An experimental drug given to paralyzed patients within 72 hours of their injury appears to help many regain the use of their legs and arms, bringing renewed hope to people who previously had little.
A 34-patient study, conducted at the Maryland Shock Trauma Center, produced such encouraging results that the chief investigator, Dr. Fred H. Geisler, spoke yesterday of a new era in which paralysis can be considered a treatable rather than an incurable disease.
Standing next to two men who recovered the ability to walk after auto accidents left them paralyzed from the neck down, Dr. Geisler said at a news briefing that the study was too small to prove conclusively that the drug works.
He said a much larger study involving a few hundred patients is needed before anyone can declare the drug, GM-1 ganglioside, an unqualified success. Such a study is in the planning stages and will involve several medical centers, he said.
But the drug is the second in about a year to signal new hope for the 9,000 people who survive paralyzing injuries each year. Researchers at Yale University announced last June that patients receiving massive doses of a steroid, methylprednisolone, within eight hours of their injury made significantly greater recoveries than those who did not get it.
"Now, two have been shown to be effective in improving neurologic outcome," said Dr. Geisler, now in private practice with the Columbia-Free State Medical Plan. "We now have to consider that spinal cord injury has changed from an incurable to a treatable disease."
Dr. Geisler and other leading experts said it is impossible to say which drug is more promising before further studies are done. But experts agreed that the biggest hope is that the two drugs given together or in sequence might produce more impressive recoveries than does either by itself.
Not all the patients in the Shock Trauma study improved. Past experience shows that about 4.4 percent of patients with severe paralysis recover significantly -- but GM-1 appeared to bring about recoveries far more frequently than that.
Seven of 16 patients -- or 44 percent -- who received the experimental drug regained significant use of their arms and legs, compared with one of 18 -- or 5 percent -- of the patients given a placebo, an inactive substance.
Results of the treatments, given in 1986 and 1987, appear in today's New England Journal of Medicine.
In the study, Dr. Geisler defined success as the leapfrogging of two grades on a five-point scale that ranges from complete helplessness to normal functioning. All patients involved in the study were severely paralyzed. Many could not move or feel any part of the body below the point of their spinal injury; others lacked the ability to move, but had some sensation below the injury.
"It meant the difference between being in bed or a wheelchair and walking," he said. The patients who improved also regained bowel and bladder control and the ability to dress and groom themselves.
Why GM-1 works is not known, but it appears either to improve the functioning of the small number of nerve cells that survive an injury -- or keep a critical number of damaged cells from being lost permanently.
Harry McDaniel, 51, was a roofer -- climbing church and courthouse steeples on occasion -- before a 1987 auto accident left him unable to move any part of his body: "I couldn't move my fingers or toes. I couldn't move my head but I could talk. Talking was it."
Now, he drives a car and walks gingerly with the aid of forearm crutches, although he uses a wheelchair to cover a lot of ground.
Another man, 28-year-old John Breeding, was equally disabled when his pickup truck flipped over in 1987 and fractured two vertebrae in his neck. Following GM-1 treatments, he regained feeling and function to the point where he can now walk -- albeit with some difficulty -- with a brace on one leg.
"Cured would mean you're returning to normal," Dr. Geisler said. "That might be too much to hope for with any neurologic disease."
Dr. Wise Young, a New York University neurologist who took part in the methylprednisolone study, said a treatment combining the two drugs appears promising because each drug seems to work differently.
Methylprednisolone, for example, is effective when given within eight hours of a spinal injury, while GM-1 appears to work when given 48 to 72 hours later.