Smart Pills and Neuroenhancement: Is It Fair?

Prescribing neuroenhancers is outside the area of medicine that is considered obligatory for a physician, so under what circumstances should it be considered unethical or unacceptable?
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The next time you are waiting in the checkout line at the grocery store, look over at the magazine rack and you are almost certain to find an article that asks, "Are we poisoning our children with ADHD medication?" But ADHD stimulants are branching out, and there is more controversy brewing over their use -- doctors have started prescribing the medication for more than just the children's disorder.
  • Ashley just started her senior year at a very competitive high school. She is enrolled in advanced-placement classes and is an officer in the National Honor Society. Her eyes are set on a top-tier Ivy League college and she knows that she will need a lot more on her application than just great grades. Over dinner, she asks her parents if she can ask their family doctor to prescribe Adderall, hoping that it will give her that extra edge.

  • Manuel is a premed student with a sister who is already in medical school. The pressure is on. She made it look so easy, but in order to keep his GPA in a competitive range he has to survive on three hours of sleep a night. His roommate tells him that he gets Modafinil from a friend on campus and it dramatically improves his ability to focus and concentrate. He can get Manuel a supply, if he can come up with the money.
  • Angela is living her dream. She graduated from law school at the top of her class and is the first minority woman on track to make partner at the top law firm in her city. But she thinks that half of the people around her must be taking something so they can bill their expected hours. How else could they pull so many all-nighters and produce those perfect briefs in record time? She has always been meticulous about her diet and exercise, but she was willing to try caffeine drinks like Red Bull and Monster. Now she is on the verge of seeking out a doctor who will give her a prescription for a "safe" stimulant.
  • What would you do if you were the any of these people, their parents, or their physician? Just tell them no, right?

    Well, it isn't as straightforward a decision as you might think. The American Academy of Neurology has issued two position papers on the ethics of prescribing "neuroenhancers" or "smart pills" to children and adults. The players in this complicated decision form a triangle with a wild card. There is the parent who clearly has the decision-making authority over a minor child. An adult like Angela can, of course, make her own informed decisions. Physicians should do what is ethical, safe and within their comfort zone. The "wild card" in all this is deciding what constitutes an emancipated adolescent who may still be living at home or who is away at school, but is still dependent on their parents. If you are the prescribing physician, how do you measure the transition point from a non-emancipated to an emancipated patient?

    We are entering a new era where not only existing drugs can enhance our performance, but where researchers focus a great deal of their time finding medications to improve memory, attention and concentration in "normal" people. The administration of prescription drugs to a person with no medical or mental health conditions is called neuroenhancement. The area of neuroenhancement has the potential to be big business, and biotech companies are actively looking for a safe and effective "smart pill." Even the military continues to pursue new drugs that will increase performance and alertness in fatigued but otherwise normal people. For many years the military has used "go-pills" (dextroamphetamine) to assist soldiers and pilots who are sleep deprived for long periods of time, but still must perform at very high levels.

    What Is Normal?

    Let me take a second to define the term "normal." I have been throwing it around, but this can be a difficult state of health to generalize. If we can agree that it is a good thing to be mentally healthy, then it is worth looking at the World Health Organization's definition of mental health: "a state of well being in which every individual realizes his or her own potential, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to her or his community." That's like juggling three chainsaws at once and may be asking for too much at any one time. I am ready for a neuroenhancer right now!

    It is clear to me, as a physician, that when I am treating disease I am prescribing a medication as a therapy. However, if I write a prescription to enhance or improve upon "normal" abilities, have I ventured into the area of lifestyle medication? Cosmetic surgery uses medical knowledge to enhance the well-being of normal people, and we don't blink at the idea of someone having plastic surgery to improve their appearance. We know that more attractive people are more likely to be hired, promoted and make more money. Likewise, sex-change operations are performed so an individual can realize their true self or identity. Is the prescribing of neuroenhancers so that an individual can realize their true mental potential any different than these everyday medical procedures?

    The Ethics of Neuroenhancement

    There is an ethical side to this discussion for both the physician and society at large. We accept wide differences in the way people live -- how they are housed, what they have available to eat, and where they go to school. I heard on the radio this morning that if you are born rich you will most likely remain rich, and if you are born poor, you will most likely remain poor. Not a very optimistic thing to hear at 7 a.m. in the morning with only one cup of coffee on board. Is it a natural extension that we will not mind that only a small, privileged portion of society will be able to afford medications that will enhance their cognitive abilities? This challenges the concept of distributive justice -- that essential goods are distributed equally to the people in a society. This usually refers to basic needs like shelter, food, health care, but should opportunity be included? However, it is difficult for me to see how society or physicians will block the introduction of neuroenhancement because it will be unjust to those who cannot afford it and further promote inequality.

    Not everyone thinks this is fair. In the article "The Quest for a Smart Pill,", published 10 years ago in Scientific American, moral philosopher Leon R. Kass is cited: "In those areas of human life in which excellence has until now been achieved only by discipline and effort, the attainment of those achievements by means of drugs, genetic engineering, or implanted devices looks to be cheating or cheap." Society seems to easily tolerate the inequality for cosmetic surgery and the emerging specialty of concierge medicine, so why not neuroenhancement? Do you care that according to some estimates, 31 percent of college students used prescription stimulants in the last year and may have an edge on your child?

    The Current Medications

    It is time for a quick review of the medications that we are talking about. Amphetamines are stimulants that have been around for a long time. A single dose of an amphetamine increases wakefulness and alertness as well as initiative, self-confidence, concentration and sustained attention. Sounds good, but these drugs are not without drawbacks: Amphetamines can cause nervousness, insomnia, palpitations, withdrawal and a whole host of other unpleasant side effects. They also are subject to abuse and addiction, which led to the development of methylphenidate (Ritalin) and the more popular form, Adderall. Adderall and drugs like it are used extensively in the treatment of childhood ADHD and the controversial diagnosis of adult ADHD.

    But it was the appearance of a new player on the scene in 1998 -- a player that looked like a game-changer -- that has been at the forefront of the quest for a smart pill. The FDA originally approved modafinil (Provigil) to treat narcolepsy, and more recently for shift work sleep disorder and sleep apnea. However, its "off-label" use has attracted the most attention.

    Just because the FDA approves a drug for a specific use doesn't mean a physician will not use it "off label" to treat other conditions. In neurology we have long used a wide variety of medications in an "off-label" manner to treat migraines, nerve pain and other problems. The biggest issue arises when a pharmaceutical company promotes their medications for uses for which they are not approved. Cephalon, the maker of Provigil, paid a $425 million fine for the illegal off-label marketing of the drug. What will the FDA do when pharmaceutical companies present valid clinical trials of medications that are true "smart pills" and safely enhance cognition and performance? It is difficult to predict if these medications will be restricted to specific situations, age groups or medical conditions. We are probably years away from making that decision but, like Adderall and Provigil, it will not stop physicians from prescribing them to those who can afford them.

    Modafinil (Provigil) has been used to treat the fatigue of patients with cancer and multiple sclerosis. The military has performed multiple studies on modafanil and the use of stimulants . A recent study of helicopter pilots who were kept awake for 40 hours and completed 15 flights showed that "modafanil, like dextroamphetamine, maintained alertness, feelings of well being, cognitive function, judgment, risk perception, and situation awareness in sleep deprived aviators."

    What Would You Pay?

    Now go back to any one of three scenarios at the beginning of this article and ask yourself whether modafinil might give those people a competitive edge. I want to interject at this point that modafinil, the generic, and its latest formulation, Nuvigil cost about $15-20 per pill and would not be covered by insurance for any off-label use. And no, you cannot order them legally online from Canada -- there is a significant financial cost if you decide to use this drug to gain a competitive edge.

    Smart pills will be developed and the FDA will approve them. There is intense research in this area and it is just a matter of time. If you think that media is oversaturated with erectile dysfunction ads, try to imagine the onslaught of direct-to-consumer advertising that will promise admission to Harvard, rapid advancement at work, and a clear head into your 90s. It will be interesting to see how physicians respond to patients beating a path to their doors for a prescription.

    Prescribing neuroenhancers is outside the area of medicine that is considered obligatory for a physician, so under what circumstances should it be considered unethical or unacceptable? Any request from an adolescent for neuroenhancement without their parent's permission should be refused. Even with parental permission, we need to consider the unknowns. Will neuroenhancement alter a child's personality, their ability to develop the skills to cope with life on their own and what will be the effect on the concept of personal responsibility?

    Many adults will want to take advantage of neuroenhancement as a lifestyle drug, and I predict that, like cosmetic surgery and erectile dysfunction drugs, it will eventually become a part of everyday life for those who can afford it. Physicians have an obligation and right to refuse any requests for treatment that they feel are inappropriate. I believe that when these drugs are available, there will be an enormous media and marketing campaign to flood the general public and medical professionals with the benefits of neuroenhancement. Instead of seeing two unusually happy people holding hands in bathtubs on top of a hill while promoting Cialis, you may be placed on a guilt trip of depriving your child or yourself the right to a "better life" if you don't take Brand X Neuroenhancer.

    Go back to the start of this article and tell us what you would do in any one of these scenarios.

    For more by Richard C. Senelick, M.D., click here.

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