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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