As children suffer, meningitis cases confirm need for FDA reform



You may have read about meningitis outbreaks at college campuses, in some instances resulting in deaths . Today's guest post is by someone whose name you may very well recognize, Dr. Julianne Malveaux. She makes a good case for urgent FDA reform:

Meningitis Cases Confirm Need for FDA Reform
by Dr. Julianne Malveaux

Julianne Malveaux is a Washington, D.C.-based economist and writer. She is President Emerita of Bennett College for Women in Greensboro, N.C.

It is virtually impossible to get Democrats and Republicans to agree on anything healthcare related these days. Even issues that everyone can agree on - like covering Americans with pre-existing conditions and keeping young adults on their parents' health plan - become political footballs.

But while Congress continues to debate healthcare policies, they are missing opportunities to genuinely effect Americans' health. There is common ground to be found, including ensuring our nation is properly expediting life-saving vaccines for a deadly disease.

Recent scares at Princeton University and the University of California Santa Barbara (UCSB) have highlighted a sluggish, reactive approach to disease prevention and that the consequences of this leadership vacuum, particularly at the U.S. Food and Drug Administration, could be deadly.

Last spring, a Princeton University student was diagnosed with Meningitis type B (MenB), a highly contagious and life-threatening bacterial infection known to strike college campuses. By November, officials made national headlines by confirming an eighth case.

Just as Princeton was taking steps to protect its students against this deadly disease, UCSB confirmed that MenB had stricken four of its students. One young man – a lacrosse player, Aaron Loy – had to have the lower portion of both legs amputated.

As a former college president, I can assure you that no university is prepared for this kind of crisis. This is particularly true because many college administrators believed they had protected their campuses by requiring incoming freshmen to be vaccinated against meningitis. But it turns out that immunizations cover every meningitis type except for MenB, which accounted for more than 30 percent of meningococcal cases last year.

Because FDA has not approved a MenB vaccine for use in the U.S., the Centers for Disease Control and Prevention (CDC) has been scrambling to respond to public health crises like those at Princeton and UCSB. Rather than proactively immunizing susceptible college students before or immediately after a meningitis outbreak occurs, the CDC can only administer “Bexsero” – a MenB vaccine that is currently in use for all ages in European Union, Australia, and Canada – weeks after students have already fallen ill.

FDA’s ad hoc approval for Bexsero means that it takes months for the vaccine to reach college students, rather than days. In the case of Princeton, CDC and FDA launched a vaccination program more than two months after university officials requested special permission to administer the vaccine. Just last week UCSB began immunizing students, some three months after the first case of MenB was confirmed. As one CDC official told CNN, “You don't go online and order 10,000 doses and get next-day delivery of this vaccine. It takes time.”

That statement underscores the need for full U.S. approval of Bexsero -- quickly. A country that has long been the world leader in developing and deploying life-saving medicines should not have to depend on partners in the EU or Canada.

Moreover, other college campuses should be afforded the opportunity to vaccinate their students proactively, well before a disease like MenB strikes their campus. But this option for college administrators, state health officials, and parents is not possible so long as Bexsero remains unapproved in the U.S.

If Congress isn’t yet convinced that there is an urgent problem, perhaps they should listen to the parents of affected students.

"It's absolutely devastating to have Aaron, in the prime of his life, be stricken,” Mike Loy said. “We hope that Aaron's horrific illness brings increased awareness and rapid approval by the FDA of the vaccine.”

I've also heard one mother whose healthy daughter contracted MenB at college and she died within 30 hours of entering the hospital with a headache. She said the FDA would be moving a lot faster if they had to watch their children suffer the way she did.

Improving efficiency at FDA is an issue that should find bipartisan support on Capitol Hill. Our system’s continued failure on the MenB vaccine is just one example that illustrates that there’s too much at stake for FDA reform to turn into the partisan fight du jour, or worse yet, be ignored by Congress altogether.