Assurex Health recently sent me an email inviting me to dine at Legal Seafood to learn about “Clinical Applications of Psychiatric Pharmacogenetics.” I didn’t go, but increasingly I am hearing from colleagues about their experiences at these dinner programs: “What do you think about this GeneSight test? The data looked pretty impressive at this dinner.”

Whether generics are really therapeutically equivalent to branded versions of drugs has long been controversial.

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.

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.

A coalition, formed to fight what it sees as an opioid epidemic, is rallying support against the US Food and Drug Administration’s (FDA) approval of the drug Zohydro.

Fingerprint biometrics may be coming to an addiction treatment program near you.

In November, drug giant Johnson & Johnson (J&J) and its subsidiaries agreed to pay $2.2 billion in fines and fees for wrongdoing related to kickbacks and misbranding of a number of their medications.

Too often our literature presents an oversimplified picture driven by some agenda, usually commercial. We prescribers, or, more accurately, “research consumers,” need a more complete and accurate description of what’s actually observed in clinical trials.

In 2006, an FDA panel recommended all manufacturers of stimulants to add a “black box” warning about an increased risk of “serious cardiovascular events.”

The ethical practices of the pharmaceutical industry have recently come under scrutiny as never before. Here is a quick rundown of the main issues involved and what reforms have taken place, or may soon take place.