During the last two years, there have been a couple of outbreaks and sporadic cases of bacterial meningitis that federal health agencies failed to address with sufficient aggressiveness. It could have been much worse, and the experience should serve as a wake-up call.
Meningitis is a devastating infectious disease, often misdiagnosed as flu, and it can become debilitating so quickly that by the time it is recognized, the patient may be too sick for effective treatment.
Over the last four decades, the threat from several types of bacterial meningitis has been significantly reduced by immunization. The first vaccine was approved in 1974, and a newer version was introduced in 2005. However, a vaccine for meningitis B, or MenB, has taken much longer to develop. The first MenB vaccine, brand name Bexsero, was not approved until 2013 by the European Union, Australia and Canada. It has not been approved in the United States.
MenB primarily infects those under the age of 25. College students and prisoners are particularly vulnerable because of their close quarters. About 10% of those infected die, and survivors can suffer brain damage, hearing loss and limb amputations. Those infected with less severe or no symptoms may become carriers.
Single fatalities from MenB occurred in New York in 2012, Michigan in 2013 and Pennsylvania this year. Since March of last year, there have been nine cases at Princeton University and four at UC Santa Barbara — none fatal, fortunately, but a Santa Barbara student needed to have both his feet amputated.
In order to make the unapproved vaccine available to the Princeton and UCSB students, the Centers for Disease Control and Prevention had to resort to a cumbersome process: filing voluminous Investigational New Drug applications, or INDs, with the Food and Drug Administration for permission to acquire and distribute the European version of the vaccine.
This process has inherent delays. The CDC had to prepare and file the INDs, establish treatment protocols, involve an institutional review board and the manufacturer, get the necessary patient or parental consents, and ensure that the vaccine would be covered for any potential liability under the National Vaccine Injury Compensation Program.
Two drug companies, Pfizer and Novartis, submitted marketing applications for their vaccines last month. It will be interesting to see how quickly the FDA will complete its review and get one or both of these on the market. (Typical review times are six to 12 months.)
Had the East and West Coast MenB outbreaks been more extensive, hundreds or even thousands of people could have died or been maimed. We need policy changes to address such threats more efficiently in the future. For example, the delayed access to Bexsero would have been avoided if the FDA had had "reciprocal" authority to rapidly approve a drug or vaccine approved abroad in the face of a public health threat in the United States. Such reciprocity would derive from the prior approval by a major foreign regulatory authority, such as Canada or the EU.
There will be other health crises. It's time for Congress to enact legislation that makes the process simple and efficient with a short turnaround time and with a trigger sensitive enough to spur action even if only a limited number of cases of a serious disease arise.
Up to now, we have been lucky. But recalling Louis Pasteur's admonition that "luck favors only the prepared mind," we need to prepare.
John J. Cohrssen is an attorney in private practice who has served in senior staff positions in the White House and Congress. Henry I. Miller, a physician and molecular biologist, is a fellow at Stanford University's Hoover Institution. He was the founding director of the FDA's Office of Biotechnology.Copyright © 2014, Los Angeles Times