The discovery that a potentially tainted drug is linked to 119 cases of meningitis nationwide has fueled debate among doctors about widespread use of the back-pain treatment, which has little proven longterm benefit.
Use of the medication, a steroid injected near the spine to quell inflammation, has increased in part because of the demands of an aging population and the relatively few risks associated with the injections when compared with surgery and other treatments, which also carry no guarantee of success.
Patients and doctors often saw a so-called lumbar injection as a safe alternative, until the outbreak of fungal meningitis cases tentatively linked to the injectable steroid supplied by a compounding pharmacy in Framingham.
“What one can say from 10,000 feet is that these are one of the most overused procedures in the United States,” said Dr. Steven J. Atlas, a primary care internist and director of Primary Care Research & Quality Improvement Network at Massachusetts General Hospital. “I think it reflects the fact that treatments for low back pain and low back pain conditions often don’t provide the relief that patients are wanting or looking for, and they in desperation or hope look to procedures that may offer them the magic cure.”
A 2007 study in the medical journal Spine found that there was a greater than 200 percent increase in steroid injections administered for back pain in two different ways between 1994 and 2001. It concluded that fewer than half were performed for medical problems for which there was the strongest evidence they worked.
The steroid drug, methylprednisolone acetate, is not approved by the US Food and Drug Adminstration for use in epidural injections for back pain, but physicians are allowed to use drugs “off-label” for unapproved uses.
Critics of the injections say that patients overestimate the benefit they will receive from a treatment, and the injections are often used to treat ailments other than those most likely to respond to the steroid treatment. But proponents say that subgroups of patients can benefit from the injections.
Dr. Ray Baker, president of the International Spine Intervention Society, said word of mouth, not just the aging population, has probably helped drive the increase in injections. His analysis of Medicare data found almost 2.5 million injections in that patient population in 2011, and he estimated that they probably make up about half of injections administered last year in the United States.
“The vast majority of practitioners are trying to very conscientiously use these injections on their patients to increase their activities and functions,” Baker said. “We have a pretty expectant population; we have a population of baby boomers that are not aging in a wheelchair or in a rocking chair. These are people that are playing tennis and golf and running into their 80s.”
The Cochrane Review, an organization that analyzes the strength of medical evidence, published a review in 2010 of 18 randomized trials. Just two of the studies were deemed to show benefits greater than possible harm. The review concluded that there was not strong evidence for or against the use of the treatments. The review added it could not rule out the possibility some groups of patients would benefit.
“I would say that there does seem to be consensus that at least in well-selected patients with . . . spinal pain that involves nerve dysfunction or nerve root dysfunction, that they at least provide some benefit and the controversy revolves about how much benefit and the duration of benefit,” said Dr. Steven P. Cohen, a professor of anesthesiology at Johns Hopkins School of Medicine.
For patients, the matter can be more clear-cut. Josephine Kendall, an 80-year-old from Methuen, said her lower back pain had gotten so bad that she could only lie down. She has to go to dialysis three days a week, and tasks as simple as bringing home groceries had become unbearable.
Two and a half years ago, she began receiving injections at New England Baptist Hospital, which she said transformed her life, for three months at a time.
When she heard the news about the possibly tainted drugs, Kendall asked her physician whether she was receiving injections supplied by the same company. She was not, and she said it has not changed her mind at all about whether to continue receiving injections.
“I can’t exist without them; let’s put it that way,” she said.
Physicians said they had been inundated with calls from patients wondering if they had received the drug from New England Compounding Center. Some said that patients who were eligible for an injection were forgoing the procedure now.
Dr. Carol Hartigan, a physiatrist at the spine center at New England Baptist, said Tuesday that more than one patient she had seen who was a candidate for an injection has declined to receive it for now.
She noted that while anecdotally, individual patients can report dramatic improvement, it is crucial to evaluate the effectiveness of an injection and that she looks for at least a 50 percent improvement that lasts three months.
“Clinicians and patients can really exaggerate the response out of hope, Hartigan said. “So many people we see come in with this list and litany of injections they’ve had,” and they still aren’t fixed, she said. “We want the quick fix sometimes.”