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http://mundelein.suntimes.com/news/mundelein_boy_denied_access_to_life_saving_drug_-MUN-01272014:article
#SaveJack
All posts by mcfadyena
Update – Jack Fowler – Shire is "Too busy to do a phone interview…"
EDIT – Shire’s PR Firm, Waggener Edstrom, has been visiting our website and the savejack.ca website. Sadly, I think Shire is more concerned with its public image and less concerned about the kids they are supposed to be helping. Be Brave Shire – the way to fix your image is to live up to your Credo, not through with some PR firm.
Hi Everyone,
Thanks for the hundreds of messages that we are receiving in support of Jack Fowler. I’ll do my best to respond to everyone, but thought I would post a quick update here. As of Monday morning, we still have not received a response from Shire CEO Flemming Orskov regarding our plea for them to objectively listen to the arguments we have to present in favour of Jack receiving access to the medication he needs.
In all of the advocacy efforts I’ve been involved with over the past few years, I’ve never experienced such a lack of compassion from any government body or pharmaceutical company I’ve dealt with. Most often, we are able to find a member of the company or government organization to objectively listen to the case presented, present counter arguments, and work through the process to best meet the needs of all involved. I am truly saddened and disappointed that no such person has stepped forward at Shire.
Shire prides itself on its relationship with the patients they try to help. It’s in their credo. It’s in the brochures, pamphlets, DVDs, and splashed all over the web. In reality, we know that they have said that they “don’t deal with patients” and they “don’t deal with families.” We have asked time and time again to be heard and to have them lay out any counter arguments they have in a rational fashion. Every time we make that ask, we are ignored.
The reason that Shire doesn’t want to respond is because we have a very strong case that supports Jack receiving treatment. We have a strong case to save Jack’s life. We have a doctor ready to provide the treatment he needs, a location and a review board ready to approve. We have the necessary funding to ensure that all baseline testing is completed. We have all the evidence from the FDA that supports our cause, and strong assurances from the FDA that anything that happens to Jack outside of the clinical trial setting will have NO bearing on the clinical trial whatsoever. We have everything we need, except the cooperation from Shire.
We have had countless media inquires about Jack and the battle he is waging for his life. So far, Shire has refused to provide a comment. They are “too busy to do a personal phone interview” for the media. I can’t imagine how anyone can be “too busy” to comment on a decision they have made, especially if they are confident that decision was the correct one – a decision based on fact, reason, and something they could stand behind.
Jack Fowler’s life is worth more than silence, and his family deserves to be heard. If Shire has GOOD reasons why they cannot provide this treatment, they should publicly address the points we would like to put forward.
I ask, once again, for Shire to listen. I ask Shire to respond to our inquiries, respond to the family that is asking to be heard. I am calling on Flemming Ornskov to take the time to remember what his ethical responsibility as a physician is. In keeping with the Pillars of Medical Ethics, physicians are compelled to do good and to do no harm. They are compelled to ensure that patients facing similar medical conditions have access to the same care. They are compelled to support access to medical care for all people.
Dr. Ornskov, please step back from your unreasonable position and remember the medical principals that you are obligated to uphold. Please remember the role you have carved out for yourself in the world of medicine. Please help us #SaveJack.
Jack’s mom has just updated her blog. Please drop over to read her latest entry HERE! And if you haven’t done so already, please watch Jack’s dad describe his meeting with Shire below.
Update – Jack Fowler – Shire is “Too busy to do a phone interview…”
EDIT – Shire’s PR Firm, Waggener Edstrom, has been visiting our website and the savejack.ca website. Sadly, I think Shire is more concerned with its public image and less concerned about the kids they are supposed to be helping. Be Brave Shire – the way to fix your image is to live up to your Credo, not through with some PR firm.
Hi Everyone,
Thanks for the hundreds of messages that we are receiving in support of Jack Fowler. I’ll do my best to respond to everyone, but thought I would post a quick update here. As of Monday morning, we still have not received a response from Shire CEO Flemming Orskov regarding our plea for them to objectively listen to the arguments we have to present in favour of Jack receiving access to the medication he needs.
In all of the advocacy efforts I’ve been involved with over the past few years, I’ve never experienced such a lack of compassion from any government body or pharmaceutical company I’ve dealt with. Most often, we are able to find a member of the company or government organization to objectively listen to the case presented, present counter arguments, and work through the process to best meet the needs of all involved. I am truly saddened and disappointed that no such person has stepped forward at Shire.
Shire prides itself on its relationship with the patients they try to help. It’s in their credo. It’s in the brochures, pamphlets, DVDs, and splashed all over the web. In reality, we know that they have said that they “don’t deal with patients” and they “don’t deal with families.” We have asked time and time again to be heard and to have them lay out any counter arguments they have in a rational fashion. Every time we make that ask, we are ignored.
The reason that Shire doesn’t want to respond is because we have a very strong case that supports Jack receiving treatment. We have a strong case to save Jack’s life. We have a doctor ready to provide the treatment he needs, a location and a review board ready to approve. We have the necessary funding to ensure that all baseline testing is completed. We have all the evidence from the FDA that supports our cause, and strong assurances from the FDA that anything that happens to Jack outside of the clinical trial setting will have NO bearing on the clinical trial whatsoever. We have everything we need, except the cooperation from Shire.
We have had countless media inquires about Jack and the battle he is waging for his life. So far, Shire has refused to provide a comment. They are “too busy to do a personal phone interview” for the media. I can’t imagine how anyone can be “too busy” to comment on a decision they have made, especially if they are confident that decision was the correct one – a decision based on fact, reason, and something they could stand behind.
Jack Fowler’s life is worth more than silence, and his family deserves to be heard. If Shire has GOOD reasons why they cannot provide this treatment, they should publicly address the points we would like to put forward.
I ask, once again, for Shire to listen. I ask Shire to respond to our inquiries, respond to the family that is asking to be heard. I am calling on Flemming Ornskov to take the time to remember what his ethical responsibility as a physician is. In keeping with the Pillars of Medical Ethics, physicians are compelled to do good and to do no harm. They are compelled to ensure that patients facing similar medical conditions have access to the same care. They are compelled to support access to medical care for all people.
Dr. Ornskov, please step back from your unreasonable position and remember the medical principals that you are obligated to uphold. Please remember the role you have carved out for yourself in the world of medicine. Please help us #SaveJack.
Jack’s mom has just updated her blog. Please drop over to read her latest entry HERE! And if you haven’t done so already, please watch Jack’s dad describe his meeting with Shire below.
Request for Collaborative Approach – An Open Letter To Flemming Ornskov
Dear Mr. Ornskov and Mr. Vickers,
I am writing to request an opportunity for you to review information we have gathered to support an Individual, emergency use, expanded access application for Jack Fowler. I am very confident that the document we have prepared will present a very compelling case to allow access to your investigational drug SHP-609 outside of the clinical trial setting. After consultations with the FDA and some of the most experienced and powerful people throughout the pharmaceutical world, I truly believe that allowing this application to move forward to the FDA can and will work to meet the the best interests of the patient, the Hunter community as a whole, and Shire plc. We are firm in our belief that the information we have gathered to support this application enhances the clinical trial process, which in turn is a direct benefit to Shire.
If you are interested in working collaboratively to meet the needs of the entire patient community that you hope to represent, please indicate in writing if you will accept our document that lays out our position. I would very much like to receive your feedback and counter arguments against supporting this application, with hopes that we can work together to come to a resolution. Perhaps an open and honest discussion could follow as we continue to find the best way to meet the needs of this patient while supporting and enhancing the clinical trial that is currently underway.
I look forward to hearing from you with a response within the next 24 hours.
Very Sincerely,
Andrew McFadyen
#SaveJack
Shared from our Instagram Feed.
Meeting With Shire – Update
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
Direct from Shire's Phil Vickers
Hi Everyone,
As I work away and prep for Saturday’s meeting between the Fowler Family, The Isaac Foundation, and Shire’s CEO Flemming Ornskov and Head of Research and Development Phil Vickers, I was directed to this youtube video featuring Phil and a few other panelists. While the discussion is interesting, it’s the end quotation from Mr. Vickers that struck me as ironic and, as it turns out, disingenuous based on Shire’s recent decision to deny treatment to Jack Fowler.
In the video, Mr. Vickers states:
We provide Hope to patients and their families. And that’s a very sobering thing. And I would say, the best times of parts of my jobs are meeting those families and some of those patients and seeing the impact we can have on their lives. And some of my worst discussions are with those same families where, there’s somebody that – you know you have to have specific enrollment criteria so you can have a successful study. It’s very tough when somebody has a child that’s outside those enrollment criteria, that may have advanced so far that the chances of them getting benefit are very, very low, and you cannot compromise your study, and you have to say that to a parent. It’s a very, very tough thing to do. And sometimes you can’t even provide therapy, in some cases, outside of the clinical trial because you’ve got no evidence of safety and you’ve got no evidence of clinical benefits, and that’s a very, very tough discussion to have.
We are proud of our early access programs. Those are very important. And at that time, you do have a sense…more than a sense…you know the safety and the efficacy issues…
Phil Vickers – Rare disease clinical trials with Shire, Novartis and more at World Orphan Drug Congress USA 2013
Thus far, I’ve not seen the Hope that Shire says they provide patients. I’ve not seen them live up to their motto of “being as brave as those we treat.” I’ve seen only a callous disregard for the life of a little boy they know they can save, and I’ve seen them ignore the telephone calls and the emails they have received, by the hundreds and thousands, asking for an explanation of their decision.
Mr. Vickers says that he is “proud of our early access programs.” In reality, Shire doesn’t have one. We requested the criteria that patients must meet in order to participate in any early access program with the company. They didn’t have criteria. In fact, they only started working on one once Jack’s case brought to light the glaring problems that a company faces without such a policy and criteria.
In the video, Mr. Vickers expresses that you have to know the safety and efficacy issues involved before opening up any compassionate or expanded access program. In this case, we do know! The trial has been going on for over 3 years and no adverse affects have been reported. We have letters from over 1/3 of the trail participants expressing their support for Jack and describing how incredible the treatment has been for their children. It’s been a lifesaver, and Jack needs his life saved. He qualifies to be saved under the FDA’s guidelines for Compassionate Use (read here). In most other pharmaceutical companies, Jack would qualify under their program as well.
I hold out hope that Saturday’s meeting brings a change of heart by Shire Pharmaceuticals. Everything is in place to save Jack. We have a physician eager to treat him, we have a site lined up and preliminary review board approval. We have funding to ensure everything is done safely and in Jack’s best interest. We have the support of thousands and thousands of people throughout the world – indeed, over 31,000 people signed THIS PETITION demanding that Shire #SaveJack! We’ve had extensive media interest in this story, and we’ve held off taking this public through such a media campaign until we’ve learned the outcome of Saturday’s meeting.
In essence – we have everything we need to Save Jack – except Shire. And without Shire leading the way, without Shire fulfilling it’s stated creedo of “being as brave as the people we treat,” Jack will die.
I’ll update as soon as we know more. For now, here’s some thoughts directly from Phil Vickers himself. The quotes from above begin at 32 mins and last until the end of the clip.
Thanks for the continued support.
With Love,
The Isaac Foundation
Direct from Shire’s Phil Vickers
Hi Everyone,
As I work away and prep for Saturday’s meeting between the Fowler Family, The Isaac Foundation, and Shire’s CEO Flemming Ornskov and Head of Research and Development Phil Vickers, I was directed to this youtube video featuring Phil and a few other panelists. While the discussion is interesting, it’s the end quotation from Mr. Vickers that struck me as ironic and, as it turns out, disingenuous based on Shire’s recent decision to deny treatment to Jack Fowler.
In the video, Mr. Vickers states:
We provide Hope to patients and their families. And that’s a very sobering thing. And I would say, the best times of parts of my jobs are meeting those families and some of those patients and seeing the impact we can have on their lives. And some of my worst discussions are with those same families where, there’s somebody that – you know you have to have specific enrollment criteria so you can have a successful study. It’s very tough when somebody has a child that’s outside those enrollment criteria, that may have advanced so far that the chances of them getting benefit are very, very low, and you cannot compromise your study, and you have to say that to a parent. It’s a very, very tough thing to do. And sometimes you can’t even provide therapy, in some cases, outside of the clinical trial because you’ve got no evidence of safety and you’ve got no evidence of clinical benefits, and that’s a very, very tough discussion to have.
We are proud of our early access programs. Those are very important. And at that time, you do have a sense…more than a sense…you know the safety and the efficacy issues…
Phil Vickers – Rare disease clinical trials with Shire, Novartis and more at World Orphan Drug Congress USA 2013
Thus far, I’ve not seen the Hope that Shire says they provide patients. I’ve not seen them live up to their motto of “being as brave as those we treat.” I’ve seen only a callous disregard for the life of a little boy they know they can save, and I’ve seen them ignore the telephone calls and the emails they have received, by the hundreds and thousands, asking for an explanation of their decision.
Mr. Vickers says that he is “proud of our early access programs.” In reality, Shire doesn’t have one. We requested the criteria that patients must meet in order to participate in any early access program with the company. They didn’t have criteria. In fact, they only started working on one once Jack’s case brought to light the glaring problems that a company faces without such a policy and criteria.
In the video, Mr. Vickers expresses that you have to know the safety and efficacy issues involved before opening up any compassionate or expanded access program. In this case, we do know! The trial has been going on for over 3 years and no adverse affects have been reported. We have letters from over 1/3 of the trail participants expressing their support for Jack and describing how incredible the treatment has been for their children. It’s been a lifesaver, and Jack needs his life saved. He qualifies to be saved under the FDA’s guidelines for Compassionate Use (read here). In most other pharmaceutical companies, Jack would qualify under their program as well.
I hold out hope that Saturday’s meeting brings a change of heart by Shire Pharmaceuticals. Everything is in place to save Jack. We have a physician eager to treat him, we have a site lined up and preliminary review board approval. We have funding to ensure everything is done safely and in Jack’s best interest. We have the support of thousands and thousands of people throughout the world – indeed, over 31,000 people signed THIS PETITION demanding that Shire #SaveJack! We’ve had extensive media interest in this story, and we’ve held off taking this public through such a media campaign until we’ve learned the outcome of Saturday’s meeting.
In essence – we have everything we need to Save Jack – except Shire. And without Shire leading the way, without Shire fulfilling it’s stated creedo of “being as brave as the people we treat,” Jack will die.
I’ll update as soon as we know more. For now, here’s some thoughts directly from Phil Vickers himself. The quotes from above begin at 32 mins and last until the end of the clip.
Thanks for the continued support.
With Love,
The Isaac Foundation
Meeting Scheduled – CEO Flemming Ornskov
Hi Everyone,
Just a quick note to thank you for the tremendous support the Fowler family has received as they seek to #SaveJack. Over the past few weeks, hundreds of email messages of support were sent to Shire CEO Flemming Ornskov, the person who made the decision not to provide life-sustaining treatment for Jack.
Yesterday, hundreds and hundreds of people telephone Mr. Ornksov to personally express their heartbreak and anger over Shire’s decision. Today, Shire reached out to the Fowler family to schedule a meeting between the Fowlers, The Isaac Foundation, and CEO Flemming Ornskov. We are hopeful this meeting will take place in Chicago next Saturday, January 18th.
We ask that you continue to share Jack’s Story, continue to express your feelings on the decision to deny Jack treatment directly to the decision makers, and to continue to keep Jack and his family in your prayers.
We will update you as soon as we have more information.
Thanks again for your incredible support.
With Love,
The Isaac Foundation