THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
rodwelch@pacbell.net
S U M M A R Y
DIARY: October 27, 2008 05:11 PM Monday;
Rod Welch
Millie notified UCSF progress on sunitinib screening requirements.
1...Summary/Objective
2...Brain MRI Specified Supplemental Sunitinib Documents Not Distributed to Patient
..............
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CONTACTS
SUBJECTS
Default Null Subject Account for Blank Record
0403 -
0403 - ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS 6 0000, ref SDS 3 0000.
040502 -
040503 -
040504 -
040505 -
040506 -
040508 - ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - Millie responded to Glenna's letter received today a few minutes ago,
040902 - 081027 16:04. ref SDS 6 ML8R Millie reports progress performing tasks
040903 - in the work plan on 081016, ref SDS 2 J36R, to start treatment at UCSF
040904 - in the sunitinib clinical study...
040905 -
040906 - 1. Subject: Sunitinib Trial Screening Need Brain MR
040907 - Date: Mon, 27 Oct 2008 16:11:05 -0800
040915 - ..
040916 - 3. I got your letter today on starting treatment in the Sunitinib
040917 - clinical study.
040918 -
040919 - [On 081029 Millie submitted updated work plan for starting
040920 - the sunitinib clinical study. ref SDS 7 H96H
040922 - ..
040923 - 4. By copy I'm asking Doctor Johnson at Kaiser to schedule the
040924 - "Brain MR" UCSF requests in your letter. ref SDS 6 ML8R
040925 -
040926 - [On 081029 called Kaiser and talked to Florida; she will
040927 - send internal message to primary care physician reminding
040928 - to schedule brain MR for Millie. ref SDS 8 FR62
040930 - ..
040931 - [On 081030 doctor ordered brain MRI. ref SDS 9 6E8N
040933 - ..
040934 - I reviewed the Consent document with Doctor Johnson last
040935 - Friday, and did not see this requirement. I told everybody at
040936 - the meeting that we needed it, but nobody could find Brain MR
040937 - in the document, so it wasn't scheduled. I'm guessing you
040938 - mentioned it when we met in the Infusion Clinic on Thursday,
040939 - and that's what I remembered the next day in the meeting at
040940 - Kaiser [but I couldn't remember where I remembered it from].
040942 - ..
040943 - This is similar to USACE cancelling change order #19 on the Oakland
040944 - Harbor project, because people in the meeting could not remember why
040945 - the order was issued, and so wound up paying an extra $8M, because
040946 - nobody would check the record, reported on 961218. ref SDS 1 5790
040947 -
040948 - [...below, on 081027, Glenna reports in a phone call that
040949 - requirements for a brain MRI test are not in the Consent
040950 - document submitted to Millie for the sunitinib clinical
040951 - study, but are listed in other study protocol documents.
040952 - ref SDS 0 OS68
040954 - ..
040955 - Millie's letter to UCSF continues...
040956 -
040957 - 5. Since I have no history of bone metastases, we may not need a
040958 - bone scan. Just let me know.
040960 - ..
040961 - 6. I had a CBC last Thursday at UCSF, and weekly for the past 2
040962 - years, so you can get it from the computer. Of course, we can
040963 - do another if required.
040965 - ..
040966 - 7. I'm not sure about urinalysis [ordered in Glenna's letter to
040967 - Millie earlier today. ref SDS 6 309F
040969 - ..
040970 - 8. Glenna thanks for following up. This is a big relief for me
040971 - knowing things are moving forward.
040972 -
040973 - [On 081029 Millie submitted updated work plan for starting
040974 - the sunitinib clinical study. ref SDS 7 H96H
040975 -
040982 -
040983 -
040985 - ..
0410 -
0411 -
0412 - 1723
0413 -
041301 - Brain MRI Specified Supplemental Sunitinib Documents Not Distributed to Patient
041302 -
041303 - Glenna called.
041304 -
041305 - She got Millie's letter per above, ref SDS 0 TU5I, and asked when
041306 - Millie can sign the Consent documents in order to set up an account.
041308 - ..
041309 - Glenna explained that requirements for brain MR in her letter today,
041310 - ref SDS 6 ML8R, and which Millie asks about in her letter to UCSF, per
041311 - above, ref SDS 0 TU5I, is not in the sunitinib study Consent
041312 - documents. ref SDS 0 OS87 The brain MR was specified in a revised
041313 - protocol that is not distributed to patients.
041315 - ..
041316 - Millie can come into UCSF on 081107 to sign the consent documents, and
041317 - perform blood tests, if needed, and do the urinalysis, called out in
041318 - Glenna's letter. ref SDS 6 309F
041320 - ..
041321 - Glenna said Millie is not scheduled to see Doctor Rugo until 081113,
041322 - but she can meet with Millie to accomplish administrative tasks.
041324 - ..
041325 - Glenna will get a ballpark amount for the cost of the drugs to the
041326 - patient. This will help address issues of cost submitted to Doctor
041327 - Rugo in a letter on 081024. ref SDS 4 XZ9Y
041329 - ..
041330 - Glenna said Kaiser may have to issue a new authorization to pay for
041331 - work in the sunitinib clinical trial. This could be another big
041332 - battle. Glenna will check with the doctor.
041333 -
041334 - [On 081029 letter to Glenna submits revised work plan that
041335 - asks for cost of care to the patient for the sunitinib case
041336 - study, ref SDS 7 SS7L, and discusses authorization from
041337 - Kaiser. ref SDS 7 NQ7L
041339 - ..
041340 - Discussed Kaiser's proposal to delay the core to test for status
041341 - change until 081117. The letter to UCSF earlier today asked how this
041342 - will affect the UCSF work plan for Millie starting treatment in the
041343 - sunitinib clinical study.
041344 - and cited the call from Karen at Kaiser this
041345 - morning.
041347 - ..
041348 - Glenna will ask Doctor Rugo if Millie needs the biopsy on status
041349 - change to start the treatment, which is the first task in the UCSF
041350 - work plan on 081016. ref SDS 2 J36R
041352 - ..
041353 - That is another thing not in the Consent documents, noted in the
041354 - letter to the medical team on 081016. ref SDS 2 J44R
041355 -
041356 - [On 081031 Glenna advised in a call that the sunitinib
041357 - study does not require biopsy for status change.
041358 - ref SDS 10 T27H
041359 -
041360 -
041361 -
041362 -
041363 -
041364 -
041365 -
041366 -
041367 -
041368 -
0414 -