Great news… @califf001 nomination for @US_FDA seems imminent. And this is a wise choice for someone with the experience, skills and vision to lead at this critical juncture. Sooner we get confirmation, the better. politico.com/news/2021/11/1… Image
@califf001 @US_FDA It is rare to have a Commissioner who has the experience to hit the ground running, and the expertise on the far-reaching responsibilities of the agency, and deeply understands the science. He also knows the potential gamechanging nature of the digital revolution for regulation.
@califf001 @US_FDA To move forward we need a Commissioner who can bring people together and fight on behalf of patients for a system that better servess them. I believe that is what @califf001 can do. I have known him a long time, and can judge by actions, not just words.
@califf001 @US_FDA My quote in @washingtonpost: “I think he would be terrific,” said Harlan Krumholz, a cardiologist at Yale School of Medicine. “It is critically important to have a commissioner who can step in and knows the job and knows how to make policy decisions.”
@califf001 @US_FDA @washingtonpost And I said, for those concerned about his relationships… Califf’s supporters say his experience strengthens his hand in dealing with industry. The agency must be “skeptical and rigorous,” but also work w/manufacturers, which “are the ones delivering the products,” Krumholz said.

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More from @hmkyale

8 Nov
We published today a study on acute hypertension hospitalization trends, led by @yuan_lu1 and news is not good. Over last 20 yrs rates markedly increased even though this can be prevented w/simple & inexpensive strategies. ahajournals.org/doi/10.1161/CI… @YaleMed @YaleCardiology @CircAHA
@yuan_lu1 @YaleMed @YaleCardiology @CircAHA And disappointingly but not surprisingly, the highest rates of acute hypertension hospitalizations were among Black patients, who also experienced the steepest increase over last 20 years. The hypertension crisis is also a health equity crisis. @AHAScience
@yuan_lu1 @YaleMed @YaleCardiology @CircAHA @AHAScience The increase in acute hypertension hospitalizations occurred in all subgroups. Makes sense since hypertension control is worse over time; hypertension deaths are rising. This must be recognized as a national crisis. @JeromeAdamsMD saw this as Surgeon General. This work is so imp.
Read 6 tweets
8 Nov
Resistant #hypertension is elevated BP despite the use of 3 antihypertensive drugs. We now introduce persistent hypertension, a broader concept of persistently elevated blood pressure. @amjmed amjmed.com/article/S0002-… @YaleMed @YaleCardiology #BloodPressure
@amjmed @YaleMed @YaleCardiology Resistant hypertension focuses attention on those already treated with maximum doses; persistent hypertension is broader, those with persistently elevated blood pressure, for a wide range of reasons - and this is the vast majority who languish at high risk. @yuan_lu1 @amjmed
@amjmed @YaleMed @YaleCardiology @yuan_lu1 To make progress against hypertension we need to focus intently on those with persistent hypertension; high bp readings over time, without progress. There are so many reasons; and many are social in nature. And this burden falls hard on Black patients in particular.
Read 7 tweets
7 Nov
So privileged to work with the brilliant @VirusesImmunity … she said @washingtonpost: “We have a big dream,” Iwasaki said, describing a sweeping goal of understanding the development of long covid and other post-acute-infection syndromes. washingtonpost.com/health/2021/11… @YaleMed
@VirusesImmunity @washingtonpost @YaleMed The dream is to bring together life science, data science, clinical epidemiology, & digital technologies/software to solve previously intractable conditions that cause much suffering. And to do so in true partnership w/those facing the condition, being worthy of trust every day.
@VirusesImmunity @washingtonpost @YaleMed We will enlist learning community, participating together, sharing wisdom, & being co-producers of research, in traditional & non-traditional ways- setting new standard for quality & speed & utility of the knowledge generated. Researchers working for & on behalf of the community.
Read 9 tweets
4 Nov
This @NEJM paper really puzzled me and I wonder what I am missing. It addresses good question…should people on antidepressants in primary care, who are doing well, discontinue them? And good methods, randomized, double-blind trial treated in the UK. But… nejm.org/doi/full/10.10…
@NEJM They randomize 478 people w/at least 2 depressive episodes and w/ at least 2 years of treatment with antidepressant agents. They discontinue in half (after a taper) and replace with placebo. Primary outcome is relapse of depressive symptoms. OK, good so far. But...
@NEJM At a year, relapse occurred in 39% of those continuing antidepressants and 56% in the discontinuation group. Now that means that 44% of those who discontinued did fine. That seems really good - and a chance many would take. And that continuing still had a horrific relapse rate.
Read 6 tweets
4 Oct
Our paper dropped: Performance Metrics for Comparative Analysis of Clinical Risk Prediction Models Employing Machine Learning. We show 'commonly reported metrics may not have sufficient sensitivity to identify improvement of
#ML models…’ @CircOutcomes ahajournals.org/doi/abs/10.116…
@CircOutcomes Risk models are ubiquitous now. In this paper, we 'propose the use of a comprehensive list of performance metrics for reporting and comparing clinical risk prediction models.’ Time to expand the metrics. @CircOutcomes ahajournals.org/doi/abs/10.116… @YaleMed @YaleCardiology @AHAScience
@CircOutcomes @YaleMed @YaleCardiology @AHAScience We review a wide range of options for assessing the performance of risk models and demonstrate the neccessity of a comprehensive view in any evaluation. Paper was led by Chenxi Huang. Also with @jbmortazavi; SL Normand; @jspertus @CesarCaraballoC @Dr_BowTie65 @DrJRums
Read 6 tweets
28 Sep
"The @PCORI Board’s approval of $61.3 million will enable eight PCORnet CRNs to optimize their infrastructure resources and capacities to support PCORnet in its third phase." What is the total spent on PCORnet to date? What are the deliverables to date? pcori.org/news-release/p… Image
@PCORI And asking w/respect, just think the accounting of resources spent & deliverables provided is good hygiene for funders. And what resources from the effort are publicly available for others to leverage? Since this is such a big investment, regular reports on ROI is useful. @PCORI
@PCORI And this might be available, I just didn’t know where to look. By the way, similarly with @NIH, who previously reported that almost half of their funded trials were never published. Quarterly reports on trial funding and deliverables (results reported), for example, also great.
Read 4 tweets

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