Biotechnology

Whose lifestyle benefits? Regulatory risk-benefit assessment of enhancement devices

Nearly everyone would agree that a device or drug that relieves pain, or alleviates symptoms of depression confers a benefit – plausibly, a substantial benefit – on its user. No matter what your goals are, no matter what you enjoy, you are likely to agree that your life will go better if you are not in pain and not depressed: whether you’re a painter, a footballer, a Sudoku-enthusiast or a musician, you will be better able to pursue your projects and engage in the activities you love. It is unlikely that you will even question whether pain relief or alleviation of depression indeed constitute benefits.

This general consensus with respect to medical benefits makes it relatively straightforward for regulators to conduct risk-benefit assessments of medical products when they decide whether a particular product can be put on the market. A very small risk of a mild rash or gastrointestinal upset, for example, will be considered reasonable in the context of effective pain relief, as long as patients or consumers are informed. Even as the risks get more significant, substantial pain relief will be considered a large enough benefit to out-weigh a range of negative side effects in many cases.

So far, so straightforward. Continue reading

Why edited embryos won’t lead to designer babies or eugenics (unless we want it too)

The UK became the first country to officially approve gene editing research in human embryos on Monday. The HFEA decision means experiments in which the genes of embryos are manipulated will likely begin at the Francis Crick Institute within the next few months.

Gene editing (GE) technologies are immensely powerful. They have already been used to manipulate mosquitos so they cannot carry diseases like malaria or Zika. They have been used in medicine to reprogram human immune cells to target cancer. When used for research purposes, they promise to greatly increase our knowledge of genetics and human heredity. This will lead to a better understanding of disease, which in turn will allow better treatments – including better drugs.

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The reproducibility problem and the status of bioethics

There is a long overdue crisis of confidence in the biological and medical sciences. It would be nice – though perhaps rather ambitious – to think that it could transmute into a culture of humility.

A recent comment in Nature observes that: ‘An unpublished 2015 survey by the American Society for Cell Biology found that more than two-thirds of respondents had on at least one occasion been unable to reproduce published results. Biomedical researchers from drug companies have reported that one-quarter or fewer of high-profile papers are reproducible.’

Reproducibility of results is one of the girders underpinning conventional science. The Nature article acknowledges this: it is accompanied by a cartoon showing the crumbling edifice of ‘Robust Science.’

As the unwarranted confidence of scientists teeters and falls, what will – and what should – happen to bioethics?

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Gene editing and eugenics

A study published last week in the journal Cell has led to speculation that a powerful new gene editing technique is about to be developed.

Gene editing has received widespread media coverage over the past few months. Most of the excitement has centred on a specific gene editing technique, the CRISPR-cas9 system. Research conducted with CRISPR-cas9 on human embryos has been highly controversial, at least partly because some people fear it will lead to gene editing being used to alter the human germline for clinical applications, and will have unpredictable effects on future generations.

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Less cooperation, please

Written by Joao Fabiano

Since the idea of enhancing human morality was proposed – and perhaps long before then – there has been a great deal of scientific research directly or indirectly inspired by the goal of improving human moral dispositions. Manipulations which result in increased levels of cooperation, prosociality or altruism are often seen as promising discoveries towards the path of developing moral enhancement technologies. The fact that increasing cooperation between individuals would be going in the wrong direction seems to be ignored. The problem moral enhancement proposes to fix is large-scale cooperation – cooperation between groups of individuals – not between individuals inside a group. Issues like global warming and nuclear disarmament arise primarily in the interaction between large groups of individuals, not in the interaction of individuals within the same group.

In actuality, humans already cooperate well inside small groups. We have evolved many emotional and cognitive mechanisms which enable us to function quite satisfactorily in the context of small cooperative groups such as the ones more frequently prominent in pharmacological research. Many have proposed local economies as the ideal design for producing sustainable management of common resources[1]. There is not that much room for improvement there.

On the other hand, when it comes to interactions between groups of different religions, nationalities and morals we can fail spectacularly. What’s more, our ability to cooperate well inside groups seems to be directly correlated with our inability for cooperation between groups. Continue reading

Doping in Hollywood

For his role in the new movie Southpaw, Jake Gyllenhaal gained 45 lbs (20 kgs) of muscle in six months. Many praised Gyllenhall for his dedication in undergoing this remarkable physical transformation. Few have questioned whether this achievement was aided by the use of performance enhancing drugs (PEDs). Some in the bodybuilding community claim that such massive weight gain would be nearly impossible without the use of steroids. For experienced bodybuilders, it is considered an accomplishment to gain 7-10 pounds of muscle in a year “naturally”. Training in combination with taking human growth hormone (HGH) can add 4.6 pounds of lean muscle mass, in three weeks.

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Anorexia Nervosa and Deep Brain Stimulation: Philosophical Analysis of Potential Mechanisms

By Hannah Maslen, Jonathan Pugh and Julian Savulescu

 

According to the NHS, the number of hospital admissions across the UK for teenagers with eating disorders has nearly doubled in the last three years. In a previous post, we discussed some ethical issues relating to the use of deep brain stimulation (DBS) to treat anorexia nervosa (AN). Although the trials of this potential treatment are still in very early, investigational stages (and may not necessarily become an approved treatment), the invasive nature of the intervention and the vulnerability of the potential patients are such that anticipatory ethical analysis is warranted. In this post, we show how different possible mechanisms of intervention raise different questions for philosophers to address. The prospect of intervening directly in the brain prompts exploration of the relationships between a patient’s various mental phenomena, autonomy and identity. Continue reading

Strange brew: opiates from yeast

A recent series of papers have constructed a biochemical pathway that allows yeast to produce opiates. It is not quite a sugar-to-heroin home brew yet, but putting together the pieces looks fairly doable in the very near term. I think I called the news almost exactly five years ago on this blog.

People, including the involved researchers, are concerned and think regulation is needed. It is an interesting case of dual-use biotechnology. While making opiates may be somewhat less frightening than making pathogens, it is still a problematic use of biotechnology: millions of people are addicted, and making it easier for them to get access would worsen the problem. Or would it?

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Speculating about technology in ethics

Many important discussions in practical ethics necessarily involve a degree of speculation about technology: the identification and analysis of ethical, social and legal issues is most usefully done in advance, to make sure that ethically-informed policy decisions do not lag behind technological development. Correspondingly, a move towards so-called ‘anticipatory ethics’ is often lauded as commendably vigilant, and to a certain extent this is justified. But, obviously, there are limits to how much ethicists – and even scientists, engineers and other innovators – can know about the actual characteristics of a freshly emerging or potential technology – precisely what mechanisms it will employ, what benefits it will confer and what risks it will pose, amongst other things. Quite simply, the less known about the technology, the more speculation has to occur.

In practical ethics discussions, we often find phrases such as ‘In the future there could be a technology that…’ or ‘We can imagine an extension of this technology so that…’, and ethical analysis is then carried out in relation to such prognoses. Sometimes these discussions are conducted with a slight discomfort at the extent to which features of the technological examples are imagined or extrapolated beyond current development – discomfort relating to the ability of ethicists to predict correctly the precise way technology will develop, and corresponding reservation about the value of any conclusions that emerge from discussion of, as yet, merely hypothetical innovation. A degree of hesitation in relation to very far-reaching speculation indeed seems justified. Continue reading

THE ETHICS OF EMBRYO EDITING

Darlei Dall’Agnol

 The British Parliament has, recently, passed Act 1990 making possible what is, misleadingly, called “three parents babies,” which will become law in October 2015. Thus, the UK is the first country to allow the transfer of genetic material from an embryo or an egg that has defects in the mitochondrial DNA to generate a healthy baby. As it is perhaps known, a defect in the mitochondrial DNA causes several genetic disorders such as heart and liver failure, blindness, hearing loss, etc. Babies free from these genetic problems are expected to be born next year. This is good news and shows how science and technology can really work for human benefit.

This procedure raised several concerns, but also revealed confusion and misunderstandings in public debates. There was the fear of opening the way to Nazi practices considered intrinsically immoral. This is certainly not the case since the prevention of mitochondrial defects does not, strictly speaking, involves any gene editing, which is a different kind of genetic engineering.[1] Now, embryo editing, which will be illustrated soon, does divide scientists and ethicists and needs further public debate. I will here present some real ethical concerns relating to embryo editing and to comment on the recent call, published by Nature, for a moratorium on the germline experiments. Continue reading

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