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 31, 2008 04:04 PM Friday; Rod Welch

Glenna calls on UCSF work plan for Millie to start treatment sunitinib clinical study.

1...Summary/Objective
2...Status Change Biopsy Test Not Required Sunitinib Clinical Study


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0403 -
0403 -    ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS 24 0000, ref SDS 22 0000.
040502 -
040503 -
040504 -
040505 -
040507 -  ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - Glenna returned the call from an hour ago. ref SDS 24 XD4O
040902 -
040903 - Glenna received Millie's letter this morning, ref SDS 24 UM8M, with a
040904 - link to the work plan on 081029 for UCSF starting treatment for Millie
040905 - in the sunitinib clinical trial. ref SDS 22 LH4O
040907 -  ..
040908 - Glenna noted that the UCSF work plan on 081029 is comprehensive,
040909 - covering all pending tasks required for Millie to start timely
040910 - treatment.
040911 -
040912 -        [...in another record today on 081031 Glenna reported that UCSF
040913 -        confirms plans to start Millie's treatment in the sunitinib
040914 -        clinical study on 081113. ref SDS 27 SJ3W
040916 -         ..
040917 -        [On 081107 Glenna reported the UCSF work plan on 081029 has
040918 -        been effective organizing the work required for Millie to start
040919 -        treatment on schedule. ref SDS 34 C35J
040921 -  ..
040922 - Glenna related during the call this afternoon that late this morning
040923 - she called Millie's primary care physician at Kaiser.  The doctor
040924 - advised Glenna that he ordered treatment for Millie with the sunitinib
040925 - metronomic protocol at UCSF, and that he submitted authorization for
040926 - Kaiser to pay for Millie's continued treatment on referral at UCSF, as
040927 - called out in the work plan on 081029. ref SDS 22 NQ7L
040928 -
040929 -        [...in another record today on 081031 Glenna reports plans to
040930 -        follow up with Kaiser to obtain payment authorization for
040931 -        Millie's treatment on referral to UCSF in the sunitinib
040932 -        clinical trial. ref SDS 27 458L
040934 -         ..
040935 -        [On 081112 Glenna reported Kaiser has not issued authorization
040936 -        for payment which the doctor submitted for Millie's treatment
040937 -        at Kaiser. ref SDS 36 ZX8F
040939 -         ..
040940 -        [On 081112 Paula McPhail reported that Kaiser's records show on
040941 -        081103 Millie's doctor ordered her treatment on referral to
040942 -        UCSF. ref SDS 36 UV4O
040944 -         ..
040945 -        [On 081112 Michelle in Expedited Claims Department advised that
040946 -        the doctor is in charge of ordering treatment for the patient,
040947 -        and Kaiser must implement the doctor's orders. ref SDS 36 P28U
040949 -         ..
040950 -        [On 081112 Doctor Johnson reported ordering on 081103
040951 -        authorization for payment of Millie's treatment on referral at
040952 -        UCSF in the sunitinib clinical study, and Kaiser management
040953 -        sent a denial to him on 081110. ref SDS 36 TH49
040955 -  ..
040956 - Glenna's report on discussion with the doctor today aligns with the
040957 - meeting at Kaiser on 080829.  At that time, on 080829 the primary care
040958 - physician found progression of disease in the left supraclavicular,
040959 - which signals requirement to change Millie's treatment. ref SDS 6 RP8T
040960 - The doctor told Millie to notify Doctor Rugo that Kaiser's referral on
040961 - 070105 for Millie's treatment at UCSF, and citing Kaiser's letter to
040962 - UCSF on 061230, authorizing payment for Millie's care at UCSF, would
040963 - be continued and that arrangements for changing treatment should begin
040964 - immediately.  These instructions were confirmed in a letter to the
040965 - medical team on 080829. ref SDS 6 RP9W  Urgency starting new treatment
040966 - was reported on 081016 when Doctor Rugo palpated the lump in the left
040967 - supraclavicular, ref SDS 9 J34X, found earlier by the primary care
040968 - physician at Kaiser on 080829.  Doctor Rugo ordered a biopsy on
040969 - 081022. ref SDS 12 NZ5N  The next day on 081023 Doctor Rugo determined
040970 - that pathology on the biopsy established progression of disease and so
040971 - stopped prior treatment with cetuximab and Carboplatin. ref SDS 15
040972 - D65G
040974 -  ..
040975 - The following day on 081024 Millie met at Kaiser with the primary care
040976 - physician.  The doctor made an examination, and reviewed patient
040977 - history, including pathology findings from the biopsy on 081022.  The
040978 - doctor entered in the medical chart approval for Millie's treatment
040979 - with sunitinib metronomic treatment in a clinical study under Doctor
040980 - Rugo's care at UCSF, as ordered previosuly by the primary care
040981 - physcian on 080829.  During the meeting at Kaiser on 081024, the
040982 - doctor implemented Kaiser's referral by ordering baseline tests at
040983 - Kaiser on 081107 - 081110, ref SDS 17 XZ8W, in time for Millie to
040984 - continue her regular treatment schedule at UCSF for the past 2 years,
040985 - and starting on Thursday, 081113.
040987 -  ..
040988 - On 070119 Jackie reported similar discussions about Millie starting
040989 - the cetuximab Carboplatin clinical study. ref SDS 3 AS96  About 10
040990 - months later the matter was resolved.
040992 -  ..
040993 - Glenna has made calls about the cost of drugs which Millie will have
040994 - to pay for getting treatment in the sinitinib clinical study, work
040995 - plan task #10, listed on 081029. ref SDS 22 SS7L  She has not received
040996 - feedback on this issue yet.  This is expected to be fairly nominal,
040997 - because they are older drugs, but need to see the numbers.
040999 -  ..
041000 - Glenna was not familiar with patient history on challenge of
041001 - processing payment authorization for Millie's clinical trial, reported
041002 - on 061230, ref SDS 2 3X6K, and as a result the primary care physician
041003 - at Kaiser needs to follow up to verify submission of referral
041004 - authorization is processed, rather than held up for financial
041005 - engineering, as occurred on 070823. ref SDS 2 1V3K
041006 -
041007 -        [...in another record today on 081031 Glenna reports plans to
041008 -        follow up with Kaiser to obtain payment authorization for
041009 -        Millie's treatment on referral to UCSF in the sunitinib
041010 -        clinical trial. ref SDS 27 458L
041012 -  ..
041013 - Glenna had received Millie's letter today showing Kaiser has scheduled
041014 - Millie's brain MRI, reported in Millie's letter to Glenna this
041015 - morning, ref SDS 24 NN4W  Glenna has talked to Arlette, and
041016 - understands Arlette will call later today about
041018 -  ..
041019 - UCSF has scheduled Millie to start treatment on 081113, and beginning
041020 - with...
041022 -  ..
041023 - Meeting Doctor Rugo 081113 0830.
041024 -
041025 -        [...in another record today on 081031 Millie received a letter
041026 -        from Glenna confirming understandings from Glenna's call
041027 -        explaining that UCSF has scheduled Millie to begin treatment in
041028 -        the sunitinib clinical study on 081113.
041030 -         ..
041031 -        [...in another record today on 081031 Millie received Glenna's
041032 -        letter, ref SDS 27 5G5H, confirming that UCSF has scheduled
041033 -        Millie's treatment in the sunitinib clinical study to start on
041034 -        081113. ref SDS 27 SJ3W
041036 -         ..
041037 -        [...in another record today on 081031 Millie commended Kaiser
041038 -        and UCSF for timely transition to the new treatment with
041039 -        sunitinib, ref SDS 28 0R3I,
041041 -         ..
041042 -        [On 081101 Millie's letter while traveling on vacation asks
041043 -        about status to start treatment. ref SDS 30 TS5H
041045 -         ..
041046 -        [On 081102 submitted response to Millie traveling on vacation
041047 -        everything is set up to start treatment on 081113. ref SDS 31
041048 -        4P84
041050 -  ..
041051 - This is excellent work maintaining continuity of Millie's treatment,
041052 - and also meeting the doctor.  Aligns with Doctor Rugo's planning on
041053 - 081016 saying to keep Millie's schedule at UCSF. ref SDS 9 N99W
041055 -  ..
041056 - Glenna advised that UCSF requires Millie to do another lab for blood
041057 - tests, as called out in the work plan on 081029. ref SDS 22 1H5G, and
041058 - also requires urinalysis prior to starting the sunitinib clinical
041059 - trial on 081113, as further called out in the work plan on 081029.
041060 - ref SDS 22 SE6W
041062 -  ..
041063 - Discussed Glenna's letter to Millie on 081027 calling out urinalysis
041064 - testing. ref SDS 20 309F
041066 -  ..
041067 - Glenna seemed to indicate during the call today that there is no
041068 - requirement for a urinalysis screening test in the Consent documents
041069 - for the suntinib clinical study, similar to...
041070 -
041071 -        a.  Status change FNA biopsy test ordered in UCSF work plan on
041072 -            081016, ref SDS 9 J36R; Millie's letter to UCSF asks where
041073 -            the requirement for status change test is specified in the
041074 -            Consent document. ref SDS 9 J44R  On 081017 the doctor
041075 -            responds that "it is not a study for triple negative
041076 -            alone." ref SDS 10 6J3T  On 081031 Glenna advised in a call
041077 -            that the sunitinib study does not require biopsy for status
041078 -            change. ref SDS 26 T27H
041080 -             ..
041081 -        b.  Brain MRI test ordered in work plan on 081029, ref SDS 22
041082 -            SE5Q, implementng guidance in the letter from UCSF on
041083 -            081027. ref SDS 20 ML8R
041085 -  ..
041086 - The doctor ordred the test for comprehensive care based on
041087 - Millie's long patient history being treatment for cancer.
041088 -
041089 -            [...in another record today on 081031 1604 Glenna confirmed
041090 -            requirement for urinalysis. ref SDS 27 SI4X
041092 -             ..
041093 -            [On 081107 urinalysis performed at UCSF. ref SDS 35 BP4J
041095 -  ..
041096 - Glenna discussed with the primary care physician in her call this
041097 - morning doing labs, including urinalysis, at Kaiser, which are called
041098 - out in the work plan on 081029. ref SDS 22 1H5G  Doctor Johnson agreed
041099 - in the call with Glenna to schedule the work at Kaiser.
041101 -  ..
041102 - Glenna proposed in this call that, since Millie's doctor at Kaiser
041103 - will schedule lab work required for Millie to start the sunitinib
041104 - clinical trial at Kaiser, the meeting planned for 081107 0800 in the
041105 - work plan on 081029, ref SDS 22 LL6Q, can be avoided to save Millie a
041106 - trip to San Francisco.
041108 -  ..
041109 - Glenna proposed using modern technology to transmit a computer file
041110 - attached to an email and with the signature page of the consent
041111 - document which Millie received from Glenna during treatment in the
041112 - Infusion Clinic on 081016. ref SDS 8 5S5K  Glenna explained Millie can
041113 - print the signature page, and then mail it to UCSF.  This is good
041114 - progress.  On 081016 Millie requested the computer file for the
041115 - Consent document. ref SDS 9 J39T  UCSF reported difficulty sending the
041116 - computer file to expedite review.  As a result, Millie spent 4.5 hours
041117 - typing the document, rather than hiking. ref SDS 11 DJ7N
041119 -  ..
041120 - Reviewed patient history showing the UCSF medical team is very
041121 - effective with timely access to patient history stored on the UCSF
041122 - computer system, similar to Kaiser.  Medical professionals everywhere
041123 - have become dependent on the computer to review patient history.  As a
041124 - result, when labs are not on the computer, people get confused.  Work
041125 - is delayed, shown today at Kaiser in another record scheduling the MRI
041126 - brain test. ref SDS 25 IO97  On 080724, Brigid was frustrated at UCSF
041127 - because results of the CT test at Kaiser on 080718 was not in the
041128 - medical chart for starting a new cycle. ref SDS 5 VE8O  Another
041129 - example of health care impacted because labs are not posted to the
041130 - computer occurred when Millie was treated on 080409 in the Kaiser
041131 - Emergency Department. ref SDS 4 439L  People have become addicted to
041132 - the computer, because tasks like lab work are fast and easy to
041133 - accomplish with the computer.
041135 -  ..
041136 - A very big problem doing lab work is recovering from mistakes.  Blood
041137 - tests are omitted, or the sample is corrupted, and so test have to be
041138 - done over.  Patient condition observed by the doctor during
041139 - examination or by the nurse during treatment shows that additional
041140 - tests are needed.  Sometimes tests are redone to verify the patient
041141 - can or cannot get treatment.  Doing the lab work at the site where
041142 - decisions are made enables cost effective care.  The patient cannot
041143 - jump in the care and drive 30 miles to Walnut Creek to correct a
041144 - mistake, then drive 30 miles back to San Franciso with the result.
041146 -  ..
041147 - Glenna said that coordination on referral patients presents difficult
041148 - challenges for medical professionals, because people like to access
041149 - lab work on the computer.  Papers get lost, faxed to the wrong
041150 - location; have fuzzy characters that are hard to read, and use
041151 - different units of measure that cause mistakes for people working with
041152 - limited time, shown by comparing Millie's blood work on 081023 at UCSF
041153 - compared with Kaiser. ref SDS 13 075H
041155 -  ..
041156 - Decided therefore to sign the Consent documents at UCSF on 081107
041157 - 0800, as shown in the UCSF work plan updated on 081029. ref SDS 22
041158 - LL6Q  Glenna suggested meeting in the lobby of the Breast Care clinic
041159 - on the 2nd floor.
041160 -
041161 -        [...in another record today on 081031 Glenna's letter to Millie
041162 -        confirms plans to meet at UCSF on 081107 0800. ref SDS 27 SI4X
041164 -         ..
041165 -        [...in another record today on 081031 Millie commended Kaiser
041166 -        and UCSF for timely transition to the new treatment with
041167 -        sunitinib. ref SDS 28 0R3I
041169 -         ..
041170 -        [On 081103 Millie notified Catherine and Diane in the Infusion
041171 -        Clinic about blood draw on 081007. ref SDS 33 5U6U
041173 -  ..
041174 - Decided to do the labs at UCSF on 081107 0800 prior to meeting with
041175 - Glenna to sign consent documents, called out in the work plan on
041176 - 081029. ref SDS 22 LL6Q
041178 -  ..
041179 - Glenna will schedule labs for Millie in the Infusion Clinic on the 2nd
041180 - floor at UCSF prior to the meeting, including urinalysis.
041182 -  ..
041183 - This plan uses the schedule for Millie's labs in the Infusion Clinic
041184 - shown in the record on 080918. ref SDS 7 YB5H
041185 -
041186 -        [...in another record today on 081031 Glenna's letter to Millie
041187 -        confirms plans to order labs when Millie meets to sign Consent
041188 -        documents at UCSF on 081107 0800, and to perform requirements
041189 -        for Millie to start treatment in the sunitinib clinical trial.
041190 -        ref SDS 27 SI4X
041192 -  ..
041193 - On 081016 the doctor ordered an FNA biopsy to test for cancer and
041194 - status change. ref SDS 9 J36R  The biopsy was performed at Kaiser on
041195 - 081022. ref SDS 12 NZ5N  The next day on 081023 Doctor Daamen reported
041196 - in a letter to the medical team that pathology on the biopsy was
041197 - positive for cancer.  This established progression of disease that
041198 - signals need to change treatments.
041200 -  ..
041201 - The FNA biopsy did not yield enough tissue to test for status change.
041202 - ref SDS 14 4Q9Q
041204 -  ..
041205 - Doctor Daamen explained that Kaiser's Lab requires a core biopsy to
041206 - test for status change.  The doctor asked if this is "necessary,"
041207 - which raises a flag of caution about safety of core biopsy, because
041208 - the question of "necessity" was not raised until the procedure was
041209 - changed from FNA ordered by UCSR to a core biopsy because the Kaiser
041210 - lab cannot check status with an FNA biopsy. ref SDS 14 4Q5V
041212 -  ..
041213 - On 050909 Doctor Shim at Kaiser in Oakland issued an opinion
041214 - recommending Kaiser test for status change because this would have a
041215 - "huge" impact on Millie's traetments. ref SDS 1 JX9P "Huge impact"
041216 - conveys justification to test within the bounds of safety, such that
041217 - core biopsy does not threaten greater harm than benefits.  The
041218 - solution is to do the FNA procedure ordered by UCSF, which has not
041219 - been cited for causing increased risks.
041221 -  ..
041222 - Later that day on 081023, Kaiser scheduled Millie for a core biopsy to
041223 - test for status change on 081024. ref SDS 14 667F  Later in the
041224 - evening on 081023 Doctor Rugo advised that UCSF uses FNA biopsies to
041225 - test for status change. ref SDS 15 4Q52  During the meeting at Kaiser
041226 - on 081024, Doctor Wong explained increased risks of core biopsy
041227 - compared to less invasive FNA biopsy, and recommended Millie defer the
041228 - core biopsy to test for status until after returning from vacation on
041229 - 081107. ref SDS 16 6N5L  The following Monday, on 081027 Kaiser called
041230 - and further deferred the core biopsy to test for status change until
041231 - 081117. ref SDS 18 G15K
041233 -  ..
041234 - Millie notified Doctor Rugo in a letter on 081027 of additional delay
041235 - performing the biopsy for status change, and asked if this will delay
041236 - the UCSF work plan to start treatment for cancer in the sunitinib
041237 - clinical study. ref SDS 19 R79W  Glenna called later in the afternoon
041238 - on 081027 and planned to ask Doctor Rugo about the effect of delaying
041239 - Millie's treatment until the status change test is accomplished.
041240 - ref SDS 21 934O  On 081029 Millie's letter to UCSF discusses doing FNA
041241 - biopsy for status check at UCSF to avoid risks of core biopsy at
041242 - Kaiser. ref SDS 22 C49U
041244 -  ..
041245 - Millie's letter earlier this morning to UCSF with copy to Kaiser asks
041246 - again about doing FNA biopsy at UCSF. ref SDS 24 NN5S
041247 -
041249 -  ..
041250 - Status Change Biopsy Test Not Required Sunitinib Clinical Study
041251 -
041252 - Glenna explained during her call this afternoon that core biopsy to
041253 - test status change is not required for Millie to start treatment in
041254 - the sunitinib clinical trial.  UCSF issued an order for medical
041255 - services to perform an FNA biopsy which is item 2 in the work plan on
041256 - 081029, ref SDS 22 SF3P, implementing Doctor Rugo's instructions on
041257 - 081016. ref SDS 9 J36R  She therefore did not investigate scheduling
041258 - the work at UCSF presented in Millie's letter on 081029, ref SDS 22
041259 - C49U, and again in Millie's letter today, ref SDS 24 NN5S  Glenna
041260 - indicated this is now a controversy, and so does not require her
041261 - support for coordination clinical studies.
041263 -  ..
041264 - Controversy centers on increased risks of core biopsy, and that Kaiser
041265 - requires this method to test for status change, while UCSF can test
041266 - status change with less risky FNA procedures.  The fact that Kaiser
041267 - has deferred the work 3 times suggest reluctance that signals high
041268 - risks using core biopsy to test for status change with Millie's
041269 - patient history, reviewed on 081027. ref SDS 18 UE6N  Huge benefits of
041270 - expanding treatments for Millie makes testing status change highly
041271 - desirable clinical solution, cited in the letter from Doctor Shim at
041272 - Kaiser in Oakland on 050909. ref SDS 1 JX9P
041274 -  ..
041275 - Glenna suggested that Millie contact Doctor Johnson at Kaiser and
041276 - Doctor Rugo about implementing the UCSF order on 081016 for an FNA
041277 - biopsy to test for status change. ref SDS 9 J36R
041279 -         ..
041280 -        [...in another record today on 081031 Millie asks about doing
041281 -        the FNA biopsy ordered by UCSF on 081016 at UCSF. ref SDS 28
041282 -        0R3I,
041284 -         ..
041285 -        [On 081101 Doctor Rugo says the biopsy to check for status
041286 -        change is not part of the sunitinib clinical study. ref SDS 29
041287 -        5G5H
041289 -         ..
041290 -        [On 081102 Millie's letter to Doctor Rugo with copy to primary
041291 -        care physician at Kaiser asks how much the FNA biopsy to test
041292 -        for status change will cost at UCSF, and notes this should be
041293 -        less expensive than doing the core biopsy at Kaiser.
041294 -        ref SDS 32 AD3F
041296 -  ..
041297 - Glenna will submit a letter confirming understandings from the call
041298 - this afternoon on Millie starting treatment in the sunitinib clinical
041299 - study on 081113.
041300 -
041301 -        [...in another record today on 081031 Millie received a letter
041302 -        from Glenna confirming understandings from Glenna's call
041303 -        explaining that UCSF has scheduled Millie to begin treatment in
041304 -        the sunitinib clinical study on 081113. ref SDS 27 5G5H
041305 -
041306 -
041307 -
041308 -
041309 -
041311 -  ..
0414 -
0415 -
0416 - 1656
0417 -
041701 - Arlette called for Doctor Johnson.
041702 -
041703 - She offered to assist scheduling Millie's brain MRI, ordered by the
041704 - doctor yesterday on 081030. ref SDS 23 FR5H
041706 -  ..
041707 - This call reflects the call earlier today from Glenna at UCSF, per
041708 - above. ref SDS 0 XJ84
041710 -  ..
041711 - Explained that earlier this morning Laura in the Kaiser Radiology
041712 - Department scheduled the brain MRI on 081108 1045. ref SDS 25 UJ68
041713 -
041714 -
041715 -
041716 -
041717 -
041718 -
041719 -
041720 -
041721 -
041722 -
0418 -