NANCY Wexler, a specialist in Huntington鈥檚 disease at Columbia University, tells a story about an American mother who came to see her recently. She wanted her two young children tested to see if they had inherited the gene for Huntington鈥檚 disease. The disease is a terrible debilitating illness, involving the progressive loss of physical coordination and mental powers. But it strikes in middle age. So why, asked Wexler, did she want two young children tested. Because, came the reply, she only had enough money to send one of them to Harvard.
Genetic testing is a growth industry. In the US, healthcare insurers already discriminate against people who have had genetic tests, according to a report in Nature Medicine (August 1995, vol 1, p 733). To get health insurance, a woman who knows she is genetically predisposed to breast cancer must lie. Employers in America also test their workers to avoid hiring people carrying genes that make them more susceptible to certain industrial chemicals.
In Britain, mail-order genetic tests became available for the first time last year when the fledgling company University Diagnostics started advertising in Cosmopolitan. Adults send in 拢65 and a saliva sample to learn whether they carry the cystic fibrosis gene and run the risk of having children with the disease if their partner is also a carrier.
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For many people a test could provide some reassurance if, for example, they were worried about carrying cystic fibrosis. For others, the wrong result in a genetic test could mean that they will never find a job or cannot get insurance. The tests are far from foolproof. With current technology, the tests detect only the most common genetic candidates. The test for cystic fibrosis carriers, for example, cannot detect the 15 per cent of the population who carry rare genetic mutations.
There is also the problem of regulating the testers. The standards of testing and follow-up counselling at University Diagnostics are high 鈥� University College London is a major shareholder. But at the moment there is nothing to stop anyone setting up a gene-testing business in their garage, says Paul Debenham, managing director of University Diagnostics.
Last July, the all-party House of Commons Select Committee on Science and Technology 鈥� recommended setting up a human genetics commission to control this industry. The MPs wanted this watchdog to have real teeth 鈥� with legal powers to regulate the quality of genetic testing, to prevent the misuse of data and control the access of insurance companies to information about their clients.
Strong reaction
Last month, the government rejected all the select committee鈥檚 key recommendations. The government favours a minimal1st approach involving self-regulation instead of legislation. All the government is going to do is to set up a modest advisory committee.
This negative response has provoked an unusually strong reaction. The select committee has decided to hold a 鈥渕ini-inquiry鈥� to canvass the views of clinical geneticists and researchers on the government鈥檚 response, says Giles Shaw, who chairs the select committee. Committee members want to 鈥渓ook further at why the government responded in the way it did鈥�, says Labour MP Lynne Jones.
And on the Tory side, MP Spencer Batiste complains: 鈥淲e are extremely disappointed that the government hasn鈥檛 been able to meet our key recommendation 鈥� that of setting up a commission that can take a strategic overview and anticipate problems. It is a big oversight on the part of the government.鈥�
Kay Davies, professor of human genetics at the University of Oxford, is also very concerned about the government鈥檚 attitude: 鈥淲ithout a commission, I don鈥檛 see how we can be ready to adjust to the new environments genetic science and technology might create. We鈥檝e never had a field like this before.鈥�
Reporting to the Department of Health, the new Advisory Committee on Genetic Testing will examine only medical tests. The advisory committee will have no say about employers who carry out tests on their workers.
In last month鈥檚 response to the select committee the Department of Trade and Industry, stressed that company policy and practice on genetic testing 鈥渋s essentially a matter for employers themselves鈥�. The DTI also rejected legislation to protect the privacy of genetic information in the workplace. Instead, it praised the contribution that genetics research can make to 鈥渆nhancing UK competitiveness鈥�.
Some critics suspect that the government鈥檚 apparent reluctance to tackle genetic issues stems in part from the last year鈥檚 reshuffle that assigned responsibility for science to the DTI. 鈥淣ow that science is in the DTI, the government is not going to recommend anything that might upset a commercial interest,鈥� says Peter Harper, professor of medical genetics at the University of Wales at Cardiff.
The select committee had unanimously recommended legislation to make it a criminal offence to misuse private genetic information. 鈥淐onservative members of the committee were vociferously behind such criminal sanctions,鈥� says Jones. But the government maintained that existing regulations concerning the confidentiality of medical records are sufficient to ensure the privacy of genetic data.
Nor does the government believe that legislation would be appropriate 鈥渘ow or in the foreseeable future鈥� to limit the access of insurance companies to genetic information about their clients.
Instead, and in line with its policy of self-regulation, the government points to the series of meetings 鈥� between leading British geneticists and the Association of British Insurers 鈥� which were set up in the wake of the select committee report. The MPs wanted the government to force insurers to come up with policy guidelines on genetic testing within 12 months, by threatening to introduce legislation. Now that the DTI has rejected this tough approach many geneticists fear that the insurers鈥� interest in guidelines will wane.
鈥淏asically the government has avoided all the difficult things,鈥� says Harper. 鈥淚t ducks all the important issues such as the use of genetic information by insurance companies or employers 鈥� issues about which scientists have long been asking for answers.鈥�
The select committee also wanted the commission to regulate businesses offering private gene testing. Debenham at University Diagnostics also sees a need to regulate the market: 鈥淚t is in the best interests of commercial genetics in the longer term. Although we welcome it, an advisory committee is just a halfway house.鈥�
Ministers have apparently been taken aback by the strength of the criticism. Lamenting the government鈥檚 鈥渉alf-hearted鈥� approach to human genetics, Angus Clarke, a clinical geneticist at the University of Wales at Cardiff, says: 鈥淲e were hoping that the government would grasp the nettle more effectively, and bring genetic issues together under one umbrella.鈥�
The select committee鈥檚 report was 鈥渧ery good quality鈥�, says Harper. 鈥淵ou don鈥檛 often get reports of that degree of thoughtfulness and consensus,鈥� he argues. 鈥淥ne has to contrast it with the abject spinelessness of the government鈥檚 response.鈥�
Alastair Kent, director of the Genetic Interest Group, an alliance of support groups for people affected by genetic disorders, based in London, is also unequivocal. 鈥淚t is a failure of government to seize an opportunity to establish a proper framework for human genetics research and services, while controlling abuses of genetic information that can be predicted to occur. The government hasn鈥檛 understood what鈥檚 going on.鈥�
Toothless committee
It is the 鈥渕inimum by way of an acceptable response鈥� to the select committee, comments David Shapiro of the Nuffield Council on Bioethics, which urged the government to set up a 鈥渃entral coordinating body鈥� for genetic screening as long ago as 1993. Martin Bobrow, professor of medical genetics at the University of Cambridge, says: 鈥淭his new committee does not have the breadth of remit nor the teeth I would have liked to see.鈥�
The government argues that 鈥渆xisting bodies鈥� already cover 鈥渢he majority of issues for which a Commission would have responsibility鈥�. Further, it claims that its new advisory committee will fill any gaps, and argues that the Gene Therapy Advisory Committee shows how well a non-statutory approach can work in genetics.
However, the select committee stressed that GTAC was not a good model because gene therapy is still tightly controlled by a small band of academics. 鈥淕enetic testing isn鈥檛 like that,鈥� says Kent. 鈥淚t can be done commercially for a whole raft of conditions, and there is a distinct commercial advantage in getting out there.鈥�
According to Kent, the government鈥檚 low-key response is misguided. 鈥淯nless we create a mechanism so that people who can be genetically identified as at risk are not unfairly disadvantaged, we will create a huge class of people not deemed commercially attractive to the private sector 鈥� or only at vast premiums they won鈥檛 be able to afford,鈥� worries Kent.
The full membership of the advisory committee has still to be decided. But the government has announced that it will be chaired by the Reverend John Polkinghorne, president of Queen鈥檚 College Cambridge and known for his work in physics and theology. Much will depend on the composition of the advisory committee, says Kent. It should represent a broad range of interests, and it must have the resources and budget to enable it to 鈥渁ctively go out and consult and investigate,鈥� he argues. 鈥淚t shouldn鈥檛 just meet in a room in the Department of Health and wait for things to come to it.鈥� Harper adds: 鈥淭his isn鈥檛 an issue that is going to go away. This government may not face things. Maybe the next one will.鈥�