.e., the sticky icky) or regulating drug use? The FDA has announced its desire to lower the amount of nicotine in cigarettes in an effort to decrease addiction, reduce smoking, and improve health. At the same time, The Washington Post reports that the FDA is delaying its regulation of trendy smoking alternatives such as e-cigarettes, hookah, and vape thingies that all the cool kids are using. The hope is that keeping these smoking alternatives easily available and less regulated will give smokers ready access to “safer” alternatives to taking in their nicotine. Here is a list of the 20 most destructive drugs, as reported in The Economist. Yikes.

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