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8-Misc: Campaign Against Human Genetic Engineering: Documents (1)
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TITLE: A) Who will benefit from the human genome?
B) The human genome gold rush
C) The threat of genetic discrimination
SOURCE: Campaign Against Human Genetic Engineering, UK
Documents from a press conference at June 14, 2000
A) by Dr Richard Nicholson
B + C) by Dr. David King
DATE: June 15, 2000
-------------------- archive: http://www.gene.ch/ --------------------
A) Who will benefit from the human genome?
Mapping the human genome is a great human achievement, rather like
climbing Mount Everest. Like climbing Mount Everest, it will benefit
few people, leaving most untouched. But unlike climbing Mount
Everest, it has the potential to damage large numbers of people. So
it is important to cut through the exaggerated expectations and to
assess the probable benefits and costs.
Benefits should arise through eventual identification of the tens of
thousands of genes in the whole genome. As genes are identified they
can be used for
- gene therapy
- tailor-made pharmaceutical products
- predictive testing, either antenatally or later
- to improve the understanding of disease mechanisms.
These possible benefits must be assessed, however, in the context of
what medicine has actually achieved. Of 32 years improvement in life
expectancy in the 20th century, just 10% was the result of advanced
medical care (and half of that was due to childhood immunisation).
Most of our good health - and being one of the rich countries of the
world, we are one of the healthiest - has come from environmental
improvements: clean water, modern sewage disposal, better housing and
so on. Yet we spend 50 times as much per head of population on health
care as is spent on the 5 billion people living outside OECD
countries.
One reason for all the hype about the human genome project may be
that recent medical research has produced little of value, and
medical scientists are desperate for something dramatic. Clinical
trials and meta-analyses get ever larger because such small
improvements are looked for; many now are only designed to show
equivalence: that the new drug is just about as good as what we have
already. But virtually no research is done on the major tropical
diseases that kill many millions each year: just 1% of the new drugs
marketed in the last 25 years are useful in such diseases. And how is
it that after 30 years of being fed a weekly diet by the main cancer
charities of the latest greatest breakthroughs, there have been only
marginal improvements in cancer cure and survival rates?
That medical research achieves so little may be because most is no
longer done for the benefit of mankind. Most is now done for personal
career advancement or to benefit the shareholders of pharma and
biotech companies. This is seen par excellence in the human genome
project. In research done for such motives there is no reason to
allow the rest of society to keep up. If the research were genuinely
intended to benefit humanity, researchers would ensure that those
assessing its social and ethical issues, and the general public,
could keep up.
Gene therapy:
much has been made of the possibilities of curing diseases caused by
single abnormal genes. But despite over a decade of hype, the
worldwide score for gene therapy is: Cures: 0, Deaths: at least 5,
Serious Adverse Events: at least 1,000. Mapping the human genome is
unlikely to help gene therapy move beyond being only occasionally
effective, in a few rare diseases, at great cost.
Pharmaceutical products:
it is claimed that precise knowledge of the proteins coded for by
specific genes will allow the creation of drugs more accurately aimed
at specific proteins. In diseases caused by a variety of genes, each
individual would be tested to see which gene he/she carried, and a
precisely tailored drug could then be prescribed. The problem is
that most chronic diseases, affecting enough Western people for the
pharmaceutical industry to be interested in them, are multi
factorial. Not only are several genes involved in the aetiology, but
so is the environment. In the case of high blood pressure only about
30% of the disease burden is genetically determined. So it is
reasonable to apply the general rule of drug development in
pharmacogenetics:
- the benefits of a new drug are overestimated before its use,
- the risks of a new drug are underestimated before its use, and
- the cost is greater than for existing drugs.
Genetic testing:
there will be a relatively small number of instances in which testing
in adult years will produce results that have an important influence
on life decisions. For instance, a positive test for Huntington's
Disease presymptomatically might lead to a decision not to have
children. There is, however, a widespread assumption among many
genetic researchers that, on the whole, people would rather know
about their genes than not know. The evidence points the other way:
most people prefer to remain in ignorance. A further problem is that
even when people have been tested, they may find it difficult to make
the lifestyle changes that the test results suggest are necessary,
leading to anxiety or fatalism. Most testing will be done
antenatally, but the only purpose is either to abort an affected
fetus or not to implant an affected embryo, thus leading us ever
further down the road to a negative eugenics.
*****
B) The human genome gold rush
"Any company that wants to be in the business of using genes,
proteins, or antibodies as drugs has a very high probability of
running afoul of our patents. From a commercial point of view, they
are severely constrained - and far more than they realize."(1) Dr
William A. Haseltine, Chairman and CEO, Human Genome Sciences.
It has been evident from the start that a major aim of the Human
Genome Project (HGP) was to support the pharmaceutical industry.
However, it is unlikely that the project's founders anticipated the
degree to which basic genomics research would turn into a gold rush,
and the unpleasant conflicts that have arisen over patenting and
sharing of data. Private companies are now going to extraordinary
lengths to monopolise information in ways that conflict with the
basic ethics of science. The result is a situation in which a a
relatively small number of companies are in a position to exert
significant control over the whole future of medicine.
Patents on human genes
In any other field of science, the HGP would be absolutely pure 'blue
skies' research. However, there is a peculiarity in genetics, which
stems from the fact that the basic data is embodied in a chemical
molecule and there is thus a precedent for patenting information. The
sequence of a gene is a discovery, whereas patents are granted on
inventions. Notwithstanding this basic distinction, pharmaceutical
corporations and entrepreneurial biotechnology companies have seized
on the opportunity to patent something far earlier in the normal
sequence from basic scientific discovery to inventive technology. In
so doing, they gain far broader patents than would normally be
possible, since a basic discovery is capable of a range of
applications, such as diagnostic tests, gene therapies and
pharmaceutical products. A patent on a gene thus allows a company to
control a very wide range of possibilities, and by getting in at the
ground floor they constrain others' opportunities to build on their
work. But despite the drugs industries 'emotional blackmailing
slogans, such as 'No Patents, No Cures', like other industries they
could perfectly well manage with patents on individual products.
In addition to violating the basic distinction between discovering
part of nature and inventing something new (which patent lawyers have
got round by various unconvincing sophistries) patents on human genes
also violate the patent criteria of obviousness. Gene discovery in
the HGP has now become entirely mechanised -- all that is necessary
to discover and patent gene sequences is the possession of sufficient
capital to buy sequencing machines. Neither is it necessary to have
the slightest idea of the function of a gene: when Human Genome
Sciences patented the CCR5 gene in the 1980s, it had no idea that it
was a receptor for the AIDS virus, and thus a potentially highly
lucrative drug target. Thus the company is likely to profit from the
gene not through any scientific merit, but rather as speculators in
the financial futures markets do.
The result of the connivance of lawyers and legislators with the
drugs industry's demands is a situation in which they are over 4
million patents on human genome sequences. This is only slightly less
than the total number of patents ever granted in the USA. Human
Genome Sciences has even gone so far as to patent the entire genome
of a number of bacteria, including one that causes meningitis.
Companies such as Incyte, Human Genome Sciences and Celera now own
hundreds of thousands of patents, the majority of which are on short
sequences of DNA. Here, the aim is purely to grab territory. It is
not without reasons that scientists such as John Sulston, the leader
of the UK section of the HGP, have described gene patenting as
barbaric. The publicly-funded HGP is to be congratulated on its
policy of immediate publication of genome sequence data. Tony Blair
and Bill Clinton's declaration earlier this year in support of the
policy is meaningless and hypocritical given their continued support
for the patenting of human genes.
The future of medicine
The result of gene patenting is to give commercial ventures undue
control over the future of medicine. Such companies can decide
whether the development of particular products deriving from a gene
is in their commercial interest or not and can prevent others from
developing them. For example, most gene therapy products are being
designed to be administered repeatedly rather than as one-time cures.
Gene patenting also distort the basic science of genetics. In
genetics more than in any other field there exists massive conflict
of interest, as corporations fund the work of academic scientists.
Such collaborations regularly require scientists to refrain from the
normal practice of sharing information and materials amongst
themselves, and since science is predominantly a collaborative
process of making small steps forward, this can only harm science and
ultimately harm the interests of patients.
In fact, commercial greed is already having harmful effects on
patients. A recent survey of American genetic testing laboratory
directors revealed that many were being forced to halt genetic
testing services due to the royalty demands of genomics companies and
the complexity of negotiations with the companies. In Britain, NHS
laboratories are being forced to pay royalties for breast cancer gene
testing to a US company, even though British scientists still claim
that they discovered the genes first.
Conclusion
Unless something is done the effects of commercialisation of the
human genome will be felt for decades to come. The Campaign Against
Human Genetic Engineering supports a ban on the patenting of genes
and living organisms. The EU should repeal its biotechnology patents
directive, and patent offices should rescind and reject patents on
human genes.
1. Fisher, Lawrence. "The Race to Cash in on the Genetic Code,"
New York Times, August 29, 1999.
*****
C) The threat of genetic discrimination
The Human Genome Project has produced a mountain of information that
it will take scientists decades to analyse. The most immediate use of
this information is in genetic testing, and we are promised that
these tests will tell us much about our future health. Such
information is not only of personal interest to us: employers,
insurers and many other institutions may want to know. If privacy is
not ensured, and institutions are not restrained from using the
information in their own interest, the result will be genetic
discrimination.
This is not a futuristic possibility: surveys in the USA show that
nearly 50% of people with genetic disorders in their families had
been discriminated against by insurers. In the UK one-third of the
people surveyed had problems with insurance, and 13 percent of those
were at no risk of developing gene-related health problems. Cases of
discrimination by employers have also been reported. There is a large
amount of research aimed at discovering genetic differences in
people's susceptibility to environmental chemicals, including
chemicals found in the workplace, and it is likely that employers
will want to use genetic tests to exclude those who are susceptible,
rather than clean up their workplace.
It has recently become clear that people seeking to adopt children in
the USA are increasingly demanding genetic tests on the child, in
order to make sure that he/she will not become disabled. If genetic
testing becomes widespread, individuals may find themselves becoming
socially stigmatised, due to rumours about their genetic
constitution, and in the extreme case, as depicted in the film
GATTACA, a genetic underclass may develop.
The fear of discrimination amongst patients is so widespread that
doctors are already reporting that patients are unwilling to take
genetic tests for fear that it will affect their insurance prospects.
In the USA with its private health insurance system this problem is
particularly severe. In fact, scientists and doctors have taken the
lead in calling for a ban on the use of genetic information by
insurers.
The problem will become most severe when genetic tests for
susceptibility to common disorders such as heart disease become
available. Because of the complexity of genetic determination, there
is a debate amongst scientists about the likelihood of this. However,
given the speed of scientific advance in genetics, it would be unwise
to be complacent about this.
Political responses
In response to pressure from scientists and the public to ban the use
of genetic tests insurance, the insurance industry has lobbied
government to prevent such a ban. The industry argues that if people
have genetic test results suggesting that they may become ill or die,
then they may take out large policies, which will have disastrous
consequences for the industry. However, they have not produced
evidence that this is likely to be a severe problem. It could only
become a problem if there developed a market for private, over-the-
counter genetic testing, which should be prevented for many other
reasons. Furthermore, the insurance industry could protect itself
through a reinsurance pool.
It seems clear that the industry's hostility to a ban on the use of
genetic tests is part of its overall hostility to government
regulation. In the USA, whilst various states have passed laws
banning genetic discrimination by insurers, the industry has
succeeded in preventing the passage of comprehensive federal anti-
discrimination legislation. In Britain, in order to prevent a ban,
the industry has compromised by promising not to use genetic test
results for underwriting mortgage-related life insurance policies of
under £100,000. However, it insists on receiving the results of such
tests. The government is co-operating with the insurance industry in
paving the way for the expanded use of genetic tests in insurance.
Last year, the government's Human Genetics Advisory Commission issued
a report on genetic testing in employment which left the door open
for widespread testing.
The insurance industry is currently mounting a sophisticated PR
campaign to assuage fears of genetic discrimination, claiming that it
will be able to insure even those with genetic susceptibilities to
e.g. Alzheimer's disease. However, these claims are based on
mathematical models which incorporate implausible assumptions. The
scale of the problem depends on government policies concerning the
NHS, and also on the insurance industry's maintenance of its system
of pooling risks. If, as in the USA, it moves towards greater
differentiation between individuals, a trend which is likely to be
partly driven by genetics, these assurances could prove false.
Conclusion
The Campaign Against Human Genetic Engineering believes that genetic
discrimination is unacceptable, and is a serious threat which can
only be addressed by a comprehensive legal ban.
--
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