Is drug research on humans who are addicted to drugs ethical?

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.

More like this

There's an interesting story on The New Republic website at the moment, "Going Under" by Jason Zengerle, that relates the sad story of a young anesthesiologist's descent into addiction. What I find interesting about it is the larger questions it raises about why this particular anesthesiologist's…
Over at On Becoming a Domestic and Laboratory Goddess, Dr. Isis looks at challenges of opening up participation in human subjects research to potential subjects who are not fluent English speakers: When one enters the university hospital here at MRU, there are a number of skilled and qualified…
One of the key requirements that researchers conducting studies with human subjects must meet is that they obtain the informed consent of the participating subjects (or of a parent or guardian, if the subject is not able to give informed consent himself or herself). However, there are particular…
Back in July, Science ran an interesting news article about an on again, off again clinical trial of chelation therapy in the treatment of autistic children. I found the story fascinating because it highlights some of the challenges in setting up ethical research with human subjects -- not to…

Very well said, as always. See now if Walters had just googled up 'ethical conduct of science' ages ago he would have found you to set him straight....

By DrugMonkey (not verified) on 26 Mar 2009 #permalink

What Janet said, especially the part about increased scrutiny in dealing with addicts and others who may need extra protection.

Awesome stuff, Janet! I think it's really important for the public to know what ethical care is taken with human subjects in any study, but drug abuse is a particularly thorny issue.

I suspect that these arguments are meaningless to those who adhere to the principle of moral absolutism.

In order to justify studies of abusable substances, it is necessary to believe that use of such substances is permissible in some situations, depending upon the context. If one believes that context does not matter -- that an allegedly immoral act is intrinsically wrong in and of itself -- then it does not matter what an IRB says, or indeed, if there even is an IRB. Wrong is wrong.

I suspect that most scientifically-inclined individuals are moral relativists, as am I. I do not mean to say that there is any sense to moral absolutism. Rather, I point this out in the hope that we may understand the seemingly boneheaded logic expressed in the article you cited.

Just because some of us are addicted does not mean we are not 1)highly educated, 2) scientists or healthcare workers ourselves, 3) unaware of how the experimental process works.
Knowing your condition and hoping for relief (that does not involve Godly 12-steps) means that you are at times willing to offer up yourself as a subject. Why do certain things occur? What complications are there? What unknown correlations exist? Us "junkies" aren't all losers.

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.

It seems incorrect to decide that no one addicted to some drug could ever make a rational decision --- I mean, it's obviously false. People with all sorts of drug addictions make all sorts of rational choices (e.g., nicotine addicts routinely make lots of rational choices about investment). It can even be a rational choice to sustain an addiction, e.g., if the alternative consequences are worse or more disruptive.

So, no need to invoke paternalism yet.

Could it be reasonable to refuse to do a study when the subject population would be drug addicts and the study involves administrating the drug? Well, yes. Always. Doing studies is not required. Avoiding doing studies for arbitrary personal reasons seems fine. I'm referring to people who had the choice to instigate a study. It's unclear that a subordinate can refuse to work on the study on the ethical ground that the subjects cannot be fully consenting and still retain their position.

However, it does seem that for various studies, depending on the drug and other features of the population and study design, one could be concerned whether it was possible to adequately screen the subjects with respect to their effective autonomy. This doesn't require believing that no drug addict could rationally consent, merely that it is prohibitively difficult to know of the selected sample whether they were rationally consenting at that time.

It seems that one can read Walters as saying, "Given what we 'scientifically' know about addiction, none of the subjects could have really properly consented. Obviously, what we know scientifically might change." or "Given what we 'scientifically' know, we can't reasonably run these studies in a way that ensures we only experiment on fully informed, consenting subjects." Or, I guess, "Look, the benefits from these studies is so scientifically low, that it's really not worth even going there, given the obvious difficulties of screening."

One thing that seems slightly confused by the tone of the original Examiner article is that there are many (numerically in the majority, even?) studies on the effects of drugs of abuse in humans that use subjects who have tried a drug but may not reach diagnostic criteria for abuse or dependence. Hard to tell if the author and the ex-Drug Czar are focusing their complaint only on studies which use people who do meet criteria for dependence (hence "addicts").

I find the ongoing commentary under the original article to be fascinating. Janet, your audience may be interested in the parallels being drawn with Tuskegee.

I will look into it when I have a little more time, but I would be incredibly surprised if these studies don't work with subjects on getting them off of the drugs they are dealing with. In fact I suspect that were one to volunteer for one of these studies, they would probably end up in a very good treatment program.

Going with that assumption, I can say that there are a lot of addicts who would give a whole hell of a lot to get into one of these studies. Treatment options aren't cheap and they aren't easy to get into. Tell an addict that you'll help them get clean, if they will only spend a little more time using, which in turn will help others in the future...

Contrary to many popular misconceptions, many addicts, if not most, would love to have an opportunity like that. We don't like being controlled by the need to use whatever drug/s we are being controlled by. Nor do we like to see others so controlled.

It's big fun when the party's just starting. Getting high is great at first. But when it is day in and day out, need it to function - don't care if the rent's not paid, need to get another hit - it stops being fun. Given the opportunity to stop, or at least to try to and help advance our understanding of addiction and the way drugs affect the brain - hells yeah, many addicts would be happy to consent.

Some of you seem to be assuming that the coercion is in the form of getting the substance of the addiction. It's bloody well not, it's in the form of getting the opportunity to stop.