A right to know?

Charlotte Augst outlines the ethical dilemmas posed by the sale of gene testing kits

Over the last few years, increasing numbers of companies have started selling genetic tests to the interested public, via the internet, "health" and drug stores and through various "health" professionals. Maybe the two most well known examples are Myriad's BRCA1 and 2 testing for an inherited breast cancer gene and Sciona's so-called lifestyle test, which claims to provide you with "personalised diet and lifestyle advice".

In February last year, the government asked the Human Genetics Commission for advice and recommendations regarding the supply of genetic tests direct to the public. The HGC is due to report in the near future, after having consulted the public and many interest groups. The HGC has heard many conflicting views regarding the nature of genetic information, safeguards for quality standards and confidentiality, the "right to know" and the need to protect the public from misleading or potentially distressing information.

It seems, however, that one message came through loud and clear, despite the chorus of contradictory voices and vested interests: the public do not want to use genetic tests that can reveal a predisposition to serious diseases like cancer outside the setting of proper, professional health care. They want the advice and guidance of a qualified health care professional to help them decide whether to take a test, and to assist their understanding of any results.

This clearly corresponds with the experience of CancerBACUP, the largest specialist provider of cancer information in Europe. Every year more than 50,000 people speak to a CancerBACUP specialist cancer nurse, either on the phone or in one of the drop-in centres across the country, requiring comprehensive, up-to-date and non-partisan information about cancer. An increasing number of callers request information about genetic risk and are concerned about a family history of cancer. Many of them are unnecessarily alarmed and confused by misleading or sensationalised media-reporting of genetic "breakthroughs" and discoveries of more and more "cancer genes".

"Many of our callers need reassurance and want some guidance about how they can access genetic services and counselling through the NHS," explains Tracy Williams, a senior nurse at CancerBACUP. "They need to know that the information they receive is not motivated by the ultimate business goal of selling them a test or a nutritional supplement, but is presenting the available, limited knowledge we have about cancer genetics in a balanced and responsible way."

The HGC is likely to propose bringing the provision of genetic tests for serious conditions under the control of the new Medicines and Healthcare Products Regulatory Agency (MHRA). Currently there are no statutory regulations dealing specifically with the quality, safety and accuracy of genetic testing kits. This move is welcomed by the Consumers' Association too. "We believe public interest should come above commercial gain in the supply of genetic tests to the public. At the moment the situation is ripe for exploitation given the current level of scientific uncertainty relating to many of these tests, gaps in consumer protection and low levels of consumer education," states Nikki Ratcliff, a senior researcher at the CA.

The Consumers' Association also believes it is worth learning some of the important lessons that have been drawn out of the debate around the direct-to-consumer advertising of prescription drugs. The CA fears that consumers may be influenced by so-called "awareness" campaigns and that advertising could lead to unnecessary consumer demand and a waste of public and private resources.

The information that individuals need with regard to genetic testing is complex, uncertain and deals with possibly distressing consequences for the individuals themselves and their families. This is why they need time and support to reflect about their options and the possible effects different test results might have for their lives. Advertising and selling genetic tests straight to the consumer might sound empowering, enabling them to take control. However without the necessary safeguards for the quality of information that guides individuals' decision making, and proper support for them to deal with the consequences of such tests, it risks being exploitative rather than empowering.

CancerBACUP has recently started to research and address the information needs of the public with regard to the evolving field of cancer genetics. They will continue to give information and support to callers with questions about their family history of cancer and are also planning to publish a series of factsheets in order to inform a wider public about genetics and cancer risk. It is encouraging that the HGC too has decided that public information and education about genetic knowledge should be the focus of its work for the next year.