10.10.12

Blame Game Underway as Meningitis Outbreak Broadens

The outbreak that’s now killed 11 people suggests either a massive series of errors and oversights or a grossly contaminated work environment, and the pharmaceutical industry and compounding centers are squaring up against each other in a nasty spat over regulation.

The national outbreak of fungal meningitis related to contaminated spine injections is now in its second week and seems to worsen with every new dispatch. As of late yesterday, Oct. 9, the numbers were up to 119 cases in 10 states with 11 deaths. The map of infected people reveals patients from Minnesota to Florida, with Tennessee and North Carolina most affected.

Make no mistake, this is a real outbreak—not one of these sky-is-falling, what-would-happen-if sorts of things where panic-stricken public health officials pump the eager masses into a wild frenzy with their predictions—and then yell at us to SHUT UP AND RELAX ALREADY. From the start this one felt different. It appeared out of nowhere, and involved otherwise sturdy outpatients; it involved oddball fungal molds that just about never cause infections of the spine or brain, meaning that one infection is one too many. And every day, we are getting 10 new cases, demonstrating that we are not approaching the end of the problem or the determination of just who screwed up.

We certainly have learned a great deal in the days since the initial announcement. First, about 13,000 people received possibly tainted injections during the risk period from May 21, 2012, to late September, when the product recall began. Second, a staggering number of Americans get these injections every year.

Finally, we now know that the outbreak appears due to more than one fungus, not just Aspergillus as originally reported, but also Exserohilum rostratum, a truly rare fungus that has been found in cultures from one patient. This suggests that the problem at ground zero of the outbreak, the New England Compounding Center in Framingham, Mass., was substantially worse than first thought; with a single organism causing the trouble, a plausible explanation is that a single mistake led to propagation of a single strain in all prepared products. But more than one organism suggests either a massive series of errors and oversights or else a grossly contaminated work environment far below any acceptable standard. The truth eventually will come out as federal authorities continue their careful investigation.

A surprise in the investigation for many is the very existence of places like NECC. Compounding centers take an already produced drug and prepare it for use by dissolving or stabilizing it or the like. Hey, that seems like a good deal. NECC claimed to provide “customized medications for patients based on what they need ... [by making] ... its own compounds, allowing practitioners to get compound medications that are no longer manufactured or are on constant back order due to shortages.”

Seems consumer-friendly enough, right? Meeting needs for the little guy, providing what the mammoth corporations don’t have sufficient time or profit motive to supply. But it turns out that the meningitis tragedy has revealed a previously obscure fault line, a Hatfield and McCoy–level nastiness between standard Pharma and the curious world of the compounders over the issue of regulation. Compared with Pharma, compounders are very lightly regulated. According to PharmTech.com, a cheerleading squad of brand-name Pharma boosters (from Merck and Pfizer, etc.), as well as lackeys and a pinch of government sorts who promise to “provide essential insights for Pharma manufacturing,” those lousy compounder guys should NEVER have been trusted.

Neither side of this particular family feud is at all attractive.

In a recent piece, they claim that they, Pharma, have fought to bring tougher regulation to the rogue compounders, who per Pharma’s count number about 7,000 internationally. They concede that compounders, assuming they stay small and focused, do indeed perform an essential public service by preparing special doses or preparations too small for the big guys to bother with. But they also claim that fewer than 200 of the 7,000 have sought (voluntary) accreditation—i.e., an embrace of regulations.

Not to take this sitting down, the compounders have their own pep squad, the International Academy of Compounding Pharmacists (IACP)—plus they have a board of directors who don’t wear ties. They are milking the little guy bit to the max: plain folk willing to take the smaller profit for the regular Joe—guys like them with open collars. Why, they’re even working with veterinarians (PDF) to help man’s best friends (and assorted farm animals) as part of their mission, to “protect, promote and advance the art and science of pharmacy compounding”—without regulatory interference.

Neither side of this particular family feud is at all attractive. The eagerness of Pharma to pin this one on the compounders is unsavory, while the compounders seem to have adopted the myopic and selfish “it’s safe to go back in the water, no giant sharks here” approach of any industry under deserved siege.

But the existence of compounding centers is a cautionary tale of regulation and its discontents. Just as the entire SUV-ization of America arose in the mind of Lee Iacocca not to give the Ozzies and Harriets of tomorrow a new way to cruise en famille, but rather to circumvent the regulation for a minimum of miles per gallon (an SUV technically is a truck), so too did the compounding centers spring up as an end run around a swelter of regulation that had slowed down the big guys.

Regulation has become the mother of invention, spawning countless struts and frets across the vast field of loopholes, those tiny escape clauses discerned only by the truly visionary, the truly greedy, the truly paranoid—Richard Nixon, for instance. With its bastard pedigree, conceived as it always is during a hasty exodus from regulation, we should expect little else from a loophole industry than a complete catastrophe. After all, the rationale for that very regulation—in this case, to assure safe drugs—once was implemented for a real reason.