Patients turn to risky treatment
After doctors cut their opioids, many turn to injection for back pain.
An injectable WASHINGTON — 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