Three years in: what has the $42M Atopic Dermatitis Research Network produced?

In July it will be three years since the NIH awarded National Jewish Health in Denver, CO $31 million to create and administer the Atopic Dermatitis Research Network, a consortium of five academic sites across the US. A contractor, Rho Federal Systems of Chapel Hill, NC, won an $11 million contract to operate a center to coordinate statistics and clinical trials for the project.

That makes $42 million—spread over five years—which puts the project on the large end of NIH funding for individual biomedical efforts. The typical NIH research grant ranges from $100 thousand to $2 million, and anything bigger is fodder for university news releases. Which raises the question: what have US taxpayers gotten in return?

I ask this as a patient who is grateful that these scientists are working to understand a disease that affects me, my family, and millions in the US and worldwide.

The answer is not obvious, since the publications page on the ADRN website hasn’t been updated since July 2011.

According to the website:

The Atopic Dermatitis Research Network (ADRN) is a consortium of academic medical centers that will conduct clinical research studies in an attempt to learn more about skin infections associated with atopic dermatitis (AD). The studies will focus on antibiotic-resistant Staphylococcus aureus infections and widespread viral infections of the skin, both of which are more prevalent among AD patients. The ADRN will build on the work of the Atopic Dermatitis and Vaccinia Network (ADVN) which conducted clinical studies focused on making smallpox vaccinations safer for people with AD. 

This research will lead to a greater understanding of the immune system in AD patients and may lead to novel therapeutic strategies to manage or prevent infectious complications associated with this disease. 

The ADRN will conduct a number of clinical studies over the next five years and will be enrolling large numbers of people with AD.

A search on clinicaltrials.gov returns two entries for the ADRN: one (open) to create a database of patients for the study of genetic markers connected to susceptibility to infections, and one (completed) to look into how AD patients respond to a new flu vaccine.

The ADRN’s NIH contract number is HHSN272201000020C. A search in the NIH’s PubMed database returns 12 papers that acknowledge funding by that contract number. Three of those are review papers (which did not involve new research).

So that makes  two clinical trials and nine research papers, three years into a five-year $42 million project.

Should US taxpayers expect more; be satisfied; or be impressed?

The answer is probably that we will have to wait to find out.

In each year, a typical top university research lab operates on about $2-3M a year and publishes somewhere around ten papers. That’s roughly $200k a paper.

Three of the five years in the ADRN contract are up; three-fifths of $42M is around $24M. We might therefore naively estimate that we should have seen upwards of 100 papers produced so far.

Most likely the reasons there are only 12 at the moment are that you don't start publishing papers right at the outset of a project. The research must be done first and then written up; and the process of getting accepted to a journal takes months. And the ADRN appears largely to rely on clinical trials--which take time to set up.

So why do we only see two trials listed on clinicaltrials.gov?

I've never had anything to do with a clinical trial, but when I was a researcher, I conducted animal experiments, and there were formidable administrative hurdles to get over before I could start work. I imagine that trials with human subjects are heavily regulated by the government, and for good reason. So the apparently small output of the ADRN to date is, I'm guessing, because it takes a long time to plan trials, get approval, and conduct them, before you can begin analyzing data and reporting it.

Still, let's keep in mind that the ADRN is an extension of the ADVN. It’s not like the ADRN began from scratch—the scientists had the momentum of existing expertise and administration and research aims.

Looking at the titles of the published papers, I can't immediately judge which are the most important. So I emailed Donald Leung, the principal investigator for the ADRN (he's a professor and head of the Division of Pediatric Allergy and Immunology at National Jewish Health), and asked him whether he could summarize the consortium’s findings so far and highlight key points. I hope to hear back from him soon and perhaps to interview him on the phone.

I’d like to know what ADRN scientists have found that surprises them. What have they learned that is truly new?

And what is going to be truly useful to patients in the end? Publishing papers should not be the be-all and end-all of scientific research. What about patents? I’d like to know whether anyone in the ADRN has thought about controlling intellectual property and commercialization. While it’s true that clinical studies may highlight the ideal dosing amount or schedule for existing therapies, and this does not involve creating a new commercial enterprise, most medical technology must pass through the marketplace before it can benefit the consumer/patient.

Someone has to do the dirty work of developing scientific discovery into therapy, and it’s not academic scientists.

More to come.

End Eczema's mission: please donate to the NEA for research

This past Thursday I spoke on the phone with Julie Block, president and CEO of the National Eczema Association, and Diane Dunn, the NEA's communications and program manager.

I thought that Julie and Diane's outlook was very similar to mine. Eczema is a disease that affects millions of people (in the U.S., 20% of children and 2% of adults, which probably means that 50 million people live with it in the home). It can drastically affect quality of life. It leaves a sufferer open to serious infections such as MRSA, and disqualifies them for military service.

And yet you hardly ever see eczema mentioned in the media. (Can you think of any blogs? Any celebrities?) You rarely, if ever, hear of any fundraising efforts for it. It is, despite being a disease of the skin--and we use the term "skin deep" for something that you have to look beyond to find the essence--virtually invisible.

This is probably because most of us cover it up. I know I do. Why would I want to expose an unsightly rash that reveals my lack of self-control? I wear long pants and shirts with collars and long sleeves. I go to the swimming pool only with great reluctance. People stare, sometimes. They hustle their babies away from your kids to avoid what looks like a contagious rash. We who live with it are ashamed; those who don't are ignorant.

The NEA was the first eczema patient advocacy organization I have heard of in my lifetime. I think they're amazing and they deserve our support. They are primarily dedicated to education and outreach; and this is good. We need to educate ourselves about the best therapies. We need to educate others so they understand. We need to exert pressure on our representatives in government so they direct federal research funding to eczema.

The NEA doesn't make a priority of research, and it can't be faulted. If you've got an annual budget of $500k and several salaries to pay, along with the travel expenses of a national association, you can't  make a significant investment in research. A single molecular biology laboratory, at any major university or institute--Johns Hopkins, U. of Washington, Stanford--runs on at least $1 million a year. A single graduate student costs $50,000 a year. Reagents, antibodies, experimental animals are terribly expensive. The responsibility for funding the research effort lies with the federal government, via the National Institutes of Health.

But there are ways in which grants on the order of $100,000 can make a difference. They can prime the pump; often, in academic research, to get money, you need to have money already, because many agencies will only deliver matching funds. And if you can show that someone believes in your project to the extent of handing over $100k, you can make a better case for why the NIH should give you $1 million. The NEA has seen this happen with grants to researchers Eric Simpson and Gil Yosipovitch.

Also, there is one crucial, oft-neglected zone called the "valley of death." Scientists may make a discovery, funded by the NIH, and this discovery may hold the potential to be a world-changing cure, but if it doesn't get translated into a product or service that can be delivered or manufactured by a commercial company, it stands virtually no chance of helping anyone in the real world. NIH funding drops off steeply after a discovery is made. And venture capitalists won't invest in a project or startup that hasn't shown a viable prototype or undergone clinical trials. The "valley of death" is the arid region between federal and venture funding where many promising ideas have met their end.

Proof-of-concept funding, in packages of $100k, can enable an academic scientist to fund a postdoctoral fellow for a year and buy equipment and supplies to run crucial experiments, build vital prototypes, and do the research to show that their technology has a market. Two examples of institutes that provide this type of funding are University College London Business and QB3, the California Institute for Quantitative Biosciences. In the U.S., proof-of-concept funding can enable a startup company to win a federal Small Business Innovation Research (SBIR) grant that helps it get off the ground.

So: if the NEA were able to make several annual awards of about $50-100k, it could give eczema research leverage that would amplify federal funding and/or increase the rate at which practical cures emerge.

I believe in the NEA and so I am dedicating this blog to the purpose of raising $1 million for the NEA to devote to research. I'm hoping that people who are thus inspired to donate to the NEA will mention my blog to the NEA, so I can have some idea whether I'm getting close to my goal.

And ultimately, the real goal is to end eczema.

Let's start with $1 million

What is the purpose of this blog?

Hey, I'm allowed to be ambitious.

I want to end eczema. Nobody should have to live with this nasty condition. It can make your life hellish; it can make you wish it was over. I know all about eczema. I was born with it about 40 years ago and it has been with me ever since. It's in my family. My father's father had it. A cousin has it. My sister does. And guess what, I've managed to pass it on to my daughter.

To start with, I want to raise a million dollars for eczema research. That's right, a million bucks. This is not a number I associate with any bank account of mine. But I work at a major research university and I know roughly what it takes to get a real project that produces results off the ground.

In fact, a million isn't anywhere near enough to start solving this problem. But we have to start somewhere.

In posts to come I will talk about what we might get started with a million dollars. Now let me say what inspired me to get off my ass and write.

Last year I signed up for the newsletter from the National Eczema Association. These folks are wonderful. I felt like "at last, here's a charity that means something to me." I'm always getting unsolicited phone calls from foundations for breast cancer research, AIDS, veterans, policemen, terminally ill children. And I know that these are all worthy causes. Hell, I have relatives who have died from cancer and someone dear to me is living with it. But I live every day with my personal curse and I never hear about anyone doing anything for me. Now it's not even about me--it's about my children and (I hope) grandchildren. And anyone else who lives with the pain and shame of chronic itch.

So yesterday I get the NEA's annual report in the mail. It lists all their accounting numbers and the times they were mentioned in the media. In short, eczema is not on the media map. And the NEA's budget is too small by a factor of 10, if I'm being generous. Total revenues for fiscal year 2009: $529,668. Total expenses: $525,582. Of the expenses, for support, education, and awareness: $372, 415. For research: $30,961.

That's right, thirty-one thousand dollars.

My business is science, and I know $31k is not enough to pay a single graduate student salary for a year. (I also know that the National Institutes of Health are the major research funding agency in the U.S., and I would like to find out at what level they're supporting eczema research.) But I am convinced, and I have evidence, that patient advocacy groups can make a difference. For one thing, the NIH tends to support basic research and loses interest once that research becomes useful for anything. Patients themselves only care about results.

I know that wealthy philanthropists regularly write checks for many millions of dollars. One or more of these people either has eczema or has a child or grandchild with it. And they might like to donate, but it hasn't occurred to them that they can, or they don't know where to give, or which scientists or doctors are really worth supporting.

I'm going to find the big donors and get their money to work. My hope is that this blog helps them find me. I'll work out the details as I go along. Are you with me?