X-Message-Number: 5119 Date: 06 Nov 95 15:56:52 EST From: Mike Darwin <> Subject: CRYONICS: Misc. Responses Bob Ettinger asks a number of questions: 1) Can he reprint the summary of Greg's recent work in THE IMMORTALIST? a) It is fine with me if GREG says its OK. Please copy him on the request. b) I had sent him a copy of Cryonet containing my post so he could correct any factual errors (there will no doubt be some, but I think I did a reasonably good job overall). He has had this since yesterday afternoon, but may not realize what it is; please advise him that he HAS the text. c) Numerous details of the work are now flooding out for publication. Greg has been in the same nasty bind we are in; he has done a lot of REALLY good work, but has been unable to publish until patents are issued. Worldwide the patent systems differ from that in the US where it is "first to invent who gets the patent." In the rest of the world it is *first to patent.* The GATT agreement will shortly bring the US into line with international standards. d) US patents for medical products are increasingly less important. Many medical products cannot be economically marketed here due to the typical quarter billion dollar cost of FDA approval. Most device manufactuers don't even bother with the US market anymore for things like artificial hearts, new ventilators, simple screening devices, and new medical products with limited market applicability (defined here as "not a major device which will come into widespread use '). e) The problem here is that many major devices now in widespread use like the Swan Ganz catheter did not start out that way; crystal balls are not very reliable. f) The upshot of the above is that we at 21st and others are increasingly not even bothering with USA marketing due to prohibitive costs of FDA approval (yes, we are sensitive to licensing as an alternative, but this is becoming problematic too). I am negotiating for clinical trials of several new things we have on the front burner here overseas. Marketing them here will come later, if at all. US marketing has simply become a factor we don't even consider on first pass, and this is rapidly becoming true of the big and intermediate sized players as well. If people are interested, I can do an educational post later documenting several products and meds that didn't make it in the US market (and didn't make it anywhere because the American companies developing them bet the farm on FDA approval). 2) Bob asks about the hyperbaric chamber: a) Bob, if you have a complete set of CRYOBIOLOGY, go back to the late 60's and look for Armand Karow's article on high pressure kidney freezing. The chamber he had is the one we have. We purchased the whole unit from him, but it was shipped uninsured and destroyed in a truck crash. The chamber itself or "bomb" as it is technically known, made it through unscathed. The machine did not. The Haskell pump, the valving and some of the controls survived and are in a box. In my opinion to be made operational the unit would need the following: * Ultra high pressure tubing (Superpressure, Inc. would be a good source). * A new pressurization system, although the existing Haskell pump may be coddled along and gotten to the point where it could work (this would save about 5K for a pump). * Barring use of motor driven pump, you can buy hand operated pressurization units, but they will take a LOT of time to use and are very inconvenient. If you want to reach target pressure with minimum exposure time and associated barotrauma, you'll want a mechanical pump. *I picked up a high pressure guage, but it only goes up to 20,000 psi. *A dewar or well insulated container and a crane would be necessary to rapidly cool the bomb by lowering it into LN2 or -190 C pentane. We have both. * A circulating pump for pentane will be necessary to pump coolant through the interior cooling channels. This can be easily done; we have the pumps and plumbing capability for this: it is low pressure. If all this sound like a lot, it is. But, if someone is willing to put in the hours, a lot can be done to shave costs. As Bob well knows, doing it yourself can save a lot of money, not just on labor, but on finding common-place devices which work as well as very costly ones which are special-purpose manufactured. Right now the bomb is sitting in the wharehouse area of the lab. It weighs a lot, I would guess nearly 1K pounds. It is intact and looks in good shape. If it is used without being returned for pressure testing, I would want to use an enclosure of a lot of sandbags; at least two thick! Since its hydrostatic pressure this will probably suffice for protection. Autoclave engineers (the builder) strongly recommends saftey check out. If it were a compressed gas vessel, I'd be inclined to comply. However, if the whole pressurized system is behind sandbags and it is NEVER operated with personnel exposed, there should be no significant risk in a sprinklered building; and what's more, the work can be done outside here in SC. The big risk is fire/explosion from the pentane being used as the heat exchange medium if the bomb blows. Finally, to put things in perspective, the estimated cost a new bomb of the same design (excluding peripherals) today is $45,000. >Wistful thought: Maybe Fahy and Ruggera will get the Nobel for the kidney >work. Seems important enough, in light of the number of kidney transplants >needed. Probably 10 years or more down the line, even if it happens; but it >would be an enormous boost for cyonics, in several ways. The problem is that the existing storage time for kidneys is now out to 72 hours with minimum muss and fuss (UW Solution). Greg's technology will NOT be easy or cheap and is far from application in a clinical setting. There are MANY times more recipients than available kidneys. Thus, current 72-hour storage time is more than adequate for logistic purposes. For most kidneys there are many possible recipients. You will note that Larry Hagman is still waiting for a liver. Mean wait time for livers is about 4-6 months. The problem is not storage, it is acute shortage. Comparatively few grafts are going to waste. A second problem is how do you want to spend you money? Rapid progress is being made in developing xenografts with recipient specific-antigens. Anybody seen the human ear growing out of the nude mouse's back? Most people who need organ transplants have waiting periods available which would allow for custom prep or creation of a genetically engineered xenograft organ. This would free up the cadaver harvested supply of organs for those with acute need: massive heart attack, trauma, toxic liver failure, rapidly developing cardiomyopathy, etc. My pot bellied pig went from about 10 pounds to 150 pounds in about 4-5 months. Her kidneys would have supported an adult neonatally (they grow to full size quite rapidly upon transplant: you can put a 3 year old's (human) kidney in an adult human male and it will be handling his needs in a month or two and be full sized!). Her heart would have supported the average woman by 4 months. Post-partum growth rate can be upregulated with feed and hormonal manipulation. Weight gain on my pet pig would have been far more rapid had she been fed ad lib instead of thoughtfully nourished and modestly calorie restricted. (This being necessary for her long-term health; pigs are, well, pigs!). If it were my bucks, I'd support continued work towards extending 0-4 C hypothermic storage time to 1-2 weeks (already possible in the lab for kidneys: 1 week anyway) and spend bucks on genetic engineering of xenografts to deal with the fundamental problem of shortage. Further, as cerebral resuscitation progresses, the number of potential donors is going to drop since head injury and and brain ischemia secondary to heart attack, drowing, and trauma will be increasingly more treatable. As helmet laws go into effect, head injuries plummet and so does graft availability. Ditto better prevention for cardiovascular disease which results in fewer strokes and fewer heart attacks (=less SCD=less organs). The same is true with better vehicle safety; airbags, side impact reinforcement, etc. The SUPPLY is where the problems are. >On hyperbaric numbers etc.: Mike Darwin says he has a hyperbaric chamber and >accessories maybe large enough for a human brain. Mike, do you have >experimental numbers on pressures needed for cooling (say) rodent brains, >without freezing, down to temperatures where freezing will be complete when >the pressure is released? If not, do you or your associates have time and >interest in finding these numbers? If you need money, how much? I have no ideas on numbers re pressures. This is not a current focus of our work, but I remain interested for a variety of reasons I will not go into here. Despite my "terrible" reputation, I am easy to work with on research, and very open. I have no idea what costs would be, but they would be confined to materials and specific labor. Here Mark Connaughton and Paul Wakfer would be the men to talk to. My time for the "biology end" of things would be at no charge, within reason. Simple readily available materials would not be charged as long as it is collaboration with equal sharing of results and understanding of patenting, etc. (we are very flexible here). The bomb has been sitting around for at least a decade gathering dust. I would love to see work done in this area, although our primary goal at this point is to adapt vitrification to brains, and we have paid for exclusive rights to the underlying enabling technology and patents for all brain or whole-body applications confined to the area of reversble human/brain cryopreservation for future revival (medical time travel) before or after legal/clinical death. Still, work is going on in lots of areas pretty far afield fromour primary goal, including and exhaustive and well done series of experiments evaluating fixation penetration rates being carried out by Mark Connaughton using cattle brains. (Mark is doing about 4-5 brains a week! and gets them within minutes of slaughter). As to the costs of getting the bomb up and running. I just don't know, but suspect they need not be high for a simple system where evaluation of principles is more important than speed and conveniece. I'll ask Greg if he has tubing and equipment he can spare, since he is currently (at least to my knowledge) not doing hyperbaric work. Bob, if you are in Phoenix now, you should fly over on a shuttle and go through the lab. We are a couple of exits from Ontario International (ONT) airport and shuttles between Phoenix and ONT run frequently and inexpensively. You can leave at 1100 and be back home by 1700 the same day. Mike Darwin Rate This Message: http://www.cryonet.org/cgi-bin/rate.cgi?msg=5119