RE: URSO study stopped-met with Dr. Lindor today

[Guest guest]

My Dad had his yearly appointment at Mayo Clinic with Dr. Lindor. My Dad has been taking the URSO medicine since around 1996-97 with his PSC diagnosis in 1996. Dr. Lindor explained, that the study has shown that URSO has caused very negative effects to the liver and that is why the study has been discontinued. My Dad is devastated by this news. Dr. Lindor seemed very concerned & down cast and didn't have much to say aside from the discontinued study and why. Does anyone have anything positive that I can share with my Dad? Does anyone know specifically what URSO does to the liver to cause this negative effect? What does it do to the liver? He had so much hope in this medicine. His liver tests always came back only slightly elevated each year but I guess the liver test

results can come back good but the URSO can still be causing serious liver damage and/or progress the disease faster. Anything I can share with my Dad would be appreciated. Does anyone know of any other studies that will be starting or talk of ones? If anyone is still taking URSO, (STOP). Thanks a lot.

Lori A.

"Aggressively Pursuing Solutions To Your Real Estate Needs!"

First Weber Group

Cell:

1507 E. Sunset Drive

Waukesha, WI 53189

LoriUSA@...

www.Lori.FirstWeber.com

E-mail to the NIH

The following is the e-mail i received back from the NIH. I hope everyone is following Dr. Lindor's advice to contact the NIH to support funding of research on PSC. The more e-mails the better.

I hope this finds everyone well!

take care,

Ross Heil

Dear Ross,Thank you for taking the time to write to me and to share your personalstory. I know it must be difficult to be diagnosed with PSC and UC butit looks like you are channeling your energies in the right direction.We, too, hope that you will complete your studies and go on to researchPSC. We can use all of the help that we can muster in studying thisdisease!I am sure that you are disappointed that Dr. Lindor's high dose URSOstudy ended the way it did. But as you know, even "negative" studieshave some positive results. Dr. Lindor and his colleagues did anexcellent job of very carefully conducting this clinical trial and theyhave collected a wealth of data that will be used beyond answering thequestion about URSO. While it wasn't the result that we all wanted, itdoes answer an important question: dose high dose URSO benefit patientswith PSC?

Now that we think we know the answer, those patients takinghigh dose URSO can stop - why take an expensive drug that doesn't appearto be of benefit? It also is an opportunity for clinicians andresearchers to look for new/other therapies other than URSO.We at NIDDK share your desire to advance the science for PSC.Unfortunately, we are limited by rules that govern how we distributefunds that are appropriated to us by congress. Decisions aboutredirecting funds from one project to another are not a simple task andmay not be permissible because of federal regulations current laws.But, please be assured that we at NIDDK will do everything we can towork with Dr. Lindor to channel the funds allocated for his presentstudy into advancing the science of PSC. I have taken the liberty of including Dr. Lindor on this email - I hopeyou don't mind. Dr. Lindor and I

have been colleagues for a long timeand share your concerns and passion for finding new treatments for PSCand other serious liver diseases. He can actually give you more advicethan I am allowed to give on how to make PSC a national priority andthus, find new funds and advance the science of finding new treatmentsfor PSC. Best regards,Pat R. Robuck, Ph.D., M.P.H.Director, Clinical Trials ProgramDivision of Digestive Diseases and NutritionNIDDK6707 Democracy Blvd., Room 659Bethesda, MD 20892-5450Telephone: FAX: Email: pr132q@...

[Guest guest]

My Dad had his yearly appointment at Mayo Clinic with Dr. Lindor. My Dad has been taking the URSO medicine since around 1996-97 with his PSC diagnosis in 1996. Dr. Lindor explained, that the study has shown that URSO has caused very negative effects to the liver and that is why the study has been discontinued. My Dad is devastated by this news. Dr. Lindor seemed very concerned & down cast and didn't have much to say aside from the discontinued study and why. Does anyone have anything positive that I can share with my Dad? Does anyone know specifically what URSO does to the liver to cause this negative effect? What does it do to the liver? He had so much hope in this medicine. His liver tests always came back only slightly elevated each year but I guess the liver test

results can come back good but the URSO can still be causing serious liver damage and/or progress the disease faster. Anything I can share with my Dad would be appreciated. Does anyone know of any other studies that will be starting or talk of ones? If anyone is still taking URSO, (STOP). Thanks a lot.

Lori A.

"Aggressively Pursuing Solutions To Your Real Estate Needs!"

First Weber Group

Cell:

1507 E. Sunset Drive

Waukesha, WI 53189

LoriUSA@...

www.Lori.FirstWeber.com

E-mail to the NIH

The following is the e-mail i received back from the NIH. I hope everyone is following Dr. Lindor's advice to contact the NIH to support funding of research on PSC. The more e-mails the better.

I hope this finds everyone well!

take care,

Ross Heil

Dear Ross,Thank you for taking the time to write to me and to share your personalstory. I know it must be difficult to be diagnosed with PSC and UC butit looks like you are channeling your energies in the right direction.We, too, hope that you will complete your studies and go on to researchPSC. We can use all of the help that we can muster in studying thisdisease!I am sure that you are disappointed that Dr. Lindor's high dose URSOstudy ended the way it did. But as you know, even "negative" studieshave some positive results. Dr. Lindor and his colleagues did anexcellent job of very carefully conducting this clinical trial and theyhave collected a wealth of data that will be used beyond answering thequestion about URSO. While it wasn't the result that we all wanted, itdoes answer an important question: dose high dose URSO benefit patientswith PSC?

Now that we think we know the answer, those patients takinghigh dose URSO can stop - why take an expensive drug that doesn't appearto be of benefit? It also is an opportunity for clinicians andresearchers to look for new/other therapies other than URSO.We at NIDDK share your desire to advance the science for PSC.Unfortunately, we are limited by rules that govern how we distributefunds that are appropriated to us by congress. Decisions aboutredirecting funds from one project to another are not a simple task andmay not be permissible because of federal regulations current laws.But, please be assured that we at NIDDK will do everything we can towork with Dr. Lindor to channel the funds allocated for his presentstudy into advancing the science of PSC. I have taken the liberty of including Dr. Lindor on this email - I hopeyou don't mind. Dr. Lindor and I

have been colleagues for a long timeand share your concerns and passion for finding new treatments for PSCand other serious liver diseases. He can actually give you more advicethan I am allowed to give on how to make PSC a national priority andthus, find new funds and advance the science of finding new treatmentsfor PSC. Best regards,Pat R. Robuck, Ph.D., M.P.H.Director, Clinical Trials ProgramDivision of Digestive Diseases and NutritionNIDDK6707 Democracy Blvd., Room 659Bethesda, MD 20892-5450Telephone: FAX: Email: pr132q@...

[Guest guest]

Lori,

I'm still on URSO and am going to stay on it. Before was started on USRO in 1999 my LFT numbers started to rising dramatically. My LFT numbers have on average bee, In lower in the last 9 years I've been on USRO then during the first 10 years after diagnosis. Unless the LFT numbers don't really mean anything my guess is that some people in the test did not have improved numbers on USRO (some people have adverse effects). I would suggest that your father try a lower dosage,

but watch is numbers. I also take a blood thinner and some thyroid medicine and they revise the dosage based on my blood tests because every body needs a different dosage. I'm on a low dosage of USRO just 500mg / day and weigh 200 lbs.

Ian (52) PSC 89

My Dad had his yearly appointment at Mayo Clinic with Dr. Lindor. My Dad has been taking the URSO medicine since around 1996-97 with his PSC diagnosis in 1996. Dr. Lindor explained, that the study has shown that URSO has caused very negative effects to the liver and that is why the study has been discontinued. My Dad is devastated by this news. Dr. Lindor seemed very concerned & down cast and didn't have much to say aside from the discontinued study and why. Does anyone have anything positive that I can share with my Dad? Does anyone know specifically what URSO does to the liver to cause this negative effect? What does it do to the liver? He had so much hope in this medicine. His liver tests always came back only slightly elevated each year but I guess the liver test results can come back good but the URSO can still be causing serious liver damage and/or progress the disease faster. Anything I can share with my Dad would be appreciated. Does anyone know of any other studies that will be starting or talk of ones? If anyone is still taking URSO, (STOP). Thanks a lot.

Lori A.

" Aggressively Pursuing Solutions To Your Real Estate Needs! "

First Weber Group

Cell:

1507 E. Sunset Drive

Waukesha, WI 53189

LoriUSA@...

www.Lori.FirstWeber.com

E-mail to the NIH

The following is the e-mail i received back from the NIH. I hope everyone is following Dr. Lindor's advice to contact the NIH to support funding of research on PSC. The more e-mails the better.

I hope this finds everyone well!

take care,

Ross Heil

Dear Ross,Thank you for taking the time to write to me and to share your personalstory. I know it must be difficult to be diagnosed with PSC and UC butit looks like you are channeling your energies in the right direction.

We, too, hope that you will complete your studies and go on to researchPSC. We can use all of the help that we can muster in studying thisdisease!I am sure that you are disappointed that Dr. Lindor's high dose URSO

study ended the way it did. But as you know, even " negative " studieshave some positive results. Dr. Lindor and his colleagues did anexcellent job of very carefully conducting this clinical trial and they

have collected a wealth of data that will be used beyond answering thequestion about URSO. While it wasn't the result that we all wanted, itdoes answer an important question: dose high dose URSO benefit patients

with PSC? Now that we think we know the answer, those patients takinghigh dose URSO can stop - why take an expensive drug that doesn't appearto be of benefit? It also is an opportunity for clinicians and

researchers to look for new/other therapies other than URSO.We at NIDDK share your desire to advance the science for PSC.Unfortunately, we are limited by rules that govern how we distributefunds that are appropriated to us by congress. Decisions about

redirecting funds from one project to another are not a simple task andmay not be permissible because of federal regulations current laws.But, please be assured that we at NIDDK will do everything we can towork with Dr. Lindor to channel the funds allocated for his present

study into advancing the science of PSC. I have taken the liberty of including Dr. Lindor on this email - I hopeyou don't mind. Dr. Lindor and I have been colleagues for a long timeand share your concerns and passion for finding new treatments for PSC

and other serious liver diseases. He can actually give you more advicethan I am allowed to give on how to make PSC a national priority andthus, find new funds and advance the science of finding new treatments

for PSC. Best regards,Pat R. Robuck, Ph.D., M.P.H.Director, Clinical Trials ProgramDivision of Digestive Diseases and NutritionNIDDK6707 Democracy Blvd., Room 659Bethesda, MD 20892-5450

Telephone: FAX: Email: pr132q@...

-- Ian Cribb P.Eng.

[Guest guest]

Ian, thanks for your response. I guess I have read that the tests really don't tell the real story but if you say some had different test/levels outcomes on the URSO perhaps there is something we don't know. Dr. Lindor did recommend stopping. I am not sure what my Dad will do. I will pass your info on. Thanks again!

Lori A.

"Aggressively Pursuing Solutions To Your Real Estate Needs!"

First Weber Group

Cell:

1507 E. Sunset Drive

Waukesha, WI 53189

LoriUSA@...

www.Lori.FirstWeber.com

E-mail to the NIH

The following is the e-mail i received back from the NIH. I hope everyone is following Dr. Lindor's advice to contact the NIH to support funding of research on PSC. The more e-mails the better.

I hope this finds everyone well!

take care,

Ross Heil

Dear Ross,Thank you for taking the time to write to me and to share your personalstory. I know it must be difficult to be diagnosed with PSC and UC butit looks like you are channeling your energies in the right direction.We, too, hope that you will complete your studies and go on to researchPSC. We can use all of the help that we can muster in studying thisdisease!I am sure that you are disappointed that Dr. Lindor's high dose URSOstudy ended the way it did. But as you know, even "negative" studieshave some positive results. Dr. Lindor and his colleagues did anexcellent job of very carefully conducting this clinical trial and theyhave collected a wealth of data that will be used beyond answering thequestion about URSO. While it wasn't the result that we all wanted, itdoes answer an important question: dose high dose URSO benefit patientswith PSC?

Now that we think we know the answer, those patients takinghigh dose URSO can stop - why take an expensive drug that doesn't appearto be of benefit? It also is an opportunity for clinicians andresearchers to look for new/other therapies other than URSO.We at NIDDK share your desire to advance the science for PSC.Unfortunately, we are limited by rules that govern how we distributefunds that are appropriated to us by congress. Decisions aboutredirecting funds from one project to another are not a simple task andmay not be permissible because of federal regulations current laws.But, please be assured that we at NIDDK will do everything we can towork with Dr. Lindor to channel the funds allocated for his presentstudy into advancing the science of PSC. I have taken the liberty of including Dr. Lindor on this email - I hopeyou don't mind. Dr. Lindor and I

have been colleagues for a long timeand share your concerns and passion for finding new treatments for PSCand other serious liver diseases. He can actually give you more advicethan I am allowed to give on how to make PSC a national priority andthus, find new funds and advance the science of finding new treatmentsfor PSC. Best regards,Pat R. Robuck, Ph.D., M.P.H.Director, Clinical Trials ProgramDivision of Digestive Diseases and NutritionNIDDK6707 Democracy Blvd., Room 659Bethesda, MD 20892-5450Telephone: FAX: Email: pr132q@...

-- Ian Cribb P.Eng.

[Guest guest]

Is this really fact that people should go off Urso . My Tyler has been on it for over a 1 yr and a half and it is the only thing that stopped the pain? Any of you pros out there like Ricky have any thing concrete. Now I am worried about this.

Stevie OStos

Lori

Lori

Sent by:

06/30/2008 09:03 PM

Please respond to

To

cc

Subject

Re: URSO study stopped-met with Dr. Lindor today

My Dad had his yearly appointment at Mayo Clinic with Dr. Lindor. My Dad has been taking the URSO medicine since around 1996-97 with his PSC diagnosis in 1996. Dr. Lindor explained, that the study has shown that URSO has caused very negative effects to the liver and that is why the study has been discontinued. My Dad is devastated by this news. Dr. Lindor seemed very concerned & down cast and didn't have much to say aside from the discontinued study and why. Does anyone have anything positive that I can share with my Dad? Does anyone know specifically what URSO does to the liver to cause this negative effect? What does it do to the liver? He had so much hope in this medicine. His liver tests always came back only slightly elevated each year but I guess the liver test results can come back good but the URSO can still be causing serious liver damage and/or progress the disease faster. Anything I can share with my Dad would be appreciated. Does anyone know of any other studies that will be starting or talk of ones? If anyone is still taking URSO, (STOP). Thanks a lot.

Lori A.

" Aggressively Pursuing Solutions To Your Real Estate Needs! "

First Weber Group

Cell:

1507 E. Sunset Drive

Waukesha, WI 53189

LoriUSA@...

www.Lori.FirstWeber.com

E-mail to the NIH

The following is the e-mail i received back from the NIH. I hope everyone is following Dr. Lindor's advice to contact the NIH to support funding of research on PSC. The more e-mails the better.

I hope this finds everyone well!

take care,

Ross Heil

Dear Ross,

Thank you for taking the time to write to me and to share your personal

story. I know it must be difficult to be diagnosed with PSC and UC but

it looks like you are channeling your energies in the right direction.

We, too, hope that you will complete your studies and go on to research

PSC. We can use all of the help that we can muster in studying this

disease!

I am sure that you are disappointed that Dr. Lindor's high dose URSO

study ended the way it did. But as you know, even " negative " studies

have some positive results. Dr. Lindor and his colleagues did an

excellent job of very carefully conducting this clinical trial and they

have collected a wealth of data that will be used beyond answering the

question about URSO. While it wasn't the result that we all wanted, it

does answer an important question: dose high dose URSO benefit patients

with PSC? Now that we think we know the answer, those patients taking

high dose URSO can stop - why take an expensive drug that doesn't appear

to be of benefit? It also is an opportunity for clinicians and

researchers to look for new/other therapies other than URSO.

We at NIDDK share your desire to advance the science for PSC.

Unfortunately, we are limited by rules that govern how we distribute

funds that are appropriated to us by congress. Decisions about

redirecting funds from one project to another are not a simple task and

may not be permissible because of federal regulations current laws.

But, please be assured that we at NIDDK will do everything we can to

work with Dr. Lindor to channel the funds allocated for his present

study into advancing the science of PSC.

I have taken the liberty of including Dr. Lindor on this email - I hope

you don't mind. Dr. Lindor and I have been colleagues for a long time

and share your concerns and passion for finding new treatments for PSC

and other serious liver diseases. He can actually give you more advice

than I am allowed to give on how to make PSC a national priority and

thus, find new funds and advance the science of finding new treatments

for PSC.

Best regards,

Pat

R. Robuck, Ph.D., M.P.H.

Director, Clinical Trials Program

Division of Digestive Diseases and Nutrition

NIDDK

6707 Democracy Blvd., Room 659

Bethesda, MD 20892-5450

Telephone:

FAX:

Email: pr132q@...

[Guest guest]

Hi Stevie,

I certainly wish I were a pro, but I am not. I, too, am

anxiously awaiting more information before deciding whether or not to continue

taking Urso. I think that we’ll have to wait until Dr. Lindor

publishes more concrete information about why the study was suspended,

hopefully soon! I am curious to hear what other hepatologists tell us

PSCers. This group is a great way to receive input from specialists

throughout the country. Meanwhile, I love the advice that Carolyn just

sent us.

Ricky Safer

PSC 2003

From:

[mailto: ] On Behalf Of Stevie Gedgaudas

Sent: Tuesday, July 01, 2008 9:26 AM

To:

Cc:

Subject: Re: URSO study stopped-met with Dr. Lindor today

Is this really fact that people should go off

Urso .

Stevie OStos

Lori