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!
I was disappointed in the Globe article to say the least. While I’m thrilled you are all getting more attention to Jack’s situation, I felt the tone and coverage of the issue was more favorable to
Shire. As for Arnskov’s comments regarding the unfortunate and difficult situation at hand, how dare he. The only difficulty Shire is experiencing is due to their own lack of pre-existing policy and completely of their own doing. If he considers the difficulty to be the fact that you aren’t willing to lie down and live with their decision, then you are doing the right thing. Keep hitting them. I would love to see nothing more than Shire to reverse their decision and throw Arnskov under the bus in the process.
Board members of Shire Pharmaceuticals need to speak up, draw on their collective scientific and clinical expertise, and guide Shire the ethically, clinically, medically, and regulatory right decision – allow the FDA to review the request for Jack Fowler to access Shire’s therapy under compassionate/extended access
Thank you for sharing Kevin’s insight…….he is very wise!! “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.” Get out of the way Shire!!!! Save Jack Fowler NOW!!!!!!!!!!!!!
Estos laboratorios médicos deben tener mayor vigilancia, pues la falta de ética y el exceso de ganancia es desproporcionada.
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