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Effectiveness of procedure behind meningitis outbreak called into question

Despite the lack of solid effectiveness evidence, spinal injections for back pain — a procedure known as lumbar epidural steroid injections — have become quite common.

The growing outbreak of fungal meningitis cases due to a contaminated steroid drug has once again raised questions not just about the safety of using spinal injections to control back pain, but also about the effectiveness of the procedure itself.

As of Sunday, 91 people, including three in Minnesota, had developed meningitis from tainted batches of a drug called methylprednisolone acetate, according to the Centers for Disease Control and Prevention. Seven of those people (none in Minnesota) have died.

Yet, as the New York Times pointed out in an article published Saturday, there is no strong medical evidence that the procedure undergone by these patients works — a conclusion reinforced last year by a team of independent medical experts for the Cochrane Collaboration.

“Patients exposed to the drug in the current outbreak may have risked their health or even their lives for an elusive goal,” write Times reporters Denise Grady, Andrew Pollack and Sabrina Tavernise.

A skyrocketing increase

Despite the lack of solid effectiveness evidence, spinal injections for back pain — a procedure known as lumbar epidural steroid injections — has become quite common. Some 8.9 million injections were given in 2010, reports Duane Marsteller in the Tennessean. That was 159 percent more injections than in 2000.

Many of those injections were unnecessary, even under current guidelines.

“Medicare and Medicaid guidelines call for paying between $200 and $600 per injection, depending on whether it is given in a doctor’s office, an outpatient facility or a hospital,” writes Marsteller. “The Centers for Medicare and Medicaid Services said it paid providers $106.4 million for 252,288 injections last year, an average of $421.74 each. Yet a 2010 audit by the U.S. Department of Health and Human Services’ inspector general found a third of the 433 injections from 2007 it studied didn’t meet Medicare requirements. They either were not medically necessary or had insufficient documentation about the need for the shot, the audit said.”

As Marsteller points out, lumbar epidermal steroid injections are not without serious risks — ones that have nothing to do with the drugs becoming contaminated during production. In rare cases, for example, the injections can cause arachnoiditis, an incurable and extremely painful condition in which scar tissue forms in the spinal column, binding the nerves together.

The Food and Drug Administration (FDA) is currently reviewing the safety of epidural steroid injections. In June, a group of patient advocates wrote to FDA officials to ask them to consider “the appalling toll” of arachnoiditis as a complication of the injections. They requested that the FDA improve its long-term reporting and tracking of the side effects of epidural steroid injections and require patient consent forms that clearly include arachnoiditis as a possible complication.

‘People should try other measures first’

The editors of Consumer Reports published an article in 2011 about the controversy surrounding steroid injections for lower-back pain. “Our analysis of the evidence, based on a recent report by the American Society of Health-System Pharmacists and several published reviews and treatment guidelines, suggests that while the shots might have limited value by providing short-term relief to some people, in most cases people should try other measures first,” they write.

They also offer a list of steps consumers can take that might make the procedure safer.

“The injection should be given in a sterile operating or procedure room where there is proper staff to assist the injector, equipment to monitor the patient during and after the procedure, safety measures for radiation if fluoroscopy is used, resuscitative equipment, and a staff that knows how to use it,” a medical expert states in the article.

Of course, that’s assuming that the drug itself has been produced in a rigorously safe environment — something that apparently didn’t happen in the recent tragic cases.

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