Pharmacogenetics
Preface
It is a familiar fact of medical life that a medicine effective for one patient may not work for
another, even though both suffer the same condition. So when we are told that there is a
pharmacogenetic technology around the corner that will provide simple genetic tests to
determine in advance which drugs will work for a given individual and which will not, our first
reaction may well be to wonder where the ethical issues lie, since we seem here to have a medical
development whose impact can only be positive.
Pharmacogenetics may indeed yield a substantial medical benefit, but like any technology it will
have diverse consequences that need to be taken into account if the benefits are to be maximised
and the negative effects minimised. The course of development and application of
pharmacogenetics will depend on scientific research, but it will also depend on decisions of policy
and administration which need to provide a combination of incentives and constraints to give the
most productive and just direction to pharmacogenetics.
The main purpose of this report is to encourage constructive thought and discussion about some
of the ethical and policy issues that pharmacogenetics raises. Many of these fall into four broad
categories. The first is information. Pharmacogenetic tests yield genetic information about
individuals, and this raises complicated and delicate questions about consent and confidentiality.
The second is resource. Certain aspects of the projected use of pharmacogenetics may lower the
cost of developing and delivering medicines, but others may drive it up, and the net effect is
difficult to calculate. The third is equity. Pharmacogenetics may significantly improve medical
treatment for some people, but it may also result in more people falling into categories for which
effective drugs are not developed, because of inadequate financial incentives to bring to market
a drug that may be very effective but only for a small population or for a large but poor
population. The fourth general category is control. Who should decide whether a patient takes
a pharmacogenetic test? Should the tests be made available directly over the counter or the
web? Should patients be entitled to a drug even if they do not wish to take an associated test?
These are some of the hard questions and problems that this report addresses. We make a
number of recommendations; but what is at least as important is that this report encourage
people from diverse backgrounds to think through the issues for themselves, from an informed
position of what we know about this new technology and also of how much we do not know. It
is early days for the application of pharmacogenetics, but certainly not too early to think about
the issues of ethics and policy that pharmacogenetics raises.
This Report has been a group effort and there are many people to thank. It has been a privilege
for me to work with such a high-powered interdisciplinary Working Party, with members so eager
to make the issues clear and the arguments cogent. We received signal support from the
members of the Council under the chairmanship of Professor Bob Hepple, from the specialists
whose brains we picked during fact-finding meetings, and from the thoughtful, constructive and
influential comments we received from respondents to our consultation document and from the
referees of our draft Report. At the Council, we are particularly grateful to Dr Sandy Thomas for
her oversight and support, and to Harald Schmidt, Natalie Bartle, Julia Fox and Nicola Perrin. And
we wish to pay special tribute to Tor Lezemore, who has done an extraordinary job across the
board, as researcher, writer, editor and conceptual analyst.
Peter Lipton