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NIH Director: Collaboration Amid Chaos, and Biden’s First 100 Days

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A new week, and a new administration that has taken over the pandemic response. Now that 1 million vaccine doses are administered almost daily, President Joe Biden has increased the daily vaccination goal to 1.5 million Americans.

What will the COVID national strategy actually look like under a new administration, and is Biden’s goal achievable?

To explore those questions, and what the future of collaboration in science looks like, we chat with NIH Director Francis Collins, MD, PhD.

The following is a transcript of his interview with “Track the Vax” host Marshall:

Francis Collins: I’m glad to be with you. Let’s talk about what’s happening.

Marshall: Let’s talk. There is a lot happening. You are now the only presidentially appointed NIH director to serve more than one administration. The country itself just underwent that transition of power, a transition of the presidency. Some feel that it’s also a transition point in this pandemic. As now the longest serving NIH director, how do you describe the moment we’re in, in our country and in this pandemic?

Collins: Well, let’s be honest. It’s been an incredibly difficult year of 2020. And here we are now with the deaths of more than 400,000 people from this worst pandemic in 103 years. And we are not done. Maybe we’re starting to see just a little bit of a turnaround in what has been the highest rate of hospitalizations and deaths ever since it began, but we still have a long way to go to get out of these terrible woods.

So for all of us at NIH, seeing that we are the largest supporter of biomedical research in the world, we have a big responsibility here to push this forward in every possible creative, innovative way to try to come up with better approaches for diagnostics, for therapeutics, for vaccines. And I have been utterly consumed by that now for more than a year. Pretty much 24-7, working about a hundred hours a week, last time I ended up. Just trying to make sure we are not missing any opportunity to bring the best possible science to bear on this terrible pandemic.

Marshall: Having transitioned now, though, from the Trump administration into the Biden administration. You’re one of the few carryovers from former President Trump’s COVID Task Force. How do you see things evolving or changing from what was set up then to what we’re dealing with now?

Collins: It’s a little hard to tell this being still very early in the Biden administration exactly how all of the science efforts are going to be organized; but there’s such a sense of encouragement that science is at the table. Science is going to be the way in which decisions are made. Science is being invited to be innovative and creative, you know, a lot of really remarkably bright people joining this administration.

So that’s encouraging to all of us. I will say maybe one of the reasons I’m still here, in my third administration is because, thank goodness, medical research remains one of those last topics that is really not gotten so deeply involved in politics. And so my relationships with people in politics, whether they’re in one party or the other, whether they’re in one branch or the other, generally tend to be pretty supportive because everybody’s counting on medical research to come to the rescue when something really bad is happening for human health. And that’s where we are right now.

Marshall: And NIH is involved with so much of the science that has gone on behind the scenes with this pandemic. You use the term that you’ve been ‘deeply involved,’ that science has been ‘invited into this process.’ But I have to ask, as much as we here at Track the Vax like to stay out of politics, we’ve heard Dr. Birx saying that she thought about quitting the task force a number of times. Dr. Fauci recently implying sort of similarly. How was it for you working under the Trump administration?

Collins: Mostly, I’ve tried to keep my eyes on what we can do and not to get too drawn into that. There have been some moments that were stressful. Whereas scientific decisions were sometimes, overruled by political considerations. And that was not a happy circumstance that you would really want to have to take part in.

And yeah, there were a couple of times where I, too, wondered am I doing the right thing by staying in this situation? But I’m glad I did. I think again, the best thing I could do is to try to bring whatever skill I have in terms of science, medicine, and management of research to try to help the people of the world who are suffering.

Marshall: We just heard President Biden set a new goal of 1.5 million vaccinations a day. Is that feasible? Should the goal be higher?

Collins: You know, it’s interesting. Everybody’s trying to figure out what should be the way in which we portray the goals and there’s various approaches to this. And I learned this running the Human Genome Project more than 20 years ago. You want to give a stretch goal so that people think, “Wow, that’s really going to be hard to meet, but maybe we’ll be inspired to do it.”

But you don’t want to be so much of a stretch goal that it’s going to fail for sure. And then everybody feels discouraged and the public gets disillusioned. So how do you hit the mark right? Some people would say you’re better off to under promise and then over deliver. Put forward something out there that you’re pretty sure you can meet and then surprise people by exceeding that kind of goal.

There is no right answer there. I guess, what’s really limiting what can be done is the ability to manufacture doses. And despite the fact that people seem to think that’s a dial you can just turn, it doesn’t work that way. The manufacturing requires a factory. It requires a production line. It has to be incredibly high quality and quality checked and sterile and all of that.

So, the main thing that’s keeping us from being able to ratchet this up right now is that between now and the end of March, even with everything going really well, there will only be about 200 million total doses of Pfizer and Moderna together. And since that’s a two dose strategy for both of those, that’s a hundred million people.

It’s really hard for me to see how we would get beyond that; unless the Johnson and Johnson vaccine ends up also being safe and effective. And we hope to learn that very soon. That would be a big boost. Although, again, let’s not be over the moon; that probably could not happen in terms of the full approval by FDA and their public committee until the middle of February.

So maybe we would get a boost in doses by March. But still, I think anybody who tells you that we’re going to be able to immunize substantially more than a hundred million people by the end of March, just haven’t looked at the realities of what the production can put forward.

Marshall: A sobering explanation of exactly where we are. And I’m glad you mentioned a moment ago the Human Genome Project. A major international, collaborative effort that you led. Did we have something similar with COVID or what lessons did you take from that experience and apply with this pandemic?

Collins: Well, it was my privilege to lead that effort, which involved, ultimately, 24 hundreds scientists in six countries. All working together. Not worrying too much about who got the credit. Setting very rigorous and yes, stretch goal milestones. And then holding ourselves accountable. I learned a lot in that process about how you can get people to work together in a fashion that might not previously have been so easy to do.

We have applied that in COVID in several ways. A particularly dramatic one, is this partnership called ACTIV, which stands for Accelerating COVID-19 Therapeutic Interventions and Vaccines, A-C-T-I-V. This was formed with efforts that I made reaching out to industry back in April. Brought together, ultimately, 20 pharmaceutical companies, multiple NIH institutes, academics, the CDC, the FDA, the veterans administration, BARDA, the Department of Defense, all around the same table to say: “Okay, how do we do some things that aren’t happening right now? How do we figure out — for therapeutics: What should we be prioritizing? There’s hundreds of ideas out there, but which of those ought to get first into the clinical trials? And how do we set up those clinical trials? And how do we write master protocols that we’ll be sure that the trials are run in a fashion — well, you’ll know what happened.”

And by the way, let’s do that for vaccines, as well. So ACTIV was a fundamental contributor to getting our show on the road here, in terms of COVID science. When you notice that those vaccines have all basically focused on 30,000 participants in a randomized trial, where did that idea come from?

Well, that was from ACTIV. In that group, which continues to work incredibly hard today. About a hundred people from industry and academia and government have continued to shape our effort in an unprecedented way. And nobody ever expected that that would be possible. And there’s a lot of skepticism about whether people would figure out how to work together.

But we did! And I co-chair that executive committee with Paul Stoffels, who’s the chief scientist at Johnson and Johnson; and the people involved at the very highest levels have thrown themselves into it. So that’s a lesson maybe came out of the Genome project that when you want to do something really hard, let’s get all the smart people involved and don’t worry too much about what country they come from or what sector they’re in.

Let’s just do this. And we did it.

Marshall: A huge lesson in collaboration. Did stepping away from the World Health Organization — – I didn’t hear you mention them as part of the players in ACTIV. But did stepping away in the midst of a pandemic hurt collaboration when it came to responding with all of those different groups and individuals?

Collins: Well, many of us thought it was really unfortunate to step away from WHO and from COVAX, but frankly science has always been international. We continued those relationships more informally. We continue to have people in Geneva talking with WHO about our shared efforts. It’s not realistic to say in a worldwide pandemic that you can’t work or you shouldn’t be working with the rest of the world.

As we see new variants arising in South Africa and Brazil. Could anybody say that it’s not, even in the U.S.’s self-interest, to be engaged with the rest of the world? Of course it is. I’m really glad we are back in that mix. I, frankly, think we got through it okay. Despite some high-level decision-making about breaking the links. The links were still there.

Marshall: And you just mentioned the new strains. I want to ask you about that and when it comes to the vaccines. You’ve said previously that there needs to be a more coordinated way to look at these ’emergency variants and understand their effect on a vaccine or monoclonal antibody therapy.’ I believe your quote was: “the data is kind of scattered around.”

So what can be done to ensure that collaboration continues? And what can we do to ensure that the vaccines we currently have are applicable to these new strains?

Collins: Well, this is the current obsession of mine. So thank you for asking. Again, tapping into this ACTIV partnership. We have now put together a more coordinated plan about how in the U.S., that kind of surveillance mostly done by CDC, can be scaled up so that we’re finding more and more about what’s out there. And also putting together database opportunities where all that information immediately gets deposited, not just: what is the latest genome sequence.

But what is the latest data about what that one would do to vaccine responsiveness or to monoclonal antibody responsiveness. Because all those experiments are getting done in academic labs and government labs and industry labs. But until now there’s been no central place for the data to be deposited.

We’ve got everybody to agree that’s what we need. We are setting that up right now to make it possible. And then of course it needs to be an international effort. There is this database called GISAID, which is the place where a lot of these viral sequences are placed and that has been helpful. But frankly, they need to work on their data access because that’s been a bit of a barrier and we’re right now trying to see if there’s a way to open that up. And working of course, with our colleagues at WHO, at the Wellcome trust in England, and with the Bill and Melinda Gates foundation who have a big stake in this, as well. So yeah, people were connecting.

Marshall: You said that you’re working to set it up. What’s that timeline look like? Can sequencing efforts and your timeline keep up with the new strains that we’re seeing?

Collins: Sequencing efforts in the U.S. are already scaling up pretty dramatically thanks to CDC bringing in more samples from all over the States. Putting out contracts to companies that can do viral genome sequencing very quickly. And so, yeah, you’re going to see a steep uptick in the collection of the data.

And that’s a good thing. And likewise, the databases I’m talking about are being put together right now. So this is not something for six months for now. This is something we need right away.

Marshall: We’ve heard so many ‘scientific wins’ in this first year of this pandemic. It sounds like what you’re describing would be another one. As someone who’s in it every day, do you feel that way?

Collins: Huh…That’s a good question. Yeah, I do feel like it’s been an amazing experience to see what science has been able to accomplish. And the vaccines are, of course, first on the list there. The idea that we had FDA granting emergency use authorization to two vaccines less than a year after we first learned about this new coronavirus. Just is unprecedented in so many ways.

And is an incredible testimony to the people who worked so hard to make that happen. And it’s not just that, it’s what we’ve been able to do with therapeutics. I’m seeing things come forward. Remdesivir, more recently. Colchicine. High dose heparin for people in the hospital. Monoclonal antibodies. All of those advances as well, happening on a scale and at a timetable never previously attempted. At the same time, I’m an impatient guy.

I see the death toll mounting and I wish we could have gone faster. And I feel like we have to do everything we can today. I have to make sure we don’t waste an hour. I’ve worked on other competitive projects. We mentioned the Human Genome Project and you felt that sense of urgency there, too, but people weren’t dying if you failed to get a good sequence out of your machine that day.

This time, it feels so much more urgent. Like we just can’t afford to make any mistakes or miss any opportunities. And so, yeah, I’m thrilled with what we’ve done, but boy, we’ve still got a ways to go and I wish we could go even faster.

Marshall: I don’t think people really realize how much goes on behind the scenes. Was there enough transparency in the data and the research as it was being done? As it was presented to the public?

Collins: Probably not. We can never over-communicate. I think at a time like this where everybody’s really hungry to find out what’s going on. And certainly a lot of the science efforts were like, you know, just trying to get the job done. Pushing the clinical trials as fast as we could. Posting information on websites that people may or may not have seen.

I think when it came to the vaccines, because it was such intense press interest that people really did know sort of day to day what was happening. And they still do. And the fact that all the data from the trials got very publicly discussed in FDA advisory committees. That was great. That’s a good model.

But when it came to a lot of other things — where we are with therapeutics. What about diagnostics? Mostly people feel like diagnostics didn’t work very well because they got off to a bad start back in the very beginning of this.

We run a program called Rad-X. Rapid acceleration of diagnostics, which has put together in the space of only about seven months, a whole set of new technologies that allow you to do detection of the presence of the virus in minutes.

And many of these now are point-of-care. They don’t have to be done in a big box laboratory somewhere. And we are just about to mount a trial to see what happens if you basically give those to people and let them use them themselves at home. Will that change the way in which this whole epidemic can be stopped? By finding out who’s infected and getting them to isolate themselves instead of finding out days later.

So all of that, I think, hasn’t received a whole lot of attention. But it is also pretty dramatic in the pace at which the science has gone forward.

Marshall: I want to ask you, because you just mentioned, that you believe vaccines perhaps had more transparency than some of those other therapeutics. We just heard from the new CDC director that they don’t know how many vaccines there are. How is that possible?

Collins: Well, let’s be clear. We know how many vaccines there are that are in phase three trials. That’s very closely watched.

Those are the ones that have the best chance of actually getting approval. But yeah, a lot of people have some other ideas about maybe this, maybe that, there are more than a hundred of those.

Most of those will never make it through to the point of being approved for clinical use. It’s good to have that creativity out there, but anything that’s likely to be offered to the public in the next few months, we sure know about those.

Marshall: And do you think those, some of those missteps in communication, undermined trust in medical institutions and doctors?

Collins: I think more of the problem about undermining the credibility of institutions and doctors comes from other sources. Partly, maybe, was that we didn’t communicate enough about what was going on. But there was this deluge of information. Now that was frankly, deeply misleading and often laden with conspiracies that basically overtook a lot of the social media discussion.

We were not prepared, I think, to try to come up with a counter attack for that kind of misinformation campaign. And that’s where we really, I think, are paying a price. When you see how many people are skeptical about whether they want the vaccine or not.

Although it’s getting a little better now that things are more realistic. And you ask those people: why are you skeptical? They will generally point you to something they read on social media, which frankly is based upon information that’s just not correct. So yeah, I think we are finding ourselves in a circumstance where from now on it will not be sufficient just to be transparent about the facts.

You also have to deal with the fact that there’s a lot of misinformation. Some of it is really quite intentionally misleading being put out there by people who have another agenda.

Marshall: Dr. Collins, it almost sounds like you’re alluding to some political officials in some ways, but also perhaps misinformation and conspiracy theories.

Collins: All of that has been a part of this past year. And I have got to say, for me, it’s kind of heartbreaking. As a scientist, as a physician, as somebody who cares a lot about health research and saving lives, to have that obstructed by information, which people should know better. Or maybe they don’t want to know better and are spreading this around. It is heartbreaking to see this.

Maybe one of the things I worry most about in our culture, our society, right now, is this ability to discount facts. To say that, you know, if you believe something, then it’s true as opposed to let’s check and see if that’s really right.

We have a serious issue in our country with that kind of culture, which does not require somebody before taking a position to actually know what they’re talking about.

Marshall: But hasn’t misinformation and conspiracy theories always been an age old problem in epidemics and public health. What do you think it’ll take to instill public trust in the scientific process?

Collins: Yeah, you’re right. If you look back when smallpox vaccination was being put forward. Even at a time where many people were familiar with how lethal that disease could be, there were a lot of conspiracies and a lot of resistance and demonstrations against it. I guess, you might think at this point that we are more scientifically sophisticated and wouldn’t fall into that trap — being the most technological society in the world.

But apparently, we human beings are still capable of getting into a mindset that’s driven by something other than evidence. It’s a tough question. How do we turn that around? Because it’s not just about how people respond to vaccines. It’s about everything in terms of what is truth? And what is your standard for deciding something really is reliable that you should attach yourself to. As opposed to accepting the latest, crazy thing that came across your Facebook post.

Marshall: Interestingly, Gallup had seen a 15-point one-year increase in the percentage of U.S. adults who now say they have a great deal or quite a lot of competence in the medical system. That’s coming in the midst of the pandemic. The highest on record since Gallup began tracking it in 1993. Fifty-one percent still seems quite low, especially when you’re talking about doctors, who people literally trust with their lives.

But at the same time, you have trust in political institutions at an all time low. How does that catch an agency like yours, the NIH, in the middle?

Collins: Well, again, I think we, NIH, have had kind of an image challenge all along. I’ve been at NIH now for 28 years. Initially coming to run the genome project. And now for the last 12 years as the director of NIH and you ask somebody on the street: “What’s NIH?” Only about 15% of them will actually know.

They will know CDC. They will know NASA at a very high percentage. But NIH? “I’m not really sure what that is.”

So, yeah, maybe that’s something we need to work harder at, or maybe it doesn’t matter too much to have the brand. I would much rather have people be able to say: “Yes, our nation is invested in really important and productive medical research that is saving lives and we need to continue to support that.”

That would be a happier kind of statement for people to sign on to. And I, again, I would argue people who want to look at the evidence about how this has prolonged survival until this past year. Thanks to COVID we’ve lost ground. How this has resulted in remarkable advances in terms of what you might call the health span for individuals being able to live long lives without being prematurely cut down by chronic disease.

Heart attacks down by more than 70%, strokes likewise. HIV, which used to be a death sentence, now compatible essentially with a normal survival. Hepatitis C now a curable disease. I mean, you could go on and on down this list and talk about an investment that has paid off in terms of suffering. And even in terms of economics. I think we’re at the top of that list and I wish that was more broadly known.

So maybe your system here that we’re talking at “Track the Vax” will hit a few ears and people will get that.

Marshall: That’s our goal. Looking forward in clinical trials in the midst of this pandemic, where do we go from here? Will we see the collaboration that we discussed earlier continue through the pandemic and perhaps into other medical diagnoses and treatments?

Collins: I think we will. But I think we really have to work at that because the default would probably be to slip back into the old ways of doing things and into complacency. And if there’s anything we should have learned from this is complacency is your worst enemy. And if we have another pandemic coming, and it would be very hard for somebody to say “that’s not going to happen” given the traditions over many years, then we ought to be prepared in a way that is guided by what we’ve learned this time.

And we’ve learned a lot this time! Things like this ACTIV partnership that I mentioned earlier. We need to keep that going — where there’s free exchange of information and scientific planning between the academic and the industrial sector. We need to continue to do things like we did with developing these new diagnostic technologies. Where we basically invited small businesses that had a beginning of an idea to jump into something we called our shark tank. And to get all kinds of free and very sophisticated advice about exactly what they needed to do to reduce their idea to practice.

And then if they look like they had promise, found money to get them the ability to scale up (thank you Congress for providing the funds).

And that’s why right now we are doing about 600,000 tests a day. It’s about a third of the total. All of that coming from this program that just started last April. All built on the incredible creativity of these small businesses in academic labs. That was an amazing experience. That was sort of NIH becoming a venture capitalist and it worked.

And we want to be sure we don’t forget that. And we could apply that to other things. So, yeah, I’m quite excited about taking this set of lessons forward. And I think everybody else kind of feels that way. But time might work against us if we get through this and people begin to forget just what we did and why it mattered and that this could be needed again.

Marshall: Dr. Collins, thank you so much for joining us. Really fascinating insights and we appreciate your time.

Collins: Glad to talk to you, Serena. We got a ways to go, but we’re going to get there. We are going to get through this.

Source: MedicalNewsToday.com