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.
Contributor: More Informed Management of Preeclampsia Is Necessary
November 29th 2023At present, it is difficult for clinicians to identify patients at greatest risk for developing preeclampsia with severe features and tailor treatment plans for them; this difficulty increases costs significantly.
Read More
Understanding the Unmet Need for Therapies to Treat Rare Bile Duct Cancer
May 24th 2022On this episode of Managed Care Cast, we bring you an excerpt of an interview with a co-chair of the 2022 Cholangiocarcinoma Foundation (CCF) annual conference, held earlier this year, about the significant unmet therapy needs facing most patients with this rare cancer.
Listen
Provisional CDC data show that US babies gained roughly a year in life expectancy in 2022; study findings indicate that the COVID-19 pandemic significantly raised the risk of preterm birth for expectant California mothers; New York Attorney General Letitia James said about 4 million New Yorkers were affected by a data breach of the medical transcription company Perry Johnson & Associates.
Read More
A Look at Racial Disparities in US HPV Vaccine Uptake
March 1st 2022On this episode of Managed Care Cast, Leslie Cofie, PhD, MPH, an assistant professor of health education and promotion at the College of Health and Human Performance, East Carolina University, discusses his work on identifying and addressing racial disparities in human papillomavirus (HPV) vaccine uptake in the United States.
Listen
Gene Therapy Success in UK Likely Depends on Overcoming Education, Psychological Support Challenges
November 27th 2023Education, psychological support, and implementation guidance are the top unmet needs identified by investigators from the United Kingdom concerning gene therapy use for hemophilia.
Read More