Anil Potti, the former cancer researcher whose work has become the subject of intense scrutiny that has already led to the retraction of five papers, didn’t tell the Journal of the American Medical Association (JAMA) about two very relevant corporate relationships he had when he published papers there, Retraction Watch has learned.
JAMA has published two papers by Potti and colleagues: 2008’s “Gene Expression Signatures, Clinicopathological Features, and Individualized Therapy in Breast Cancer,” and 2010’s “Age- and Sex-Specific Genomic Profiles in Non-Small Cell Lung Cancer.”
The Cancer Letter, which has been way out front in the Potti case, first reported Potti’s relationships with Eli Lilly and CancerGuide Diagnostics (formerly Oncogenomics, Inc.). As The Chronicle, Duke’s student newspaper, reported last September, the two companies cut their ties with Potti in July 2010 after allegations of misconduct and lying about a Rhodes Scholarship came to light.
But that was after the two papers were published, and Potti had relationships with both since 2006. As The Chronicle notes, he was a director at CancerGuide Diagnostics (formerly Oncogenomics, Inc.), and
Eli Lilly paid Potti $15,000 in 2010 to speak to other doctors, according to a disclosure document on the company’s website. Cox said Potti lectured to oncologists about one of Eli Lilly’s chemotherapy drugs.
Late last week, JAMA told us that the reason why neither paper reports any corporate ties is that Potti had not disclosed those relationships:
JAMA publishes financial disclosures as reported by the author.
Apparently, Retraction Watch was the first to ask JAMA about the implications of The Chronicle story:
We will take the information about the corporate relationships mentioned in that article under consideration and follow our usual approach for evaluating it.
Journal conflict of interest policies are not uniform, but JAMA’s is very clear and includes this language:
- Any potential conflicts of interest “involving the work under consideration for publication” (during the time involving the work, from initial conception and planning to present),
- Any “relevant financial activities outside the submitted work” (over the 3 years prior to submission), and
- Any “other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing” what is written in the submitted work (based on all relationships that were present during the 3 years prior to submission).
It also says
Although many universities and other institutions have established policies and thresholds for reporting financial interests and other conflicts of interest, JAMA requires complete disclosure of all relevant financial relationships and potential financial conflicts of interest, regardless of amount or value. For example, authors of a manuscript about hypertension should report all financial relationships they have with all manufacturers of products used in the management of hypertension, not only those relationships with companies whose specific products are mentioned in the manuscript. If authors are uncertain about what constitutes a relevant financial interest or relationship, they should contact the editorial office.
In our experience, this kind of failure to disclose would warrant a correction or clarification, not a retraction.
The JAMA papers are not among the five that Potti has retracted so far, and the editors have no plans to retract them at this time, JAMA said Tuesday. (We’ve been asking since January.)
We checked the five retracted papers, and none of them includes a disclosure about the two companies, either.
Failure to disclose ties and conflicts-of-interest is more common than one may imagine.
http://onlinelibrary.wiley.com/doi/10.1002/cncr.25917/full
The above highlights one such instance. These relationships have not been disclosed in any of the group’s works – which, interestingly always show the proprietary GEP test to be highly significant, and happen to have an extraordinary proportion of deaths from “unknown” causes (http://jco.ascopubs.org/content/29/5/e125.full?sid=b8438587-8b37-4192-9e7a-e6aabe16f39c).
The comment in “Cancer” is as follows:
Questions were raised by a reader about the financial disclosures provided by some of the authors of the above paper. The published disclosures were as follows:
“Supported in part by Program project grant CA55819 from the National Cancer Institute, Bethesda, Maryland.”
In response to the concerns raised by the reader, the journal followed up with the authors and asked if there were any additional disclosures that should have been included prior to publication. The authors disclosed the following information:
Dr. Shaughnessy holds patents, or has submitted patent applications, on the use of gene expression profiling in cancer medicine, use of FISH for chromosome 1q21 as a cancer diagnostic, and targeting DKK1 as a cancer and bone anabolic therapy. Dr. Shaughnessy receives royalties related to patent licenses from Genzyme and Novartis. He has advised Celgene, Genzyme, Millennium, and Novartis, and has received speaking honoraria from Celgene, Array BioPharma, Centocor Ortho Biotech, Genzyme, Millennium, and Novartis.
Dr. Barlogie has received research funding from Celgene and Novartis. He is a consultant to Celgene and Genzyme, and has received speaking honoraria from Celgene and Millennium. Dr. Barlogie is a co-inventor on patents and patent applications related to use of gene expression profiling in cancer medicine.
The editors of the journal have reviewed this additional information and determined that although the disclosures are relevant to the publication, they would not have altered the decision to accept the paper. We apologize for the lack of transparency caused by the authors’ failure to disclose this information.
Please also follow up on the disclosures of people like Joseph Nevins, who owns a company that performs gene expresaion analysis, and Geoff Ginsburg from Duke who seem to be co-authors. I have read their papers including the JAMA papers and their lack of disclosure of financial ties seems worse.
This type of undisclosed relationship is common and pernicious. When discovered, it leads to doubts in the minds of skeptical readers as to the validity of the research published. There is no bias so pernicious as the bias caused by money and the anticipation of more money for positive results. There could be a huge rotten hole in the fabric of current clinical research, especially in such fast growing and lucrative fields as cancer chemotherapy.
So, just to get this right, the companies cut their ties over concerns they had about unethical behaviour from an academic author? And these companies (or at least Lilly) had made appropriate disclosures of their previous financial relationships with this author? Sounds like a for-profit company behaved the way the scientific community would want them to…or am I just naive in thinking that organisations (whether profit or not-for-profit) are now starting to be judged on their current actions?
With yet another wave of academic-related retractions for misconduct being reported on Retraction Watch, I am still interested in an answer to the question I posted to you some time ago – how many incidents of misconduct retractions have you covered and how many of these have been due, directly, to unethical actions by a pharmaceutical company? I continue to be curious over the seeming imbalance in checks and balances for commercially vs non-commercially sponsored research. I work in both environments and believe that nobody occupies the moral high ground (despite popular media assertions). When will our system of checks and balances focus on where the problems are the greatest? See our paper (Woolley et al., CMRO, 2011) for the basis of my curiosity…and ongoing concerns about the imbalance in checks and balances….
We’ve responded to this question in another thread: http://www.retractionwatch.com/2011/12/29/seven-retractions-a-resignation-and-lawsuit-settlements-havent-stopped-anil-potti-from-publishing/#comment-8480
Thanks for your comments on both threads. I don’t see a mechanism for following up to your reply on the other thread, and rather than spend time asking detailed questions and providing in-depth replies to each of your points there, I’ll just make a couple of observations here and subscribe to both threads by RSS feed to see if there is any follow-up in the discussion.
Increasingly, I feel that there is an inherently censorial flavor to the disclosure policies now permeating biomedical science. Not to pick on Dr. Seitz, but his comments above reflect an increasingly widespread bias against commercially-sponsored research that I feel unfairly excludews huge foundations with undeniable financial interests in study outcomes. I fear that the new Scarlet letter will soon become a capitol “P” (for Pharma). This is a shame, since budget cuts and an ever-growing supply of newly minted Ph.D.’s means that industry funds will play an increasing role in advancing biomedical science.
To be clear, I support failure-to-disclose retractions whole-heartedly, since they often reveal an unacceptable level of carelessness in the rest of their work. By way of example, when we are inspected by the FDA, they use simple paperwork errors as indicators of deeper process control issues, and dive into a deeper investigation of our labs. This strategy can uncover deeper problems and often leads to warning letters requiring remediation. I think the same approach should apply to publications.
The assumption that money from Pharma necessarily taints the data is typically unprovable and likely arises from a minority of publications that involve industry-sponsored research. Do people automatically distrust company-sponsored studies of any kind? I hope not. In my position (pre-clinical translational sciences and early phase clinical development), the ONLY thing I get to publish is data from “dead” compounds. Because of project publication strategies, studies for compounds that make it to late-stage clinical development aren’t published until ~5 years after I do the work.
FWIW, the more I see of Academic science (via in-licensing of new drug targets), the more I realize that much of the current work coming from the Ivory Tower is shoddy and irreproducible, or downright fraudulent. In my experience, the bigger the lab, the more likely it is that we will have to drop a drug target for exactly those reasons. Since some Academic labs now have larger research budgets than many small biotech companies, it only seems fair to include disclosure of the number of scientists employed by the PI and the total lab budget as a potential conflict of interest.
It’s pathetic, really, that we in the biomedical sciences have become so adversarial and untrustworthy. Resurce scarcity will do that, I guess.