By Sally Greenberg, NCL Executive Director
It appears that a cheaper alternative to expensive, federally regulated pain medication is now causing panic in the health care system. I first read about this story of injectable pain medication carrying a fungus that causes meningitis in the Wall Street Journal
last week. I scanned the story and handed it to our health care associate and said “want to read something scary? Take a look at this.”
Totally innocent patients – the Centers for Disease Control estimates possibly 13,000 patients - who trusted their physicians and their medications - were administered doses of the drug and as a result may have been exposed to a contaminated steroid compound used for back treatments linked to a strain of fungal meningitis. As of October 10, the death toll is now at 12 with 137 cases of meningitis.
Here’s the thing – federal regulators at the FDA oversee the safety of pharmaceutical company drugs. Yes, their record is not perfect, but they are required to maintain very careful records and oversight of their production facilities. But a compounding center, like the producers of this pain medication, is regulated like a pharmacy, by the state, and the regulations are far more lax.
States cite several reasons why they don't require compounding pharmacies to adhere to more strict industry-created guidelines. The higher costs and the need to conduct more frequent monitoring and sampling of the work areas are the most commonly cited reasons by compounding pharmacies for not complying.
The latest news on this outbreak suggests the lack of quality control is astounding. The New York Times reported
that federal inspectors examined the steroid solution created by New England Compounding Center and "found a sealed vial of the steroid afloat with so much foreign matter that it could be seen with the naked eye," later discovering that "the particles were a fungus."
According to an article from Reuters, two House Democrats have announced plans to introduce new legislation to strengthen FDA oversight and protect consumers. Democrats in the House and Senate have also called for congressional investigations and hearings.
So 12 patients have died and others are clinging to life because, it appears, that the New England Compounding Center operated in a slipshod manner, out of the watchful eye of competent regulators. Everyone cries “where are the government safeguards and regulators when we need them?” Exactly. This kind of outbreak is predictable when the focus is on cutting costs and not maintaining extremely careful controls over safety of the manufacture and handling drugs. This case reminds us why groups like NCL insist that sensible and strong regulation is needed to protect consumer safety, health and wellbeing, whether it's in drug manufacturing or doctors and hospitals. Without it, we get the health care crisis created by New England Compounding Center’s shoddy practices and the consumer or patient, in the end, always pays the price.