A Reuters special report released last week looks at the business of post-mortem body donation. You know how organ donation has a bunch of regulations surrounding it so that shady practices like organ harvesting before death (warning: graphic but fake) don’t occur? Well Americans may be surprised to know there’s little regulation protecting your body after you’re gone. While the UK has bodies (ha) like the Human Tissue Authority, in the US your torso could end up being defrosted by an unemployed guy using a hose… and he wouldn’t even be breaking any major laws. Don’t get us wrong, body donation is a very important aspect of scientific research and should continue—which is exactly why we should get serious about regulating it. Happy Halloween!
We are fairly sure someone famous said that once. For those readers who haven’t been involved in pharma clinical development for the past 15 years, let us drop some knowledge on you. ‘Cause that’s what InsightCity does. 10 years ago, having clinical development operations in India was all the rage, companies were hiring in droves. Then came some quality issues and the wage gap closed and suddenly India was on the outs. In 2015, India revised some clinical trial guidelines. Apparently that was not enough, so last week the government made it mandatory for pharma to include Indian patients in global clinical trials if they want to market in India. One could argue this move helps ensure patient safety in India, but it will certainly help the local economy.
There’s some debate as to whether cancer patients should have drugs that are proven to work, or whether instead they should have access to as many drugs as possible that might work. At least that’s what we’ve gathered from a recent study identifying that more than half of cancer drugs approved by the EMA between 2009 and 2013 showed no benefits for either survival or quality of life. While that’s not extremely terrible considering, 1) the EMA focuses on timely patient access to new drugs and, 2) trials focusing on survival outcomes are expensive and (more importantly) time-consuming, one has to wonder if we can’t do better than half. Otherwise we’re just provoking cancer patients to the point of rampage.
Last week, researchers found that exercise can counteract the cognitive decline some patients experience post-breast cancer treatment. It’s the 457th publication since 2012 to use a Fitbit device in research. Or to put it a different way, this study found that 83 percent of clinical trials used a Fitbit as opposed to another brand. Researchers apparently just really prefer it. That’s good news for the company, since it now has a slew of clinical data under its belt, and it’s thinking about a run at a medical device designation a few years in the future. According to their GM of Health Solutions, “as we start going deeper down the health road with more and more advanced sensors, I’d say, just stay tuned.” Oooooh, mysterious.
When a medical device malfunctions, it is up to the doctor to alert the hospital, the hospital to alert the device maker, and the device maker to alert the FDA 30 days later. Not exactly a fast process. Well the US House of Representatives just approved a renegotiated agreement between the FDA and device industry that would push this 30 days back to three months. While device makers are happy because this agreement also includes lowering the proposed annual user fees, it has some watchdog groups and critics up in arms and bringing up all the bad memories the device industry wishes they could forget. Who knows, maybe malfunctioning trends will become more apparent with this extension, but it certainly doesn’t scream “patient safety.”
For the first time, the FDA is requesting that a drug maker remove its product from the market for public health reasons. Endo Pharmaceuticals’ Opana ER—an opioid designed to continuously manage moderate to severe pain—has already faced scrutiny for being easy to abuse via snorting. Turns out addicts aren’t too fond of the ‘extended’ aspect of the drug. To combat this, the company added a coating that made the drug harder to crush… so abusers injected it instead. Not only did this reformulation not meet the FDA’s standards of officially being abuse-deterrent, but the rise in injection abuse is also tied to an HIV/Hep C outbreak caused by needle sharing. God save us from people who mean well.
The FDA has again delayed implementation of its requirement for food sellers (supermarkets, chain restaurants, etc.) to post calorie counts of food items on their menus. Originally set to go in effect on May 5, the affected businesses now have until May 7, 2018 to get calorie counts up. While some trade groups representing the industry are happy to see this get delayed, they’re also hoping that a regulation-averse White House will either weaken the requirement, or do away with it altogether. There are certainly some valid criticisms of the requirement, especially in regard to how the hell sellers without menus are supposed to be labeling their products (like convenience stores already starved for space,) however, there’s also things like this to consider.