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The ethics of innovation for Alzheimer’s disease: the risk of overstating evidence for metabolic enhancement protocols

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Abstract

Medical practice is ideally based on robust, relevant research. However, the lack of disease-modifying treatments for Alzheimer’s disease has motivated “innovative practice” to improve patients’ well-being despite insufficient evidence for the regular use of such interventions in health systems treating millions of patients. Innovative or new non-validated practice poses at least three distinct ethical questions: first, about the responsible application of new non-validated practice to individual patients (clinical ethics); second, about the way in which data from new non-validated practice are communicated via the scientific and lay press (scientific communication ethics); and third, about the prospect of making new non-validated interventions widely available before more definitive testing (public health ethics). We argue that the authors of metabolic enhancement protocols for Alzheimer’s disease have overstated the evidence in favor of these interventions within the scientific and lay press, failing to communicate weaknesses in their data and uncertainty about their conclusions. Such unmeasured language may create false hope, cause financial harm, undermine informed consent, and frustrate the production of generalizable knowledge necessary to face the societal problems posed by this devastating disease. We therefore offer more stringent guidelines for responsible innovation in the treatment of Alzheimer’s disease.

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Notes

  1. For reference, the methods are respectively abbreviated as follows: quantitative electroencephalogram (qEEG), Montreal cognitive assessment (MoCA), magnetic resonance imaging (MRI), Saint Louis University Mental Status (SLUMS), fluorodeoxyglucose-positron emission tomography (FDG-PET), and mini-mental state examination (MMSE).

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Acknowledgments

The authors thank Katelyn MacDougald for her invaluable copyediting. Timothy Daly thanks the Fondation Médéric Alzheimer for financial support for his doctoral work, and acknowledges helpful support and input from Hervé Maisonneuve, Anouk Barberousse, Mathieu Bourdenx, and Felicitas Holzer.

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Authors and Affiliations

  1. Sorbonne University, Paris, France

    Timothy Daly

  2. National Scientific and Technical Research Council, Buenos Aires, Argentina

    Ignacio Mastroleo

  3. Barbara Ann Karmanos Cancer Institute, Detroit, MI, USA

    David Gorski

  4. Institut du Cerveau et de la Moelle épinière (Brain and Spine Institute), Paris, France

    Stéphane Epelbaum

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  1. Timothy Daly
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  2. Ignacio Mastroleo
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  4. Stéphane Epelbaum
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Correspondence to Timothy Daly.

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Daly, T., Mastroleo, I., Gorski, D. et al. The ethics of innovation for Alzheimer’s disease: the risk of overstating evidence for metabolic enhancement protocols. Theor Med Bioeth 41, 223–237 (2020). https://doi.org/10.1007/s11017-020-09536-7

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