Jeffrey Lieberman, M.D., chairman of the Department of Psychiatry at P&S and director of the New York State Psychiatric Institute, led two recent studies on antipsychotic drugs that attracted much news attention. The studies found that so-called “second generation” drugs are no more effective than “first-generation” drugs in alleviating symptoms. These results have led Dr. Lieberman to question why so much drug development focuses on therapies that offer only slight, or no, improvement over existing drugs. His commentary on this subject was in the October 2006 Archives of General Psychiatry, the same issue in which the latest trial results on schizophrenia drugs appeared.
The results of the NIH-sponsored, multicenter schizophrenia study, dubbed CATIE, published in September 2005 in the New England Journal of Medicine showed that the new class of antipsychotics did no better than the older antipsychotic drugs. In the companion Alzheimer's trial, called CATIE-AD, published in October 2006 in the NEJM, the results showed that the new class of antipsychotics did no better than placebos and often produced intolerable side effects. The findings run contrary to the widely held perception that second-generation antipsychotic agents are safer and more effective compared with the less expensive, older medications.
“It’s been shown that all too often, new medications do not live up to their advance press when used in real-world practice,” says Dr. Lieberman, principal investigator of the CATIE project. “Why has the $250 billion pharmaceutical industry been unable to develop innovative and improved treatments for devastating illnesses?”
Many factors slow drug development, such as the unpredictability of research breakthroughs, cost and difficulty of drug testing and safety concerns. It now costs about $900 million to bring a drug to market, and fewer than one in five drugs that reaches clinical trials is eventually approved.
The solution, Dr. Lieberman believes, is to better leverage the latest scientific knowledge and advanced technologies for drug development.
“The FDA and other government agencies could alleviate the situation and protect the public by taking just a few steps to accelerate research on innovative therapies,” he says. Those steps should include:
- expedited review and longer patent protection for groundbreaking drugs
- a category of provisional drug approval that requires additional data be gathered in Phase IV testing to confirm effectiveness and safety
- a system of post-marketing surveillance for drug side effects, involving family members and care- givers in reporting side effects
- procedures to study how new drugs whether novel in their mechanism of action or not compare to existing treatments.
“The National Institute of Mental Health has already taken such steps with studies like CATIE,” Dr. Lieberman says. “These efforts need to be expanded.”
Two additional papers based on data from the CATIE trials were published in the December 2006 issue of the American Journal of Psychiatry. The articles delve further into the cost effectiveness of atypical antipsychotics as compared with first- generation antipsychotics.
“My hope is that these latest findings will add to the mounting pressure for
much needed change in drug development in the United States,” Dr. Lieberman says.