Meningitis outbreak highlights lack of oversight
10/07/2012 12:00 AM
10/06/2012 10:47 PM
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.
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 back surgery. The injections combine a steroid and a numbing drug in an effort to soothe inflamed 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 FDA-approved drugs.
For example, they provide a far cheaper alternative to Makena, a new brand-name version of an old drug used to reduce the risk of premature births. Once the drug got FDA approval, the manufacturer of Makena began charging about a hundred times more for the drug than compounders. Officials from the FDA wanted to ban the pharmacy-made versions on grounds that Makena had met the agency's rigorous safety standards, but senior officials in President Barack Obama's administration, concerned about Makena's much higher price, blocked 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 from New England Compounding now under suspicion. 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 factory after receiving a warning letter from the FDA about manufacturing quality problems.
The other manufacturer, Sandoz, said it stopped selling the product in the United States this year but would not provide a reason. Sandoz also has been reprimanded by the FDA for manufacturing problems.
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