nhaliday + fda   19

Secular decline in testosterone levels - Rogue Health and Fitness
A Population-Level Decline in Serum Testosterone Levels in American Men: http://sci-hub.tw/10.1210/jc.2006-1375
Secular trends in sex hormones and fractures in men and women: http://www.eje-online.org/content/166/5/887.full.pdf
https://twitter.com/toad_spotted/status/984543033285898246
https://archive.is/dcruu
Small n and older sample, but interesting that while testosterone decreases have been large for men they’ve been even larger (in % terms) for women; wonder if this contributes to declining pregnancy and sexual frequency, rising depression.

https://www.labcorp.com/assets/11476
http://www.theamericanconservative.com/articles/sperm-killers-and-rising-male-infertility/
https://www.theguardian.com/lifeandstyle/2017/jul/25/sperm-counts-among-western-men-have-halved-in-last-40-years-study
https://www.weforum.org/agenda/2017/08/most-men-in-the-us-and-europe-could-be-infertile-by-2060
Strangelove: https://youtu.be/N1KvgtEnABY?t=67

https://www.scientificamerican.com/article/sperm-count-dropping-in-western-world/
https://news.ycombinator.com/item?id=14855796
https://news.ycombinator.com/item?id=14857588
People offering human-centric explanations like cell phones: Note also that the sperm quality of dogs has decreased 30% since 1988.

mendelian rand.:
https://www.ncbi.nlm.nih.gov/pubmed/28448539
1 SD genetically instrumented increase in BMI was associated with a 0.25 SD decrease in serum testosterone
https://twitter.com/SilverVVulpes/status/857902555489341441

Ibuprofen linked to male infertility: study: https://nypost.com/2018/01/08/ibuprofen-linked-to-male-infertility-study/
http://www.pnas.org/content/115/4/E715.full

Tucker Carlson: "Men Seem To Be Becoming Less Male": https://www.realclearpolitics.com/video/2018/03/08/tucker_carlson_men_seem_to_be_becoming_less_male.html
Carlson interviewed Dr. Jordan Peterson who blamed the "insidious" movement being driven by the "radical left" that teaches there a problem of "toxic masculinity." He said ideological policies focus on "de-emphasizing masculinity may be part of the problem."

...

Those are the numbers. They paint a very clear picture: American men are failing, in body, mind and spirit. This is a crisis. Yet our leaders pretend it’s not happening. They tell us the opposite is true: Women are victims, men are oppressors. To question that assumption is to risk punishment. Even as women far outpace men in higher education, virtually every college campus supports a women’s studies department, whose core goal is to attack male power. Our politicians and business leaders internalize and amplify that message. Men are privileged. Women are oppressed. Hire and promote and reward accordingly.

https://pinboard.in/u:nhaliday/b:bd7b0a50d741
But it also hints at an almost opposite take: average testosterone levels have been falling for decades, so at this point these businessmen would be the only “normal” (by 1950s standards) men out there, and everyone else would be unprecedently risk-averse and boring.
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may 2017 by nhaliday
I Want a New Drug | West Hunter
Big pharma has taken a new course over the past few years. In the past, most useful drugs originated in some kind of living organism – penicillin, quinine, insulin, etc etc. Nowadays, big pharmaceutical companies use combinatorial chemistry and computer modeling. Merck has sold off its biological-products research arm. This new approach, combined with doubled spending on drug R&D, has been a resounding failure. The rate of development of fundamentally new drugs – ‘new molecular entities’ – is running about 40% of that seen in the 1970s. Since big pharma makes its money from drugs that are still on patent, this slowed innovation is a real threat to their bottom line.

...

I think that this is an instance of a more general trend: often a modern, advanced approach shows up, and it persists long after it’s been shown to be a miserable failure. You can see some of the reasons why: the people trained in the new technique would lose out if it were abandoned. Hard to imagine combinatorial chemists rooting around in a garbage can looking for moldy fruit.
west-hunter  discussion  pharma  medicine  FDA  randy-ayndy  regularizer  critique  minimalism  bio  nature  low-hanging  drugs  error  scitariat  info-dynamics  innovation  ideas  discovery  meta:medicine  stagnation  parasites-microbiome  the-trenches  alt-inst  dirty-hands  regulation  civil-liberty  proposal  corporation  fashun 
february 2017 by nhaliday
Personnel decision | West Hunter
https://westhunt.wordpress.com/2016/09/20/personnel-decision/#comment-83814
I think we are about due for a career civil servant within the agency or relatively recently retired from it (ideally to academia), with a PhD or M.D. and probably a pay grade of either GS-15 or Senior Executive Service (SES), who has a reputation for integrity, for intelligence, and for getting things done bureaucratically, with some low profile political connections (at least to the ruling party but ideally to both political parties) in private life as well (e.g. through friendships made at a top college, a politician or top political aide parent, or friendships made while attending a top D.C. private school like Sidwell Friends or St. Albion’s or National Cathedral School).

Few federal agencies call for more subject-matter competence to understand its functions well enough to run it well.
--
The problem is that the typical member of the set you describe is nuts. Members have a lot of incorrect ideas in their heads: in fact, you have to express support of those ideas or you are expelled. So, that means that every educational improvement plan pushed by the Feds fails: you can’t do anything realistic, or you would be a bad person. Every intervention in the Middle East fails: same reason. AIDs shows up, so we abandon quarantine: Fidel Castro deals with the situation 50 times better than we did.

The Aztecs thought that the world would end if they didn’t keep cutting people’s hearts out on an industrial scale. They were crazy. But were they crazier than we are?
FDA  regulation  discussion  government  rhetoric  commentary  west-hunter  pharma  policy  meta:medicine  scitariat  proposal  counter-revolution  innovation  stagnation  randy-ayndy  trump  2016-election  alt-inst  money  elections  politics  polisci  variance-components  data  corruption  gilens-page  questions  multi  poast  info-dynamics  institutions  elite  ability-competence  truth  westminster  roots  usa  virginia-DC  is-ought  education  MENA  iraq-syria  disease  spreading  gender  sex  sexuality  prudence  ideology  social-science  empirical  evidence-based  religion 
september 2016 by nhaliday
EpiPenomenon – Put A Number On It!
I am no longer confident that the FDA harms more lives than it saves, and thus I no longer endorse setting fire to it, pending further investigation. What changed my mind was not the commenters disparaging me as a “101 economist” in the comments. What changed my mind was my mom, a long-time professional in the pharmaceutics industry, explaining in detail the rules the FDA plays by and the exact procedures and standards they follow.
ratty  healthcare  drugs  regularizer  policy  len:long  ssc  FDA  regulation  pharma 
september 2016 by nhaliday
Blue or Green on Regulation? - Less Wrong
The FDA prevents 5,000 casualties per year but causes at least 20,000-120,000 casualties by delaying approval of beneficial medications. The second number is calculated only by looking at delays in the introduction of medications eventually approved - not medications never approved, or medications for which approval was never sought. FDA fatalities are comparable to the annual number of fatal car accidents, but the noneffects of medications not approved don't make the evening news. A bureaucrat's chief incentive is not to approve anything that will ever harm anyone in a way that makes it into the newspaper; no other cost-benefit calculus is involved as an actual career incentive. The bureaucracy as a whole may have an incentive to approve at least some new products - if the FDA never approved a new medication, Congress would become suspicious - but any individual bureaucrat has an unlimited incentive to say no. Regulators have no career motive to do any sort of cost-benefit calculation - except of course for the easy career-benefit calculation. A product with a failure mode spectacular enough to make the newspapers will be banned regardless of what other good it might do; one-reason decisionmaking. As with the FAA banning toenail clippers on planes, "safety precautions" are primarily an ostentatious display of costly efforts so that, when a catastrophe does occur, the agency will be seen to have tried its hardest.
policy  government  drugs  medicine  rationality  arbitrage  regulation  lesswrong  healthcare  FDA  unintended-consequences  ratty  pharma  cost-benefit  incentives 
august 2016 by nhaliday
The Future of Genetic Enhancement is Not in the West | Quillette
https://qz.com/750908/the-future-of-genetic-enhancement-is-in-china-and-india/

If it becomes possible to safely genetically increase babies’ IQ, it will become inevitable: https://www.washingtonpost.com/news/volokh-conspiracy/wp/2015/07/14/if-it-becomes-possible-to-safely-genetically-increase-babies-iq-it-will-become-inevitable/

Baby Genome Sequencing for Sale in China: https://www.technologyreview.com/s/608086/baby-genome-sequencing-for-sale-in-china/
Chinese parents can now decode the genomes of their healthy newborns, revealing disease risks as well as the likelihood of physical traits like male-pattern baldness.
https://gnxp.nofe.me/2017/06/16/the-cultural-revolution-that-will-happen-in-china/
https://gnxp.nofe.me/2017/07/26/the-future-will-be-genetically-engineered/
http://www.nature.com/news/china-s-embrace-of-embryo-selection-raises-thorny-questions-1.22468
http://infoproc.blogspot.com/2017/08/embryo-selection-in-china-nature.html

China launches massive genome research initiative: https://news.cgtn.com/news/7767544e34637a6333566d54/share_p.html

research ethics:
First results of CRISPR gene editing of normal embryos released: https://www.newscientist.com/article/2123973-first-results-of-crispr-gene-editing-of-normal-embryos-released/
http://www.bbc.com/news/health-32530334
https://www.technologyreview.com/s/608350/first-human-embryos-edited-in-us/
http://infoproc.blogspot.com/2017/07/first-human-embryos-edited-in-us-mit.html
https://news.ycombinator.com/item?id=14912382
http://www.nature.com/nature/journal/vaop/ncurrent/full/nature23305.html
caveats: https://ipscell.com/2017/08/4-reasons-mitalipov-paper-doesnt-herald-safe-crispr-human-genetic-modification/

https://www.scientificamerican.com/article/first-crispr-human-clinical-trial-gets-a-green-light-from-the-u-s/
http://www.nature.com/news/crispr-gene-editing-tested-in-a-person-for-the-first-time-1.20988
https://news.ycombinator.com/item?id=12960844
So this title is a bit misleading; something like, "cells edited with CRISPR injected into a person for the first time" would be better. While CRISPR is promising for topological treatments, that's not what happened here.
https://www.scientificamerican.com/article/chinese-scientists-to-pioneer-first-human-crispr-trial/
China sprints ahead in CRISPR therapy race: http://science.sciencemag.org/content/358/6359/20
China, Unhampered by Rules, Races Ahead in Gene-Editing Trials: https://www.wsj.com/articles/china-unhampered-by-rules-races-ahead-in-gene-editing-trials-1516562360
U.S. scientists helped devise the Crispr biotechnology tool. First to test it in humans are Chinese doctors
https://twitter.com/mr_scientism/status/955207026333929472
https://archive.is/lJ761

https://www.npr.org/sections/health-shots/2018/01/24/579925801/chinese-scientists-clone-monkeys-using-method-that-created-dolly-the-sheep
https://twitter.com/0xa59a2d/status/956344998626242560
https://archive.is/azH4S
https://twitter.com/AngloRemnant/status/956348983303114753
https://archive.is/RclJG
https://twitter.com/AngloRemnant/status/956352891287228416
https://archive.is/BfHuV

http://www.acsh.org/news/2017/03/07/did-gene-therapy-cure-sickle-cell-disease-10950

lol: http://www.theonion.com/infographic/pros-and-cons-gene-editing-56740

Japan set to allow gene editing in human embryos [ed.: (for research)]: https://www.nature.com/articles/d41586-018-06847-7
Draft guidelines permit gene-editing tools for research into early human development.
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august 2016 by nhaliday

bundles : guvnor

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