Shortly after the launch of Solving Diabetes we received a number of penetrating questions from “J P Marat”. With his permission the resulting dialogue with Scott King has been edited for inclusion in Straight Talk. “J P Marat” is the pen name of a diabetes researcher in Canada. The dialogue has been formatted to enable further dialogue from readers.
With respect to the cost, how much of this comes from the supposed need to raise the pigs used for the islet cells in sterile conditions? In European fresh cell treatment centers, patients are given intramuscular and subcutaneous injections of organ tissue from ordinary farm animals to treat functional defects in their corresponding organs. These animals are not raised in sterile conditions and are only given a cursory examination by a veterinarian prior to the cells being harvested. The cells are prepared for injection only by mechanical reduction and then mixed with a nutrient medium. The entire procedure, from slaughtering the animal to injecting the patient, takes only about 40 minutes. At no point are the cells sterilized, and yet of the more than ten million patients treated by this therapy from 1931 to the present, no cases of transmission of an animal source virus were reported. Although I recognize that the suspicions of public health authorities must be assuaged, the results of an empirical experiment on a massive scale with fresh cell therapy suggest that the expensive process of ensuring a sterile environment for the pigs providing the grafts is unnecessary.
The cost of pig Islets: Too High?
The Marat/King Dialogues
By J P Marat - July 9th, 2009
I am not familiar with the European fresh cell treatment centers, at least not on that scale. Can you send a reference? I do know that lots of Europeans take the cure in old uranium mines to get the beneficial effects of radiation (the hormesis theory of radiation damage).
I agree with you that the concerns about pig tissue are overblown. When I see LCT demonstrate that their pig islets are free of every known dangerous virus, and the reply is, what about unknown viruses?, I just want to pull my hair out. The dangers of islets made through manipulation of stem cells strike me as underestimated as the dangers of pig islets are overestimated. I have some knowledge of what they do to cells in their laboratories. In general, the more processing of cells the weirder the cells get. That’s why the autologous cell devices invented by our sister company Hanuman Medical have such short processing times. In fact, if I were presented with Islet Sheets containing pig islets and Islets Sheets containing stem cell derived islets, I would ask to be implanted with the pig Islet Sheets.
In my own business planning I am assuming pig islets will be expensive. At least half the expense will be regulatory, not manufacture. Our first clinical products will use Islet Sheets with primary human islets, the sort used in the Edmonton Protocol. Eventually I expect to sell human stem cell-derived Islet Sheets. A period in the middle when pig islets make sense is possible but uncertain. We keep an eye on LCT and wish them luck in demonstrating safety and efficacy with encapsulated pig islets.
Even though human biology is basically the same on both sides of the Atlantic, I always find it interesting how completely different the practice of medicine is in Europe and North America. While in every Sunday newspaper in Germany you can read ads for fresh cell therapy clinics, for some reason this form of treatment — which has demonstrated great success in a few areas of medicine, such as in the treatment of children with Downs Syndrome — is entirely unfamiliar in North America. I am sure that a Google search under ‘Fresh Cell Therapy’ or ‘Frischzellentherapie’ will give you the information you seek. I presented the example of fresh cell therapy to the New Zealand Commission studying the safety of LCT’s work, so I hope it helped move things along. The only sources I can cite for you are in German, but you might want to look at Siegfried Block, ed., ‘Dokumentation ueber die Frischzellentherapie: Theorie und Praxis,’ Munich: Dr. Edmund Banaschewski, 1983.
It is certainly frowned on by the US Medical establishment. The second Google hit is an article on ‘quackwatch’. The American Cancer Society warns against fresh cell therapy: “there is no scientific evidence that fresh cell therapy is effective in the treatment of cancer. In fact, serious side effects can result from fresh cell therapy.” On the other hand the Clinique Lemana (’since 1952′) give prices for therapy at their Swiss facility.
I remember the first time I ran into the effect of national culture on therapy. Thirty years ago Japanese diabetics were not allowed to self-inject insulin. They had to go to their doctor every day for their injections.
There is also opposition to fresh cell therapy from establishment medicine in Germany, but the German Government not only licenses it there, but also publishes guidelines for its use, including regulations (from 1979) on the procedures to be followed in raising herds of animals (usually dogs, goats, mountain sheep, pigs, or cattle) for fresh cell treatment. I wonder if any of those developing encapsulated islet cells for xenotransplanation have taken a look at the German regulations for raising relatively germ-free animals for fresh cell therapy? There are also two branches of cell therapy in Europe, fresh and dry, with dry cells being freeze dried and sold to patients for self-injection, usually without a prescription, depending on the cell group.
I tried both fresh and dry cell therapy when I was a student in Germany in the 1980s, but noted no benefit after getting pancreatic cells i.m. from a placental goat. However, after injection of retinal cells from a placental dog, I experienced a distinct sharpening of vision, which lasted for only about three days. This is a well-known phenomenon among fresh cell therapy clinics, called the ‘Abklingungseffect,’ or ‘ringing off effect,’ and to counter it most clinics re-inject the patients every three days or so to produce a more lasting improvement. I have never suffered any negative side-effects from these interventions.
Fresh cell therapy has a bad name in part since it is still associated today with its precursor rejuvenation movement in the late 19th and early 20th centuries, when Drs. Brown-Sequard and Voronoff used to insert monkey testicle slices in narrow surgical incisions in the testicles of their patients. Most commentators assume this treatment must have been useless and its apparent effects merely psychological, given the hyperacute rejection that they suppose must have followed this primitive xenotransplantation, though there may have been some effect, given that the sertoli cells of the testes act as a barrier against the immune system. Pope Pius XII was injected with cells from simian testicles in 1953 by the founder of fresh cell therapy, Prof. Paul Niehans, which further reinforced in the public imagination the nexus between fresh cell therapy, rejuvenation therapy, and Serge Voronoff.