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Scant oversight of drug maker in fatal outbreak

Published October 6, 2012 3:21 pm

Meningitis • Death toll grows, raising questions about loose regulations.
This is an archived article that was published on sltrib.com in 2012, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.

Atlanta • Eddie C. Lovelace, a Kentucky judge in his late 70s, had a penchant for reciting Shakespeare from memory and telling funny stories in his big, booming voice. But a car accident last spring left him with severe neck pain, and in July and August he sought spinal injections with a steroid medicine for relief.

Instead, Lovelace died in Nashville in September at age 78, one of the first victims in a growing national outbreak of meningitis caused by the medicine that was supposed to help him. Health officials say they believe it was contaminated with a fungus.

The rising toll — seven dead, 57 ill and thousands potentially exposed — has cast a harsh light on the loose regulations that legal experts say allowed a company to sell 17,676 vials of an unsafe drug to pain clinics in 23 states.

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.