Congress moved much closer to passing a bill (S 558) that would require companies that offer health insurance and employ more than 50 people to provide parity of coverage for mental and physical benefits. The Senate passed its bill on September 18 after Senate sponsors accepted an amendment from Sen Chris Dodd (D, Conn) that makes it easier for states to maintain stronger laws than what the bill would mandate nationally.
Dodd had been concerned that the version of the Mental Health Parity Act of 2007 that passed the Senate Health, Education, Labor, and Pensions Committee on February 14 by a vote of 18 to 3, would have cancelled state laws such as Connecticut's that require better mental health coverage than that mandated by the Senate bill. Dodd had been holding up Senate consideration of the bill because of that issue.
But on the Senate floor on September 18, Dodd noted that the bill being voted on removed the broad federal preemption language entirely. Senators Edward Kennedy (D, Mass), Mike Enzi (R, Wyo), and Pete Domenici (R, NM) were the sponsors of the Senate bill, and Dodd thanked them for agreeing to change the committee-passed version.
Business groups had threatened to pull their support from the Kennedy/ Domenici/Enzi bill if the committee-passed version was amended on the Senate floor. But Neil Trautwein, vice president and employee benefits policy counsel of the National Retail Federation, said business groups worked with Dodd to write his amendment. All employer groups support the Senate bill, Trautwein added.
Mental health groups were overjoyed, of course, by passage of the Senate bill. Carolyn Robinowitz, MD, American Psychiatric Association president, said, "Passage of this bill is a tremendous victory for the public, and the APA is proud to have been a part of this effort."
There are still some significant differences between the Senate and House bills. Most important, the Senate bill essentially allows health plans to decide which mental health conditions to cover. That gives them considerably more flexibility than the rival House bill (HR1424), which a House subcommittee passed on September 19. Trautwein explained that the House bill was triply objectionable because it also included provisions prohibiting companies from medically managing the benefits and provisions concerning out-of-network providers.
But it appears Rep Patrick Kennedy (D, RI), sponsor of the House bill, may now be willing to fold his tent. He said passage of the Senate bill with the Dodd amendment was a "historic step in ending insurance discrimination against Americans living with brain diseases." He implied that he could now support the Senate bill, which he had previously opposed.
The clinical trials that were the basis for the FDA's approval of risperidone (Risperdal) for treatment in adolescents aged 13 to 17 years who are suffering from schizophrenia and for short-term treatment of bipolar mania in children aged 10 to17 years give psychiatrists some valuable new information about use of the drug, which physicians have been prescribing off-label for some time. Those trials also underscore at least 1 potential red flag that has been raised about the Janssen product.
The FDA first approved Risperdal in 1993 for the treatment of schizophrenia in adults. The drug later was approved for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old.
The 2 new indications were approved on the basis of short-term clinical trials with about 600 adolescents. The actual results of those 2 trials will not be released. However, the FDA review of the trials will be available on the agency's Web site.
Janssen performed those clinical trials at the request of the FDA, which offered the company an extra 6 months of marketing exclusivity in return for carrying out the trials, authority it has under the Best Pharmaceuticals for Children Act. In an interview, Thomas Laughren, MD, director of the FDA's psychiatric drug products division, explained, "These trials looked at 2 dosage ranges for Risperdal, a higher dose range of 4 to 6 mg/d and a lower dose range of 1 to 3 mg/d, and for both indications, the lower dosages appeared to work as well as the higher dosages." This is information psychiatrists did not have before, he emphasized.
Risperdal is the first drug the FDA has approved for schizophrenia and bipolar mania in young people. Some older antipsychotics, such as chlorpromazine (Thorazine), have vague language in their labels that refers to their effectiveness in behavioral disturbances in children.
Given some of the controversies surrounding Risperdal and the debate about children and antidepressants, some observers criticized the FDA for not asking for input from the Psychopharmacologic Drugs Advisory Committee. But Laughren explained, "We take issues to our advisory committee when we feel we need some help. If an application is straightforward, and the drug is clearly effective and acceptably safe, we generally act without the committee's advice. In the case of Risperdal for pediatric schizophrenia and bipolar disorder, the evidence supported both efficacy and a safety profile similar to what we have seen in adults, and we felt that we could act without outside advice."
However, Risperdal's safety profile differs from that of other antipsychotics in one significant way. "Most antipsychotic drugs elevate prolactin levels to some extent; however, Risperdal appears to have a greater effect on prolactin than other drugs in this class," Laughren explained.
The FDA hopes to be getting additional information on Risperdal's adverse effects in adolescents. The agency asked for a postmarketing study when it approved Risperdal for irritability associated with autism in October 2006. That study will look at glucose, insulin, and growth hormone levels and insulin resistance, and results should be reported by March 2010. The findings from this study will apply to any pediatric patients. "We don't have any strong regulatory authority to ensure completion of this study, but we fully expect the sponsor to comply with this request," Laughren said.