Wednesday, December 28, 2011

Copyrights and Copylefts in Medicine: The Case of the Wayward MMSE



The Mini-Mental State Exam (MMSE) is the most widely used cognitive screening test. Many have attributed this to the relative simplicity, portability, and brevity of the MMSE, as well as its ability to track the change in cognition over time. However, undoubtedly the biggest reason is that for most of its nearly 40 year life span, it has been free for anyone to use and reproduce, as the creators of the MMSE never enforced their copyright.

Our previous GeriPal post on the MMSE's copyright describes how times have changed:

“This test used to be freely available online, in books, and on pocket cards that were distributed to medical students and residents throughout the country. This all changed in March of 2001 when MiniMental, LLC (the current owners of the MMSE copyright) granted Psychological Assessment Resources (PAR) the exclusive rights to publish, license, and manage all intellectual property rights to the MMSE. Suddenly, after decades of neglect, PAR began enforcing the copyright on the MMSE (see "stealth patents"). Now physicians would have to pay about $1 per test, and importantly, another barrier to cognitive screening was erected.” 

Now I’m not against people making money out of their work, but I do believe that it is an ethically and academically bankrupt act to quietly hold on to a copyright until a market emerges for it, and then enforce it for financial gain.

It can’t be legal though, right? Despite talk from many arguing that the MMSE’s copyright has been lost due to lack of enforcement, no one has contested PAR’s position in court. In fact, PAR is aggressively taking down other improved cognitive screening tests – most notably the Sweet 16 (see the comment section of our previous geripal post on this subject).

Some academicians are fighting back, although not necessarily in a court of law. John Newman (a research fellow at UCSF’s Division of Geriatrics) and Robin Feldman, a professor of law at the University of California Hastings, shot an opening salvo of sorts in their New England Journal of Medicine (NEJM) perspectives piece titled “Copyright and Open Access at the Bedside” (which is free to download).
John Newman, MD, PHD

Drs. Newman and Feldman warn that the case of the MMSE should be viewed as harbinger of things to come when copyright law mixes with medicine:

“Many clinical tools we take for granted, such as the Katz Index of Independence in Activities of Daily Living, fall into the same “benign neglect” copyright category as the MMSE did before 2000. At any time, they might be pulled back behind a wall of active copyright enforcement by the authors or their heirs.” 

As a way around this sad state of affairs, Drs. Newman and Feldman argue that:

"Any new tool developed with public funds should be required to use a copyleft or similar license to guarantee the freedom to distribute and improve it, similar to the requirement for open-access publication of research funded by the National Institutes of Health."

I couldn’t agree more with the authors. In fact, if you scroll down to the bottom of the GeriPal webpage, you’ll find a type of copyleft license, a Creative Commons Attribution-Share Alike 3.0 United States License. This means you are free to share (to copy, distribute and transmit the work), to Remix (to adapt the work), and to make commercial use of any work on GeriPal. The two requirements are that you cite GeriPal and that you agree to “Share Alike” (if you alter, transform, or build upon a GeriPal post than you must distribute the resulting work only under the same or similar license to this one.)

I’d also like to take it one step further than the NEJM perspectives piece. As clinicians, educators, and researchers, we should also avoid using clinical tools that do not conform to the copyleft standard. The MMSE is no longer a major part of my teaching as a clinician-educator.  I actually now advocate against its everyday use. In addition to PAR's stance on the MMSE's copyright, I find that the MMSE is far to heavily weighted on orientation and language questions, and largely ignores executive functioning tasks. It also does a poor job discriminating between cognitively normal adults and those with MCI or with early dementia.

There are alternatives to the MMSE, most notably the Montreal Cognitive Assessment (MoCA).  It is a free, brief, and validated screening tool with high sensitivity and specificity for detecting MCI and dementia (http://www.mocatest.org).  And unlike the MMSE, the MoCA has never wavered in its copyright permissions.


By: Eric Widera


References:

Newman, J., & Feldman, R. (2011). Copyright and Open Access at the Bedside New England Journal of Medicine, 365 (26), 2447-2449 DOI: 10.1056/NEJMp1110652

11 comments:

ken covinsky said...

Great post Eric. John makes a compelling case that the authors of the MMSE had the full legal right to pull the MMSE from the public domain. But what is legally right is not necessarily right. And the actions of the MMSE authors are wrong. Very wrong.

What is so bad about what they did? Well, they did this work as academics and allowed the work to infiltrate clinical practice for years. Maybe they did not extract royalties, but they were richly paid. Very richly paid. They won academic fame and accolades. These were well deserved. These are what most academicians consider the rewards of their work. To accept all these awards, and pull the test from the public domain after its widespread use is just awful.

There is something else really bad about this. A clinical scientist developing a clinical tool should hope that the tool will improve public health and the care of patients. This means expecting that future investigators will try to improve on their tools.

The Sweet 16 research team was acting in this proud scientific tradition, improving the MMSE by making a shorter, more usable test. The squelching of the Sweet 16 by PAR is deplorable.

I agree with Eric that the MMSE should no longer be used. The Geriatrics community should declare the MMSE dead--a test now of historic significance. Instead, we should advovate for newer and better tests, whose authors act in the public health interest.

ChrisO said...

SLUMS is another option out of St Louis Univ .

Alex Smith said...

This is a serious issue, and as John Newman and Robin Feldman describe in their perspective, it's an issue that extends beyond mental status testing. The Katz ADL inventory could be removed from the public domain at any time. New small molecules are discovered and patented everyday. Often the funding for these discoveries can be traced to public health funds (NIH grants). How far does the academic responsibility to the public extend to make these discoveries, inventions, and intellectual property freely available?

It may be that the holders of these patents who decided to profit from them envisioned making money by licensing to private industry/pharma for use in large trails. I heard one of the creators of the SF-12, one of the most widely used measures of health related quality of life, say that was his intended purpose, and that public researchers could obtain the test at a reduced rate or for free.

Still, attention needs to be brought to this issue. A collective boycott of the MMSE is a good start.

As I was reading John's essay, I wondered what has become of the MMSE creators, Paul McHugh, and Marshal and Susan Folstein? Have they commented on this issue? Have they given up all rights to the Psychological Assessment Resources (PAR) firm? Is that firm a "patent troll"? See great NPR story about patent trolls - just google "when patents attack". Perhaps pressure can be brought to bear on the originators of the MMSE to make it public use, or on PAR.

Eric Widera said...

Marshal and Susan Folstein replied to the an article in the Journal of Geriatric Psychiatry and Neurology titled ''The death knoll for the MMSE: has it outlived its purpose?'' (http://jgp.sagepub.com/content/23/3/158.extract)

They state:

"We always held the copyright, but began to enforce it for two main reasons: the plethora of unauthorized and inaccurate translations, and its commercial use by pharmaceutical companies and others. The cost of the MMSE is very low compared to most psychological tests, and PAR considers requests for exemptions for users of limited means"

This doesn't really answer the question of why charge for it. A work can be free of charge (gratis) and/or have little to no restrictions on its use (libre). It appears that the Folsteins decided that the MMSE should no longer be "free" in either the gratis nor libre meaning of the word.

Eric Widera said...

It also makes we wonder where other commonly used tests fall with their copyright license? Are we to expect the same from these tests:

Edmonton Symptom Assessment Scale (ESAS)?
iADLS?
Two question depression screen?
The Wells score for PEs?
Ranson's Criteria?
The MELD or Child Push Score?
The anion gap equation?
The cockroft-gault?
CHADS2 for A Fib?
Framingham Risk Score?
TIMI Risk?

Makes you wonder if we will need virtual vending machines in the near future where we feed a dollar into the machine every time we use one of these clinical tools. Actually, I'm guessing there already is an app for that.

SB. Leavitt, MA, PhD said...

Copyright can be a sticky issue. We have always retained copyright to original works at Pain-Topics.org; whereas, we put Opioids911.org under a Creative Commons copyright. I've never refused anyone who wanted to freely reproduce and distribute our work for educational or clinical purposes. The real concern is that without some form of copyright protection, someone can take our work, copyright it themselves, and charge for it. Technically, they could then turn around and acuse us of violating their copyright on our own work. I don't think Creative Commons offers adequate protection against this sort of predatory behavior. It is saddening how greed can sometimes trump the public good.

Sam Blaine said...

Someone should sue. A good "intellectual property" attorney could likely convince a court that everyone who had used the test for free in the past was given a "license" to use it by the copyright holder. The LLC could only buy what the copyright holder owned and that would not include the previous licenses.

John Newman said...

Great discussion! Thank you all for your thoughts, my goal in writing this was to get people thinking and talking about how copyright will affect medicine. Very glad to see that happening!

I wanted to share a few links that didn't make it into the article, regarding PAR strategy in all this. The owner of PAR comes out quite firmly against "piracy" of their tests, and says they actively seek out infringers on the internet. I found one example of an actual take-down letter. Their official stance is to not permit full copying of the MMSE in any format, even under license.

But this is emphatically not about "bad behavior". All of this is within their legal rights, and if the Folsteins and PAR didn't do it, their heirs eventually would have - the copyright on MMSE will last until 2065 or so.

I agree with Eric that the scariest part of this is that similar action could happen with so many common tools. As it stands, anyone who writes a cognitive assessment tool needs to fear PAR's lawyers - until 2065! So much worse if the same happens with functional assessments, disease severity scores, etc etc.

John Newman said...

Drs. Leavitt and Blaine... copyright can be a very sticky issue, and it has its own legal idiosyncrasies.

Dr. Blaine, prior unauthorized use is no protection - since the MMSE was under copyright even before 2000, anyone who copied it without explicit permission was technically infringing the copyright, even if the Folsteins didn't sue them at the time. There are a few examples of authorized MMSE copies from before 2000, but none that permit re-copying. We all technically infringe many clinical tools in our practice, and the odds of any author deciding to sue people is slim - but copyright lasts a long, long time and does not lapse for neglect.

Dr. Leavitt, I think it's wonderful that you've adopted a Creative Commons license for some of your work! I'd be curious to hear about your practical experience with it. Lawsuits to defend a CC or copyleft license against infringement aren't common, but they do happen. Copyright infringement is copyright infringement - violating your CC license is the same under the law as violating the much more restrictive license of a Hollywood movie. One of the real keys to copyleft is that you retain both ownership and all copyright protections, so you can go after someone for violating your very-generous license. This is the big advantage of using copyleft licensing over placing works in the public domain. You're absolutely right, I think, that some form of copyright protection is critical. I just think we should use it to our own ends, as you are with your CC licensing.

Wes Ashford said...

I am sorry that I am about a year late on this blog, but I was attacked by PAR in the era of 2005 and asked to remove a version of the MMSE that I had on my website that was the #1 hit when MMSE was put on Google. I discussed the issue with several lawyers, and the final conclusion was that the fight was not worth the price and a better test was needed and a better place to put effort. So I hid the link. I published a paper in 2008 that fully reviewed such tests, showing that the MMSE did not have enough uniqueness to be defended in court (Ashford, Aging Health. (2008) 4(4):399-432.
http://www.medafile.com/jwa/Ashford_AH08.pdf), but PAR is a large company, and it is really pointless to pursue the issue. However, better tests are needed, particularly tests developed with "modern test theory" (not one night during an attending physician's flirt with a trainee), including "item response theory", concepts outlined in my 2008 paper. I have proposed several better tests, but that is another story.

Brett Metelerkamp said...

The Folstein's could have gone down
in medical history for making a fantastic contribution to mankind. Instead they will now be remembered for their greed. How very sad!