One of the most debilitating conditions a person can face is chronic back pain, and unfortunately a majority of patients who suffer from the condition are not candidates for surgery. Back pain is usually caused by congenital conditions, most notably stenosis or a narrowing of the spinal canal and traumatic injury. Nerve root inflammation is the cause of most chronic back pain, and the most effective drug for reducing this inflammation is steroids. It must be noted, however, that this is not without side effects.
In the past, patients were prescribed oral dosages of steroids, but the most efficacious delivery system for administration is by epidural injection (injection into cerebrospinal fluid in the spinal canal). Direct injection of a steroid results in a targeted and more concentrated dose. This procedure is usually performed by pain management physicians (anesthesiologists). Until now, patients needed only to rely on the skill of their doctor to administer the injection without incident and with good follow-up care.
According to a continually updated story in The New York Times, more than 650 people in nearly 20 states have been infected by fungal meningitis, a potentially deadly condition that requires long-term treatment, in the course of their treatment for fungal meningitis. This outbreak has resulted in 39 deaths since it began in October 2012.
Fungal meningitis is an infection of the meninges, or the membranes covering the brain and spinal cord, in which cerebrospinal fluid is tainted with fungal growth. The Centers for Disease Control explains that symptoms of the disease may include fever, headache, nausea and vomiting, sensitivity to light, slurred speech and altered mental states like confusion. Each of these 650-plus cases has been linked to a single drug compounding company in Framingham, Mass. that has since “shut down, surrendered its license and recalled all its products, not just the steroid.” Its owners have also filed for Chapter 11 bankruptcy protection.
This company, called the New England Compounding Company, provided personalized medications for medical professionals throughout the country. Compounding simply means combining medications that are tailored to an individual patient’s dosage requirements, but the practice is not without risks: it is impossible for the FDA to comb through thousands of personalized doses and thoroughly check on the safety of each one of them.
The drug in question is methylprednisone acetate, a common treatment for neck and back pain. The Times claims that about 5 million people per year take this drug in the United States. Methylprednisone acetate is usually administered by an injection near the spine, and in many of these cases the injection site, too, has become a problem, developing into what is known as an epidural abscess, or an infection near the spine.
Many of the patients who have contracted fungal meningitis from medications manufactured by the New England Compounding Company have filed suit, and in November the FDA published a 20-page report detailing many hygiene issues in the germ-ridden, rusty and unsanitary Massachusetts office park building. The New York Times quotes an FDA official, who said that these conditions “demonstrated that the firm could not consistently assure that their injectable products were sterile and safe for use by patients.” Reporters note that a 321-vial batch from one lot was tested and that 83 vials contained “greenish black foreign matter” and 17 more held “white filamentous material.”
The facts of the case are changing constantly as new evidence comes to light, but the New England Compounding Company and its sister companies operated well below the standards of cleanliness that its customers required. And the governor of Massachusetts is currently attempting to introduce new legislation that will force compounding companies like NECC to abide by stricter standards in the future.