AUTISM: Promising Drug Has No Effect, New Study Reports
The drug secretin, which has brought hope to thousands of parents of autistic children, "showed no benefits for children with the mysterious disorder," according to an NIH study published in today's New England Journal of Medicine (Maugh, Los Angeles Times, 12/9). After injecting 28 autistic children ages 3 to 14 with a synthetic human secretin and another 28 with a placebo comprised of saltwater, researchers at the NIH's Institute of Child Health and Human Development conducted a range of behavioral tests at the one day, one week and four week marks. The two groups showed no statistical differences in improvement, with a third of both the treatment and placebo children displaying progress "on some of the same measures," the New York Times reports. Study leader Dr. Adrian Sandler, of the Center for Child Development at North Carolina's Thomas Rehabilitation Hospital, attributed the similar improvements to the "significant placebo effect," noting, "Parents are extremely invested in the possibility of new treatments and have high expectancies. They are looking for subtle improvements. Kids with autism show variability in their day-to-day behavior and it would be easy to attribute normal variations to the secretin," he said. NICHHD Director Duane Alexander added that the findings "strongly suggest that secretin should not be recommended to treat autism until the results of other ongoing studies are known." Several other studies are underway, but "early indications are that their results are the same as ours," University of North Carolina psychologist James Bodfish, one of the report's leaders, said (Los Angeles Times, 12/9). A smaller University of Chicago study involving 20 autistic children revealed similar findings in October (AP/Worcester Telegram & Gazette, 12/9).
Keeping the Faith
But defenders of the drug's powers on autism denounced the study. Pointing out that 70% of parents involved in the trial asked that their children continue to receive the drug despite the researchers' conclusions, Dr. Bernard Rimland of the Autism Research Institute said that the findings remain "suspect" since researchers "used psychological examinations that are designed for diagnosing autism but are not really appropriate for assessing the effects of therapy." He added that "there are at least 13 or 14 other studies of secretin in the pipeline that I know of. This is just the first half of the first inning" (Los Angeles Times, 12/9). Walter Herlihy, who heads secretin's maker, Repligen, and has an autistic daughter, agreed, arguing that the trial relied on only one dose of the drug and four weeks observation. "What they did is analogous to measuring behavioral changes in an Alzheimer's patient with one dose of a drug. We have always said a single dose does not produce significant results," he said (Rosenberg, Boston Globe, 12/9). Victoria Beck's autistic son was given the drug to treat gastrointestinal disorders, and she says he showed a drastic improvement in his autistic symptoms, sleeping through the night and speaking some words. A published report on the case by her son's physician and a subsequent "Dateline" report brought the drug's potential national attention, sending thousands of parents scrambling to get the hormone (Los Angeles Times, 12/9). "No one has ever claimed that secretin is a miracle cure for autism," she said, noting, "It really bothers me that parents are portrayed as this desperate group of people with vacant minds. They claim we can't tell the difference between an improvement and a mirage. But when a child stops vomiting, sleeps through the night and makes eye contact, we know something is happening" (New York Times, 12/9).