The practical ethics of smart drugs

In this first post of a new feature on HumanistLife, one blogger tackles a contemporary ethical concern from a humanist, rationalist or evidence-based position. Below, Laurie Pycroft discusses the smart drug modafinil, and addresses concerns over its use.

Photograph: Anders Sandberg

What if you could make yourself smarter simply by taking a pill? The concept of drugs that improve cognitive functions has been prevalent in science fiction for many years, but only relatively recently has the proliferation of such pharmaceuticals been a serious possibility. “Nootropics” or “smart drugs” have been hitting the headlines lately, with the promise of increased focus, memory, and wakefulness being an appealing prospect for many. Most widely discussed have been stimulants, normally prescribed for medically recognised conditions, being used off-label by healthy individuals seeking to improve their performance at mentally demanding tasks. Modafinil (AKA Provigil) is probably the most prominent of these drugs in the UK. Originally developed as a treatment for narcolepsy, modafinil also improves wakefulness in healthy people and evidence suggests that it may improve other aspects of cognitive function in some individuals. As with any drug, however, modafinil has risks associated with it and may be harmful to those taking it. Furthermore, there is a danger of smart drugs having negative side-effects on a societal level. As such, it is important to carefully consider the ethical ramifications of widespread use of smart drugs such as modafinil. This is a substantial question, far too large for this short article to consider in depth, but hopefully this piece will provide a reasonable overview of the issue and pose a few interesting questions worthy of deeper consideration.

The first important point to consider is the fact that cognitive enhancement, whether using drugs or other methods, is nothing new. Perhaps the most obvious example is caffeine, a substance that many millions of people use on a daily basis with the intent of reducing tiredness and improving focus. Less obvious are technologies such as computers and organised education, along with healthy diet and exercise, all of which offer substantial improvements to our cognitive abilities. When considering the issue of smart drugs, one should always consider the comparison with established cognition enhancement techniques and remember that all of them have potential down-sides. The important question here is – what amount of benefit does the intervention offer, and is the level of risk associated with it acceptable?

Most established cognition enhancement techniques carry relatively little risk, from an individual standpoint. Caffeine is perhaps the best point of comparison for drugs such as modafinil. Caffeine is addictive and can produce unpleasant side-effects, but it is unlikely to seriously threaten health in most people, except at very high doses. Conversely, its benefits are quite minor – primarily improving perceived wakefulness for a short period of time. Modafinil’s benefits are likely somewhat greater, with research indicating that it can significantly improve working memory, concentration, alertness, and other cognitive abilities in sleep deprived individuals. Results are less clear-cut when it comes to those who have had sufficient sleep, but some studies have reported enhancements to aspects of memory and concentration, especially in individuals with a lower baseline performance in the experimental tasks. The negative effects of modafinil use in healthy people are still not fully understood – while it is not associated with the same level of addiction or cardiovascular damage seen with many stimulants, it is thought to carry a small risk of inducing some extremely rare but potentially life-threatening dermatological conditions. Relatively little research has been done into its long-term health effects and future smart drugs are likely to be similarly poorly understood. These risks are compounded by the fact that, currently, modafinil is illegal to sell (although not to buy) without a prescription in the UK, meaning that healthy users must purchase it from underground sources, raising the possibility of being sold impure or mislabelled products. Whether this level of risk is acceptable is, ultimately, a question that each potential user must ask themself.

The issues surrounding smart drugs are not, however, exclusive to the individual. Any new technology that has the potential to alter the cognitive processes of millions of people is bound to have effects on society as a whole. Two inter-related societal issues that smart drugs could impact are those of inequality and competition. The inequality issue comes down to the possibility of expensive new smart drugs exacerbating existing social divides – while modafinil is relatively inexpensive and the benefits it offers are modest, it is not inconceivable that new drugs could be developed offering greater improvements to cognition while being substantially more costly. Such a situation could lead to the rich having preferential access to cognition enhancement, making it even more difficult for the poor to compete. While this is a potential problem, it is far from insurmountable. A drug that offered such major benefits could be worth providing for free (or at reduced cost) to the population at large, whether through state health service or charity.

This already occurs with education, which requires a vast investment of time and money, but offers such great benefits that society is willing to foot the bill. The competition issue is often raised with regards to education – if one group is able and willing to take these drugs, do they have an unfair advantage over those who do not? A problem with this line of reasoning is its comparison of education to a zero-sum game such as competitive sports. In sport, if one person has an advantage, everyone else is negatively impacted as they are less likely to win. In education, however, the goal is not to “win”, but rather for everyone to learn as much as possible, with a better educated workforce tending to benefit society as a whole. There is still the issue of perceived competition and coercion – if society gets to the point where most people are benefiting from smart drugs, those who are not taking these drugs may feel pressured into doing so. Is this fair to those who, for issues of health, ethics, or religion do not want to ingest these drugs? If not, is the unfairness sufficient reason to restrict smart drug usage in the whole population, or to pass legislation preventing employers making hiring decisions on basis of smart drug use?

This coercion issue becomes more complex still when considering those whose job performance can seriously impact others’ lives. A recent study headed by Prof. Barbara Sahakian at Cambridge suggests that sleep deprived doctors may perform significantly more effectively at certain cognitive tasks after taking modafinil, and therefore could be more effective at their jobs when taking the drug. In an ideal world doctors would always get enough sleep, but in the real world modafinil may offer a way to reduce medical errors and improve the lives of patients. If this is the case, should doctors be encouraged or even required to take modafinil when tired? One can extend this reasoning to other professions that are relied upon to make important decisions when deprived of sleep, such as pilots and politicians. Is the risk of side effects outweighed by the risk to patients, passengers, and citizens posed by cognitively compromised decision-makers?

As with the public debate surrounding many drugs, both legal and illegal, the discussion of smart drugs is often typified by moral panic, political posturing, and a poor understanding of the science involved. News outlets are often content to discuss amazing miracle-pills or evil mind-destroying drugs, without seriously considering the risk/reward ratios of putative cognitive enhancers, and how they compare with existing methods. If modafinil and similar drugs continue to become more popular, the individual and societal ethical issues surrounding them will grow in importance. A sober and rational consideration of these issues is critical if policymakers are to make informed decisions on the topic, rather than simply following the knee-jerk reaction of the tabloid press. The questions posed above aren’t trivial, but finding acceptable solutions to them could be highly beneficial to society; if modafinil and future smart drugs can be harnessed appropriately, many people would be able to perform better at their jobs, be more productive, and have more fulfilling lives. Hopefully the novelty and potential risks of these drugs won’t completely overshadow the potential benefits.

 

Further reading:

 

Homeopathy, celebrities and marketing

By Lee Turnpenny

Photo by Philippa Willitts

Those who subscribe to the cult of homeopathy tend to be afflicted with a continually confused attitude to the concept of evidence. On Weds 25 November 2009, the House of Commons Science and Technology Sub-Committee convened for an Evidence Check on Homeopathy. Amongst the ‘witnesses’ was Dr Peter Fisher, Clinical Director and Director of Research at the Royal London Homeopathic Hospital (now the Royal London Hospital for Integrated Medicine). Dr Fisher unashamedly described the process of succussion (forward to 11:06). In case you’re not familiar, this is the action of vigorously shaking/striking a vial of liquid in order to activate the memory of a substance (ie, the ‘remedy’) that has been diluted out of it, whilst simultaneously detoxifying the effects of all the other stuff the water will inevitably have come into contact with (because water is promiscuous stuff).

The Government Response to the Committee’s report concluded overall that:

By providing homeopathy on the NHS and allowing Medicines and Healthcare products Regulatory Agency licensing of products which subsequently appear on pharmacy shelves, the Government runs the risk of endorsing homeopathy as an efficacious system of medicine. To maintain patient trust, choice and safety, the Government should not endorse the use of placebo treatments, including homeopathy. Homeopathy should not be funded on the NHS and the MHRA should stop licensing homeopathic products.’

However, despite this concurrence, the Government then weasel-y left it to Primary Care Trusts to decide whether to continue wasting NHS funds on homeopathy, under the sopping guise of patient ‘choice.’ (Homeopathy enjoys sympathy among MPs – including from the Secretary of State for Health.)

The majority of homeopathic products licensed by the MHRA are registered under a 1992 Simplified Scheme that prohibits ‘indications’ – ie the associated description of disease/conditions, and medical/therapeutic claims thereon. These MHRA regulations on the advertising of medicinal products thus inform the Advertising Standards Authority, which on 1 March 2011 widened its scope to encapsulate marketing/advertising on UK websites. And thereafter received copious complaints about the online claims made by an array of homeopaths/homeopathy organisations (to the extent that it requested abeyance). The ASA contacted the complained-of advertisers – and those UK bodies that represent homeopaths and homeopathy. Its letter explicitly states:

‘You must remove any content from your website that claims directly or indirectly that homeopathy and homeopathic products can diagnose/treat/help health conditions.’

This letter (well worth a read, by the way) also informed addressees that their sites were under surveillance, with three months in which to comply with guidance on the marketing of health-related products and services, as stipulated by the Committee of Advertising Practice (CAP).

During British Homeopathy Awareness Week back in June last year I took umbrage with various homeopathy organisations’ cheap, egregious, fallacious resort to endorsement by celebrity, including (to take just one) the British Homeopathic Association. The British Homeopathic Association’s ‘Celebrity Photography Project’ comprises quite fetching images of partaking celebs ‘… holding the source material of one of the homeopathic medicines that has helped them’ . If I’ve piqued your interest then, rather than take up word space here with quotes, I urge you to peruse for yourself this Goof’s Gallery.

I’m sure these celebrities are being ‘genuine’, in that they believe what they say. (After all, they subscribe to a belief system for people who like to feel all “Speh-shull.”) But I found this puzzling. Doesn’t that ASA letter apply to ‘… those bodies that represent homeopaths and homeopathy in the UK…’? Which must surely, I figured, encapsulate the British Homeopathic Association. Indeed, the Association’s website proudly boasts:

The British Homeopathic Association exists to promote homeopathy practised by doctors and other healthcare professionals.’ (My emphasis in bold.)

I therefore decided to flag this up to the ASA, because, to my eye, these celebrities are not only making/implying ‘… claims directly or indirectly that homeopathy and homeopathic products can diagnose/treat/help health conditions’; but they also imply ‘indications’ for these products, the majority of which are listed as registered under the MHRA Simplified Scheme (which prohibits indications). The ASA letter contains a paragraph I find particularly pertinent here:

Please note that testimonials from patients (which must be genuine) that imply efficacy for homeopathic treatment do not constitute substantiation but may give a misleading impression that efficacy is proven. Therefore it is essential that any testimonials also only make general references to an improved sense of well-being.’

Clearly, these celebrity statements constitute patient testimonials which imply efficacy for (unsubstantiated) homeopathic treatments. It appears to me that this project overall constitutes website content that (at the very least) ‘… claims directly or indirectly that homeopathy and homeopathic products can diagnose/treat/help health conditions.’ Which, to reiterate, are ‘Claims you cannot make’ under the CAP Code, as applies to advertisers, ‘… as well as those bodies that represent homeopaths and homeopathy…’.

The ASA declined to pursue this apparent anomaly. I had also written to the MHRA, whose guidelines also prohibit celebrity endorsement, but was informed (even though the remedies named by the celebrities marry with product names in its registration listing) that it only concerns itself with direct advertising of specific homeopathic medicinal product.’ As the BHA is not itself selling products, its celebrity endorsement falls outside the MHRA remit, as it constitutes promotional material, and on which it suggested I contact… the ASA. However, the ASA is likewise adamant that this complaint does not come under its remit (in apparent contradiction of its own letter) because the British Homeopathic Association is not itself directly supplying or transferring goods. So much for acting in the public interest.

Why does the British Homeopathic Association (and many other homeopathy-promoting bodies) seek testimonials, or mine for quotes, by celebrities? Just when does ‘raising awareness’ become ‘promotion’ become ‘advertising’? Although NHS support for homeopathy is on the wane (as of the end of last year, only 15% of PCTs were continuing to fund it), public money on this inefficacious ‘rubbish’ continues to be wasted, as chief medical officer Professor Dame Sally Davies recently reminded the CST committee. And in order to circumvent the ASA’s imposition on the advertising of their wares, homeopaths and homeopathy organisations such as the British Homeopathic Association have resorted to the patronising logical fallacy that is the appeal to celebrity (presumed) authority. Although the British Homeopathic Association does not itself (as far as I am aware) supply products and services, it represents – and promotes indirectly on behalf of – those homeopaths/homeopathic product providers who do. As the latter are covered by the ASA remit and can no longer legitimately advertise, the British Homeopathic Association is, it seems to me, exploiting a loophole – through the under-the-radar guise of ‘awareness-raising’ celebrity testimonials, which, in my opinion, are in contravention of the CAP Code.

As if a ‘senior homeopath’ spouting aqueous nonsense without compunction to a parliament committee is not ridiculous enough. What we have here, in effect, is a situation wherein, if you sell or provide certain dubious products and/or services, but are barred from making claims as to their efficacy, you can happily watch your representative umbrella organisation, which does not itself directly supply/sell/provide those products/services, make those claims indirectly on your behalf. Hence this permitted proxy-promotion of indication-prohibited, homeopathy products through a bunch of docile celebrities. A snake-oil-lubricated loophole.

www.leeturnpenny.com
First published in The Leicester Secularist,  (Jan 2013: see: http://www.leicestersecularsociety.org.uk/newsletter/index.php).