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/
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/
Dr. Cavazzoni may be a fine person, wonderful physician and scientist. That is NOT the point. So don't go there. We've seen a bending over backwards from @US_FDA over the past few years, so the question of industry influence is real and needs to be investigated by Congress. 4/
Hey there @SenWarren, @RepKatiePorter. Seems like this is right up your alley. 5/
We just had an approval for a wide indication rammed through the agency, with objections from its own advisory panel, independent experts who are aghast at the post-hoc analyses that don't even themselves show much of a signal of clinical effects. And yes, it's $56,000 a year. 6/
And yes, industry folks shouldn't be barred from public service, but if you cannot see the problems with veterans of an industry going in to regulate the same industry they came from, I don't know what to say to you. 7/
As many have noted, there has been a shift at the agency over the past few decades, in which coziness with the industry is showing up in the way they talk about these shoddy approvals (e.g. remember Exondys). 8/
And please, the industry is the largest lobby in the US and is used to getting its way. In fact, someone recently said to me that industry thinks that the FDA Commissioner post under Biden is "their" choice to make. 9/
So, one bad move is a mistake, a series of them over the past few years is policy. I've watched the agency since at least 1990, protested and went out to protect it, but the latest decisions there are warning signs we should all heed. 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
9 Jun
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…
Read 8 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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