Mrs. Wilkerson Goes to Washington

Oh boy. This is going to be a long one for sure. Since I have two types of readers – those that want to know every detail, and those who just prefer the 50,000 foot level – I have done this as a choose-your-own-adventure style of post. Immediately below is the high level version of my story. (Or, at least, as much as I can make it that way.) Lower down, I have my notes from the meetings I have been in. Enjoy, and thanks for the support!

Back when Noah had died, there was an evening of us all sitting around the dinner table, Chris and I and our family and close friends, just before the funeral. It was a time of life when I fluctuated from being numb to being so overcome with grief I could hardly breathe. I knew at the time that stepping up and doing something to prevent others from going through the excruciating pain that I felt at having lost my son was going to be part of my journey. We talked a lot about it that night. My aunt is a legislator in the state of Missouri, and my dad was a political science major in college, and has since always had a healthy respect and sense of ease in our governmental processes, and our rights as Americans to step up and say something if need be. I couldn’t figure out how we would get there. I just knew that if it was meant to be (and I felt that it was) that somehow this would all come together.

Through a crazy set of circumstances, the way to do it appeared in my life, and last May, we were able to change the way newborn screening is handled in the state of Colorado. I got to fully enjoy that victory for a day or two before I had a really tough grief week, ruminating on the fact that I can work hard to save every other baby in my state, but not my own son, and how completely unfair that was. Also, that we had won the battle, but what of the war? Things are good in both of my home states: Missouri and Colorado. But what about the others? Can I rest knowing that children are at risk there too? That another new family may experience the gut wrenching moment of their new baby being healthy and normal to not in a split second? I don’t wish my experience on anybody, so it was time to think bigger.

I started off by reaching out to all the contacts that I had made through our journey to change the Colorado state policies. Does anyone have any contacts? Can I get on the national news to share my story? Who do I need to speak to in Washington? How do I get that valuable appointment to do it? How would we do this trip? I haven’t ever left Aaron overnight since he was born. How would I handle that? Or would we just all go, plus a grandma to help?

An option that presented itself was the Save Babies Through Screening Foundation. A mom in Denver saw our story unfold when we pursued legislation at the state level that was highly active in this group. She contacted me, and we have since gotten to be Facebook friends. She put me in touch with the leadership of this group, and it has been interesting to learn from them.

I saw them post on their Facebook page about attending an upcoming meeting called the Secretary’s Advisory Committee on Heritable Diseases in Newborns and Children through the Health Department in Washington DC. I couldn’t breathe when I saw it. (Who says Facebook is a complete waste of time?!) Basically, the Secretary of Health and Human Services in Washington DC has an advisory committee of doctors and geneticists from the CDC, the American Academy of Pediatrics, from all the leading genetics organizations and labs across the country. They meet to discuss the latest issues in the field, and then make recommendations to the Secretary of the Health Department. The Secretary then chooses which things to make an official policy. Finally! HERE is where I need to be! It was too late for me to register and go at that specific meeting, but I saw that they meet once a quarter or so, so I knew September would likely be when the next one would be.

I contacted the Save Babies Through Screening group and told them that I would like to speak to this committee, and to ask how I would go about getting on the agenda. They said that this was the perfect environment to take my concern, and that they allow comments from the public. Furthermore, they would pay for my travel to get me there!

The trip came together quickly, just two weeks before the actual meeting, once we were sure I could register and get on the agenda. I started to organize my comments and practice them. Everyone said that they usually give three minutes, so that was what I prepared. I did some shopping to make sure that I looked really professional and put together as well. I also did some research into the committee members too. It seemed to me like a large committee would break up into sub-committees that would address the various issues brought before the group. Looking at their website, I saw that they have a laboratory standards and procedures sub-committee, which seemed like a perfect fit for what I was fighting for – a more aggressive turnaround time on newborn screening tests. I found lists of the sub-committee members and googled them to find pictures and any kind of biographical information that would be relevant so I would easily recognize these people and know how I should address them when I met them face to face. The Save Babies group also put me in touch with another mom that was going, and a genetic counselor that advocates for the group as well as having a more active role with this committee. I also put together a handout with my story and my contact information that I could give out to help them remember me when I talked to them. I started to feel nervous, but ready.

There was some stress over speech length. In the past, they have given people 5 minutes to talk. More recent meetings, they backed it off to 3 minutes each. I panned my comments based off of that time estimate. The week before the meeting, I got an email saying that I would have a minute. WHAT?!?! I talked to the Save Babies group that was sending me, who promptly went in and negotiated it up to two minutes. She stressed that the chairman of the committee is a real stickler about that, and if I went over, he WOULD cut me off and be a jerk about it. Crap. After cutting things back, I still was at 2 minutes, 20 seconds. There was literally nothing left I could cut out. So…read fast?!

Finally, it was time to jump on a plane and go. I got to Washington DC with no problems. I got checked into my hotel and had a nice dinner, and ran through my speech one last time. I skyped with by boys, and then tried to sleep, despite how anxious I was for what was to come the next day.

They usually do the meeting at a hotel in the DC area, but this time, they did it at the Health Department, right next to the Capital building. How surreal to be at the mother ship, and right down in the main legislative action in DC! Security was pretty tight, with going through a metal detector, and then having to be escorted anywhere I went in the building. No internet for laptops either. No one was allowed on their network. Still, it was cool to see it.

Right away, my research into the committee members paid off, and I could begin to easily identify key people. I was one of the first ones up on the agenda, so I waited to start talking to people until I delivered my speech. I met with the Save Babies genetic counselor right off, and she immediately emphasized the speech length issue, and reiterated that they WILL cut me off, so watch my time. Shoot. Must look again to see if I can take anything out. The meeting started, and the first presenter was late, so they decided to go ahead with public comments, and emphasized again that you only have two minutes. There was no time for me to cut anything out! I got up there, and prayed, prayed, prayed they would be nice to me. Fortunately, they were, and I did get through my whole speech. I asked the lady sitting next to me to record it, and for your viewing pleasure, here’s my speech (note how FAST I am talking!!)

In case you have any problems with the video, you can read my speech here.

I had practiced and practiced this speech so many times so that I could look the committee members in the eyes as I did it. I also held up a big picture of Noah for them to see. It really did go well, and I got a lot of comments on it from people at the breaks. Whew! I breathed a huge sigh of relief afterwards and steeled myself for what was next…hunting down all those doctors I found in my research on the committee to talk to them one-on-one about what I wanted to do, and to ask for their help. I also kept an ear open through all their presentations on their current projects to see how my issue might be worked in, and then went and talked to the contacts in charge of those projects at the breaks. I felt like I was never “off” because I just had to use every precious minute I was there to try to push my issues forward.

At the end of both days, I was just POOPED and so overwhelmed with information. I don’t believe that these guys will do one big blanket fix like I was able to see in Colorado, but I do have some very good ideas on how I can move things forward in several small ways. I met some amazing people as well, and I hope I get to talk to them more in the future. There was tremendous value in being there and understanding how these guys operate, and making them as a whole aware that this issue of turning around test results is real, and lives are lost as a result. I was sitting there on the second day reminiscing about the days when I was having my first baby, my Noah, and could be blissfully ignorant to that innocent heel prick they did that was his newborn screening test. Most people don’t even know it was run on their babies. It is just such a simple little test. Who knew there was SO MUCH that goes along with it and behind it? Huge debates. Long discussions. Ethical battles. Consistency issues across all the states. Budget and time concerns. It is a huge deal. Lives are saved and lost by that simple test. Lives like Noah’s, and so many other precious babies that I have come to know over the last three years. My head is full, as is my heart as I begin to plan out how to do what I can to move this needle forward.

At the end of the meetings, I jumped in a cab and headed straight to the Lincoln Memorial. Silly fact about me: I find Abraham Lincoln to be a pretty fascinating guy. This is ever since I was a kid studying American history in school, so going to this national landmark was a must do even for the 20 minutes of free time I had while I was in DC. It was fun to see it again, and to enjoy the view up the national mall. Wandering around in the gallery there, I found myself reading the Gettysburg Address that is engraved in there. President Lincoln was no stranger to loss. I think only one of his children made it to adulthood, and his wife literally went crazy with the grief of it. He also lost his parents at a young age (or was it just his mother?) In the moment of that speech he was addressing the war-torn country that had sustained terrible losses, and his words really moved me. He talked about how those lives were lost so that others might live, and challenging those left to keep fighting so that their lives would not have been lost in vain. At the end of the exhausting past few days, I found myself crying in that gallery reading that speech. It was the icing on the cake for this incredible trip to make myself be heard. Put science aside, and think about what it is like to be the parent of these sick children, and please, please, please give them the chance they deserve. This is only the beginning. I will keep fighting.

My notes...

Below are my thoughts and notes from the meetings. 

What the committee is like:

They are ridiculously, insanely smart people that are highly, highly, highly trained in genetics. Within the group of experts, I kept thinking of American Idol auditions (I know!). You know how in the beginning when the contestants start auditioning and you can so easily see the good singers from the bad ones? You think to yourself “man, there is a lot of talent…how will they ever get it down to the top 24 best ones?!” But then, when you get all the best in one room and they start competing, you start to see that among the best, there are clearly some that are spectacular, and some that are just merely good. Same applies in this room. Amongst the experts, as they would comment and ask questions of each other, you could so easily see the ones that are really sharp, and those that are just…missing something. The thing that I see them missing the most is making the leap between what is just science and what is real life living with illness. Some were so clued in on both their area of expertise, and the fallout of what the committee would propose and what is actually practical. Others were just into their science and the governmental processes around it. It was kind of frustrating to see, with my heart crying out for those that see this from my point of view as a parent.

They are really tough. The various presentations were interesting because someone would get up to the microphone to present an update on a project, or propose something new, and would talk about it with PowerPoint slides for 15-20 minutes. Then, for 45 minutes, the committee would just rip the idea apart, asking really tough questions. To get up there in front of them, you seriously had to know your stuff and have your act together. I almost felt bad in a few cases with how much they would ride some of the presenters. Wow…

They say no (or turn deaf ears) to a lot of things. One of the more heartbreaking things to witness was watching the group that came to represent the illness Adrenoleukodystrophy, or “ALD.” This is the illness featured in the movie “Lorenzo’s Oil.” I was shocked to learn that with as much publicity as that disease has gotten, and with how organized the parents are (there are multiple advocacy groups to support it) that it is not on the newborn screening panel. It was up for potential addition to the panel at the meeting. One of the advocacy groups came out en masse with lots of speakers, including kids and one of the doctors that pioneered most of the viable treatments with her husband before he passed away (I sat behind her, and I *think* she was one of the characters in the movie! I need to watch it again. I think her husband was in it for sure.) It was amazing to hear them all speak, especially the kids. They talked about what it was like to live with the illness, to watch their cousins and other relatives die from it (one girl lost her father to it) and how important it was to screen for it. 

Then, one of the doctors that was on the committee presented their report on making a case for whether or not to add it. He felt that they needed another year to collect more research before putting it forward, so he asked the committee to vote against it. It was heartbreaking watching the committee chair go around the room collecting votes, and to hear all but one of them vote against adding it to the panel. The ALD advocates were pretty disappointed. I think they thought they would speak, hear the vote, and then go out to lunch to celebrate, but no such luck. There were other things too, where someone would present, asking for support, and expected to get a yes. The committee would ask a million tough questions, and then shoot it down. Or not ask any questions, and move on, brushing it under the rug.

Some of the interesting things they are currently discussing or constantly doing:

• They put together recommendations to add new illnesses. I heard about three illnesses during the whole thing, and HOLY COW what goes into that is extensive. Years of work, hundreds of pages written, hundreds of pieces off feedback from experts to be culled through. Wow…
• They are considering and studying the effect of having states do two screenings. Once when a baby is just born, and again, when they are a week or two old. Nine states have it mandated to do this. Several other have it recommended. 
• They do what they can to standardize the collection of information. They have a program they are starting where they are collecting family history info when a woman is pregnant for example. They also put forward a matrix for how they review illnesses. That got a LOT of debate.
• They also review illnesses that have been on the screening panel to see how they are doing, and if there are areas for improvement.
• They are also beginning to talk about what it would be like if we screened for carriers of illnesses – as in, not wait until a sick baby is created. Find out that you are a carrier of something beforehand. Can you imagine? It is far-fetched that this would happen in the near future, but it is something they have their eyes on.

Don’t they get it?! (slaps forehead)

• One of the primary criteria for adding an illness to the core group of disorders that the states test for is that it HAS to have a viable treatment. They are looking for illnesses where they feel that they can have the greatest medical benefit, from screening to what happens afterward. What they don’t take into consideration is what it is like to have a child that is seriously ill, and no one is giving you any answers. You spend a lot of time doing invasive tests to find out what is wrong (in the field, they call this “diagnostic odyssey”) rather than being focused on making a child comfortable at least, and enjoy their last days (as much as is possible anyways) rather than being a science project.
• Something else I learned that I thought was kind of nuts is that we are light years ahead of what any other country is doing. We screen for about 30 disorders, no matter the state you live in. That is mandatory. In Europe, they only screen for two things. China screens for one illness. Most countries do no screening at all. Wow, and I thought our program sucks…

Hope for me?

I don’t believe that my issue will be fixed with one broad sweeping policy change, as much as I desperately want it to be (I was prepared for this, so don’t worry). Instead, I have to keep my eyes out for any small way that this can be sneaked into current things they are working on.

Option #1

They have a new project they are kicking off, where they have identified the top ten “Quality Indicators” for the state labs across the country. Basically these are ten questions they will ask labs that rates their overall performance in relation to their fellow labs across the country. Some of their “Quality Indicators” are:

• Number of false negatives or positives they get in their lab when they screen new babies.
• When is the illness revealed? During the first time they screen? The second? Later?
• Number of eligible infants that qualify for testing
• Number of times a parent refuses testing
• And, my personal favorite, they plan to ask them to record the timing of the test, reporting and diagnosis to measure the turnaround time of the test (yay!). 

There is pushback on this program in that it will take time for the already overloaded labs to participate in this collection of data. To entice participation, they plan to put together a certification around it combined with other things I am sure. Though, my concern is, collecting data is one thing. Actually doing something with it is quite another thing entirely. It will take two years to get up and running.

Option #2

I spent a lot of time talking with doctors from the CDC (Centers for Disease Control). The CDC just released a book of best practices for public health labs. They presented on it to ask the committee for it’s support. It is a really thorough book that my layman’s eyes have a hard time getting through (I have my very own copy which is kind of fun!), BUT, they address the issue in there by directing labs to be sure to send their blood spot cards to the state lab within 24 hours of collecting it. I was excited to see this in there. Though the best practices are a great source of information, participation is voluntary. It seemed like, from the conversations I heard that public health employees must do a certain amount of continuing education credits a year, and reading this book counts. Since the report was released in April, they have had 107 sign up to do it, and 69 have completed it, earning their continuing education credits so far.

When they presented their report to the committee, they ripped it apart and chose not to endorse it. They were concerned that the CDC didn’t build in a way to measure success or value of having the book available. They thought it regurgitated things that are already out there, and that it was too short sighted. They also asked why they wanted the committee to endorse it, and the CDC didn’t really have a good answer. I was thinking though, that since having the backing of this group was so important to the CDC that perhaps a revision of the best practices might be considered at some point perhaps, so I made sure I met all the doctors that were a part of the project. I thanked them for being so thoughtful about turnaround time of tests that they thought to include that point. I gave them my little one-sheet story with my requests listed on there, and asked if they revised the book, if they would consider expanding on that point by adding in my requests. They were flattered that I found that helpful, and said that of course they would. Yay!

Option #3

I talked with the March of Dimes representatives. I really think these people are kind of done with me. They were polite and friendly, but didn’t spend too much extra time on me if they could help it. Since they don’t have it in them to formally tell me to buzz off yet, I will keep trying. In a few minutes of brainstorming, they thought that perhaps the committee would be interested in doing best practices. I asked a bunch of committee members and their response was “I think we already have that somewhere?”

The other idea that came out was establishing a ranking system of all of the states, that looks at the number of disorders that each state tests for, when the initial blood sample is taken, how it gets to the lab, how long the lab takes to return results, etc. We figure out a ranking system of who does this the best, and who does it the worst, and then we publish it.

When talking to the committee members, they kept saying “well that Colorado…I can’t believe they do that!” as if the problem was only in Colorado. I patiently explained to them that it is in multiple states across the country. They’d ask me which ones, and I would list off the ones I knew, and say that I know that there are more. I think it is on me to get that data.

I talked with one of the doctors about it, and she pointed out the doctor doing the big data project, and said that I should ask him. Also, she counseled me to be careful about how this information is published. It’s the old phrase, “you catch more flies with honey.” If I give a big public stink eye to the worst states, they can be defiant and decide not to participate in any change. I am thinking the March of Dimes may be the best helpers on this if they will do it, since they have representatives to help in each state to deliver information conscientiously. If they will help. We will see.

Option #4

The folks I talked to at the Association of Public Health Laboratories are gearing up to start celebrating the 50th anniversary of newborn screening in 2013. They have a number of activities coming up. They are doing a “Day on the Hill” in Washington DC in September 2013. Possible next trip to DC perhaps? Curious what that will end up being. Another great opportunity to speak with people perhaps.

They are also putting together a coffee table book that will be published in 2013 about the history of Newborn Screening. They need real stories from families, and a couple of the docs asked if I would do it. I said “yes of course,” granted, I can’t help asking myself why they would want my story, considering that we have one of the worst stories of newborn screening! Whatever. If it pans out, it is another great opportunity to network with people who are in a position to fix things.

Option #5

Boy, do I dare say this one out loud?! One of the things I asked after Noah died was “Why wasn’t I screened for this when I was pregnant??? Of all the vials of blood they took, and as much as we know about genetics, why?!!” I was told that that sort of thing is coming, but it likely won’t be available until my grandchildren are born. I am unsatisfied with than answer. 

This article was recently in the New York Times about doctors from the University of Washington that have developed a test that uses a blood sample from a pregnant mom in her first trimester, and a check swab from the dad, and do a full genetic profile. The test is insanely expensive at $20,000-$50,000 to run.

I talked about this with a few people and I feel there *might* be room for progress here, in terms of making this something that is cheaper and more widely available. This would circumvent the inefficient system in place today through the health department, so I am pretty excited about it. I don’t want to show all my cards publicly yet, since I don’t know how viable my fragile steps forward are, but I am chasing it down. It could be nothing, or it could be something. Who knows? Stay tuned.

My Speech

Hello. My name is Sarah Wilkerson. I am here today as a parent, and advocate for the Save Babies Through Screening Foundation. I would like to tell you about my son Noah. Noah lived for four precious days in June of 2009, before he suddenly stopped breathing and quickly passed away. My husband and I were devastated, and desperate for answers. The next day, his newborn screening test came back, indicating that he had a rare genetic illness called MCADD. MCADD is 90% treatable if you have the diagnosis, but his test result came back too late for us to be able to do anything about it.

My husband and I moved to the state of Colorado before Noah was born, but are originally from the state of Missouri.

Missouri has four state labs that run continuously. They have policies that dictate when blood samples are collected, when and how the samples are shipped to the state labs, and when the results are turned around to parents. As a result, Missouri hasn’t lost a child to a disorder like MCADD since 2004.

Our new home state of Colorado didn’t have a newborn screening policy in place that was as aggressive as what Missouri had to offer. Colorado hospitals could use the US postal service, and wait to batch test samples together until they had enough to warrant sending a package to the state lab. The state lab also didn’t run on weekends, holidays, or evenings, so depending on the day of the week your baby was born, you could be in for a bit of a wait before you hear back.

If we had never moved, if we had stayed in Missouri, it is likely that Noah would still be here. Quite literally, something as trivial as a state border line ended up meaning life-or-death for my son.

Today, I ask you to standardize the turnaround time of newborn screening tests in the United States. In my view, this would include:

• Recommending that hospitals collect the initial blood sample at 24 hours after birth
• Using a courier service to get the sample to the appropriate state lab, no longer condoning the use of the US Postal Service
• And, recommending that state labs process and report the test results 48 hours after receiving it.

It is vitally important that these recommended procedures be put into place, and that the Secretary of Health and Human Services adopts them because in the cases of infants like my son, days, hours, even minutes, matter.

In the end, parents like me deserve to know that their child has a potentially fatal illness as soon as is humanly possible so that they have the opportunity that I didn’t have – to fight for my son’s life.

Thank you for your consideration.