Please see The Isaac Foundations clarifying statements around yesterday’s publishing of the Boston Globe.
On a positive note, the masses responding and commenting around the article see through the PR mumble jumble and side with Jack! It’s obvious the majority continue to see Shire’s goal to be the securing of a profit versus being brave and saving a beautiful 6 year old boy. I guarantee if it was Flemming or Vicker’s son or daughter who was dying, the dollar bill would no longer matter, it would be all about saving a life.
A dear friend from growing up, Kevin Tamlyn, reached out to share his knowledge. Kevin is a very successful business man working in the world of financial services. I had to share…
“It seems clear that Shire is fearful. They fear of losing money. They value their ‘investment’ more than they value human life. They are not willing to do the right thing as long as one of their board members or officers believes there could be the slightest chance of an outcome that could unfavorably influence the perceived value of their asset. The whole thing is a cop-out stating, “regulatory agency guidance”. What they really mean is they want to continue to cover their back and stay in the shadows until, hopefully in their case, phase III is granted approval. This non-sense about, “efficacy, drug benefit, safety” is the biggest fallacy because it is not relevant and does not address the real life situation of Jack. This is a ‘straw man’ argument in many ways – just a sellout and distortion of reasoning in an attempt to justify them being cowards – invalid.”
The Facts Remain:
– compassionate usage does not whatsoever effect a clinical trial and/or approval of a drug, therefore it would NOT “destroy a trial”.
– Jack meets the FDA criteria for Expanded Access, emergency use
a) The patient treated must have a serious or immediately life-threatening disease or condition and there are no approved treatments available to halt or slow down the progression of the disease.
b) The potential benefit outweighs the potential risk.
-We have a willing physician ready to treat, a local IRB board to present too, and meet FDA guidelines. The missing piece is sponsorship from Shire Pharmaceuticals, all they need it to submit an application, that’s it! The FDA makes the final decision if Jack can be provided compassionate usage, not Shire.
Shire’s lack of intelligence (connecting with FDA, and working with experts) clearly defines who they are – profit focused!