The American Hospital Association will refile its 340B lawsuit against HHS after an appeals court ruled the lawsuit was premature; therapies approved by the FDA with breakthrough designation often lack strong medical evidence; a study has suggested that frequent use of digital media may increase the odds of adolescents developing symptoms of attention-deficit/hyperactivity disorder (ADHD).
On Tuesday, the US Court of Appeals for the District of Columbia Circuit rejected the 340B lawsuit brought by the American Hospital Association (AHA) against HHS. The 3 judges ruled that the lawsuit was premature since the new regulation had not gone into effect yet when AHA filed the lawsuit, reported The Hill. AHA is challenging HHS’ cuts to the 340B Medicare discount drug program. AHA said it will refile in district court because the appeals court didn’t rule on the merits of the case but instead ruled on how and when the challenge can be filed.
Research into the studies behind therapies approved by the FDA through the breakthrough therapy designation found that these approvals often lack the strongest kind of medical evidence. According to The Washington Post, these drugs are accelerated through development and are tested with less rigorous studies. For instance, 40% of the approved drugs had no randomized trial. Nearly half of the trials did not include a placebo and in half the studies were not completely blinded.
A study has suggested that frequent use of digital media, such as computers, tablets, and smartphones, may increase the odds of adolescents developing symptoms of attention-deficit/hyperactivity disorder (ADHD), reported NPR. The researchers followed more than 2500 10th-graders over 2 years, assessed them using a standardized questionnaire for ADHD symptoms, and asked them about the frequency of their participation in online activities, such as texting, checking social media, streaming or downloading music, or online shopping or browsing. Students who used at least 6 online activities many times a day had a higher likelihood of developing ADHD symptoms.