In the past two decades, pain control has become a growth industry, bolstered by the worn-out knees and aching backs of baby boomers.
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, 78 died in September, 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, more than 60 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.
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None of the vials were sent to Washington state.
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 in Nashville, Tenn. “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.”
Richard Jenkins, 81, also was treated at the Saint Thomas clinic. He is among the hundreds, maybe thousands, waiting to find out if he has been infected.
“Sure I’m apprehensive, but there’s not a thing I can do except wait and see what happens,” said Jenkins, who received his most recent pain shot Sept. 11. It could be weeks before any of the patients are in the clear.
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 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 growing demand
In 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 — soared. 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, said 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.
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.
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, (hospital) pharmacies are turning to external compounding companies to help them,” said Cynthia Reilly, of the American Society of Health-System Pharmacists.
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.
PainCare paid New England Compounding $25 for a vial containing five 80-milligram doses, he said. A similar vial of the Depo-Medrol by Pfizer, with the alcohol preservative, costs about $40 to $46, according to the website of Clint Pharmaceuticals, a distributor.
About 186 of PainCare’s patients were injected with the suspect product. About two dozen have had symptoms that could indicate meningitis and have come in for spinal taps. The lab results are not back.
Some physicians who work in big hospitals may not even know whether the drug they use is from a compounder.
Anders Cohen, the chief of neurosurgery and spine surgery at New York’s Brooklyn Hospital Center, said: “We ask for the medication, it’s in stock, we use it. I don’t know if it’s coming from A, B or C. This is kind of a wake-up call about where your stuff is coming from.”
Because of the outbreak, Cohen has stopped performing spinal injections, and he was planning to declare a moratorium on them at his hospital until he was certain all the medicine was clean, even though his hospital is not on the list of facilities that received the potentially contaminated drug.
Meningitis can be caused by viruses, bacteria or fungi. Doctors say the fungal type is the hardest to treat and devastating to patients because it can cause strokes. And some of the patients in the current outbreak have had strokes.
Federal inspectors last week removed samples of the suspect drug from New England Compounding to test for fungal contamination. The center, which takes in about $2.2 million a year, according to the company’s corporate filings, is housed in a two-story brick building.
The company’s offices in suburban Boston were locked on Friday, with a “no soliciting” sign on the door. The company did not respond to repeated requests for comment.
Before it went offline, the company’s website said New England Compounding was licensed in all 50 states. State and federal officials said it had shipped out a prodigious amount of the potentially contaminated medicine to 75 pain clinics in 23 states.
Material from The Associated Press is included in this report.