Policy making at the federal Centers for Disease Control and Prevention is in disarray. Faced with the question of whether to add a meningitis vaccine to the schedule of vaccines routinely recommended for infants, officials at the CDC are asking the wrong questions to the wrong people, and in a non-transparent way.
First, the basics. Meningococcal disease is a rare but devastating illness caused by a bacterium, Neisseria meningitidis, which primarily affects infants and children. It is both unpredictable and deadly, killing 10% to 15% of those who contract it. Among those who survive, as many as 1 in 5 will suffer permanent disability from amputations, seizures, paralysis or hearing loss. Its onset is rapid, and it can be fatal within 24 to 48 hours of the first non-specific symptoms.
The narrow window of time to diagnose and successfully treat a patient makes the treatment â€” instead of the prevention â€” of meningococcal disease difficult. Vaccines are by far the best approach.
It is no wonder that complete elimination of meningococcal disease has been on the CDC's list of priorities since 1999. Vaccines have played a role in the declining rate of the disease in recent years. In 2007, the CDC estimated that there were 1,000 cases and 130 deaths nationally from meningococcal disease, compared with 2,800 cases and 300 fatalities a decade earlier. History has shown, however, that spikes in the incidence of meningococcal disease can occur over a short time period and without warning, and the prevailing strains of meningococcus could mutate to become more virulent.
The addition of the vaccine to the list of CDC-recommended infant immunizations should not be controversial. If the CDC fails to add the vaccine to the list, it would become hard to get: Many doctors wouldn't stock it, it wouldn't be covered by most private insurance plans, and Medicaid wouldn't cover it. Also, investors and vaccine developers would get the message that widespread use of new vaccines is no longer a priority for health officials, putting a damper on critical research and development.
CDC is scheduled to announce its decision by February of next year.
What has changed since the CDC made elimination of meningococcal disease a priority in 1999? For one thing, the federal government's increasing involvement in health care. Every decision made about which vaccine is recommended has a financial component that concerns government officials. According to CDC officials and experts working with the Advisory Committee on Immunization Practices (ACIP), the CDC group that will make a recommendation on the meningitis vaccine, "cost-effectiveness, not just science" will be considered in the decision making process. This is the future of American health care. The Heartland Foundation's Dr. Richard Dolinar wrote in June that as ObamaCare is implemented, "decisions based on cost-effectiveness instead of effectiveness will become the norm, and access to health care will shrink considerably."
The CDC's approach to the meningitis vaccine appears to reflect Dolinar's concerns. Dr. Glen Nowak, a senior advisor in the CDC's National Center for Immunization and Respiratory Diseases, called the deliberations a "complex issue" that goes beyond science and cost-effectiveness. His colleague, Dr. Amanda Cohn, the lead CDC scientist on domestic meningococcal disease, explained that the CDC will also consider the impact on "population health" as an important factor, noting that although meningitis is a devastating disease, it is "rare," striking "only" about 50 American infants annually.
The bureaucrats then construct a tenuous row of dominoes, postulating that adding another safe and effective vaccine to the schedule could somehow have a negative impact on population health by prompting parents to "delay and defer" more important vaccines. That in turn could precipitate a "potential tipping point," according to Cohn.
Lacking evidence to support this counter-intuitive argument, the CDC set out to gin up some evidence â€” at a series of four public meetings that cost taxpayers $375,000, according to CDC's own estimates. Strangely, the meetings were not even publicized on the CDC's webpage. Nowak, who spearheaded the meetings, explained, "We went out and took interested citizens and got their input" about vaccines in general and the specifics of the meningitis vaccine for infants.
However, Heartland's Kendall Antekeier, who attended the Chicago meeting this summer, reported that the purpose of the meetings clearly was less to elicit views than to "frame participants' opinions to match the CDC's desired outcome: a vote against recommendation [of the vaccine]." The questions posed to the public participants were part of what Nowak described as a "structured agenda." Think of it "as a focus group," he suggested. But the questions, which all suggested that the vaccine was too expensive to justify saving "very few lives" and would wreak havoc by overburdening the country's public health infrastructure, sounded more like a push-poll than a focus group.
In spite of the obvious bias of the questions, 86% of the public participants at the Chicago meeting voted in favor of adding the vaccine to the immunization schedule, according to Antekeier. (Nowak refused to release the results, which incidentally were recorded on taxpayer-funded hand-held polling devices.)
So if they aren't interested in the results of their poll, what were they looking for? Presumably, trying to document that the addition of this vaccine to the immunization schedule for infants will cause parents to skip or delay their kids' vaccinations. The CDC's entire approach to this issue is marked by poor judgment and lack of leadership, traits that seem endemic in the federal government these days.
Taxpayers â€“ and infants â€“ deserve better.
Henry I. Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at the Hoover Institution; he was the founding director of the Office of Biotechnology at the FDA.
Jeff Stier is a Senior Fellow at the National Center for Public Policy Research and directs its Risk Analysis Division.