Written 8 January, 2013
Stroke. Baldness. Blindness. Deafness. Amyotrophic lateral sclerosis. Myocardial infarction. Muscular dystrophy. Diabetes. Cancer. Brain injuries. Learning disorders. Alzheimer’s disease. Parkinson’s disease. Missing teeth. Wound healing. Bone marrow disease. Spinal cord injury. Osteoarthritis. Rheumatoid arthritis. Celiac disease. Huntington’s disease. Birth defects.
The above is a long list of conditions that many of us have or may have. For many of these conditions there is no cure.
But what if there were a promising new technology with the potential for treating these conditions? Anything that could possibly provide such a huge benefit to humanity would be pursued vigorously around the world, right?
Wrong. Amazingly, a number of countries actually prohibit research that could result in effective treatments for the conditions on this list. Including the United States.
We are talking about stem cell research.
First, what are stem cells? They are cells that can either change into other types of cells, or continue propagating as the same cell type. So, for example, a stem cell from amniotic fluid could possibly be induced to make a new liver. Pretty simple concept. Stem cells can potentially be derived from many sources to treat every single condition on the list—stem cells placed into gums could cause new teeth to grow; stem cells placed in the scalp could possibly grow hair, and on and on. Sounds almost too good to be true.
However, there IS a controversy surrounding the use of stem cells. And that is because the most useful stem cells are derived from human embryos. That’s right—if you take a human embryo at the stage where it has between 50 and 150 cells (around 4-5 days old), pluck out some cells from the inside of this cell mass, these are stem cells. As you might imagine, they have the potential to make all the different tissues in the human body. After all, that’s what an embryo is programmed to do.
And so stem cells can be categorized as being either non-embryonic stem cells (NESC) or embryonic stem cells (ESC). NESCs can be derived from many many types of tissues—skin, amniotic fluid, umbilical cord fluid, bone marrow, fat, etc. Even urine! A very recent paper (November 2012) demonstrated that stem cells derived from the kidney can be isolated from only 30 ml of urine and induced to form stem cells that have the potential to form many other types of cells and, therefore, tissues.
Scientific experiments on NESCs have been conducted since 1908, when the term “stem cell” was coined. Research on the use of NESCs for the treatment of disease has been going on since the 1960s, when a bone marrow transplant (in effect, a stem cell transplant) was first used to treat severe combined immunodeficiency, or “SCID”, an extremely rare disease popularized by the “bubble boy”. In addition to bone marrow transplants, NESCs are being used around the world today in the treatment of cancer and various immunologic conditions. In fact a survey conducted in 2006 indicated that there were 50,000 uses of NESCs in 71 countries. However, these treatments are not without hazards—for example, NESCs have the potential to differentiate into the wrong type of tissue—themselves forming tumors. And even if all goes well at the tissue-generation stage, the treatment may ultimately fail because the recipient’s body sees the NESC as “foreign” and rejects it.
Unlike NESCs, ESCs have NOT been used in any clinical treatments in the United States. This is because research on human ESCs has been stopped/delayed/handicapped by federal law. I guess you can see the source of the controversy: deriving stem cells from human embryos kills the embryo. But wait—human ESCs are derived from embryos that are slated for destruction. They are essentially already dead, or soon will be.
All human ESCs are derived from embryos that have been created by in vitro fertilization (IVF). In IVF, eggs are removed from a female and placed in a Petri dish, where they are flooded with sperm. A healthy looking embryo is then plucked off the Petri dish and implanted in the female. This procedure is widely used around the world to treat infertility—in the U.S. there are 126 IVF procedures per 1 million couples each year, resulting in about 60,000 live births. The numbers are even higher in other countries—899 procedures for each million couples in Iceland and over 1,600 for Israel. What a wonderful thing! And, by the way, children born by this procedure are just fine. The world’s first IVF baby, Louise Brown, was born in 1978, and she gave birth to her first child in 2006. I guess I’d ask those who oppose IVF if they’d rather that Louise Brown had never been born. Well, that is a topic for another day.
Back to the controversy surrounding human ESCs, but first a tiny bit of history. The first human ESC was developed in 1995 at the University of Wisconsin. Of importance here is that these ESCs were developed with private funds— no federal money was involved. This is important because United States law prohibited federal funds from being used for research on human embryos, and the ESCs were extracted from human embryos—embryos derived from IVF. When the paper describing these experiments was published in 1998, much controversy ensued. Suffice it to say that no federal money was made available to do research for making NEW human ESCs. In 2001 during the Bush administration, a law was passed that permitted the use of federal funding for research on EXISTING human ESCs—the cell lines already made by the University of Wisconsin—but stated that no new human ESCs could be made using federal funding.
Private companies, however, continued doing this kind of research and making products for sale. It is also interesting to note that in 2004 the state of California, believing that research on human ESCs was vitally important to mankind, passed Proposition 71, which authorized $3 billion in bonds to fund research on human ESCs. When funding subsequently stalled, in 2006 the Terminator (Gov. Schwarzenegger) authorized $150 million in loans to jump-start the process. Many other laws during this time were debated, passed, vetoed. Congress dithered. States that were not as forward-thinking as California either restricted or imposed complete bans on human ESCs. These include Arkansas, Iowa, Kansas, Louisiana, Nebraska, North Dakota, South Dakota, and Virginia. I presume it would be fair to prohibit the use of any future therapies based on human ESCs in these states?
Finally, in 2009 the US Food and Drug Administration approved clinical trials using human ESCs—gee, that was nice of them. So glad they are on our side.
Also in 2009, President Obama removed the restriction on the use of federal money to support the production of new human ESCs. But in August 2010 a Federal District Court ruled that Obama’s executive order was invalid. In 2011 the injunction was lifted, and in September of 2012 the U.S. Court of Appeals for the District of Columbia Circuit unanimously ruled that the federal government can fund research on human ESCs.
(Caveat: The above has been garnered from many sources, and the spin may not be quite right as I have seen different dates for certain events. But one thing is clear: no new human ESCs have yet been produced using federal funds.)
Just imagine if you were a scientist wanting to do work in this area. You would never know if you’d get funded, and even if you were, another law might be passed making it illegal for you to do the research. Right in the middle of your experiments!
Certainly one effect of the ban on research developing/using human ESCs is that it has forced researchers to find ways of getting around the use of human ESCs, such as mentioned above. But clearly stem cell research worldwide is not benefiting completely from U.S. genius. In fact, Finland, Greece, Italy, and the Netherlands allow for the production of human ESCs. As does China.
Now, I guess one can argue that hey, if Finland or China is doing this work, then why be bothered about it? Won’t they share their results the U.S.? So what’s the big deal? Actually there are several “big deals.” First, if U.S. universities are not involved in this research, then U.S. universities will not be making any inventions in this area. If those inventions don’t exist, U.S. companies will not be getting preferential access to them, and entrepreneurial startup companies will not be formed to commercialize them. Second, it means that U.S. scientists are not being trained in this field, putting the U.S. behind in cutting-edge science. And it also follows that students are not learning “at the bench.” So the next generation is not being trained. Third, it means that the United State’s considerable power in science is not being applied to this area, at least not to its full potential. And so the world’s collective effort to develop therapies for a long list of diseases is not as effective as it could be.
So tell me, how is this to the benefit of mankind?
And what if researchers in Hong Kong make a huge future breakthrough—would we be denied access to therapies because they were derived from human ESCs? That should give pause to those of us who are getting long in the tooth. Maybe someday we will have to fly to China to get treatment. My bet is that that’s where the cutting edge research will take place.
There is no historic example of the world benefiting from reduced science and technology.
Stroke. Baldness. Blindness. Deafness. Amyotrophic lateral sclerosis. Myocardial infarction. Muscular dystrophy. Diabetes. Cancer. Brain injuries. Learning disorders. Alzheimer’s disease. Parkinson’s disease. Missing teeth. Wound healing. Bone marrow disease. Spinal cord injury. Osteoarthritis. Rheumatoid arthritis. Celiac disease. Huntington’s disease. Birth defects.
The above is a long list of conditions that many of us have or may have. For many of these conditions there is no cure.
But what if there were a promising new technology with the potential for treating these conditions? Anything that could possibly provide such a huge benefit to humanity would be pursued vigorously around the world, right?
Wrong. Amazingly, a number of countries actually prohibit research that could result in effective treatments for the conditions on this list. Including the United States.
We are talking about stem cell research.
First, what are stem cells? They are cells that can either change into other types of cells, or continue propagating as the same cell type. So, for example, a stem cell from amniotic fluid could possibly be induced to make a new liver. Pretty simple concept. Stem cells can potentially be derived from many sources to treat every single condition on the list—stem cells placed into gums could cause new teeth to grow; stem cells placed in the scalp could possibly grow hair, and on and on. Sounds almost too good to be true.
However, there IS a controversy surrounding the use of stem cells. And that is because the most useful stem cells are derived from human embryos. That’s right—if you take a human embryo at the stage where it has between 50 and 150 cells (around 4-5 days old), pluck out some cells from the inside of this cell mass, these are stem cells. As you might imagine, they have the potential to make all the different tissues in the human body. After all, that’s what an embryo is programmed to do.
And so stem cells can be categorized as being either non-embryonic stem cells (NESC) or embryonic stem cells (ESC). NESCs can be derived from many many types of tissues—skin, amniotic fluid, umbilical cord fluid, bone marrow, fat, etc. Even urine! A very recent paper (November 2012) demonstrated that stem cells derived from the kidney can be isolated from only 30 ml of urine and induced to form stem cells that have the potential to form many other types of cells and, therefore, tissues.
Scientific experiments on NESCs have been conducted since 1908, when the term “stem cell” was coined. Research on the use of NESCs for the treatment of disease has been going on since the 1960s, when a bone marrow transplant (in effect, a stem cell transplant) was first used to treat severe combined immunodeficiency, or “SCID”, an extremely rare disease popularized by the “bubble boy”. In addition to bone marrow transplants, NESCs are being used around the world today in the treatment of cancer and various immunologic conditions. In fact a survey conducted in 2006 indicated that there were 50,000 uses of NESCs in 71 countries. However, these treatments are not without hazards—for example, NESCs have the potential to differentiate into the wrong type of tissue—themselves forming tumors. And even if all goes well at the tissue-generation stage, the treatment may ultimately fail because the recipient’s body sees the NESC as “foreign” and rejects it.
Unlike NESCs, ESCs have NOT been used in any clinical treatments in the United States. This is because research on human ESCs has been stopped/delayed/handicapped by federal law. I guess you can see the source of the controversy: deriving stem cells from human embryos kills the embryo. But wait—human ESCs are derived from embryos that are slated for destruction. They are essentially already dead, or soon will be.
All human ESCs are derived from embryos that have been created by in vitro fertilization (IVF). In IVF, eggs are removed from a female and placed in a Petri dish, where they are flooded with sperm. A healthy looking embryo is then plucked off the Petri dish and implanted in the female. This procedure is widely used around the world to treat infertility—in the U.S. there are 126 IVF procedures per 1 million couples each year, resulting in about 60,000 live births. The numbers are even higher in other countries—899 procedures for each million couples in Iceland and over 1,600 for Israel. What a wonderful thing! And, by the way, children born by this procedure are just fine. The world’s first IVF baby, Louise Brown, was born in 1978, and she gave birth to her first child in 2006. I guess I’d ask those who oppose IVF if they’d rather that Louise Brown had never been born. Well, that is a topic for another day.
Back to the controversy surrounding human ESCs, but first a tiny bit of history. The first human ESC was developed in 1995 at the University of Wisconsin. Of importance here is that these ESCs were developed with private funds— no federal money was involved. This is important because United States law prohibited federal funds from being used for research on human embryos, and the ESCs were extracted from human embryos—embryos derived from IVF. When the paper describing these experiments was published in 1998, much controversy ensued. Suffice it to say that no federal money was made available to do research for making NEW human ESCs. In 2001 during the Bush administration, a law was passed that permitted the use of federal funding for research on EXISTING human ESCs—the cell lines already made by the University of Wisconsin—but stated that no new human ESCs could be made using federal funding.
Private companies, however, continued doing this kind of research and making products for sale. It is also interesting to note that in 2004 the state of California, believing that research on human ESCs was vitally important to mankind, passed Proposition 71, which authorized $3 billion in bonds to fund research on human ESCs. When funding subsequently stalled, in 2006 the Terminator (Gov. Schwarzenegger) authorized $150 million in loans to jump-start the process. Many other laws during this time were debated, passed, vetoed. Congress dithered. States that were not as forward-thinking as California either restricted or imposed complete bans on human ESCs. These include Arkansas, Iowa, Kansas, Louisiana, Nebraska, North Dakota, South Dakota, and Virginia. I presume it would be fair to prohibit the use of any future therapies based on human ESCs in these states?
Finally, in 2009 the US Food and Drug Administration approved clinical trials using human ESCs—gee, that was nice of them. So glad they are on our side.
Also in 2009, President Obama removed the restriction on the use of federal money to support the production of new human ESCs. But in August 2010 a Federal District Court ruled that Obama’s executive order was invalid. In 2011 the injunction was lifted, and in September of 2012 the U.S. Court of Appeals for the District of Columbia Circuit unanimously ruled that the federal government can fund research on human ESCs.
(Caveat: The above has been garnered from many sources, and the spin may not be quite right as I have seen different dates for certain events. But one thing is clear: no new human ESCs have yet been produced using federal funds.)
Just imagine if you were a scientist wanting to do work in this area. You would never know if you’d get funded, and even if you were, another law might be passed making it illegal for you to do the research. Right in the middle of your experiments!
Certainly one effect of the ban on research developing/using human ESCs is that it has forced researchers to find ways of getting around the use of human ESCs, such as mentioned above. But clearly stem cell research worldwide is not benefiting completely from U.S. genius. In fact, Finland, Greece, Italy, and the Netherlands allow for the production of human ESCs. As does China.
Now, I guess one can argue that hey, if Finland or China is doing this work, then why be bothered about it? Won’t they share their results the U.S.? So what’s the big deal? Actually there are several “big deals.” First, if U.S. universities are not involved in this research, then U.S. universities will not be making any inventions in this area. If those inventions don’t exist, U.S. companies will not be getting preferential access to them, and entrepreneurial startup companies will not be formed to commercialize them. Second, it means that U.S. scientists are not being trained in this field, putting the U.S. behind in cutting-edge science. And it also follows that students are not learning “at the bench.” So the next generation is not being trained. Third, it means that the United State’s considerable power in science is not being applied to this area, at least not to its full potential. And so the world’s collective effort to develop therapies for a long list of diseases is not as effective as it could be.
So tell me, how is this to the benefit of mankind?
And what if researchers in Hong Kong make a huge future breakthrough—would we be denied access to therapies because they were derived from human ESCs? That should give pause to those of us who are getting long in the tooth. Maybe someday we will have to fly to China to get treatment. My bet is that that’s where the cutting edge research will take place.
There is no historic example of the world benefiting from reduced science and technology.
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