HCV Field Is Getting Crowded
Johnson & Johnson’s Janssen Sciences unit will end development on a hepatitis C virus (HCV) drug. According to Reuters
, the decision came in response to the increasing number of effective HCV treatments already on the market. The unit had been working on a drug that was a combination of 3 direct-acting antivirals, and the ongoing phase 2 studies will be completed as planned. Janssen will continue development efforts on a treatment for chronic hepatitis B.
Inaccurate Reporting of Suicides in Drug Trials
A lawsuit against GlaxoSmithKline alleges that suicide data in antidepressant clinical trials were incorrectly reported. A new report in The New York Times
outlines the challenges the company is facing regarding how it reported suicides in its clinical trials. The trials had shown patients treated with Paxil had a suicide rate of 1 in 600 compared with the suicide rate of 1 in 275 among patients on placebo—more than double the drug group. The lawsuit alleges that the placebo deaths took place during a period when patients entering a clinical trial are weaned from prior medications and before patients are randomized. This is a risky time for patients, and taken in a different light, the safety of Paxil is called even more into question, the lawyers argue.
Asking Questions Around Off-Label Prescribing
Off-label prescribing isn’t uncommon, and can be used to help patients who haven’t responded to the FDA-approved drugs or who have a condition for which there is no drug approved yet. There are drawbacks to off-label prescribing, and The Washington Post highlighted
some questions patients should ask to get better informed. Importantly, patients may want to start by asking if the drug is being prescribed for an off-label use, since doctors often don’t tell patients when they do so. In addition, patients should ask about the risks and side effects for off-label medications and what evidence there is for using the drug off-label.