.@ScottGottliebMD at a #postlive event on AI medical devices: imaging apps are here but applying AI broadly (like in clinical trials) further away from a reg standpoint
On precision medicine: lots of Qs that need to be answered. Can’t answer those in “reasonably sized” clinical trials so FDA allowing approval based on small trials. Need for robust post market follow up
.@SGottliebFDA on the Post’s story re: Pfizer not publishing data on Enbrel and Alzheimer’s
Says there wasn’t a need to publish the research. Already known anti inflammatories didn’t have large effect
“Damned if you do, damned if you don’t”
A little side note that’s unrelated: Gottlieb notes earlier he’s worked with Pfizer in the last and “I’ll be working with them most likely in the future”
.@ScottGottliebMD on fentanyl and opioid crisis: getting prescribing #s down and keeping them down important but we must look at imports and seizures on the border—that’s where lots of problems now happening
“The growth in seizures dwarfed the decline in medical prescribing”
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Most of the CEOs testifying today and tomorrow are not from the same companies as last year. I bring up last year's hearing as a reminder to fact check what you hear during hearings like this where there's so much $ on the line
Also, you're going to hear a lot about spending on R&D to explain high drug prices
Collins: The pause in AstraZeneca's Covid-19 vaccine should be "reassuring" to people bc it shows that companies taking safety of a vaccine very seriously
"We won't compromise on safety. This is exhibit A."
Some thoughts on this well researched @washingtonpost piece on student health centers
Idk if it's just bc of the sample pop that responded to Qs from reporters, but a lot of the examples in this story are from women. Many instances where a symptom--physical pain-- is minimized
Women (especially women from minority groups) are more likely to have their pain minimized or misunderstood & be misdiagnosed bc of it. The Atlantic has some great stories on this
Thread: What's frustrating about Gilead's announcement re: remdesivir's '62% reduction in the risk of mortality' is that it will create even more confusion for people about what we know about treating #COVID__19
bc Gilead itself says it needs to actually confirm that 62% (1)
As others point out, we had a double-blind, randomized, placebo-controlled trial of remdesivir use in adults from May👇
-'Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant' (2)
Senate hearing on FDA inspections of foreign drug plants starting now. Quality concerns have existed for years
Remember: FDA paused most foreign drug plant inspections in March due to #COVID19 March
In mid-May FDA said still postponing routine domestic and foreign inspections
From last week, per @annaedney: 'U.S. regulators are contacting pharmaceutical companies that make a popular diabetes medication after some of the pills were found to contain high levels of a chemical that can cause cancer.'
.@RonWyden says FDA commissioner @SteveFDA should be at the hearing. He's not here "bc the Trump administration blocked his testimony" to "prevent the committee from holding the point person for the FDA accountable"
THREAD: Here's what this means in English, why it matters, and how it's another example of FDA weighing heavily on the pharmacy community during #COVID2019 (1/7)
What FDA did was add the malaria drug Trump keeps touting as a potential covid19 treatment, hydroxychloroquine, to a special list of drugs.
Certain pharmacies can now make big batches of it & sell it to health care facilities w/out getting dinged by FDA (2/7)
Since Trump keeps pushing the malaria drug, it's been hoarded & places around the US have spot shortages
It doesn't ONLY treat malaria. It treats lupus, rheumatoid arthritis& other conditions. A lot of those people now can't get it bc everyone is buying it for #COVID2019 (3/7)