Ethical problems of gene modification in babies.

The creation of genetically-modified babies is not only ethically justifiable but “highly desirable”, according to new academic research from a leading UK bioethicist.

Dr Kevin Smith from Abertay University in Dundee, Scotland, has published ethical analysis concluding that the risks of gene editing are now low enough to justify its use with human embryos, with a view to producing genetically-modified (GM) people.

In the paper, published in medical ethics journal Bioethics, Dr Smith argues that an ethically sound attempt could be less than two years away, and predicts such research could kick-start a revolution in human genetic modification.

It is difficult to see what the nature of this research would be.  The problem does not lie in the ethics of 'designer babies', but in the possible complications of such research.  This is the point I and my colleagues made in a paper we published a few years ago.  Genes are rarely specific for a given characteristic.   Most human diseases are complex phenomena and not specifically genetic.  This is also true of most of our characteristics and behaviour.  It is certainly true for most late-onset disorders. 

The ethical problem lies in what the unforeseen consequences of gene-editing might be.   This is the same problem in research on any medication or treatment.   Fiddling around with this or that gene in a complex set of functions might produce partial success, or a baby may be born with disabilities that were unforeseen.    

It is difficult to see how ethical consent could be given for work on human babies unless these possible poor outcomes could be resolved or prevented.   Research on animals is ongoing.  Gene therapy is being investigated as a possible way to prevent poor fetal development in the womb by altering the function of the placenta.

The author of this paper, who is programme leader for Abertay’s Biomedical Science courses, said research in gene modification would offer hope to parents at risk of transmitting serious genetic disease to their future children. Yes, it might, but caution in research is necessary.

There needs to be thought given to how consent could be obtained without prejudice and pressure. If a gene therapy were to fail, the consequences might be a baby born with unforeseen disabilities. What pregnant woman or mother would volunteer for the research necessary? How would the consent be obtained? This is particularly problematic given when we do not know the possible risks.

The author states that modern genetic studies have revealed that most genetically-influenced human diseases result from the actions of several genes, and show that genetic modification is the only conceivable way to deal with multiple disease-associated genes within an embryo.  This is indeed the problem with a gene-centric approach to disease.  In most cases, we still do not know how many genes are involved, and the more research that is done, the more genes there are that are involved. 

Gene editing is not the magic bullet this author suggests.

Dr Smith said: “The human germline is by no means perfect, with evolution having furnished us with rather minimal protection from diseases that tend to strike in our later years, including cardiovascular disease, cancer and dementia." 

I am not at all sure that is correct.  Evolution has furnished us with an extraordinary capacity to buffer genetic modifications.  It is an ongoing biological process.  So much so that the system will buffer such changes.  Indeed, if this was not the case, then no organism would be able to maintain its integrity.  The buffering and repair process is robust.  

Dr Smith says

“GM techniques offer the prospect of protecting future people against these and other common disorders. This has previously been achieved to an extent in GM experiments on animals."

Here lies the problem.  It has been achieved 'to an extent' in GM modified animals.  But it isn't the foundation of the revolution he claims.  If it were, then there would have been more successful.  

Dr Smith also says:

“If several common disorders could be avoided or delayed by genetically modifying humans, the average disease-free lifespan could be substantially extended.”

Dr Smith says the sooner that scientists are permitted to start creating GM people, the sooner a wide range of benefits will be attained.

However he warned that an ethical approach must be at the heart of any advances if public trust is to be won. Indeed it must.

Dr Smith said: “Society is largely opposed to genetically modifying humans, and the negative publicity generated by the ethically problematic first-ever production of GM babies in China last year was strongly criticised by most geneticists and ethicists, further hardening attitudes against the creation of so-called ‘designer babies’.

“However, by delaying an ethically-sound move towards a world where we can reduce genetic disease, we are failing those who suffer through disease and debilitating conditions.

Yet,  Dr Smith provides no answer to the fundamental ethical problems presented by such research.  The problem is not 'designer babies'.  The problem is consent and potential risk. 

He goes on to say

“If such negative attitudes to biomedical innovation had prevailed in the 1970s, the development and use of IVF – a massively beneficial medical technology – would have been severely delayed, and indeed might never have come to fruition.”

This is no argument for throwing caution to the wind when it comes to experiments on humans.  it simply says progress won't be made unless we are willing to take risks. Furthermore, Dr Smith's assumption that it is 'ethically justifiable' has not been demonstrated because he does not address the issue of how such patients would be recruited ethically. 

On one note I agree entirely.  Dr Smith concludes that 

"considering residual safety concerns and the negative publicity engendered by an ethically problematic recent (2018) first attempt at HGGM, it seems prudent—and ultimately generative of the greatest amount of utility—to delay implementing HGGM for a modest period of time, in the order of 1–2 years."

Although I wonder what 1-2 years would do to answer the acute non-utilitarian concerns.  The principle of consent is not simply a utilitarian one.   It is not something that can be averaged out in the balance of potential benefits in a population; more successes than failure etc.  Ethics of consent isn't simply a calculation.  It is also a duty. 

Dr Smiths paper is a useful contribution to a needed debate.  But debatable it is and there are no easy ethical fixes. 

Ray Noble

Ray Noble was formerly Director of the Centre for Reproductive Ethics at the Institue for Women's Health at UCL.

Ray's relevant publications include:
Developmental origins of health and disease: ethical and social considerations

Ethical considerations of fetal therapy

Pandora's box: Ethics of PGD for inherited risk of late-onset disorders