FDA investigating unauthorized trial, CRISPR and The Rock, & depression drug responses

STAT

Thursday, April 12, 2018

Morning Rounds by Megan Thielking

Sponsored by

  

Good morning, everyone! Welcome to Morning Rounds. 

FDA investigating unauthorized herpes vaccine research

The FDA is conducting a criminal investigation into unauthorized herpes vaccine research run by a Southern Illinois University professor, Kaiser Health News reports. The professor, William Halford, gave patients an experimental herpes vaccine in Illinois hotel rooms in 2013 and in St. Kitts and Nevis in 2016 — without any standard safety oversight. Halford died in June, but four people with knowledge of the FDA's investigation say the agency is digging into whether anyone else was involved in the unauthorized research. Last fall, KHN reported that the school had promoted the research and that American investors – including Trump adviser Peter Thiel — shelled out $7 million to help fund the study. 

The next effort to expand access to naloxone

Rep. Elijah Cummings is calling on President Trump to implement a recommendation made by his opioid task force nearly nine months ago: let HHS negotiate the price of the overdose-reversing drug naloxone directly with drug companies. Cummings sent a letter urging the president to “empower the HHS Secretary to negotiate reduced pricing for all governmental units.” His request comes hot on the heels of a rare public health advisory issued from Surgeon General Jerome Adams, who called on the family members and friends of people at risk of opioid overdoses to carry naloxone.

Meanwhile, a traveling memorial to victims of the opioid epidemic is opening to the public near the White House today. The memorial features 22,000 pills, each engraved with the face of a victim who died of an opioid overdose.  

A potential new way to find the right depression drug

Psychiatric researchers are working on a potential new way to predict whether a patient with depression will respond to a particular treatment. In a new paper published in JAMA Psychiatry, researchers at Harvard and McLean Hospital looked at activity in an area of the brain called the rostral anterior cingulate cortex, or ACC, which they thought might serve as a biological marker of depression. They studied more than 300 patients, some of whom were taking the antidepressant sertraline, and found that ACC activity predicted their response to the drug after two months. Given that other studies have found the same connection, the study's authors say the marker should be considered as a potential tool to guide depression treatments. 

Sponsor content by The Jackson Laboratory

Forget me not: Living with early on-set Alzheimer’s

Jackie Frisk can no longer recall how many children she has, but she can still play the piano beautifully. This strange juxtaposition is one of many changes that have come with the progression of her Alzheimer’s disease. Click here to learn more about how researchers at JAX are helping the fight against Alzheimer’s.

Inside STAT: Our review of The Rock's new CRISPR movie

The gang's all here! (kid at movie theater for stat)

We cover CRISPR a lot at STAT — but we don’t often get to cover Dwayne “The Rock” Johnson. But The Rock and the genome-editing meet in a new movie, “Rampage,” coming out this week. The gist of it: a gorilla, a wolf, and a crocodile ingest some CRISPR complexes, which edit their genomes to make them stronger, bigger, and more aggressive. They then wreak havoc on the city of Chicago. I went to an advance screening this week with my colleague, Andrew Joseph, to see how close the movie sticks to the actual science of CRISPR and also just to see The Rock. Read our review here.

Lab Chat: How melanoma evades the immune system

Scientists have pinpointed a pathway that helps melanoma evade the immune system's attacks — and in turn, have found a a potential reason why the cancer cells doesn't always respond to certain drugs. Here’s what Michele De Palma of EPFL told me about the work, published in Science Translational Medicine

What did you set out to study?

With the advent of immunotherapies, patients with advanced melanoma have new options for more effective treatments. Some of these immunotherapies, like immune checkpoint blockade (ICB), can eradicate the tumors, and some of the patients achieve long-term remission. However, ICB is not effective in the majority of the patients, so [we] are looking into what limits its efficacy. 

What did you find that might limit how well it works? 

The immune system plays dichotomous roles in melanoma. Some immune cells can recognize and kill the cancer cells, potentially leading to eradication of the tumor, [including] CD8 T cells, which are stimulated by immunotherapies. But melanomas also contain "bad" immune cells. For example, when many macrophages get into the tumor, they can suppress the CD8 T cells and limit the efficacy of the immunotherapy. When we specifically eliminated macrophages with a drug that selectively kills them, the efficacy of ICB was greatly improved in experimental models of melanoma.    

Discouraging news about polio eradication piles up

This year marks the 30th anniversary of the launch of an ambitious program to wipe out polio. And this year, as with the past few years, supporters of the effort optimistically declared that this could be the year that polio ends. But just three months into 2018, the projection looks less rosy. Eight cases of polio have already been reported this year in Afghanistan and Pakistan, compared to five during the same period last year. "We would like it to be the year, but the first few months of the year have not been all that positive," Michel Zaffran, director of polio eradication at the WHO, told STAT's Helen Branswell. More here

What to read around the web today

§  Republicans couldn't knock down Obamacare. So they're finding ways around it. New York Times

§  Louisiana legislature considers sweeping changes to investigations of doctor misconduct. The Advocate

§  Why Scott Gottlieb is the one Trump administration official everyone seems to like. Vox

More reads from STAT 

§  The 8 juiciest things we learned from John Carreyrou’s new Theranos book

§  NIH director: Agency is looking at alcohol industry influence ‘in a very aggressive way.'

The latest from STAT Plus

§  FDA-designated ‘breakthrough’ therapies may not actually be scientific breakthroughs. 

§  Senator lashes out at drug makers for stock buybacks, but not cutting prices. 

Thanks for reading! More tomorrow,

Megan

 

 

 

Facebook

Twitter

STAT

5cP.gif?contact_status=Newsletter Only