Sunday, November 18, 2012

Steroids and Back Pain - An Uneasy Match -

RANDALL KINNAIRD'S legal clients had steroids injected into their backs last summer for a wide range of reasons. Of the 25, one got three shots in a two-month period when pain never totally disappeared. Another got one as a preventive measure because she was going on a trip to Europe and was worried that cobblestones would aggravate an old injury.

Now the 25 — or their survivors — have engaged Mr. Kinnaird, one of Nashville's leading lawyers, to sue the New England Compounding Center. Three have died, one is paralyzed, several more are still hospitalized and all suffer blinding headaches — victims of themeningitis that resulted from vials of steroid medicine contaminated by fungus.

The New England Compounding Center certainly seems deserving of its current status as the prime culprit in a tragic outbreak that has killed 32 and sickened 438. The bottles of supposedly sterile steroid medication it shipped were reportedly so tainted that white fuzz could be seen floating in some vials.

But, experts say, the now notorious Compounding Center has a nationwide network of unwitting enablers and accomplices: There are the doctors who overprescribe an invasive back-pain therapy that, in studies, has not proved useful for many of the patients who get it. And there are the patients, living in an increasingly medicalized society, who want a quick fix for life's aches and pains.

The use of steroid injections to treat back pain has skyrocketed in the past 15 years — out of proportion to growth in the number of patients with back pain, or the aging of the population. The frequency of steroid injections dispensed to Medicare patients rose 121 percent from 1997 to 2006. Washington State found that the use of back injections grew 12.6 percent between 2006 and 2009, at a cost to the state of $56 million. Some people received more than 10 shots a year.

The increase in treatment has not led to less pain over all, researchers say, and is a huge expense at a time of runaway health costs. "There are lots of places doing lots of injections for conditions that haven't been shown to benefit," says Dr. Janna Friedly, a researcher at the University of Washington, who added, "Sadly, some of the patients who got meningitis were probably in that category — they did not have conditions where steroid injections were indicated."

Studies are at best inconclusive about exactly which groups of back-pain patients are likely to benefit from steroid shots. Though some patients clearly get much-needed relief, health researchers are nearly unanimous that the treatment is vastly overused in the United States.

But Dr. Laxmaiah Manchikanti, head of the American Society of Interventional Pain Physicians, said the increasing number of spine injections was just part of "an exponential increase in all interventional techniques" and is a good thing, reflecting a better understanding of chronic pain and patients' demands for improved pain relief.

Though doctors are still arguing, most academic researchers say there is no evidence that steroid injections are useful in easing straightforward chronic low back pain. Professional guidelines say such shots should generally not be used for back pain that is less than four to six weeks old, which studies show almost always gets better with noninvasive treatments. Although many Medicare patients get spinal injections to treat a condition called spinal stenosis, a narrowing of spaces between bones of the spine, Dr. Friedly said, shots are not used for that condition in many European countries.

Spinal injections, which can cost between $600 and $2,500, including the fees for treatment rooms, have been fostered and promoted by the rising number of pain clinics and pain specialists — mostly anesthesiologists and rehab doctors — who invest in extra training to learn procedures like spinal injections.

"There used to be only a small number of people who did this, but that's gone way up, and reimbursement has gone up, too," says Scott Forseen, a doctor who studies the treatment of back pain at the Georgia Health Sciences University. The number of spinal injections given in any geographical area correlates better with the number of local specialists trained in the procedure rather than the amount of back pain, Dr. Friedly says. There is an old saying in medicine: "When you go to Midas, you get a muffler."

The shots — which may include a steroid and an anesthetic — are often dispensed at for-profit pain clinics owned by the physicians holding the needle. "There's a lot of concern about perverse financial incentive," Dr. Friedly added.

Mr. Kinnaird's clients got their injections at the St. Thomas Outpatient NeurosurgeryClinic, a limited-liability corporation half owned by doctors, which occupied a floor of one of Nashville's major hospitals. It gave 5,000 injections a year, or about 20 each business day, and epidural steroid injections are listed on its Web site as its "top procedure."

Since guidelines for injections are being disputed among doctors' groups, it is hard in most cases to say if a particular patient should or should not have been offered an injection, says Marc Lipton, a Michigan attorney who is representing more that 20 patients with fungal meningitis. Though he believes that steroid shots are overused, he says many of the patients he represents were treated appropriately, for example, receiving an injection for pain from a herniated disc in an attempt to stave off back surgery. He and other lawyers are, for now, targeting the Compounding Center in product liability lawsuits.

But, says Dr. Forseen: "You have to use injections selectively, and selectivity has gone way down. In some places, people get injections because they've walked in the door."

Patients have proved eager consumers of the new medical offering, desirous of a quick cure rather than waiting the weeks or months for the normal healing process to occur.

Mr. Kinnaird, the lawyer, says: "If I hurt my back in the '70s, my doctor would say, go to the beach, get a few beers, relax, you'll be fine. Now if you hurt your back, you go to the doctor and right away there's an M.R.I., and they need to fix something. Maybe you should take an injection."

And steroid shots are not a cure-all, even for the conditions for which doctors agree an attempt is worthwhile: low back pain accompanied by signs of nerve injury like tingling or weakness in a leg. One-third of such patients will get better, one-third will show some improvement and some will show no improvement at all, Dr. Forseen said.

When Oregon's Health Evidence Review Commission earlier this year explored narrowing reimbursement for injections to certain conditions, it got an earful of public comment from groups like the International Spine Intervention Society.

"Obviously they are not utilizing the literature correctly," said Dr. Manchikanti, adding that attempts to limit the shots were motivated in part by an effort to control costs and by competition from other medical specialties.

Private insurers vary considerably in coverage for the procedure, though some will pay after two weeks of back pain.

Back pain is, of course, a debilitating condition. And modern medicine has produced some miraculous cures. But from now on when doctors and patients are tempted to say "what's the harm in trying an injection" to dispense with a nagging back — they will be more aware of just how big the risk can be.