About eight in 10 Americans suffer from back pain at some point in their lives, and many try everything from bed rest to spinal surgery for relief--with mixed results. Millions are still hurting, and desperate for answers that doctors often can't provide.
Of the many therapies that are touted in newspaper and radio advertisements, perhaps the most visible in Southern California is a treatment program known as DiskCure. Ads for DiskCure promise a "breakthrough" drug treatment at a clinic known as the Institute for Neurological Research. "Freedom from pain. At last. Without surgery," says the clinic's Web site.
The clinic, operated by Dr. Edward Tobinick, a dermatologist and internist, is housed at 100 UCLA Medical Plaza, in the heart of one of the world's premier teaching hospitals. The clinic's Web site also asserts that the treatment, using "a new class of biotechnology medications," has brought relief to patients with various forms of back, neck or leg pain associated with disk disease.In an interview, Tobinick said his patients usually are given a single injection, applied under the skin. "It's a miracle cure, a magic bullet," he said.
Some other pain specialists are skeptical, however. Decades of research have failed to yield a single, all-purpose answer for back pain, they say, and doctors often don't even agree on what's causing the pain.
Tobinick said his clinic, with locations at UCLA and in Newport Beach, has treated about 1,500 people and that about two out of every three patients have had "a significant improvement in their symptoms." The clinic charges about $2,200 for a one-time treatment and consultation. Some patients may require more than one treatment, he said.
Kathleen McGarry, of Santa Maria, said she was "flat on her back for nine months with back and leg pain" and had gone from doctor to doctor before visiting Tobinick's clinic in October. "Within two minutes of the treatment, the pain was gone," said the 55-year-old administrative assistant, one of several former patients whose names were provided by Tobinick. "That was six months ago, and I'm back to work; I'm fine."
Tobinick is reluctant to discuss the DiskCure drug regimen in detail. He would not name the medications he uses, saying only that they are anti-inflammatory agents that moderate the body's immune response. The drugs are approved by the Food and Drug Administration, he said, but not specifically for treatment of back pain.
It's not unusual for doctors to prescribe a drug to treat a condition other than that approved by the FDA. For example, physicians experimented with injections of botulism toxin, or Botox, to smooth wrinkles, for years before the FDA finally approved the drug for that purpose last month.
Typically, doctors making use of an FDA-approved drug in a novel way share their findings, by presenting data at professional conferences or publishing their research in medical journals: This is how other doctors learn about and evaluate new uses for medications. Tobinick acknowledges that, so far, he has done neither. No studies of the drugs' effectiveness in treating back pain in humans have yet been made public, he said.
But Tobinick pointed to experiments in laboratory animals that have shown that the anti-inflammatory drugs he is using can be effective in treating disk injury. The studies were done in pigs and in rodents, he said, while declining to cite any specific studies.
Dr. James N. Weinstein, an orthopedic surgeon at Dartmouth University's Medical School and editor of the medical journal Spine, said he was aware of two such studies. In one, published in the April 15, 2001, issue of Spine, Swedish researchers reported that the drugs etanercept (whose trade name is Enbrel) and infliximab (Remicade) limited nerve damage and inflammation after disk injury in a group of pigs. In the other, Japanese doctors found that a similar anti-inflammatory drug limited disk damage in rats.
But, Weinstein noted, "studies in animals in no way suggest that the drugs are efficacious for all back problems. You would have to do clinical trials in humans to determine that."
Tobinick said he is organizing a human trial. The experiment, he said, will include 20 people with back and leg pain: Ten will receive an injection of the principal drug used in the DiskCure treatment and 10 will get a placebo injection, of saline solution.
Says Tobinick: "We are going to publish a big article in the New England Journal of Medicine, we hope."
The Trial Process
Dr. Eric Matteson, a rheumatologist at the Mayo Clinic in Rochester, Minn., who is studying anti-inflammatory drugs, said doctors who develop novel uses of a drug typically conduct initial pilot studies. "What you do first is develop a hypothesis, then a protocol for testing the drug," he said. "If you haven't formally studied novel uses, then you don't know that the treatment really works."