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The Lancet Oncology Volume 4, Number 2 01 February 2003 A legislative minefield In November 2002, Severino Antinori, an Italian embryologist, announced that three women in the late stages of pregnancy were carrying cloned human foetuses. Antinori, who runs a fertility clinic in Rome, has previously supported the notion of human cloning and has suggested that the approach used to create Dolly the sheep (somatic- cell nuclear transfer) could be easily applicable to humans. In an unrelated but similar disclosure, Clonaid, an associate group of the Raelian religious cult, added further fuel to the public debate by claiming that that two baby girls, born on 26 December 2002 and 3 January 2003, were the world's first human clones. These two events have lead to widespread calls for stringent legislation. Many researchers fear that an ill-informed backlash against all types of cloning would jeopardise research in to novel ways of tackling serious diseases such as heart disease, diabetes, Alzheimer's and Parkinson's disease, and cancer. There is a danger that the current media circus surrounding these stories and the amount of overt publicity gained by both Antinori and Clonaid may overshadow a crucial distinction between reproductive cloning and therapeutic cloning. There is a possibility that this may cause a knee-jerk reaction, lead by public pressure, outlawing all forms of cloning. Such an eventuality must be avoided if potential advances in medical research are not to be substantially harmed. The disclosures by Antinori and Clonaid relate to reproductive cloning, ie, the replication of identical animals or humans by implantation of a somatic cell nucleus from one individual into an enucleated oocyte and the subsequent full-term gestation of the oocyte in a host. It is entirely right that reproductive cloning should be banned. Notwithstanding the far-reaching ethical, moral, and religious arguments, there are also a many biological questions. Animal research has shown that cloned organisms are at greater risk of gross abnormalities. These include developmental delays, respiratory deformities, malformed foetuses, and oversized young. In addition, there are unknown long-term complications such as the effect on natural evolution and the loss of genetic variation, the accumulation of genetic deflects by successive cloning, and the age of cloned cells and their influence on life span. Some researchers have suggested that cloned cells are older than normal foetal cells and this can contribute to premature ageing of the animal. Aged cells, with their inherent increased level of DNA mutation, are susceptible to loss of regulation and neoplasia. Thus, one could also speculate that cloned animals might carry a greater predisposition for cancer. Therapeutic cloning, however, is entirely different ethically and essential for medical progress. This type of cloning can provide material for replacement tissues and organs, facilitate successful organ transplantation, enhance immunological surveillance, or correct genetic defects via the introduction of functional genes. All of these applications have potential clinical utility in the treatment of cancer and other major diseases. A clear distinction between therapeutic and reproductive cloning is recognised by the legal situation in some countries, indeed, human reproductive cloning is banned in the UK and Australia. Other countries, however, have yet to follow suit and many have deferred making a decision by adopting moratoria. A lack of clear legislation can lead to many problems. The situation in the United States is a good example. In 1997, the Clinton administration implemented a 5- year moratorium on human reproductive cloning, which has now expired. During the intervening 5-year period, the House of Representatives voted to ban human cloning but draft legislation did not permit embryonic stem-cell research (ie, therapeutic cloning). An amendment to allow this application was subsequently rejected and a suitable bill has yet to be ratified. Confusingly, a separate piece of active US legislation bans federal funding for human embryo research but not human embryonic stem-cell research. Thus, although some precedence exists, the situation is very unclear and US pharmaceutical companies are worried that recent events may lead to a blanket ban on all forms of cloning. The legal situation in many countries needs to be clarified quickly, but this will only occur in a rational and sensible way if evidence- based conclusions are used to formulate new legislation. Medical research and its potential to find cures for major diseases such as cancer should not be influenced by legal solutions designed to address similar, but essentially different, issues. The myriad of nationally administered laws and unclear legislation are patently insufficient to prevent human reproductive cloning and, taken together, potentially endanger clinical research. A worldwide commitment to legal harmonisation, uninfluenced by propaganda or public pressure, is urgently needed to resolve the current situation. SOURCE: The Lancet Oncology http://oncology.thelancet.com/journal/vol4/iss2/full/lonc.4.2.the_lead ing_edge.24214.1 * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn