DrugMonkey responds to the outgoing Drug Czar’s deep concerns about research with illegal drugs conducted with subjects who are addicted to those drugs, those concerns reported in an article in the Washington Examiner. From that article:

The federal government is giving crack and powder cocaine, morphine, and other hard-core drugs to taxpayer-funded researchers for testing on addicts, The Examiner has learned.

For decades, the government has authorized, funded and lobbied for studies in which otherwise illegal drugs were given to addicts in cities such as Washington, Bethesda, Baltimore, New York, Minneapolis and San Antonio. The studies continue today and have an array of aims, from documenting the ways cocaine warps the brain to the intensity of pain from morphine withdrawal. …

John Walters, drug czar during both terms of George W. Bush’s administration, said he learned about the studies near the end of Bush’s term. “It’s not only questionable ethically, but probably — given the science — it may not be able to be defended at all,” Walters told The Examiner recently. …

“Most people see the things that people will do to themselves when they’re addicted — what they’ll do to themselves, to their families, to their loved ones,” Walters told The Examiner. “I think that when you bring someone in and say, ‘Well, they’re not seeking treatment yet and therefore it’s OK to use them as an experimental subject’ — that’s not the understanding that the current science gives us about this disease.” …

“The question is whether the results justify using these individuals as disposable subjects,” Walters said.

Walters seems to be saying that the use of people who are addicted to drug in research on those drugs cannot be ethical under any circumstances. (His claim that “it may not be able to be defended at all” at least strongly suggests that this is his position.) Is he right?

It is true that ethical research with human subjects depends on prioritizing the well-being of the subject (beneficence). It also requires valuing the autonomy of the human subject, providing the subject will thorough and understandable information about the research aims and the possible risks and benefits of participation (respect for persons). And, it demands that the risks and benefits of producing the new knowledge in the research and in applying the new knowledge be distributed fairly (justice). So, without speaking to the details of particular federally funded research projects on illegal drugs in which persons addicted to these drugs are enrolled as human subjects (since Walters doesn’t speak to such particular details, either), do the three central ethical principles rule out any such research project on ethical grounds?

One thing to consider is whether the autonomy of drug addicts is so damaged as to render them incapable of understanding the details of the research as described to them, evaluating the risks and benefits of participation in the research, and rendering their consent freely. Some might argue that addiction sets up an inescapable coercive force upon the addict, such that if participating in the study provides access to the substance of choice, nothing else will make a difference in the addict’s choice — as if it is the addiction, rather than the person with the addiction, who elects to participate in the study.

I don’t think this is a silly thing to be worried about. Guidelines for ethical research with human research note that researchers have extra duties to human subjects who may be especially vulnerable to coercion, or who may not have the capacity to render proper consent themselves. This kind of situation is the sort where researchers and their Institutional Review Boards ought to work together to ensure that human subjects are respected and protected. We shouldn’t forget, though, that paternalism is also a violation of respect for persons, and it may be paternalistic to decide that no one addicted to drugs could ever make a rational decision, whether such a decision involved drug-seeking or his or her own well-being over the short and long term.

In terms of the well-being of the human subjects, even if we stipulate that the drug use under study causes harms to the human subjects, we need to examine the potential benefits. Some of these research projects may uncover effective means to treat addiction, while others may find effective ways to prevent addiction. Effective treatment could surely be a benefit to people with addiction, even if good preventative measures benefit only those not yet addicted.

Participation in the research itself might also have a benefit in terms of communicating what is already known about the effects of addiction to the subjects. Even if it’s small, there’s a chance that the information about the risks and benefits of participation might help a subject reevaluate whether the benefits of maintaining his or her addiction really outweigh the risks. Beyond providing the human subjects with information, participation in the research puts these subjects under the supervision of medical professionals who recognize an ethical duty for their well-being even in the event that they decide to halt their participation in the study. Plausibly, this supervision could help addicts avoid some of the tragically bad outcomes they might experience taking the same drugs unsupervised (especially in conditions made dangerous by factors beyond the drugs themselves).

It is true that human subjects who are already addicted to drugs are likely to have degraded their own well-being somewhat. This makes it all the more important for researchers to prioritize their well-being and treat them as persons worthy of respect rather than as disposable means by which to generate data. But treating people who are addicted to drugs with respect, and caring about their well-being, seems to demand that science generate prevention and treatment strategies that are grounded in good evidence. If we are to make treatment a good option, getting their requires good data from studies involving people of the sort the treatment is intended to help.

What are the options for getting meaningful data about the effects of drugs of abuse in humans? Researchers can either study humans who are already using these drugs, or they can recruit human subjects who do not use these drugs and administer them in the course of the study — that is to say, researchers can get data from existing addicts or from newly-created addicts. Given that treatments are most likely to benefit the population that is already addicted, placing harms on human subjects drawn from the population that is not arguably distributes the risks and the benefits unjustly.

None of this to say that ethical drug research on drug-addicted human subjects is easy to design. But it looks like it should be possible to strike a good balance between the ethical principles of justice, beneficence, and respect for persons in order to protect human subjects while generating sound scientific knowledge that may make it possible for people to loosen the grip of addiction.

In the absence of such knowledge, we can’t do much more than just say no — a response which does little to help those currently struggling with drug dependency. To my mind, not finding ways to conduct ethical studies on drugs of abuse amounts to treating drug addicts as disposable.