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A STAT Investigation: Brain biopsies on DBS patients sparked FDA alarm

May 1, 2024
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Morning Rounds Writer and Podcast Producer
Good morning! Today we've got a STAT investigation you don't want to miss. And, if you'll allow me to put on my podcasting hat for a second, the First Opinion Podcast is back! We've got a full season ahead, starting with this conversation about a new method of state execution that clinician Joel Zivot calls "cruel and painful."

hospitals

A STAT Investigation: Brain biopsies on DBS patients sparked FDA alarm

MIKE REDDY FOR STAT

Peter Bauman was desperate to ease the symptoms of his early onset Parkinson's disease when he decided to undergo deep brain stimulation, a procedure in which an electrode is inserted into the brain and emits electrical impulses. In March 2020, as he prepared to undergo the procedure at Mount Sinai in Manhattan, he was invited to participate in a research study. During the operation, he agreed, a neurosurgeon would take up to a 1 cubic centimeter piece of tissue from each side of his brain.

His sample would go toward the Living Brain Project, which aims to be the largest-ever molecular study of the living human brain (most brain research is conducted on postmortem tissue). "I don't remember them mentioning anything that it would hinder or harm," Bauman said. But more than 3,500 pages of federal agency documents, dozens of pages of internal Mount Sinai documents, and interviews with over 60 sources suggest that patients like Bauman may have been given a "false justification," as determined by an FDA review, for the removal of brain tissue. 

Read the story from STAT contributor Katherine Eban about the still-ongoing project, and why federal regulators were concerned. You can also read all the questions STAT sent to Mount Sinai about the research, along with the institution's answers.


cancer

Breast cancer screenings should start at 40, not 50, per national panel

The United States Preventive Services Task Force — widely considered to be the most influential voice in population health recommendations — lowered the suggested age to start breast cancer screenings by 10 years yesterday. All women should start at age 40, rather than 50, and continue every other year until age 74, the task force wrote. 

The change is bound to be controversial, STAT's Angus Chen reports, and adds fresh fuel to a long-standing debate around when people should begin breast cancer screening, how often they should do it, and if specific groups, such as Black women, ought to be screened differently. Read more from Angus on the evidence behind the recommendation and what cancer researchers have to say about it. 


menopause

Entering menopause can increase the risk of depression

For people with ovaries, the transition into menopause comes with a 40% higher risk of both experiencing depressive symptoms and getting diagnosed with depression than those who are premenopausal, according to a study published Tuesday in the Journal of Affective Disorders. But the increase isn't permanent — researchers found no difference in risk between people who were pre- and postmenopausal. 

Researchers analyzed data from previous studies to assess the risk of depression associated with each stage of menopause, capturing more than 11,000 people. Their highest risk occurred during the years of perimenopause, when a person's ovaries begin to stop working, fewer hormones are produced, and periods become irregular. The results indicate a need for early depression screening and treatment for women in midlife, the authors write, as well as more research on the mechanisms that increase risk. However, other scientists argue that the recent surge in health services and new medications geared toward menopause frame the experience too much like a disease, and call for more non-medical approaches to manage symptoms. 



first opinion

More research is needed on colorectal cancer in younger adults

GARETH CATTERMOLE/GETTY IMAGES FOR DISNEY 

The rate of colorectal cancer among adults under age 50 in the U.S. has been climbing steadily and mysteriously since the 1990s. Three years ago, STAT's Nicholas St. Fleur reported on this alarming trend and the "hot spots" that have cropped up across the country for early-onset colorectal cancer. Nick has a family history of the disease, and invited STAT to document in a video his first colonoscopy at age 30 — 15 years before the procedure is typically recommended.

Nick's colonoscopy and reporting was partially inspired by the shocking death of actor and writer Chadwick Boseman from colon cancer at age 43. Now, in a First Opinion essay, artist, advocate, and caregiver Simone Ledward-Boseman emphasizes that there's still a need for better understanding of why colon cancer is affecting more younger adults. "I am not writing here to talk about my husband," she begins. Instead, Ledward-Boseman calls on Congress to prioritize funding around colorectal cancer. Read more on how she believes the country can invest in better preventing this deadly disease


h5n1 bird flu

Can bird flu survive in pasteurized milk? An update

Tests run by researchers at Ohio State University and St. Jude Children's Research Hospital show that pasteurization is working to kill off bird flu in milk, STAT's Megan Molteni reports. The scientists involved told Molteni late Tuesday that they had tried and failed to grow H5N1 from 58 samples of retail dairy products that had tested positive for genetic traces of the virus. The U.S. Food and Drug Administration is conducting its own, larger study of 297 samples of retail dairy products from 38 states: Results are expected later this week. 


primary care

Walmart will close down its medical clinics and online care

In January 2020, former STAT reporter Megan Thielking described a screaming crowd outside a Walmart in Calhoun, Ga., where actor Mark Wahlburg appeared for the grand opening of the superstore's second primary care clinic in the country. Walmart's network of clinics attached to stores was intended to be a cheaper, less intimidating way to access care. But yesterday, the retail giant announced it is shuttering all 51 medical clinics across five states, as well as its virtual care offering. 

The about-face comes just months after Walmart executives continued to tout their hopes for the clinics and telehealth options, and roughly a year and a half after the company kicked off a partnership with UnitedHealth Group to manage care for people enrolled in Medicare Advantage. Read the full STAT+ story from reporter Bob Herman on Walmart's reasoning for the closures and retailers' overall spotty track record with care delivery.


disabilities

HHS protects health care for people with disabilities

Forty-seven years after sit-ins across the country secured rights for disabled people, the Department of Health and Human Services is extending protections under the Rehabilitation Act of 1973 to ensure that people with disabilities do not face discrimination in healthcare settings, STAT's Timmy Broderick tells us. The rule has several provisions, including a mandate that disabled folks have accessible medical equipment for routine appointments, like adjustable exam tables or mammography machines that don't require someone to stand.

These changes will apply to any program or activity that accepts federal funding. The rule change also emphasizes the importance of supporting community-based care for people with disabilities. Stay tuned for more from Timmy about how the rule will affect the healthcare industry, and be sure to check out their separate story this morning about how private-equity-owned companies are leaving wheelchair users waiting months for repairs.


More around STAT
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What we're reading

  • LGBTQ+ employees can't be misgendered or denied bathrooms at work, new federal rules say, The 19th

  • DEA will move to reclassify marijuana in a historic shift, AP sources say, STAT
  • From baby talk to baby A.I., New York Times
  • Former MIT biologist David Sabatini, forced out after sexual harassment accusations, to lead new Boston team, STAT

Thanks for reading! More tomorrow,


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