APPENDIX 7
Memorandum submitted by GlaxoSmithKline
As the UK's leading healthcare company with
substantial investment in research laboratories, the ability to
conduct genetic research effectively and to high ethical standards
is central to GSK's aim of discovering new medicines to combat
diseases with unmet needs. We therefore welcome this enquiry and
hope that the enclosed submission will prove a valuable contribution
to the Committee's debate.
INTRODUCTION
1. GlaxoSmithKline (GSK), the UK company
recently formed from the merger of Glaxo Wellcome plc and SmithKline
Beecham plc, is a world leader in the research and development
of innovative, life-enhancing pharmaceuticals. The ability to
conduct genetic research effectively to high ethical standards
is central to GSK's commitment to:
— Discover new medicines to combat
diseases with unmet needs.
— Deliver medicines to those patients
likely to derive the most benefit.
The success of GSK's efforts and the resulting
health benefits are inextricably tied to the willingness of individuals
to participate in genetic research.
2. GSK is a UK based multinational company
with substantial investment in UK research laboratories and operations
facilities. Accordingly, the Committee's continued interest and
deliberations regarding the impact of using genetic test results
for life insurance on the research environment for genetics in
the UK are of profound interest to GSK.
3. In this regard and the broader issues
of genetic research in the UK, GSK is providing evidence to the
House of Lords Science and Technology Select Committee Inquiry
on genetic databases and providing input to the Human Genetics
Commission (HGC) in response to a recently distributed discussion
document.
4. This memorandum provides information
specifically relates to the question:
What effect could the use of test results by
insurance companies have on research in the UK?
The other two questions posed by the Committee
relate to the assessment of actuarial evidence and the regulation
of insurance services. These are areas where GSK does not have
specific business interests or experience and, therefore, is not
qualified to comment in detail. However, GSK welcomes an approach
in which all relevant stakeholders, including consumer representatives,
assess the scientific and actuarial reliability and predictive
value of specific single gene genetic tests before they are used
for insurance purposes.
INSURANCE USE
OF GENETIC
TEST RESULTS
AND RESEARCH
IMPLICATIONS
5. GSK recognises that the potential use
by insurance companies of genetic information has been the source
of some public concern.
6. In October 2000, the Genetics and Insurance
Committee (GAIC) announced that the reliability and relevance
of genetic tests for Huntingdon's Disease are sufficient for insurance
companies to use the results when assessing applications for life
insurance. This type of test for a single gene disorder detects
the presence or absence of a mutation or mutations in one or both
copies of a single gene, which leads to disease. Thus, there is
often a strong causal relationship between the presence of the
mutation and the manifestation of the disease. There are currently
few, if any, effective interventions that alter the progression
of many of these diseases. This gives rise to a number of ethical,
legal and social considerations associated with diagnostic (symptomatic)
and predictive (asymptomatic) genetic tests for single gene diseases.
These issues include the:
— Potential for unlawful discrimination.
— Healthcare implications and psychological
impact on patients and family members.
— Need for pre- and post- test genetic
counselling.
7. Given the public concern already expressed
related to genetic test results and insurance, the use of certain
single gene test results by insurance companies could be perceived
negatively and reduce the willingness of subjects to participate
in GSK genetic research initiatives. This is despite the fact
that it is made clear to potential participants in the informed
consent process that:
— The results of genetic studies sponsored
by GSK are for research purposes only and not for clinical diagnosis
or use by unconnected third parties.
— GSK's human genetic research (as
is increasingly the case for genetic research in general) is focused
on understanding patients' responses to medicines (pharmacogenetics)
and the genetic basis of common diseases such as asthma, heart
disease and diabetes (disease susceptibility). For common diseases,
unlike single gene disorders, alternative forms (alleles) of multiple
genes interact with each other and environmental factors to cause
disease. The presence of a version of a single gene associated
with a common disease is not thought to be sufficient, by itself,
to cause the disease.
— GSK employs multiple processes and
security procedures designed to protect research subjects' privacy
and confidentiality. For example, patients' personally identifiable
information are not transferred to GSK (only a code number is
used to identify the data) and data security and access restrictions
are implemented to prevent unauthorised access. Additionally,
no research results are returned to participants (unless legally
required).
8. To prevent the use of genetic test results
for single gene disorders by insurance companies from reducing
subject participation in genetic research, it is important to
increase public understanding of modern genetic science and the
procedures in place to protect individual participant confidentiality
in research. These initiatives could include:
— Encouraging the media to present
a balanced view of modern genetic science and its applications.
— Raising awareness and understanding
of modern genetic science amongst physicians and healthcare providers
and the potential of modern genetic science to deliver significant
healthcare benefits.
— Introducing modern genetics into
school curricula with less historical emphasis on single gene
genetics.
These initiatives would help potential participants
in research make a balanced judgement regarding their involvement
and enable the potential benefits and risks of different genetic-based
applications to be fully appreciated (figure).
9. It is important that educational initiatives
present a balanced view of modern genetic science and its applications.
For example, in the future, the ability to predict more accurately
patients' responses to medicines may have medical insurance implications.
The magnitude of such implications remain to be determined but
are likely to be less than those associated with single gene tests
and life insurance.
CONCLUSION
10. The UK is well positioned to assume
a leadership role in creating an environment in which genetic
research can flourish in a manner that advances the interests
of the public and healthcare communities. It is important that
the UK maximises this opportunity to ensure that the UK population
can reap the benefits of genetic research and the UK can attract
further investment into the science and life science sectors in
an increasingly competitive global environment.
11. To this end, it is important that legitimate
uses of single gene genetic testing information for insurance
purposes are communicated effectively to the UK population. These
communications should include the rigour of the validation and
approval process that includes all relevant stakeholders and the
potential benefits to those individuals who have a family history
of a single gene disorder but have not inherited the mutated gene.
It would also be helpful if such communications are placed in
the broader context of modern genetic science and research. This
would help differentiate the use of specific single gene genetic
test results for insurance purposes from the use of genetic research
data to help discover new medicines for common diseases and deliver
medicines to those patients likely to derive most benefit.
January 2001
| 
