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The Clinical Research of Nanomedicine: A New Ethical Challenge?

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Nanomedicine promises unprecedented innovations for diagnosis and therapy as well as for predicting and preventing diseases. On the other hand it raises fears linked to new and unknown characteristics of nanoscale materials. Both, promises and fears, are closely linked to the realm of uncertainty. To a large extent it is currently not known which expectations could become reality and which suspected adverse events might come true. Medicine is quite familiar with decision-making under uncertainty. Rules and regulations for clinical research have been developed to reduce possible harm for research participants without abandoning necessary investigations. Here we examine whether clinical research trials of nanomedicine need new regulations and conclude that the established rules should suffice.

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Notes

  1. The risk is then calculated by multiplying the amount of damage with the probability of occurrence. In a rational decision, the option with the lowest risk would be selected

  2. In Parexel’s pharmacological testing institute at Northwick Park Hospital in London on 13 March 2006, the monoclonal antibody TGN1412 was tested on humans for the first time. TGN1412 is a strong agonist for the CD28 receptor of the immune system’s T cells. Initially, there was hope to treat chronic lymphocytic leukemia and autoimmune diseases with the drug. It was developed by order of the start-up company TeGenero of the company Boehringer Ingelheim. Paraxel also worked on behalf of TeGenero. The previous animal experiments had shown no evidence of adverse effects.

    Of the eight healthy subjects, six received the active treatment, two placebo. A few hours after the injection, all six subjects who had received the active treatment experienced a severe immunological reaction known as the cytokine release syndrome that resulted in significant, life-threatening health problems. They suffered from multi-organ failure and some had to be treated in intensive care for weeks. All six subjects survived, but with significant damage to their health.

    Despite the fact that the substance class of monoclonal antibodies is not new (17 substances of this kind in Europe have already been approved) as well as the existing regulations, it still had these serious, life-threatening effects.

  3. The sequential application to one person was not performed; all six subjects received the drug at the same time, while two individuals received a placebo.

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Authors and Affiliations

  1. International Center for Ethics in Science and Humanities, Tübingen, Germany

    Urban Wiesing & Jens Clausen

  2. Werner Reichardt Center for Integrative Neuroscience (CIN), Tübingen, Germany

    Jens Clausen

  3. Institute for Ethics and History of Medicine, Gartenstr. 47, 72074, Tübingen, Germany

    Urban Wiesing & Jens Clausen

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  1. Urban Wiesing
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  2. Jens Clausen
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Correspondence to Jens Clausen.

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Wiesing, U., Clausen, J. The Clinical Research of Nanomedicine: A New Ethical Challenge?. Nanoethics 8, 19–28 (2014). https://doi.org/10.1007/s11569-014-0191-0

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