Duane Marsteller, The Tennessean
October 6. 2012 - NASHVILLE -- As authorities continue to focus on a potentially contaminated steroid as the source of a widening outbreak of fungal meningitis, some patient-safety advocates are calling for greater restrictions on the type of injection involved.
They say epidural steroid injections, like the ones given to the meningitis victims, are far too dangerous and should be limited or even banned. But those who give the injections say they are safe when done properly and note the current outbreak appears to have originated from the medicine, not the procedure itself.
The debate was being waged long before the meningitis outbreak began with the Sept. 17 death of a 78-year-old man in Nashville. Since then, at least 46 other people in Tennessee and six more states have come down with the rare and noncontagious infection, federal health officials said Friday. Five, including three in Tennessee, have died.
All received spinal injections of a steroid solution prepared by New England Compounding Center, a compounding pharmacy in Framingham, Mass. The pharmacy has voluntarily ceased operations and recalled the steroid, which health officials suspect was contaminated with one or more fungi. Almost 17,700 vials were shipped to about 75 facilities in 23 states as far away as California.
As a precautionary measure, the pharmacy also has recalled nearly a dozen other medications it produced that have not been linked to the outbreak.
John Dreyzehner, Tennessee's commissioner of health, said investigators have found no indication that the three Tennessee clinics that administered the steroid injections did anything to cause the outbreak.
"Evidence indicates this is a product issue, and we emphasize that," he said, repeating the first part twice for effect.
But some critics say the steroid solution shouldn't have been injected in the first place, saying the procedure's risks far outweigh any medical benefits. They say the outbreak is just the latest example of how dangerous the injections really are.
"I hate that this happened, but it was inevitable," said Terri Lewis, a psychological rehabilitation specialist from Cookeville, Tenn. "This procedure is not safe."
Lewis said her 29-year-old son was injured by epidural steroid shots unrelated to the menigitis outbreak. She claims the shots caused him to develop arachnoiditis, an incurable condition in which scar tissue slowly builds in the spinal column, compressing nerves that lead to debilitating pain and, ultimately, death.
She said more people like her son are being hurt as the number of injections grows.
The number of Medicare patients receiving such injections grew by 159 percent between 2000 and 2010, according to a recent study by Dr. Laxmaiah Manchikanti, chairman of the American Society of Interventional Pain Physicians.
Manchikanti, who operates pain-management clinics in Paducah, Ky., and Marion, Ill., estimated 8.9 million such injections were given in 2010. He did not return calls seeking comment.
Such widespread use with relatively few reported cases of adverse side effects, plus coverage by Medicare, Medicaid and other major insurers, are evidence in support of the procedure's safety, an industry official said.
"The risk of complications from these epidural injections is very small," said Dr. Ray Baker of Kirkland, Wash., president of the International Spine Intervention Society, which has about 3,000 members. "We're not talking about a very risky procedure. We're talking about a very safe procedure that has been performed for a very long time."
While there are no definitive figures available, he estimated that serious complications occur in only one of every 100,000 injections.
Yet critics contend the growth in epidural steroid injections is based more on money than on medical need.
"It does make a lot of easy money for pain clinics," Lewis said.
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. 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.
Physicians' groups say they don't view the injections as a money-maker but as a proven, effective way to relieve their patients' back pain and suffering. But Baker acknowledged that often the drugs injected are not approved for epidural use.
Some have been approved for injection elsewhere on the body but are being used "off-label" -- or in a way that is not specifically approved -- for epidural injection. Others were compounded, or created by combining, mixing and/or altering active ingredients to make custom medications, a process that is not regulated by the U.S. Food and Drug Administration.
But the growing numbers of reported complications from the injections prompted the agency to launch a review panel last year.
The FDA review is focusing on the transforaminal approach, in which steroids are injected into the foramin, a small area just outside the spinal canal where nerve roots exit. This method brings needles within millimeters of crucial spinal arteries.
The review is limited to FDA-approved epidural steroid injections, which does not include those implicated in the fungal meningitis outbreak, FDA spokeswoman Erica V. Jefferson said.
"These compounded steroid injections (methylprednisolone acetate) being investigated as part of the outbreak were NOT approved by the agency," Jefferson said in an email. "Compounded products are not reviewed by FDA for safety, efficacy, and quality prior to marketing."
Patient advocates such as Matthew Clark say more needs to be done.
Clark, of Rogersville, Tenn., received several epidural steroid injections when he lived in Michigan. He stopped after one shot resulted in his sphincter muscle relaxing, causing his intestine to temporarily protrude from his anus.
He now has arachnoiditis, which he blames on the shots.
"It's like having the pain of cancer without the relief of death," he said. "Those shots should be banned."