Better late than never? Congress is close to closing a Theranos-sized loophole

(JUSTIN SULLIVAN/GETTY IMAGES)

Now that Theranos founder Elizabeth Holmes (above) and company executive Ramesh “Sunny” Balwani are on their way to prison for fraud and conspiracy, it’s odd to think the whole affair might have been avoided had Congress closed a regulatory loophole. STAT’s Rachel Cohrs and Sarah Owermohle report that key decision-makers in Capitol Hill are close to revamping how the government regulates some diagnostic tests that patients use to make health care decisions.

Now, tests developed in clinical labs — at academic medical centers and hospitals — don’t undergo the same scrutiny as tests developed by big commercial test companies. The separate categories allowed Theranos to develop its business model under looser oversight. Translation: The company didn’t have to prove its tests actually worked before giving them to patients. The VALID Act, now being negotiated, would create a new category of FDA oversight for high-stakes tests for patients, no matter where they were developed. Read more.

Cell therapy trial in melanoma 'plants a flag' for TILs

Much of current cancer research revolves around finding better ways to power our immune cells to disarm tumor cells that disable their defenses. Immunotherapy drugs and CAR-T therapies have been joined by a technique called tumor infiltrating lymphocytes, or TILs, a therapy that harvests immune cells from a patient’s tumor, grows an army of them in the billions in a lab, and releases them back into the patient. TILs date back to work done by Steve Rosenberg at NCI in the 1980s and has lately shown promise in observational studies.

Now, a more rigorous trial described as a proof of concept in yesterday's NEJM offers evidence that TIL therapy can work, soundly beating an approved immunotherapy for metastatic melanoma. “This plants the flag that the treatment works," Amod Sarnaik, a surgical oncologist not involved in the study, told STAT’s Angus Chen. Read more.

Cancer patients endure difficult treatments. Then they have to pay for parking

Think about dealing with cancer. You go to the hospital often for chemo or radiation or both. Each time you have to pay for parking. A neighbor once told me he donated blood to get one day’s fees covered while his wife was being treated for ovarian cancer. That’s one anecdote, but a new paper in the Journal of Medical Imaging and Radiation Sciences confirms the financial toxicity for people already burdened with pain and suffering.

Study author Mustafa Al Balushi, a radiation oncology resident at the University of Alberta, noticed how many patients hearing about their treatment plans become upset about paying for parking repeatedly. And this is in Canada, STAT’s Bob Herman notes, with a publicly funded health system. Mirroring the study’s findings in Canada, parking fees are usually higher in U.S. cities that have higher costs of living. Read more.

Closer look: Clues that a cystic fibrosis drug could help pneumonia patients, too

(COURTESY CHARITÉ)

Caveats first: The research is only in mice and it’s a long way from patients who may be far sicker than the lab animals. But a new study in Science Translational Medicine is intriguing because it hints that a line of drugs that transformed one deadly rare disease could moonlight as a treatment for a more common one. The researchers report success giving a cystic fibrosis drug to mice modeling the early stages of pneumonia-induced acute respiratory distress syndrome, or ARDS, an acronym all too familiar from the early days of Covid-19.

In people with pneumonia, a protective lining in the lung known as the endothelium (above) becomes leaky, a phenomenon called barrier failure. A cystic fibrosis drug made by Vertex targets and boosts a gene that regulates fluid flow through the endothelium. Which could explain why mice responded to the drug. STAT’s Jason Mast has more.

ARPA-H is hiring and food is 'under-resourced' at FDA

ARPA-H is hiring, the new agency’s director Renee Wegrzyn wants you to know. The Advanced Research Projects Agency for Health, launched in March with an initial $1 billion allotment, is charged with curing some of the U.S. health system’s biggest problems. Her top priority: “Hire program managers. Loud and clear, way above everything else,” she told STAT’s Sarah Owermohle. “Program managers come with the ideas, the big problems in health that they want to solve. We can’t pursue those research projects without them.” At the Milken Institute Future of Health Summit, Wegrzyn defended housing ARPA-H within NIH. “Over time, as we grow up, we’ll probably gain more independence in certain aspects.”

Also at the Milken conference, FDA Commissioner Robert Califf said the agency’s food program has been “under-supported, under-resourced. … Maybe the commissioners have all been medical people, so not so interested in that.”

Seeing green light as a pain reliever (in lab rats)

Photomicrograph of coronal sections showing fluorescent signals in the bilateral superior colliculus and lateral geniculate nucleus after injection. (Y.-L. Tang, et al., Science Translational Medicine 2022)

Here’s another eye-catching study that requires a caveat: This one is only in rats. It’s intriguing because it tests green light as a way to relieve chronic pain, a huge need in humans. Ongoing research has explored low-intensity light therapy to manage low-back pain, migraines, and fibromyalgia. Yesterday’s study in Science Translational Medicine shows that green light relieved pain in arthritic rats via rod and cone photoreceptors, the retinal structures in the eye we know from elementary school science class are responsible for sensing light.

The scientists discovered that cones and rods activated neurons that expressed a hormone in a part of the brain that previous research linked to green light-mediated pain relief. These neurons also convey light signals to another part of the brain that modulates pain. “It may be clinically useful to investigate the potential mechanisms of green light analgesia, which is simple, safe, and economical,” the authors write.

Yesterday we told you about a study of post-Covid conditions published in the Journal of Internal Medicine. Because of a production delay at the journal, the paper posted later than scheduled. Here's the link.

What we're reading

Biden administration unveils dashboard to track nonfatal drug overdoses, STAT
They brought their sick baby to the hospital. Three days later, the state took their kids away, Washington Post
Lasik patients should be warned of complications, FDA draft says, New York Times
Workers across America break their silence on decades of asbestos exposure, ProPublica
FDA scolds company that raised red flags over impurities in many widely used medicines, STAT
Oldest DNA reveals life in Greenland 2 million years ago, Associated Press