February 2, 2014

Shire Pharma says No - won’t save dying 6 year-old

February 2, 2014. Mundelein, IL. Six year-old Jack Fowler is dying and Massachusetts-based Shire Pharmaceutical won’t help him. According to Shire CEO Flemming Ornskov, his corporation isn’t in the business of helping people. And that’s a shame. Because an army of doctors, donors, facilities and volunteers have come together to save Jack’s life. But they can’t do it without Shire Pharma.

Shire Pharma CEO Flemming Ornskov. Image courtesy of TheIsaacFoundation.com.

Jack Fowler is a 6 year-old from Mundelein, Illinois. He suffers from Hunter Syndrome, a disease caused by the absence of a certain enzyme in the blood that breaks down cells. Without the enzyme, waste builds up in the cellular tissue until it eventually suffocates and clogs the body, bloodstream and even the brain. Symptoms of Hunters can begin with joint stiffening and cloudy thoughts and end with complete immobility, a vegetative state, and eventually, death.

Treatment denied for ailing child

The headline of the email we received two weeks ago read, ‘Treatment denied for ailing child.’ After reading through the lengthy appeal for help, it was obvious that one, this child was from our own Chicago area. And two, he desperately needed help. Without it, six year-old Jack Fowler is going to die.

“Massachusetts based Shire Pharmaceuticals has denied access to a life-saving drug required by a Chicagoland area child,” the appeal from The Isaac Foundation in Canada began, “The Fowler family appealed to the pharmaceutical company to provide pre-approval access to the investigational drug under the FDA’s expanded-access guidelines.”

Basically, changes have been made over the years to the restrictions of life-saving drugs not yet approved for widespread use. Now, if a person needs a certain drug to save their life and it’s the only hope they have, drug companies have been willing to sell and administer the unapproved prescriptions to the dying and desperate patients. Under most people’s impression of the program, Jack Fowler should definitely qualify.

But 6 year-old Jack’s only hope, Shire Pharmaceutical, said no. The call for help from two weeks ago explained, “Shire made the decision to withhold treatment for Jack, even though a physician is ready to provide the treatment and funding has been made available to ensure baseline safety data is collected and ongoing efficacy is monitored. Without access to the therapy, Jack faces certain death.”

Jack’s cause goes continental

Explaining how they got involved in the Chicago-area crisis, Andrew McFadyen, Executive Director of The Isaac Foundation in Canada, explains that their organization specializes in helping the victims and families of those suffering from diseases like the very rare Hunter Disease. Only 200 children suffer from the syndrome in the US while just 2,000 current cases are known worldwide.

McFadyen says, “Shire has the ability to step in and save this child. FDA regulations allow for expanded-use of investigational drugs in cases like this. As a company developing life-changing and life-saving medications, it’s their responsibility to provide those medications to those that most need them. To do otherwise is inhumane and shows a callous disregard to human life.”

Two days ago, NBC Chicago joined the chorus of folks calling on Shire Pharma to step in and let Jack take their promising new medication currently still in trial stage. NBC described how Jack was first diagnosed when he was just 15 months old. Pulling on viewers heartstrings even more, the network explained how it’s been over a year since Jack’s had the ability to verbally tell his parents that he loves them.

Shire Pharma officially refuses to help

Jack’s parents - Jason and Jamie - described to the network their heartbreak when Shire representatives personally and officially refused to allow Jack to take their drug during an in-person meeting with the family two days ago. "I screamed and I broke down," Jamie exclaimed, "By not sponsoring him, they're delivering him certain death."

The Fowlers and their doctors explained to Shire executives that a world-renowned physician at Lurie Children’s Hospital agreed to administer the drug and take medical responsibility. So, not only won’t Shire Pharmaceutical allow Jack into its trials, the corporation won’t even sell his family and the Children’s Hospital their drug so Jack won’t die. Why?

Feeling the heat, Shire Pharmaceutical released a statement explaining their refusal to help 6 year-old Jack. Needless to say, they’re not backing down from their inexplicable resistance to helping save the life of an innocent child. Personally, this author fears it’s no more than the company’s fear that the fluid on Jack’s brain may make their drug less effective, giving it bad publicity in an environment outside their tight PR control. According to the corporation’s statement 48 hours ago, it’s for other reasons. The statement reads (from The Isaac Foundation):

“We remain deeply sympathetic to Jack Fowler and his family. Patients have been, and will always be, at the heart of what we do, and have driven our desire to research potential new therapies for more than 20 years. Guidance from regulatory agencies is that expanded access to investigational medicines and devices outside of a clinical study setting should be based on the existence of compelling evidence of efficacy, or the drug’s benefit, and safety. Efficacy is typically studied in later stage trials; these data are not yet available for our investigational treatment as we have only just initiated our Phase II/III study. Shire does support, and has provided, expanded access at the appropriate stage in the development process - when clinically validated efficacy and safety information is available. We remain focused on completing our Phase II/III trial with the hope of making our investigational treatment available to as many Hunter syndrome patients as possible, as quickly as possible.”

Jason Fowler’s appeal

In a seven-minute video appeal published on SaveJack.ca, Jack’s father Jason details his, Jamie and Jack’s recent ordeal with Shire Pharma CEO Flemming Ornskov. After taking their plight to local media outlets, blogs, friends, family and anyone who would listen, Shire phone systems were lit up with calls to the point that they were forced to temporarily shut them down. Finally, the Shire CEO agreed to meet the family in person at a hotel near the Fowler’s Chicago-area home.

“We were hoping for good news. We brought Jack with us,” Jason Fowler described the meeting with Shire’s Flemming Ornskov, “It was definitely a different environment than we expected. There were actually three security guards there with ear pieces in. I don’t know what they expected we were going to do. We were walking in with our six-and-a-half-year-old disabled son, you know, making a plea for them to save his life.”

Jason goes on to describe his personal discussion with the Shire CEO. “The first thing out of Flemming’s mouth was something to the effect of, maybe Jack shouldn’t be in the room for the meeting. And we felt it was very important for Jack to be there, for them to see the patient” he continues his recollection, “Jack is not the poster child of MPS. He’s a majority of the MPS patients. But he’s definitely not the ones that are on the brochures, and on the CD’s, and in the promotional materials for Shire.”

Unfortunately, it was immediately apparent that Shire Pharma only agreed to the meeting to again refuse to help their son, only directly to their faces. As Jason explained, the fact that they confirmed their immoral decision to not help Jack to their faces doesn’t make it any less immoral. After the Fowlers refused to remove 6 year-old Jack from the room at the Shire CEO’s request, the five-minute meeting was apparently over.

"The news shouldn't be left wing or right wing, conservative or liberal. It should be the news. It should be independent" - Mark Wachtler, Illinois Herald owner/editor

Speaking of CEO Flemming Ornskov and the other Shire executive that met with the Fowlers and the way they treated their son Jack at the meeting, Jason says, “The way they treated him was inhumane. It was indescribable, the sadness that I felt. It was anger later, but immediate sadness, that these are two people that made the decision not to save my son’s life.”

Jason goes on to explain his reaction to the Fowler’s in-person meeting with the executives of Shire Pharmaceutical saying, “They said it themselves during the meeting, which is so contradictory - they don’t make those decisions. So we said, exactly. Grant access to the drug, sponsor and get out of the way. Let the FDA decide. Let his physician decide. And yet they continue to stand in the way, and are in essence making the decision. The decision they’re making is to not save Jack’s life. And it’s not about anything else. It’s about a little boy who needs life-saving treatment.”

For more information and to find out how you can help, visit SaveJack.ca.


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