Title: Adherence to Adjuvant Neuropathic Pain Medications in a Palliative Care Clinic
What Caught Our Attention: We’ve found a fourth retraction for the unlicensed use of a common research tool, an issue we explored in depth for Science last year. Quick recap: When researchers use a copyrighted questionnaire (MMAS-8) without permission, they get a call from its creator Donald Morisky (or his representative), asking them to pay up — sometimes thousands of dollars. There’s another option: Retract the paper. That was the choice made by a group of researchers in Arkansas, who — in a nicely detailed notice — note that, since the scale was developed using federal funds, “they dispute the validity and reasonableness of Dr. Morisky’s demands in light of the National Institutes of Health’s Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.”
Journal: Journal of Palliative Medicine
Authors: Lindsey Dayer, Sarah Harrington, Bradley Martin
Affiliations: University of Arkansas for Medical Sciences, Arkansas, USA
The Brief Report article entitled, “Adherence to Adjuvant Neuropathic Pain Medications in a Palliative Care Clinic,” by Lindsey Dayer, Sarah Harrington, and Bradley Martin in the May 2016 issue of Journal of Palliative Medicine (JPM), [19(5): 538 – 541; DOI: 10.1089/jpm.2015.0230] requires a retraction due to a legal dispute regarding the eight-item Morisky Medication Adherence Scale (MMAS-8) which was adapted for use in the article.
Dr. Dayer’s article appropriately cited the original article in which the MMAS-8 scale appeared, and the original MMAS-8 article notes that the development of the scale was supported with federal funds. However, after publication of her article, Dr. Dayer was notified by Dr. Morisky’s legal counsel that Dr. Morisky asserted a copyright interest in the MMAS-8 scale, and that its reuse required both a substantial royalty payment and the licensed use of an electronic grading system developed by Dr. Morisky. Dr. Dayer and her institution dispute the validity and reasonableness of Dr. Morisky’s demands in light of the National Institutes of Health’s Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources, 64 Fed. Reg. 72,090 (Dec. 23, 1999). As a result of Dr. Morisky’s demands, Dr. Dayer contacted the Editor of JPM and requested that the scale be removed from her published paper. The Editor agreed.
It is important to note that the retraction of Dr. Dayer’s article is not the result of any misconduct on her part or that of her team. The retraction serves to remove the published version of the article that contains the MMAS-8 scale, and replace it with a revised version that does not contain the tool or any references to it. The elimination of the scale does not alter the conclusions of the study.
Date of Article: February 2016
Times Cited, according to Clarivate Analytics’ Web of Science: 0
Date of Notice: February 2, 2018
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Federal funds are frequently used to create intellectual property that is copyrighted/patented and subsequently licensed by researchers or their institutions. If folks want to change the regulations for intellectual property generated with federal funds, that is a worthwhile discussion, but they should be wary because it won’t stop at questionnaires – drugs, devices, software, techniques, etc. that are developed under grants could also be subject to such a regulatory change.
Just because the government funded its creation does not mean that it is in the public domain.
The point of the retraction notice isn’t that the regulations need to be changed, or that Dr. Morisky’s scale is in the public domain. Rather, the point is that Dr. Morisky’s demands are incongruent with the NIH’s published guidelines on the dissemination of research tools developed with federal funds. The U.S. Government has rights in such tools pursuant to the Bayh-Dole Act. Those rights are triggered when a grant recipient refuses to engage in the highest and best use of IP developed with federal funds.
The NIH guidelines set forth a thorough and thoughtful analysis. The following statements are particularly relevant to Dr. Morisky’s demands:
“Reach-through royalty or product rights, unreasonable restraints on publication and academic freedom, and improper valuation of tools impede the scientific process whether imposed by a not-for-profit or for-profit provider of research tools…
“[NIH funding] Recipients should take every reasonable step to streamline the process of transferring their own research tools freely to other academic research institutions using either no formal agreement, a cover letter, the Simple Letter Agreement of the Uniform Biological Materials Transfer Agreement (UBMTA), or the UBMTA itself.”
The whole reason Dr. Morisky’s actions are newsworthy is that he refuses to freely transfer the right to use the MMAS to other academic institutions in violation of NIH Guidelines. Notably, the Guidelines themselves prescribe the appropriate response to these types of actions — they encourage academic institutions to “refuse to yield on unacceptable conditions” placed on the acquisition of research tools supported by federal funding.
In my opinion such tools should be free to use, but if US law protects this kind of copyright, then that’s how it is. Something is suspect about an 8-question list that requires a “proprietary scoring algorithm” for correct evaluation. Scientists should be able to examine what they and their colleagues do. Self-respecting, public-spirited researchers can develop alternative scales.
In case it wasn’t noted here before, there’s a curious “systematic review and meta-analysis of the Morisky Medication Adherence Scale-8” by Moon et al. on PLOS ONE (2017), https://doi.org/10.1371/journal.pone.0187139.
The last author as stated is Donald E. Morisky. Nontheless, enthusiasm for the scale’s performance is modest: “Conclusions: The MMAS-8 had acceptable internal consistency and reproducibility in a few diseases like type 2 diabetes. Using the cut-off value of 6, criterion validity was not enough good to validly screen a patient with nonadherence to medication…”
Moreover, there’s a statement: “Competing interests: The authors have declared that no competing interests exist.”
Something seems strange about authorship, the competing interest statement, or both.