Date: 19 Mar 96 00:18:15 EST
From: Mike Darwin <>
Subject: BPI TECH BRIEF #18

Cryopreservation of CryoCare Patient #C-2150 
     by Mike Darwin 


     On December 12th, 1995 James Gallagher, a 55-year-old 
software developer from Sunset Beach, California, became 
CryoCare's first member to enter cryopreservation. He also 
became the first patient ever to benefit from new 
technologies developed to reduce three forms of injury: 
     * pre-mortem shock 
     * warm ischemia (the time interval between pronouncement 
of death and restoration of adequate blood circulation) 
     * cold ischemia experienced during initial blood washout 
and cooling, and also during iced-transport from the location 
where legal death occurred to the facility where 
cryoprotective perfusion is carried out. 

     The following is not quite a full technical report, but 
neither is it simply a lay-level of summary of key events 
without reference to the technical details and the impact 
those details had upon this patient's care and potentially, 
future patents' care. It is the aim of this report to 
include enough quantitative detail that direct comparisons 
can be drawn with previous cases. It can be argued that this 
is just *one* patient, that solid inferences or statistical 
significance cannot be established with n=1. Generally, this 
would be true. However, this patient's course is being 
compared with many other animals and humans subjected to 
similar protocols. 

     Using relevant animal models over the last three years, 
BioPreservation, Inc. (BPI), the transport and 
perfusion/cool-down service provider for this patient, in 
conjunction with 21st Century Medicine (21st) has been 
evaluating aspects of the protocol used on this patient. 
Further, BPI and several of BPI's core technical staff have 
had extensive experience applying pre-mortem medication, 
transport, and cryoprotective perfusion protocols with 
patients from other cryonics organizations in the past, and 
also have access to relevant case data from other cryonics 
patients whose illness, agonal course, and time to post-
arrest intervention are directly comparable with this 

     At a minimum, we believe that the close correlation of this
patient's response to that observed in the canine experiments using
the same protocol, and especially when contrasted with results
achieved in comparable human cryopreservation patients treated with
previously used protocols (including a patient treated by 
BPI; ACS Patient #9577), is significant. Of particular 
importance is this patient's core temperature cooling data, 
since cooling is constrained by physical laws which are well 
understood, and where the predictability and simplicity of 
the system used to carry out cooling allows for little 
variation from case to case (where patient mass, body fat 
content and distribution, and surface area, are comparable, 
of course). 

     The significance of other measured parameters in this 
case, such as tissue-specific enzyme release (markers of 
ischemic injury for specific organs and for the patient as a 
whole) and metabolic parameters, is presently more open to 
debate. However, even here we believe that the results 
achieved with this patient are so different from that 
observed in patients with comparable diagnoses and agonal 
courses (and in such close agreement with animal data) that 
careful consideration should be given to the results. 

     Social and Medical Background 

     The patient first contacted CryoCare (CC) on 15 July, 
1995 to inquire about cryopreservation services. He was 
familiar with cryonics due to prior association with a 
contract worker whom he employed in the early 1980's who was 
heavily involved in cryonics. He had also read cryonics 
organizations' literature and met with various cryonics 
organization members and personnel (where cryonics was a 
topic of discussion) again since the early 1980s. The patient 
had been in-touch with several cryonics organizations before 
contacting CC, after being informed he was terminally ill. 

     Formal communication with CC administration began by e-
mail on 17 July and Mike Darwin, President of BPI was brought 
in for a cryonics consult with the patient on 20 July. 

     At that time the patient informed BPI that he had been 
recently diagnosed with terminal cancer and was interested in 
putting cryopreservation arrangements in place. BPI 
questioned the patient extensively about his medical history 
and treatment and discovered the following relevant 

     * The patient did not have health insurance and was 
paying for medical care piecemeal as crises or problems 

     * The patient had not had a definitive diagnosis of 
cancer. After more than five months of sacral pain, the 
patient had been CT'ed by his family physician, and the 
diagnosis was presumptively based on a single CT scan of the 
chest and abdomen which revealed numerous solid lesions which 
appeared to be tumor, present in the left kidney and 
obliterating the left adrenal gland, and also present in the 
caudal lobe of the liver, and possibly the descending colon. 

     * The patient was seeing an alternative medicine 
provider (a biochemist, not a physician) who told him he 
probably had primary cancer of the kidney (primary renal 
carcinoma) and prescribed a nutrient supplementation regime 
coupled with the administration of large doses of urea and 
creatinine (waste products of metabolism normally excreted by 
the body in the urine) purportedly to stop the spread of the 
cancer and convert the cancer cells back to more "normal 
morphology." Nutritional supplements of a wide variety but 
notably including co-enzyme Q10, vitamin A, beta carotene, 
selenium, vitamins E and C, and cesium chloride (13 g/day 
cesium chloride ostensibly to stimulate the immune system to 
attack and destroy the cancer) were also being administered. 

     At this time Mike Darwin refused to accept the patient 
as a BPI client until a definitive diagnosis of terminal 
illness was established. The patient was told that some 
moderately to highly treatable cancers such as non-Hodgkin's 
lymphoma may appear indistinguishable on CT from other, 
untreatable cancers. It was also noted that on the initial 
radiology report (which was read to Darwin) that the 
radiologist reading the CT remarked on what he felt might be 
a mass in the posterior part of the descending colon, but was 
unable to tell with certainty due to the presence of feces in 
the bowel. The radiologist listed primary adenocarcinoma of 
the colon (the most common type of bowel cancer) as the 
number one possibility to rule out. 

     Since the patient did not have health insurance, a 
variety of options was discussed to determine the nature and 
the treatability of the apparent malignant disease. The 
patient was referred to BPI's medical consultant Steven B. 
Harris, M.D. and the number of options was rapidly pared 
down. If it *was* primary renal carcinoma, the only way to 
definitively establish that would be to obtain a sample of 
the tumor using CT-guided needle biopsy or to do an "open 
biopsy" or lapropscopic biopsy wherein surgery is performed 
to open or access a body cavity with a trocar and fiberoptic 
scope, to inspect and directly obtain a sample of the 
questionable tissue. 

     Due to the statistically comparatively low likelihood of 
primary renal carcinoma in a 55 year-old man (versus the 
likelihood of primary adenocarcinoma of the bowel), the 
remarks of the radiologist about the possible presence of a 
bowel mass on the CT scan, and the absence of health 
insurance, it was decided that the most cost-effective and 
medically most conservative way to proceed would be to have 
the patient undergo fiberoptic colonoscopy (direct 
visualization with a flexible fiberoptic viewing device) of 
the colon and look to see if there was any tumor present. 
(Common things are common; metaphorically the CT was the 
equivalent of loud hoof beats in the distance, and when one 
hears hoof beats in the Western United States one generally 
thinks of horses, not zebras. In this case horses = primary 
adenocarcinoma of the bowel). 

     A few days later the colonoscopy was performed and our 
suspicions were confirmed; there was a large mass nearly 
obstructing the descending colon which appeared on visual 
inspection to be a malignancy. 

     Dr. Harris and Mike Darwin both advised the patient that 
bowel obstruction by the rapidly growing tumor was imminent 
and that he should consider a palliative colostomy. The 
patient was resistant to doing this for several reasons. 
First, he had considerable confidence that enemas with urea, 
and his alternative cancer treatment regime would at least 
shrink the tumor (he was receiving considerable encouragement 
from his alternative care provider in this regard), so that 
surgery could be avoided. Secondly, the anticipated cost of 
a colostomy and associated care would jeopardize the funding 
the patient had set aside from his savings for 

     This created a new and difficult ethical problem for 
both BPI and CC. Clearly CC needed to maintain its funding 
minimums at a level sufficient to provide reasonable safety 
margins for continued cryogenic care of the patient. And, 
clearly, BPI is not in the charity business and has staff to 
pay and marginal costs to address. On the other hand, it is 
hardly tenable to confront a patient with the choice between 
foregoing cryopreservation or facing a gruesome and agonizing 
death from an obstructed bowel (months earlier than would be 
the case if colostomy or colectomy were performed) 

     Since this patient was low on funds already (nearly 
$50,000 of savings having been spent on piecemeal alternative 
"medical" care) he had already agreed to the use of new 
procedures and to the biopsying of his brain in exchange for 
reducing the basic cost of BPI's procedures. Confronted with 
this new situation, BPI reduced its charge to below the 
break-even level and the patient volunteered to cooperate 
with what then constituted extraordinary antemortem 

     This was the first time BPI, CC, or, to our knowledge, 
any cryonics organization has been faced with a situation 
where a patient (and his cryonics organizations) was 
confronted with a choice between reasonable standard of care 
(avoiding a serious, life shortening, and definitely quality-
of-life reducing complication of the illness), and being 
cryopreserved. This was deeply disturbing for all involved, 
and merits intense discussion in the immediate future, not 
just by CC and BPI, but by the cryonics community as a whole. 
While it is inappropriate to belabor this point here, this 
case points up that increasingly cryonics organizations will 
be dealing with both members and non-members who have no 
health insurance (not even HMO coverage), no access to 
government healthcare such Medicaid, Medicare or VA care, 
and/or who have limited access to health care with HMO, PSO, 
PPO or other care which forces them to make major quality of 
life or length of life decisions based on use of their non-
healthcare allocated funds such as savings, property equity, 
and even accumulated cash value or resale value of life 
insurance policies--including those specifically earmarked 
for cryonics. 

     Further, in some cases the state, acting through the 
courts, may appropriate these assets at the request of 
guardians or relatives. The issues raised by the 
inevitability of a massive restructuring of health care cost 
and availability in the United States which is occurring now, 
should be considered now. This case should serve as a 
sentinel in this respect. 

     A few days after his colonoscopy, the patient began to 
experience symptoms of bowel obstruction (increased anorexia, 
nausea, shot-gun pellet stool, vomiting and abdominal 
distention), and so a double-barreled colostomy was performed 
on 29 July. This procedure was uneventful and the patient 
returned home where he was cared for by his sister, his 
brother-in-law and his nephew. The patient continued with 
his alternative medicine regime, although, due to increasing 
nausea, he abandoned use of the cesium chloride. 

     At this point BPI became disengaged from close 
involvement with the case over issues related to funding 
details. This was an issue between the patient and CC, and 
until the patient became a fully signed-up CC 
cryopreservation member, it was inappropriate for BPI to be 
as closely involved. 

     As financial negotiations proceeded favorably, BPI again 
became involved and made a home visit on 15 October with 
medical advisor Dr. Harris and BPI staff members Carlotta 
Pengelley, LVN, Joan O'Farrell, Sandra Russell, and Mike 
Darwin also present. The purpose of this visit was to 
evaluate the home for logistics of access (it was a second-
story apartment with outside stair-access only) and equipment 
set-up, meet the family and prepare them for the reality of 
transport, assure the patient's medical and pain control 
needs were being met, encourage the patient to enroll in home 
hospice, and to carefully medically examine the patient in 
order to determine "staging" or likely time-course to legal 
death for cryonics reasons. 

     Dr. Harris examined the patient thoroughly during this 
visit and baseline blood chemistries were drawn, including 
samples collected, spun-down and frozen to dry ice 
temperature on-site for subsequent baseline antioxidant and 
lactate levels (the former to be done by Pantox Labs of San 
Diego, CA) as well as for a routine chemistry panel an a 
screening for infectious diseases. 

     During this visit Dr. Harris noted that the patient had 
right leg weakness (barely noticeable) a right visual field 
cut (right homonymous hemianopia), nausea and anorexia (lack 
of appetite) and that he weighed 73.1 kg down from a previous 
healthy weight of 86-88 kg. Careful history taking also 
disclosed recent (2 weeks duration) inability to read, which 
the patient attributed to lack of ability to concentrate, and 
urinary incontinence. The patient was noted to have cancer 
wasting syndrome and complained of severe back pain of eight 
months duration. Further, Dr. Harris felt it very likely the 
now nearly immobilizing back pain (the patient was 
constrained to lie face down on a specially modified cot most 
of the time) was due to involvement of the sacrum with 
metastatic disease. 

     Dr. Harris' presumptive diagnoses at the conclusion of 
the home visit were probable large metastases (4-6 cm) of the 
primary colon cancer to the left occipital lobe of the brain 
which was likely responsible for the right-sided visual field 
cut, weakness, and incontinence. Probable metastatic 
involvement of the sacrum was assumed, with resulting 
uncontrolled bone pain. Further presumptive diagnoses were 
tumor necrosis factor (TNF) and related cytokine cancer 
wasting syndrome, and poor nutritional status (calorie count 
estimated at 1500 kcal/day or less). The family was urged to 
take the patient to an imaging center and have an MRI or CT 
of the head done to rule out malignant involvement of the 
brain (the patient's family was informed of the high 
probability of the metastasis, but the patient at this time 
was not). 

     A CT scan with and without contrast was performed on 17 
October and a 6cm mass was indeed found in the left occipital 
lobe of the brain. Dr. Harris, in conjunction with the 
patient's newly acquired primary care physician persuaded the 
patient that it was imperative that he undergo palliative 
radiotherapy to his head and to his sacrum (lower back). The 
patient was resistant to undergoing this treatment because of 
his disdain for "radiation treatment of cancer" and because 
of his concerns about possible damage to his brain from the 
radiation which might compromise his chances for good 

     Dr. Harris was instrumental in convincing the patient to 
get palliative radiation treatment. He explained that 
failure to do so would result in hemiplegia (paralysis on one 
side) possible loss of speech, complete incontinence of 
bladder and stool, and likely death from elevated 
intracranial pressure which might very likely expose his 
higher brain to extended periods of periods of minimal or 
absent blood flow (ischemia) for hours prior to cardio-
respiratory arrest and pronouncement of legal death. The 
consequences of unchecked growth of an aggressive malignant 
tumor in the brain, versus the by comparison trivial effect 
of palliative radiotherapy (increased sleepiness and 
fatigue, hair loss and modest compromise of short-term 
memory) were emphasized. 

     (In cases of metastatic brain disease the entire brain 
is usually radiated both to hold down the costs associated 
with shielding and selective irradiation of the tumor, and, 
more importantly, to "head off" the proliferation of other 
metastases; where you see one seed sprouting there are likely 
other to be others germinating. Whole brain irradiation 
decreases the likelihood of secondary tumors developing in a 
patient who is terminal with aggressive malignant disease). 

     The patient had previously been scheduled to have a 
chronic intrathecal line placed into his lumbar spine for 
delivery of chronic intrathecal morphine by pump for chronic 
pain control, and on 16 October, this was done. Within 48 
hours, however, the patient was unable to walk, and was 
admitted to the hospital. There, neurological exam showed 
profound bilateral leg weakness and normal spinal fluid. X-
rays also showed a metastatic lytic lesion to the right 
sacrum, with possible nerve compression to the right leg. 
The neurologist examining the patient for the first time 
thought that the new weakness was due to cauda-equina 
compression syndrome from tumor; and rejected the idea, put 
forth by Dr. Harris, that the very rapid onset of weakness 
coupled with the relationship to the intrathecal line 
placement, made that procedure suspect. Dr. Harris, however, 
was able to convince the patient's primary physician of this 
possibility, and the intrathecal morphine was discontinued. 
Within a day the patient recovered use of his legs, but a 
definitive diagnosis of the problem was never made. He 
continued for the rest of his course, however, on morphine 
delivered via peripheral line. 

     During hospitalization for the leg problem, the patient 
was seen by a radiotherapist, and radiotreatment to his brain 
and sacrum was initiated. In particular, he underwent 10 
fractionated doses of palliative radiotherapy to his head, 
with 4,000 rads (cGy) to the whole brain and a 10,000 rad 
boost to the tumor. 

     The patient was also enrolled in a good Home Hospice 
program which did much to help the family by providing basic 
care advice and improved pain management. 

     Financial negotiations between the patient, the 
patient's representative family member and CC continued (with 
some last-minute input from BPI) and the patient became a 
fully funded CC cryopreservation member on 7 November, 1995. 

     On 5 November the patient spoke with Dr. Harris by phone 
and reported himself as being very depressed and wishing to 
withdraw from the program of anti-TNF and immune stimulating 
drugs the patient had been started on after the withdrawal of 
the alternative medicine practitioner. Dr. Harris noted that 
the patient sounded sort of breath (dyspneic) on the phone 
and asked the patient if he was, which the patient denied. 

     That evening the patient was transported to the 
emergency department (ED) of a nearby hospital acutely short 
of breath and panicky with air hunger. The paramedics who 
carried out the transport noted that the patient had 
diminished breath sounds on the right side nearly to the base 
of the right lung, and began oxygen at 2 liters per minute 
(LPM) during transport. When the patient was examined in the 
ED the ED physician said he could find no diminished breath 
sounds, stopped the oxygen, waited "a few minutes," noted the 
patient's oxygen saturation by pulse oximetry was 96%, and 
told him to go home. At that point Dr. Harris spoke with the 
ED physician and requested that arterial blood gases be drawn 
and a chest X-ray be taken. This was a medically sound 
request for several reasons: first, it would help establish 
the basis of the patient's shortness of breath and determine 
if palliative oxygen therapy should be considered to reduce 
or eliminate "air hunger." Or, failing relief of air hunger 
with oxygen supplementation, increase the degree of sedation 
to make the patient more comfortable. Second, from a cryonics 
standpoint it was important to know if the patient was 
experiencing a complication or exacerbation of the primary 
disease (such as pneumonia; a big risk here since the brain 
tumor required immunosuppressively high doses of 
dexamethasone to control intracranial pressure) which would 
justify deployment of the standby team. 

     The ED physician politely but firmly brushed off Dr. Harris'
request (even though the patient was willing to pay for the
requested tests in cash) and sent the patient home. During the
trip home the patient again became acutely dyspneic and spent the
night miserable and panicky with air hunger.

     The next morning the patient's HMO waiting period was up 
(he had HMO coverage available regardless of pre-existing 
illness, but only after a waiting period) and the patient was 
again transported by ambulance, this time to the office of 
the internist employed by the HMO. The physician lifted the 
blanket, looked at the patient, informed the patient that 
"pneumonia was the cancer patient's friend," further informed 
the patient that he had end-stage cancer, and sent the 
patient home, *again without oxygen*. At this point Dr. 
Harris intervened and arranged for palliative oxygen therapy 
in conjunction with the patient's private physician. 

     The following weeks saw an up and down course for the 
patient. The radiotherapy restored his vision and ability to 
work initially, and he experienced much less bone pain. 
(Prior to this time the patient had worked as a consulting 
programmer on a part-time basis as his illness had 
permitted.) However, he continued to lose weight and 
eventually began to experience intermittent but progressive 
dyspnea, constant nausea with occasional vomiting, and 
exogenous depression associated with clearly deteriorating 
quality of life. Finally, he became unable to work once 
again. The patient was now receiving more or less continuous 
IV morphine administered peripherally through a strap-on 
battery-operated pump. 

     The day after Thanksgiving, 24 November, a second home 
visit by BPI staff (without Dr. Harris) was carried out for 
the purpose of collecting baseline cerebral functioning 
monitoring (CFM) data and evaluating the patient's condition 
first hand. The patient was noted to appear slightly more 
wasted, to be largely oxygen dependent, but to have well 
managed pain and to be ambulatory for hygiene, and limited 
socialization. Baseline EKG and CFM data were collected and 
the patient's feelings and thoughts about cryopreservation, 
and his informed consent were videotaped. 

     An unfortunate and unexpected sequelae to this visit was 
that one of the BPI team members was infected with influenza 
A and unaware of it at the time of the visit. Within 48 hours 
of the visit the patient was febrile (39 degrees C), severely 
dyspneic, and suffering profound malaise and myalgia. The 
patient called BPI to report he was ill and the hospice nurse 
was called in to evaluate breath sounds and consult with 
BPI's medical advisor (Harris). The hospice nurse reported no 
change in breath sounds, no cough and no evidence of 
pneumonia, but rather a febrile illness with myalgia 
consistent with the flu. 

     It was explained to the patient that he probably had 
early influenza (onset of symptoms was that AM) and that this 
could probably be treated with combination anti viral drugs 
and an antibiotic to protect against secondary infection. 
Alternatively, the patient was told he could elect to refuse 
treatment which would carry with it the likelihood of death 
from pneumonia or some other inter-current infection. These 
choices were reviewed with the patient because of the 
patient's prior, repeatedly stated desire to refuse further 
life-extending care, including refusal to see a pulmonologist 
and oncologist to evaluate the cause of the dyspnea and 
perhaps treat it, if it was secondary to tumor-related 
compression of a large bronchus. (Such treatment can be 
simply carried out with additional localized radiotherapy, or 
even laser ablation of tumor growing into a bronchus.) 

     The patient decided to accept treatment for the 
influenza infection and was started on p.o. (oral) ribavirin 
400 mg q. 8 hours, and 100 mg b.i.d. rimantidine, an 
antiviral specific for influenza A. Antibiotic prophylaxis 
for secondary infection was instituted with doxycycline 100 
mg b.i.d. 

     There was prompt improvement in symptoms and signs of 
the illness with the patient becoming afebrile in less than 
24 hours from the start of treatment with antivirals and 

     During the closing days of November the patient 
experienced the typical interleaving of relatively "good" 
days with progressively worse and more frequent "bad " days. 
The patient's p.o. medications at this time were: 

     aspirin 1.25 grain, p.o., daily
     co-enzyme Q10, 100 mg p.o. t.i.d. 
     dexamethasone, 4 mg t.i.d.
     doxycycline, 100 mg, b.i.d. 
     d-alpha tocopherol, 1,000 I.U., t.i.d.
     ascorbic acid, 1 g t.i.d.
     phenytoin (Parke Davis), 300 mg q.d. 
     morphine sulfate by IV pump p.r.n. for pain.
     50 mg thalidomide, p.o. before retiring
     10 mg melatonin, p.o. before retiring