RE: **Note from Dr Lindor** on UDCA study

[Guest guest]

Barb -

If you haven't already, could you send an email to Dr Lindor, on behalf of those of us reading his response, thanking him for his response, as well as his dedication and persistence in PSC research. (wow, was that a run-on sentence or what - no comments from Ricky on my sentence structure, please !)

And Barb, thank you for asking him!

Joanne H

(, Ca., mom of , 18, UC/PSC 2-06, JRA 1998, who graduated last week - hurrah!)

This morning, I thought.....why not just ask Dr Lindor? So I did, hereis his response. HTH Barb in Texas

..

[Guest guest]

I actually spoke with my Doctor yesterday more in depth about the

decision to end the study and take me off the medication. I was

concerned because although there was no evidence to support benefit

with long term outcomes with my liver there are still some potential

benefits in the colon, etc.

My doctor confirmed what Dr. Lindor communicated to Barb. I don't

think any of the doctors truly believes that the Urso was actually

harming anyone but it is true that statistically there was a trend

developing where people on the real drug were progressing to transplant

faster. This is most likely a statistical anomoly based upon the

randomness of the drug vs placebo assignments. It could be that by

chance some of those on the real drug happened to be further along in

disease course.

They are informing all the participants whether or not they were on

placebo or Urso. I found out yesterday I was actually on Urso which

was not a surprise since I had seen a significant decline in lab values

at the start of the study. For now my doctor has recommended staying

off Urso for the short term while they sift through the data and can

study what the impact to my labs are post urso. In the coming months

as they sort things out they will look at other benefits and determine

if PSC patients should be on some dose of Urso in the future. He has

asked me to sit tight until the results are better understood.

in Seattle

>

> -----Original Message-----

> Can you Help me understand the " numerically more poor outcomes in the

> UCDA group than in the placebo group " ? Does the study show harm from

> taking UCDA?

>

> It sounds that way, but I'm not a doctor.

>

> Barb in Texas - Together in the Fight.... Whatever it Takes!

>

[Guest guest]

How did they notify the participants that they are cancelling the

study? I am involved in the test, but I have not yet been notified.

Rick