Rod Welch
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
S U M M A R Y
DIARY: October 19, 2005 08:04 AM Wednesday;
Rod Welch
Submit treatment options for Millie on recovering from IBC.
1...Summary/Objective
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CONTACTS
SUBJECTS
Due Diligence Mastectomy Surgery Time Out Risk Management Evaluate I
1103 -
1103 - ..
1104 - Summary/Objective
1105 -
110501 - Follow up ref SDS 13 0000, ref SDS 12 0000.
110502 -
110503 -
110504 -
110505 -
110506 -
110507 -
110508 -
110509 -
110511 - ..
1106 -
1107 -
1108 - Progress
1109 -
110901 - Submitted ref DIT 1 0001 to Millie saying...
110902 -
110903 - 1. If you like, we can submit the request for a "Time Out" work up
110904 - on the proposed surgery to Arlette, and ask her to make
110905 - distribution to the doctors, so that Kaiser has a reasonable
110906 - time for review prior to the mastectomy scheduled for this
110907 - Friday. The letter can be submitted as a draft asking if any
110908 - additional issues need consideration, or if due diligence can
110909 - be consolidated. This makes the exercise less demanding, and
110910 - more like collaboration in the model of a doctor-patient
110911 - partnership, called out in Kaiser's Healthwise Handbook.
110912 - ref DIT 1 0001 [see review on 990625. ref SDS 1 4185]
110914 - ..
110915 - 2. I made a few changes in the draft notice to Kaiser on
110916 - performing due diligence, ref DIT 1 2P6I, for your pending
110917 - surgery. ref DIP 1 0001 (see below... ref SDS 0 SW4O)
110919 - ..
110920 - 3. Please let me know what you think (sounds like Doctor
110921 - Riley-Paull -- ref DIT 1 XJ7G, she asked "What do you think?"
110922 - 3 or 4 times when met on Sep 23rd, ref SDS 7 WI6K)
110924 - ..
110925 - 4. Right now, you are healthier than at any time in the past four
110926 - (4) years, ref SDS 0 DY8R, so there is no need to rush into
110927 - surgery without assurrance that mastectomy planned by Kaiser
110928 - has a good chance of reducing your risk of relapse. The core
110929 - tenant of medical practice is to "Do no harm." Kaiser's "Time
110930 - Out" requirements (discussed in the record of meeting with the
110931 - primary care physician in Oncology on 050913, ref SDS 4 Q95M)
110932 - are designed for proactive risk management to force busy people
110933 - to slow down the rush to perform an irreversible act with
110934 - significant questions of risk, and questionable benefits, as
110935 - set out in the draft letter to Kaiser. ref DIP 1 LQ4F You are
110936 - entitled to have these questions answered prior to taking
110937 - action on Friday under the common rule of due diligence...
110938 - "Better to be safe than sorry!" ref DIT 1 UM7F
110939 -
110940 - [On 051027 biopsy report on tissue from mastectomy surgery
110941 - on 051021 found atypical cells consistent with ductal
110942 - carcinoma in situ (DCIS). ref SDS 16 615K
110944 - ..
110945 - 5. If you wish, you can stop treatments right now, and continue
110946 - testing with CA 15-3, CT and PET scans every quarter. If lumps
110947 - recur, if testing shows problems down the road, we can consider
110948 - surgery along with other treatment options. As well, you can
110949 - request a treatment plan with chemotherapy that is less
110950 - vigorous to reduce side effects. In either case, if you have
110951 - surgery on Friday, or not, you remain at risk for relapse, and
110952 - so we will remain on guard for early intervention going
110953 - forward.
110955 - ..
110956 - 6. Really good news is that you appear to have a complete response
110957 - to treatment (i.e., possibly a "cure" or more properly near
110958 - term remission) with Taxotere and capecitabine, as recommended
110959 - by Doctor Benz. We probably want to send the doctor a note of
110960 - thanks. It's comforting to know that your body responds
110961 - favorably to a particular regimen.
110963 - ..
110964 - 7. Post Script
110965 -
110966 - Sending a copy to Doctor Bailey and to Doctor Grissom, because
110967 - they asked to be kept in the loop on your progress.
110968 -
110969 -
110971 - ..
110972 - Revised the draft ref DIP 1 0001 originally prepared on 051012,
110973 - and
110974 - revised initially yesterday on 051018. ref SDS 13 OX9N
110975 -
110976 - 1. Subject: Time Out Mastectomy Surgery Due Diligence
110978 - ..
110979 - Dear Doctor:
110981 - ..
110982 - 2. I was notified today of favorable results from biopsies you
110983 - took on October 12. Very good news! You may recall that
110984 - inflammatory breast cancer (IBC) was diagnosed from a biopsy
110985 - you took on April 19, 2004; now 18 months later, your follow up
110986 - biopsies show no evidence of cancer. Favorable results of the
110987 - mammogram test on September 22nd, and a week or so later the
110988 - PET scan test on October 5th showing no evidence of distant,
110989 - nor locoregional metastatic disease all present a "clean bill
110990 - of health" that relieves a big weight off my mind. Right now,
110991 - thanks to Doctor Johnson and the Kaiser team, I feel so healthy
110992 - and grateful I could cry! ref DIP 1 0001
110993 -
110994 - [On 051021 biopsy report received shows no residual
110995 - evidence of inflammatory carcinoma. consistant with
110996 - findings of PET scan and mammogram tests. ref SDS 14 LH6O
110998 - ..
110999 - [On 051027 biopsy on mastectomy surgery finds ductal
111000 - carcinoma in situ (DCIS) in nipple tissue that is commonly
111001 - discovered with mammogram tests, and conflicts with PET
111002 - scan and mammogram testing which reported no findings of
111003 - cancer. ref SDS 16 615K
111005 - ..
111006 - 3. At this time the Surgery Department has scheduled a mastectomy
111007 - to remove my left breast on Friday, October 21. ref DIP 1 P15N
111008 - Thanks very much for expediting the request, which my primary
111009 - care physician in Oncology asked me to file with the Surgery
111010 - Department, ref SDS 9 MW6O, after I met with him on October
111011 - 7th.
111013 - ..
111014 - 4. During our meeting on September 23rd, you seemed to indicate
111015 - plans for ordering a retest of the biopsy on April 19, 2004,
111016 - which, as noted above, diagnosed inflammatory breast cancer.
111017 - ref SDS 7 RX4I Retesting was recommended by Doctor Shim, in
111018 - Kaiser's Oakland office, for the purpose of status change that
111019 - might increase treatment options in the event of relapse.
111020 - Second opinions by Doctor's Grissom and Bailey concurred. The
111021 - report I received on your notes of our meeting makes no mention
111022 - of this retest having been ordered. Similarly, status change
111023 - retesting was discussed with the primary care physician on
111024 - October 7th, ref SDS 9 ZR6J, however, the doctor's notes, also,
111025 - do not mention this issue. ref SDS 11 PJ5L Please investigate,
111026 - and let me know when retesting the biopsy was ordered for
111027 - status change. ref DIP 1 8C62
111029 - ..
111030 - [On 051022 surgeon reported retest was ordered with no
111031 - record in surgeon's notes received on 050927, and that
111032 - results of retesting have not been received; doctor
111033 - following up to obtain results. ref SDS 15 NE9J
111035 - ..
111036 - 5. I deeply appreciate the time you have given my case. Doctor
111037 - Smith and Doctor Johnson cite your strong commitment to patient
111038 - care. I have a few questions about the purpose, risks and
111039 - benefits of mastectomy surgery, which can be addressed with
111040 - Kaiser's team care practice for a "Time Out" to implement
111041 - treatment guidelines followed by Kaiser and presented in the
111042 - Healthwise Handbook listed on your website. ref DIP 1 DU6I
111044 - ..
111045 - Doctor Smith commended the surgeon's work during a meeting on 050928,
111046 - ref SDS 8 258K, and earlier on 050329 the primary care physician
111047 - credited the surgeon as a top practitioner for breast surgery.
111048 - ref SDS 2 IE8O
111050 - ..
111051 - Time Out for Due Diligence letter continues...
111052 -
111053 - 6. I am informed by you, and others, that my case is unusual and
111054 - high risk. Therefore, workup for this surgery requires special
111055 - attention. Before signing a consent for surgery, I want to
111056 - know what is being done and how this will benefit in relation
111057 - to risks for complications, which you and Doctor Smith mention
111058 - in your notes. ref DIP 1 BW5O Please coordinate with Doctor
111059 - Johnson and submit written explanation of the proposed surgery
111060 - following Kaiser's outline in the Healthwise Handbook, that
111061 - says in part...
111063 - ..
111064 - On 050727 the surgeon explained unusual character of Millie's patient
111065 - profile. ref SDS 3 YK78 On 050923 the surgeon presented risks of
111066 - mastectomy for Millie's condition. ref SDS 7 VL4O Second opinion from
111067 - Doctor Grissom received on 050920 cited Millie's difficult situation,
111068 - ref SDS 5 XL5S, and further explaining indefinite dimensions of high
111069 - risk. ref SDS 5 XL9Y Doctor Bailey presented similar explanations of
111070 - high risks for Millie to have surgery, reported on 050922. ref SDS 6
111071 - XD6U
111073 - ..
111074 - Time Out for Due Diligence letter continues...
111075 -
111076 - 7. Shared Decisions About Surgery, ref DIP 1 UL8K
111078 - ..
111079 - This is part of Healthwise Handbook entered in the record on 040923.
111080 - ref SDS 7 HF7M
111082 - ..
111083 - Time Out for Due Diligence letter continues...
111084 -
111085 - 8. Every surgery has risks. Only you can decide if the benefits
111086 - are worth the risks.
111088 - ..
111089 - a. Learn the facts:
111090 -
111091 - • What is the name of the surgery? Get a description of
111092 - the surgery. ref DIP 1 4I90
111094 - ..
111095 - Doctor Johnson called for a "standard mastectomy," and
111096 - this was submitted in a written request to the Surgery
111097 - Department on October 7th. ref DIP 1 HB42
111099 - ..
111100 - Will surgery include axillary node dissection proposed
111101 - by Doctor Shim in her 2nd opinion consultation on
111102 - September 8, 2005? Why or why not? ref DIP 1 8D53
111103 -
111104 - [On 051021 surgeon evidently related to Millie that
111105 - another axillary lymph node dissection was not
111106 - performed during surgery in order to reduce risk of
111107 - further lymphedema. ref SDS 14 QU5I
111109 - ..
111110 - On October 12th four (4) biopsies were taken on the
111111 - left breast for the purpose of assessing recovery from
111112 - IBC by complementing clinical examination, and PET scan
111113 - testing. These biopsies were proposed by Doctor
111114 - Grissom in a 2nd opinion letter on September 20, 2005
111115 - to, also, help layout the boundaries for a very wide
111116 - mastectomy that removes previously infected skin, and
111117 - for the purpose of reducing the risk of IBC relapsing.
111118 - Positioning of the biopsies was based on memory of the
111119 - examination on March 24th, when you observed IBC
111120 - inflammation had spread toward the neck. At that time,
111121 - on March 24, 2005, you advised that a mastectomy could
111122 - not be performed, because there was not enough healthy
111123 - skin to close the surgical wound. This record
111124 - indicates that not removing breast skin previously
111125 - diagnosed with IBC presents post-operative risks cited
111126 - by Doctor Smith and by Doctor Johnson explaining the
111127 - problem of microscopic disease causing relapse.
111128 - ref DIP 1 HB44
111130 - ..
111131 - On September 28th, Doctor Smith showed photographs
111132 - which she described as a "standard mastectomy." There
111133 - was a single line of incision, slightly angled,
111134 - approximately 2" - 3" long, and .5" to 1.5" above the
111135 - nipple. The nipple was removed and the skin was flat
111136 - against the chest signifying loss of underlying breast
111137 - mass. The impression was that minimal breast skin was
111138 - removed in the photograph presented as a "standard
111139 - mastectomy." ref DIP 1 HB60
111141 - ..
111142 - This scope therefore does not seem to contemplate using
111143 - the four (4) biopsies taken on October 12th to guide a
111144 - very wide mastectomy for removal of previously infected
111145 - skin, and in fact most of the original skin, where
111146 - microscopic cancer cells may remain, will remain in
111147 - place under a "standard mastectomy" scheme? ref DIP 1
111148 - HB6X
111150 - ..
111151 - Please provide any additional explanation to clarify
111152 - the planned procedure for a "standard mastectomy" to
111153 - treat a patient profile of secondary IBC, multiple
111154 - relapse, and pulmonary emboli. ref DIP 1 HB79
111156 - ..
111157 - • Why does your physician think you need the surgery?
111158 - ref DIP 1 LQ4F
111160 - ..
111161 - On October 7th, the primary care physician in Oncology
111162 - recommended a "standard mastectomy" for the purpose of a
111163 - "palliation strategy" needed for future relapse, which
111164 - may be caused by microscopic remnants of IBC disease not
111165 - currently detected by tests. In previous meetings the
111166 - purpose of mastectomy was presented to maintain "local
111167 - control," which seems closely related to reducing the
111168 - risk of relapse in the left breast. ref DIP 1 LQ4F
111170 - ..
111171 - Is "palliation" the same as "local control" or, if local
111172 - control succeeds in avoiding relapse, and distant
111173 - metastatic disease continues to test negative, does this
111174 - scenario avoid the time and expense of palliation
111175 - measures? ref DIP 1 HB9S
111177 - ..
111178 - How will a "standard mastectomy" that leaves most of
111179 - the previously infected left breast skin in place, and
111180 - which may contain microscopic remnants of disease,
111181 - support "palliation" to maintain "local control," when
111182 - removing the breast mass also removes blood vessels
111183 - that bring treatment and nutrients to the breast skin?
111184 - ref DIP 1 HB8S
111186 - ..
111187 - Cited by Doctor Bailey on 051011, ref SDS 10 G65S, and reflecting risk
111188 - analysis by Doctor Smith at Kaiser on 050928. ref SDS 8 248I
111189 -
111190 - [On 051027 surgeon reports having stretched skin and
111191 - tissue sufficiently for standard closure of a wider
111192 - than normal mastectomy, and this maintains
111193 - sufficient blood vessel and related body mass for
111194 - delivering nutrients and treatment, if necessary,
111195 - for normal healing of the surgical wound, and in the
111196 - event of IBC relapse. ref SDS 16 QY8K
111198 - ..
111199 - Time Out for Due Diligence letter continues...
111200 -
111201 - If all of the skin with remnants of disease is not
111202 - removed by a "standard mastectomy," does this risk
111203 - another surgical wound that fails to heal for a year,
111204 - as occurred with the punch biopsy? What strategy is
111205 - planned to meet this contingency? Patient history in
111206 - this case shows that chemotherapy treatment with
111207 - Taxotere and capecitabine (Xeloda) provided palliation
111208 - that healed the punch biopsy wound. Is this the plan
111209 - for healing the mastectomy surgical wound? What other
111210 - measures are planned for this contingency. ref DIP 1
111211 - HB89
111213 - ..
111214 - On May 17, 2004, I received from the primary care
111215 - physician the report on the biopsy you took that
111216 - discovered IBC. ref DIP 1 BL88 At that time, research
111217 - was performed and cites published guidance for primary
111218 - IBC that says in part...
111219 -
111220 - If the inflammatory cancer has not spread beyond the
111221 - breast, a mastectomy (removal of the entire breast)
111222 - may be performed to remove the tumor. However,
111223 - because inflammatory breast cancer involves lymphatic
111224 - vessels of the skin, mastectomy can increase the
111225 - chances for the cancer to recur (since the skin is
111226 - stitched together after mastectomy). ref DIP 1 BL88
111228 - ..
111229 - As you know, I have secondary IBC, discovered two (2)
111230 - years after you performed surgery to remove the tumor in
111231 - the breast. PET testing reported on October 7th show
111232 - there is no tumor in the breast to remove. ref SDS 9
111233 - L66M On March 24, 2005 you found IBC had spread above
111234 - the breast line toward the neck. Does Kaiser have
111235 - published guidance that supports standard mastectomy
111236 - treatment in my case? If there is no tumor to remove in
111237 - the breast, and if previously infected breast skin is
111238 - not removed to reduce the chance of relapse, what is the
111239 - purpose of mastectomy, given the prior spread of IBC
111240 - disease above the breast line? ref DIP 1 BL4F
111241 -
111242 - [On 051021 surgeon reported finding no evident tumor
111243 - during mastectomy surgery to remove the left breast,
111244 - and attempted a very wide mastectomy to remove
111245 - previoulsy involved skin infected with IBC.
111246 - ref SDS 14 MM6M
111248 - ..
111249 - How will the proposed surgery accomplish palliation
111250 - and/or local control better than chemotherapy, and
111251 - sufficient to justify risks of surgery complications
111252 - cited by Doctor Smith on September 28? ref DIP 1 K35I
111254 - ..
111255 - Previous relapse in December 2004 spread inflammation
111256 - from IBC disease, and cancer blisters began popping out
111257 - on the skin of the left breast. How will mastectomy
111258 - surgery of the left breast prevent or otherwise palliate
111259 - this problem, when skin with microscopic cancer cells
111260 - are left in place? Will this be treated with
111261 - chemotherapy for palliation? ref DIP 1 HB6G
111263 - ..
111264 - On September 28th, Doctor Smith proposed a step-by-step
111265 - strategy to begin with a "standard mastectomy," and
111266 - after clear margins are achieved, then review options
111267 - for removing previously infected skin and reconstruction
111268 - with non-infected skin to reduce the risk of relapse
111269 - from remnants of microscopic cancer cells cited by
111270 - Doctor Johnson. How does this step-by-step strategy
111271 - align with palliation objectives for handling relapse?
111272 - ref DIP 1 HB65
111274 - ..
111275 - Is standard mastectomy surgery in a case of secondary
111276 - IBC expected to prolong disease-free survival, such that
111277 - chemotherapy can be paused. If so, how long might this
111278 - pause last, before chemotherapy must be restarted? Are
111279 - we talking weeks, months, hopefully a year or so? Or,
111280 - is it expected that chemotherapy will be required
111281 - immediately following surgery, as in the case of primary
111282 - IBC? ref DIP 1 SK34
111284 - ..
111285 - What criteria will be used to determine the scope and
111286 - degree of tissue removal? If more tissue is removed
111287 - will this increase palliative benefits? ref DIP 1 SK42
111289 - ..
111290 - • Is this surgery the most common one for this problem?
111291 - Are there other types of surgery? ref DIP 1 4I4F
111293 - ..
111294 - What assessment has been made of performing a "very wide
111295 - mastectomy" discussed with the surgeon on September 23
111296 - for the purpose of reducing the risk of relapse?
111298 - ..
111299 - b. Consider the risks and benefits:
111300 -
111301 - • How many similar surgeries has the surgeon performed
111302 - where the patient is extremely high risk for surgical,
111303 - postoperative and anesthetic complications, while
111304 - recovering from secondary IBC, and diagnosed with
111305 - pulmonary emboli, noted by Doctor Smith? ref DIP 1 CO5J
111307 - ..
111308 - How many surgeries like this are done at this hospital
111309 - on patients with secondary IBC and diagnosed with
111310 - pulmonary emboli? ref DIP 1 4I5N
111312 - ..
111313 - • What can go wrong?
111314 -
111315 - What complications of mastectomy surgery are increased
111316 - for a patient with secondary IBC, noted in Doctor
111317 - Smith's report? What solutions are proposed to avoid
111318 - these complications? ref DIP 1 CP30
111319 -
111320 - [On 061027 Millie diagnosed lymphedema and Cellulitis
111321 - caused by removing lymphatics during mastectomy
111322 - surgery, which was not a risk presented by Kaiser.
111323 - ref SDS 17 HZ7N
111325 - ..
111326 - If skin previously infected with IBC is not removed, and
111327 - if there is no tumor within the breast to remove, shown
111328 - by PET tests, then what will prevent IBC from relapsing
111329 - in previously infected skin which contains microscopic
111330 - cancer cells left in tact by standard mastectomy?
111331 - ref DIP 1 YN8G
111333 - ..
111334 - If the left breast mass is removed through a standard
111335 - mastectomy how will loss of blood vessels that normally
111336 - service the skin limit ability of the patient to recover
111337 - in the event of relapse? Does loss of blood vessels to
111338 - the remaining breast skin from mastectomy surgery risk
111339 - losing local control for a patient with secondary IBC,
111340 - in the same way Doctor Smith explained that prior
111341 - surgery in the lower stomach area during the late 1960s
111342 - prevents harvesting this tissue for reconstruction due
111343 - to loss of blood vessels? ref DIP 1 LK9H
111345 - ..
111346 - On November 4, 2004 I was notified by Doctor Kaufman,
111347 - substituting for the primary care physician, that I was
111348 - diagnosed with pulmonary emboli based on a CT scan test
111349 - performed the day before on November 3, 2004, and that I
111350 - would therefore require treatment with anticoagulants
111351 - (Coumadin) for the rest of my life. Subsequent
111352 - discussion over ensuing months with the primary care
111353 - physician confirmed this prescription. A few weeks ago,
111354 - on September 28, 2005, Doctor Smith cited pulmonary
111355 - emboli requiring Coumadin treatment as one of the
111356 - factors in my patient profile that makes me very high
111357 - risk for complications from undergoing mastectomy
111358 - surgery. Last week, on October 7th the primary care
111359 - physician related that Kaiser's standard practice for
111360 - pulmonary emboli is treatment for one (1) year, and that
111361 - chemotherapy patients are treated for life, as related
111362 - previously by Doctor Kaufman. Also, on the 7th the
111363 - primary care physician ended my treatment for pulmonary
111364 - emboli, perhaps reflecting a determination of successful
111365 - treatment with chemotherapy, as shown by the PET scan
111366 - test performed last week on October 5th, and presented
111367 - by the doctor on the 7th. Does this patient history
111368 - eliminate pulmonary emboli as a high risk for
111369 - complications in mastectomy surgery? If not, what are
111370 - Kaiser's plans for addressing this risk during and after
111371 - surgery? ref DIP 1 HC49
111372 -
111373 - [On 051021 Millie has mastectomy surgery; nurse
111374 - draws blood to evaluate pulmonary emboli risk
111375 - related to treatment with Coumadin. ref SDS 14 QW4I
111377 - ..
111378 - • How long will it be before you're fully recovered?
111379 -
111380 - How many days in the hospital for close observation of
111381 - complications cited by Doctor Smith? ref DIP 1 AQ38
111383 - ..
111384 - On October 12th, you mentioned, while performing minor
111385 - biopsy surgery, that Kaiser plans a one (1) day hospital
111386 - stay for my patient profile. How does this address
111387 - Doctor Smith's report of high risk post-operative
111388 - complications? Does Kaiser have experience showing that
111389 - one (1) is sufficient for evaluation of mastectomy
111390 - post-op complications on a secondary IBC patient with
111391 - pulmonary emboli? Would this be the same if Kaiser
111392 - performed a very wide mastectomy to remove previously
111393 - infected breast skin? What signals will the medical
111394 - team be checking to establish that one (1) day is
111395 - sufficient evaluation for releasing the patient to go
111396 - home in this case? ref DIP 1 HD43
111398 - ..
111399 - • How can you best prepare for the surgery and the
111400 - recovery period?
111402 - ..
111403 - What should I expect for recovery complications as a
111404 - secondary IBC patient, that are different from other
111405 - patients who have mastectomy surgery? How will Kaiser
111406 - handle these uncommon risks? ref DIP 1 AQ41
111408 - ..
111409 - What is the treatment plan going forward after surgery,
111410 - and how will this plan be different if surgery is not
111411 - performed? Is there a workup showing alternate
111412 - strategies? ref DIP 1 0X3N
111414 - ..
111415 - 9. I would like to get a draft of your report on the above issues
111416 - by Thursday, so there is time for review and finalization. You
111417 - can submit draft language via email to expedite the process
111418 - (millie****@*******.***). After we agree on the language, I
111419 - will then attach your signed report to the consent form I sign
111420 - for the mastectomy operation on Friday, October 21. A copy of
111421 - this letter to the primary care physician facilitates
111422 - collaboration on Time Out review. ref DIP 1 LK5J
111424 - ..
111425 - 10. Thanks again for your excellent work in my case, and please
111426 - extend to Doctor Smith my deep appreciation for her clear and
111427 - informative presentation on September 28th. ref DIP 1 01XY
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1115 -