Eddie C. 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, Judge 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 — 7 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 has 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. "They had sought out a respected neurosurgeon who had been referred by their family doctor, at a respected hospital," he said, referring to the St. Thomas Outpatient Neurosurgery Center. "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.
The outbreak has also brought new scrutiny to the widely used procedure that Judge Lovelace and millions of Americans undergo 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 drug in the current 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.
Many people seek them in hopes of avoiding surgery. The injections combine a steroid and a numbing drug in an effort to soothe inflamed and irritated nerves. Patients are told they may get weeks, months or even a year of relief.
The injections created a demand for steroids, including methylprednisolone acetate, the drug that New England Compounding was making.
To be sure, many compounding pharmacies perform well, producing formulations of drugs for specialized needs. Compounders have also provided hospitals and doctors with cheaper alternatives to F.D.A.-approved drugs.
For example, they are providing a far cheaper alternative to a drug called Makena, a new brand name version of an old drug used to reduce the risk of premature births. Once the drug got F.D.A. approval, the manufacturer of Makena began charging about a hundred times more for the drug than compounders. Officials from the F.D.A. wanted to ban the pharmacy-made versions on the grounds that Makena had met the agency's rigorous safety standards, but senior Obama administration officials, concerned about Makena's much higher price, stepped in to halt the ban.
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 F.D.A. about manufacturing quality problems.
The other manufacturer, Sandoz, stopped selling the product in the United States this year, according to the company, which would not provide a reason. Sandoz has also been reprimanded by the F.D.A. for manufacturing problems.
While the F.D.A. 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.
Jess Bidgood and Sheelagh McNeill contributed reporting.
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