THE BLOG

When Government Bureaucracy Proves To Be More Than Annoying -- Perhaps Even Fatal

03/20/2014 02:11 pm ET | Updated May 20, 2014

She was a sophomore at Drexel University, in Philadelphia, who played on the softball team and majored in mechanical engineering. At Upper St. Claire High School, outside Pittsburgh, she was a National Merit scholar and community volunteer. She was so active in school affairs one of her high school teachers would remember her as "the kind of student you will never forget." Her final Facebook post announced that she was donating eight inches of her long, brunette hair to a charity that provides wigs to children with cancer.

Her name was Stephanie Ross. When her sorority sisters at Phi Mu-Beta Tau discovered her in her room last Monday morning, she was unconscious and unresponsive. They rushed her to Penn Presbyterian Medical Center, but it was too late. Doctors pronounced her dead. The next day, her best friend summed up the emotions of those mourning her loss. "To say that you will be missed is an understatement," the friend observed. Ross was nineteen years old.

Four months earlier, at the University of California, Santa Barbara, Aaron Loy, a freshman, came down with what he thought was the flu. Suffering from a headache, fever, and vomiting, he displayed the same early symptoms as Ross. But soon he became so ill friends admitted him to the hospital. His deteriorating condition included blood poisoning, tissue wounds, and kidney failure. When blood stopped flowing to his lower extremities, doctors amputated both feet. Handsome, strapping, the picture of youth, Loy was a member of the varsity lacrosse team who was such a standout in the sport he was twice named all-conference in high school.

Both students had succumbed to a serogroup B strain of meningitis. A dangerous infection, meningitis produces a swelling of the protective tissue covering the spinal cord and brain. Besides initial flu-like symptoms, a victim can suffer a stiff neck, sensitivity to light, and disorientation. The disease is not spread by casual contact or by breathing air near a person who is infected but through the exchange of saliva resulting from activities like kissing or sharing a drink. With their close living quarters and active social scene, college campuses are the perfect breeding ground for meningitis. Treated early with potent antibiotics, many victims survive, but 15 percent of the cases are fatal and another 15 percent leave the victims with long-term disabilities such as deafness or loss of limbs.

According to the World Health Organization, 170,000 deaths are caused globally each year by meningitis. There are five strains of the infection: A, B, C, Y, and W-135. In the United States, the disease has all but disappeared because vaccines exist to prevent the A, C, Y, and W-135 strains. Many colleges and universities require freshman to receive vaccinations before coming to campus. However, no vaccine for meningitis B -- the strain that struck down Ross and Loy -- is available in the U.S., even though Bexsero, a meningitis B vaccine produced by a Swiss pharmaceutical company, is in widespread use in Europe, Canada, and Australia.

Why is Bexsero unavailable in America? One reason. The Food and Drug Administration hasn't approved it. Not because it isn't safe and effective -- it is in common use in Europe and much of the English-speaking world -- but because the FDA has become so immobilized by a stupefying bureaucracy and by what one former FDA scientist calls a "fanatically risk-adverse" attitude toward decision-making that on average it takes an astonishing 14.2 years for a drug to proceed from discovery to FDA approval.

So far, the FDA has balked at putting Bexsero on a fast track, even after Aaron Loy and three other students at UCSB came down with meningitis B, creating widespread panic on campus that saw more than one thousand students who had come in contact with the victims end up on powerful antibiotics.

And it's not as if the FDA had not been warned. In March, eight months before the UCSB outbreak, a student at Princeton University was diagnosed with meningitis B after returning from spring break. By May, there were three victims. By November, seven students and one visitor were diagnosed. Some recovered with antibiotic treatment, but two remained ill throughout November, the month the UCSB students became sick. Concern was so intense at Princeton that, in December, university officials received special permission from the FDA to import Bexsero and vaccinate at-risk students and faculty. That month, 5,471 individuals -- 95 percent of those eligible -- were vaccinated.

After the vaccination program at Princeton, no new cases appeared on campus. Would such a large sample pool help win quick approval for Bexsero? Not with an agency as ladened with caution and systemic inertia as the FDA -- in stark contrast to its counterparts in other civilized nations. But consider this. If the vaccine had been approved -- even on an emergency basis -- perhaps Stephanie Ross would be alive today.

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