Scant oversight in fatal outbreak

Denise Grady, Andrew Pollack and Sabrina Tavernise / New York Times News Service /

Published Oct 7, 2012 at 05:00AM

Eddie Lovelace, a Kentucky judge still on the bench into 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 very 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. Federal health officials said Friday 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 turned away from major drug manufacturers and 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.”

The outbreak has also brought new scrutiny to the widely used medical procedure that Lovelace and millions of Americans receive each year.

Patients most likely assumed there was strong evidence that the procedure itself works. But the Cochrane Collaboration, an international group of medical experts, reviewed the data last year and found there was “no strong evidence for or against” the injections. Patients exposed to the tainted drug in this outbreak may have risked their health or even their lives for an elusive goal.

A large demand

Over the past two decades, pain control has become a growth industry, bolstered by the worn-out knees and aching backs of baby boomers. Pain clinics began popping up around the country.

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 Dr. Ray Baker, president of the International Spine Intervention Society.

In recent years, compounding pharmacies have sometimes filled gaps left by shortages of drugs made by pharmaceutical companies.

“As drug shortages have become more complex and common, pharmacies are turning to external compounding companies to help them,” said Cynthia Reilly, of the American Society of Health-System Pharmacists, referring to hospital pharmacies.

Shortages may have played a role in the large purchases of the injectable steroid now under suspicion from New England Compounding. The two manufacturers of the generic version of the drug had stopped making it.

Teva halted production in 2010 when it temporarily closed its Irvine, Calif., factory after receiving a warning letter from the FDA about manufacturing quality problems.

The other manufacturer, Sandoz, stopped selling the product in the U.S. this year, according to the company, which would not provide a reason. Sandoz has also been reprimanded by the FDA for manufacturing problems.

While the FDA says the drug is not in short supply, the brand-name product still available may have been considered too expensive, prompting some medical practices to turn to compounding pharmacists.

PainCare, a medical practice with 12 locations in New Hampshire, turned to New England Compounding for the injectable steroid now under suspicion when its usual supplier ran out, said the company’s chief executive, Dr. Michael O’Connell. The company’s two main locations alone do more than 100 injections a week.

O’Connell said he also preferred compounding pharmacies because they could make the drug free of an alcohol often used as a preservative in drugs manufactured by big companies that he worried could damage nerves.

In addition, Medicare and many private insurers reimburse a fixed amount for the injections — about $300, giving doctors a financial incentive to prefer the less costly compounded versions, he said.

“If you are using a more expensive product, there would be less left over,” O’Connell said.

Compounding falls in a legal no man’s land, between the federal government and the states. The FDA regulates big manufacturers, but compounders register as pharmacies, putting them under a patchwork of state rules. The FDA did develop a clear set of rules for compounding, but subsequent litigation that culminated in a Supreme Court decision in 2002, struck them down.

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