So the #Aduhelm approval is just the latest and worst example of regulatory capture by the @US_FDA. Read this story by @matthewherper from 2016 starring @DrWoodcockFDA. 1/ forbes.com/sites/matthewh…
And over at oncologics, it's just a shitshow. 2/ healio.com/news/hematolog…
I was there when accelerated approval was pushed for @FDA for HIV. We made a devil's bargain: early access with a promise of data, evidence later. In many cases, this data never arrived. 3/ treatmentactiongroup.org/publication/ac…
Now industry, along w credulous, desperate or conflicted patient groups are all-in on approval now, data later, we'll figure it out with "real world" info or doctors can figure it out in clinical practice. We've lost the battle we hoped to win in 2015. 4/ nytimes.com/2015/06/11/opi…
And what the fuck is @POTUS doing? There is no permanent commissioner and @DrWoodcockFDA is the problem NOT the solution. @WHCOS 5/ statnews.com/2021/01/24/hig…
And the large cancer groups and docs who pushed @DrWoodcockFDA because they support approvals with little or no data on clinical benefit and endpoints can go to hell. That doesn't serve patients at all. It's peddling false hopes with a high price tag. 6/
With the #Aduhelm approval, the floor just fell out of the @US_FDA. There is no bottom anymore. This was an irresponsible decision set up after years of erosion of standards at the agency, a drift from its public health mission into a giant rubber stamp. 7/
This is just wealth transfer to companies and private actors on the backs of patients, the backs of taxpayers. It's deeply, deeply corrupt. Time to clean house @US_FDA. end/

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More from @gregggonsalves

10 Jun
Great to talk to @adamfeuerstein @megtirrell & @damiangarde today for the #Readout for @statnews. 1/
The @US_FDA approval of @biogen’s Alzheimer’s drug is a shanda, an abominable disgrace. 2/
Adam asked me if I was “anti-industry” as part of the conversation. 3/
Read 6 tweets
10 Jun
What does it mean when the @FDACDERDirector's pre-@US_FDA life is almost exclusively @pfizer & @LillyPad with a short stint in academia of about 3 years? This is at least raises conflict of interest concerns. 1/ Image
In a larger sense, it's like someone in the coal industry going into the @EPA to "regulate" emissions from coal-fired plants. It just raises the question, who at @FDA thought "fox regulating henhouse" was a good idea? 2/
It's also a case study in regulatory capture. Handing the keys to drug regulation to an industry veteran is not a good look for @DrWoodcockFDA or @US_FDA. 3/
Read 10 tweets
8 Jun
I have never spoken publicly about my father’s descent into dementia. He survived polio in the 1930s, the poverty of his upbringing to become an educator in NYC for 30+ years. 1/
He never got a definitive diagnosis but was lost to us ten years before he died. My mother kept him safe and comfortable for a decade at home at great expense for a family of NYC schoolteachers. 2/
So fuck you @DrWoodcockFDA. You approved this drug not to help people like my dad but to appease industry. You have surrendered the public trust long ago. This is the first time you’ve put business before people, the public health and the public trust. I abhor you. 3/
Read 6 tweets
7 Jun
So proud of our @YaleSPH & @YaleLawSch students in our @YaleGHJP clinic who put out this provocative, new report on public health funding. 1/ law.yale.edu/yls-today/news…
Short version. You get what you pay for. Decades of underinvestment paved the way for the catastrophe of the American #COVID19 pandemic. We need a bold new strategy to dig us out of this mess. 2/
First step: The centerpiece of sustainable public health funding in America should be a new mandatory funding stream insulated from attempts to divert these funds to other uses. 3/
Read 27 tweets
6 Jun
There is an all out assault on the right to vote happening across the country. For @Sen_JoeManchin and @SenatorSinema this does not matter. A core tenet of democracy is not worth fighting for in their minds. 1/
There is nothing sacred about the filibuster in an age when one party is hell bent on pure obstruction. They are willing to trade away people’s right to vote for a fantasy of bipartisanship. In the end the right to vote comes in second to comity. 2/
Let this sink in. They will not resist stripping the right to vote from Americans, will support attacks on the franchise, will ASSIST in making it harder to vote coast to coast. 3/
Read 5 tweets
3 Jun
This thread isn't about #COVID19, but #HIV, #HCV, about #opioids, about people in this country who are more interested in political point-scoring, whose own beliefs are mired in myths about drug use, who will ignore science, again & again to serve their careers. 1/
This thread is also about heroes. The people of Scott County, Indiana who showed up at their county commissioners' meeting last night to speak truth to power, to shine a light into the darkness of these men's souls. 2/
Let's be clear: Mike Jones and Randy Julian--two Scott County Commissioners--killed needle exchange last night. They've become the best-friends-forever of HIV and HCV in their county. Each new case is on them. The sorrow. The expense of it. 3/
Read 21 tweets

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