FDA transparency, drug approvals, database investigations | Erick Turner
Erick Turner, MD, is a Professor Emeritus of Psychiatry at Oregon Health & Science University. He is a clinician-researcher with regulatory experience as an FDA Medical Officer, in which capacity he reviewed INDs and NDAs on psychotropic drugs being considered for FDA approval. More recently, while in academic medicine, he served as a member of the Psychopharmacologic Drugs Advisory Committee (PDAC).
Dr. Turner consults with clients regarding drugs already approved and those in the pipeline. To give the most objective advice, he is free of financial conflicts of interest, so he neither invests in, nor consults to, parties with a vested interest in particular drugs, esp. pharmaceutical and biotech companies. Instead, typical clients are investment firms trying to estimate the likelihood of FDA approval for new drugs based on clinical trial results and other factors.
In his academic research, he has revealed the selective publication of clinical trial results by comparing drug efficacy as conveyed by published journal articles vs. regulatory sources, esp FDA Drug Approval Packages. His best-known publication (NEJM 2008) revealed a striking amount of publication bias with antidepressant trials, leading to an inflation of their apparent efficacy. This paper received wide coverage in the national and international press, and, according to Scopus, has been cited by over 1900 other journal articles, placing it in the 99th percentile. Overall, he has authored or co-authored ~90 publications in peer-reviewed journals.
Other research interests include FDA drug approval standards, esp how they have been evolving over time.
Motivated by his FDA experience, Dr. Turner and co-authors have published articles re-examining the efficacy of various psychotropic drug classes, the best known of these being a paper published a January 2008 article in the New England Journal of Medicine entitled “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy”. This article received wide coverage in the national and international press and was ranked the 10th most highly cited scientific article in 2008 and, as of the end of 2015, has been cited by over 1000 peer-reviewed journal publications and 700 books.
OUTLINE:
0:00 - Intro
0:57 - Erick's role at the FDA
1:35 - Reviewing psychiatric drugs at the FDA
9:21 - How bias reverberates through the review process
10:53 - Erick's 2004 paper on taxpayer-funded clinical trial registry and results database
15:30 - Transparency around drug/disease pairs
17:06 - Erick's 2008 study in the New England Journal of Medicine about negative clinical trials of psychiatric drugs not being published
21:47 - The 2022 update of Erick's 2008 study; what changed?
26:14 - Erick's workflow for investigating unpublished drug trials
30:27 - Why does publication bias happen? Why do trials go unpublished?
36:47 - Registered reports for clinical trials
44:10 - Uptake of registered reports for clinical trials
48:02 - Registered reports ensure the informativeness of null results
50:05 - Erick's JAMA Psychiatry study of the effectiveness of the antidepressant Gepirone
57:28 - Solutions to problems of transparency and incentives around clinical trials; role of the FDA
1:03:24 - The role of physicians
1:10:01 - Unpublished trials are PUBLIC! They are in open vaults; Erick's study on how to use them for research
1:12:23 - Advice for young listeners
1:16:42 - Outro
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