Below are my responses to some of Michael ("Mike Darwin") Federowicz' postings on the Cold Filter forum:
Federowicz: Her position also denies the reality that cryonics once had both a professional perfusionist and a licensed hemodialysis technician (with extensive CPB experience) setting the standards and determining the technology used on cryopatients and that both these men used the medical model and, wherever possible, well vetted conventional medical equipment in delivering cryopatient care.
My position is that both these people have publicly claimed to have been "board-eligible perfusionists," when I don't believe either one ever was, and both of them seem to have engaged in other unethical behaviors and perhaps a few cryonics "cover-ups." As far as I know, neither Leaf or Federowicz ever attended an accredited school of perfusion and performed the 100 (live human) clinical cases required to sit for the boards. In "Mothermelters," Alan Kunzman claims Jerry Leaf, (the "professional perfusionist"), was never licensed to work with humans, (whether alive, or dead). Since I think it is unlikely someone would mistakenly think they have met the requirements to sit for the perfusion board exams, (and even more unlikely someone who has met the requirements would neglect to sit for the exams), I have to believe they lied, intentionally. This makes it impossible for me to put much faith in any information they have provided about their activities in cryonics, (or information on ANY topic, for that matter).
In addition, Federwicz publicly claims to have perfused "approximately 1,000 dogs." There is no evidence that many dogs have been subjected to cryonics experiments. My guess is, the number of dogs perfused in cryonics experiments is nowhere near that high. If Federowicz wants to maintain he has done 1,000 dog experiments, I'm sure PETA and other agencies would be interested in seeing the paperwork.
Federowicz: Perhaps most perniciously, her position denies the remarkable and successful research accomplishments attained during this period by these two men, and others working with them, using dogs in a survival model of CPB.
Where is the evidence of these "remarkable and successful research accomplishments"? Thus far, other than the write-ups published in "Cryonics," (Federowicz was an editor of that publication), I have only been able to locate ONE published paper on the cryonics dog experiments. If there have been 1,000 experiments, as Federowicz claims, they must not have been as "remarkable," or "successful," as he thinks.
Federowicz: In 1977 perfusionist and biomedical researcher at UCLA, Jerry D. Leaf, became involved in cryonics and began two organizations with the express mission to develop, validate, and standardize evidence-based procedures for every aspect of cryonics suspension using a medical model.
Former deputy coroner of Riverside, California, Alan Kunzman, publicly accused Jerry Leaf of ordering hundreds of thousands, if not millions, of dollars worth of medical equipment, on UCLA's tab, and having it delivered to Alcor. ***In the interest of fairness, I have revised this paragraph.*** Someone I trust has informed me that Alcor did purchase these items from UCLA surplus equipment, but they couldn't produce the receipts at the time because they had been confiscated by Kunzman's office. My informant states it is typical for the metal ID tags to remain on the equipment when it is sold, and I believe that is probably true.
Leaf was also involved in the cryopreservation of Dora Kent, whose death was somewhat suspicious. Allegedly, Saul Kent and Federowicz, (wearing white lab coats and driving a used ambulance with the ambulance company's name still on the side), picked Dora up and drove her to the Alcor facility, where she conveniently died and was cryopreserved, two days later. Leaf and Darwin, foolishly, declared her dead without a physician present and proceeded with a cryopreservation. (None of them had enough common sense to realize people were going to find these activities suspicious?)
According to Kunzman, Steve Harris MD admitted to signing not one, but three, death certificates. He said Alcor wrote up the death certificates and he "just signed them." Though Harris had already admitted to not being at Alcor, at the time of Dora's death, (and this was allegedly confirmed in Mike Perry's journal), Leaf later called the Coroner's office and provided them with a list of names of people who were, allegedly, present for Dora's death, and included Harris.
Federowicz: In short, Ms. Maxim is attacking the very people she says she feels are essential in cryonics while at the same time effectively denying that they once existed *and that a high standard of care (the same as a patient undergoing CPB in hospital at that time) was once the reality, at least in cryonics as practiced by Alcor at that time.*
I am "attacking the very people I feel are essential in cryonics"??? I am NOT. I don't believe people like Federwicz and Leaf, (people who seem to have thought they were above the law, and were willing to engage in some rather questionable activities), are "essential in cryonics," or that a "high standard of care (the same as a patient undergoing CPB in hospital at that time)," has ever been a "reality," in cryonics.
Federowicz: ...of understanding of how cryonics differs from conventional perfusion, and lack of understanding of the fairly large body of knowledge that has been accumulated which is unique to cryonics cases.
I'm quite familiar with the "large body of" speculation that has been accumulated, in regard to cryonics cases, I see more propaganda and narcissistic pride in unproven "accomplishments" than I see actual achievement.
In regard to my comments about flow probes:
Federowicz: Had Ms. Maxim established a dialogue with me this information would have undoubtedly been quickly passed along.
First of all, I do not respect Federowicz enough to seek out his advice, or opinions. Secondly, I didn't need Mike to tell me how electro-magnetic flow meters work. I wasn't sure of the exact composition of CI's solutions, but I was well aware the flow meters would very likely not function properly with those solutions. Regardless, I wanted to demonstrate the pump to Ben, because I felt it would add a margin of safety, for CI's patients. At the time, I believed it was more important for CI to avoid pumping air, and to learn to measure a more accurate patient pressure.
Federowicz: Why is knowing flow so important?...The history of scientific, evidence-based medicine is a testimony to the criticality of vigorously collecting data which is consistently and ACCURATELY collected. That means precision in quantification. Ms. Maxim seems not to grasp this.
Federwicz is in no position to state that I am not capable of understanding the importance of perfusion-related issues, even in cryonics. HE seems not to grasp the fact that he is calling for excellence from people who have little-to-no knowledge about basic perfusion. Does he really expect laymen, with little opportunity to develop clinical skills, to perform perfusion procedures with precision? Get them to stop pumping air to patients, and subjecting patients to inappropriate pressures, and THEN worry about accuracy.
Federowicz: 1) Knowing flows with precision and accuracy (indeed knowing them at all!) was critically important. It is absolutely essential in cryoprotective perfusion because flow rate is the primary perfusion parameter that determines cryoprotective agent equilibration in the patient. Flow is also the primary determinant of cooling rate (along with heat exchanger efficiency and the temperature of the wall water) during in-field CPB of cryopatients. Knowing when the patient will be cold enough to come off the pump is often really important since it can mean catching or missing a commercial flight. Roller pumps give a very consistent flow regardless of temperature, pressure, viscosity or perfusate composition. RPM can be converted directly into flow.
This may seem impressive to laymen, but it's absurd, to me. Cryoprotective agent (CPA) uptake is going to rely on a number of factors, and vary from patient-to-patient. You need a way to accurately measure the actual concentration of the CPA, not try to calculate it by flow rate, which will need to be adjusted, depending on patient pressures. As for the washout procedure, the flow rate, (and, therefore, the cooling rate), is going to be largely dependent on the pressure. It doesn't matter what time the next flight is. Yes, "roller pumps give a very consistent flow regardless of temperature, pressure, viscosity or perfusate composition," (even if the perfusate is AIR)...herein lie the fundamental problems with amateurs using these pumps.
2) It is possible to design TBW systems so that no macro air can be perfused using roller pumps. This was done with the ATP.
Nothing could be further from the truth. I believe the "ATP" at SA, when I first went to work there, was virtually identical to the circuit Federowicz designed, for Alcor, and there was NOTHING on the "ATP" that would have prevented the pumping of macro air.
3) The notion that centrifugal pumps cannot cause physiologically devastating over-pressure injury is incorrect. While centrifugals cannot generate an infinite head of pressure under occluded conditions as can roller pumps, the static pressure of most medical centrifugals under no-flow (occluded arterial or venous line) conditions varies from ~500 to well over 700 mm Hg. Such pressures will NOT rupture the extracorporeal circuit (i.e., explode oxygenators, filters, or blow apart circuit connections) but they can cause tremendous damage to patients.
More distraction. The reality is that, unlike a roller pump, a centrifugal pump will decrease flow in response to increased outlet pressure. If I am perfusing a patient at 60mmHg at 2,000RPM and 3L of flow per minute, and the pressure increases, the flow is going to go down without any adjustment of RPM's and a "low flow" alarm is going to go off, well before the pressures Federwicz mentions are ever reached. A person would have to be TRYING to reach those pressures and ignoring the pump alarms, when using a centrifugal pump. Also, if the people in cryonics wouldn't slide the tubing over every available barb on the connectors, and double-band the connections, I believe the circuit would blow apart, before those pressures were reached.
Federowicz: 4) No cryonics patient, to my knowledge, has ever been air embolized during in-field TBW due to a roller pump or due to pumping the venous reservoir dry.
How many in-field total body washouts has Federowicz been present for? I have a very hard time believing no cryonics patients have been subjected to air embolization in the field, where the conditions are certainly not as good as those at the cryonics organizations, where we know air-embolization of patients is a blunder that occurs with an alarming frequency.
Federowicz: 7) Centrifugal pumps are not acceptable for CPA perfusion and personnel MUST learn how to reliably and safely use roller or other occlusive positive displacement pumps.
I'm not sure this is true. Ben Best and I ran a centrifugal pump with CI's most viscous solution, at temperatures near zero C, without any problem other than those associated with the flow probe, and there are alternatives to using that flow probe to measure flow.
Federowicz:The solution is to have *only properly trained/skilled personnel perform TBW*. Clinical perfusionists are the ideal (with additional training)...
Agreed, but "properly trained" personnel shouldn't be trained by people of questionable capabilities. The "additional training," in regard to the washout procedure, would be minimal and could be carried out using a bucket of water as a "patient." I'm sure the SA staff feels good about themselves for "playing doctor" with a pig, but it was unnecessary.
Federowicz:...but the fact is that any intelligent, motivated person with the right temperament and reflexes can be trained to operate an open circuit TBW system (with the proper safeguards) with a high degree of safety.
Nonsense. There's not enough proper training available, in cryonics, where there is little opportunity for clinical experience.
Federowicz: There was a time when that was done both safely and effectively (if you count me as a non-perfusionist).
Federowicz is a "non-perfusionist." People don't become perfusionists by qualifying for such in their own minds.
Federowicz: I refused to provide CI with a more complex circuit absent extensive training to a level where I was satisfied that the personnel using the system would be reasonably safe.
I have no idea how Federowicz ever convinced himself, much less others, that he is one of the world's leading perfusion experts. (Actually, I do have an idea, judging by the number of times he writes "I did this...I did that...I...I...I..." As I recall, he began his review of SA by comparing himself to some misunderstood mythological god. I only read Kunzman's book, last week, and he had the same opinion as I, regarding Federowicz self-absorption.
Federwicz: Countless CPB cases have been pumped worldwide with roller pumps with a microscopic incidence of air embolism due to the presence of the roller pump, per se; and with excellent outcomes.
As I've written before, ALL CPB cases have introduced microscopic air to the patients, regardless of the type of pump being used. It's absurd for anyone in cryonics to be concerned with the elimination of microbubbles in perfusion circuits, when they haven't even mastered basic perfusion with a level of competency that was achieved in conventional medicine, DECADES ago.
Federowicz: Outside of cryonics, in the world of clinical medicine, I have almost no doubt that centrifugal pumps will become the standard of care...
If this were true, it would have probably happened nearly two decades ago. There are two main reasons why this is unlikely to happen:
1. The cost of a small length of tubing for a roller pump is only a few cents, while the least expensive centrifugal head runs about $80. (They were closer to $150, a decade ago, but I doubt they'll ever be as cheap as a piece of tubing.) With managed healthcare, this will continue to be a factor in the choice of pumps.
2. Occlusive pumps in conventional medicine are components of computerized heart-lung machines that provide automatic flow adjustment in response to changing pressure, and complete shutdown with automatic line clamping in the presence of dangerous pressures or air in the lines, making the safety of the less expensive occlusive systems comparable to that of the significantly more costly centrifugal systems.
Federowicz (in response to me asking why he demanded to know if the SA flow probes worked with their washout solution, and then suggested Mathew Sullivan test the probes with water): I suggested tap water because it is cheap and readily available. If the flowmeter reads tap water flows accurately then it is worth proceeding to test it with perfusate (really expensive) under real-world conditions. I suggested tap water for the same reason you used it in training circuits: it is a cheap liquid which you can pump and which behaves enough like blood for the purpose at hand. If the SCPC flowmeter gives an invalid number for tap water, particularly if it is misleadingly close to a believable flow, then you should proceed with real caution if you proceed at all.
Why do we need to use "a cheap liquid which you can pump which behaves enough like blood for the purpose at hand"? The question wasn't whether the probe would work with blood, (and I assure everyone it would), but if it would work with SA's washout solution. Federowicz' argument for the flow probe to be tested with water was just a foolish waste of time and money (Mathew's time and salary). It should be tested with SA's washout solution.
Federowicz: I'm glad SA has such a fine perfusionist. But, no matter how good this man is, he will almost certainly not have expertise unique to and essential to proper extracorporeal management of cryopatients.
I believe SA claims to have NINE "fine perfusionists," who I am sure have a knowledge base and experience that far exceeds Federowicz'. Regardless, how could ANYONE have "expertise unique to and essential to proper extracorporeal management of cryopatients"? Other than Leaf, cryonics has a long history of reliance on amateurs who seem to think they know a lot more than they really do, a history of pumping air and subjecting patients to inappropriate pressures, and no outcomes to determine if what has been done has been of any benefit, whatsoever.
Federowicz: No patient presenting for clinical CPB even approximates the average cryopatient presenting for TBW and/or asanguineous ECMO. Even within perfusion there are areas of specialization that require additional knowledge and training: extended ECMO, emergency fem-fem CPB, nenonatal and paediatric CPB, and normothermic CPB, to name a few. What is so extraordinary about the idea that cryonics should be the same?
What is "extraordinary," here, is the degree of the "god complex" Federowicz has, and the number of people who have been buying into his alleged expertise, if you ask me.
Federowicz: As just one small example, Ms Maxim had no idea how or why conventional CPB flowmeters worked, or that they would not work in cryonics.
Federwicz assumes I didn't understand how the flowmeters worked. What I wasn't sure of, was the composition of CI's solutions. I knew it was highly likely the flowmeters wouldn't work with CI's solutions but, again, I felt the safety features were worth exploring alternate methods of measuring flow. This exploration cost ME a lot more time and money than it cost CI, and I would do it again, in a heartbeat. I still think the safety of the centrifugal pump would be of benefit in cryonics procedures, especially if amateurs are sitting behind the pump.
There was a time when I held some degree of respect for Federowicz, but that was before I read his narcissistic ramblings and complaints about medical professionals on another forum, before I started studying the dog experiments, before he lied about having been a "board-eligible perfusionist," and before I read Kunzman's book. If you ask me, it's people like Federowicz who give cryonics a bad name.