Home About RSS

Law and Biosciences Blog
Law and Biosciences Blog

Patent on Pain Detection?

Shortly after our conference on Pain and Neuroimaging, I learned that Dr. Robert England received a patent on pain detection, entitled “Objective Determination of Chronic Pain in Patients,” issued on December 9, 2008 (U.S. Patent No. 7,462,155).

The claims are directed to methods for determining whether a patient claiming to suffer chronic pain in fact has chronic pain.  By observing neuron activity, the patent claims that the determination can be made without subjective input from the patient.   In essence, the broadly claimed methods compare differences in brain activity between a person claiming chronic pain when a pain stimulus is applied and people who are not in pain when the stimulus is applied.

The claims may not be adequately supported by the disclosure, such as the step of “deciding that the patient claiming to suffer chronic pain suffers chronic pain if the neuron activity observed in the patient while the stimulus is applied is judged to be statistically significantly increased from the neuron activity in the plurality of patients who are free of pain.”  How much of a statistically significant increase must be observed to make that decision?  Insurers would likely prefer a dramatically significant increase, while claimants would want the lowest possible level to show they are in pain.

It’s not clear whether an increase or decrease in brain activity of a patient, when compared with a “control” group, demonstrates the presence or absence of chronic pain when a stimulus is applied.  Because brain activity in response to pain differs from person to person (and one person may rate an experience as more painful with less brain activation, or less painful with more brain activation), any such comparison would likely not help in determining malingering.

-Brenda Simon

4 Responses to “Patent on Pain Detection?”

  1. kafka26 says:

    Brenda,

    Thanks for bringing this to my attention. In my forthcoming dissertation on the undertreatment of pain in the U.S., I critique at length the (to my mind) absurd notion that observing blood oxygenation levels in the brain is equivalent to objective evidence of a quintessentially subjective experience like pain. It is a giant category error (see Searle on this), or, in slightly different terms, what Bennett and Hacker term the mereological fallacy.

    Moreover, you may or may not be interested in a discussion I had with Adam Kolber regarding my fundamental inability to understand why so much discourse on pain and fMRI focuses on malingering, when all of the available evidence strongly suggests the proportion of undertreated chronic pain sufferers dwarfs that of malingerers by orders of magnitude. I tend to think the ethical priority is relatively clear, and detection of malingering is ethically problematic if it dominates attention and resources, which it seems to do.

    The blog exchange is summarized here:

    http://www.medhumanities.org/2009/01/on-pain-neuroimaging-neuroethics-and-justice.html

    In any case, thanks for bringing this to my attention.

    –Daniel S. Goldberg

  2. Brenda Simon says:

    Thanks for your post, Daniel. A patent rewards innovation, rightfully so I think, regardless of whether the allocation of resources is optimal. While I appreciate how important funding decisions are to policy outcomes, as you may know, the patent system is not meant to address these sort of issues. We would not want to deter innovation by denying a patent based on the possibility that the “detection of malingering is ethically problematic.” There are better avenues than the patent system for addressing these concerns (perhaps through the tax system, funding, or direct legislation).

  3. kafka26 says:

    Hey Brenda,

    Just to be clear, I was not expressing any view on whether the patent should have been granted.

    Rather, my comments were directed more to the substance of the application, namely, whether in fact the proposed methods objectively detemine pain. I think that they do not. In point of fact, I think such a claim is an absurdity, based on a number of conceptual confusions and fallacies.

    However, I’m not entirely sure I agree the patent system, or any other social enterprise engaged in the stewardship of scarce resources, should pretense to avoiding concerns about allocation and distribution. I do agree that there are other social structures better suited for dealing with them, but don’t necessarily think that facilitating rent-seeking behavior in individual actors while simultaneously devaluing the ethical imperative to consider questions of justice and allocation is an optimal way of devising the system.

    Because patents have obvious economic implications, I think the award and rejection of patents cannot be an endeavor insulated from issues of allocation and justice.

    Obviously, the system we do have strongly favors innovation, but just as obviously, whether such a tilt is normatively desirable is an open question.

  4. amyknight says:

    This sort of thing makes me very curious about the difference in pain perception among different people — and particularly between men and women. Do you know of any studies, particularly fMRI studies, that attempt to address these differences that are so often anecdotally observed? (I’m sure there are many women out there who have seen their husbands and boyfriends get bend out of shape over a stubbed toe…)
    I’m curious if the conventional wisdom about pain thresholds has been expressed in this kind of data — and if we’re able to determine whether it’s a difference in actual magnitude of response in the brain, or in attention to or more subjective experience of a very similar response. Or perhaps there’s no significant difference in either.

    What kind of issues would we be facing if it turned out that pain standards were, in general, different for different groups?

Leave a Reply