COLUMBUS — Her daughter Kayla, now 12, began having violent outbursts at age 4 “and it just got worse and worse” as she grew older, Lisa Bettis recalled.
“She’d hit me, kick me, bite me,” she said. “One time I tried to hold her down and she called the police on me.”
At school, fights with other kids became a regular occurrence. In fourth grade, she lashed out at one boy who had taken her animal crackers and broke his nose and ribs and fractured his jaw.
Throughout the years, doctors prescribed a half-dozen different mood-stabilizing and anti-psychotic drugs for Kayla — the standard treatments for such behavior — but they had little effect, Bettis said.
Then last December, Columbus pediatrician Dr. Ed Cutler tried an unorthodox approach devised by Cedarville psychiatrist Dr. Ralph Ankenman. Cutler prescribed a common heart medication, called an alpha blocker, that also reduces the activity of adrenaline in the body.
Within two weeks, Kayla “was like a brand-new kid,” Bettis said. “Every teacher she had before called and said, ‘I can’t believe it’s Kayla. She’s so much calmer now.’ ”
Kayla herself said, “I don’t want to fight any more, and now more people want to be around me.”
Cutler, who practices in one of the poorest neighborhoods of Columbus, said he has placed about 30 of his patients with impulsive, violent disorders on Ankenman’s adrenaline-blocking therapy during the last two to three years. “The vast majority have had good results,” he said. “The few who didn’t we immediately took off” the medications.
Cutler said the therapy not only changes children’s lives but strengthens families. “And instead of spending hundreds of dollars a month on newer (standard) medications, many of which did not work, we’re getting much better control with drugs that cost only $4 a month.”
Cutler is so persuaded by Ankenman’s approach that he is collaborating with the Cedarville psychiatrist on a book about his therapy and the families whose lives have been transformed by it. The two physicians have been joined by a third co-author, Dr. Elisha Injeti, the director of research and development at Cedarville University’s school of pharmacy.
“I think there is value in what (Ankenman) is doing,” Injeti said.
A national survey released last year by the National Institute of Mental Health found that, among American children ages 8 to 15, nearly one in 10 (8.6 percent) had been diagnosed with Attention Deficit-Hyperactivity Disorder and two in every hundred (2.1 percent) had some type of conduct disorder, including verbal and physical aggression.
Ankenman, Cutler and Injeti realize that mainstream medicine will not give much credence to adrenaline-blocking therapy as long as it hasn’t been proven safe and effective in double-blind randomized clinical trials — the gold standard for evidence-based medicine. That’s why the trio feels a book is needed to get their message out to the public.
Ankenman said securing the millions of dollars for a large double-blind study, in which some children would receive his therapy and others receive a placebo or lookalike pill, is unlikely. Drug companies have no interest in studying drugs that are no longer under patent and won’t yield them a profit, he said. And because the adrenaline blockers have been approved for other uses, such as controlling high blood pressure in adults, they don’t qualify for “orphan drug” funding from the National Institute of Mental Health, he said.
But Dr. Floyd Sallee, a professor of psychiatry and neurology at the University of Cincinnati College of Medicine who has studied adrenaline’s role in ADHD, said putting drugs to a new use — a practice known as “off-label” prescribing — poses risks for patients, especially children.
“Any time you have an off-label use for a medication in a population for which a drug was not intended, you run the risk of unintended consequences,” Sallee said.
Bob Kowatch, director of psychiatric research at Children’s Hospital Medical Center in Cincinnati, said he, too, needs more than anecdotal evidence to be persuaded.
“Thirty to 40 percent of kids will respond to placebo” — that is, any pill that they and their parents think might make them better, Kowatch said. “All kinds of doctors work up little concoctions of some kind and everybody thinks it works well — at least for a while.”
But Cutler and Ankenman say they have had patients on the adrenaline-blocking therapy for years with good results.
One of those is 24-year-old Michael Rosengarten of Beavercreek. When he was 14, Michael’s impulsive behaviors included running into streets and climbing on to roofs, clearly endangering himself.
Standard medications had little effect, said his father, Sam Rosengarten. Ankenman’s therapy not only calmed his son but helped bring him out of his shell. “He has many friends now,” Rosengarten said, including his co-workers at Hidy Ford, where Michael has worked for the last five years.
“He’s one of the gentlest people I know,” said his supervisor Chris Nolan.
Off-label uses for medications are “very common” among physicians and “perfectly ethical,” said Dr. Gary Onady, a professor of pediatrics and an expert on evidence-based medicine at Wright State University’s Boonshoft School of Medicine. Onady points out that 70 percent of therapies for children are not based on controlled studies, in large part because, until recently, the federal government had placed numerous restrictions on conducting trials with minors.
Onady said good therapies can be based on educated hunches. “Certainly, it’s possible to get a good outcome (for patients) by reverting back to an understanding of the physiology and pharmacology of different medications,”
Ankenman notes that he uses extremely small doses of adrenaline blockers, including Inderal, which already has been approved by the U.S. Food and Drug Administration for treating heart problems in children.