Sign and Circulate Jamie Heywood’s Declaration of Health Data Rights Petition Today

Wired Magazine is running a great article about Jamie Heywood, co-founder of PatientsLikeMe, and his quest to make personal medical records electronic and easily accessible online.

Heywood is behind HealthDataRights.org, a movement to declare our individual right to have and share our health data. Heywood has started the Declaration of Health Data Rights petition and supporters can publicly endorse it by going to HealthDataRights .org. Essentially by having access to all the health data about ourselves in a timely (key word!!) manner we can make better health decisions and save lives.

I am one person who would happily share all of our medical records like Heywood proposes.  I have been looking into a way to try and opt-out of the Hippa law Privacy Rule requirements.  I am not interested in keeping our medical records private. In fact, I want people all over the world to access our medical records in the hopes that someone can help save the lives of our twin daughters who suffer from a fatal cholesterol disease.  In some cases my doctor’s can’t talk to each other unless I give written permission.

I am asking everyone I know to endorse the Health Data Rights petition today. Our family has literally spend hours collecting Addi and Cassi’s medical records from hospitals including Lucille Packard Children’s Hospital at Stanford, Mayo Clinic, Children’s Hospital Michigan, Children’s Hospital Oakland, National Institutes of Health and Renown Children’s Hospital.

You can see the picture of the 3 inch binders I have created that contain the most important medical information on Addi and Cassi (we have two each so far). The orginal stack of paper was two feet tall!  To get all of our data to doctors at various hospitals throughout the country, I have sent hard copies of the binders to them. If they requested the records themselves, they would have to sift through the two foot stack.  Do the top doctors in the world have time to do this?

Currently, we are six months behind in gathering all of the new records – it’s a constant battle as we try and keep up and request the records for two sick kids.  There is no reason why medical records could not be in electronic form and available to anyone at a click of a button to share and easily SEARCH.

At one point, we were going to scan all of Addi and Cassi’s medical records and put them online allowing any doctor or researcher in the world to access them.  We figured out quickly that it’s simply too time consuming to tackle and manage. When you’re trying to save your kids lives you don’t have time to send Hippa release forms to hospitals and weed through fax cover sheets and garbage that hospitals often send by mail. If someone is chronically sick and dying, trying to collect all personal medical records is virtually impossible.

As a society, we are living in fear of the health and life insurance companies and the issues surrounding pre-existing conditions. We need additional legislation with health and life insurance companies to make sharing electronic medical records a reality. We would probably save billions of dollars in productivity time as well.

“I” for Insane, “R” for Ridiculous, “B” for Broken – America’s Institutional Review Boards

Regulations, Regulations, and more Regulations!

Some people have asked me why I am not blogging about different topics every day. I really wish I could be blogging more but besides having 1000 things on my to do list, I am actually scared to death to actually talk about some things that are happening to us right now out of fear we might not get the help and cooperation we need to try and save Addi and Cassi’s lives. There are many doctors, researchers and scientists who are being highly cooperative and it has been a truly remarkable experience. Thank you!

On the other hand, there are others who are not as cooperative. I have found that there are a lot of major egos in the medical and science community. A lot of science is about publishing papers about experiments in mice and petri dishes, not about finding near term treatments and therapies that can save the lives is kids like Addi and Cassi. The system is certainly not designed around sharing and collaboration – it’s really a collection of silos all competing against each other for funding or who will get the next Nobel Prize. Someday I will have the opportunity to explain more.

What I can and will talk about is IRBs – in my mind the term stands for "Insane, Ridiculous and Broken" ethics oversight committees. I had never even heard of the term “IRB” until a few months ago when a doctor said we have to, “get this idea through the IRB and this is going to take lots of time.”  An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB) is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects if they are involved in research studies.

One of the biggest problems we are facing at the moment with Addi and Cassi centers around the IRBs. These IRBs now standing in the way of Addi and Cassi getting critical tests done which will ultimately lead us to therapies more quickly. The bottom line is that IRBs are severely impeding progress of medical research in the United States today and something needs to be done about it at a national level.  I know my rights and I want testing done.

Let me give you an example of just how ineffective an IRB can be when you are facing a rare and fatal disease like NPC and you’re in a sprint, not a marathon, to save your kids lives. The National Institutes of Health (NIH) needs spinal, blood and urine samples from healthy children to compare against NPC children who they are currently studying. Both Addi and Cassi are in the study. If the NIH can compare normal kids samples directly against NPC kids samples, they might actually find something called a biomarker (a sign of illness in the bodies of NPC kids). Piece of cake to get samples, right? Wrong. The problem is it can take MONTHS to put together a “protocol” and get it approved through an IRB. Once you get a “protocol” designed, you need to get group of committed physicians (most likely ER doctors) who will be at the front lines to get consent from families to obtain these specimens.

I have been working with the NIH and my local hospital, Renown Regional Medical Center, to try and make this happen.They both have been very cooperative and are trying to move as quickly as possible under the rules but I’m now seven weeks into this process between getting the protocol, the consent form, and begging our local doctors to participate. I still have to get approval from the local IRB so cross your fingers. Why am I even having to do this? If I don’t do this, it will take months, if not years, to get these samples because there are not enough resources in the NPC community to accelerate the process more quickly.

I told this story to a friend who offered to send her child down to get the blood and urine sample done so we could send them to the NIH immediately. Problem is, you can’t do this, it’s against the "rules."  So while millions of samples are being flushed down the toilet or disposed of on a daily basis at hospitals around the country, kids are dying. These samples literally could provide clues into Niemann Pick Type C that could lead to treatments more quickly. 

This is an absolute nightmare of all nightmares. No parent should be faced with getting a diagonosis of Niemann Pick Type C and then enter into a totally dysfunctional medical and drug development system on top of it. While I realize that IRBs do serve a purpose, the regulations have simply gone too far and therefore are becoming ineffective. It seems like IRBs are far more worried about litigation when they should be focused on saving lives.