Welch Company
San Francisco, CA
S U M M A R Y
DIARY: June 5, 2009 10:15 PM Friday;
Rod Welch
Letter to Zoe at Kaiser requests quality care review Millie getting Gemzar.
1...Summary/Objective
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CONTACTS
SUBJECTS
Default Null Subject Account for Blank Record
0403 -
0403 - ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS 18 0000, ref SDS 14 0000.
040502 -
040503 -
040504 -
040505 -
040506 -
040508 - ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - Background on this letter...
040902 -
040903 - 1. Millie's cancer relapsed with IBC
040904 - expanding on lower left arm reported
040905 - by letter to medical
040906 - team.................................. 090331, ref SDS 8 Q69V
040908 - ..
040909 - 2. Doctor Hus at UCSF advises that new
040910 - rash on Millie's lower left arem
040911 - is likely IBC......................... 090401, ref SDS 9 R24X
040913 - ..
040914 - 3. Millie's letter to medical team reports
040915 - IBC worsening on left arm,
040916 - hyperthermia.......................... 090412, ref SDS 10 XN8J
040917 - requests treatment next week to
040918 - prevent cancer from cascading out
040919 - of control............................ 090412, ref SDS 10 9S9Y
040921 - ..
040922 - Millie notifies medical team IBC spreading;
040923 - asks about getting treatment of cancer
040924 - as a chronic disease.................. 090415, ref SDS 11 KG8Q
040926 - ..
040927 - Examination at UCSF confirms Millie suffers
040928 - relapse of IBC; Doctor Hsu recommends
040929 - treating Millie first with systemic
040930 - agents prescribed by Doctor
040931 - Rugo.................................. 090423, ref SDS 12 UG5L
040933 - ..
040934 - Examination at UCSF Doctor Rugo sends a
040935 - letter recommending to Doctor Johnson at
040936 - Kaiser treatment with MPA "targeted
040937 - treament
040938 -
040939 -
040940 -
0410 -
SUBJECTS
Default Null Subject Account for Blank Record
0503 -
050401 - ..
050402 - On 090601 Brad called with the Kaiser Oncology Pharmacy in Walnut
050403 - Creek and advised that Doctor Johnson prescribed treatment of Millie's
050404 - cancer with Gemzar. ref SDS 14 PQ7V Brad explained concerns that
050405 - Millie will have difficulty tolerating side effects of Gemzar,
050406 - ref SDS 14 8J8L, and that Gemzar will be more difficult for Millie to
050407 - maintain blood counts, than with prior regimens, again because her
050408 - bone marrow system has been degraded with 8 relapses.
050410 - ..
050411 - On Wednesday 090603 1500 Millie got a call from Queenie who works with
050412 - Brad in the Kaiser Oncology Pharmacy. She discussed with Millie for
050413 - about 30 - 40 minutes the Gemzar protocol and how Kaiser would help
050414 - Millie tolerate side effects, including treatment with Compazine.
050415 - ref SDS 16 6W9H
050417 - ..
050418 - Yesterday, on 090604, Bella in the Chemotherapy Infusion Clinic called
050419 - and advised that Kaiser has scheduled Millie to start Gemzar treatment
050420 - on 090611 1400.
050422 - ..
050423 - Zoe called earlier today about 1330, and discussed quality care
050424 - concerns.
050426 - ..
050427 - After Zoe's call, Millie received the letter from Queenie which
050428 - purported to confirm discussion on Wednesday of Gemzar risks and side
050429 - effects. ref SDS 18 V37O Queenie provided a link in her letter to a
050430 - website that presented a great many new and significant issues not
050431 - previously discussed by Queenie nor Brad nor the doctor. ref SDS 16
050432 - 6W9H
050434 - ..
050435 - Based on Queenie's letter earlier today, submitted a letter to Zoe at
050436 - Kaiesr listing quality care defects in Kaiser's prescription to treat
050437 - Millie with Gemzar, and that evidence shows other treatments are
050438 - better for Millie at this time.
050440 - ..
050441 - The letter to Zoe says...
050442 -
050443 - 1. Subject: Quality Review Gemzar Prescription Millie's 8th Relapse Oncology Standard of Care
050444 - Date: Fri, 05 Jun 2009 23:12:03 -0700
050452 - ..
050453 - 3. This confirms understandings from your call this afternoon
050454 - representing Kaiser's Quality Care Department, and reported in
050455 - another record on 090605 1233. ref SDS 17 UD5H I am copying
050456 - Paula simply to say thanks for facilitating quality care
050457 - review.
050459 - ..
050460 - 4. Zoe, you are leaving the office at 1400 today, and so may not
050461 - see this until Monday. Millie is now scheduled to start Gemzar
050462 - treatment on Thursday, 090611 I think at 1400. Our discussion
050463 - today cited a range of issues where care can be strengthened.
050464 - Some require immediate action. Others can be considered with
050465 - extended deliberation.
050467 - ..
050468 - 5. Today, you proposed addressing Gemzar treatment first, since it
050469 - is scheduled to start next Thursday on 090611.
050471 - ..
050472 - 6. After our call today, Millie received a letter dated today,
050473 - 090605 at 1006, ref SDS 18 V37O, from KWAN N LAU ("Queenie") in
050474 - Kaiser's Walnut Creek Oncology Pharmacy, and which confirmed a
050475 - telecon she had with Millie on Wednesday explaining side
050476 - effects of Gemzar. Queenie transmitted a link to Kaiser's
050477 - protocol guidance for Gemzar...
050478 -
050479 - http://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=11338
050481 - ..
050482 - 7. Please note that except for Coumadin, none of the following
050483 - evident serious risks were discussed during Queenie's call on
050484 - Wednesday. If Millie had not requested a written report, we
050485 - would be starting Gemzar on 090611 without ever being aware of
050486 - these risks.
050487 -
050488 - [On 090608 1209 Zoe responds that planning in Kaiser
050489 - Quality Control Department to facilitate quality care with
050490 - medical team was a mistake. ref SDS 20 CN4G
050492 - ..
050493 - 8. Failing to present risks and plans to mitigate in relation to
050494 - patient history presents a separate quality care issue.
050496 - ..
050497 - 9. Kaiser's guidance received this afternoon says in part...
050498 -
050499 - 1. Gemcitabine should be used with extreme caution if you have
050500 - just received radiation therapy. ref SDS 18 745O
050502 - ..
050503 - 10. Vague generalities need careful review in Millie's case. How
050504 - much radiation, how long ago, and where was radiation given?
050505 - If radiation occurred 2 years ago to the little toe, possibly
050506 - nothing to worry about. Millie just received a lot of
050507 - radiation to large portions of the upper body that have vital
050508 - organs, and within the past few months.
050510 - ..
050511 - 11. On 090317 Millie completed 4 weeks of radiation given 4 days a
050512 - week at UCSF on referral from Doctor Johnson at Kaiser. This
050513 - treatment occurred over the entire upper left arm, the left
050514 - supraclavicular area, much of the right breast, the entire left
050515 - chest wall from below the neck to the lower left abdomen,
050516 - wrapping toward her back, all where IBC was occurring. Thus,
050517 - Millie has recently had massive radiation therapy.
050519 - ..
050520 - 12. What does "just received" mean for Millie's patient profile?
050522 - ..
050523 - 13. On 090312 the attending physician at UCSF, Doctor Hsu, advised
050524 - that radiation Millie received continues to provide recovery
050525 - from cancer for many months. The recent blood test on 090602
050526 - indicates Millie may be having continuing recovery from
050527 - radiation because her CA 15-3 cancer marker came down at a time
050528 - when IBC is expanding outside areas treated with radiation
050529 - during Feb-Mar. Since Millie has had no systemic treatment
050530 - since 090122, there is a reasonable inference that radiation is
050531 - continuing to kill cancer cells in treated areas.
050533 - ..
050534 - 14. There is nothing in the record showing "extreme caution" called
050535 - out in Kaiser's guidance has been affirmatively reviewed. What
050536 - does Kaiser's experience indicate "just received" means in the
050537 - context of Millie's patient history?
050539 - ..
050540 - 15. Does Gemzar present "extreme risks" for Millie after "just
050541 - receiving" radiation mean "yesterday," "last week"; or, does
050542 - evidence of continuing effects from radiation indicate
050543 - continuing extreme risk that presents quality care issues which
050544 - should be avoided, if possible?
050546 - ..
050547 - 16. What "extreme caution" has Kaiser taken to prepare Millie for
050548 - Gemzar treatments? It wasn't discussed by Queenie. Doctor
050549 - Johnson has never mentioned it. There is nothing in the
050550 - medical chart about this issue.
050552 - ..
050553 - 17. Can Kaiser point to patients who have had radiation comparable
050554 - to Millie's treatment, which is a fairly rare application [see
050555 - Doctor Hsu's radiation plan received on 090226, ref SDS 4 D452]
050556 - and they received Gemzar 2 months or less later [Millie's
050557 - treatment ended on 090317, ref SDS 6 9L7K], without adverse
050558 - effects? "Extreme caution" requires thorough evidence. On
050559 - 090515 Doctor Johnson seemed to mention another patient treated
050560 - with radiation for IBC. She suffered similar recurrence with
050561 - IBC along the periphery of radiated areas. Did she get Gemzar?
050562 - How did that work out? If not, does this suggest Gemzar may
050563 - not be the best care for Millie?
050564 -
050565 - [On 090609 1422 Doctor Johnson disclosed having treated
050566 - patients for pancreatic cancer with Gemzar after getting
050567 - radiation, and they survived; he said Millie should
050568 - ignore Kaiser's published guidance, ref SDS 21 VV75; and
050569 - refused to confirm medical advice to ignore Kaiser
050570 - published guidance for safe treatment with Gemzar.
050571 - ref SDS 21 DC4K
050572 -
050574 - ..
050575 - 2. Rarely, gemcitabine may increase your chance of bleeding.
050576 - Because of this, you should avoid using blood thinners, or
050577 - drugs that also affect bleeding... ref SDS 18 793G
050579 - ..
050580 - 18. Millie has been treated for pulmonary embolism with warfarin
050581 - (Coumadin) since 041103. She was taken off Coumadin for
050582 - surgery on 051021. This 10-day pause was extended to 060930
050583 - when she was diagnosed again with PE relapse in another CT.
050584 - Research indicated 40% of patients who relapse with PE die.
050585 - This record indicates grounds to continue Coumadin blood
050586 - thinner.
050588 - ..
050589 - 19. Does Kaiser guidance on Gemzar risks for bleeding conflict with
050590 - Millie's patient profile that requires taking blood thinner
050591 - (Coumadin), which compounds bleeding; does risk of excessive
050592 - bleeding present quality care issues that should be avoided, if
050593 - possible?
050595 - ..
050596 - 20. Kaiser's Gemzar guidance received today from Queenie then
050597 - presents a long list of the "most common" Side Effects,
050598 - ref SDS 18 0G3L, that include...
050600 - ..
050601 - 1. Rash, itchy skin ( mainly on arms and legs)
050602 - 2. Swollen arms and legs
050604 - ..
050605 - 21. Millie now has IBC occurring on the lower left arm. Millie has
050606 - been in the ER 4 times for treatment of severe lymphedema with
050607 - Cellulitis in the left arm, most recently on 080409. In the
050608 - past 12 months, this problem has been controlled, because
050609 - remaining lymphatics have become more robust, according to the
050610 - surgeon, Doctor Riley-Paull. Now, however, since April, spread
050611 - of IBC to the lower left arm has brought back continual
050612 - swelling for the past 2 months. Millie must wear a compression
050613 - sleeve continually all day.
050615 - ..
050616 - 22. Additionally, will radiated skin across the top of the left
050617 - arm, and across most of the upper chest, and lower left abdomen
050618 - present risks from scratching skin irritated by Gemzar? Doctor
050619 - Hsu at UCSF notified Millie that she would have to avoid
050620 - scratching this radiated skin because it will not heal well.
050622 - ..
050623 - 23. Do Gemzar risks for Millie's patient profile causing itchy
050624 - IBC skin and compounding existing swelling in the left arm
050625 - present quality care issues that should be avoided, if
050626 - possible?
050628 - ..
050629 - 3. Joint /muscle pain
050631 - ..
050632 - 24. Millie suffered dislocated right shoulder on 090122, and was
050633 - treated in the ER at Kaiser Walnut Creek. The doctor said
050634 - recovery would take more than a year. Millie is getting
050635 - physical therapy. Her last treatment was on 090601, this past
050636 - Monday at Kaiser in Park Shadelands. While she is working hard
050637 - in the gym to rehab the shoulder, she continues to suffer joint
050638 - and muscle pain.
050640 - ..
050641 - 25. Does Gemzar risks for Millie's patient profile compound
050642 - existing joint and muscle pain present quality care issues that
050643 - should be avoided, if possible?
050644 -
050645 - 4. Low white blood counts, fever and chills, infections
050647 - ..
050648 - 26. While this is listed as "less common" it was the focus of
050649 - Brad's call on 090601 for the Kaiser Pharmacy advising that
050650 - Doctor Johnson prescribed Gemzar. ref SDS 14 PQ7V
050652 - ..
050653 - 27. When Millie was last treated with chemotherapy during November
050654 - and December 2008, nearly all of the CBC elements fell below
050655 - the safe level for chemotherapy [reported on 081219.
050656 - ref SDS 2 JK7H
050658 - ..
050659 - 28. Doctor Johnson listed Millie's condition in the medical chart
050660 - on 081219 as both cytopenia and pancytopenia, which present
050661 - risk of fatal infection. ref SDS 2 NE6M
050663 - ..
050664 - 29. Even with Neupogen, Millie was often below the level for safe
050665 - treatment, and so was at risk much of the time getting
050666 - sunitinib. On the positive side, for the first 2 months,
050667 - Millie had a strong recovery from cancer with sunitinib,
050668 - reported for "Examination" in the Kaiser medical chart on
050669 - 081219 (see para e and f). ref SDS 2 HT6V
050671 - ..
050672 - 30. See as well "Plan" to continue positive response. ref SDS 2
050673 - UN8M
050675 - ..
050676 - 31. Brad seemed to indicate on 080601 that Millie's chronic low
050677 - blood counts continuing through 090515 indicate this will be a
050678 - bigger risk with Gemzar. Since Doctor Johnson noted on 090528
050679 - that Gemzar may not work at all, Millie is being placed at
050680 - significant risk without evident prospects for any recovery.
050682 - ..
050683 - 32. Millie's recent lab this past Tuesday on 090602 showed a
050684 - significant recovery of blood counts. The ANC elements more
050685 - than doubled. This reduces danger from fatal infection at this
050686 - time starting Gemzar scheduled for 090611. However, recovery
050687 - of blood counts took 5 months to achieve. Brad related on
050688 - 090601 that positive labs will not last with weekly Gemzar
050689 - treatments. Millie's history of 8 years with chemotherapy
050690 - shows physical ability to recover from low blood counts has
050691 - been degraded.
050693 - ..
050694 - 33. Do Gemzar risks for Millie's patient profile present quality
050695 - care issues that should be avoided, if possible?
050697 - ..
050698 - 34. During the meeting at Kaiser on 090515 Doctor Johnson seemed to
050699 - indicate that a quality care audit would criticize prescribing
050700 - Navelbine for not complying with standard of care for Millie's
050701 - patient profile. ref SDS 13 658J Review today of Kaiser's
050702 - guidance shows that prescribing Gemzar presents similar quality
050703 - care concerns [reported on 090605 1447, ref SDS 18 V34K].
050705 - ..
050706 - 35. Since Kaiser has avoided Gemzar for 5 years and prescribed
050707 - clinical trials for oncology standard of care with "targeted"
050708 - systemic treatments which do not present risks posed by
050709 - conventional chemotherapies, like Gemzar, and most recently
050710 - prescribed treatment with radiation and hyperthermia, and since
050711 - these treatments have been very effective, and since the doctor
050712 - reported on 090515 that Gemzar would not be effective, and then
050713 - stated in a letter on 090528 that Gemzar may not work at all,
050714 - this presents a quality care issue of what to prescribe for
050715 - Millie?
050717 - ..
050718 - 36. Based on new information received just today, there is
050719 - heightened concern now about proceeding with Gemzar on 090611.
050720 - Does Gemzar meet Kaiser's oncology standard of care to treat
050721 - Millie's 8th relapse of cancer?
050723 - ..
050724 - 37. Assuming Gemzar passes quality care issues presented above, and
050725 - Millie can start treatment on 090611, Millie needs a treatment
050726 - plan for follow on care if the treatment doesn't work, as
050727 - expected by the doctor, or if she cannot get treatment because
050728 - of low blood counts, as expected by Brad in the Pharmacy? We
050729 - have requested criteria for evaluating when to switch
050730 - treatments in time to be effective, based on Doctor Johnson's
050731 - expression that Millie will have very little time to start
050732 - another treatment before cancer cascades out of control, as set
050733 - out in the letter to the medical team on 090324. ref SDS 7
050734 - CT6R, and reflecting Doctor Johnson's explanation during the
050735 - meeting at Kaiser on 090213 that Millie's patient profile
050736 - requires timely treatment because there is a narrow margin for
050737 - delay to start treatment in time to be effective. ref SDS 3
050738 - PL5K
050740 - ..
050741 - 38. The doctor's urgency for Millie to get treatment at UCSF
050742 - because Kaiser does not have treatments for Millie's patient
050743 - profile was first presented in the medical chart on 080829.
050744 - ref SDS 1 PX5V
050746 - ..
050747 - 39. Millie has been treated the past 3 years at UCSF on referral
050748 - from Doctor Johnson. Doctor Rugo and her team have maintained
050749 - careful measurements of Millie's IBC sites for evaluating
050750 - progression. They take a lot of time, because IBC occurs as
050751 - irregular shapes, and so drawings are required to capture
050752 - Millie's condition. Doctor Johnson has never measured IBC
050753 - sites, because he has appropriately relied on UCSF's IBC
050754 - experts. Review of Kaiser's medical chart shows no
050755 - measurements and no drawings. Of course Doctor Johnson is an
050756 - outstanding oncologist, and so can recall from memory Millie's
050757 - situation distinguished from many other patients to generally
050758 - recognize improvement and progression. However, the current
050759 - situation to assess effectiveness of Gemzar which is expected
050760 - not to be effective, requires more than generalities.
050762 - ..
050763 - 40. We have asked to set cancer marker targets. If the marker is
050764 - tested week to week along with labs to assess whether Millie's
050765 - blood counts are safe for treatment, then there should be
050766 - agreement that if the CA 15-3 289 from the most recent test on
050767 - Tuesday, 090502, goes up even 10 points will that be sufficient
050768 - to stop treatment and move to the next regimen in order to have
050769 - a chance for Millie to get effective care? If not 10, then 50,
050770 - what about 100? What will be the criteria?
050772 - ..
050773 - 41. When will a CT test be performed to evaluate progression to
050774 - internal organs?
050776 - ..
050777 - 42. At this time, there is no evidence of distant metastasis to
050778 - internal organs. The longer Millie goes without systemic
050779 - treatment the greater the risk cancer will migrate, causing
050780 - precipitous failure. But right now that is not the case. On
050781 - clinical trial, Millie had CT tests every month. How will
050782 - Kaiser address CT testing with the Gemzar regimen, assuming it
050783 - goes forward?
050785 - ..
050786 - 43. If Gemzar does not meet standard of care for Millie's patient
050787 - profile, per above; or, if it does, but does not work; or, if
050788 - Gemzar does work, but Millie cannot get the treatment due to
050789 - low blood counts, or even if she can get a few treatments, then
050790 - at progression of disease, what will Kaiser prescribe next for
050791 - oncology standard of care for Millie's patient profile?
050793 - ..
050794 - 44. Millie has asked a few times about getting more hyperthermia
050795 - with radiation, Doxil, or something, which worked well in
050796 - February and March. Is this part of the treatment plan? If
050797 - so, when, and if not what evidence supports failure to
050798 - prescribe more treatment that worked extremely well, in the
050799 - face of the current prescription for Gemzar expected not to
050800 - work at all?
050802 - ..
050803 - 45. Kaiser received a recommendation on 090129 from Doctor Rugo at
050804 - UCSF to prescribe MPA, because it will have little to no impact
050805 - on blood counts. MPA is less expensive than Gemzar by orders
050806 - of magnitude; it does not require weekly labs, and has a much
050807 - better chance of being effective because MPA is "targeted" to
050808 - Millie's patient profile. MPA treatment does not cause
050809 - congestion in the Infusion Clinic, cited by Sheree as delaying
050810 - treatment on 090601 at Kaiser. Getting treatment off-site in
050811 - pill-form with MPA significantly reduces stress on the system,
050812 - accomplishing health care cost containment requirements.
050814 - ..
050815 - 46. MPA has no evident serious side effects, although like all
050816 - treatments some patients may suffer adverse effects.
050818 - ..
050819 - 47. For the past 5 years beginning in 2004, Doctor Johnson has
050820 - implemented UCSF recommendations with good results. If Kaiser
050821 - has more effective treatment at less cost, then that should be
050822 - prescribed.
050824 - ..
050825 - 48. What is Kaiser's work plan to treat Millie's patient profile?
050827 - ..
050828 - 49. Doctor Johnson has always been a good partner to resolve
050829 - issues. The simplest solution is to make another referral for
050830 - more hyperthermia and related modalities, or for the MPA
050831 - protocol, or request another proposal from UCSF, who has done a
050832 - good job the past 5 years supporting Kaiser with Millie's care.
050834 - ..
050835 - 50. Attached is background communication for the past 2 weeks with
050836 - the medical team, including Doctor Johnson and showing work
050837 - leading to the current prescription to begin treating Millie
050838 - with Gemzar on 090611.
050840 - ..
050841 - 51. Our first order of business to resolve the new information
050842 - received today on risks and side effects of Gemzar for Millie's
050843 - medical history.
050844 -
050845 - [On 090607 2337 followed up, ref SDS 19 OL5X
050847 - ..
050848 - 52. In our call today, you planned to call Doctor Johnson to alert
050849 - him of discussions on Millie's treatment plan. By copy to the
050850 - doctor, this letter provides a common set of issues for quality
050851 - review.
050853 - ..
050854 - 53. Over the next few days we need to confirm Gemzar is okay for
050855 - Millie, and in that case Millie needs a letter from Kaiser
050856 - presenting a mitigation plans for each of the issues in
050857 - Kaiser's guidance on Gemzar that are relevant risks to Millie,
050858 - per above.
050859 -
050860 - [On 090607 2337 Millie notifies Zoe that in addition to
050861 - problems prescribing Gemzar that conflicts with Kaiser's
050862 - guidance for Millie's patient profile; Millie has
050863 - suffered extended side effects from radiation treatments
050864 - performed on referral from Kaiser by UCSF. ref SDS 19
050865 - OL5X
050867 - ..
050868 - [On 090608 1209 Zoe responds that planning in Kaiser
050869 - Quality Control Department to facilitate quality care
050870 - with medical team was a mistake. ref SDS 20 CN4G
050872 - ..
050873 - [On 090609 1422 Doctor Johnson refused to submit a
050874 - letter with written confirmation of verbal medical
050875 - advice to ignore Kaiser published guidance for safe
050876 - treatment with Gemzar of Millie's patient profile.
050877 - ref SDS 21 DC4K
050879 - ..
050880 - 54. Millie needs a letter presenting follow on oncology care for
050881 - her patient profile with criteria for evaluating Gemzar
050882 - failure, per above.
050883 -
050890 -
050891 -
050892 -
050893 -
050894 -
050895 -
050896 -
050897 -
050898 -
050899 -
050900 -
050901 -
050902 -
050903 -
050904 -
050905 -
0510 -