Year in Review: Meningitis Outbreak Still a Challenge

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There were "many, many adverse effects, some of which, in the case of AmB, we were prepared for, but many, in the case of voriconazole, were not expected or were much more common than realized previously," she said.

The optimum duration of therapy – especially given the adverse effects -- remains an unanswered question. So far, according to Chiller, all treated patients remain on therapy, although many have been discharged from hospital.

How long that will last is anybody's guess, especially because the effect of treatment on the fungal infections involved is difficult to monitor. If no pathogen can be isolated, is it gone? Or is it still there but just refusing to grow in the lab, or possibly in a dormant state?

"If we had injected people with steroids and a bacteria, this thing would be over," Chiller said. But fungi, which he called "challenging, interesting, and unpredictable" organisms, have the ability to "hang out and do nothing," he added.

Then, after a long period of apparent dormancy, they can begin again to cause disease, Chiller said.

And that may be linked to another puzzle of the outbreak – why some people got sick and others did not.

"We understand the route of infection," Chiller said. "What we don't understand and have a good handle on is what happened after the injection."

Infection Control, Appropriate Oversight

While the outbreak is likely to give mycologists interesting research for some time, the bottom line is that contamination of a product that was supposed to be sterile led to hundreds of cases of disease, 39 deaths, and immense suffering.

The FDA has been blamed for not cracking down on the company involved much earlier. The head of the Massachusetts pharmacy board, which is charged with regulating compounding pharmacies in the state, was fired. The company itself is shuttered.

"This disastrous outbreak need not have happened if standard infection control techniques and appropriate oversight had been in place and heeded," Kauffman said.

Like many others, she believes the federal government should regulate compounding pharmacies, something that is now in the hands of the states.

Under fire from lawmakers, FDA Commissioner Margaret Hamburg, MD, has said her agency's authority over compounding pharmacies is "limited, unclear, and contested."

She has suggested a tiered approach under which "traditional" compounding pharmacies – which made up prescriptions for individual patients in limited numbers – would continue to be regulated by states.

But "nontraditional" pharmacies, which make up large quantities of a drug in anticipation of orders, should come under FDA authority, Hamburg has said.

The International Academy of Compounding Pharmacists countered that the FDA already has all the authority it needs. In a statement to a House of Representatives committee, David Miller, RPh, the organization's executive vice-president, said the problem was that NECC was breaking state laws in a way that gave the FDA clear authority to intervene.

Current law, he said, "allows FDA oversight when a pharmacy is not operating in conformity with governing state laws, or akin to a drug manufacturer."

Both Miller and others have characterized NECC as a rogue company that was not interesting in complying with the law.

"Unfortunately, NECC showed a blatant disregard for existing rules and regulations," Miller said.

Inspections of the Framingham plant showed lapses in processes that seemed almost certain to lead eventually to problems, if only because potential contaminants were everywhere.

"We know that sort of contaminant is ubiquitous," Chiller said. "You need to have a system in place to eliminate them."

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