Milkshakes and Medical Ethics

November 13, 2014

Liver disease had been a puzzle for decades by the time Saul Krugman got interested. Outbreaks of hepatitis were common among soldiers in World War II and no one knew how to treat the condition. Blood transfusions, which became a mainstay of medical care during that same war, were also leading to hepatitis. With more than 13 million units of blood collected by the Red Cross during the war, the U.S. military knew it had better figure something out about how to prevent and treat this debilitating condition.

 

Or was it conditions? That was one of the major questions when Krugman, a pediatrician at New York University, got involved. The end result was liver disease—the inflammation known as hepatitis that would lay a soldier out for days and could be fatal. But what was the cause? Krugman and many other researchers of the day knew the condition was viral, but was it always a single virus? Or were humans susceptible to multiple liver-targeting viruses? If the latter, what were the implications for treatments and vaccines? If science were going to make any headway in treating the disease, someone needed to discern whether hepatitis was caused by one virus, two viruses, or more, and then to characterize the different natures of each one.

 

Of course, being about viruses, which are minuscule and strange, such research was not so easy. Since the virus could not be studied directly—you cannot physically see a virus go from a dripping nose onto a hand, then onto some surface, then onto another hand and into mouth of the body to which that next hand belongs—Krugman knew he had to design a study that would enable him to track the path of infection in the most controlled environment possible.

 

But the only way to do that is to actually do the infecting. Only if you forcibly infect someone with a virus can you know the exact moment at which they received the pathogen and know for certain that the subsequent unfolding of illness is a direct result of the infection.

 

Where on earth could a scientist find a suitable place for such research? Under what circumstances could forcible infection be acceptable? Krugman knew the answer: a place where everyone was destined to get infected anyway. From NYU, Krugman only had to look a few miles and one river crossing away to find such a place. The Willowbrook State School, on Staten Island, NY, was the ideal Petri dish.

 

A home for intellectually disabled children that began enrolling children in the late 1940s, Willowbrook was a deeply unsanitary place. Every single child—all of them—eventually got hepatitis. Why? One of the ways the disease is transmitted is by the fecal-oral route. Hands left unwashed after wiping carry the virus and deposit it on beds, walls, doorknobs, light switches. When we hear about food-borne hepatitis, it’s because someone handling the food along the way did not wash his or her hands after defecating. A large institution with unsanitary conditions is, for this virus, the perfect place to settle down.

 

Knowing that every child there was going to get hepatitis anyway, Krugman believed Willowbrook was the ideal place for his research. The approach was simple: he would deliberately infect children with the virus through either food or injections and then watch what happened to them. In addition, some children would receive gamma globulin, a blood protein that contains antibodies that the U.S. Army and many clinicians were interested in as a potential anti-hepatitis preventive measure. 

 

Starting in 1955 and continuing until the studies were shut down about 15 years later, Krugman investigating the different transmission routes of the virus and the different courses of the disease. With children already enrolled there, Krugman either injected them with gamma globulin or did not, and waited to see how many in each group got sick. All newly arriving children were given the possibly protective injection and a subgroup was deliberately infected.

 

Krugman knew that the virus, or viruses, traveled in one of two ways: the fecal-oral route or through blood. So some children were injected with blood from individuals who had the disease. And some children were fed food known to be contaminated with the virus. To be more explicit, they were given milkshakes that contained a bit of feces from sick children at the institution.

 

Scientifically speaking, the research led to major breakthroughs in the understanding of hepatitis. Krugman confirmed that the disease was caused by two separate viruses: hepatitis A (fecal-oral) and hepatitis B (blood). He showed that hepatitis A infections tended to resolve themselves but that hepatitis B infections were more serious, possibly leading to chronic illness. The work also confirmed the preventive benefit of gamma globulin against hepatitis A. The results were published in The Lancet in 1971 (behind a paywall). Here is an abstract of a further analysis of the data, published in 1978.

 

Krugman was celebrated for the breakthrough. In 1983, Krugman was awarded the Albert Lasker Public Service Award, just under the Nobel in terms of prestige in the medical world, for distinguishing between infectious (A) and serum (B) hepatitis. As the award dedication read:

 

“…To Dr. Krugman, for his courageous leadership in conceiving, developing, and testing vaccines against various viral diseases, especially hepatitis B, with vast impact on world health, this 1983 Albert Lasker Public Service Award is given.”

 

And it’s true: Krugman’s work led to huge advances in the treatment and prevention of hepatitis. With the two viruses now discerned, Krugman’s subsequent research led to the development of a vaccine for hepatitis B, the concrete identification of the two viruses, the elimination of hepatitis B from the blood supply, and eventually the realization that there existed a third liver-targeting viruses, eventually called hepatitis C, which infects more than 100 million people worldwide. Krugman was highly respected and liked by his colleagues. “The nicest person you ever met,” one hepatitis researcher told me. (Here is Krugman’s obituary in the New York Times)

 

Yet the study is deeply disturbing. Instead of improving the conditions at Willowbrook, the staff and researchers used it as justification for the research. Children were infected without their permission. When Willowbrook became overcrowded, parents seeking a place for their child at the institution were told that the only building where there was space was the one with the hepatitis studies. Also, it later emerged that the hepatitis rates at Willowbrook were lower than originally asserted.

 

The consent form provided to parents was deeply misleading. The letter parents received with the permission form read as follows:

 

Dear Mrs. ________:

 

We are studying the possibility of preventing epidemics of hepatitis on a new principle. Virus is introduced and gamma globulin given later to some, so that either no attack or only a mild attack of hepatitis is expected to follow. This may give the children immunity against this disease for life. We should like to give your child this new form of prevention with the hope that it will afford protection.

 

Permission form is enclosed for your consideration. If you wish to have your children given the benefit of this new preventive, will you so signify be signing the form.

 

(Per the NIH science education guide on the Willowbrook studies) 

 

These may have been the intentions of the study, at least in part, but the omissions are egregious: no discussion of how the virus would be given to children, no mention of the fact that some children would be infected and some not, no discussion of whether the children needed to be informed, and an out of proportion optimism about the protective benefits of the research.

 

Willowbrook, which many people will remember as the site of Geraldo Rivera’s exposé, was shut down in 1987. Krugman wrote his own look back at the studies in 1986 to enable readers to “make an independent objective judgement of the ethics of the Willowbrook hepatitis studies.”

 

So how to think about all this? Do we put ourselves in the context of the time and understand that this study was approved and celebrated by many serious and responsible individuals? Or does the matter come to rest at: What on earth were they thinking? Like everything in life, bioethics evolve. But unethical studies still go on today. Violations of autonomy crop up in all manner of ways, we just don’t always have the eyes to see it at the time. The contributions of the Willowbrook studies to medical advancement are indisputable, but the question at the heart of the matter is one at the heart of all ethical considerations: do the ends justify the means?

 

More about Willowbrook: 

http://willowbrookstateschool.blogspot.com/p/history.html

NPR, Remembering an Infamous New York Institution

 

Photograph from Atlas Obscura: 

http://www.atlasobscura.com/places/willowbrook-state-school

 

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November 13, 2014

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