Health
Auditors and Experts Raise Serious Concerns Over Acclaimed Tennessee Study on Pregnant Opioid Users
Dr. Craig Towers' research suggested detoxing pregnant opioid users and treating them with naltrexone was safe, but a university audit and independent specialists found major data and ethical flaws.
The short version
- Dr. Craig Towers gained national recognition for a study suggesting that detoxing pregnant patients and putting them on naltrexone was safe and highly effective.
- A University of Tennessee audit and independent experts uncovered major flaws, including a lack of proper university approval, unverifiable data, and potential informed-consent issues.
- Despite these findings, the publishing journal only issued a brief 78-word correction, which ethics experts criticized as highly inadequate.
Key facts
- Dr. Craig Towers published a study of 230 pregnant participants—including 121 who took naltrexone—concluding that detoxing was far less harmful to fetuses than previously believed.[ProPublica]
- The study's results stood out to specialists because the reported naltrexone success rates were unusually high compared to typical relapse rates, which average 72% in nonpregnant patients across other major studies.[ProPublica]
- A University of Tennessee audit found that Towers failed to obtain university approval for the study, provided inaccurate or unverifiable source documentation, and failed to provide requested research databases or data analysis.[ProPublica]
- Eight addiction and pregnancy specialists wrote to the university to raise concerns regarding whether proper informed consent was obtained and why there was an unusual absence of serious medical events reported among the participants.[ProPublica]
- In 2023, the American Journal of Obstetrics and Gynecology published a 78-word correction acknowledging the study was improperly categorized as a prospective study, which ethics experts criticized as failing to address the deeper issues.[ProPublica]
- Towers disputed the audit's findings and the external criticisms, maintaining that his research is sound, that patients gave proper informed consent, and that the journal's decision to keep the study published validates his work.[ProPublica]
What remains uncertain
- It is unclear whether all study participants were fully and properly informed that using naltrexone to manage addiction while pregnant was an experimental treatment.[ProPublica]
- University auditors were unable to verify the underlying data analysis or determine the extent to which patient health information was protected.[ProPublica]