Monday, December 23, 2013

Meningitis Outbreak .....A Near Miss

I doubt if the family's and students at UCSB or Princeton who had Type B meningitis don't feel it was a "near miss"  For them regardless of the low risk of contracting the type B strain when it occurs to you statistics mean nothing.

Meningitis is a particularly challenging illness to diagnose and treat early.  It often presents as a mild sore throat which quickly escalates into a high fever, mental changes, stiff neck and rash.  Unless intervention occurs early loss of limbs, and other severe complications can arise.  Sore throats and headaches and fever are ubiquitous at any school in the fall and winter.

Meningitis  can be caused by multiple etiologies, (fungal,parasites, viral, and bacterial).  Multi-valent and univalent vaccines have been developed.

Nearly 2,000 Princeton University students lined up for shots Monday as the New Jersey school began offering an emergency vaccine aimed at halting an outbreak of potentially deadly meningitis that has sickened eight since March, health officials said.
That's about one-third of the estimated 6,000 students and others expected to get injections this week of an imported drug approved in Europe, Australia and Canada, but not in the U.S. It protects against the B strain of meningitis — the bug behind the illnesses — which isn’t covered by the vaccines that most college students already receive.

Statistics can prove almost anything. Logic and probability are terms that 'QUANTS" use.  Quants are the statisticians that develop and consult algo's (algorithms) .  Algorithms have always been important in the insurance world, engineering, weather forecasting and much more.

Algorithms have not so quietly slipped into the mainstream of medicine in terms of managed care, cost,risk factors for disease and in basic research. Most of us remember the 'P' factor as the liklihood something would happen by chance in an experiment.  It indicated how many times the event would occur by chance if repeated 100 or1000 times

The non-availability of Meningitis type B vaccine was due to one of those algorithms that determined it was NOT COST EFFECTIVE to import Bexsero into the  U.S.  It was deemed by decision makers that it would be too expensive to run through the U.S. FDA investigative new drug application process.  For most really new drugs this can be one or more years.

The drug manufacturer, of Bexsero, a vaccine licensed only in Europe and Australia that protects against meningitis B, a strain not covered by the shots recommended for college students in the U.S.   had to apply to the FDA to initiate the process (started in October 12-13  at about the same time as the first cases at Princeton and UCSB were diagnosed.

The first doses were given at Princeton  December 9, 2013.  The process obviously was fast-tracked but it required  two months because of the arduous bureaucracy.

The take-aways here are:
1. Many preventive measures are calculated on the basis of similar algorithms
2..A centralized authority such as the Affordable Care Act and the proposed IPABs  establish many         procedures and/or treatments that are acceptable, not recommended, or 'not covered' by the affordable   care act as a standardized practice, all based upon statistical algorithms.
3. Diverting from a standard practice, or an emergency practice can be delayed considerably by these processes.

Inevitably the physician has the moral and the ethical responsibility for the decision.  The patient's welfare is the ultimate arbiter.

Our health system is becoming dangeously close to interfering with a physician's hippocratic oath.

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