Starting from this scenario we will now analyze the most important ethical questions that need to be addressed by public policy, and formulate some policy advices.
Should the Government Prohibit or Promote Enhancement Research?
A first important issue is whether the development of enhancing drugs should be forbidden or on the contrary, as some philosophers argue, whether we have a moral obligation to pursue enhancement [8, 52].
The argument for a moral duty to enhance is often made from a utilitarian point of view: if a certain development or intervention will benefit us, both individually and as a society, it ought to be pursued. The assumption of proponents is that the development and use of enhancers will create benefits—longer, healthier, happier, better lives for more people. Harris even defines enhancements as those interventions or techniques that do benefit us in this way, which makes the duty to enhance a re-statement of a general duty of beneficence. As such, the duty to enhance is an imperfect duty: a duty to aim at a certain end. In contrast to perfect duties, imperfect duties do not spell out exactly when and how to act. While perfect duties clearly describe the acts do be done (or omitted, in case of negative duties) and the conditions under which these ought to be done, imperfect duties allow more latitude. It is typical for imperfect duties that the acts they require cannot be spelled out exactly but give persons some freedom to decide how and on what occasions to fulfill them. Therefore, an imperfect duty to enhance (i.e. a duty of beneficence) does not give us much direction or guidance. It is unclear to whom this duty applies (the government, organizations that fund research, biomedical researchers, doctors, all of us); what it implies (exactly which actions are required?); and under what conditions it applies. Finally, it remains unclear how we are supposed to prioritize the myriad ways in which we could benefit people. Why develop cognitive enhancers and not malaria drugs? Why spend money on drug development instead of education?
In order to transform this very general imperfect duty of enhancement into one or more perfect duties, a number of steps needs to be taken to specify whom the duty addresses, which concrete actions it requires and under what conditions it applies. All these steps will require additional arguments, deliberation about concrete cases informed by relevant empirical data, and weighing against other moral duties (like a duty of justice, or other ways of fulfilling a duty of beneficence). Until those steps are taken a ‘duty to enhance’ appears to be little more than a pro-attitude to enhancement.
A very problematic move in the discussion on the duty to enhance is the fact that enhancement is too easily equated with beneficence. The proponents of a duty to enhance either define enhancement as beneficial , or claim that if enhancements benefit us, it is our duty to pursue them . However, by doing so they avoid the important discussion on whether various types of enhancements do indeed benefit us. In the case of psychopharmacological enhancers it is not obvious that they will, not only because we presently lack sufficient empirical evidence about effects and side-effects, but also on a more fundamental level because it is not clear what conception of a good life or a good society we ought to use to assess the effects of enhancement. From a utilitarian point of view only the net happiness of the largest number of people may count, but other views on the good life stress different aspects of well-being. For example, many people would find it problematic to use enhancers if this would affect their self-identity .
With regard to the individual good life the liberal solution is to let everyone have his own way (as long as it does not cause serious harm to others). With regard to the good society, however, the question is more complex and requires, at least, more public discussion. A ‘wake enhancing’ substance like modafinil could have important social effects, e.g. on our working schedules and on the 24/7 economy. It is not obvious that this will be an overall benefit for society (or individuals) .
Another aspect is that of justice. Especially from a perspective of global justice it is not obvious that developing cognitive enhancers should have priority over, say, developing new anti-malaria drugs. A lot of lives could be saved and health could be much improved for many people by developing and distributing medication for old-fashioned treatment purposes, so it is not clear at all that investing money, time and expertise in developing cognitive enhancers would make more people better off.Footnote 4 Even if it would increase net happiness in the world, the question of distributive justice could still be held against this utilitarian point of view.
For these reasons we believe it is too quick to claim that the development of psychopharmacological enhancers is a moral obligation, or that it should have any special priority over the development of other drugs.
Although we do not argue for any special priority for research on enhancing drugs, we see no reason why such research should be categorically prohibited. Freedom of research is an important good and one must have serious reasons to prohibit research. Enhancement might have undesirable societal effects in the long run, like unjust inequalities or pressure to use them, but we believe these should give rise to regulation and careful application, not to a general prohibition of researchFootnote 5. A more practical argument is that the development of enhancing drugs is often the spin-off of medical research and thus difficult to prohibit altogether. It is often impossible to tell in advance what the effects and applications of new findings will be. Moreover, if enhancing drugs are prescribed off label or used without prescription, it is useful to know about their effects and side effects in healthy subjects as well. If we are willing to discuss the option of allowing some drugs on the market for enhancement purposes, we must have sufficient knowledge about them. Testing the effectiveness and side-effects of enhancing drugs even appears to be indispensable, because it would provide important facts necessary for further decision making about the regulation of such drugs [54, 55]. The important question is therefore not if research ought to be allowed, but what moral framework ought to be used to regulate research with enhancing substances in human subjects; whether research should be restricted to those aiming at improving medical knowledge and therapies or including purposes of enhancement .
For now this discussion renders two important conclusions for policymaking. First, that it is neither ethically justified, nor practical, to prohibit the research and development of enhancing drugs; on the other hand, it is not yet clear that there is a moral obligation to promote such development either, e.g. by publicly funded research. More work is needed to specify the imperfect duty of beneficence, in order to render perfect duties concerning enhancement-research and development. Second, the ethics of research into potentially enhancing psychopharmaceuticals deserves separate attention.
How to Evaluate the Expansion of Medical Categories?
The expansion of existing medical categories and the emergence of new medical categories promoted by pharmaceutical companies are processes that require a critical evaluation. Both processes are examples of medicalization: social processes in which more and more aspects of daily life come to be seen in medical terms, and problems come to be understood in a medical framework. This also implies an increase in medical interventions. Medicalization can be a moral good: many people who experience real problems may be helped by new therapies or by the mere recognition of their problems. There are, however, also some morally problematic aspects to medicalization.
First, the harm-benefit ratio of medication deserves constant attention. While the risks and side effects of medication are acceptable if they cure disease or improve the quality of life of people, these same risks and side effects may become unacceptable when benefits are small. The smaller the benefit that is created by pharmacological intervention, the more serious the possible risks, and the lack of information regarding long-term effects, should be taken. When drugs that have been tested and admitted for serious diseases and complaints, come to be used more and more by those who are less seriously afflicted, the risks-benefit ratio that used to be acceptable in the serious cases, may shift to unacceptable. This is still insufficiently recognized. For example, large numbers of people have been prescribed SSRI’s for mild depressive complaints, while their effectiveness has only been (contestably) proven for very serious clinical depression [43, 56]. According to a study of the Health Committee of the British Parliament in 2005, 95% of antidepressant users are exposed to the drugs’ risks and side-effects without clear evidence that the drugs benefit them . So, physicians ought to make their own risk-benefit assessments for individual patients, keeping in mind this shift in risk-benefit ratio. They ought to consider the seriousness of the patient’s condition and his degree of suffering. Such consideration also ought to be included in professional guidelines regarding the use of psychopharmaceuticals. However, as we will discuss later on, the influence of pharmaceutical industries and lack of reliable scientific data may hinder objective assessment and prescription practices.
A second problem of medicalization is the focus on medication or other medical interventions as the solution to complex problems. Such a focus leaves less room for alternative approaches like psychotherapy, lifestyle changes or educational or pedagogical measures that may have less side-effects than medication, or may be more effectiveFootnote 6.
Third, an important related issue is that social factors contributing to problems are downplayed in comparison to individual biological and psychological factors. With adult ADHD, for example, the increased pressure to perform and to keep up the pace of our hectic society is not really recognized as part of the problem. The problems that patients encounter are individualized instead of socialized.Footnote 7 Increasing performance pressure in an increasingly complex society leads to growing numbers of people who cannot keep up the pace and cannot live up to the high expectations. Likewise, the current focus on happiness as the ultimate goal in life, alongside the claims that happiness can be ‘made’ and that everyone is responsible for their own happiness, makes more and more people feel they fail .
Finally, especially in cases of disease mongering medicalization works by emphasising and magnifying existing problems, or even by stimulating feelings of insufficiency, insecurity, unhappiness or underperformance in people who did not feel that way before. In brief: people are made to feel miserable first, in order to help relief this misery afterwards by offering a medical label and accompanying treatment. Advertisements and other marketing instruments are employed to ‘sell sickness’. People are influenced into believing they have a problem that they did not realize they had before. Such practices should be understood as a violation of the principle of non-maleficence. It would indeed be more honest, and probably do less harm, if medication to enhance certain traits would be clearly named as such, and not sold under the guise of ‘treatment’. As Bostrom rightly remarks, however, current regulatory frameworks make this difficult .
The gradual expansion of medical categories is a process that professionals and professional organizations, as well as patient and consumer organizations, should be aware of. They should learn to recognize the mechanisms that are at work in expanding disease categories and of their own role in these processes—doctors still hold an important power in defining what disease is. The risks and negative effects of drawing disease boundaries too narrow (underdiagnosis and undertreatment) have to be weighed against the risks of drawing them too wide (over treatment, stigmatization). This should have a place in professional training and education programs. Professional organizations ought to stimulate awareness and discussion among their members, for example by publications in their journals, and organization of workshops and symposiaFootnote 8.
The problem of influence of the drug companies on research, medical guidelines and medication use is very complex and does not have one single easy solution. Only a combination of actions and regulations will be able to improve the current situation. We believe that the influence of the pharmaceutical industry on physicians and patient organizations should be strictly regulated, and awareness should be raised, e.g. through initiatives such as No Free Lunch (UK and USA) and Healthy Skepticism (Australia, The Netherlands). Direct-to-consumer advertising of medication should remain prohibited as it currently is in Europe. Major biomedical journals have requirements for manuscripts such as statements of authors accepting responsibility for the conduct of the study, that they had access to data and whether the authors controlled the decision to publish . It seems these requirements are not sufficient to avoid the phenomenon of ghostwriting and ghostmanagement: pharmaceutical companies that influence and control the research, analysis, writing and publication of articles . Moffatt and Elliott for example propose a few measures to combat ghostwriting practice, such as the installment of a task force whose task is to track cases of ghostwriting and to sanction authors as well as to inform the public about ghostwritten papers . There are no easy solutions to avoid such phenomena but at the least awareness of all parties involved (investigators, universities, editors etc) of the mechanisms of company influence may help create adequate measures.
May Doctors Prescribe Off-Label for Enhancement Purposes?
Before a drug can be marketed, a registration authority (the FDA in the USA, the EMEA in Europe) ensures itself of the safety and effectiveness of the pharmaceutical company’s product. Safety and effectiveness are determined in light of the specific purpose of the product. Approval of a product implies approval of the label for that product. That label should include detailed information about the product, approved indication dosage, method of administration, and use in specific populations . This means that when a drug is prescribed off-label, an official assessment of effectiveness and safety for that purpose has not taken place. Off-label use of medication to treat diseases is common practice [44, 45] but it is not clear how often medication is prescribed off-label for enhancement purposes. In case of Modafinil, estimates are that 90% of prescriptions is off-label . In other cases, the borderline between enhancement and therapeutic purposes may not be all that clear. For example, the prescription of propranolol for exam- or performance-anxiety is considered good medical practice in many countries but can also be seen as a form of enhancement.
An important moral concern regarding off-label use of enhancing drugs regards the health risks of such use in relation to effects—which are not always what they are expected to be. Professionals should assess this risk-benefit ratio of any drug they prescribe off-label, but potential users have their own responsibility as well. The model proposed by Synofzik elsewhere in this issue adequately describes how physicians should deal with off-label prescription .
One aspect that receives little attention in Synofzik’s model concerns the moral responsibility of physicians for participating in certain enhancement practices. In a highly competitive society, social pressure or even coercion may occur to use drugs in order to live up to society’s requirements. Are doctors ‘complicit’ if they support such a society by prescribing performance supporting drugs on demand? In the context of cosmetic surgery, Little has argued that doctors are complicit if they side “with the suspect norms of appearance”; norms that reflect or reinforce an unjust system of beliefs, attitudes and practices, such as racism and sexism . While this kind of suspect norms may play a part in cosmetic surgery, this seems hardly the case in the context of psychopharmacology. While some may find society’s emphasis on cognitive performance, 24/7 economic activity, or individual happiness undesirable, and resist the stimulation of these by way of psychopharmacology, it would be difficult to argue that these norms are unjust. However, some norms or practices might be undesirable for other reasons and it can be questioned to what degree doctors should become ‘complicit’ in these practices. For example, by prescribing modafinil for shift workers sleep disorder one could argue that doctors become ‘complicit’ in adapting workers to the demands of employers and society. Direct or indirect forms of coercion may take place if employers would require their employees to use enhancers . Some professions, like those that require high concentration and carry heavy responsibilities like air traffic controllers, surgeons or military, may by more prone to such demands than others. This again raises the question of the role and responsibility of physicians who would prescribe such drugs off-label. According to Glannon, “doctors may prescribe medication necessary for certain types of work” [2, p.114]. We believe, however, that more discussion is necessary before reaching any conclusions here.
These concerns regarding the responsibilities of doctors in prescribing off-label drugs for enhancement purposes have important implications for policy. First, more research into the safety and efficacy of off-label use is necessary, because currently there is a “gap in empirical research on off-label indications for psychotropic medications” . According to a recent Dutch report there is a demand among physicians for more information about off-label prescription . The same report notes that 22–45% of the physicians —depending on their specialism—are not aware when a prescription is off-label and that a considerable number of physicians do not inform or ask patients their consent. It is therefore, secondly, the task of professional medical organizations to raise awareness and increase knowledge regarding off-label practices in general, and to start the discussion regarding off-label use for enhancement purposes in particular.
A promising approach in order to gain insight in the use and safety of enhancers may be to find new ways of pharmacovigilance; “the process of evaluating and improving the safety of marketed medicines” . In the current system, safety of off-label use of enhancers can only be assessed after they are being introduced to the market. The existing system, however, is criticized as having a limited effectiveness, limited stakeholder participation and a lack of transparency and legitimacy . Moreover, it is questioned whether the existing model of pharmacovigilance can meet the challenges of 21st century drug development, the increasing expectations of consumers and the benefits of new, more complex technologies . New ways of pharmacovigilance may provide more opportunity for active stakeholder participation such as users of enhancers, health care professionals and the pharmaceutical industry and for communicating safety information with health care professionals, patients and consumers . Consultation of consumer and patient organizations can be involved, as well as weblogs and Internet communities of people who experiment with such drugs.
Regulating Non-Prescription Use of Enhancers?
Considering the global market in pharmaceuticals it seems practically impossible to prevent the use of drugs with enhancing effects. Even when prescriptions or over the counter sales of certain drugs for enhancement purposes would be prohibited, people would still find ways to use them. Especially when enhancing medicines are at the same time registered for treatment of acknowledged medical conditions, it will be near impossible to prevent people from obtaining and using them. Online access is easy and many people will probably be interested in possibilities to enhance cognitive and other mental functions, as is the case with cosmetic surgery and sexual function. Right now, people are using drugs for their enhancing effects, but without any medical supervision or safety-checks.
Safety is an important issue in regulating drugs and one argument in favour of making enhancing drugs available though doctors or pharmacists is that this might prevent unsafe illegal practices. Many drugs purchased on the Internet are not of good quality, or may be counterfeit . Another issue is that the information regarding these drugs is not very reliable; balanced information is hard to come by, so truly informed use is difficult. From the point of view of safety, it would be wise policy to find ways to make reliable information available for potential users, and to warn against false promises, and risky or unsafe practices. Such information should preferable be aimed at groups who are prone to abuse (e.g. students during examination time). The government should take responsibility to make sure potential users are informed of the realistic effects and risks of online ‘smart drugs’, for example by publishing a consumer alert for such drugs, as has been done, e.g. for at home genetic testingFootnote 9. Such an alert should warn about inflated expectations and the risks of Internet purchases, give a realistic image of side effects, and advice to seek professional help or consultation in case of underlying psychological, social or physical problems.