The Problems With Drugs That Get Speedy OKs
Many drugs that have been granted accelerated approval lack the advantages of existing therapies, and additional testing of these drugs to confirm benefits is associated with financial risk for manufacturers, according to new research.
Context: About 40% of drugs with accelerated approvals in the US had "high added" therapeutic value based on post-approval evidence.
The findings support efforts to increase the power of the FDA in the bargains it makes with companies on accelerated approvals and confirmatory trials.
Other studies found that under current federal rules, drug makers appear to have little to gain and much to lose, for completely confirmatory trials on drugs with accelerated approval.
Recommendation: Researchers suggest that Congress should introduce new rules to address the current "failure of the market to reward reduced uncertainty about drug's true benefits."
"Doomscrolling" Takes a Toll on Mental and Physical Health
"Doomscrolling" the news is a common phenomenon that increases the risk for poor mental and physical health, according to new research.
Doomscrolling is most prevalent among "news addicts" who obsessively check the 24-hour media coverage of worrisome global events.
No good news: Online surveys show that nearly 17% of people showed signs of "severely problematic" news coverage.
Bad news, bad health: Seventy-four percent of those with severe levels of news consumption reported experiencing mental problems. Sixty-one percent reported physical problems.
"It's important for healthcare providers to be aware that problematic news consumption may be a significant driver of mental and physical ill-being, especially because a lot of people might be unaware of the negative impact the news is having on their health," said lead author Bryan McLaughlin, PhD.
Early Menopause Linked With Increased Risk for Heart Problems
Higher risk: The study of more than 1.4 million women showed that the younger the age of menopause, the higher the risk for heart problems.
Estrogen's effect: Women typically experience cardiovascular disease 10 years later than do men, and premenopausal women are thought to benefit from estrogen's protective effect on the cardiovascular system.
More vulnerable: The researchers suspect the cessation of menstruation and related decline of estrogen levels may make women more vulnerable to cardiovascular disease. Women who experienced premature menopause were found to have a 33% higher risk for heart failure and a 9% higher risk for atrial fibrillation.
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Cite this: Accelerated Approval Drug Problems; Doomscrolling Takes Its Toll on Health; and Early Menopause Linked to Heart Problems - Medscape - Aug 26, 2022.