The HOME III meeting: sausage-making in San Diego

Otto von Bismarck is reputed to have said “Laws are like sausages; it is better not to see them being made.” You could say the same for the process of determining clinical standards for a complex disease. Although I thoroughly enjoyed the meeting I attended last weekend, Harmonising Outcome Measures for Eczema (HOME), I witnessed some sausage-making in San Diego.

Three things became clear to me during HOME. First, eczema (atopic dermatitis) is a difficult disease to diagnose and quantify improvement of. What exactly do you measure when you have an eczema patient undergoing therapy and you want to see if they’ve improved? Dry skin? Redness? Oozing? Does the area of coverage matter? The aim of the HOME organizers was to settle on universal standards.

Second, setting standards is taking a long time. This was HOME III (HOME I took place in 2010 in Germany) and people were already talking about where to hold HOME IV (possibly Japan). Over the course of the first day I became aware that in HOME III we were basically voting on questions that had been left open at the previous meeting.

Third, if you were going to choose anyone to lead a diverse, international group of dermatologists, and hope to get a democratic outcome which everyone could agree was fair, you could do no better than pick Jochen Schmitt and Hywel Williams, who led HOME III. Especially Williams—he kept things moving forward, but his genial, friendly style ensured everyone had a voice and that, though we knew we would rarely have full agreement on any topic, the criteria for coming to a decision were always made clear beforehand. (There were about 50 people in the room, all voting using those wireless clicker devices.)

So what got decided? Boy, I wish I had been taking notes. I don’t completely remember, to be honest! At some point the meeting minutes will get posted.

For the first day of the meeting, Dr. Jasvinder Singh from the University of Alabama seemed to dominate. I wondered why, especially since he apparently didn't know anything about eczema--in particular he didn't know why we were concerned about itch. Later I understood better the reason for his presence and why he was given the floor--he is an expert in "outcome measures" for rheumatoid arthritis. He was there to explain how doctors and scientists have approached characterizing a complex disease, and to help develop a system for eczema.

We spent an awfully long time deciding between two clinical “instruments” for measuring eczema severity: EASI and SCORAD. Both are essentially surveys that ask a doctor to note how severe eczema is across various regions of a patient’s skin, and then calculate a weighted sum, taking into account surface area, to produce a single final number that purports to measure overall severity.

EASI was the winner. (On a side note, I want to say how amusing it was to hear the Danish and Swedish attendees pronounce “EASI” as “ee-AH-zi,” oblivious to the acronym.)

Apparently EASI was chosen because it somehow allows a doctor to rate a patient as having severe eczema even if the condition is confined to a small area. That was my understanding, anyway. While we were discussing the matter in small groups, I argued for SCORAD in the belief that it did what EASI was later touted as doing. The general feeling, though, was that  it didn't matter which one got picked, as long as we chose one, so everybody would be using the same "instrument."

Then we discussed quality-of-life measures. I was asked for my opinion, but had to admit that I hardly understood what they were talking about because the jargon was so foreign to my experience as a patient.

And next, we talked about what symptoms patients might be able to use to report their subjective experience of the disease (e.g. in long-term studies where patients have to keep diaries or report via the internet). I made a rather incoherent point that the symptoms should include not only physical measures but also psychological effects such as shame, anger, and depression. A discussion followed about whether this counted as symptoms or quality of life measures. The result was that I was asked to join the ongoing Quality of Life group. We shall see what this entails.

And finally we had a rather unsatisfying discussion of “long term control” that quickly devolved into an argument about what a flare is. I think people ran out of steam, the meeting ran out of time, and Tijuana and tequila were beckoning for several participants. Hence we didn’t reach any conclusion. Guess it'll get sorted out at HOME IV!

Being part of this felt like watching C-SPAN. At certain points, when things seemed to be going in circles, we benefited from the clear perspective of David Margolis, an epidemiologist at the University of Pennsylvania. Possibly because of his mathematical perspective, he was able to cut through the BS and say that we were using the wrong concept or debating points that had already been decided. I was told later in the meeting by a senior member that Margolis was an extremely valuable contributor. Because he had seemed so critical throughout, I was surprised when he told me afterward that he thought the meeting had made a great deal of progress.

Margolis said that the FDA is not obliged to use the standards that the HOME group decided upon when it comes to judging the success of clinical trials. So this leaves me wondering what the point was; but as the sage said, a journey of a thousand miles begins with a single step. You have to start somewhere, and where better to start than HOME?

San Diego eczema meeting: an intense experience

After you’ve been tormented by eczema your entire life, and always avoided talking about your embarrassing condition, and dealt with doctors whose solution is to prescribe more steroids and expect you to go away happy, what is it like to spend two days in the company of some of the world’s leading eczema experts, talking about nothing else?

It’s pretty intense, I found out last weekend at the HOME (Harmonising Outcome Measures for Eczema) meeting in San Diego, California, where I and four other patient representatives helped clinicians and pharma reps from the US, UK, Germany, Japan, Brazil and other countries define how eczema severity should be characterized in clinical trials.

I’ll cover the technical details in a later post. Right now I just want to describe the experience.

I had been invited by Julie Block of the National Eczema Association. She introduced me to Gil Yosipovitch, Jon Hanifin and others. My initial feeling was one of awe. Many years ago I realized that scientists were actually studying itch and eczema when I read a New York Times article about Yosipovitch’s work. Now here I was on Saturday sitting with him and Block, eating fish tacos and getting my balding head sunburned.

And  then Hanifin walked by. He developed the original criteria, now used worldwide, for diagnosing eczema in the clinic. In the conference room, was that Eric Simpson of Oregon Health Sciences University? And Hywel Williams of the University of Nottingham, the UK leader in eczema research? It was surreal—the equivalent for a tennis fan, say, would be being in the same room as Roger Federer, Rafael Nadal, Andy Murray and the Williams sisters.

Also present along with me were several other patient representatives, three of whom either had eczema themselves and one who was the father of two affected children. Among them were Stephanie Merhand, founder of l’Assocation Francaise de l’Eczema (from Toulouse, France) and Rosemary Humphreys from the National Eczema Society (in the UK).

At first, it was a bit strange to meet people with whom you have nothing in common but a medical condition, but over the course of the two days I came to realize that it was not so much the eczema we shared but similar life experiences: the days and nights of itch, the social anguish.

During a short car ride, Tim Burton (a UK patient) and I traded stories about the various pharmaceuticals we’d inflicted on ourselves. It was hilarious. I’d given up on Protopic because it burned so badly. Tim uses it on his face. “It’s like holding your face to a three-burner fire for a couple weeks, but it eventually stops,” he said. Sounds like fun! I informed him that the best way to take prednisone was as an injection in the buttock.

In the working sessions I had cognitive dissonance hearing my condition discussed openly and unemotionally. I’ve spent nights tearing with my nails at scalp, my arms, my feet. I’ve endured, as anyone with chronic eczema does, the social pain of high school and university, the outings and activities missed, the relationships that never happened. Eczema is something that makes me want to hide in the basement. And here were people calmly displaying Powerpoint slides and droning on like it was a graduate seminar in statistics or comparative literature.

The jargon really was incredible. In casual conversation you were supposed to know what “xerosis,” “oedema,” “erythema,” and other words meant. You were supposed to be familiar with the acronyms for what seemed like fifty different clinical techniques. You were supposed to know the difference between “signs” and “symptoms,” which turned out not to be so clear-cut.

At one point I was asked what I thought about a topic they’d been discussing for fifteen minutes. I had to admit I hadn’t understood a word. It felt a bit like being a laboratory rat listening to scientists describe experiments they’d done on you.

That is why we patients were invited—to humanize things. “You might not realize it, but you are changing the tone of the session just by being here,” Roberto Takaoka, a dermatologist from Brazil, told me. Several of the presenters opened their talks by showing pictures of children or adult patients and reminding everyone that we were doing this for the patients. Apparently many doctors tend to “treat the disease, not the patient” and meetings without patients can become even more abstract and academic. Rosemary Humphreys told me that it she was on a crusade to get scientists to use the word “patient” instead of “subject”—“I’m a linguist and I know what the difference means,” she said.

At the same time, I remarked that we patients were treated as equals by the academics at this meeting. And everyone was committed and attentive and sincere. If anyone was checking their iPhone it was me. That says something.

As time went on, I realized that I was surrounded by some of the world’s top dermatologists and could get free consultations for myself and my kids just by asking. For example, if your daughter says that Cerave (a ceramide cream) is burning her cracked hands, you can get the clinical benefit of the cream by first rubbing her hands with olive or safflower oil, than applying Cerave, and then putting Vaseline on the cracks. And apparently 3M has a great new surgical tape that sticks to anything but doesn’t hurt the skin when you peel it off. You can use it like a Band-Aid on greasy skin.

It was sobering to know that after having gone to this meeting I now know as much as most people on Earth about the state of eczema therapy at the moment and in the near future. There are no miracle cures in the offing. But there are many intelligent, motivated doctors and scientists working on our behalf to make things better. Not as many as there should be, and they are not funded nearly well enough. We need to get involved to let them know how important this work is and to make sure they get the support they need.