time to see dr. faustman again :)

[czardoust]

Katerina will be going to see her August 9th. Its just her and her daddy going this time..... any questions you want me to pass along?

[PatriciaMidwest]

Inquiring minds want to know if she will publish the data from Phase 1, and if so when and where.

Thanks.

[danismom79]

Do you know if this is the correct information?

http://clinicaltrials.gov/ct2/show/N...and+bcg&rank=1

If so, it looks like it needs to be updated.

ETA: Since she can't be in the study based on this info, do you know why they're still taking blood?

[PatriciaMidwest]

Phase 1 is complete. I did get an email from Faustman's lab saying they still accept blood on certain days of the week. I think it is just for general research purposes, and not part of any formal clinical study.

[buggle]

They've been collecting blood for years. They sort the blood to separate the T cells that cause type 1 and they're building a database to get some idea of what the population of these T cells looks like in diabetics of different ages, different numbers of years with disease, etc. It does improve the odds to get into a clinical trial if they already have this info about a person from donating blood. But very few people are accepted into clinical trials and hundreds have given blood. The lab is booked out for a year and people come from all over the world to donate.

[joshualevy]

Originally Posted by czardoust

Katerina will be going to see her August 9th. Its just her and her daddy going this time..... any questions you want me to pass along?

The only really important question is: when/where will she publish the results of her phase-I clinical trial (especially her concentration of autoreactive t-cells measurements and the c-peptide levels) in a scientific journal. (If she said that she did not collect this data, I would particularly want to know that.)

If you don't get an answer on that, then I would ask if she has any plans to present this data at a symposium, in a poster session, or at any scientific talk.

If she can't answer either of those questions, then I would ask her what doses of BCG the trial participants got. (And if you get a vague answer like "depends on their weight", I'd ask what was the maximum dose that anyone got.) I'd also ask how the BCG was given. Was it injected just under the skin? Or injected into a specific organ? (This information is not about her results, so even if she can not talk about her results, she can still answer these questions.) Knowing the answers to these questions would help figure out how her research compares with previous BCG clinical trials.

Joshua Levy

[Sarah Maddie's Mom]

Wow, Joshua! You've come up from the bowels of CWD to the forums where real parents of real kids with D talk about their lives with their D kids. First time, is it not?

[buggle]

Joshua -- Why don't you call Dr. Faustman or arrange a meeting and ask all those questions yourself? MGH, Harvard Medical School, the Iacocca Foundation and Faustman herself will release the data at the time they feel is best, likely in a peer-reviewed, top journal. Because of naysayers like you, that's obviously the best choice.

I think it's a bit much to ask a lay person parent to go in there demanding answers and asking about unpublished research. Asking about unpublished research is strictly taboo in the world I came up in when I was a research scientist and I don't think anything has changed. It's the height of poor taste and bad etiquette.

[joshualevy]

Originally Posted by buggle

Joshua -- Why don't you call Dr. Faustman or arrange a meeting and ask all those questions yourself?

I have asked those questions via email, and I got back a very polite response, that did not answer any of them in a useful way. No news at all of any future publication, no specific dosage information (only a vague statement about different people getting different dosages), and nothing about plans to present the data in any scientific forums.

As you say, the best place to publish is in a peer-reviewed, top journal. Some of journals have long lead times, and so if she was going to be published in one of those (even many months from now) she would know now, because it would already be in the peer review or editorial process, and would be able to say so. Often not the exact journal, but she would be able to tell people that her manuscript was in the publishing process somewhere.

Other journals have shorter lead times, but in those cases, it is even easier to say when it would be published, even if not exactly who will publish it.

Originally Posted by buggle

I think it's a bit much to ask a lay person parent to go in there demanding answers and asking about unpublished research.

czardoust asked specifically for questions, I gave her some.
It is for her to decide what questions (and answers) are important to her.

Originally Posted by buggle

Asking about unpublished research is strictly taboo in the world I came up in when I was a research scientist and I don't think anything has changed. It's the height of poor taste and bad etiquette.

I've asked many researchers about when data will be published. (Which is obviously different from asking them what the results were.) Sometimes they can tell me specifically, and sometimes only in general terms. They can almost always tell me something. It's never bad form to ask. They know the importance of their own data.

The question about dosing is not an unpublished result. It is part of the experimental design, and a researcher can always talk about the design of the study if they want to. It is only their results that are sometimes embargoed pending publication. So asking about that is no problem at all. Indeed most clinical trials aimed a curing diabetes include dosing information in the public clinical trial record from the start of the trial. Dr. Faustman's experiment is a little unusual in that it doesn't.

I must admit that I don't understand why you are so touchy about asking when results will be published. Results are the whole purpose of doing a clinical trial. She's already announced that the trial is done. The trial specifically was designed to get this data. She's already asking for more money for the next phase. The very least she can do is tell us when she will publish her results of the previous phase.

Joshua Levy

[Lee]

Edited because I was needlessly rude to Joshua.