Roche Pharmaceuticals’ potential new medication for schizophrenia, bitopertin (RG1678), failed its first two phase III trials. In both trials, adding bitopertin to antipsychotics for 24 weeks failed to improve persistent negative symptoms of schizophrenia as measured by PANSS (Positive and Negative Symptoms Scale) scores when compared to placebo, according to a report released by the company in January.
Despite this setback, the manufacturer is continuing several other phase III trials. A third trial is under way for persistent negative symptoms, while three additional trials are studying bitopertin for positive symptoms—such as hallucinations and delusions—that do not resolve with standard antipsychotic therapy. All in all, Roche is conducting six phase III studies, enrolling more than 3,600 people in 32 countries.
Currently, no medications are approved specifically for the treatment of negative symptoms of psychosis, such as social withdrawal and lack of motivation. Bitopertin is a glycine reuptake inhibitor that is thought to improve NMDA receptor function and, if approved, would be the first glutamate-based pharmacological treatment for schizophrenia.
J&J Starts Sharing Clinical Trial Information
Johnson & Johnson will begin providing all clinical trial data gathered through its Janssen pharmaceuticals arm to Yale School of Medicine’s Open Data Access (YODA) Project. Physicians and researchers will be able to request access to the anonymized data through YODA, and not the drug company.
According to J&J, “under the agreement, YODA will independently review and make final decisions regarding all requests for the company’s clinical trial data, including clinical study reports (CSRs) and de-identified patient-level data.”
These are the raw data that researchers report in the published literature, and that the drug company interprets to justify the superiority of its product. Presumably, independent researchers will be able to use these data to identify which patients may benefit more from a drug than others, or to reevaluate the risks of drugs.
Outside of the FDA, it’s no easy feat to obtain raw clinical trial data. Scientists and doctors have always had the option of requesting data directly from the drug company, but the decision as to whether data would be shared lay in the hands of the drugmaker. The argument for the benefit of YODA is that it is not biased in any way to the interests of the pharmaceutical company in making these decisions.
CDC: Only 1 in 6 Has Ever Talked about Alcohol with Doc
A January 2014 report from the Centers for Disease Control and Prevention says that alcohol screening and brief counseling by physicians can significantly reduce weekly alcohol consumption and binge-drinking episodes, but that only one in six people has ever talked with their doctor or other health professional about alcohol use.
The report says that at least 38 million Americans drink too much, defined as binge drinking (five or more drinks for men and four or more drinks for women in one sitting), high weekly use (15 or more for men or 8 or more for women), and any alcohol use by pregnant women or those under age 21.
Drinking too much is associated with heart disease, breast cancer, sexually transmitted diseases, unintended pregnancy, fetal alcohol spectrum disorders, sudden infant death syndrome, motor-vehicle crashes, violence, suicide, and other health problems, according to the CDC.
The CDC recommends that all physicians screen patients for alcohol use through an “alcohol screening and brief intervention (ASBI).” This process can be as easy as asking about drinking, explaining in plain language the dangers of drinking too much, and providing next-step options for people who want to reduce their drinking. The Affordable Care Act requires new health insurance plans to cover ASBI and compensate providers for the service, according to the report.
While psychiatrists may be more on top of this issue than some other physicians because of the nature of our work, this serves as a reminder to ask everyone—including pregnant women and those under age 21—about their drinking habits and their motivation to change them. The report can be found at http://1.usa.gov/1aYcRLY.