BETHESDA, Md. — At what was supposed to be the end of his tenure atop the National Institutes of Health, Dr. Francis Collins is still a very busy man.
In his seven and a half years leading the agency, Collins has been involved in the response to Ebola and Zika. He has helped secure the first funding increases for the NIH in decades. Congress just this month funneled billions of dollars into several major projects — the Precision Medicine Initiative, the cancer moonshot — that Collins helped craft.
This was supposed to be the finale for Collins. But, as he told STAT in a recent interview in his offices here, he loves the NIH and believes in public service, so if asked he would consider it a “privilege” to remain director under President-elect Donald Trump. Many researchers and members of Congress would like to see him stay. Nobody knows yet if he will.
Below is his full conversation with STAT, in which he reflects on NIH’s past and future. The transcript has been lightly edited for clarity and length.
Tell us about a few programs that you are most excited about.
As far as areas of exceptional opportunity, I’d start with the Precision Medicine Initiative. This unprecedented national study of health has recently been renamed and now it is called “All Of Us.”
The very bold agenda is to seek a million or more Americans to become our research partners. The new name conveys what we want to say, which is that this is not an academic exercise; this is about all of us. We want our participants to be at the table in every way. They’re partners, they’re not passive subjects. They are intimately engaged in all we’ve done so far and everything we will do. And we expect to launch the recruitment process in the spring.
I’m not saying a specific date right now, because we want to sure that we have everything completely in place, particularly the security systems, which have to be of the highest possible quality.
How will you ensure the security?
The information we’re going to collect from volunteers will include electronic health records, and personal information that the participants answer about themselves. It will include laboratory data — and ultimately complete genome sequences. All of this needs to be treated with great sensitivity if we’re going to honor the relationship we have with our participants to protect their confidentiality. We are building the data system to be state of the art. And, we will be doing a hack-a-thon, probably around February, and just invite a bunch of smart hackers to see if they can break into our system. If so, we’ll ask them, “tell us how you did it,” and we’ll be sure we patch that hole.
Just imagine how transformative this program will be! We had a really interesting session a couple of weeks ago with all of the NIH institute directors, where Eric Dishman [the director of the initiative] laid out what this platform is going to look like for doing research. You’ll have a million people on whom you’ve already collected a lot of data and who are consented for recontact if you wanted to ask them to participate in additional studies.
With a million people you’re going to have 80,000 to 100,000 diabetics, for example, and if you want you can offer to those folks an opportunity to test out some new biomarker for diabetic control or say, “Hey, would you like to be somebody who take part in a clinical trial of an artificial pancreas clinical trial?” This should enable the setting up and implementation of clinical trials at the fraction of the time and a fraction of the cost that it currently requires.
Newt Gingrich is considered a champion of federal research funding, and is close to president-elect Trump. Have you talked to Mr. Gingrich about staying here?
I have had interactions with Newt every few weeks, and that includes since the election. It’s my routine.
Have you been asked to stay?
I have not.
Would you be willing to stay?
The NIH director is appointed by the president. In almost every instance, when there is a change in administration, there is a new NIH director. You have to go back to 1960 to find an exception. So my assumption had always been that come Jan. 20, I would be going back to my lab. There I was planning to have a really excellent time working with postdocs, students, and techs to continue the research on diabetes and aging that I’ve gotten very attached to.
But there has been, as you are no doubt aware, an effort on the part of congressional leaders to propose that it might be reasonable for me to stay on.
Who are the NIH champions now?
We have many champions now — people like Tom Cole, Roy Blunt, Fred Upton, and Lamar Alexander, the four that signed that letter, and quite a few others as well. That’s gratifying and having that strong relationship to build on gives me confidence that going forward we should see some sort of a stable trajectory for NIH support.
There have been other individuals and organizations that have been reaching out saying, ‘Would you be willing to stay?’
I love NIH. I think the mission of this organization is extremely compelling. I’d even say it’s a noble mission, aiming to try and reduce suffering. People are looking to us for hope for with illnesses that currently can’t be managed. I’m also someone who believes in public service. So if I was asked to stay, I would I would consider it a privilege to do so.
What has it been like to work with a true science-nerd president, Barack Obama?
Having the chance to spend time with President Obama and seeing how his mind works has been an amazing experience. He really does ask the best questions of anybody in the room.
What is it like to talk science to Congress?
It’s been a really positive experience to be able to build a relationship with people in Congress who are not generally scientists, but who can get really interested and can learn a lot and can become real advocates.
Believe me, it’s not because they’re pushovers — but because they want to understand what NIH is doing and why it matters. Then they are often willing to put their weight behind it.
People say to me, “Oh, part of your job is you have to go talk to Congress, that must be horrible.” Not at all!
I really can’t remember any of those discussions that went badly, and most of them went really well. I guess I kind of like explaining what our biomedical research community does, because it’s so compelling. It’s not like I have to make up stuff. I just explain the reality of it and then people get excited.
You mentioned what it’s like to work for President Obama, who has a deep, abiding interesting in science. If you had, hypothetically, somebody coming into the office who was just not wired that way, how might you approach that situation?
I’d like to understand how that person generally likes to receive information. There are people who like to read books, there are people who are not interested in books — they say, “Tell me something interesting.” And then there are people who are visual learners — “show me a diagram of what you’re talking about,” versus people who want to have tables or want to have words. I’d first want to know what’s the best way to convey information to somebody who is ready to receive it.
When I’m meeting with a member of Congress, I bring along written materials, I bring along diagrams, I bring along my words, and I try to figure out early on what kind of information is getting the best reception. And if I can, I invite leaders to visit us here at NIH. I accompany them into a laboratory to see what people are doing, or we walk onto one of the wards here where you have children with cancer who are being treated with experimental therapy. Anyone who talks to that child or that child’s parents will be changed. Nobody has that experience without having a memory of it for years to come.
Have you heard of anyone other than Scott Gottlieb or Jim O’Neill to run FDA?
There’s been some suggestion that maybe Rob Califf might be asked to stay. I’ve seen at least one mention of that.
And you two work well together?
Very well together. He’s been fantastic as FDA commissioner and a research partner. Right now, the relationship between NIH and FDA is closer than it’s been in a long time.
Why is that important?
Well, we are sister government agencies. We’re charged to try to move research forward and make sure that the results of the research benefits the public by being effective and safe.
With Peggy Hamburg, I started an NIH-FDA Leadership Council, shortly after I became NIH director. That has continued up until now, with the senior leadership of both agencies meeting every quarter.
You are a strong proponent of partnerships, including industry-government partnerships. Why are they important to you?
I really believe in the value of partnerships — whether that’s between government agencies or whether it’s between public and private funders. A good example is the Accelerating Medicines Partnership (AMP) that I had the privilege of helping to found, and that’s now going fantastically well. AMP involves 10 pharmaceutical companies working with NIH on Alzheimer’s disease, type 2 diabetes, rheumatoid arthritis, and lupus. It’s now two years along and includes a very precisely defined set of research milestones, virtually all of which have been achieved so far.
That same model is now being explored for cancer with something called PACT, the Partnership for Accelerating Cancer Therapies. That has 12 companies working with us at NIH. Tentatively the focus will be on two particular areas. One is the development of biomarkers that would be good predictors of response to therapy. The other is development of a template to support combination trials for cancer, because none of us expect that single therapies are going to cure cancer very often.
The problem is most investigational cancer drugs are made by individual companies, and each company only has a few. If you want to design a trial to test the ideal combinations, it will often involve drugs from different companies. In the past, it has been difficult to figure out how to work together.
How are you working on that?
The idea is to just put together a template, which the companies now agree is needed. That framework would allow initiation of combination trials that could get people quickly enrolled without having three years of lawyers fighting with each other. Combinations of targeted drugs and immunotherapy are how we’re going to get cancer cures much more of the time.
With the Cures bill finished, what is coming up in Congress that’s important for you?
As thrilled as I am about the Cures bill — and I really am — my anxiety is that it might be seen as the only thing that NIH needs in FY17. As you know, the funds in that bill, wonderful as they are, are limited to four projects: cancer, precision medicine, the BRAIN Initiative and regenerative medicine.
But the regular appropriations process is now postponed by a continuing resolution until April 28, 2017. That means all of the efforts in basic science — the work in multiple different disease areas including Alzheimer’s and infectious disease, or rare disease research — will basically be in a holding pattern until April.
And there are certainly a lot of people that are anxious that by delaying a decision until April, we might end up with a yearlong continuing resolution. That would be disastrous for the momentum that has been built so strongly across our entire research area portfolio, which would then be seriously slowed down.
I have wonderful allies in that effort in Roy Blunt and Tom Cole; they are appropriators who like to appropriate.
Their FY17 mark-ups last summer provided strong indication that they wish to continue the upward trajectory for NIH that they started last year. I would like to be optimistic about a good outcome, but there are going to be an awful lot of things happening this Spring on the Hill that could potentially distract from taking care of this issue.
Do you have any regrets?
I wish I’d been able to inspire decision-makers to provide more resources for NIH. I’ve been here for seven and a half years. For the first four or five of those, we saw steady erosion of the purchasing power for research. That put the squeeze on scientists that depend on us for grant support, particularly scientists stage investigators who are just getting started.
We watched success rates gradually shrink back from where they should have been to under 20 percent. I regret that we did not get that situation turned around until the last couple of years.
What have you been most pleased with?
One of the joys of the job was the founding of the National Center for Advancing Translational Sciences (NCATS), which happened in the first couple of years that I was director, against some resistance. NCATS focuses on translational science and has done some amazing things to accelerate treatments and cures.
It has also been enormously gratifying to help design and launch a few other significant projects: the BRAIN Initiative, the cancer moonshot and the Precision Medicine Initiative.
That being said, I fully recognize that the main source of progress in biomedical research will continue to be the individual investigator with a great idea — but these large scale community resource projects can empower all of those scientists.
Let’s say you’re not NIH chief. What kinds of changes would you be wary of?
NIH has benefited greatly, over many years, by being kept outside of partisan jockeying and political interference. The administrations and the Congresses have generally kept hands-off when it came to inserting earmarks or special preferences about where the funding should go.
They have generally agreed that scientific leaders are in the best position to understand where scientific opportunities reside and to adjust the funding accordingly. But political leaders also want us to defend how we make those decisions. And that’s entirely reasonable.
We did that in a particularly concrete way a year ago in the strategic plan that we published. That explanation of stewardship won us a lot of additional support and credibility.
But if this longstanding dynamic were to shift, and decisions started to be made more on the basis of political expediency or special interest, rather than on the basis of scientific opportunity, that would be a major concern.
I think the United States has led the world in biomedical research for the past many decades, in large part part because the steering of research directions has been free of that kind of political influence. Instead NIH has been able to focus on where the greatest opportunities were. I wouldn’t want to see that damaged in any way.
An earlier version of this story incorrectly identified the Partnership for Accelerating Cancer Therapies as the Partnership for Advancing Cancer Therapies.