Memorandum submitted by Professor Martin Bobrow
CBE, Head of Department of Medical Genetics, Wellcome Trust Centre
for Molecular Mechanisms in Disease, Addenbrooke's NHS Trust
BACKGROUND
1. Genetic tests can predict future ill
health. The subject has been previously considered by the Science
and Technology Committee (Third Report, 1995). The Human Genetics
Advisory Commission reported on the implications of genetic testing
for insurance in December 1997.
2. Because of fears that insurers would
use genetic information to create a "genetic underclass"
who would be disadvantaged in access to insurance products, several
countries have banned insurance companies from using genetic information.
The HGAC recommended that access to genetic test results should
be permitted, but only when a strong evidence base for the specific
insurance product had been established to the satisfaction of
an impartial external controlling body. This led Government to
establish GAIC (Genetics and Insurance Committee). HGAC also recommended
a two year moratorium, to draw a clean line under past practise
and to allow the collection and examination of evidence. Government
did not agree this moratorium, and the ABI has continued to use
tests for seven sentinel conditions, while awaiting the verdict
of GAIC on whether or not this use is justified.
3. A few years ago there were many examples
of poor decisions by insurance underwriters, on the basis of misunderstanding
genetics. Since then, the ABI has established a code of practice,
and an advisory committee. They have also agreed a "voluntary
concession", relating to mortage related life policies up
to an arbitary £100k. (No limit has been discussed with regard
to disability or employment insurance). Although not enough, these
are welcome improvements.
4. I would like to address the following
questions:
4.1. Is this field something that can be
left to market forces?
4.2. What is the potential for harm in current
practice?
4.3. What are the defects in current and
future genetic tests for insurance usage?
4.4. Why is there so much discussion about
a small number of relatively uncommon disorders?
4.5. What are the arguments for and against
a total ban on the use of genetic information by insurers?
5. Can this be left to market forces? If
insurance were simply a fashion accessory, a competitive market
and normal consumer protection may suffice. However, in today's
society, insurance access is necessary for full participation
as a home owner, and as a responsible family member. Increasingly,
we will rely on insurance to provide pensions, and care in old
age. Insurance is an instrument of social policy.
6. What harm is done by current practice?
Currently, ABI insist on insurers right of access to genetic test
results. This stance causes significant public unease. In genetics
clinics, it is common for patients considering genetic testing,
to raise the question of whether they would be disadvantaged in
the insurance market. Medical care might well become distorted
by fear of loss of insurance access. Secondly, making good use
of knowledge derived from the Human Genome Project will require
substantial clinical studies, correlating genetic combinations
with health outcomes of research volunteers. Fears of insurance
consequences may deter people from consenting to such studies,
slowing the realisation of potential health gains from human genetics.
Thirdly, this concern fuels a public unease about potential misapplication
of genetic science, "giving genetics a bad name"—and
may therefore add to a public climate which is not conducive to
maximising health gain from the potentials of genetic science
in the UK.
7. What are the weaknessess of current genetic
tests? The tests under discussion (eg in relation to the ABI "7
conditions") are used for medical purposes, and their technical
characteristics are not in doubt. The question asked in a medical
context is however very different from that asked of the test
in an insurance context. For medical purposes, the test is used
in conjunction with expert interpretation, and intensive counselling,
to decide whether a person carries an altered gene, whether this
poses a risk to future health, and what can be done about it.
For life insurance purposes, the issue is (put crudely) "will
this person die within 20 years?"
8. Genetic tests are very good at distinguishing
those who carry a particular gene from those who do not. They
are somewhat less accurate at identifying who will and who will
not eventually get the disease—even for these seven highly
heritable conditions, a minority of people who have the defective
gene do not develop a clinical problem. They are not at all good
at predicting when the disease will start, how rapidly it will
progress, and thus when death will occur. Specific research correlating
gene changes with mortality experience is necessary before insurance
implications can be safely assessed. The medical genetic literature
is poor in this area, insurers appear to have conducted little
research of their own, and actuarial research is also thinly supported.
9. The precision with which genetic test
results can predict expected time of death is also compromised
by a number of systematic biases in the way medical research studies
must be conducted, which need great care when extrapolating the
test results outside an expert medical context:
9.1. The likelihood of being affected (the
gene penetrance), and the average severity of the disorder, is
prone to being exaggerated by early medical studies, which for
obvious reasons focus on the most florid disease (less possibility
of mistaken diagnosis), and the largest families which are easy
to study, but which over represent gene changes that are particularly
likely to cause disease. Understanding of the factors which interact
with the primary gene change to actually cause disease, is still
very rudimentary.
9.2. They take no account of possible beneficial
effects of early diagnosis and treatment, which for some conditions
may be considerable. Because these tests are relatively new, there
is little evidence on the mortality prospects of someone who is
diagnosed today and appropriately managed. Evidence of such benefit
will inevitably accrue many years after the development of the
relevant test and its associated treatment, as the treated cohort
of patients is followed through future life experiences.
10. If tests are developed for common disease,
early data are again likely to be seriously biased:
10.1. Gene penetrance and disease severity
will tend to be over-estimated by early studies (see para 9.1).
10.2. The beneficial effects of treatments
which have not yet been fully developed or deployed will be underestimated
(para 9.2)
10.3. For common gene variants associated
with common disease, beneficial effects which counter-balance
the harmful effects of the gene combination may be quite common—the
genes would not remain common were that not the case. Because
medical studies are usually conducted on groups of patients with
specific diseases, harmful effects will be identified long before
any counter-balancing beneficial effects. ("Cohort"
studies, which follow through a group of healthy people to correlate
their genetic makeup with future ill-health in an unselected and
therefore unbiased way, are a slow but important way of avoiding
this problem).
11. These possible distortions in the early
data, which are very likely to occur and will take years to unravel,
all happen to favour the insurer rather than the insured.
In summary, I believe that genetic tests in
insurance are currently being overinterpreted and being given
a predictive weight that the scientific evidence does not yet
support. I would suggest there is need for a great deal more reseach
in this area, and until such research has been undertaken a moratorium
should be enforced.
12. Why is there so much discussion about
a small number of relatively uncommon disorders?
The seven diseases seem too uncommon to represent
a real financial threat to insurers. Some protection against unusually
large policies, and the common catch-all clause which obliges
insurance applicants to declare any relevant known health factor,
should suffice to protect the companies. Several major insurers
take this stance, do not ask for genetic tests results, and have
come to no obvious harm.
13. I have heard two explanations. First,
the "right to underwrite", a hypothesised freedom of
the unfettered market to operate as it wishes, seems to me a principle
long abandoned in other areas of activity with serious social
impact.
14. Secondly, the expectation that better
discriminatory tests are on the way, and that to concede anything
in these simple conditions would lock the industry into a potentially
serious position if in future many individuals gained access to
high quality predictive information for common diseases. I believe
this fear is unfounded, because the nature of genetic contribution
to common disease is such that it will have only weak predictive
power, but others take a different view and this remains to be
worked through in practice. Some flexibility in the long term
is therefore reasonable.
15. What are the arguments for and against
a total ban on the use of genetic information by insurers? Notwithstanding
some frustration, I remain unconvinced about legislative prohibition
on insurers access to genetic information:
15.1. Supression of information is a dangerous
and uncertain path to tread in any situation, in part because
it is ineffective and open to abuse.
15.2. We have long conceded, perhaps without
deep thought or discussion, the industry's right to ask for our
family history. Family history is genetic information. I still
wait to be persuaded that insurers use this information reasonably,
but legislation that did not also ban this long established practice,
would still allow access to genetic information.
15.3 Legislation is rigid. Genetics is developing
rapidly, and even the medium term future is hard to predict with
any confidence.
16. Despite these reservations, the ABI
stance, of continuing to use information on tests for their "seven
conditions" until banned by GAIC, rather than agreeing not
to use them until they had been agreed as valid, instils no feeling
of confidence. Rather, it leaves the taste of arrogance, and seems
to point ever more to the possibility that legislative intervention
may be undesirable in principle but unavoidable in practice.
18 January 2001
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