The Atlanta Journal-Constitution
Patients turn to risky treatment for back pain
After doctors cut their opioids, many turn to injection.
An injectable drug that the manufacturer says is too dangerous to use along the spine is growing in popularity for back pain as doctors turn away from opioids.
The anti-inflammatory drug, called Depo-Medrol and made by Pfizer, is approved for injection into muscles and joints. Once a drug is approved, however, doctors may legally prescribe it however they see fit. And doctors have long given Depo-Medrol shots, or the generic equivalent, close to the spinal cord for painful backs, necks and conditions like spinal stenosis.
What few doctors or patients know is that Pfizer, faced with hundreds of complaints about injuries and complications related to the shots, asked the Food and Drug Administration to ban that type of treatment five years ago. The company cited the risk of blindness, stroke, paralysis and death in the request, which neither the agency nor Pfizer made public.
The FDA declined to issue a ban but toughened the label warning. Other countries — among them Australia, Brazil, Canada, France, Italy, New Zealand and Switzerland — heeded Pfizer’s request.
After concerns were raised about the off-label treatments, use of the injections declined. But the opioid epidemic appears to be spurring their popularity despite risks known to public health officials and doctors.
According to the FDA, back problems are the most common cause of disabling, chronic pain. Weekend classes to train physicians in the procedure are flourishing. Critics like Dr. Terri A. Lewis, a rehabilitation specialist and lecturer at the Southern Illinois University, say they are responsible for transforming pain clinics into “drill mills.”
And in June, as part of legislation to tackle the opioid crisis, the House of Representatives approved an increase in Medicare reimbursement for the procedure.
The number of Medicare providers giving steroid injections along the spine, including Depo-Medrol and other drugs, had increased 13 percent in 2016 from 2012. The number of Medicare beneficiaries receiving these injections is up 7.5 percent. The Department of Veterans Affairs reported a 17 percent increase in the injections from 2015 to 2017.
And total sales of brand name and generic Depo-Medrol grew 35 percent to $185 million from $133 million from 2015 to 2017, according to the IQVIA Institute for Human Data Science, a health data firm.
It’s a troubling trend to antiopioid crusaders like Dr. Andrew Kolodny, co-director of opioid policy research at Brandeis University.
“The victims of our era of aggressive opioid prescribing are being exploited in some cases by interventional pain doctors, who will continue them on opioids in exchange for allowing them to perform expensive procedures that they don’t need,” Kolodny said. “These are not benign procedures. Patients can be harmed and are harmed.”
Now, interviews with dozens of pain specialists show that pressure to wean patients off opioids is prompting many doctors to refer patients to pain intervention specialists who promote the shots. The cost per shot varies widely, from $100 up to $800, with an additional fee going to the hospital or clinic where it is administered.
“The truth underlying it is that doing an injection is faster and results in higher reimbursements, compared to other ways of managing the same pain,” said Dr. James P. Rathmell, chairman of anesthesiology, perioperative and pain medicine at Brigham and Women’s Hospital. It was Rathmell who first brought the issue to the FDA and oversaw a panel charged with recommending guidelines on safety.
“The use of injections has increased dramatically, yet the prevalence of back pain has remained relatively unchanged,” Rathmell said.
A review of FDA records show that there were 2,442 serious problems reported from Depo-Medrol injections from 2004 through March 2018, including reports of 154 deaths. Pfizer declined to comment on the deaths, pointing to the product’s warning label: “Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.”
In West Virginia, the heart of the opioid epidemic, anesthesiologist Dr. Brian Yee said more general practice physicians are referring patients to his clinic for epidural steroid injections and other procedures, like spinal cord stimulation, than in past years.
Yee believes spinal injections are valuable if administered properly. But he worries that weekend classes aren’t sufficient training.
“With people trying to take away opioids now, we are opening up another doorway for people to overutilize other options that can be helpful with the right doctors and the right patients,” he said.
Carrie Flaten thinks she was one of the wrong patients. A selfdescribed Montana cowgirl, Flaten badly injured her back and shoulder in a car accident at age 28 in 2007. Months later, she was still in terrible pain and began physical therapy, along with a series of epidural steroid injections.
At first the shots made her feel better. But the relief never lasted, and she ended up having so many Depo-Medrol and other injections over the years that a nurse started calling her “our pincushion.”
Her last shot, in late 2015, left Flaten in what she described as frequent excruciating pain, with difficulty walking, little bladder control and loss of sexual function. Flaten said she could not return to her job as a mechanic, and still has trouble keeping up with her children.
Flaten said her clinic has refused to give her any painkillers unless she resumes the injections — something she does not want to do. Had someone told her that Pfizer sought a ban on using the shots this way, “I would have said absolutely no,” Flaten said.
Sherry Brandt did say no, and claims that refusal led her pain clinic to dismiss her as a noncompliant patient. The 56-year-old Tennessee resident had suffered back pain for years, and received several epidural steroid injections that did not seem to harm her. But she said they did not help, either.
Physical therapy and opioid painkillers left her stable, but she still had difficulty standing or walking — which worsened after a back surgery several years ago. She said she became more reliant on painkillers until her doctor, nervous about continuing to prescribe them in the current climate, referred her to a local pain specialist. The clinic staff suggested more shots, but by then Brandt had discovered their risks and declined. Then she got hit by a truck. Brandt went to another pain clinic, where doctors also told her they would only prescribe painkillers if she agreed to an epidural steroid injection, she said. Again she declined, fearing it could worsen her condition. “It’s blackmail,” she said.
The clinics that Flaten and Brandt visited declined to comment.
Pfizer said it cannot track how much Depo-Medrol is used for off-label shots. Company spokesman Thomas Biegi said without an FDA ban, there was nothing Pfizer could do to stop the off-label shots.
“We believe this is a question of medical practice and defer to clinicians and pain experts who utilize these medicines in their practices for the treatment of pain conditions,” Biegi said.