4 ms·
90% of all drug candidates that are brought to the FDA for approval fail one of the FDA’s required studies. It is probable that some of the 10% that pass and ar
by db48x 5y ago
90% of all drug candidates that are brought to the FDA for approval fail one of the FDA’s required studies. It is probable that some of the 10% that pass and are approved are marginal, and someone at the FDA has to make a judgement call. Thus it is likely that occasionally a drug is approved which later turns out to be ineffective or even dangerous. But it seems to happen fairly rarely, and it’s quite rare that people resign in protest.
- gnicholas 5y agoWhat I couldn't tell was whether the "scientific advisors" are FTEs or some other role. It would take a lot for someone to give up a government job/pension, so three resignations of that nature would be incredible. But if these are just part-time consultants, the statement would be less notable.
- wiredearp 5y agoIf it's a fake drug that's been priced at a level to break American health care [1], they could potentially be this kind of employee that actually care or perhaps they just considered the corruption too obvious even for the FDA and wanted to clear themselves of charges. [1] https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-drug-alzheimers-cost-medicare/619169/ https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-dr...
- jdavis703 5y agoGovernment STEM positions tend to be under paid vs the private sector. A lot of these people are taking a pay cut because they want to serve the greater good or work on an interesting problem.
- prepend 5y agoIt depends on the position, TE are probably less than tech sector, but salary for PhDs in basic sciences are great in government (ie, biology PhD starting at gs12/13 is $120-150k). So if you want to do “science” then a government job is likely one of the highest paid jobs you can get.
- stonogo 5y agoYou may have misread the pay schedule. You'd have to be a GS14 in San Francisco to make $150k. In most of the country a GS12-qualified biologist would only bring in six figures at the highest stepping. Good universities and national labs (contractors, not DOE employees!) pay way better.
- prepend 5y agoYes, you’re right and I overestimated the pay. But it’s still good. It does vary by location [0], but is still good compared to universities, I’m not sure about National labs. For example, the first regional pay table for Albany has gs13s starting at $93k and topping out at $121k [1] and San Francisco starts at $112k and tops out at $146k [2]. [0] https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2021/general-schedule/ https://www.opm.gov/policy-data-oversight/pay-leave/salaries... [1] https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/21Tables/html/AL.aspx https://www.opm.gov/policy-data-oversight/pay-leave/salaries... [2] https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/21Tables/html/SF.aspx https://www.opm.gov/policy-data-oversight/pay-leave/salaries...
- sgent 5y agoThese are outside advisors, probably about 1/2 of them or more are academics as well as patient advocates, etc. They maybe paid some amount, but its not their primary income source.
- amanaplanacanal 5y agoIt looks like in this case it was known to be ineffective when it was approved. I thought the FDA was supposed to protect us from snake oil like this?
- lazide 5y agoThey are - it’s also a thing that corruption happens. There has been a lot more corruption than usual the last 4+ years in gov’t offices, and it will be a long time before it’s all identified.
- WarOnPrivacy 5y agoFDA's state of compromise goes a lot farther back than 4 years. ref: https://www.forbes.com/sites/matthewherper/2016/09/20/approving-a-muscular-dystrophy-drug-ignites-civil-war-at-the-fda/ https://www.forbes.com/sites/matthewherper/2016/09/20/approv...
- naasking 5y agoJust go back to the history of anti-depressants 20+ years ago. Technically they don't work any better than placebo.
- l33t2328 5y agoWhat evidence is there that there has been an abnormal amount of corruption? What is the normal baseline?
- kbelder 5y agoI suspect the baseline is measured in outraged Twitter posts per hour.
- Supermancho 5y agoThis is some data about corruption over the years https://trac.syr.edu/tracreports/crim/646/ https://trac.syr.edu/tracreports/crim/646/
- hanselot 5y agoIn reality mail-in emergency authorized gene therapy related mortality-cases are extremely rare and the FDA and WHO are bastions of integrity and truth. In fact, you will find that all the agents at the FDA have been secretly engaged in a campaign to "secure" the approval process, to protect our democracy and society from the evils of critical thought and reason.
- unishark 5y agoIt is also possible that some which are rejected can actually help people, but that the study targeted the wrong outcomes or included subjects with the wrong disease. Alzheimer's is especially difficult because there are many dementias with the same symptoms and different causes.