COI: Alive & Thriving at NEJM

COI: Alive and Thriving at the NEJM
by David J. Elpern, M.D.

Abstract: As a reader of the New England Journal of Medicine for more than 50 years, I have observed its growing entanglements with the pharmaceutical industry.  This analysis of a recent NEJM research article highlights authorial and editorial conflicts of interest (COI) and discusses how the Journal benefits financially from pharmaceutical advertisements for the very drug reported on in the Original Article.  What does this say about top tier medical publishing when the world’s most prestigious medical journal is clearly intertwined with the drug industry?

The December 3, 2020 issue of the New England Journal of Medicine (NEJM), has an Original Article about a new indication for the anti-cancer drug pembrolizumab.1 The disclosures for the 21 lead authors’ run 149 small-font lines. In the last paragraph of this section is the statement “thanking Luana Atherly-Henderson (Merck Sharpe and Dohme) for medical writing assistance.” In other words. LA-H was the “ghost-writer.”  Her website leads with “As a medical writer for more than 10 years, I am well-versed in the preparation of succinct, submission-ready manuscripts.”2  Ms. Atherly-Henderson appears to be primarily a medical writer, subcontracted to prepare this article, not a full-time employee of MS&D.

Of the 21 lead authors, only three are from the US. CMS Open Payments for the three US authors is revealing:
Johanna Bendell – $10,869,000 of Associated Research Payments
Dung T Le – $2,366,000 Associated Research Payments
Luis A. Diaz’s name does not appear on OpenPayments

Dr. Luis Diaz is Head of the Division of Solid Tumor Oncology at Memorial Sloan Kettering Cancer Center.  Before he joined MSKCC, it had recent scandals of its staff regarding conflicts of interest.3 It seems that Diaz may have figured out a way to hide his industry connections. Diaz has founded several companies that focus on cancer genomics, including Inostics, PapGene, and Personal Genome Diagnostics and was named to the Board of Directors of Jounce Therapeutics, a publically traded company, in 2017.4  His annual reimbursement for that role in 2018 was $85,553.5 He may be a bigger fish than the key opinion leaders who can be tracked by OpenPayments.

This NEJM issue has an editorial on pembrolizumab by Axel Grothey, M.D. a researcher at the West Cancer Center and Research Institute in Tennessee.6  CMS OpenPayments shows that he has received $6,143,354  of Associated Research Payments from 2014 – 2019 as well as $560,000 in General Payments.  Dr. Grothey’s disclosure statement for this editorial reports that he has “received grants from Merck” (the company that makes pembrolimizab (Keytruda®). Should a clinician with ties to a company that makes the drug discussed write an editorial about the drug?

The December 3, 2020 issue of the NEJM has 99 pages of pharmaceutical advertisements.  Among these are nine full-page of ads for Keytruda (Pembrolizumab) and one is the prominent back cover. In addition to the Keytruda ads, 78 are for other cancer drugs and only 12 pages of ads are for other medications.

The NEJM has the highest Impact Factor of any medical journal in the world.  Here we dissect a ghost-written drug study preformed by respected academic and clinical researchers who are highly remunerated by industry.  The editorial on the study was written by an oncologist with significant ties to the pharmaceutical industry, and some to the company that makes pembrolimizab.  In addition the Journal benefits financially from drug ads, in this case even ads for the treatment that was studied in the Original Article.1

As a dermatologist, I am keenly aware of how aggressively biologic drugs are researched, promoted and marketed.  Cancer medications appear to be an even more lucrative field.  Here we see how one of our most respected journals benefits financially from running these articles.

References:

1. Thierry André  et. al. Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer. N Engl J Med. 2020 Dec 3;383(23):2207-2218.

2. Luana Atherly-Henderson’s website. ANKHMEDICAL http://www.ankhmedical.com/

3. Memorial Sloan Kettering Leaders Violated Conflict-of-Interest Rules, Report Finds (Published NY Times April 2019)

4. Luis A. Diaz, M.D., Wikipedia https://en.wikipedia.org/wiki/Luis_A._Diaz, (accessed December 6, 2020)

5. Salarycom  https://www1.salary.com/JOUNCE-THERAPEUTICS-INC-Executive-Salaries.html  (accessed December 6, 2020)

6. Axel Grothey, M.D., https://westcancercenter.org/doctor/axel-grothey-md/

Image from Financial Times, 2019
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