Reports detail FDA failure to speed up drug and device approvals
The Government Accountability Office is out with two new reports knocking the FDA. The first finds that the FDA lacks concrete goals to stay on top of scientific advances, and also fails to track the money spent on those efforts. The other report says the FDA’s strategic plan to speed drug and medical device approvals isn’t as strategic as it should be. GOP Senator Lamar Alexander jumped on the reports to urge fellow members of Congress to get moving on its version of the 21st Century Cures Act, which is supposed to speed up the process of getting drugs and devices to market. More on Congress’ response to the reports here.
|
Botulism outbreak in Mississippi prison tied to home-brewed booze
The CDC is investigating a botulism outbreak among Mississippi inmates who fell ill after drinking homemade alcohol brewed in the prison. So far, 17 inmates have turned up with botulism poisoning, which can cause blurred vision, slurred speech, muscle weakness, and in some cases, paralysis. The inmates were hospitalized and treated with an anti-toxin, and the CDC is analyzing samples from those patients. Officials from the Federal Bureau of Prisons say they’re digging into the cause of the outbreak, too. The Clarion-Ledger has more on the situation here.
|
Lab Chat: Attempting to break the blood-brain barrier
The blood-brain barrier presents problems for drugs that aim to reach the brain. A new technique aims to overcome that hurdle with a combination of ultrasound and teeny tiny bubbles that vibrate to temporarily open the barrier. Researchers tried it out on 15 brain cancer patients and found they were able to deliver more of a drug to the brain. Here’s what neurosurgeon Alexandre Carpentier told me about the findings, published in Science Translational Medicine.
What's the problem you were trying to solve?
Brain pathologies are difficult to treat because 99 percent of medications can’t penetrate into the brain. Even though we have many medications that are efficient on animals, they fail when going to human trial because they penetrate poorly in the brain.
Why try ultrasound?
Since 2001, we’ve known that low intensity pulsed ultrasound can temporarily disrupt this BBB (blood-brain barrier) in animals, but the transfer of this technique to humans was impossible because of the thickness of the human skull, which distorts and absorbs 90 percent of ultrasound energy. For the first time, we solved this problem by implanting a 10mm ultrasound-emitting medical device in the patient’s skull. Activation of the device will emit low intensity pulsed ultrasound for two minutes.
What’s working in tandem with the device?
Microbubbles are injected intravenously in the circulation. Ultrasound makes the microbubbles vibrate. Inducing a slight mechanical stress within the brain vessels leads to BBB opening for the next six hours. That’s perfect timing for intravenous chemotherapy treatment to be started. Then, the BBB seals back to normal.
|
Inside STAT: What we don't know about how drugs work
Molly Ferguson for STAT
It seems like drug makers ought to fully understand how the medicines we take every day work. But that’s often not the case — even commonly consumed drugs like acetaminophen become a mystery once they’re inside of us. In the new episode of our Signal podcast, Meg Tirrell and Luke Timmerman talk Tylenol, Viagra, and why the science behind drugs should give you pause.
|
Undercooked chicken livers behind bacterial spread in UK
Undercooked chicken livers are causing health problems in the UK, and researchers say it might be because we’re all getting too fancy with our food. Outbreaks of campylobacter infections in the country have been tied to rare chicken livers, and the study estimated that between 19 and 52 percent of livers sold by restaurants in the UK don’t reach the necessary core temperature. Researchers' poll of chefs found that they could correctly identify safely cooked livers — however they overestimated the public’s hankering for rare meat. The researchers therefore say this appears to be an instance of “‘gourmet-fication’ of foodborne disease.”
|
Is mental health care reform on the way?
Reform could be on the horizon for the troubled US mental health care system. Yesterday, a House committee marked up and then unanimously passed the Helping Families in Mental Health Crisis Act. The bill would expand Medicaid coverage of mental health treatment, increase prevention efforts to address youth suicide, and fund outpatient programs for people with serious mental illness. The legislation will now move forward to the House floor.
|
FDA clears up confusion over nutrition info on menus
If you've ever sat down at a Chili's and wondered what to make of the calorie and sodium counts on your honey chipotle chicken crispers, you're not alone. The FDA is now trying to clear up the confusion in the industry to standardize nutrition counts from one restaurant menu to the next. Back in 2014, the agency published a rule that requires chain restaurants to display calorie counts on menus, and if customers ask, to provide other nutritional information too. But that guidance was dense, and many in the restaurant industry did not comply, so the FDA is aiming to push the enforcement a bit harder. They're starting with two workshops aimed at the public, but particularly those in the restaurant industry. More on the meetings here.
|
What to read around the web today
- Senator's report finds fundamental concerns about Red Cross finances. NPR
- Amid opioid epidemic, more schools offer sober dorms. Stateline
- The design bias of heart failure. Motherboard
|
What to read around the web today
|
