Jacquie Lee Profile picture
Jun 11, 2019 5 tweets 2 min read Read on X
.@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 Image
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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More from @_jacquie_lee

Sep 30, 2020
As drug CEOs begin their testimony they're getting sworn in to tell the whole truth &nothing but the truth

CEOs had to do that at last year's drug pricing hearing too, but some statements were misleading

Here's a reminder of what happened last time: news.bloomberglaw.com/health-law-and…
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

Last year @Genna_Douglas @JasmineHanYe and I looked at spending on R&D vs CEO pay. We found instances of CEO pay rising at a much faster rate than R&D spending: news.bloomberglaw.com/health-law-and…
Read 12 tweets
Sep 9, 2020
Senate HELP hearing on #COVID__19 and flu vaccines starting now

Francis Collins from NIH and Surgeon General Jerome Adams testifying

Trump and CDC says a vaccine could be ready by Nov. Fauci says that's unlikely.
Today will be about fostering public trust in the FDA/potential vaccine

Public messaging blunders (like w convalescent plasma) has shook some confidence but scientists assure safeguards will prevent a rushed process

more details about vax hesitancy here: news.bloomberglaw.com/health-law-and…
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."
Read 5 tweets
Jul 13, 2020
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

theatlantic.com/health/archive…

theatlantic.com/family/archive…
This part of WaPos story really stuck out to me: 'At the clinic, Shriber told a nurse and a doctor that she worried she had appendicitis.

After pressing down on Shriber’s abdomen, a doc claimed she would have been “screaming in agony” if she had appendicitis, Shriber recalled.'
Read 4 tweets
Jul 10, 2020
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)

nejm.org/doi/full/10.10…
When should we release info about a #COVID__19 drug and when should we hold on to it to get conclusive results?

It's a hard thing to balance...people are so hungry for info, docs/scientists tell me

What do to? (3)
Read 4 tweets
Jun 2, 2020
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"
Read 13 tweets
Mar 26, 2020
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)
Read 7 tweets

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