3 ms·

1) Metabolic side effects tend to be slow and subtle. Vioxx caused increased heart attacks over time. Passing a phase 1 safety trial is fine and dandy, but it’s

1) Metabolic side effects tend to be slow and subtle. Vioxx caused increased heart attacks over time. Passing a phase 1 safety trial is fine and dandy, but it’s a far cry short of long-term safety in a drug targeting metabolism, and it’s not even where most drugs fail. 2) Lab evidence for a biomarker for a metabolic process is so far short of evidence of clinical improvement that it’s a joke. I will never stop deriding studies that point to proxy markers (or in this case, proxy proxy markers) as evidence of benefit. This has been proven to be inadequate so many times, across so many different studies, that it’s just not worth talking about anymore. This is a perfectly fine and valid phase 1 study. It says “we have identified a dose range that doesn’t immediately sicken people.” That’s what phase 1 trials do. The rest is press release hype.

utopcell 7y ago
Do all "we have identified a dose range that doesn’t immediately sicken people” studies make it to Nature journals ?
- danieltillett 7y ago
  Only if the right people were involved in the study.
  - looeee 7y ago
    Or if it's to do with curing aging, cancer, HIV, or heart disease.
- arkades 7y ago
  Nature is a high impact factor, prestigious journal. It’s million sub-journals, like Nature Metabolism ... well, vary. A lot. They mostly coast on papa’s brand recognition. Nature Endocrinology Reviews is a relatively ranking journal in endocrinology - roughly second place, by impact factor. This didn’t get published there. Nature Metabolism was only opened in 2017, as an online-only journal. It doesn’t even rank in the top 50 for endocrine and metabolism journals - granted, that may be in part because it doesn’t even have an impact factor yet (calculating impact factor requires two years of publication history preceding the year being calculated for. In 2020, we should see a 2019 IF.) So, one can say they might be enormously prestigious, and we just won’t see until 2020. It’s more likely that people aren’t bothering publishing their best articles in a 0 IF journal, because in academic circles the Nature Subbrand is recognized as not inherently meaningful, so the 0 IF pub just hurts (unless you think your pub would otherwise end up in an unimpressive journal, and you want to gamble that the future IF will be higher and pay off.)
  - utopcell 7y ago
    Thank you for the thorough explanation.

utopcell 7y ago

Do all "we have identified a dose range that doesn’t immediately sicken people” studies make it to Nature journals ?

danieltillett 7y ago
Only if the right people were involved in the study.
- looeee 7y ago
  Or if it's to do with curing aging, cancer, HIV, or heart disease.
arkades 7y ago
Nature is a high impact factor, prestigious journal. It’s million sub-journals, like Nature Metabolism ... well, vary. A lot. They mostly coast on papa’s brand recognition. Nature Endocrinology Reviews is a relatively ranking journal in endocrinology - roughly second place, by impact factor. This didn’t get published there. Nature Metabolism was only opened in 2017, as an online-only journal. It doesn’t even rank in the top 50 for endocrine and metabolism journals - granted, that may be in part because it doesn’t even have an impact factor yet (calculating impact factor requires two years of publication history preceding the year being calculated for. In 2020, we should see a 2019 IF.) So, one can say they might be enormously prestigious, and we just won’t see until 2020. It’s more likely that people aren’t bothering publishing their best articles in a 0 IF journal, because in academic circles the Nature Subbrand is recognized as not inherently meaningful, so the 0 IF pub just hurts (unless you think your pub would otherwise end up in an unimpressive journal, and you want to gamble that the future IF will be higher and pay off.)
- utopcell 7y ago
  Thank you for the thorough explanation.