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This story is from the Anamnesis episode called Abandoned and starts at 3:10 on the podcast. It’s from Marty Makary, MD, MPH, editor-in-chief of MedPage Today and professor of surgery and health policy at Johns Hopkins University. Following is a transcript of his remarks:
Early on in the pandemic, in the months of March and April, doctors were asking really good questions like, “What percent of those infected are asymptomatic?” Or, “When are you most contagious? If you do a viral swab on somebody every day, on what day do they have the greatest virus shedding? How much virus particle is in the air? How much is aerosolized or spread through microdroplets?”
Well, as a researcher who has five national grants and spends over 80% of my time now doing research, I of course said, “How do we pivot our research team to study coronavirus?” We wanted to study these most basic questions and what we learned is that the hiring process to get a nurse to run some of these trials at our institution is about six months. We learned that the IRB has to approve it and us getting an IRB together with all the intricacies of the irrelevant questions we have to answer, it takes at least a week to put together and then the IRB meets once a month. We learned that in order to get funding for it we had to apply for a grant and those grants take about a year.
Oh my God!
We went to the CDC, the NIH websites, we called around, and we were told that there should be some upcoming announcements on grants through the traditional mechanisms. Well, those mechanisms take a year and I realized, oh my God, our entire research infrastructure is unable to do research in an emergency, and everyday Americans, everyday docs, are left without an answer to the most basic questions the public is asking.
Finally, I went to a private institution. They saw the vacuum of research and how all these crazy opinions and politicians were filling that vacuum with all sorts of extreme radical ideas on both sides that were not scientifically based — that’s what happens when there’s a research void — and overnight they were able to fund Johns Hopkins and FAIR Health to do some very important research to ask some basic questions.
So we decided, “Hey, we’ve got access to the largest claims-based data in the country, all the Medicare claims data in real-time, and we can use this to study COVID risk factors in the largest study of COVID mortality risk factors ever done.” We did an intense literature review, confirmed it had not been done before, and we decided — the “we” meaning my research team at Johns Hopkins — that we would embark on this study to do the ultimate analysis with a very sophisticated regression modeling to identify the risk factors of dying of COVID. Something that was, we thought, desperately needed to understand who should get the vaccine or the new therapeutics like antibody therapy, or in cases of rationing care, who should we put first?
These were some basic questions that we wanted to answer, so we went to our Medicare dataset and we said, “Let’s pull the data using the new COVID diagnosis code that Medicare established on April 1st.” What we found is that the files with the COVID data, the most recent files, were not available to us. I contacted people at CMS and explained to them we wanted access to this. We were told, “Well, you have to go through and submit an additional request for an additional data use authorization.”
People Are Dying — They’re Playing Games
We basically said, “Look, it’s covered under our existing data use authorization.” They said, “OK, well send it and we’ll review it.” They reviewed it, they took their good old time, and they said, “You need to do another data use authorization.” I’m like, “OK. By the way, 2,000 Americans are dying every day as you guys play games over there.”
I finally called the head of CMS, Seema Verma, and told her, this is absurd. We already have access to the data. We’ve already gone through the cybersecurity training. We’ve used this data for years. This is access to the servers. Just let us see the COVID files. They wanted to charge us $35,000 to allow us to see the COVID files in the CMS database. Now, OK, fine. I’ll pay you $35,000, CMS, to see the files, but the payment system is clunky. It takes time. They need, like, a paper check with a photocopy that it’s been cashed.
Seriously, the absurdity of these bureaucratic games with the government … and I told them when we were going through this long $35,000 fee that we had to pay to just add the COVID files to our existing data access on the servers. By the way, I negotiated it down to like $25,000. Finally, we got the data. By the end of the summer, after haranguing and calling all sorts of officials in the government, we got access to the data.
We did the analysis, reported the largest study of COVID mortality risk factors to date, including several novel risk factors. I had no idea that sickle cell disease had such a high risk of mortality. We basically took these results, turned it around into a paper quickly, and within days I got on the phone with the editor of the Journal of the American Medical Association, JAMA, and explained to him what we had and that we were ready to release it, and we were ready to give them sort of an expedited submission.
Well, I was told, “I’ll give you a call back.”
They ran it by their team, and I was told they’re going to pass on it, and I’m thinking, “What? Oh, my … OK.” I said, “Look, we’re just going to put out a report. We’re going to send it to other journals, but in the meantime, because of a moral duty to inform the public of our findings, we’re going to post it on the preprint server, the preprint access site called medRxiv.”
‘We’re Going to Hold Off’
We put this out and we told our communications department at Johns Hopkins, “Hey, can you put out a press release that we’re releasing a report with the largest study to date of COVID risk factors of mortality in the world?” They came back with, “We are going to hold off on putting out any press release until it’s in a journal and published.”
We’re like, OK, you know what? We got blockers from outside the institution. We got blockers from inside the institution. We had all sorts of hurdles we had to cross at our own IRB not getting back to us. Again, during a health emergency, very frustrating. It’s been a journey. Ultimately, the research has gotten out there. But we used the platform of Johns Hopkins and the platforms that I have. I do worry that everyday docs that had basic research questions about coronavirus transmission and prevention were unable to act on those research questions because of this giant bureaucratic infrastructure dominated by the old guard medical establishment. Nobody wants to cut corners on research, but we’ve got to cut out the waste.
Our normal time and cycle for discovery and dissemination of information is way too freaking long. It’s absurd, this idea of you put something in an abstract form, you submit it, then you sit back and relax and wait to hear back three months later, then the conference says, “Sure, you can present it next fall.” Then you present it at the meeting, and then you submit it to a journal, then it goes into a queue, and a year and a half after the research discovery the rest of the medical community learns about it in a peer-review publication. That’s a disgrace and it doesn’t work during a health emergency.
Check out other stories from the Abandoned episode including “The System Failed Us” and “Patients in Pain Left Out and Left Behind”
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Source: MedicalNewsToday.com
