NIH...you worry me.

As most of you know, I am a research fanatic.  I love to read it, I love to participate, I love to move science forward.  I know the difference between correlation and causation.  I understand what a double blind study is.  I understand statistics. I understand the reason for a 13 year old to have to have a pregnancy test to reduce skewing the results.  I don't know EVERYTHING.  But I know enough.

Hannah is currently in the midst of a National Institutes of Health study on brain development (see here).   Hannah spent a day at NIH for preliminary cognitive testing and getting acclimated to the MRI.   We had a good day.  We have to go back again to complete the testing and have the real MRI.   It should have been done weeks ago, but there have been scheduling snafus.  Good thing too.

On November 17th we received a form letter from the NIH Medicolegal section of the Medical Record Department.  (I've blocked our address on these documents.)

Attached was a report on "Hannah's" physical exam and test results. 

We weren't expecting any 'reports' since the cognitive test results were not going to be released to us, and she didn't have the MRI.  Or did she?  Apparently, Dr. Giedd thought she did. "MRI scan of brain performed without complication on 10/12/2012"

In fact, there was only one factual thing on the report: Hannah had a urinalysis (to prove that she wasn't pregnant).   The rest of it was ENTIRELY FALSE.  False, or mistaken.

This is not what we expected from NIH.

Fortunately we met Dr. Maddox this summer at the NDSC conference in Washington D.C.  Dr. Maddox spoke about the new Down Syndrome registry (a much needed resource to streamline research).  Since she is the Deputy Director of the National Institute of Child Health and Human Development, she seemed to be a good person with whom to share our concern.

________________________________________________________

November 17, 2012

Dr. Yvonne Maddox

NICHD Deputy Director

National Institutes of Health

PO Box 3006

Rockville, MD 20847

Re: XX-XX-06-5  XXXXXX, Hannah Duston

Dear Dr. Maddox,                                                            

My husband and I met you this summer at the National Down Syndrome Congress convention.  We are very pleased with the progress of the DS registry which you described in your talk.

Our family is very interested in research for the sake of science; our daughter has been involved in many many research studies in the past 14 years.  The very first study actually saved her life when she was three days old!

Recently we agreed to have Hannah (age 14, DS) participate in the ongoing NIH clinical research study 89-M-0006 “Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Controls”.  Dr. Jay N. Giedd is the principal Investigator.

We made our initial trip to NIH on October 11th, 2012.  We were met by Dr. Nancy Lee.  Dr. Lee and her assistant Elizabeth Adeyemi were very warm and helpful.  The day was filled with hours of cognitive testing, surveys and a mock MRI.   We were very impressed with how they introduced Hannah to the noisy MRI.  It was clear that they had taken many steps to make sure that Hannah had a successful learning experience and was comfortable in the “pretend” MRI.  No doubt this will ensure that Hannah will be prepared for the actual MRI later this month.  Our appointment is Friday, November 30th.

However, we have concerns.  Today we received a form letter from Amanda Thume, from the Medicolegal Section (Medical Record Department).  Included with her letter was a copy of a summary of the findings. 

We were VERY surprised to find the attached Medical Record, with progress notes by Dr. Giedd.  We never met him.  He has never seen or touched Hannah, nor did any other physician give her a physical examination, yet the record shows that there was a “Detailed exam” and that she has “Typical physical features of Down syndrome”.  Dr. Giedd also determined that Hannah is neurologically “normal”.  In addition, Dr. Giedd believes that Hannah already has had her MRI scan of her brain “without complication on 10/12/12”.

This is very disturbing for us.   We expected the NIH to have high standards, especially for a research study.  Imaginary records?   How is this possible?  Our faith in NIH is wavering.   Should we continue with the study?  Has it been corrupted?  

Any information you could provide to reassure us would be appreciated.

We are attaching a copy of the letter and the medical record for you to review.  

Thank you for your assistance,

Beth and James XXXXXX

XXXXXX@comcast.net

804-XXX-3060

cc: Dr. Nancy Lee

Dr. Jay Giedd

Dr. John Gallin

_________________________________________________

We sent off copies of everything to everyone.  The day we popped the letter in the mail we received a phone call postponing our next appointment.  We are now re-scheduled for early January.    

And then we forgot about it.

Until this morning.   The phone rang.  (I've been hesitant in answering the phone still being gun-shy from all those political calls--ARGH!!)    Caller ID said "PUB HLTH SVC".    So I answered.  It was Dr. Maddox  (SCORE: 1 for Beth!).  She was very concerned.  She just received the letter (I chose the wrong mailing address).   She wanted to get some clarification on the situation.  She wanted to get this resolved before we arrived tomorrow (the appointment that was re-scheduled to January).   Dr. Maddox was worried that the appt. was canceled because the researchers were trying to cover-up the problem.  I assured her that it wasn't the case.  She said all the right things and asked all the right questions.  Did I have any ideas that could explain the situation? (error, sinister plot?)  She was glad that she had time to investigate.   

I find it difficult to believe that none of the other three letters arrived until today.  Really?  I know that at least two have offices in the same building.  I have the address from the letterhead from research correspondence.   

Dr. Maddox obviously rattled some cages.   This afternoon I received a call from Dr. Lee (who really had nothing to do with any of this).  She was really surprised.   We talked about it, and her theory is that it must be a clerical error.   The error must have been made by Dr. Giedd (pronounced ghee-ed).

Dr. Giedd called next.   He groveled a bit, and admitted that it most likely was him.  He somehow put someone else's record in Hannah's record.   He also never knew that medical records actually sent the records out to doctors and patients.  I wonder how long he's been working at NIH....either WAY too long, or he's brand new.   Or, it was just a plain old human error.  He did apologize.  He was more human than I was expecting.

It's amazing how easy it is to make a mistake.  This one wasn't a big thing--at least in terms of direct  impact on Hannah's health.  Hannah wasn't so lucky when a Rite-Aid pharmacist made a pharmaceutical error after Nan's Tonsillectomy.   She had a torturous and prolonged recovery since she basically had no pain relief for days post-op.

I know, people are people. I make mistakes, and I always hope for forgiveness.  I'm glad that this NIH drama was only a "mistake".  It could have been a system issue.  Or something else.

So that's that.  I think I have NIH back in order.   Maybe they'll give me free valet parking in January.  Oh.  Wait.  Valet parking is free for everyone.