In 1998, the pharmaceutical company Wyeth introduced an injectable vaccine against rotavirus, a childhood illness that kills about 500,000 infants per year worldwide. Soon thereafter, the vaccine was withdrawn because of concerns about a rare side effect called bowel intussusception, which can be fatal. This side effect was rare, and the vaccine would have done more good than harm for children living in impoverished areas without access to quality medical care.
Last week, the FDA approved a new oral vaccine for rotavirus that does not cause this side effect. This new vaccine, however, will cost $187.50 to administer to children--much more than many parents can afford. And the children who will not be able to afford the vaccine are the ones who most need it.
The clash between the interests of Western consumers of health products and the interests of patients in less developed areas highlights the complexities of providing quality medical care to the majority of people around the world.
Rotavirus is a virus that primarily affects infants under one year of age, though people of any age can be affected. Its primary symptoms are vomiting, watery diarrhea, and a low-grade fever. By age five, nearly every child has been infected with the group A strain of the virus. Approximately 500,000 children per year die from the disease, and only about one hundred of those deaths are in the United States. The deaths are usually caused by prolonged dehydration as a result of the vomiting and diarrhea.
Rotavirus is a classic illustration of the differing affects of disease on differing populations. In the United States, very few children die from rotavirus. Why? Because if children become severely dehydrated here, they are hospitalized and given IV fluids to stabilize them until their immune system can successfully fight off the infection. Thus, in the U.S. the disease is generally just an annoyance, and at worst requires a couple of days in the hospital for stabilization--death is exceedingly rare, and generally only occurs when parents refuse to seek treatment or when there is some other underlying pathological condition.
In places without access to quality medical care, however, the disease can be much more severe. Because these infants do not have access to the IV fluids that are ubiquitous in the U.S., they more often die as a result of the disease. Therefore the danger to these patients is much higher than the danger to patients living in countries with developed medical systems.
Pharmaceutical companies have developed three vaccines for rotavirus. The first, Rotashield, was introduced by Wyeth in 1998, but pulled from distribution in 1999 due to a serious side effect called bowel intussusception. This side effect was extremely rare, but occurred often enough that the vaccine was deemed unfit for use in the United States. In the last year, GalaxoSmithKline has developed Rotarix and Merck has developed RotaTeq. RotaTeq was approved by the FDA last week after one of the largest safety trials in history (more than 70,000 children were vaccinated), and Merck has said it intends to charge $187.50 total for the three doses of vaccine. Rotarix has not yet been approved by the FDA.
Whenever a doctor is trying to decide whether to offer a particular treatment to a patient, (s)he weighs the costs and the benefits. (S)He looks at the probable positive outcome of the treatment (in this case, protection from disease) and the possible negative outcomes (in the case of the Rotashield vaccine, primarily bowel intussusception). (S)He then decides whether the benefits outweigh the costs.
The issue with the rotavirus vaccines is that the decision calculus is different in the United States than it is in other parts of the world. In the U.S., the benefit of getting a rotavirus vaccine is relatively small: rotavirus is annoying, but unlikely to be fatal. By contrast, in the developing world, the benefit to getting vaccinated against rotavirus is much higher, as the chance of dying from the disease is far greater. The original Rotashield vaccine was withdrawn in the U.S. because the small benefit to American children was outweighed by the remote possibility of a severe side effect. In other countries, however, most experts agreed that the benefits of the vaccine far outweighed the possibility of side effects.
So why was the vaccine pulled from the market outside of the U.S.? Two reasons. The first was that governments in many of these countries were unwilling to accept what they viewed as a second-rate vaccine. They saw that U.S. parents were unwilling to accept the vaccine, and they did not want to subject their citizens to a vaccine that U.S. parents were unwilling to use. In other words, they only wanted medical care that was at the same standard as care within the United States. The second reason is that there was some concern on the part of Wyeth that using a vaccine with known severe side effects could lead to legal liability.
Today, then, we're left with a situation that is likely to continue to unnecessarily cause the deaths of hundreds of thousands of children per year. In the United States, it seems clear that one of the new vaccines should be used. Here, the risk of developing side effects from the original, cheap vaccine outweigh the benefit of vaccination. Elsewhere, however, the logical course of action would be to offer the old, cheaper vaccine to all infants. Doing so would almost certainly prevent hundreds of thousands of deaths with only a small number of adverse reactions. In other words, we would end up saving hundreds of thousands of infants' lives per year. In fact, had the vaccine been available continuously since its introduction, and vaccine programs had been widely available, we could have saved nearly three million children's lives.
What stands in the way? Two things: First we must convince the leaders, both political and health authorities, that the old rotavirus vaccine will benefit their citizenry. They clearly want access to the new vaccine, and in a perfect world, they would have it, but right now, there is simply no way to afford it. Even in the United States, local health authorities say that they may not be able to include rotavirus vaccine in free clinics because the cost is too high. By using the original vaccine, we would still have many benefits that do not exist today. The second obstacle is convincing Wyeth to make the vaccine even with the threat of legal liability and without access to the lucrative markets in the United States and Europe.
If we can convince both the leaders of these countries and the drug manufacturers to use the original vaccine to save lives, we will go along way toward preventing the needless deaths of hundreds of thousands of children.