In updated figures posted to its website Saturday, the Centers for Disease Control and Prevention says the outbreak has spread to more than 60 people across nine states.
Federal health officials said that all patients injected with the steroid drug made by that company, the New England Compounding Center in Framingham, Mass., which had a troubled history, needed to be tracked down immediately and informed of the danger.
"This wasn't some obscure procedure being done in some obscure hospital," said Tom Carroll, a close friend to the Lovelace family, and their lawyer, referring to the Saint Thomas Outpatient Neurosurgery Center. "They had sought out a respected neurosurgeon who had been referred by their family doctor, at a respected hospital. How does this happen?"
The answer, at least in part, is that some doctors and clinics have taken their business to so-called compounding pharmacies, like New England Compounding, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge and with little of the federal oversight of drug safety and quality that is routine for the big companies.
"The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts," said Kevin Outterson, an associate professor of law at Boston University. "But that's not the FDA's fault."
During the past two decades, pain control has become a growth industry. Starting in the 1990s, spinal injections for back pain, known as lumbar epidural steroid injections, skyrocketed. They have since leveled off, but the number remains high. In 2011, 2.5 million Medicare recipients had the injections, as did an equal number of younger people, according to Ray Baker, president of the International Spine Intervention Society.