Two contrasting incidences of contamination recently have shown how difficult it is to make a proportionate reaction to the risks involved
The pharmaceutical community has had a hard time defending its safety and diligence recently, as various product recalls have hit the headlines once again. At the time of going to press, the US Centers for Disease Control and Prevention (CDC) put the number of meningitis cases caused by contaminated steroid medicines at 347 so far, resulting in 25 deaths.
The CDC and FDA have confirmed the presence of the fungus Exserohilum rostratum in unopened medication vials of the methylprednisolone acetate from two of the three implicated lots from the New England Compounding Center (NECC). The FDA has listed a number of observations regarding insanitary conditions in the cleanroom at NECC’s Framingham, Massachusetts facility, and vials of the steroid were also reported to have been shipped two weeks before the pharmacy had received confirmation that those vials passed inspection.
While the NECC’s is possibly one of the worst cases of its kind, at the other end of the industry spectrum we find the multinational Novartis, which did follow procedures and alerted the Italian authorities that visible protein aggregates had been found in one batch of flu vaccine, amid a recall crisis for Agrippal and Fluad.
Protein agglomeration is a common problem in some types of medication and can lead to reduced efficacy, but this is in no way comparable to the NECC’s failings. Yet Novartis is now at the centre of a major recall situation as the Italian Health Ministry decided to ban distribution of approximately 488,000 doses. The Swiss, German and Canadian authorities have since followed suit.
The Italian government said it took the action as it had not been provided with enough information about the cause and effect of the protein agglomeration. Perhaps the Italian authorities still had ringing in their ears the echo of the prison sentences recently passed on seven scientists and experts found guilty of manslaughter after failing to give adequate predictions of the severity of an earthquake that killed more than 300 people.
Getting the balance right in quantifying the risks of contamination in such vital products as drugs remains as difficult as earthquake or weather predictions. Companies that take precautions should be lauded, while prison sentences for those whose job it is to make such difficult decisions but get it wrong seems the wrong way to go.