Summary and recommendations - Nuffield Council on Bioethics
Summary and recommendations - Nuffield Council on Bioethics
Summary and recommendations - Nuffield Council on Bioethics
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Pharmacogenetics: ethical issues<br />
The development of new medicines<br />
6 The applicati<strong>on</strong> of pharmacogenetics to the development of new medicines has implicati<strong>on</strong>s for<br />
the way in which basic research <str<strong>on</strong>g>and</str<strong>on</strong>g> clinical trials are designed <str<strong>on</strong>g>and</str<strong>on</strong>g> managed, <str<strong>on</strong>g>and</str<strong>on</strong>g> for the cost<br />
of undertaking clinical trials. The applicati<strong>on</strong> of pharmacogenetic analysis could, in some cases,<br />
identify those individuals participating in research who are less likely to resp<strong>on</strong>d or who are at<br />
risk of adverse reacti<strong>on</strong>s, at later stages of clinical trials. These individuals could then be<br />
excluded from participating in the trials, which could lead to better protecti<strong>on</strong> of participants<br />
in research. The selecti<strong>on</strong> of smaller groups of genetically homogenous participants in clinical<br />
trials may be advantageous, leading to more robust <str<strong>on</strong>g>and</str<strong>on</strong>g> reliable scientific findings regarding the<br />
group of patients who might eventually be prescribed the medicine. There may be regulatory<br />
<str<strong>on</strong>g>and</str<strong>on</strong>g> legal pressures to incorporate pharmacogenetic analysis into clinical trials (paragraph 3.5)<br />
but such analysis will not always be feasible, nor will such an approach necessarily be<br />
appropriate, given available pharmacological evidence. We recommend that the appropriate<br />
use of pharmacogenetic analysis in clinical trials should be promoted. Regulators should be<br />
encouraged to promote the collecti<strong>on</strong> <str<strong>on</strong>g>and</str<strong>on</strong>g> storage of samples in clinical trials such that they<br />
could be subjected to pharmacogenetic analysis either during the trial, or subsequently<br />
(paragraph 3.12).<br />
Using pharmacogenetics to improve existing medicines<br />
7 Pharmacogenetics could be used to improve the prescribing of existing medicines, whether by<br />
reducing the incidence of adverse reacti<strong>on</strong>s, or by restricting prescripti<strong>on</strong> to those patients likely<br />
to benefit. Some potential examples include the medicine clozapine, used to treat<br />
schizophrenia, <str<strong>on</strong>g>and</str<strong>on</strong>g> the medicine warfarin, used to prevent the formati<strong>on</strong> of blood clots<br />
(paragraphs 3.21-23). It is by no means certain that research would successfully identify genetic<br />
variants which could form the basis of a clinically useful test. Factors that will affect whether a<br />
test is likely to be of use in clinical practice include the scale of the negative effects experienced,<br />
the size of the patient populati<strong>on</strong>, the likely clinical value of the pharmacogenetic test, <str<strong>on</strong>g>and</str<strong>on</strong>g> the<br />
existence of other treatments. Nevertheless, in some cases, the development of a test could<br />
make a significant c<strong>on</strong>tributi<strong>on</strong> to improving the prescripti<strong>on</strong> of existing medicines. It is not<br />
clear that the private sector will be motivated to pursue pharmacogenetic research in relati<strong>on</strong><br />
to medicines not covered by patent protecti<strong>on</strong>. We therefore recommend that efforts should<br />
be made to encourage pharmacogenetic research <strong>on</strong> existing medicines, where there is reas<strong>on</strong><br />
to believe that such research could significantly improve efficacy or safety. Funding <str<strong>on</strong>g>and</str<strong>on</strong>g><br />
support should be made available within the public sector <str<strong>on</strong>g>and</str<strong>on</strong>g> public–private partnerships<br />
encouraged. We welcome the recent announcement by the Department of Health that £4<br />
milli<strong>on</strong> will be directed towards research in pharmacogenetics over the next three years<br />
(paragraph 3.26). 1<br />
The use of pharmacogenetic informati<strong>on</strong> collected in research<br />
8 There are numerous codes of practice <str<strong>on</strong>g>and</str<strong>on</strong>g> guidance regarding the c<strong>on</strong>duct of clinical research.<br />
It is comm<strong>on</strong> practice to require c<strong>on</strong>sent for the collecti<strong>on</strong> <str<strong>on</strong>g>and</str<strong>on</strong>g> banking of tissue <str<strong>on</strong>g>and</str<strong>on</strong>g> DNA<br />
samples of participants in research, especially if it is intended to combine genetic informati<strong>on</strong><br />
with other informati<strong>on</strong> from the patient’s medical record. Most researchers obtain written<br />
c<strong>on</strong>sent from participants <str<strong>on</strong>g>and</str<strong>on</strong>g> are required to provide written informati<strong>on</strong> in advance of<br />
obtaining c<strong>on</strong>sent. In the c<strong>on</strong>text of pharmacogenetic research, as in other forms of research,<br />
the nature of the informati<strong>on</strong> likely to be revealed <str<strong>on</strong>g>and</str<strong>on</strong>g> its implicati<strong>on</strong>s for the patient should<br />
1 Department of Health (2003) Genetics White Paper. Our inheritance, our future – realising the potential of genetics in the<br />
NHS (Norwich: The Stati<strong>on</strong>ery Office, CM 5791).<br />
xiv