Retraction Watch

Tracking retractions as a window into the scientific process

If you use this research tool without permission, you’ll hear about it

with 24 comments

Sometimes, a seemingly run-of-the-mill retraction notice turns out to be much less straightforward.

Such was the case with a recent retraction of a 2016 paper in a journal published by the U.S. Centers for Disease Control and Prevention, apparently over permission to use an evaluation scale designed to test whether patients take their medications as prescribed. But when we looked into this story, we learned this retraction was only the tip of the iceberg – a representative of the evaluation scale (titled “Chief Investigator”) told us he has contacted hundreds of so-called “infringers” over the last year who used the scale without permission. The authors must then apply retroactively and show they’ve used it correctly, and may even have to pay fees. Or, in the case of the retraction we saw (and at least one other in 2016), pull the paper.

According to the chief investigator, Steve Trubow, who oversees licensing and use of the scale worldwide, for some uses, there is no fee – but depending on what the researchers are using the Morisky Medication Adherence Scale (MMAS-8) for, it can cost up to $100,000. Once they’ve used it without permission, there are fees for that, too, Trubow told us:

Retroactive license[s] cost $100 to $40,000…In the United States one large hospital system paid $40,000.00 in 2016.

He said thousands have licensed the MMAS, but too many don’t:

As the Chief Investigator one of my responsibilities is to protect the integrity of the MMAS from Infringers who misuse the MMAS…I have contacted hundreds of Infringers over the last year.

One such infringement led to the following retraction notice for “Health and Nutrition Literacy and Adherence to Treatment in Children, Adolescents, and Young Adults with Chronic Kidney Disease and Hypertension, North Carolina, 2015,” published by Preventing Chronic Disease:

Due to an unintentional error, the MMAS-8 scale in our article, “Health and Nutrition Literacy and Adherence to Treatment in Children, Adolescents, and Young Adults with Chronic Kidney Disease and Hypertension, North Carolina, 2015” (1), published on August 4, 2016, by Preventing Chronic Disease, was used without proper permission from Dr Donald E. Morisky and coauthors. We regret any problems our article may have caused, and we retract it from the literature.

When Trubow first came across Patel’s article in August, he contacted her to check whether she had received a license to administer and use MMAS scale. According to emails Trubow forwarded to us, Patel said that she had asked for permission in 2015 from Donald Morisky, a professor in the School of Public Health at the University of California in Los Angeles who created the scale — and forwarded the email to prove it.  After not receiving a reply, however, she and her coauthors published the article using the MMAS scale, which she said they found online.

Trubow informed her that she could apply for a license retroactively. The license includes 13 questions about the authors, the study, and how the scale was administered, which Patel then answered.

As Trubow asked more questions about the scoring the researchers used in the paper, he and Morisky realized the researchers had applied the scoring incorrectly. In an email sent August 15, Morisky informed Patel that the scoring approach she and her coauthors used “will incorrectly identify individuals who are “highly adherent” as “low adherence” and vice versa…” This scoring approach, he continued, “will result in an inappropriate educational counseling intervention. This is a very serious misrepresentation of the validated MMAS-8. I am very concerned as to the repercussions of the inaccurate information you have published in a highly valued journal.”

Patel responded to Morisky the same day, apologizing and saying she had no intention of misusing the material.

On August 20, Trubow reached out to the journal’s editor-in-chief, Leonard Jack (and CC’ed Patel), to investigate the copyright infringement issue as well as the changes the authors made to the scale.

On December 21, Jack informed Morisky and Trubow of the journal’s final decision to retract the article:

After reviewing the information provided to us from the authors and from University of North Carolina’s institutional investigation, we recommended that the authors issue a retraction of the article. The authors have agreed with this recommendation, and a retraction will be published in PCD on Friday, December 23, 2016. Further, the retraction will be indexed in the literature according to AMA guidelines.

Jack also provided us with further context on the retraction:

The article was submitted for our annual Student Paper Research Contest and published on August 4, 2016, and used [Morisky’s] copyrighted survey instrument, the MMAS-8, without proper permission and was incorrectly scored. We promptly looked into these concerns and reached out to the authors for an explanation. Ultimately the authors decided to retract the article, and the retraction was published on December 23, 2016. To address any potential for a similar circumstance in the future, we have added survey instruments to the authorship statement of our manuscript submission system, which requires authors to acknowledge that the appropriate permissions have been obtained.

We reached out to the three study authors for comment, and have not yet heard back.

Regarding the unlicensed use of his scale, Morisky told us:

I have worked my entire career to protect the integrity of my intellectual property and unauthorized use is a serious infringement of international copyright laws.

Trubow forwarded us email correspondence that led to another recent retraction in the International Journal of Integrative Medical Sciences for a similar copyright infringement issue regarding unlicensed use of the MMAS scale. Here’s the retraction notice for “Prevalence of Patients Compliance among Hypertensive Patients and Its Associated Factors in Klinik Kesihatan Botanic Klang, Malaysia,” published in 2016:

The editor and Publisher regretfully retract the article [1] as per the request of the author’s, “upon the careful consideration of the issue”. We apologize to all affected parties for the inconvenience caused.

As part of that correspondence, the first author also apologized to Trubow for the use of the scale, saying the work was done by students who found the information online for free. The researcher answered the questions Trubow sent, then asked that the fee be waived, as the work was done without any grant. Trubow responded on December 28, 2016:

There will be a cost of $750.00 (USD).

This is a reduced fee for a corrective license.

The usual cost for serious infringements is $1000.00.

It costs us a lot of money to investigate and correct the infringements

If you don’t want to pay the fee, I will not prepare the license.

Let me know.

A few hours later, the author wrote back, saying they were no longer interested in using the scale, and had asked the journal to remove the paper.

Trubow stays busy — he forwarded us some emails he sent regarding a recent BMC Women’s Health paper, “Compliance and treatment satisfaction of postmenopausal women treated for osteoporosis. Compliance with osteoporosis treatment,” which he claimed violated the scale’s copyright. In this case, however, an assistant general counsel for GlaxoSmithKline (the company that funded the study) rejected Trubow’s claim that the article infringes on any copyright, also noting that the MMAS-4 questions and methodology are in the public domain. Trubow then contacted representatives of BioMed Central on January 14, saying:

Unless the BMC journal notifies us that it plans to remove the attached article, we will be forced to have our lawyer, Mr. Kenneth Gross use all legal means necessary to remove the article.

Trubow has licensed the scale to thousands of papers and many studies acknowledge that the Morisky scale is copyrighted material. For instance, according to a 2015 paper published in the Eastern Mediterranean Health Journal, a World Health Organization journal:

Use of the MMAS© is protected by United States copyright laws. Permission for use is required. A license agreement is available from Donald E. Morisky …

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Comments
  • Marco January 26, 2017 at 10:47 am

    Obvious question to ask: how would people know you need a license for MMAS-8?

    • steve trubow March 5, 2017 at 11:19 am

      My name is Steve Trubow. I am the Chief Investigator for the MMAS-8 scale. Our primary concern is the misuse of the scale, NOT COPYRIGHT or TRADEMARK INFRINGEMENTS.
      This scale is more than just a one off raw score for medication adherence. It has been validated in over 80 languages in 50 counties as a diagnostic assessment instrument that predicts the risk level of non-adherence behavior that can be correlated with physiological measures of disease. We now have 110 condition specific MMAS-8 tests for hypertension, HIV, Diabetes, etc, that have sensitivity of 93% . The MMAS-8 if used correctly can save lives. If used incorrectly with counterfeit scoring and coding that can be downloaded on the internet, it can put patients at risk of severe harm. If you no of anyone who is using the MMAS-8 without license or anyone who would like to obtain a license, please contact me at trubow1@gmail.com

      • Anonymous March 6, 2017 at 6:39 am

        Maybe you can explain how obtaining a license is preventing the licensee from misusing the scale.

  • DWalker January 26, 2017 at 2:05 pm

    Marco: I would guess that if you use the scale, you need a license.

    • Marco January 27, 2017 at 1:30 am

      But if you get it from the paper that describes it, and it does not say you need a license? Again, how would you know?

  • anon January 26, 2017 at 2:53 pm

    I’m not an expert in medicine or public health, but this kind licensing scheme sound very fishy to me.

    • ELF January 27, 2017 at 11:35 am

      Licensing is very common and the requirements vary considerably. Some copyright holders require signed agreements, some require payment of fees (which may differ depending on types of use and/or number of participants), some require those administering the scale to have specific training and/or qualifications. In my training sessions with clinicians and researchers, I suggest they identify copyright holders and licensing requirements as one of the first steps in evaluating scales.

  • Kathy January 26, 2017 at 5:02 pm

    The scale doesn’t even look particularly valid to me. One of the items (out of a total of six items) is, “Do you know the long-term benefit of taking your medicine as told to you by your doctor or pharmacist?” How does a patient answer if they know the long term benefits from a source OTHER than their doctor or pharmacist (like reading the information insert?). I could explain more how to improve the reliability and construct validity of this scale, but my fee is $1,000.

  • Jack January 26, 2017 at 6:19 pm

    How do you copyright something that is a) funded by government grants, b) published by a journal, c) is 8 questions.

    • MM January 27, 2017 at 2:32 am

      I can answer to your questions, but I’m afraid you’ll ask me to pay.

    • Anonymous January 27, 2017 at 3:36 am

      I have the same question. How on earth is it possible to make a business out of a set of 8 questions?

    • Kathy January 27, 2017 at 5:21 pm

      I got to the 4 item scale and modified six version scale from the link in the post:
      “MMAS-4 questions and methodology are in the public domain.” This links to the Guidelines from the Case Management Society of America for improving patient adherence to medication therapies (2006). Case Management Society of America.

  • Paul January 26, 2017 at 10:30 pm

    The scale was generated in this publicly funded project (NHLBI grant Award Number RO1 NH251119 and NIA grant R01AG022536):

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2562622/

    • ELF January 27, 2017 at 9:41 am

      The original MMAS-4 was supported by different grants (https://www.ncbi.nlm.nih.gov/pubmed/3945130) :
      1-R25-HL1701603/HL/NHLBI NIH HHS/United States
      1-T32-HL0710-02/HL/NHLBI NIH HHS/United States
      RR 5542/RR/NCRR NIH HHS/United States

      The Bayh-Dole Act in the USA means that IP generated from government funding belongs to the grantee (UCLA), not the funder. Many major grant funding organisations have similar policies regarding IP generated through research funding.

  • Gary January 27, 2017 at 6:36 am

    Hmm – if the people who used the scale downloaded it from a site that did not explicitly explain a licence would be required before use (and then are retro-actively billed by the licence holders) then, I think, the site should be help accountable for the payments (it is after all the same as allowing the download of pirated videos/music).
    If a site is actually run by the licence holders (and no mention of fees are made) then its a scam.
    I had a scan of the document (by the Case Management Society of America) in the link in the main article above and the entire scale (questions are listed along with a description n how to use them, Chapter 7). No mention is made at all of a licence or the need to get one. Either this is a large oversight by the CMSA or they did not know this either (which suggests it is a little known fact).
    Also $40 000 for the right to ask a handful of questions!!!
    I hope the money is going back to the body who funded this work.

    • ELF January 27, 2017 at 9:30 am

      The CMSA document is bizarre. First, it doesn’t even cite the correct publication for the original MMAS-4 , which was published in 1986 (not 1983) – https://www.ncbi.nlm.nih.gov/pubmed/3945130 ). Second, it has no citation at all for the “Modified Morisky Scale”. I work with both MMAS scales and have never seen a publication co-authored by Morisky for a 6-item scale. Third, MMAS does not have two domains. The scoring shown in the CMSA document therefore not only reverses the true MMAS scoring (compared with MMAS / Morisky publications), but shows domains which have never been defined or validated.

  • Diana January 28, 2017 at 2:44 pm

    This is a fascinating situation from a copyright/IP point of view. It seems to be a fuzzy use of copyright to protect the expression of the questions but also the idea of the scale itself. Doesn’t this open the, I think, undesirable possibility of similar “licensing” of e.g. predictive statistical models?

  • Diana January 28, 2017 at 2:47 pm

    P.S. I also think the commerce side of this is fascinating. The licensors want to encourage enough use to embed the scale as a standard, while maximizing their income. It would be very interesting to see who gets charged what.

  • George February 6, 2017 at 3:38 am

    Indeed Diana, it may be very interesting to know whoelse is suffering under these claims?

  • Benjamin Nasara Joseph April 14, 2017 at 2:58 am

    Do i have to request for permission to use the Morisky scale if my study seeks to validate the scale for use in my local community/country?

  • Trubow April 24, 2017 at 10:14 pm

    If you don’t have a signed MMAS license
    Don’t use it
    Get legal or pay the consequences
    Morisky.org

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