Thread by @KatherineEban

BREAKING: Out today, our 2-year @statnews investigation into a Mount Sinai research study called Living Brain Project (LBP), which biopsies brain tissue from living patients undergoing deep brain stimulation (DBS) to make new disease discoveries 🧵👇/1statnews.com/2024/05/01/bra…

STAT's reporting found Mount Sinai researchers made statements to patients and regulators that 8 neurosurgeons - 4 consulted by @US_FDA/4 interviewed by STAT - contend were untrue or ambiguous, when they said brain biopsies resulted in no greater tissue loss than standard DBS. /2

“To say that a DBS procedure involves the routine sacrifice of even a small block of cortical tissue is completely untrue…. It’s crazy to say that,” Kim Burchiel, head of division of functional neurosurgery at @OHSUNews told us. /3

Our investigation began at @newmarkjschool where we FOIAed, then sued, @US_FDA, @HHSGov, @NIH for Living Brain Project research documents. @FundFIJ provided a reporting grant. Over next 2 years, here's what we learned. /4

Starting in 2013, Mount Sinai DBS patients seeking relief from Parkinson's/other ailments were invited to enroll in LBP, biopsying up to 1cc of brain tissue from left & right sides of dorsolateral prefrontal cortex. (1cc roughly = size of small bouillon cube) /5

Mount Sinai documents explain biopsies result in “the same amount of tissue loss” and “in effect, the same level of risk” for patients as standard DBS, because they are removing tissue that would otherwise be cauterized. /6

In 2013, when Mount Sinai applied to FDA to enroll small group of DBS patients in LBP, consulting neurosurgeons advised FDA that tissue loss was not routine part of DBS. FDA first disapproved, then approved, study and limited it to 6 patients. /7

LBP grew, w/ Mount Sinai IRB clearing researchers to take 2 biopsies per patient, enroll DBS patients w/ any diagnosis, and by 2017 expand to 500 patients. LBP is co-led by son of Dennis Charney, Icahn School of Medicine dean, who served as key advisor in study design. /8

In 2019, LBP came back on FDA's radar, when a device maker asked to modify electrode. FDA reviewers studied LBP history, grew alarmed, wrote internal report stating: “investigator-physicians are abusing or exploiting the trust of their patients” + "TISSUE REMOVAL MUST STOP..." /9

But it didn't. We found no evidence FDA shared its concerns w/ Mount Sinai, even though FDA review determined that study was "likely out of compliance with the Common Rule" that protects human subjects, and advised FDA work w/ @HHSGov Office for Human Research Protections. /10

“The numerous actors and the diffusion of responsibility apparently led to no one being responsible for the safety of the patients,” @caraET told us. “The fact that there are so many safeguards and none of them worked is a structural tragedy." /11

In 2020, Mount Sinai researchers obtained NIH grant to expand biopsy study to a second site, Rush Medical Center in Chicago. Researchers told NIH that LBP had been "approved by FDA and IRB." /12

Mount Sinai told us that FDA had no jurisdiction over LBP, that its study has appropriate IRB oversight and that the average LBP biopsy is 0.04cc. The story posts their responses in full: /13statnews.com/wp-content/upl…

It was an honor to work with the A+ team at @statnews, including @JasonUkman @rickberke @GideonGil Laura Chang @sarahmupo @alissa_ambrose Karen Pennar Alex Hogan and others. /14

Thank you to many experts who were generous w/ their time, including: Kim Burchiel, Ruth Macklin, @GrossRobertE, @JaimieHenderson, @Dr_Weinberger, @ktkadakia, @caraet Stephen Rosenfeld Karen Rommelfanger /15

The @NewmarkJSchool grads who worked on this are among the best & brightest: @emily_nadal @ZackMS @brucgl @audreyjcarleton. Lastly, the article is behind a paywall, so please subscribe to @STATNews; producing quality journalism costs $$ /16statnews.com/subscribe/