Chronic immunologic injury appears to be a key factor in the development of accelerated atherosclerosis in patients who have received a heart transplant. Maintaining consistent immunosuppression should, therefore, be important to minimize the likelihood of this poor outcome. The highly variable oral bioavailability of the current formulation of cyclosporine A, Sandimmuner, necessitates frequent drug level monitoring and dose modification to maintain therapeutic levels. This variability may contribute to the accelerated atherosclerotic process by enhancing a state of chronic rejection. Neoral, a new microemulsion formulation of cyclosporine A, has demonstrated a more predictable pharmacokinetic profile than Sandimmune.
The clinical benefit associated with this more consistently absorbed formulation is being investigated in several American trials. We are conducting an open-label, single-center study designed to evaluate the safety, tolerability, and logistic feasibility of converting stable heart transplant recipients from Sandimmune to Neoral. A secondary objective of this study is to develop clinical support guidelines for this conversion. Patients who are a minimum of 6 months post transplantation and have demonstrated stable graft function are eligible for this trial. Patients will be converted to Neoral starting at the same total daily dose as the preconversion Sandimmune dose.
All patients will then be followed regularly for 1 year. Follow-up evaluations include routine safety assessments (physical examinations, laboratory tests), and cyclosporine A blood level monitoring. To date, 88 patients have been converted from Sandimmune to Neoral and followed for up to 2 months. Data will be presented on patient demographics, adverse events, graft
function, renal function, mean dose, cyclosporine A levels adjusted to dose, and number of dose adjustments during the study period.
Klaus Pethig, Th. Wahlers, A. Korn, A. Ruhparwar, U. Christians - Hannover Medical School, Hannover, Germany, Sandoz AG, Nuremberg, Germany
In the form of Neoral, a new galenic formulation of cyclosporine A is available. We report on clinical and pharmacologic findings following the conversion from Sandimmuner to Neoral in 70 stable heart transplant recipients (56 men, 14 women), 1,357 n 887 days following heart transplantation. In a prospective study, cyclosporine A trough levels, creatinine, and bilirubin were documented at days 4, 15, and 30. Pharmacologic profiles and calculations of the area under the time-concentration curve (AUC) were available in ten patients.
Following a 1:1 conversion, dose adjustments were made as required to maintain a constant trough level. Analyzing the pharmacologic profiles of Neoral, an improved bioavailability with a significant increase in the AUC, a shorter time to peak, and higher maximum levels of cyclosporine A could be demonstrated. Under clinical conditions this improvement of bioavailability was obvious especially in one group of patients. Based on the final cyclosporine A dose 30 days after conversion, a group of responders (31 patients [44.2%]) with a reduced cyclosporine A consumption (-14.4%) could be discerned. In three patients a dose increase was necessary due to changes in concomitant medication.
The responders were characterized by a higher cyclosporine A consumption before conversion (327 n 108 vs. 264 n 108 mg/d; P = 0.02), suggesting a status of malabsorption. There were no episodes of acute rejection in either group. Constant levels of creatinine and bilirubin 30 days after conversion showed no additional organ toxicity.
In conclusion, an improved bioavailability of Neoral compared with the standard formulation could be demonstrated in heart transplant recipients. Especially in primarily malabsorbing patients, significant lower cyclosporine A doses are necessary to maintain a constant trough level. All patients demonstrated stable graft function. Additional renal toxicity or hepatotoxicity was not observed.
Andrew J. Murday, M. Meara, L. Reynolds, D. Wright, A. Johnston, D. Holt, B. Madden - St George's Hospital, London, UK
Purpose: Use of the currently available oral formulation of cyclosporine A (Sandimmuner) is characterized by variable absorption. The new oral microemulsion formulation (Neoral) has been shown to provide more rapid absorption and greater bioavailability in renal transplant patients. We report a pharmacokinetic study to compare the two formulations in a cohort of 20 stable heart transplant recipients.
Methods: The 20 subjects had undergone orthotopic heart transplantation 12 to 88 months prior to the study. Our target trough cyclosporine A levels at this stage after transplantation are between 80 and 120 ng/mL. Each patient had a cyclosporine A blood concentration profile carried out after their morning dose of Sandimmune.
The following day they were converted to Neoral at the same dose. One week later a further cyclosporine A profile was performed. Patients were then left on Neoral and were followed up for 6 months during which time their Neoral dose was adjusted on the basis of repeated trough levels.
Results: Neoral increased mean (11 SD) cyclosporine A maximum concentration (Cmax) from 581 (1,196) ng/mL to 910 (1,268) ng/mL (P <0.0001; paired two-tailed t-test), area under the time-concentration curve (AUC) from 2,939 (1,590) ng/mLuh to 3,686 (1,575) ng/mLuh (P <0.0001; paired two-tailed t-test), and decreased mean time to achieve Cmax (tmax) from 134 (163) minutes to 97 (128) minutes (P = 0.03; paired two-tailed t-test). Although initial trough cyclosporine A levels were unchanged, after 6 months the mean cyclosporine A dose had been reduced, on the basis of repeated trough level measurements, by 11%. After 6 months there was no change in plasma creatinine levels, nor any increase in side effects of cyclosporine A.
Conclusion: In stable heart transplant patients, changing from Sandimmune to Neoral provides greater speed of absorption and bioavailability. In the long term there was a reduction in cyclosporine A dose of 11%. There was no evidence of increased side effects.
Jost Niedermeyer, S. Sackmann, U. Christians, A. Maibacher, H.J. Schafers, H.Fabel - Hannover Medical School, Hannover, Germany, Sandoz Pharma Ltd, Nuremberg, Germany
Immunosuppression with cyclosporine A in lung transplant patients with cystic fibrosis (CF) is hampered by high dose requirements and considerable fluctuations in trough levels. These problems are thought to be at least partially due to variable absorption rates. A new microemulsion of cyclosporine A (Neoral), is thought to improve cyclosporine A absorption. In an ongoing study, we therefore studied pharmacokinetic profiles of cyclosporine A in lung transplant recipients with CF and cyclosporine A profiles of patients who underwent lung transplantation for other reasons (controls).
These profiles were examined before and after the patients were switched to Neoral. Individualized cyclosporine A doses were administered in equally divided doses every 12 hours and adjusted to the desired trough levels in both groups. Serial blood samples were obtained over a 12-hour period at steady state for each formulation, and cyclosporine A blood levels were determined by high-performance liquid chromatography.
Safety and tolerability were assessed in a prospective fashion by clinical evaluation, lung function tests, and laboratory tests. So far 14 patients have been included in the study. Only four of the ten CF patients, but all four control patients showed pharmacokinetic profiles that could be described by an open two-compartment pharmacokinetic model.
The area under the time-concentration curve improved from 3,655 n 1,932 mguh/L (mean n SD) to 4,342 n 1,464 mgfih/L in CF patients, and from 2,819 n 131 mguh/L to 3,454 n 253 mguh/L in control patients (P <0.04) after being switched to Neoral.
Steady-state peak concentrations increased from 529 n 253 mg/L to 797 n 253 mg/L (mean n SD) in lung transplant recipients with CF, and from 529 n 143 mg/L to 734 n 200 mg/L in control patients. An unequivocal positive effect of concomitant therapy with pancreatic enzymes (seven of ten patients) or itraconzaole (four of ten patients) in the CF group could not be differentiated.
In conclusion, the bioavailability of cyclosporine A was improved when patients were switched to Neoral. The improvement was more pronounced in patients who did not suffer from CF.
Monitoring trough levels alone does not allow the assessment of cyclosporine A bioavailability in most lung transplant recipients with CF.
Cyber Symposium - Internet
SANDOZ PHARMACEUTICALS CORP. AND VALUE HEALTH INC. SIGN LETTER OF INTENT: WILL WORK WITH TRANSPLANT COMMUNITY TO ENHANCE PATIENT CARE
East Hanover, NJ (January 16, 1996) - - Sandoz Pharmaceuticals Corporation, which discovered the medication that revolutionized solid organ transplantation, and Value Health, Inc., a leader in the field of disease management programs, today announced a letter of intent regarding the development of innovative programs, products and services to benefit the transplant community. Sandoz and Value Health said they plan to work with transplant physicians, transplant centers, health maintenance organizations and other service providers to design and offer programs, products and services that will help health care providers enhance patient care, further improve organ survival rates, promote organ donation and manage costs.
The effort, which will be administered by Sandoz and Value Health's subsidiary, Value Health Sciences (VHS) of Santa Monica, CA, will combine Sandoz' expertise in immunology and transplantation with Value Health's experience in developing sophisticated disease management tools. Solid organ transplantation, including kidney, heart, liver and lungs amounted to approximately $4 billion or 0.4 percent of total health care expenditures in 1994.
More than 18,000 solid organ transplants were performed last year at 278 centers around the country. Mark A. Pulido, chief executive officer of Sandoz Pharmaceuticals Corporation, said the company has been working with experts in transplantation to develop and test tools to assist health care providers. He said the company has received a very favorable reception from the pilot program which encouraged the company to broaden its efforts substantially.
"With more than 18,000 transplants performed in the United States each year, organ transplantation already is a model for the delivery of sophisticated medical care across a wide spectrum of participants," said Pulido. "As part of our ongoing partnership with the transplant community, we are seeking to provide our customers with additional resources that will assist them in continuing to foster improvements in patient care," Pulido said. Citing the special needs of transplant patients and their families, the companies said they would work with experts in the field to examine all aspects of the transplantation process.
The programs, products and services will focus on the period before a patient receives a transplant, post-transplant recuperation and the critical time frame after a patient leaves a specialty area and begins receiving treatment in the general community. The effort will examine opportunities to improve patient education before a transplant and reinforce compliance with treatment regimens well after the transplant surgery is completed.
"We are very excited about the prospects of working with the leader in the field of transplantation and bringing together physicians, hospitals, health maintenance organizations and patients," said Leslie D. Michelson, chairman of Value Health Sciences. "This program will combine the knowledge of Sandoz and transplant centers with our experience in developing clinically sound protocols and guidelines. This will provide a new framework for transplantation that will ensure high-quality, cost-effective care in this complicated and fast-growing field." Value Health, Inc. is a leading provider of specialty managed care benefit programs and health care information services.
The company is based in Avon, CT. Value Health provides services to 78 million people and its customers include 126 of the nation's 250 largest corporations. Value Health already has major disease management contracts with Pfizer and Johnson & Johnson Health Care Systems.
Sandoz Pharmaceuticals Corporation is a leader in the discovery, development, manufacturing and marketing of innovative pharmaceuticals and high-quality consumer health products. Particular emphasis and expertise are currently focused on finding new breakthrough treatments or cures in the area of transplantation, oncology, dermatology and disorders of the central nervous system.
Sandoz Pharmaceuticals Corporation, located in East Hanover, NJ, is an affiliate of Sandoz, Ltd. of Basel, Switzerland, a leading worldwide pharmaceuticals and nutrition company with additional activities in seed, agro-chemicals and construction chemicals.
Sandoz revolutionized organ transplantation a dozen years ago with the introduction of Sandimmune (cyclosporine) a medication that allowed specialists to dramatically improve the rate of organ survival in transplant patients.
It's time again for the "Annual", in this patient's case the 8th edition of same. So it's up in the morning and out on the road, leaving at 5:45 AM with nothing to eat or drink, at least that I'll admit to later, and arriving at the hospital at 7:15 AM. First the blood draw (must be about a quart), the ECHO gram, and the stress ECHO (enough to collapse a hod carrier). Then at 9:30 it's onto the table for the annual "check of rental pump, valves, piping, and allied equipment, i.e. the run the pipe cleaner up Don and see if he been 'good'" drill.
The total disrobe under the one top sheet can be disconcerting, what with one nurse working on shoes and two others on each side of the pants, all pairs of same, until the body has been completely peeled. In my youth it would have been a situation of my wildest dreams, but now I merely worry that their nails will scratch. And then they hookup the EKG wires that will only really mean something, if they show nothing, as in "flat-line." The blood pressure is taken for about the 10th time this morning. "Gee, it's a bit high Mr. Marshall." Oh my goodness, I wonder if it could have anything to do with the fact that a nurse is presently shaving a very unattractive section of me in full public view, while yet another is measuring to see what selection of wires they will need with which to view my insides by holding a fist full of them in the air and kind of eyeballing a distance from groin to center chest. Interestingly, the nurse doing the shaving comments that she's doing a bit of extra area. "Just so the tape will be easier to remove." I grunt out something in appreciation, as I wonder just where the "extra" might be, geographically speaking.
We' re now getting down to the business at hand. Because of the 11 other times someone has put one there, and the time a resident at another hospital seemingly used a hammer for the task, installing the thimble in the groin now hurts even this stoic old pro. First it's necessary to stick enough needles into the groin area to try and numb everything including the artery. Then they cut through the skin and expose the artery. It's apparently easy to find because it's big. Now the trick is to cut a small slit, about 3/8" into this artery while at the same time jamming a slightly larger, approximately 1/2 inch round grommet type thimble with a valve on it into the hole, both before the patient either bleeds to death or the ceiling of the O.R. become discolored. It's a tight fit, because the slit had better not be larger than the thimble, or it will literally blow out right in the middle of things and make a difficult to explain mess, both of the O.R. and the patient's life. So they say, "You're going feel a little pressure now." And you feel like someone has impaled your groin on the end of a very dull sword.
Anyway, with the entrance site squared away the fun begins. First they insert what appears to be Pac-Man on the end of a wire. This thing goes up to the heart and proceeds to bite match head size chunks out of it, which are retrieved out the groin hole thimble and placed one at a time in ajar of preservative. They do this about 4 times or more until they get what they think is enough material to either make a hamburger for a small mouse, or test in the lab for rejection. Each time they take a bite, they say, "Now you're going to feel the heart jump a little." Of course you feel it jump for cripes sakes, it's been snuck up on by a steel snake that eats pieces of heart!
Then they start running the camera up the 'ol arterial system with special attention to the one's that supply blood to the heart muscle itself. Of course, while they're doing this, the entire show is available beside the table on several TV type monitors. So one gets to see this seemingly fully alive wire dancing literally through your center chest. In my case it' s all that much more interesting because 1. the wires that now hold my rib cage together are clearly visible (one looks a bit loose and I could swear another is tied in a bow) and 2. There's a blockage in one of the main arteries that shows up to the doctor and the techies, but to me like not at all. They all keep saying, "There it is, see it?" I'm seeing a gray foggy smear with a wire in the middle of it, but I kind of nod in the affirmative, and shake my head as if I too realize what a terrible thing this could be, but how wonderful it is that they are there with their talent and machines to make sure I know I've got a bad thing going.
Then comes the finale - the radioactive dye injection, hot flash that these invasive procedures are famous for, and sort of makes the morning, if indeed you don't have much of a life anyway.
Finally at 11 AM they're done and it's off to the holding tank where the hole is literally plugged by hand pressure until it appears any immediate geyser potential has ceased, and a pressure dressing is applied. This situation is in no way similar to holding hands, and in my case there were 2 nurses, however, one pleaded stomach upset and was let off of the duty. Apparently, I severely lack groin appeal. In this application, there is a rule in the handbook that states one must be sure to see to it that the heavy tape extends at least 2 inches into the unshaved area of the groin and leg. So much for the extra shaving. I find the best way to remove this replacement for welded armor plate a day or so later is to get totally blitzed on "annual celebrational joy juice" then stand in the tub, tie a short length of 150# fishing line to one end of the bandage and the other end of the line to the tub faucet with no slack. Then have the wife turn on the cold water full blast, run out of the room, and even possibly to the neighbors lest she risk her life by staying nearby. The bandage will suddenly be off, and if you don't need any skin grafting, you're home free. Just before they wheel you out of this area, the nurses draw straws to see who gets to drop the sand bag on your groin on top of the bandage. This is sort of an intramural sport where accuracy is not necessarily the goal, it's the height to which the patient's body lurches into the air above the gurney that counts. A good miss with the bag can produce some surprising results in body launching. Then the patient is told they will be allowed to keep the bag in place for the next 4 to 6 hours, depending on doctor's orders.
Now these orders are in a realm of mystery in and of themselves. They are not written in stone. Often they are not written at all. You will go to your room and lie on your back and stare at the ceiling for an open ended number of hours. You will try to read Popular Science. You will listen to some old Captain and Teneille tapes you found in a drawer just before bed last night. Nothing makes the clock move forward at all. If they finally tell you it's four hours, it will seem like it's been forever. If some one tells you "the protocol is from 4 to 6 hours" beware, not only can you be assured you will be there the full 6 hours, but it will still be forever, and you will still find that before you can leave the doctor has to show up and discharge you. Then if the nurses can find him, you'll usually learn that he's up to his elbows de-sludgeing someone' s heart, but "to be safe you should walk around for a couple of hours in the hospital to make sure you're not going to bleed." Unfortunately, this patient has been known to use the test walk to get to his car after signing himself out without a visit from the doctor. Of course, if you choose this drastic approach, be prepared that if you do bleed on the way home, just call the hearse, because the ambulance crew has been tipped off to the "guy from room 309, who took a hike on us about 30 minutes ago."
Oh yeah, the results. Well, most of them were placed in those highly scientific medical terms, "Looks good", or "You did fine", so I'm positive there couldn't be a problem they didn't make me fully aware of. The fact that when I peeked at the notes I saw the phrase "patient has moderate ventricular hypertrophy" must mean I have an above average, trophy winning transplanted heart. I mean that sounds reasonable doesn't it?
I guess there is also the possibility that the transplant operation 8 years ago, followed by the advice 3 years later that cessation of work would be medically advisable, has been so successful that there's just a chance I might outlive my disability insurance, and thus die of malnutrition and exposure! DM
Jan. 13, 1996
I went into end-stage renal disease in May, last year while we were on holiday in Washington D.C. and New York City. The failure was due to 10 1/2 years of cyclosporine toxicity (cardiac transplant was June 23, 1985). We came home and I had to go on immediate dialysis. My wife, Jean, read your article dated Aug. 1995 "Kidney Transplants Get Even Easier and More Successful", (about) spouses making good kidney matches. On the basis of your story, she started testing at Calif. Pacific Medical Center and was found to be a near perfect match. Identical twins, the gold standard for kidney matches are a plus 6 antigen match. Even though my wife is A positive and I'm A negative my antibodies did not attack or kill hers, the results were cold negative.
To add to your article - 20 states do not allow spousal donors, how sad. Some research is coming down that shows long-term married couples due to exchanging body fluids, sperm, etc. That they become compatible and especially with women who carry children with her husband's body fluids supplied for the baby. "Bone of my bone, flesh of my flesh and the two shall become one." Amazing that body fluids used in the right context can bring forth life and in the wrong context bring death i.e. H.I.V., A.I.D.S., Hepatitis, etc.
I received my wife's right kidney on Jan. 5, 1996 and we're both home and doing fine. I want to thank you for your information and newsletter and very timely article.
The Heartman #13
Cliff is the gentleman who has made a crusade of making presentations to young people throughout central California promoting a drug free healthy life style, as opposed to what he feels his life was prior to transplant. His "Exhibit A" is his original scarred and oversized heart, which after some real fast talking on Cliffs part he was to obtain from his transplant center, has been kept preserved in formaldehyde. It accompanies him to his speaking engagements. Those interested in one of those talks can reach Cliff at 408-268-5912.
Can you imagine the dollars that could be made by selling hospital ceilings for advertising? I mean really, first we could have sort of inspirational sayings for the gurney riders on their way to the O.R. Thoughts like, "Last year 76% of the patients passing this way actually returned." Or little pieces of advice, like "Always be sure the bottom end of the urinal is much lower than the point of entry." Or even reminders like, "Stop, has your HMO approved this trip?" But then there's the potential for the hard core stuff like, "Next time you have pain be sure to ask for a Tylenol with codeine." Or even, "You' d be amazed how many of the Staff have a cold Red Dog Beer after a hard day in the O.R. Ask your nurse to stock it."
Speaking of ceilings and the staring at thereof, why is it that all too often as you return from a vigorous morning of angiography with your sand bag lover, and the robot nurse who constantly and automatically says, "Don't lift your head." You find a lunch of chicken noodle soup, pot roast with gravy and mashed potatoes and pudding for dessert? All to be fed to yourself with fingers only.
How can it be that there is any positive influence from using an acronym like NOTDAW - National Organ and Tissue Donors Awareness Week? Perhaps that's the best that can be made out of the required words, but if that's the case, let's be sure and use the words, not the acronym. I sounds too much like the standard "big brother says don't do something".
UpBeat can be found on the Internet at http://www.wwnet.com/~bmarsh/upbeat.html but if everyone reads it there, we'll be out of funds in a hurry, so in a sense we urge you to ignore progress. On the other hand, if you want to show someone what it's like, so that they can then send in a mega-donation and subscribe, please be our guest.
Our interest and understanding in artificial lungs comes by way of clinical trials, most prominently in children, of extracorporeal membrane oxygenation (ECMO). The advance that made this treatment possible in the late 1970s was the use of membranes that prevented significant deterioration of the formed elements of the blood during respiratory exchange. The work of Bartlett, Kolobow, Gattinoni, and others has proved the role of ECMO but also suggests that this therapy is limited by current material science. Ongoing efforts in place in Pittsburgh to produce a paracorporeal artificial lung (PAL) began with studies of low resistance oxygenation powered by the right ventricle.
The PAL will be disposable, powered by an integral axial flow blood pump, and rest between the right atrium and the pulmonary artery. It is hoped that early versions can be available clinically within 2 years. It is likely that composite hollow fiber technology will find a replacement for the less durable fibers currently available and successfully used in various oxygenators throughout the world. The challenge is to -reduce water logging the pores and to provide low thrombogenecity while preserving a high gas diffusion gradient at the bloodprosthetic fiber interface.
O. Howard Frazier Texas Heart Institute at St Luke's Episcopal Hospital, Houston, Texas
A major challenge for the future of cardiovascular research is to find definitive treatment for patients with chronic endstage heart failure. The goals of such a treatment should be not only to extend life but to improve its quality. To achieve these goals the treatment must be reliable, cost effective, easy to implement and maintain, and capable of providing a nearly physiologic level of circulatory support. In the United States of America, it is estimated that nearly 60,000 people each year could benefit from cardiac replacement or long-term circulatory support. Heart transplantation is a good therapeutic option for patients with end-stage heart failure, but its effectiveness is limited by the number of donor hearts available. Other therapies, such as cardiomyoplasty, cardiac xenotransplantation, and transgenic cardiac transplantation still require considerable refinement before they can be commonly employed. Therefore, the therapies most likely to be available in the early part of the next millennium will probably be mechanical circulatory support systems.
A number of these systems are currently being developed and tested as potential treatments for patients with chronic endstage heart failure. The Texas Heart Institute is investigating three different implantable devices: a pulsatile-flow left ventricular assist system (HeartMate, Thermo CardiGsystems, Inc, Woburn, Massachusetts), an axial-flow pump (J-2000, Robert Jarvik, New York, New York), and a total artificial heart (Abiomed, Danvers, Massachusetts). The Abiomed total artificial heart will probably be ready for clinical trials as the new millennium begins. In the meantime, a pneumatically actuated version of the HeartMate (the IP-LVAS) already has been approved by the Food and Drug Administration as a safe and reliable device for use as a bridge to cardiac transplantation, and clinical trials of a battery-powered, wearable version (the VE-LVAS), also for use as a bridge to transplantation, are currently under way. A patient in this trial was released from the hospital 6 weeks after being implanted with the VE-LVAS and has now returned to work as an oil and gas trader.
All the devices under investigation are designed to provide freedom of mobility, an important quality-of-life characteristic that was missing from earlier mechanical circulatory support devices.
Internet Cyber Transplant Symposium
LONDON, Nov 17 (Reuter) - Heart transplant patients have a better chance of survival if they are given the heart of a donor with matching tissue, British doctors said on Friday.
Heart transplants must be carried out within about four hours of the donor's death so there is very little time for the tests required to establish whether tissues match.
The usual method for testing matches is called HLA typing comparing spleen lymphocites, but this is a lengthy process.
Another quicker, though less-accurate method, using blood samples, is available, said the doctors from London's Imperial College of Science and Technology and Hare field Hospital.
Despite the urgency of heart transplant operations it is worth making the tests, the doctors said. Patients given a badly tissue-matched heart run the risk of opportunistic bacterial infections and even cancer, they said.
"Because cadaveric organs are in limited supply, it can be argued that these resources should be used more efficiently to improve long-term survival and function," said the team's leader, Sir Magdi Yacoub, writing in the Lancet medical journal.
The team studied 1,135 heart transplant patients over a 14-year period. They concluded that the patient' s chances of survival over the long and short term varied in direct relation to how closely their donor heart matched their own tissue.
(Not exactly a breakthrough I would guess. Ed.)
Shelby America Inc. chief Don Rager said Shelby, 73, and his son Michael, 50, were both fine after the operation at an undisclosed medical facility.
Doctors expected both to make a speedy recovery, publicist Jeff Perlman quoted Rager as saying.
Shelby, a Texan, famous as a driver and developer of so-called "muscle cars"-- souper-up street drag-racers-- including the Shelby Cobra, had been awaiting a kidney donor for several months, while undergoing dialysis treatment.
(Now for the life of me, I can' t figure out why this squib doesn't mention that Shelby has had a heart transplant for about 8 years - and we all know if that's the case why he needed a kidney transplant. I can't believe there'd be a deliberate effort to keep the nasty cyclosporine side effects "in low profile. "And, is it possible that someone thought that a celebrity having two major organ transplants would be more celeb. negativity visa vis organ donation? DM)
They and 14 others are suing Nu-Hart Hair Clinic Inc. of suburban Green Tree, saying the clinic lured them into transplant treatments by lying about how much work they needed, then botched the job. A lawyer for Nu-Hart Hair, Barry Lipson, said the company fully informs all clients and uses medically accepted procedures.
"I was butchered," said actor David Jeffryes of New York. He said a Nu-Hart representative told him he would need three transplant sessions at $2,000 each. He said he ended up with 11 sessions at a cost of $37,000 and is spending $45,000 to have the work corrected.
"It was pluggy and scarred. They left divots in my head," college student Alfred Hanna Jr. said. "It looks like a child with a pocketknife did it," said carpenter Scott Straley of Ripley, W.Va. He said he was told to expect to spend $6,000 but gave up after $8,000 worth of work and can't afford corrective work. "I just wear a hat everywhere I go," Straley said.
The lawsuit was filed earlier this month. Gosh, with NOTDAW coming up in a month or so, this is terrible publicity for transplantation. And just think, there's no mention of the donors at all. Wonder if TRIO could help them. Ed.
Florida Heart Institute is the thirteenth clinical site to participate in the protocol evaluating the effectiveness of The Heart Laser in treating coronary artery disease. Cary L. Stowe, M.D. will head the clinical trials at the Florida Heart Institute. The Heart Laser was shipped to the hospital under the placement model in the fourth quarter of 1995.
Dr. Rudko also stated that through December 31, 1995,350 patients have been treated with Heart Laser Revascularization in the United States and over 900 patients have been treated outside the U.S. PLC Systems Inc. is a cardiac revascularization company developing medical systems and technology with the potential to provide patients suffering from coronary artery disease a third alternative to angioplasty and cardiac bypass surgery. PLC Medical Systems, Inc., a wholly owned subsidiary of PLC Systems Inc., has developed The Heart Laser(TM) which uses PLC' s patented technology for anew cardiosurgical procedure known as Transmyocardial Revascularization (TMR) or Heart Laser Revascularization. The Company has been granted expedited review of its Pre-market approval (PMA) application for TMR using the Heart Laser to treat some cardiac patients.
Disclaimer: The material in this document has been collected by Don Marshall and friends. If any of the views and opinions expressed here are taken the wrong way, we can be nothing more than sorry. New ideas and materials are welcome all the time. As a policy, UpBeat is sent upon request to heart and heart/lung transplant recipients and other interested parties. Donations of $15 per year, or more, from Tx recipients, if not a burden, are vital. From all others the donation is specifically requested. The date shown after the name on the address label indicates the last time a donation was received. Please make checks payable to Don Marshall, as we cannot afford to become non-profit. Send materials, letters, or checks to:
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