For
three decades after its publication, in 1975, the Mini–Mental State
Examination (MMSE) was widely distributed in textbooks, pocket guides,
and Web sites and memorized by countless residents and medical students.
The simplicity and ubiquity of this 30-item screening test — covering
such functions as arithmetic, memory, language comprehension,
visuospatial skills, and orientation — made it the de facto standard for
cognitive screening. Yet all that time, it was under copyright
protection. In 2000, its authors, Marshal Folstein, Susan Folstein, and
Paul McHugh, began taking steps to enforce their rights, first
transferring the copyright to MiniMental, a corporation the Folsteins
founded, and then in 2001 granting a worldwide exclusive license to
Psychological Assessment Resources (PAR) to publish, distribute, and
manage all intellectual property rights.
1,2
A licensed version of the MMSE can now be purchased from PAR for $1.23
per test. The MMSE form is gradually disappearing from textbooks, Web
sites, and clinical tool kits.
1
Clinicians'
response to this “lockdown” has been muted. A few commentators have
expressed concern about continuing to use a now-proprietary tool in
training
2 or about implications for the developing world,
1
echoing debates about patented pharmaceuticals. In our experience, many
clinicians are either unaware of the MMSE's copyright restrictions or
simply ignore them, despite the risk of copyright infringement.
But
then in March 2011, a promising new cognitive screening tool that was
to be available through “open access,” the Sweet 16 — a 16-item
assessment of thinking, learning, and memory developed by Harvard's
Tamara Fong
3 — was removed from the Internet at the request of PAR in an apparent copyright dispute.
4
The Sweet 16 includes orientation and three-object recall items,
similar to the MMSE's, along with a digit-span item. This action,
unprecedented for a bedside clinical assessment tool, has sent a chill
through the academic community; clearly, clinicians and researchers can
no longer live in blissful ignorance of copyright.
Copyright
derives from one of the few powers explicitly mentioned in the U.S.
Constitution. Any new intellectual work is under copyright protection
automatically from the moment it is fixed in a tangible medium of
expression — a category now including blog posts, iPhone apps, and
cognitive screening tools. Copyright law grants the author (or owner,
for copyright can be transferred) exclusive rights to copy the work,
distribute it, make works derivative of it, and perform or display it
publicly. These rights last for 70 years past the date of the author's
death, or up to 120 years from the time of creation if the work was done
“for hire.” This duration has been retroactively extended several
times, so that works published as early as 1923 may remain under
copyright today (and will until at least 2019).
For persons or
entities other than the copyright holder to copy or distribute a work,
they must have permission from the owner, usually in the form of a
license. Copying or distribution without permission is copyright
infringement and carries stiff civil or even criminal penalties. There
is limited protection under “fair use” law for certain nonprofit uses of
limited parts of a work — for example, for teaching or research — but
that exception is narrower than it sounds. One need not have intended to
infringe someone's copyright to be subject to damages of up to $30,000
per work, and willful infringers pay up to $150,000 — and may, under
certain circumstances, be subject to a jail term.
For clinicians,
the risk of infringement is real. Photocopying or downloading the MMSE
probably constitutes infringement; those who publish the MMSE on a Web
site or pocket card could incur more severe penalties for distribution.
Even more chilling is the “takedown” of the Sweet 16, apparently under
threat of legal action from PAR (although PAR has not commented
publicly). Are the creators of any new cognitive test that includes
orientation questions or requires a patient to recall three items
subject to action by PAR? However disputable the legal niceties, few
physicians or institutions would want to have to argue their case in
court.
The MMSE case may be a harbinger of more to come. 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.
What can researchers do to ensure
that our colleagues can use the tools we develop to improve patient
care? One option is to essentially place works in the public domain by
declaring free and open rights for all users. The Geriatric Depression
Scale, the Patient Health Questionnaire (PHQ-9) depression scale, and
the Saint Louis University Mental Status (SLUMS) cognitive assessment
tool are all in the public domain. That domain, however offers no
mechanism for ensuring that authors are recognized or compensated and no
means of guaranteeing that later improvements will be made freely
available. The ability to improve a clinical tool is crucial. Even
licenses granting wide permission to copy, such as those of the Montreal
Cognitive Assessment and the Lawton Instrumental Activities of Daily
Living (IADL) scale, while laudable, might still inhibit innovation by
permitting legal challenges to improved tools perceived as derivative
(as may have been the case with Sweet 16 and the MMSE).
A better
solution is to apply the principle of “copyleft” from the open-source
technology movement to encourage innovation and access while protecting
authors' rights. Copyleft is intellectual jujitsu that uses copyright
protection to guarantee the right of anyone to use, modify, copy, and
distribute a work, as long as it and any derivatives remain under the
same license. The author retains the right to offer the work under a
different license simultaneously — for example, giving a company
specific license to commercialize the work without copyleft protections.
Popular copyleft licenses include the Creative Commons
Attribution-ShareAlike license and the GNU Free Documentation License.
Google,
Apple, Facebook, and Twitter all use open-source software at the heart
of their products, because there is a clear economic benefit to using
well-tested, well-validated, continually improved software in the core
of complex products. Similarly, there is a clear clinical benefit to
using well-tested, well-validated, continually improved clinical tools
in complex patient care — as demonstrated by the MMSE's use before 2000.
In a sense, copyleft is how academic medicine has always been assumed
to work.
2
Restrictive licensing of such basic tools wastes resources, prevents
standardization, and detracts from efforts to improve patient care.
We
suggest that authors of widely used clinical tools provide explicit
permissive licensing, ideally with a form of copyleft. 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.
5
The solution can be as simple as placing a copy of the tool on the
authors' Web site, with a statement naming or linking to the license.
Clinicians and researchers would be free to use, copy, and improve the
tool; improvements would have to offer a similar copyleft license,
perpetuating the benefits. Yet authors would maintain ownership and
copyright of their tool and could profit by licensing it for a fee to
commercial users or publishers who wished to include it in a
non-copyleft work.
The restrictions on the MMSE's use present
clinicians with difficult choices: increase practice costs and
complexity, risk copyright infringement, or sacrifice 30 years of
practical experience and validation to adopt new cognitive assessment
tools. By embracing the principles of copyleft licensing, we can avoid
such setbacks and build a more open future of continually improving
patient care.
(12/23, Sandle, De Sa'pinto) reports the European Medicines Agency
announced Thursday that it is reviewing medicines containing aliskiren
due to the ALTITUDE study, which showed that Novartis' Rasilez
[aliskiren] did not appear to benefit patients. In addition, patients
on aliskiren had more adverse effects including renal complications,
hyperkalemia, hypotension, and stroke. Also covering the story is Dow Jones Newswire 