No one has done more to convince Americans that even small children can suffer the dangerous mood swings of bipolar disorder than Dr. Joseph Biederman of Massachusetts General Hospital.
"We need to treat these children. They are in a desperate state," Biederman said in an interview, producing a video clip of a tearful mother describing the way her preschool daughter assaulted her before the child began treatment for bipolar disorder. The chief of pediatric psychopharmacology at Mass. General, he compares his work to scientific break throughs of the past such as the first vaccinations against disease.
But the death in December of a 4-year-old Hull girl from an overdose of drugs prescribed to treat bipolar disorder and attention deficit hyperactivity disorder has triggered a growing backlash against Biederman and his followers. Rebecca Riley's parents have been charged with deliberately giving the child overdoses of Clonidine, a medication sometimes used to calm aggressive children. Still, many wondered why a girl so young was being treated in the first place with Clonidine and two other psychiatric drugs, including one not approved for children's use. Riley's psychiatrist has said she was influenced by the work of Biederman and his protege, Dr. Janet Wozniak.
"They are by far the leading lights in terms of providing leadership in the treatment of children who have disorders such as bipolar," said J. W. Carney Jr., lawyer for Dr. Kayoko Kifuji, a Tufts-New England Medical Center psychiatrist who temporarily gave up her medical license after Riley died on Dec. 13, 2006. "Dr. Kifuji subscribes to the views of the Mass. General team."
Numerous psychiatrists say Riley's overdose suggests that bipolar disorder is becoming a psychiatric fad, leaving thousands of children on risky medications based on symptoms such as chronic irritability and aggressiveness that could have other causes. Riley's father, for example, had only recently returned to the home after being accused of child abuse, according to police. Since the girl's death, state officials have stepped up a review of the 8,343 children taking the latest antipsychotic medications under the Medicaid program for conditions including bipolar disorder, to be sure the treatment is appropriate.
Psychiatrists too often prescribe these medications, which carry side effects such as weight gain and heart disease risk, without addressing problems in the children's lives, said Dr. Gordon Harper, director of child and adolescent services at the state Department of Mental Health. He likened the approach to "tuning the piano while the subway is going by."
"I find Biederman and his group to be morally responsible in part," said Diller, whose popular book, "Running on Ritalin," accused psychiatrists of over treating another childhood condition, attention deficit hyperactivity disorder. "He didn't write the prescription, but he provided all the, quote, scientific justification to address a public health issue by drugging little kids."
Biederman rejects the idea that Riley's death is a cautionary tale, accusing critics of exploiting a tragedy to fan fears about psychiatry, a profession that has long faced prejudice. "The fact that she had XY drug or XY treatment is irrelevant to what happened. . . . If this child had the same outcome from treatment for asthma or seizures, we wouldn't have this frenzy," said Biederman in an interview at Mass. General's Cambridge mental health clinic.
Biederman dismisses most critics, saying that they cannot match his scientific credentials as co author of 30 scientific papers a year and director of a major research program at the psychiatry department that is top-ranked in the "US News & World Report" ratings.
The critics "are not on the same level. We are not debating as to whether [a critic] likes brownies and I like hot dogs. In medicine and science, not all opinions are created equal," said Biederman, a native of Czechoslovakia who came to Mass. General in 1979 after medical training in Argentina and Israel. He now lives in Brookline
Biederman's thinking on bipolar disorder grew out of his work in the early 1990s, when he observed that many children referred to Mass. General's psychiatric clinic seemed to have periods where they were extremely aggressive, deeply depressed, or angry. And they were not getting better from taking medications such as Ritalin, which is prescribed for attention deficit hyperactivity disorder.
Biederman was already quite successful as an ADHD researcher, establishing close ties with companies that manufactured drugs such as Ritalin to fund research projects that the federal government would not pay for. He also received payments for giving speeches about mental health issues and serving on scientific advisory boards that typically meet a few times annually to discuss research. He declined to say how much he receives, but said that all of the income was approved by both Harvard Medical School and the hospital.
Biederman's boss said he does not believe the money affects Biederman's judgment.
Biederman said he quickly discovered that drug companies were less interested in bipolar disorder than the more established ADHD. He and Wozniak, who did not respond to a request for an interview, struggled to get funding for research on bipolar children. "The more controversial a diagnosis is, the harder it is to get funding from conventional sources," he explained.
Occasionally, they received small grants from drug companies or private philanthropies to test drugs on children, but Biederman admits these studies are not enough to prove the drugs are safe and effective. Nonetheless, the Mass. General studies were enormously influential: their 2001 study, in which 23 children diagnosed as bipolar received the drug Zyprexa for eight weeks, became one of the most frequently quoted articles in the history of the Journal of Child and Adolescent Psychopharmacology. The study showed that the drug eased outbreaks of aggression, though children typically gained more than 10 pounds.
Biederman was disappointed that he could not do more comprehensive studies, but he saw no reason to delay treatment. "At least the line of drugs I'm talking about gives some relief," he said. "The only way to understand the side effects is in the context of the seriousness of the illness."
As bipolar disorder received increasing media attention, Biederman and Wozniak's research was often cited as the scientific rationale for diagnosing and treating the disease aggressively (disease? huh? where's the blood test for that? - ed). Another leading researcher, Dr. Barbara Geller of Washington University in St. Louis, adopted a more restrictive view, requiring that children have a series of specific symptoms such as reduced need for sleep before she would diagnose the disorder. But the Mass. General team used broader categories, saying that children who are extremely irritable or aggressive might be bipolar. Skeptics said those symptoms were too common, leaving too much room for dispute over who is really sick.
The rapid rise raised concerns at the National Institute of Mental Health, prompting its top officials to convene leading specialists, including Biederman, to urge them to come up with diagnosis and treatment standards. The resulting guidelines, released in 2001, acknowledged that Biederman was right: Bipolar disorder can strike before puberty. However, the guidelines also stated that identifying the disease among children is challenging because normal children are prone to be irritable, aggressive, or giddy.
"We don't know the first thing about safety and efficacy of these drugs even by themselves in these young ages, let alone when they are mixed together," said Hyman.
Police charge that her parents, Carolyn and Michael Riley , repeatedly convinced Kifuji to give them extra Clonidine, ultimately accumulating dozens of extra pills that they used to control the little girl. Long before the child finally died on the floor beside her parents' bed, the police report said, teachers and school nurses noticed that she had become lethargic like a "floppy doll" on a nurse's lap.
Carney said his client, who is not practicing while the investigation continues, did nothing wrong in writing the prescriptions for the girl. Although some were shocked that the child was taking so much medication, Carney said Kifuji was practicing mainstream psychiatry for a very troubled child. He observed that Biederman's "research and teaching validates Dr. Kifuji's work with patients."