Cross-posted at WLF’s Forbes.com contributor page
President Obama often makes reference to how trying times can provide “teachable moments.” The recent outbreak of bacterial meningitis on college campuses is such a moment, but don’t expect the President to notice. The fact that school officials had to seek federal government permission to import a vaccine not yet legally available in the U.S., reveals anew the human cost of overbearing government regulation.
Seven cases of infection with the “B” strain of bacterial meningitis have occurred at Princeton University, and four have been confirmed at the University of California at Santa Barbara (UCSB). Statistically, 10% of those infected with meningitis B die, and 20% of those who recover suffer from severe side effects such as deafness and limb loss. Vaccines for every strain of meningitis have been approved for use in the United States except meningitis B; however a vaccine called Bexsero has been approved for use in Europe, Australia, and Canada.
At Princeton. Last October, with terrified students and their parents demanding action, school and state health officials had to ask federal health officials if Bexsero could be imported and administered at Princeton. Cue the creaky wheels of bureaucracy. The Centers for Disease Control and Prevention (CDC) asked the Food and Drug Administration (FDA) to issue an investigational new drug application, which is required to import Bexsero. The vaccine finally arrived at Princeton in early December, and immunization began there last week.
At UC Santa Barbara. From an east coast Ivy League school, some of whose graduates serve at the highest levels of the federal government, we now turn to meningitis developments at UCSB, a west coast state school. There, almost two weeks after immunization began at Princeton, and after a UCSB student lost both feet to the infection, the process to obtain Bexsero is just beginning. On December 12, California health officials formally sought permission to import the vaccine. Reports assert that CDC is “poised” to advance the process. Such assertions have not mollified UCSB parents’ outrage. One mother, a Massachusetts obstetrician, told NBC, “The government’s response at UCSB versus their response to the Princeton outbreak is baffling.”
U.S. Approval Hurdles. Also baffling—why a vaccine for such a deadly strain of meningitis must be imported from countries like Canada because it’s not legally available here. Bexsero is currently bottled up in FDA’s plodding approval process. The agency could, as the Hoover Institution’s Henry Miller recently argued, pursue accelerated approval, and perhaps now it will. But even if it does, the regulatory road to acceptance and use of Bexsero would not end there.
As a May 2011 Legal Pulse post discussed in the context of meningitis vaccines for vulnerable infants, drug makers must also convince a little-know entity at the CDC, the Advisory Committee on Immunization Practices (ACIP) of their products’ worth. ACIP reviews new vaccines and new uses of existing vaccines and makes recommendations to the CDC on which should be routinely administered to the public. These recommendations impact not only billions of dollars in federal purchases of vaccines, but are also unfailingly followed by pediatricians and other doctors. And though ACIP has just recently accepted an infant meningitis vaccine, it had initially opposed that FDA-approved drug on “cost-effectiveness” grounds.
A decision last July by ACIP’s counterpart in the United Kingdom may foreshadow Bexsero’s future use in the U.S. UK immunization advisers deemed the meningitis B vaccine too costly, and they refused to include it on the national health plan’s vaccination schedule. Given U.S. health officials’ affinity for Euro-style health cost containment, that decision does not bode well for at-risk Americans.
The meningitis B outbreak is a teachable moment that no one wants to have, and we doubt it will resonate with government officials, who are too busy federalizing health care. But if they do wish to reflect on the human cost of government overcaution and inaction, perhaps they should also talk to people like Alicia Stillman, whose 19-year old daughter died last February from meningitis B just 36 hours after entering a hospital with a headache. She told NBC in reaction to the Princeton inoculation, “I hope there will come a time it can be used routinely here. It’s a horrible, horrible disease.”
It appears that CDC may assent to Bexsero inoculations soon at UCSB. Now only if there were an inoculation available to protect us all against overregulation.