THREAD: This year’s #shotwave tweet is unusual. Not about a flu shot (though I got one back in September). This year I am participating in a randomized, controlled trial with my mom. We are both enrolled in a #COVID-19 vaccine trial. 1/15 @DrsMeena #StandBackImGoingToTryScience
We enrolled on day 1 at our University of Michigan site, in the Michigan Clinical Research Unit (MCRU), where I enroll and see a lot of #IBD patients participating in clinical trials. #IBD patients (on immunosuppression +/- steroids) would not be eligible for this study. 2/15
20K participants will get vaccine, 10K will get salt water (saline) placebo. This is one of 4 vaccines that are likely to be ready in large numbers in January (if they work and are safe) 3/15
Why did I participate? In part, because my patients can’t. And they need an effective vaccine (preferably, multiple effective vaccines) as quickly as possible. And lots of my patients volunteer for trials to get access to new therapies before they reach the market. 4/15
I figure this is my turn to volunteer. Even if I get placebo, I will have helped move a (likely) effective vaccine closer to approval, and helped establish safety. We need a lot of doses – about 640M for the US, about 15B for the whole world. 5/15
Why did my mom do this with me? In part, she is high risk (75 y/o) and would love to go back to socializing normally and seeing people again. But it is also family tradition to participate in vaccine trials, going back to 1954. 6/15
In 1953, her baby brother, Robert (Bo), was diagnosed with polio, and spent more than 6 months in a hospital recovering motor function. When the Salk vaccine trial was announced, her parents made sure to get their other kids in line. (picture of Bo ~ 50 y later w/family) 7/15
My mom was 8 years old when she got an injection at her local fire house with 2 of her brothers (Polio Pioneers). They were cluster-randomized by fire station, so they all got placebo (but did not get polio that summer – all the pools were shut down) 8/15
More than a million children were enrolled, still the largest randomized controlled trial in human history. When the trial results were announced on April 12, 1955, it was done live at an international press conference in Rackham Auditorium at the University of Michigan. 9/15
Because Salk was a virologist, he needed a clinical trialist to test the vaccine, especially with the low event rate. He knew Tommy Francis (his former mentor) was the right person. Dr. Francis had embraced the new (at the time) technology of punchcard computing. 10/15
The press conference was broadcast live in every country in the world, and began with “The vaccine works. It is safe, effective, and potent.” president.umich.edu/wp-content/upl… 11/15
So, in the fall of 1955, all of the children who received placebo (including my mom and her brothers) went back to their local fire stations to get the Salk vaccine (for free) before they returned to school. 12/15
Today there is a plaque on the 5th floor of the University of Michigan hospital dedicated to Tommy Francis, and residents rotate on the Francis service. 13/15
Vaccine technology has changed a lot (mRNA vaccines, adenovirus vaccines with exchangeable cassettes), but the need for lots of volunteers hasn’t. My mom and I will be getting our 2nd injections this Friday. I hope you will consider volunteering for a trial. 13/15
We will have to science our way out of COVID-19, as public health measures have not worked well in the US (unlike NZ and Australia), largely due to poor leadership. I hope you will consider joining a vaccine trial 14/15
And I hope you will get vaccinated when we have approved vaccines available. #shotwave mmheadlines.org/2020/11/covid-… 15/15

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More from @ibddoctor

1 Nov
THREAD: More data about PPIs and SARS-CoV-2 coming out. Is there a consistent association across studies? @statsepi @DrToddLee @supermarioelia @mikejohansenmd @ADAlthousePhD Increased prevalence of ARDS in those taking PPI at baseline: onlinelibrary.wiley.com/doi/full/10.11…
prior use of PPIs associated with higher rate of death in COVID-19 infected patients. medrxiv.org/content/10.110…
Severe COVID-19 outcomes in Korea associated with PPI use gut.bmj.com/content/gutjnl…
Read 8 tweets
14 Jul
@MaartenvSmeden @AllonKahn @georgemsavva @IBDMD @ADAlthousePhD @doctorira @tmorris_mrc @BrennanSpiegel @NYUDocs @statsepi There is some very weird stuff going on in this sample (as pointed out in the open letter), and given the high response rate to an online survey, lots of hard questions need to be asked of CINT (the survey company) about how they get respondents.
@MaartenvSmeden @AllonKahn @georgemsavva @IBDMD @ADAlthousePhD @doctorira @tmorris_mrc @BrennanSpiegel @NYUDocs @statsepi I worry about the data source more than the analysis (though people certainly can make coding/labeling errors, and data/code repositories and code review are helpful). I can imagine a lower rate of respondents >60yo in an online survey. And maybe low rate of GERD depending...
@MaartenvSmeden @AllonKahn @georgemsavva @IBDMD @ADAlthousePhD @doctorira @tmorris_mrc @BrennanSpiegel @NYUDocs @statsepi On how the question is asked. Asking about "heartburn" tends to be a lot more sensitive than asking about GERD (jargon). But ~16x lower vs a comparable sample seems too much. The gender ratio is odd, but odd things happen. But when you get to the high RR for SARS-CoV-2 in 30-39..
Read 9 tweets
29 Apr
This Saturday, May 2nd, will be a little sad for me. I (and about 13,000 of my GI friends) would have been in Chicago for @DDWMeeting. That won't happen. So I decided (with a few friends) to have a get-together. A #TotallyUnofficial "Poster Rounds".
In a webinar format over 1 hour, at 3PM EDT, noon PDT, 8 PM UK time, 9 PM CET, with informal presentations and discussion of 4 posters. We will have two posters that would have been presented at the meeting, and two "late breakers"/works in progress.
Our new IMIBD section vice chair, Fernando Velayos @Realcecum and I will host. @charlie_lees will lead off with a presentation of his new study of #IBD telemedicine across countries, a topic we have all had to become familiar with very rapidly in the Time of #COVID19
Read 8 tweets
25 Feb
Questions today about the risk of coronavirus nCoV-19 in #IBD patients on immunosuppressive therapies. We don't know a lot, as this is quite new. The most up-to-date information can be found at the CDC website cdc.gov/coronavirus/20…
It appears to be spread by respiratory droplets, generally when you inhale droplets from a cough or sneeze from a nearby person (usually within 6 feet). Do #IBD patients have increased risk for this respiratory virus?
By analogy to influenza, another respiratory virus spread by droplets that we know more about, #IBD patients have about a 50% increased risk of influenza. This risk goes up by about 20% more if you are on steroids. ncbi.nlm.nih.gov/pubmed/30020478
Read 8 tweets

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