Breaking News

DNA test that predicts opioid addiction should be pulled off the market, critics tell FDA

April 4, 2024
Reporter, Morning Rounds Writer
Good morning. A genetic test to predict opioid addiction generates scorn as "bogus," Florida's six-week abortion ban is called a "public health catastrophe," and hospital costs are "out of control." But it's not all gloom and doom. There's a glimmer of hope for Parkinson's, a hopeful sign for a new mRNA target, and "a new beginning" for the first patient to receive a CRISPR gene-edited pig kidney.

health tech

Critics urge the FDA to pull a DNA test that predicts opioid addiction off the market

Opioid use disorder takes more than 130 lives every single day, mostly from illicit fentanyl and heroin. STAT's Lev Facher has documented obstacles to treatment, but today we hear about a different challenge in the government's attempts to stall this public health disaster. Last year, the Food and Drug Administration approved a DNA test rejected by its advisory panel to help guide physicians' opioid-prescribing decisions. Called AvertD, it uses a cheek swab and a computer algorithm to predict an individual's genetic risk of opioid addiction.

The problem is, 31 scientists write in a letter to FDA and to the Centers for Medicaid and Medicare Services, it doesn't work. Geneticists, public health researchers, and experts in addiction and device regulation say the test analyzes just 15 genetic markers, woefully inadequate to reliably predict an individual's risk of opioid use disorder. "It's not that it's a not-very-good test, it's that it's 100% bogus," said Andrew Kolodny, a public health researcher at Brandeis University and one of the letter's authors. STAT's Megan Molteni has more, including potential harms from the test.


reproductive health

What Florida's six-week abortion ban means
GettyImages-1242531688

Chandan Khanna / AFP Via Getty Images

Florida's six-week ban on abortion will go into effect May 1, six months before a November ballot measure will give Floridians the chance to enshrine abortion protections in the state constitution. Meanwhile, most Floridians wanting abortions will have to either continue their unwanted pregnancies or leave the state for medical care. Florida, whose neighboring states also have imposed abortion restrictions, had more than 84,000 abortions last year, a little over 8% of the estimated total abortions across the U.S. in 2023.

"We see this as a public health catastrophe. We're the second largest abortion-providing state after California," said Amy Weintraub, the reproductive rights program director at Progress Florida, a nonprofit advocacy group for progressive causes. "There's no way clinics in other states could provide the load that providers in Florida currently do." STAT's Olivia Goldhill has more on the implications.


chronic disease

An old GLP-1 drug shows promise in Parkinson's

First, the target for GLP-1 drugs was diabetes. Then obesity followed, with  impressive success stories for both diabetes control and weight loss. Mental health disorders, including Alzheimer's, came next. Now that roster may include Parkinson's disease, a neurodegenerative movement disorder currently without a treatment to halt its progression. Caveat: The reason for this hope is a mid-stage trial that showed a small difference that did not reach clinical significance between the treated and placebo groups.

In the Phase 2 trial, described in NEJM, patients with early Parkinson's taking an older GLP-1 diabetes drug called lixisenatide saw their motor symptoms get no worse over a year, while patients on placebo had worse tremors and rigidity. Scientists hypothesize that GLP-1 drugs may help with Parkinson's by reducing inflammation and protecting neurons from dying. Why lixisenatide? It was easier to find than scarce blockbusters Ozempic and Wegovy — and it may be better at reaching the brain,  STAT's Elaine Chen tells us.



closer look

Opinion: Price caps can help cut out-of-control hospital costs

prices

Adobe

We know hospital prices are sky high and getting higher. Private health insurance premiums are also rising rapidly. That means many Americans skip necessary medical care, Roslyn Murray of the University of Michigan and Andrew Ryan of the Brown University School of Public Health write in a STAT First Opinion. But there's a better way, they say, and Oregon is proving states can cap hospital prices without disrupting access to care.

Since 2019, the state has limited what it pays hospitals for services provided to the 300,000 members of its state employee plan to twice the Medicare rate for hospital payments. "The typical market forces that keep prices in check are missing in hospital markets. At sporting events, a venue can sell a bottle of soda for upwards of $6 because fans don't have other options," they write. "Hospitals are doing something similar, except in their case it's for essential health care." Read more.


biotech

Early results illuminate Moderna's other mRNA targets

Long before Covid-19 catapulted Moderna into our collective consciousness for its mRNA vaccines, the company had hoped to enlist strands of this genetic material in the fight against cancer and other diseases. The idea behind mRNA as a therapy is to induce cells to become their own drug factories. Cells are adept at reading protein-making instructions from mRNA, so why not tell them to make versions of proteins that some people's bodies lack?

That's an approach being applied to a rare disease called propionic acidemia, in which the body makes defective versions of enzymes required to break down fats and proteins. Yesterday, scientists reported in Nature interim results from an early study, primarily focused on safety and testing different doses, in which some patients saw a reduction in the life-threatening metabolic emergencies that can crop up with the disease. STAT's Andrew Joseph has more about this study, most of whose participants were children, and what might be next for the field.


xenotransplantation

'A new beginning': Patient with transplanted pig kidney heads homeScreenshot 2024-04-03 at 5.35.34 PM

Michelle Rose / Massachusetts General Hospital

Last month saw a historic first in transplantation: A medical team at Massachusetts General Hospital transplanted a kidney from a CRISPR gene-edited pig into a living patient. Now the man who received the organ, 62-year-old Richard Slayman (above), has headed home to continue his recovery. A manager with the Massachusetts Department of Transportation, he had previously received a human kidney transplant, but it failed after about five years, requiring him to resume dialysis in 2023.

"This moment – leaving the hospital today with one of the cleanest bills of health I've had in a long time – is one I wished would come for many years," he said in a statement released by the hospital yesterday. "I'm excited to resume spending time with my family, friends, and loved ones free from the burden of dialysis that has affected my quality of life for many years."

Slayman thanked his well-wishers, including patients waiting for a kidney transplant. "Today marks a new beginning not just for me, but for them, as well."


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