In the brave new world of health care, cost of treatment has become an increasingly central concern. As patients see their out-of-pocket expenses rise, some treatments are being curtailed, often significantly. Intended or not, the net result with some illnesses is a patient population at higher risk of acquiring the disease. No example is more dramatic -- and alarming -- than the one presented by a childhood illness known as Respiratory Syncytial Virus.
Producing cold-like symptoms, including fever, nasal congestion, and a runny nose, RSV is one of the most common respiratory viruses in the world today. "It is by far the most important respiratory virus in the first year of life," says Dr. Giovanni Piedimonte of the Pediatrics Institute at Cleveland Clinic in Ohio. "Sixty percent of infections in the lower windpipe in children are caused every year by this virus. By the second year of life, every single child in the world has contracted the infection at least once."
Highly contagious, RSV is spread through the air in the minute water particles generated when someone sneezes or coughs. Carriers of the virus are contagious for between three and eight days. The disease is so prevalent that for infants under the age of one it is the leading cause of bronchiolitis and pneumonia in the United States; globally, it is the second leading cause of death behind malaria. Each year, 14,000 deaths and two million hospitalizations result from RSV. It is the most common reason why American children under the age of one are admitted into the hospital.
Most infants can fight off the virus, but premature babies are especially susceptible to severe RSV, and because of advances in medicine the survival rate among premature infants has never been higher. At present, 500,000 babies are born every year in the US before they reach 37 weeks of gestation, more than 12 percent of all pregnancies. That's a noteworthy population of premature babies highly vulnerable to severe RSV. Because of their weakened state, these babies need help fighting off RSV.
No vaccine exists, but there is a treatment. The drug is Palivizumab, marketed as Synagis, and while it is highly effective it is also expensive. RSV is acquired during a "season." According to the Center for Disease Control and Prevention, the RSV season lasts for some four to five months between the fall and the spring, the specific timeframe varying from region to region in the country. An infected child should be treated with monthly shots for the entire RSV season. The total cost of treatment is $10,000.
From the time Palivizumab hit the market in 1998, the American Association of Pediatrics issued guidelines on how it should be used. Those guidelines, based on extensive evidence, dictated what insurance companies were required to pay to cover the cost. Palivizumab was so effective at combating RSV that all premature babies born less than 35 weeks gestation could, if needed, receive a treatment of five monthly shots given over the duration of the RSV season -- an expense the insurance companies covered.
In recent years, however, the AAP has become keenly sensitive to costs. Then, in 2009, the AAP abruptly issued a policy statement entitled "Modified Recommendations for the Use of Palivizumab for Prevention of Respiratory Syncytial Virus Infections." Citing "expert opinion" -- but providing no clinical evidence -- the AAP rewrote the guidelines for severe RSV and reduced both the number of infants eligible for the drug and the number of times the drug could be given to an infant. Some babies could receive three monthly doses, some only one. In June 2012, the AAP restated its position in its Red Book, and even though ample time had passed during which the committee could have accumulated evidence to support the revised position, none was presented.
"The AAP," according to Sally Pipes, author of The Top Ten Myths of American Health Care, "shrank the pool of infants deemed at risk for RSV and lowered the maximum time for treatment from five months to three. Never mind that no study had verified the efficacy of a three-month dosing regimen, in contrast to the proven five-month program. The AAP's justification for the change? 'To ensure optimal balance of benefit and cost.'"
In other words, tens of thousands of premature babies were at great risk of acquiring a potentially deadly disease, all because of the actions of a committee of doctors who appeared motivated more by cost than by medicine. "As a result of health care reform," says Wayne Winegarden of the Pacific Research Institute, a California-based think tank, "we are pushing ourselves toward centralized decisions. The people on these panels are quite intelligent and they are probably well meaning. However, science and medicine do not progress by consensus."
But just as some observers are noticing an increase in cases of RSV because of the AAP's revised guidelines, the dynamics of the controversy changed last week when the results of a study conducted by researchers in the Netherlands appeared in The New England Journal of Medicine. For premature babies, RSV can cause wheezing episodes. In the study, 429 premature babies, born at a gestation of 33 to 35 weeks, were examined in a double-blind, placebo-controlled trial during RSV season. The use of Palivizumab resulted in an impressive 61 percent reduction of wheezing days in the first year of life -- stunning proof of the efficacy of the drug.
What's more, the Netherlands study also suggested a link between RSV and asthma. "Severe RSV bronchiolitis," the study stated, "has been associated with an increase in subsequent rates of early wheezing, asthma, and possibly allergic sensitization later in life... These findings suggest that asthma is most likely to develop in infants who are at highest risk for severe viral bronchiolitis."
For the last 40 years, says Dr. Piedimonte, the big question in the field of pediatrics is whether RSV predisposes children to develop asthma. "I believe that it does," he says. If that link is proven, as a result of this new study as well as other studies to come, it will be hard for the AAP, and by extension the insurance companies, to continue to scale back treatment of RSV, since asthma is a full-fledged epidemic that affects one in ten children in the United States alone.
After all, in the brave new world of heath care, it's the numbers, not the medicine, that matter most.