flemming ornskov

Hi Everyone,

It’s with a heavy heart, and with anger and frustration, that I update you on the meeting that took place this morning between the Fowler family, The Isaac Foundation, and Shire Pharmaceuticals.  The meeting was organized after Shire’s decision to deny Jack Fowler the life saving treatment he immediately requires.

This meeting was supposed to take place at the Fowler home, 45 minutes outside of the city of Chicago.  It was set to take place at 1:30 p.m.  However, a few days before the meeting, Shire’s CEO Flemming Ornskov abruptly changed the location of the meeting to the Chicago airport, and changed the time to an unseemly 7:30 am.  The Fowler family struggled to put child care in place.  And when you are dealing with a special-needs child, that is no easy task.

We made it to the meeting on time, and brought Jack in with us to meet with the Shire team.  Present members for Shire were CEO Flemming Ornskov and Head of Research and Development, Phil Vickers.

The Isaac Foundation began the meeting by thanking Shire for taking the time to meet with the Fowler family.  We expressed that the purpose of the meeting from our point of view was to discover how we could work collaboratively with Shire Pharmaceuticals so that we can find the best treatment options for Jack Fowler and in a timely fashion.  We expressed that if Shire was present to simply reiterate their position from December and deny Jack the treatment he needs, then the meeting would need to come to an abrupt end.  I made very clear to Mr. Ornskov one very simple fact – an immoral decision is still immoral, even if it’s delivered while looking us in the eye and said to our face.

Flemming looked at us and said “We are not changing our decision.  I guess this meeting is over.”  With that, the hopes of the Fowler family were dashed, and our hope to work together with Shire to save this little boy was ended.   We left a large print out of the 32,000 signatures that were signed in the online petition, as well as letters of support from a high percentage of the families currently participating in the clinical trial of the drug that Jack desperately needs.

As we were leaving, Jack walked around the table and gave Flemming a hug.  Close to tears, Jack’s mom said “If he could talk, he would be asking you to Be Brave, like your motto says, and save him.”  It was one of the most heartbreaking moments of my life – watching a sweet little boy who doesn’t have any idea what is going on give a hug to the man who just gave him a certain death sentence.  I told Flemming that I had a hard time understanding how he can go home and look his children in the face after that moment.  He just looked at us and said “It was nice to meet the family.”

The facts of this case remain the same, and are very clear.  Jack Fowler needs access to a drug that will save his life.  He easily qualifies for individual use access through the FDA’s Expanded Use guidelines.  It is those guidelines that decide whether any investigational drug is safe for use outside the bounds of a clinical trial.  The question of whether enough safety data exists to proceed or not doesn’t rest with Shire Pharmaceuticals, nor does it rest with any pharmaceutical undergoing the same process.  It rests with the FDA first and foremost, and it rests with the physician in charge of treating the patient.  All Shire has to do is begin the application process on Jack’s behalf and leave the decision to the FDA.  When I stated this very clearly to Mr. Ornskov and asked if he would submit the application, he flatly refused.

There are things in this world that many people would be better off not knowing.  What lurks in the minds of pharmaceutical decision makers should be at the top of everyone’s list.  To have the ability to provide help and support, to be able to save the life of a precious little boy, and then choose not to, shows a callous disregard toward life.  That callous disregard is a painful reminder of what Big Pharma is after – money, product, fortune, and fame.  Don’t ever be fooled that the patient comes first.  As Flemming so plainly stated before I gave my introduction – “We don’t work with patients.  We don’t work with families.  We are in the business of developing product.”

With that, there’s nothing left to be said.

Our press release goes out early this week.  Stay tuned on how you can help us #SaveJack.  We will never quit when the life of a child hangs in the balance.

Thank you for your ongoing and tremendous support.

With Love,

The Isaac Foundation