After Doctors Cut Their Opioids,

After Doctors Cut Their Opioids, Patients address a Risky Treatment for Back Pain

WASHINGTON — An injectable drug that the manufacturer says is just too dangerous to use along the spine is growing in popularity for back pain as doctors shy away from opioids.

The anti-inflammatory, 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, on the brink of the medulla spinalis for painful backs, necks, and conditions like spinal stenosis.

What few doctors or patients know is that Pfizer, faced with many complaints about injuries and complications associated with the shots, asked the Food and Drug Administration to ban that sort of treatment five years ago.

The corporate cited the danger of blindness, stroke, paralysis, and death — an invitation that neither the agency nor Pfizer made public.

The F.D.A. 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, the 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 F.D.A., back problems are the foremost common explanation for disabling, chronic pain.

Weekend classes to coach physicians within the procedure are flourishing.

Critics like Dr. Terri A. Lewis, a rehabilitation specialist, and lecturer at Southern Illinois University, say they're liable for transforming pain clinics into “drill mills.”

And in June, as a part of legislation to tackle the opioid crisis, the House of Representatives approved a rise 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 by 13 percent in 2016 from 2012.

The amount of Medicare beneficiaries receiving these injections is up 7.5 percent.

The Department of Veterans Affairs reported a 17 percent increase within the injections from 2015 to 2017.

And total sales of brand name name and generic Depo-Medrol grew 35 percent to $185 million from $133 million from 2015 to 2017, consistent with the IQVIA Institute for Human Data Science, a health data firm.

It’s a troubling trend to researchers and experts 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,” said Dr. Kolodny, who is additionally executive of Physicians for Responsible Opioid Prescribing.

“These aren't benign procedures. Patients are often harmed and are harmed.”

Pfizer, in 2013, quietly asked the F.D.A. and regulators in other countries to ban Depo-Medrol for epidural use.

“It must not be employed by the intrathecal, epidural, intravenous, or the other unspecified routes,” the corporate wrote.

It is unusual for a pharmaceutical company to request a contraindication for one among its own products.

During this case, some doctors say Pfizer was worried about liability from off-label use, which doesn't provide a manufacturer an equivalent degree of protection as approved uses.

When the F.D.A. authorized a stronger warning in 2014, it noted that giving steroid shots on the brink of the spine could cause rare but catastrophic injuries or death.

The warning applied to the whole class of epidural steroid injections, estimated at about nine million a year — and to not be confused with the pain blocks, often called epidurals, given to women during childbirth.

Now, interviews with dozens of pain specialists show that the pressure to wean patients off opioids is prompting many doctors to refer patients to pain intervention specialists who promote the shots.

The values per shot varies widely, from $100 up to $800, with a further fee getting to the hospital or clinic where it's administered.

“The truth underlying it's that doing an injection is quicker and leads to higher reimbursements, compared to other ways of managing an equivalent pain,” said Dr. James P. Rathmell, chairman of anesthesiology, perioperative and pain medicine at Brigham and Women’s Hospital.

It was Dr. Rathmell who first brought the difficulty to the F.D.A. 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,” Dr. Rathmell said.

Doctors can choose among several sorts of epidural steroid injections. Depo-Medrol features a major share of the market.

Epidural steroid injections within the cervical (neck) area and midback are considered the foremost dangerous.

They work like this: A steroid is injected into the epidural space within the vertebral canal.

Most of the injuries occur if the needle misses its target and directly injures nerves or places the drug into the cerebrospinal fluid or arteries, depriving the medulla spinalis of blood.

A review of F.D.A. records show that there have been 2,442 serious problems reported from Depo-Medrol injections from 2004 through March 2018, including reports of 154 deaths.

Pfizer declined to discuss the deaths, pointing to the product’s warning label: “Serious neurologic events, some leading to death, are reported with the injection of corticosteroids.

Specific events reported include, but aren't limited to, medulla spinalis infarction, paraplegia, quadriplegia, cortical blindness, and stroke.”

In West Virginia, the guts 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 medulla spinalis stimulation, than in past years.

Dr. Yee believes spinal injections are valuable if administered properly.

But he worries that weekend classes aren’t sufficient training.

“With people trying to require away opioids now, we are opening up another doorway for people to overutilize other options which will be helpful with the proper doctors and therefore the right patients,” he said.