US pharma firms are cashing in on unapproved treatments and raking in bns thanks to an FDA shortcut, Bloomberg reports. The Food and Drug Administration’s (FDA) accelerated approval pathway allows pharma companies to sell medications before conclusive trials are completed, especially in situations where patients have no other treatment options and where initial studies point to their likely success. This has raised concerns that some firms are misusing the shortcut to market ineffective drugs. A drug used to treat muscular dystrophy — a disease affecting young children — has raked in over USD 2.5 bn in sales despite a lack of evidence for its efficacy, and some 19 drugs that have yet to complete their confirmatory trials are currently being distributed under accelerated approvals, according to Bloomberg data.
The FDA’s trying to get them to finish their trials quicker — but it hasn’t been successful: The FDA has attempted to tackle these concerns in recent years, demanding in a new law that companies carry out additional trials in a timely fashion to substantiate the efficacy of their drugs. This has resulted in a number of drugs losing their accelerated approval. But the FDA’s new law does not completely eliminate the possibility of delayed trials and leaves some details up to interpretation, one physician said. Drugmakers can appeal a proposed withdrawal to the FDA commissioner, but details of how the process would work are unclear.
People can’t decide on the color of the sun: The sun is neither yellow nor white, that’s just the way our brain interprets it, scientists agreed in an article by the Washington Post last week. A debate sparked on Twitter about the color of the sun and whether it has changed over the years is working to disprove a commonly held belief that colors are facts, instead of being subjective. While our eyes capture the same wavelengths when we look at the sun, our interpretations of what we see are different based on our cultures, language and place of birth. The thickness of the atmosphere at different times of day also changes the way molecules are scattered, affecting its color, according to W. Dean Pesnell, a scientist at NASA’s Solar Dynamics Observatory,
The sun is actually green, Pesnell said, adding that the shade of green is so bright that our eyes cannot take in the intensity, which causes us to see it as white.