Posted by request from Dr. Dan Ecklund
Dan Ecklund MD
Loja, Ecuador
13 June 2009
Dear Senator Hatch,
I write to you as a former Utah resident, BYU graduate, veteran US Army intelligence and medical officer, and as a physician interested in making stem cells available to needy patients.
I have observed the actions of the federal government against stem cell proponents in 2003 or so, when any and all clinical stem cell research was shut down by SWAT teams1, and when entrepr eneurs were charged with over 50 counts of fraud for providing stem cells to patients.2 It appeared to me that every attempt possible to scare physicians from the use of stem cells was being applied. This in spite of the fact that oncologists had used umbilical cord stem cells in the U nited States for over 20 years!
I have experienced being jailed on trumped-up charges (?Oh, I see you have white powder in your lab!?) on three occasions, while I conducted my own research into ethical and legal umbilical cord stem cell therapy. And faced with the constant harassment from the medical establishment, I moved my laboratory to South America.
After a stem cell law was enacted, US Title 21. Chapter I, subchapter L, part 1271, I discovered that contrary to the desires of the FDA, as expressed in their position papers before the enactment of the law, this law left a reasonable exception to their desire that all stem cells be considered drugs or med ical devices. As you are aware, this exemption is for cells which are ?not more than minimally manipulated?.
In accordance with Title 21 Section Chapter I,=2 0subchapter L, part 1271, stem cells, like other human tissues, are treated similarly to human blood for transfusions. The uses of blood components for transfusion are taught to physicians, and they are able to make appropriate decisions as they use these human cells for medical treatments. Production of blood and blood components occurs locally, and are used locally. There is no need for the FDA to get further involved. Appropriately, in the enacted statute, unaltered human stem cells are treated in a similar fashion.
After I read the actual statute, I realized that there is a way of providing natural, unadulterated stem cells to physicians in the United States, to be used according to their medical expertise. I also realize that there is a tremendous pres sure against providing natural, unmodified stem cells to physicians in the United States, and that this pressure originates in Big Pharma, and is expressed through its government mouthpiece, the Food and Drug Administration.
In the past few weeks, it has come to my attention that the original definitions of ?human cell, tissue, or cellular or tissue-based products? (HCT/P?s), subsequently codified in 21 CFR 1271.3(d), was: ?Articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into another human recipient.? Since then, the word another has been removed. This was undoubtedly done to prevent the use of autologous stem cells by physicians, since it prevents these stem cells being used after cell culture, which is usually performed to make the number of cells effective. Culturing the cells converts them, according to this law, into ?drugs or medical devices?. But I would like to point out that this change in definitions also includes vein grafts removed from a patient for his own heart bypass surgery, skin gra fts for burns, and other similar surgeries. This change of language brings the FDA right into the middle of medical practice, a place which the FDA itself agrees that it does not belong. Regulating one?s own cells or tissue as a ?drug or medical device? is a ludicrous expansion of governmental regulation.
I should point out that reversing this language change would not affect my own stem cell business. Since I supply only unmodified umbilical cord stem cells, and do not culture them for use in the United States, my cells still meet the exemption in this part, and are regulated as a blood transfusion, not as a ?drug or medical device?. But I recognize that, given the amazing success that our own patients are seeing with stem cell transplants, keeping the door to autologous stem cell transplants open would benefit millions of patients, and would hurt no one except the giant pharmaceutical organizations.
I therefore encourage this committee to recommend that the definition of HCT/P?s revert to the original meaning, with the word ?another? still intact.
Dan Ecklund MD
Loja, Ecuador
Dan Ecklund MD
Loja, Ecuador
13 June 2009
Dear Senator Hatch,
I write to you as a former Utah resident, BYU graduate, veteran US Army intelligence and medical officer, and as a physician interested in making stem cells available to needy patients.
I have observed the actions of the federal government against stem cell proponents in 2003 or so, when any and all clinical stem cell research was shut down by SWAT teams1, and when entrepr eneurs were charged with over 50 counts of fraud for providing stem cells to patients.2 It appeared to me that every attempt possible to scare physicians from the use of stem cells was being applied. This in spite of the fact that oncologists had used umbilical cord stem cells in the U nited States for over 20 years!
I have experienced being jailed on trumped-up charges (?Oh, I see you have white powder in your lab!?) on three occasions, while I conducted my own research into ethical and legal umbilical cord stem cell therapy. And faced with the constant harassment from the medical establishment, I moved my laboratory to South America.
After a stem cell law was enacted, US Title 21. Chapter I, subchapter L, part 1271, I discovered that contrary to the desires of the FDA, as expressed in their position papers before the enactment of the law, this law left a reasonable exception to their desire that all stem cells be considered drugs or med ical devices. As you are aware, this exemption is for cells which are ?not more than minimally manipulated?.
In accordance with Title 21 Section Chapter I,=2 0subchapter L, part 1271, stem cells, like other human tissues, are treated similarly to human blood for transfusions. The uses of blood components for transfusion are taught to physicians, and they are able to make appropriate decisions as they use these human cells for medical treatments. Production of blood and blood components occurs locally, and are used locally. There is no need for the FDA to get further involved. Appropriately, in the enacted statute, unaltered human stem cells are treated in a similar fashion.
After I read the actual statute, I realized that there is a way of providing natural, unadulterated stem cells to physicians in the United States, to be used according to their medical expertise. I also realize that there is a tremendous pres sure against providing natural, unmodified stem cells to physicians in the United States, and that this pressure originates in Big Pharma, and is expressed through its government mouthpiece, the Food and Drug Administration.
In the past few weeks, it has come to my attention that the original definitions of ?human cell, tissue, or cellular or tissue-based products? (HCT/P?s), subsequently codified in 21 CFR 1271.3(d), was: ?Articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into another human recipient.? Since then, the word another has been removed. This was undoubtedly done to prevent the use of autologous stem cells by physicians, since it prevents these stem cells being used after cell culture, which is usually performed to make the number of cells effective. Culturing the cells converts them, according to this law, into ?drugs or medical devices?. But I would like to point out that this change in definitions also includes vein grafts removed from a patient for his own heart bypass surgery, skin gra fts for burns, and other similar surgeries. This change of language brings the FDA right into the middle of medical practice, a place which the FDA itself agrees that it does not belong. Regulating one?s own cells or tissue as a ?drug or medical device? is a ludicrous expansion of governmental regulation.
I should point out that reversing this language change would not affect my own stem cell business. Since I supply only unmodified umbilical cord stem cells, and do not culture them for use in the United States, my cells still meet the exemption in this part, and are regulated as a blood transfusion, not as a ?drug or medical device?. But I recognize that, given the amazing success that our own patients are seeing with stem cell transplants, keeping the door to autologous stem cell transplants open would benefit millions of patients, and would hurt no one except the giant pharmaceutical organizations.
I therefore encourage this committee to recommend that the definition of HCT/P?s revert to the original meaning, with the word ?another? still intact.
Dan Ecklund MD
Loja, Ecuador