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!
sull
· 1 year ago
happy to hear! best wishes...
missbhavens
· 1 year ago
YES!!!
This indeed superfantastical! I'm SO glad!
funtime7777
· 1 year ago
Congrads Andrew.. We'll be pulling for you and your family. Keep us all up to date. I"m sure this will help, positive thoughts.
Monica
· 1 year ago
Cool - I wish I had friends like your father had. Almost like a get out of jail free card, wink wink.
Seriously, I hope you're still able to sue the hell out of Biogen, anyone who screws with a friend of Clinton or Edwards should PAY THE PRICE!
Karma
· 1 year ago
They should be sued - how can they be legally selling a "safe" drug to some people, but then when someone else wants it they say it is too dangerous. I bet they are just trying to get back at Frederick for his support of Democrats. Give 'em hell - sue them 'till they surrender!
Rolled
· 1 year ago
Karma, this drug is not permitted by the FDA to be sold off-label. And, Tysabri, although a miracle drug, was pulled from the market despite being safer and more efficacious than any other MS med because 2 patients contracted PML while on the drug. These patients were extremely immune suppressed - like Fred Baron - and their side effect caused the drug to be withdrawn to the detriment of 10's of 1,000's of patients. Biogen is fearful that off-label use and a death that would be no fault of Tysabri's would be lain at the door of Tysabri yet again and jeopardize Biogen's future. That is the CEO's job: to protect patients and shareholders.
andrewbaron
· 1 year ago
Rolled, Biogen decided **on their own** that they wanted to remove the drug and thus decided to deprive 10's of 1000's of people from the drug for their own internal reasons.
Rolled
· 1 year ago
Not exactly...the situation was akin to resign or we will fire you.
andrewbaron
· 1 year ago
The bottom line is that Biogen may have too much control over the destiny of who gets the drug and who does not. Its in a rare category and only a few other companies have this power.
MainstreetMadman
· 1 year ago
I'm happy he got Tysabri and I hope it works. I wish him the best.
I can understand the companies resistance as Tysabri has been under intense scrutiny. Two patients recently got PML from Tysabri and many feel that those side effects will significantly reduce demand for the drug. Two companies have a large stake in this drug and their futures depend on it. The stocks of these companies were crushed when news of recent PML cases arose. Future negative news regarding Tysabri could negatively affect perceptions about the drug. Biogen has predicted 100,000 patients on the drug in 2 years, and by them taking risks the companies futures are risked. If there was no PML risk I'm sure he would have agreed sooner. The fact that your doctor couldn'\t just give it to him is a testament to how much scrutiny the drug is under - one more side effect could destroy it regardless of how good it is.
rolled
· 1 year ago
Maybe drug companies should not have control over their drugs, but that would basically leave companies with no authority and all accountability for their products. I doubt you would like no control over who you work for - and your Dad would hate to be told what cases he had to take.
All companies currently have the power to choose who they do business with - and to take that away would mean that we would become the first pure communist country. And maybe that is OK, but then your extreme wealth needs to be put back in the pot for all to share. And I bet that is not OK.
I really am happy for your Dad and think that is a product is on the market then docs should be able to prescribe off-label. However, you obtained a waiver for your Dad due to extraordinary influence, and that option is not available to the vast majority. I would bet that Biogen would gladly allow off-label Rx for Tysabri if that were allowed generally - but it is not. The other 70,000 US MM patients do not have the option that your Dad has - and they should.
I doubt that Biogen is the enemy here. They and Elan Pharmaceuticals developed the drug and want people to use it. But they do not want use off-label to jeopardize approved uses for patients. The Barons are in a position to help correct the system: use your influence to make changes to remove the liability overhang that threatens pharmaceutical companies and makes it more difficult to bring effective treatments to patients.
KG
· 1 year ago
Fantastic!! I'm a big fan of your dad's and we're all praying for a miracle here in Dallas.
Pamela
· 1 year ago
Congratulations and best wishes for your father! Sue the bastards for delaying this and I hope it works out!
CMose
· 1 year ago
"sue the bastards" Typical
GermanCowboy
· 1 year ago
Congratulations, that took guts. That's how we know you!
wtl
· 1 year ago
Andrew, that is great news! I wish him well!
roblifford
· 1 year ago
Nice! My dad is a multiple myeloma patient, now three years cancer-free, but if and when it recurs, I'm glad I learned about this new possibility via your site. I'm very happy for you and your family. Please keep us posted on progress if possible.
asn
· 1 year ago
Does your dad know Bill Clinton?
Kelly
· 1 year ago
Congratulations!!! I'm so glad that they were able to get it. I hope that he's able to pull through this!
Ron Weindruch
· 1 year ago
Wonderful news. Angie and I wish Fred all the best. Thanks for keeping us informed.
Victoria Morgan
· 1 year ago
Andrew, all our love from Adelaide, Australia - We've only just logged into Twitter after a long absence to read of your Father's, yours and your family's plight. Our thoughts are with you and we are looking forward to hearing about the positive outcomes. Best wishes. Victoria & Adam Morgan
Goodshow
· 1 year ago
The rich and famous always gets what they want.
USA is so corrupted that is beyond repair.
Hope Baron gets well enough to sue the big pharmas again.
There is no justice after all!
Kathy
· 1 year ago
Goodshow -
If you were as beautiful and important as Fred and Andrew are, believe me, we would be pushing you to have access to the drug.
Sorry
Goodshow
· 1 year ago
So you said "beautiful and imnportant" people have special previleges and above all people. Are you saying that they are above us "fat and dumb" small guys?
You must have lived in Russia or China before WW2, or must be a Democrap who committed woman-slaughter by driving over that damn bridge and got away with it.
This is sad.....
Scorpaen
· 1 year ago
that's so damned evil!
anonyanony
· 1 year ago
Are you truly that nasty?
celeste
· 1 year ago
Blast from the past here. So happy to hear the fabulous news about your dad. I read about it in Austin.Your determination, wisdom and vision continue serve you and yours well!! I know he is so absolutely proud of you. Here's to family, friends, health and happiness!
andrewbaron
· 1 year ago
Hey Celeste! Great to hear from you, thanks so much for the nice words, I hope things are going great for you!
px00001
· 1 year ago
Good luck to your Dad. I hope he recovers quickly and is out golfing on Thanksgiving! Hopefully everything works out well. He will need his second infusion 28 days from today (November 13th), so you better do what you can to get it lined up through the FDA or somewhere.
andy169
· 1 year ago
I hope Fred pulls through and get well enough to play golf next week.
After that, I think he will sue the hell out of J. Mullen for delaying the approval of Ty so that he suffered needlessly for 48 hours. He should ask for $500,000,000 in compensation from Mullen and Biogen.
R Cohen
· 1 year ago
I was praying for your Dad to get the drug. Now I pray that it will help!
Robbie Cohen
Darryl Mitteldorf, LCSW
· 1 year ago
Well done.
ronen
· 1 year ago
:)
Dirk Klein
· 1 year ago
Wonderful News. I am pulling for you and your family. My Best Wishes from "Od Europe"..
sobriant
· 1 year ago
Let's not forget to give credit to our Father. Thanks be to God and the prayers that so many lifted up in Fred's name.
Jo Ann
· 1 year ago
My brother died of multiple myeloma in 1996. I'm so glad that your father now has access to this drug.
vic rogers
· 1 year ago
I was shocked to hear about your dad (a friend of mine in college) and am equally pleased that you were able to obtain Tysabri--please give him my best wishes.
Vic Rogers
NATHAN AND KAREN EDDINS
· 1 year ago
KAREN AND I ARE DEEPLY SADEND TO HERE OF FREDS CONDISION. KAREN WAS FREDS SECRETARY FOR NEARLY 30 YEARS. PLEASE TELL FRED AND LISA THERE IN OUR PRAYERS.
dmarlin
· 1 year ago
Dear Andrew,
I am so very proud of you. It is heartrendering to see what you have done for your Father. And, I don't think a Father could love his son more. My prayers and thoughts will be with you and your family each second of the day as I know thousands of others will be as well. All my love to you, Deborah Rubin Marlin
MaryLou
· 1 year ago
Wonderful! A life so well-lived should not end so soon.
Wendell Wood
· 1 year ago
Hope TYSABRI along with the good folks at the MAYO CLINIC, helps save your dad's life! When your dad gets better, perhaps he can help the MAYO CLINIC publicize the TYSABRI clinical trials for myeloma. Right now, the MAYO CLINIC doesn't even show on it's clinical trials website that there is a trial with TYSABRI for myeloma. Nor does the clinicaltrials.gov website for the "natalizumab trial for myeloma" mention either the MAYO CLINIC or TYSABRI.... ....so others can get TYSABRI, too! Wendell Wood, Fairborn, OH
Anthony
· 1 year ago
I wish your dad the very best. I also hope this may lead to wider availability of experimental therapeutics for others that desperately need them...
drewolanoff
· 1 year ago
Hoping for the best.
narendra
· 1 year ago
Andrew, our thoughts are with you and your father. Best, Narendra and Julie
CMose
· 1 year ago
Hope it works. Good thing to have buddies like Bill Clinton and Lance Armstrong. The rest of us would just be SOL>
Kevin Stouwie
· 1 year ago
You dad is a hero. I'm a 39 year old trial lawyer in San Antonio, and I am well aware that your dad is not only a legendary attorney, he is one of the most honorable, generous, and decent men in our profession. I am very very sorry to hear of his battle with cancer. I hope the drug is a miracle!! God bless you and your family in this most difficult time.
Clyde Greenhouse
· 1 year ago
So glad to hear this news. All my best to Fred.
Angela Moody
· 1 year ago
Andrew,
Thanks for the text. Ed and I are grateful that persistence prevailed and he received the Tysabri. Thanks for keeping us posted. I know you must be exhausted so your updates to us are valued greatly. It is an absolute travesty that it took a former president to make obtaining this medicine possible. Our healthcare system truly is a crisis because most people don't have the ability to have a former president be their advocate. Your dad has always fought for the little guy who didn't have an advocate so it's wonderful to know that someone fought for him and prevailed. I know this must be such a relief. Please tell Lisa and the rest of your family that Ed and Angela Moody are deep in prayer for their strength and tell Fred we are praying for him and to keep fighting.
Kelly Martine
· 1 year ago
Andrew, congrats to your effort in obtaining Tysabri. Like Jim, I am against the compassionate usage of Tysabri because it will ruin the safety profile of this drug. In addition ambulance chasing litigations will follow. Back in July, one patient died because of such use and both Biogen and Elan were taken out to the woodshed for a beating when the press media claimed that the drug was unsafe. Jim and I know that we could not control the paid media which seems to have special agendas. We believe forbidding the off label use is our best defense to protecting the MS and CD franchises.
Best of luck to your dad.
KM
andrewbaron
· 1 year ago
Kelly and the few other people who are concerned about the negative effect this may have on the future of the drug:
In my own personal opinion, Biogen should not be allowed the ultimate decision on who gets the drug, and who doesn't get the drug. I think the government should have the ultimate decision. The government decides what to do based on justice, whereas Biogen is a company that decides what to do based on money. Mr. Mullen's job in steering the company is to make as much money as possible and Mr. Mullen seems to have no compassion.
It's very possible that Biogen could have a different kind of a CEO who was no less concerned about making as much money as possible, but also had human compassion. It's a difference in style. Some would argue that having compassion would itself lead to more money.
When this very important drug was removed from the market a couple of years ago, it was because Biogen decided on their own to stop the distribution, causing a lot of people a lot of strife, determining that **nobody** would be allowed to have to the drug.
All of these decisions about who gets it and when are very convoluted and I think that the government for justice should have the ultimate say.
While many drug companies act responsibly, Biogen should not ever be in a position to ultimately decide because human life is clearly more valuable than money.
Tead Lover
· 1 year ago
Well said Andrew. Biogen should not be allowed to play God and decide who should get Tsabri. Besides its NOT their drug in the first place. My sister-in-law became disable when Tysabri was withdrawn because Mullen decided to protect the Avonex/Tysabri franhise. It hurts me a lot whenever I see her struggle with the wheelchair.
I sincerely wish well to your dad and pray that he will WALK OUT of the freaken Mayo hell very soon.
There is hope straight ahead.
Kate
· 1 year ago
you fucking piss me off!
Rolled
· 1 year ago
Andrew, Biogen's Tysabri was unfairly removed from the market once before and the companies are fearful that use off-label may result in negative consequences for this miracle drug yet again. It is not, IMO, the government that should decide how this drug is used, but doctors and patients. If your Dad's doctor believes Tysabri is the thing to treat his MM, then your Dad should be able to get it - even if the government has not approved the use.
I hope your Dad gets better fast as a result of your efforts. But, it is a little ironic that your Dad made off-label use expensive to pharma companies themselves in the past - resulting in their being gun shy. Maybe when he returns to full health, he can bring his considerable intellect and money to bear to make it possible for doctors to prescribe what they think is best.
andrewbaron
· 1 year ago
Rolled, over the last several years, my father donated around $1,000,000 to Mayo to conduct the research which led to this discovery of Tysabri.
Chris
· 1 year ago
Andrew Baron,
I am very pleased that you were able to obtain the drug and I'm sorry that you had to do so in such a stressful situation. But your response greatly upsets me. I plead with you to respect the incredibly difficult decision that Biogen Idec had made. Mr. Mullen is weighting a lot of factors, a good number of them independent of money and you should acknowledge the existence of those factors. It is very important that you take advantage of the large media attention and your influence to change this restrictive system in place and not create a witchhunt out it.
As a scientist myself, I am skeptical about the scientific basis of the Mayo Clinic and concerned about the lack of Phase I data but I wish your father the best since cancer is disease that haunts us all. The best happy ending for everyone is if this drug truly is a miracle. I pray for you and your family.
"Justice" has nothing to do with safety or efficacy and in any case probably doesn't include the people most afraid of innovation being the first to benefit from it due to political influence. How exactly are you going to fine a "druge justice czar" who can make better decisions? If anything, we need to remove restrictions and delegate as much decisions making as possible to the people most concerned, usually doctors and patients, by using the govt to insure that quality, accurate information is available long before people are confronted with situations similar to yours.
Everytime a legal person doesn't get his way, he starts calling innovators greedy or some other term. Is this a joke? You can't possibly be serious.
tina chandler
· 1 year ago
i am on tysabri for ms .. and it has had a major impact on my life ,,, good impact .,.. i wanted to let you know ppl do care and i will pray with all my heart for your family.... no one really knows what all sick people go through just to get the help we need... tina chandler ... keithville louisiana
Mike Kalliontzis
· 1 year ago
I am happy for Mr Baron. I wish you all the best and success with Tysabri. it seems to be helping me so far.
God bless
myelomamike
· 1 year ago
Congratulations on getting through brick wall. I hope and pray that this drug will help your father.
This sounds very much like the story of Beth Wolmer, who some years ago went through a similar experience in securing thalidomide for her husband. At the time, thalidomide was only authorized for use in treating leprosy. It has since become a standard treatment for myeloma and has spawned derivative drugs that are also being used and/or are in trials for myeloma. Her story can be found in the New York Times at http://tinyurl.com/62km9q.
As an 18 year myeloma survivor and a member of the board of the International Myeloma Foundation, I reiterate my congratulations and hope that this drug will work for your father and ultimately find its way into the arsenal we have to fight this horrible disease.
Michael Katz
andrewbaron
· 1 year ago
I received an incredible amount of emails over the last week with some awesome information, ideas and suggestions which I will slowly start adding to the friendfeed room at http://friendfeed.com/rooms/myeloma
gary levinson
· 1 year ago
Andrew,
Bravo to you for your eloquent no holds barred letter. How inconceivable it is that a pharmaceutical company would have a drug so readily available and NOT bend over backwards (with proper releases) to make it available. I deeply hope that this not only saves Fred's life but becomes a watershed event for all business to reflect on what they do and why they do it. Fred, we love you and are pulling for you!
Gary
rolled
· 1 year ago
Gary, there is a MM trial for Tysabri ongoing right now. The FDA helped set up the acceptance criteria for this trial. The trial is not fully accrued and Mr. Baron did not apparently qualify. But, the FDA has given permission for Mr. Baron to receive the drug. By this logic, all MM patients should be allowed access to this drug. And I would bet Biogen would like to sell it to as many MM patients as possible.
new widow
· 1 year ago
I wish your father and all his family and friends the very best of luck. After a 5+ year battle with MM my husband died earlier this month in terrible pain and agony. I had never heard of tysabri but Revlimid extended his life about two and one half years.
All of you being so hard on the drug company should be aware that many of us who suffer from RA would give everything we have to get our drugs which were effective back after massive class action law suits forced their withdrawal from the market. Not many things in this complicated world can effectively be seen as being either black or white (or only good or bad).
Dwight James
· 1 year ago
Andrew, I have known your father and Lisa for many years. I have admired the fine person that he is. He has lived his life well for good purpose and we pray he has many more meaningful days ahead. Please tell Fred and Lisa that they are in our thoughts and prayers. Dwight and Lois James
George
· 1 year ago
Fantastic news! Godspeed and swift recovery to your dad.
Shareholder
· 1 year ago
Andrew, As a shareholder, I read your blog with concern that Mr. Mullen has been so uncooperative. Please forward your information to Jim Cramer's blog and to Carl Ichan's blog. Mr. Mullen should be placed on Jim Cramer's Wall of Shame! Carl Ichan has been attempting to oust him as well.
confused
· 1 year ago
I've read on pharmalot:
"The FDA has provided no such assurance to the company. Our policy is to consider all available information when evaluating the safety and effectiveness of drugs. We recognize and appreciate that expanded access programs involve less-controlled use of experimental treatments than the well-controlled environment of a clinical trial, and thus we would consider information that might be obtained in this instance within that context.”
contrast this with your claim:
". 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."
this makes you a liar: fda said it would consider the information within the extraordinary circumstances, which is very, very different from excluding it.
FDA also does not choose to apply its laws depending on if an individual knows senators or not. It cannot -- it would be liable to many lawsuits. Thus should FDA mandate access to Tysabri to all multiple myeloma patients positive for this marker?
Also:
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”.
This is misleading. In America, as you well know, if something is legal or not is decided by the courts, not Bill Clinton or John Harkin. No one can assure you there will be "no legal risk", especially not a bunch of senators.
Marcus
· 1 year ago
Sorry - President Obama is about to win and the Democrats can determine whether it is legal or not. Biogen just took a huge legal risk trying to kill a major Democrat and lost. The FDA is only liable if it choose to be, sovereign immunity and all.
Casey McKinnon
· 1 year ago
As soon as I heard that you were trying to get the drug from Biogen, I told Rudy. Rudy's father used to work there, so Rudy then passed the message onto his father. I don't know if it helped at all, but just want you to know we care. I hope your father is in full remission. <3 Casey
Tony
· 1 year ago
It is great news that your father has obtained Tysabri and we hope it turns out to be the miracle cure for MM for everyone’s sake.
We wish your father a speedy and full recovery and that he is back on the golf course before you know it.
Joe
· 1 year ago
Andrew, many MM patients would love to be kept updated on Fred's improvement. I certainly hope that Tysabri will enable life back into Fred and many patients with MM. I know that it is early, but with good vibrations and thoughts of love for all, and we continue to see positive outcome, could you give back to humanity, and fight for the media and public awareness of this success. Many drug makers would love to keep the chemo-regime in power so that they can maintain their profit margins at the cost of innocent lives. One of the reasons Biogen said no was that Jim Mullen wanted to ensure their primary drug Avonex sales would not be impacted by this off label use for Tysabri. This is an atrocity in itself, it places the value of money above human life which is manifested today in spades within our society. Your father fought for many injustices in the world. Please follow your father's footsteps...Namaste!
Laura
· 1 year ago
I am so happy that you were able to obtain this drug for your father. I hope that it works for him. As a multiple myeloma patient, I am always glad to see new drugs being tested. My prayers are with you and your family.
RandB
· 1 year ago
My dad died from multiple myeloma in March 03. He had been rejected from a clinical trial just before he died. Best of luck to yours!
Kyen
· 1 year ago
Very sorry for your loss. What was the reasoning given for his being turned down?
Suzann Lowe-Richard
· 1 year ago
Hi Andrew... It's been almost 2 weeks since your dad received Tysabri. I was just wondering if there was an update on his condition... Is it helping?! (Very hopeful) We are keeping Fred in our prayers. Suzann Richard and Sam Richard
James Mc Gowan
· 1 year ago
I wish the best for your father's recovery, Andrew. In the event that Fred Baron is able to extend his living days with the benefit of Tysabri, a drug that has excellent results for MS patients as well, but is unfairly maligned by competitors, would it be reasonable to expect that you and your father would use your resources to fight for use of Tysabri for multiple myeloma patients that are appropriate candidates for this therapy?
It would be a good turn for your father to use his clout to better the survival and quality of life opportunities for patients who desperately need Tysabri, but are challenged due to unreasonable restrictions on it's use. You were able to convince the FDA to allow your Dad to get Tysbari, the Mayo Clinic also found cause to fight for this compassionate use, why not fight for others to get the same treatment, if they are found to be at death's door for a lack of therapies that could extend their remaining days.
I realize your father made a successful career in litigation representing people afflicted with diseases secondary to exposure to various toxic substances, but he also has great knowledge and experience and contacts, no doubt, in litigation matters with pharmaceuticals. It would see that those who supported your Dad's effort for access to Tysabri would surely come to the aid of others so afflicted with multiple myeloma, and hasten their access to this potential life extending medication.
After all, what do they have left? Not much more that your Dad did just a few short days ago.
Regards,
James Mc Gowan
Kyen
· 1 year ago
Deepest sympathies to you and your family, Andrew. You did all you could for your father, I'm sure he was quite proud.
Tony
· 1 year ago
Andrew, our hearts go out to you and your family you have our deepest condolences.
andrewbaron
· 1 year ago
Thank you again to all. My dad lived the best life anyone could ever hope for.
One day soon, I will post an update on the details of how we obtained Tysabri in hopes that others might benefit. I personally think the drug may turn out to be everything we expected but may have come too late. Anyone who is concerned that this special use of Tysabri granted to my Dad was unfair or effected others negatively should know that over the last several years, my father donated at least $1,000,000 to Mayo to conduct research on MM which led to this discovery of Tysabri as a possible cure for his disease (the main reason why I personally think James C. Mullen and Naomi Aoki are COMPLETELY evil, to put it nicely).
All Comments
This indeed superfantastical! I'm SO glad!
Seriously, I hope you're still able to sue the hell out of Biogen, anyone who screws with a friend of Clinton or Edwards should PAY THE PRICE!
I can understand the companies resistance as Tysabri has been under intense scrutiny. Two patients recently got PML from Tysabri and many feel that those side effects will significantly reduce demand for the drug. Two companies have a large stake in this drug and their futures depend on it. The stocks of these companies were crushed when news of recent PML cases arose. Future negative news regarding Tysabri could negatively affect perceptions about the drug. Biogen has predicted 100,000 patients on the drug in 2 years, and by them taking risks the companies futures are risked. If there was no PML risk I'm sure he would have agreed sooner. The fact that your doctor couldn'\t just give it to him is a testament to how much scrutiny the drug is under - one more side effect could destroy it regardless of how good it is.
All companies currently have the power to choose who they do business with - and to take that away would mean that we would become the first pure communist country. And maybe that is OK, but then your extreme wealth needs to be put back in the pot for all to share. And I bet that is not OK.
I really am happy for your Dad and think that is a product is on the market then docs should be able to prescribe off-label. However, you obtained a waiver for your Dad due to extraordinary influence, and that option is not available to the vast majority. I would bet that Biogen would gladly allow off-label Rx for Tysabri if that were allowed generally - but it is not. The other 70,000 US MM patients do not have the option that your Dad has - and they should.
I doubt that Biogen is the enemy here. They and Elan Pharmaceuticals developed the drug and want people to use it. But they do not want use off-label to jeopardize approved uses for patients. The Barons are in a position to help correct the system: use your influence to make changes to remove the liability overhang that threatens pharmaceutical companies and makes it more difficult to bring effective treatments to patients.
USA is so corrupted that is beyond repair.
Hope Baron gets well enough to sue the big pharmas again.
There is no justice after all!
If you were as beautiful and important as Fred and Andrew are, believe me, we would be pushing you to have access to the drug.
Sorry
You must have lived in Russia or China before WW2, or must be a Democrap who committed woman-slaughter by driving over that damn bridge and got away with it.
This is sad.....
After that, I think he will sue the hell out of J. Mullen for delaying the approval of Ty so that he suffered needlessly for 48 hours. He should ask for $500,000,000 in compensation from Mullen and Biogen.
Robbie Cohen
I am pulling for you and your family.
My Best Wishes from "Od Europe"..
Vic Rogers
I am so very proud of you. It is heartrendering to see what you have done for your Father. And, I don't think a Father could love his son more. My prayers and thoughts will be with you and your family each second of the day as I know thousands of others will be as well. All my love to you, Deborah Rubin Marlin
Right now, the MAYO CLINIC doesn't even show on it's clinical trials website that there is a trial with TYSABRI for myeloma. Nor does the clinicaltrials.gov website for the "natalizumab trial for myeloma" mention either the MAYO CLINIC or TYSABRI....
....so others can get TYSABRI, too!
Wendell Wood, Fairborn, OH
Thanks for the text. Ed and I are grateful that persistence prevailed and he received the Tysabri. Thanks for keeping us posted. I know you must be exhausted so your updates to us are valued greatly. It is an absolute travesty that it took a former president to make obtaining this medicine possible. Our healthcare system truly is a crisis because most people don't have the ability to have a former president be their advocate. Your dad has always fought for the little guy who didn't have an advocate so it's wonderful to know that someone fought for him and prevailed. I know this must be such a relief. Please tell Lisa and the rest of your family that Ed and Angela Moody are deep in prayer for their strength and tell Fred we are praying for him and to keep fighting.
Best of luck to your dad.
KM
In my own personal opinion, Biogen should not be allowed the ultimate decision on who gets the drug, and who doesn't get the drug. I think the government should have the ultimate decision. The government decides what to do based on justice, whereas Biogen is a company that decides what to do based on money. Mr. Mullen's job in steering the company is to make as much money as possible and Mr. Mullen seems to have no compassion.
It's very possible that Biogen could have a different kind of a CEO who was no less concerned about making as much money as possible, but also had human compassion. It's a difference in style. Some would argue that having compassion would itself lead to more money.
When this very important drug was removed from the market a couple of years ago, it was because Biogen decided on their own to stop the distribution, causing a lot of people a lot of strife, determining that **nobody** would be allowed to have to the drug.
All of these decisions about who gets it and when are very convoluted and I think that the government for justice should have the ultimate say.
While many drug companies act responsibly, Biogen should not ever be in a position to ultimately decide because human life is clearly more valuable than money.
I sincerely wish well to your dad and pray that he will WALK OUT of the freaken Mayo hell very soon.
There is hope straight ahead.
I hope your Dad gets better fast as a result of your efforts. But, it is a little ironic that your Dad made off-label use expensive to pharma companies themselves in the past - resulting in their being gun shy. Maybe when he returns to full health, he can bring his considerable intellect and money to bear to make it possible for doctors to prescribe what they think is best.
I am very pleased that you were able to obtain the drug and I'm sorry that you had to do so in such a stressful situation. But your response greatly upsets me. I plead with you to respect the incredibly difficult decision that Biogen Idec had made. Mr. Mullen is weighting a lot of factors, a good number of them independent of money and you should acknowledge the existence of those factors. It is very important that you take advantage of the large media attention and your influence to change this restrictive system in place and not create a witchhunt out it.
As a scientist myself, I am skeptical about the scientific basis of the Mayo Clinic and concerned about the lack of Phase I data but I wish your father the best since cancer is disease that haunts us all. The best happy ending for everyone is if this drug truly is a miracle. I pray for you and your family.
http://blogs.wsj.com/health/2008/10/17/lance-ar...
"Justice" has nothing to do with safety or efficacy and in any case probably doesn't include the people most afraid of innovation being the first to benefit from it due to political influence. How exactly are you going to fine a "druge justice czar" who can make better decisions? If anything, we need to remove restrictions and delegate as much decisions making as possible to the people most concerned, usually doctors and patients, by using the govt to insure that quality, accurate information is available long before people are confronted with situations similar to yours.
Everytime a legal person doesn't get his way, he starts calling innovators greedy or some other term. Is this a joke? You can't possibly be serious.
God bless
This sounds very much like the story of Beth Wolmer, who some years ago went through a similar experience in securing thalidomide for her husband. At the time, thalidomide was only authorized for use in treating leprosy. It has since become a standard treatment for myeloma and has spawned derivative drugs that are also being used and/or are in trials for myeloma. Her story can be found in the New York Times at http://tinyurl.com/62km9q.
As an 18 year myeloma survivor and a member of the board of the International Myeloma Foundation, I reiterate my congratulations and hope that this drug will work for your father and ultimately find its way into the arsenal we have to fight this horrible disease.
Michael Katz
Bravo to you for your eloquent no holds barred letter. How inconceivable it is that a pharmaceutical company would have a drug so readily available and NOT bend over backwards (with proper releases) to make it available. I deeply hope that this not only saves Fred's life but becomes a watershed event for all business to reflect on what they do and why they do it. Fred, we love you and are pulling for you!
Gary
year battle with MM my husband died earlier this month in terrible pain and
agony. I had never heard of tysabri but Revlimid extended his life about two and
one half years.
All of you being so hard on the drug company should be aware that many of us who
suffer from RA would give everything we have to get our drugs which were effective
back after massive class action law suits forced their withdrawal from the market. Not
many things in this complicated world can effectively be seen as being either black or
white (or only good or bad).
As a shareholder, I read your blog with concern that Mr. Mullen has been so uncooperative. Please forward your information to Jim Cramer's blog and to Carl Ichan's blog. Mr. Mullen should be placed on Jim Cramer's Wall of Shame! Carl Ichan has been attempting to oust him as well.
"The FDA has provided no such assurance to the company. Our policy is to consider all available information when evaluating the safety and effectiveness of drugs. We recognize and appreciate that expanded access programs involve less-controlled use of experimental treatments than the well-controlled environment of a clinical trial, and thus we would consider information that might be obtained in this instance within that context.”
contrast this with your claim:
". 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."
this makes you a liar: fda said it would consider the information within the extraordinary circumstances, which is very, very different from excluding it.
FDA also does not choose to apply its laws depending on if an individual knows senators or not. It cannot -- it would be liable to many lawsuits. Thus should FDA mandate access to Tysabri to all multiple myeloma patients positive for this marker?
Also:
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”.
This is misleading. In America, as you well know, if something is legal or not is decided by the courts, not Bill Clinton or John Harkin. No one can assure you there will be "no legal risk", especially not a bunch of senators.
We wish your father a speedy and full recovery and that he is back on the golf course before you know it.
Suzann Richard and Sam Richard
It would be a good turn for your father to use his clout to better the survival and quality of life opportunities for patients who desperately need Tysabri, but are challenged due to unreasonable restrictions on it's use. You were able to convince the FDA to allow your Dad to get Tysbari, the Mayo Clinic also found cause to fight for this compassionate use, why not fight for others to get the same treatment, if they are found to be at death's door for a lack of therapies that could extend their remaining days.
I realize your father made a successful career in litigation representing people afflicted with diseases secondary to exposure to various toxic substances, but he also has great knowledge and experience and contacts, no doubt, in litigation matters with pharmaceuticals. It would see that those who supported your Dad's effort for access to Tysabri would surely come to the aid of others so afflicted with multiple myeloma, and hasten their access to this potential life extending medication.
After all, what do they have left? Not much more that your Dad did just a few short days ago.
Regards,
James Mc Gowan
One day soon, I will post an update on the details of how we obtained Tysabri in hopes that others might benefit. I personally think the drug may turn out to be everything we expected but may have come too late. Anyone who is concerned that this special use of Tysabri granted to my Dad was unfair or effected others negatively should know that over the last several years, my father donated at least $1,000,000 to Mayo to conduct research on MM which led to this discovery of Tysabri as a possible cure for his disease (the main reason why I personally think James C. Mullen and Naomi Aoki are COMPLETELY evil, to put it nicely).
From Lance Armstrong:
http://livestrongblog.org/2008/10/30/rip-fred-b...
From the Dallas Morning News:
http://dembot.com/post/57248104/frederick-marti...