Memorandum by Pfizer Global Research and
Pfizer has been requested to provide information
for the House of Lords inquiry into Human Genetic Databases. The
questions posed and the specific answers are detailed below. Pfizer
is committed to the discovery and development of medicines that
can contribute significantly to the treatment of disease and quality
of life. As part of this commitment we use the best scientific
evidence and technologies available to improve our ability to
deliver new medicines. The revolution in genetics and genomics
that has delivered the draft sequence of the human genome during
2000 is giving rise to improved opportunities to diagnose disease
and identify predictors of response to medicine at the individual
level. We believe that it is imperative to make use of this information
to improve our ability to develop medicines. As a result, Pfizer
Global Research and Development is pursuing the collection and
databasing of genetic information that can contribute to our research
efforts, but we recognise the sensitivity with which genetic information
is viewed. Thus in order to support our research we have invested
heavily in the technology that will allow us to conduct the research
whilst affording the greatest possible protection to individuals
who donate samples.
1. What current projects involve collecting
genetic information on people in the UK? What other projects are
about to start? Are there collections of material (eg tissue samples)
that could be used to generate databases of DNA profiles?
Currently, Pfizer Global Research and Development
collects samples from subjects participating in clinical trials
for the purpose of genetic analysis using two different approaches:
(a) Collection of samples for non-anonymised
analysis. The first approach is to collect samples which will
be analysed for specific genetic variants that are appropriate
to study for the disease, or drug, being evaluated. An example
would be the analysis of variants in drug metabolising enzyme
genes. This genetic analysis can help to explain the variation
in drug levels among individuals when the results of the clinical
trial are analysed. These samples are collected and labelled in
the same way as samples which are collected for the analysis of
biochemical parameters. The samples are destroyed after the studies
(b) Collection of samples for anonymised
analysis. The second approach is to collect samples for future
DNA analysis for genes not currently identified. In this approach
a broader consent is requested from the subject. This sample is
treated differentlyit is anonymised and linked to the anonymised
clinical data from that patient using a specially designed and
secure anonymisation process. Subject to Ethics Committee approval
and patient informed consent we aim to collect samples for anonymised
genetic analysis from all subjects participating in phase II and
phase III clinical trials conducted by Pfizer Global Research
and Development. These collections of samples are used only for
clinical research purposes and cannot be used to generate databases
of DNA profiles.
2. Why are these genetic databases being assembled?
How are these activities funded? What practical considerations
will constrain developments? Are there alternative ways of fulfilling
These genetic databases are being assembled
primarily to allow us to examine the genetics of drug response.
In future, when all genes and the variants of genes are known,
we will be able to examine those specific genetic factors which
contribute to the efficacy and safety of the compounds we develop.
A secondary use of these data will be to explore the association
between genetic variation and disease which will help us better
understand the diseases we are targeting our compounds at. These
activities are funded from the research budget of Pfizer Global
Research and Development. Practical considerations that constrain
the development of these databases at the level of collection
concern ethics committee approval and subject informed consent.
The key to understanding and evaluating the genetics of drug response
lies in the access to the data collected during our clinical trials.
These data together with stored samples provide the only mechanism
to support analyses of genetic variability in drug response. Examination
of the genetics of disease could be examined through collaboration
with other companies or academic institutions which have appropriate
collections of samples and clinical data. This is done on a specific
collaboration by collaboration basis.
3. What is the genetic information that is
being collected? How is it being stored and protected?
The genetic data derived from non-anonymised
samples are given the same degree of protection afforded to clinical
and biochemical data collected from an individual subject during
a clinical trial. The standard operating procedures (SOPs) applied
to clinical trials data apply with equal force to any genetic
data derived as part of a clinical trial.
The genetic data derived from anonymised samples
are given additional protection. For the anonymised samples, genetic
analyses cannot be performed on the samples until the link to
personal identifying data has been permanently deleted. The data
derived from these samples are linked with anonymised clinical
data and kept in a separate database with strict controls over
4. How do the organisations involved see their
responsibilities regarding privacy; consent; future use; public
accountability; and intellectual property rights?
We take our responsibilities with regard to
consent and privacy very seriously. We recognise the sensitive
nature of genetic information and have designed our anonymisation
process to provide maximum protection to individual sample donors.
Before any sample is taken for any genetic analysis (anonymised
or otherwise) we seek approval from an Independent Ethics Committee.
Subject to this approval, informed consent is then obtained from
each participating individual. Our anonymisation and security
procedures have been developed in order to ensure that no-one
in the future will be able to make the link between an anonymised
sample and the individual who donated it. We abide by the regulations
and ethical imperatives applied to clinical trials and incorporate
these principles into our genetic analyses. We routinely protect
our ideas and investment, and the genetics area is no different
from any other. Thus the intellectual property associated with
the samples and data is derived from the analysis and resides
with the company.
5. How do they see their activities in the
area of genetic databases developing in the future? What advances
in sequencing, screening and database technology are they anticipating?
We see the value of genetic databases in improving
our ability to design and develop better drugs for patients. The
development of genetic databases is designed to support this by
improving our understanding of diseases and individual responses
to treatment. Advances in high-throughput genotyping will reduce
cost and improve efficiency such that genome-wide screening of
individuals using variants called SNPs will become a reality,
improving dramatically our ability to predict the contribution
of genetic variation to disease and drug response. These advances
will make the development of genetic diagnostics for drug response
a reality over the next 10 years. Advances in database development
will make it possible to handle enormous quantities of data making
complex data analysis practicable.
6. What lessons should be learnt from genetic
database initiatives in other countries?
There is considerable variation in attitudes
and understanding about the value and use of genetic databases
from country to country. Concerns and protection for the individual
are the paramount issues although the approaches to solving these
problems are different. Developments in other countries highlight
the need to ensure that informed public debate takes place. In
addition, regulatory, legal and ethical positions vary from country
to country. A standard position adopted and agreed by many countries
would considerably improve the ability to conduct this kind of
Pfizer Global Research and Development is pursuing
the collection of samples and the development of genetic databases
which will allow us to examine the relationship of genetic variation
to drug response and disease aetiology. Specific technologies
and procedures have been developed to protect individual subject
confidentiality in addition to that normally accorded to subjects
who participate in clinical trials. We believe that the sensitive
and appropriate use of genetic information will lead to significant
improvements in the development of drugs in the future.