Princeton University and UC-Santa Barbara are both reeling from outbreaks of bacterial meningitis.
The strain afflicting the two campuses can’t be prevented by the vaccine that college freshmen typically get before heading to school. But a new vaccine can stop the spread of this particular strain — if the government will only allow its use in the United States.
Bexsero is readily available in Europe, Australia and Canada. Twenty years in the making, the vaccine has undergone numerous clinical trials involving nearly 8,000 infants, children, adolescents and adults. US health officials, alarmed by the outbreak, have taken the unprecedented step of importing the drug as part of an emergency vaccination campaign at Princeton.
Yet Bexsero is still awaiting approval by the Food and Drug Administration. A combination of excessive caution and regulatory inertia has left thousands of Americans vulnerable to this dangerous disease.
A strong dose of caution when it comes to approving new treatments may seem like a virtue. But as the students and families affected by these outbreaks know, excess caution can have grave consequences.
Bacterial meningitis is an uncommon but serious threat. It’s especially dangerous because of its swift onset and because it can be easily misdiagnosed as flu. It claims the lives of one in 10 people who contract it, sometimes within 24 hours of onset, and one in five survivors will experience lifelong disabilities.
The disease is also highly contagious; it spreads through sneezing, coughing or living in close quarters — like college dorms.
Fortunately, most of the recent victims are expected to recover fully. But one student, a UC-Santa Barbara lacrosse player, had to have his feet amputated after the infection disrupted circulation to his legs.
In the face of this terrible tragedy, the FDA has opted to do almost nothing. Not only has it refused to expand the use of Bexsero to other affected campuses — despite the urging of California health officials and parents — it won’t even fast-track the vaccine through the approval process to prevent outbreaks elsewhere.
Sadly, Bexsero is just the latest example of a deeply broken system at the FDA. Regulatory hurdles and a bureaucratic culture that is highly risk-adverse have delayed countless potentially life-saving medicines and treatments.
For example, a seven-year delay in approving beta-blockers contributed to over 100,000 premature deaths among heart-disease sufferers. And during the 3½ years it took the FDA to approve the drug Interleukin-2, 3,500 patients died of kidney cancer even as the drug was being used successfully in nine other countries.
The FDA’s slow approval process is understandable given the skewed incentives under which the agency operates. If the FDA releases a drug with unexpected side effects, the immediate consequences will be public outrage, bad headlines and congressional investigations. But if it insists on more testing and greater delay — however excessive — it will largely escape bad publicity.
Already, the average process of shepherding a potential drug from discovery through approval takes 14.2 years, according to Tufts University researchers. For every 5,000 compounds screened, the FDA will approve only five for human testing, and (eventually) license only one for marketing.
These are long odds, and they keep getting longer as the FDA pushes for ever-more data and ever-longer trials. In the case of rare diseases — like bacterial meningitis — many drug companies may find that there aren’t enough patients to make it financially feasible to jump through the hoops of the FDA’s approval process.
The result is a record number of drug shortages — many of which can be attributed to “actual or anticipated action by the FDA,” according to a joint report by the American Society of Oncology, the American Society of Health-System Pharmacists and other stakeholders.
No one is arguing that untested drugs be made available for sale. But the FDA can and should change its internal incentive structure to allow Americans speedier access to lifesaving drugs, and to empower those most affected — patients and their doctors.
And it should immediately approve Bexsero for American patients.
Sally C. Pipes is president, CEO and Taube Fellow in Health Care Studies at the Pacific Research Institute. Her latest book is “The Cure for ObamaCare.”