cc: Lance Armstrong, President Bill Clinton, Senator John Kerry, Senator Tom Harkin, Senator Ted Kennedy, Dr. Andrew von Eschenbach (Head of FDA)
Mr. Mullen, my name is Andrew Baron and my father Frederick (61 yrs. old), who has final stage multiple myeloma has been recommended the drug Tysabri as a last chance effort for life.
Please read this carefully.
Last Thursday, his doctors at the Mayo Clinic determined that he may only have about 24-48 hours to live.
In what can only be defined as a miracle in timing, a few days ago, one of his doctors who has been studying his tumor cells in the lab for years found an antibody with an exact match: Tysabri which is manufactured by your company, Biogen Idec. In the test tube, it attached to the antigens on the surface of the tumor 100%.
Though the drug has never been used before in this way, and because time is running out, the head of the FDA, Dr. Andrew von Eschenbach has granted special approval for use of the drug for this purpose but you have personally decided “no”.
Lance Armstrong, who you spoke with on Friday, has also pleaded with you to say “yes” to my father, but you personally said “no”.
President Bill Clinton, Senator John Kerry, Senator John Harkin, Senator Ted Kennedy, Dr. Andrew von Eschenbach and others who you spoke with on Friday and again yesterday on Monday have all pleaded with you to say “yes”, assuring you that there would be no legal risk and no negative consequences to your company if something went wrong, but you continue to say “no”.
If this drug was rare, scarce, or if people were waiting in line to obtain it, we would not be expecting any privileges. But the drug is readily available, cheap and even sitting in our clinic’s pharmacy just 6 floors below us right now… . All we need is for you to just say “yes” to save his life.
I’m the CEO of my company so I can appreciate the pressure of doing what’s best for your company. Is denying my father access the best thing for your company? How could it be? What’s the risk?
What is the justification? No one knows. We have gotten back reports from everyone that spoke with you and others at your company and they do not see any justification as to why. All I know is “No because no”.
The very best doctors in the entire world from the Mayo clinic which is one of the most experienced treatment centers in the world have recommended this drug to save my father’s life and it’s the only thing known that could work.
After you refused on Friday, the doctors decided that they must do something, and resorted to another antibody called Campath which is working to prolong his life.
Please Mr. Mullen, there is no time left. There is no justification. Just say yes.
To anyone else who reads this: Please help! My father is a saint who has given his life and his resources to better humanity. He has spent his entire life seeking to protect the rights of others from harmful death and has spent an enormous amount of money and time in helping to shape our government to protect the rights of people everywhere. He is a philanthropist at heart.
1. Call Mr. Mullen or anyone at Biogen and ask them to please say yes (or provide a justification for whynot). Speak with anyone in the company in any department that you can find: http://www.biogenidec.com/site/contact.html
2. Contact an elected official and plea with them to call Biogen to seek approval:
3. We have been searching all over the world for international options and continue to look for a country that we could fly to to obtain and administer the drug. Do you know of anywhere that we could go? So far we have found that by law, Biogen controls use in every country that the drug is distributed in.
4. Do you know of any options in alternative medicine?
5. Do you know how we can obtain this drug?
Please comment here, email me at email@example.com or post and discuss here: http://friendfeed.com/rooms/myeloma
We are trying to figure out what to do.
**Update: There is a PR rep from Biogen by the name of Naomi Aoki who has not been willing to respond to me personally (I have not been contacted by anyone in the company), but appears to be out on the other blogs trying to spin this in a positive direction for Biogen. Aoki tries to provide the justification that if something were to go wrong, it would lead to bad marks against Biogen’s trial sessions, and thus jepordize the ability to treat others, but my understanding is that the FDA told Mullen that they would consider a compassionate use case with my Dad to not count against the company. In other words, considering the life and death circumstances, if the drug did not work or if it caused an adverse reaction, the FDA would be willing to exclude this data from any future considerations against the company. Thus it’s my understanding that Biogen has been told that they have nothing to worry about but Mullen decided personally that he did not want to take it in this direction.
Also, for some reason, unlike most other drugs, I have been told that Biogen designed their contract with care providers in a way that prevents any off-label use of Tysabri without the companies approval, a rare stipulation apparently.
** Update II (October 16th, 2008 3:30pm Central) – Thanks to the persistence and hard work of so many friends, Frederick has received Tysabri. The Mayo Clinic working with the FDA found a legal basis for this use. We have every expectation of a positive result. We cannot thank you enough for all of your thoughts and support!