Prevention of Cocaine Addiction through Vaccination

Article from TIME Magazine

The Ethics of Vaccinations

by Tom Murray

Scientists at Baylor College of Medicine in Houston have developed a vaccine that may protect against cocaine addiction. The drug is still years away from FDA approval, but as with many new medical technologies, it raises some profound ethical questions about how, when and in whom it should be used. TIME asked Tom Murray, president and CEO of the Hastings Center, a bioethics research institute, to answer the most pertinent and thought-provoking questions.

Should we be concerned about giving the vaccine to children?

In general, parents will want to use any tools at their disposal to help their children, and a vaccine that prevents cocaine addiction could well fall into this category. There are a couple of problems, however: The vaccine as currently designed is not for prevention of addiction, but for use by current or former addicts who want to guard against relapsing. The drug is not likely to be tested in children, but if trials in cocaine-addicted adults lead to FDA approval, the vaccine will be available for "off-label" use — meaning that doctors will be free to prescribe it for anything they want.

Plenty of drugs that are not specifically approved for use by children are nevertheless given to them off-label, but medically speaking, children are not merely tiny adults, and scientists cannot predict how children will respond to a drug that has been tested only in adults. Without solid research confirming that the vaccine works in children as a preventive against addiction — without damaging side effects — parents who decide to give it to their children will be exposing them to unknown and possibly serious risks. At a minimum, if children are given the vaccine, doctors should follow them carefully in order to pick up any evidence of side effects.

Since drug addiction is a costly societal problem, should there be mass vaccination? If so, who should pay for it?

If the cocaine vaccine proves to be safe and effective, why not offer it to every adult who is a current or former user? If the vaccine is not outrageously priced and if it safeguards people against relapsing into addiction, it's hard to imagine that it would not yield enormous savings in the long run. The wisdom of mass vaccination, however, is not so clear. Even the safest vaccine has side effects. Complications may be rare, but the more people you vaccinate, the more adverse effects we'll see.

When we balance the risk of side effects against an addict's freedom from the grip of cocaine, uncommon risks are easily justifiable. But when we vaccinate tens of millions of people, most of whom will never get nearer to cocaine than the traces on the $20 bill in their pocket, even a one-in-million risk may be too high.

Will the vaccine exacerbate health care and social disparities, with the rich having more access to it than the less advantaged?

That, of course, depends upon who pays for it. Many of the newer vaccines listed by the Centers for Disease Control run from $75 to $125 a dose at your doctor's office, so it's reasonable to anticipate that a cocaine vaccine could cost upwards of $100 a pop. That's real money for most of us. If common sense prevails, addicts and recovering addicts will get the vaccine at no or nominal cost. It's in everyone's interest — including the health insurer's — to immunize addicts against cocaine intoxication. As for vaccinating children or people who have never used cocaine, until we can be sure that it will be an overall benefit to them, we should hold off. We have plenty of other real injustices in health care to remedy first.

Would people being offered the vaccine be able to give informed consent? Many people with drug addiction suffer from other problems, such as mental illness, and addiction itself might impair consent.

Making certain that someone gives fully informed and voluntary consent is fundamental to good ethics in both treatment and research — especially research. The days of testing new drugs on hapless victims are, we hope, long past. Researchers will have to be sensitive to the challenges of assuring that people enrolled in clinical trials for the cocaine vaccine understand what they're agreeing to and have the clarity of mind to give meaningful consent. The bare fact that a person is or was addicted to cocaine or may suffer from a mental illness does not render them incompetent to consent. But it does require researchers to be especially vigilant to ensure that the person has the mental capacity to consent — and that the vaccine is not being forced on them.

Will biomarkers remaining in the blood after patients receive the vaccine be a "stain" that can be used to discriminate against them for employment, travel, insurance, or legal purposes — even though use of the vaccine does not mean that cocaine was ever taken?

Sometimes wisdom is knowing when to ask someone else. So I asked my dear friend Mark Rothstein to answer this question. He is one of the world's experts on medical information and privacy and the director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine. He says: "It's safe to assume that any information that can be used will be used. Obtaining test results will become increasingly easier, as testing technology gets cheaper and electronic health-record networks more efficiently transfer large data files. As a legal matter, to take the example of employment, the Americans with Disabilities Act prohibits discrimination against individuals who have engaged in the illegal use of drugs but who have successfully completed or are participating in a supervised rehabilitation program and are no longer using drugs. Therefore, if the vaccine biomarker were used to identify former cocaine users who are no longer using drugs, then discrimination based on a positive test would be unlawful. There are many other contexts besides employment in which the test might be used, however, and it will be necessary to examine (and perhaps amend) various laws to protect against discriminatory use of this information."

Cocaine is an illegal substance. Might use of the vaccine lead to trouble with the law? Or might it be a condition of parole, and is this ethical?

We'd like ethics and law to be good friends or, at least, not complete strangers. But they have different purposes and different ways of reasoning. The biological footprints left in the blood by the cocaine vaccine are not proof that the person ever used the drug. The cocaine molecule itself will leave traces in the body for a while, but it's too tiny to trigger our immune system; that's why the vaccine hooks it up to a larger one. Unless the law goes completely berserk, it won't confuse the antibodies created in response to the vaccine with the drug itself.

What's more likely is that judges and parole boards will look favorably upon addicts willing to take the vaccine, and suspiciously at those who refuse. Rehabilitation is a primary goal of the justice system. There's a good argument to be made that someone whose addiction led to crimes and thence to prison, but who is no longer an addict thanks to the vaccine, has to a significant degree been rehabilitated and deserves to be released. Ethically, however, that looks like a coercive offer: Take the vaccine or go back to the slammer. It's not an unreasonable judgment by the law. But I anticipate a pretty vigorous argument about whether it's ethical.