During the campaign for President this election season, candidates have debated the merits of a government-sponsored health care coverage system for Americans. Although there has been a lot of discussion about pre-existing conditions and affordability of care, there has been little to no discussion about drug safety. The recent outbreak of fungal meningitis illustrates how important an issue drug safety is to American health.
The outbreak first gained attention at the beginning of October, when a Tennessee man developed fungal meningitis and investigators traced the fungus back to a compounding pharmacy that manufactures injectable medications such as back steroid medications. The initial investigation revealed a fungus contamination at New England Compounding Center’s facilities. NECC recalled the back steroids that had been linked to the outbreak on October 6; 13,000 people had already potentially been infected. Two weeks later, over 200 people have developed fungal meningitis and 19 of those people–almost 10 percent–have died. The ongoing investigation is looking into whether any of NECC’s other drugs were contaminated, how the contamination occurred and whether state regulators did an adequate job of overseeing NECC’s activities. At least two patients who received other injectable drugs from NECC are under observation for potential fungal meningitis.
NECC may face criminal charges if the investigation shows that it broke state or federal drug safety laws. The compounding pharmacy has already lost its license to practice in Massachusetts and Michigan, and at least one civil lawsuit has been filed by a patient who developed fungal meningitis. For many Americans, criminal and civil consequences may be enough to make them feel that justice has been served.
The problem is that the meningitis outbreak is far from an isolated incident. Although most outbreaks aren’t as severe or dramatic in nature as this story, they are still fairly common. Patient advocates have been calling for better regulation of these pharmacies for over a decade, but it hasn’t happened yet. This case demonstrates many of the problems that cause Americans to risk their safety when taking prescription medications. For example, the FDA had safety concerns about NECC in 2006, yet the pharmacy continued to operate for another six years before the meningitis outbreak finally forced a shutdown. There are also questions about whether NECC followed standard safety procedures and whether state regulators inspected this plant appropriately.
This outbreak potentially affected 13,000 people in 23 different states. The next outbreak could affect even more Americans. So it’s important that the questions of how this happened and who was responsible be answered. It’s also important that regulators see this as a warning of what might come in the future and allow the FDA to oversee compounding pharmacies.
Compounding pharmacies are a fast growing industry. These pharmacies make customized medications for patients and are used for everything from cough syrup to chemotherapy treatments. Thus, it’s vital to the health of Americans that they be regulated appropriately. Drug safety is as much a health crisis as adequate access to health care providers; the federal government needs to address it.