EPIDURAL INJECTION–PLACING STEROID IN THE SPINAL CANAL
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Use of epidural steroid injections questioned after meningitis outbreak
, Oct 9, 2012 |
BY Duane Marsteller
Dr. Pinna says…
I am personally acquainted with these “epidural injections” since I had one.
As the procedure was being done, I told myself: “You’re an idiot!”
Because the procedure is worthless to the patient, and its raison d’etre is to
put money in the pocket of the specialist doing the procedure.
What happens in the procedure?
A specialist (sometimes a GP) puts a needle into the spinal canal and threads
a catheter to that area where he believes the pain is originating.
Then he deposits a steroid which has an average life span of two weeks!
In my case nothing! In most studies physicians have found no specific
benefits. Results are up to chance. 50/50! Complications are many.
Yet patients want relief from pain and do not want surgery.
Thus, this half-way measure.
The usual medical explanation: “If this doesn’t work, we’re going to have to do surgery.”
In the meantime insurance company pays doctors and hospital bills.
In my case I opted for No Surgery and No More Epidurals!
Since that time I have always advised against both—with rare exceptions for surgery
when neurological function was being lost.
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.
As of Sunday, the number of people sickened had risen to at least 91 patients in nine states, with seven deaths, health officials said. Potentially hundreds more could be affected.
They say epidural steroid injections, such as 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 outbreak began with the Sept. 17 death of a 78-year-old man in Nashville. Tennessee, Virginia, Maryland, Florida, North Carolina and Indiana had previously reported cases. Now Michigan, Minnesota and Ohio have joined the list.
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.
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
“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.
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.
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.
“These compounded steroid injections (methylprednisolone acetate) being investigated as part of the outbreak were NOT approved by the agency,” FDA spokeswoman Erica V. Jefferson said in an email. “Compounded products are not reviewed by FDA for safety, efficacy and quality prior to marketing