Culprits

10.18.12

Why Regulation Matters: Investigating the Meningitis Outbreak

What was going on at the Massachusetts business under investigation in one of the worst manufacture-related outbreaks in U.S. history? Dr. Kent Sepkowitz on why regulation matters.

The national outbreak of fungal meningitis related to therapeutic spinal injections officially became a historic health catastrophe this week as cases continued to pile up--more than a dozen new ones reported over the last 24 hours--and the FDA sent members of their Office of Criminal Investigation to seize whatever could still be seized from the infamous New England Compounding Center (NECC).

The sad story grows sadder with each update. The count is now 247 cases and 19 deaths with many more certain to come. As with wars and other calamities, the surest evidence of continued trouble is a steady or increasing number of cases each day, as has occurred with this outbreak. There is no evidence yet that this one is petering out.

To review the details quickly--compounding companies are in-betweener concerns that buy already prepared (and heavily regulated) drugs from the big-shot pharmaceutical companies (Merck, Pfizer and those guys) and mixes the purchased drug, which comes as a powder, into a liquid or else makes a cream or a poultice of it. They have successfully flown below regulatory radar because they don't exactly make anything--they just add a little of this or that inert substance to the active ingredient. What could possibly go wrong? And the people getting sick are those who, despite evidence of non-efficacy, continue to receive steroid shots into the area outside the spine in hopes of obtaining relief from low back pain.

Furthermore, there is concern that NECC, the same compounding company that gave us fungal meningitis from contaminated steroid injections, might have shipped other contaminated products for additional medical uses.  Right now this seems unlikely given the tiny drips and dribbles of cases rather than the oh-my-god-it's-worse than we ever feared crescendo we have seen with of the meningitis, one of the worst manufacture-related outbreaks of its type in the history of the United States.

As a doctor I work in perhaps the most regulated of all industries and it gets in the way every day. I hate this aspect of my work. But I hate the danger of no regulation far more.

How then did we get here--a federal agency storming a business to determine whether a criminal activity has occurred? (A lawyer for NECC said in a statement that “it is difficult to understand the purpose of this search, since we have been clear that [NECC] would provide, and has provided, anything requested. We’ve been clear that warrants weren’t needed.”) The exact details and the timing will probably never be known exactly, but this action suggests that rather than just a series of unfortunate events, a string of almost-trivial oversights that somehow tragically added up to a catastrophe, there is concern of willful negligence. (Or else the co-owners gave big time to Mitt the governor or Mitt the you-know-what, as they had to Republican senatorial candidate Scott Brown who returned the $10,000 -- though even Forbes smells a semi-rat.  Obviously an investigation is not the same as proof of a crime; however, there must be deepening concern about just what was going on at NECC -- despite the fact they agreed to close up almost 3 weeks ago.

As with almost all medical calamities from thalidomide to Celebrex--a debate about regulation and the national pipedream that, like Goldilocks and her soup, there is an amount that is just right. There isn't --we either have too much regulation (the left's dream) or too little (the sound you hear is the right licking their lips). Like everything else in adulthood there is no real middle--one must overplay to one side or the other and suffer the consequences of such irrational exuberance in whichever direction you choose. From this perspective then, the point is not to examine the benefits of one approach but rather what happens if the approach is not taken. When looking strictly at the benefits side, deregulation makes perfect sense -- after all regulation is the most reviled of all bureaucratic endeavors. Since its demonization by Ronald Reagan, regulation has been a favorite punching bag for the right. They have a winner too; everyone knows that regulation sucks. It is clumsy and burdensome and it surely slows innovation. It adds costs and discouragement.  As a doctor I work in perhaps the most regulated of all industries and it gets in the way every day. I hate this aspect of my work.

But I hate the danger of no regulation far more.  And since the golden mean is not available, the choice is simple: better to suffer the slings and arrows of paperwork and inane-seeming inspections than to witness the hundreds of preventable family tragedies now occurring across the country. As annoying as he is--and he is very annoying, we continue to need the extremely nosy presence of dear old Uncle Sam.