Abstract
The ethical treatment of cancer patientsparticipating in clinical trials requiresthat patients are well-informed about thepotential benefits and risks associated withparticipation. When patients enrolled in phaseI clinical trials report that their chance ofbenefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type(e.g., ``On average, 5 out of every 100 patientswill benefit'') can be confused with expressionsof uncertainty of the belief type (e.g.,``The chance that I will benefit is about80%''). Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subservemultiple speech acts, some of which may beindirect. For example, a patient reporting ahigh expected benefit may be reporting a beliefabout the future, reassuring family members,and/or attempting to improve his or her outcome by apublic assertion of optimism. These sources oflinguistic confusion should be considered injudging whether the patient's reported expectation isgrounds for a bioethical concern that there hasbeen a failure in the informed consent process.
Similar content being viewed by others
REFERENCES
Alston, William P. The Philosophy of Language. Englewood Cliffs, NJ: Prentice-Hall, 1964.
Appelbaum, Paul S., L.R. Roth, C.W. Lidz, P. Bensons, and W. Winslade. “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception.” Hastings Center Report 17 (1987): 20–24.
Austin, J.L. How to Do Things With Words, 2nd ed. Cambridge: Harvard University Press, 1962.
Austin, J.L. “Performative Utterances.” In Philosophical Papers. 2nd ed. Edited by J.O. Urrnson and G.J. Warnock, 233–252. Oxford: Oxford University Press, 1970.
Berg, Jessica W., P.S. Appelbaum, C.W. Lidz, and L.S. Parker. Informed Consent: Legal Theory and Clinical Practice, 2nd ed. New York: Oxford University Press, 2001.
Biley, A., I. Robbe, and C. Laugharne. “Sources of Health Information for People with Cancer.” British Journal of Nursing 10 (2001): 102–106.
Butters, Ronald R., J. Sugarman, and L. Kaplan. “Semantic and Pragmatic Variability in Medical Research Terms: Implications for Obtaining Meaningful Informed Consent.” American Speech 75 (2000): 149–168.
Cheng, Jonathan D., J. Hitt, B. Koczwara, K.A. Schulman, C.B. Burnett, D.J. Gaskin, J.H. Rowland, and N.J. Meropol. “Impact of Quality of Life on Patient Expectations Regarding Phase I Clinical Trials.” Journal of Clinical Oncology 18 (2000): 421–428.
Daugherty, Christopher K. “Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective.” Journal of Clinical Oncology 17 (1999): 1601–1617.
Daugherty, Christopher, M.J. Ratain, E. Grochowski, C. Stocking, E. Kodish, R. Mick, and M. Siegler. “Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials.” Journal of Clinical Oncology 13 (1995): 1062–1072.
DiMascio, Jeffrey, J. Babb, S.L. Corbett, E. Slater, A.B. Benson, A. Balshem, K.A. Schulman, H. Wang, and N.J. Meropol. “Discordant Perceptions of Fellows and Attending Physicians Regarding Phase I Trials. Proceedings of the American Society of Clinical Oncology 21 (2002): 259a.
Faden, Ruth R. and T.L. Beauchamp. A History and Theory of Informed Consent. New York: Oxford University Press, 1986.
Hacking, Ian. An Introduction to Probability and Inductive Logic. Cambridge, UK: Cambridge University Press, 2002.
Meropol, Neal J., K.A. Schulman, K. Weinfurt, C.B. Burnett, A. Balshem, A.B. Benson, L.D. Castel, S.L. Corbett, J. Marshall, J. Rowland, E. Slater, D.P. Sulmasy, and D.A. VanEcho. “Discordant Perceptions of Patients and Their Physicians Regarding Phase I Trials.” Proceedings of the American Society of Clinical Oncology 21 (2002): 245a.
Muha, Catherine, K.S. Smith, S. Baum, I. Ter Maat, and I.A. Ward. “The Use and Selection of Sources in Information Seeking: The Cancer Information Service Experience. Part 8.” Journal of Health Communication 3 Suppl (1998): 109–120.
Redelmeier. Donald A., D.J. Koehler. V. Liberman, and A. Tversky. “Probability Judgement in Medicine: Discounting Unspecified Probabilities.” Medical Decision Making 15 (1995): 227–230.
Searle, John. Speech Acts. New York: Cambridge University Press, 1969.
Searle, John. “What is a Speech Act?” In The Philosophy of Language, 2nd ed. Edited by A.P. Martinich, 115–135. New York: Oxford University Press, 1990.
Sugarman, Jeremy, N.E. Kass, S.N. Goodman, P. Perentesis, P. Fernandes, and R.R. Faden. “What Patients Say About Medical Research.” IRB 20 (1998): 1–7.
Teigen, Karl H. “Variants of Subjective Probabilities: Concepts, Norms, and Biases.” In Subjective Probability. Edited by G. Wright and P. Ayton, 211–238. London: Wiley and Sons, 1994.
Tversky, Amos and D. Kahneman. “Judgements Under Uncertainty: Heuristics and Biases.” Science 185 (1974): 1124–1131.
Wittgenstein, Ludwig. Philosophical Investigations. Oxford, UK: Blackwell, 1953.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Weinfurt, K., Sulmasy, D.P., Schulman, K.A. et al. Patient Expectations of Benefit from Phase I Clinical Trials: Linguistic Considerations in Diagnosing a Therapeutic Misconception. Theor Med Bioeth 24, 329–344 (2003). https://doi.org/10.1023/A:1026072409595
Issue Date:
DOI: https://doi.org/10.1023/A:1026072409595