In 1978, the world's first test-tube baby was born, ushering in a new era in reproductive technology. Childless couples with seemingly insurmountable obstacles to conception flocked to IVF centers and paid thousands of out of pocket dollars to achieve what was tantamount in importance to them. I clearly remember American patients mortgaging their homes and taking “vacations” to England, continental Europe, and Australia for the opportunity to have a baby. The United States lagged behind the rest of the world in reproductive technology for years until private funding obtained by Drs. Howard and Georgiana Jones in Norfolk, Virginia, paved the way for IVF, which has become the most prominent treatment for infertility. It was music to our patients' ears. However, the absence of federal funding and support led to entrepreneurship, privatization of a scientific industry, and eventually a need, the federal government believed, to regulate the very industry it had chosen not to support. One unfortunate result of the delay in government involvement was expensive and cumbersome software to make the many existing record-keeping systems uniform, the need for additional personnel to implement it, and an enormous amount of lost time and confusion that could have been spared if it had been incorporated from the start.
Intracytoplasmic sperm injection (ICSI), in which a single sperm is injected directly into an egg to achieve fertilization, was a major refinement of IVF, as was preimplantation genetic diagnosis (PGD), a procedure in which a single cell of an early dividing embryo is removed and tested for genetic diseases so that only unaffected embryos can be transferred back into the mother. Like IVF, these major achievements were developed and thrived initially only outside the United States.
In February of this year, scientists in the United States again watched as South Korea announced that for the first time, stem cells were successfully harvested from cloned human embryos. This significant advancement ignited international excitement. Some who oppose stem cell research worry for the loss of the human embryo known as a blastocyst from which the cells are derived. This 0.1- to 0.2-mm hollow microscopic ball of approximately 150 cells resembles a sphere the size of a grain of sand. Although it bears no resemblance to anything we know as human, it does possess that potential if implanted into a human uterus. But blastocysts used for stem cell research are unused IVF embryos that would have been discarded had they not been donated for stem cell research. According to the Boston Globe (Gareth Cook, April 4, 2004, B10), about 400,000 of these embryos are in frozen storage around the country, awaiting their fate.
As in all debates, proponents see it differently. Stem cells are a “blank slate” with the potential to grow into any defective cell in the human body. They could be the next wave of treatment for Parkinson's disease (providing needed dopamine in deficient areas of the brain; roughly one million Americans), diabetes (yielding insulin for a waning pancreas; roughly 18 million in America), and hearing deficits (restoring hair cells in the middle ears of approximately 28 million hearing-impaired Americans) (Boston Globe, Robert Cooke, February 3, 2004, C1). The list of diseases that could potentially benefit from stem cells also includes Alzheimer's disease (affecting >4.5 million Americans and growing), heart disease (America's number one killer), and spinal cord injury (up to 400,000 Americans), and some cancers.
On August 9, 2001, President Bush sought a compromise and said that he would allow federal funding for stem cell research, but restricted it to work that was performed on 60 existing stem cell lines, already derived from human embryos. This was very encouraging. Unfortunately, his good intention turned out to be much more restrictive than envisioned. Scientists have access to only 15 of those 60 cell lines, with reportedly 8 more in the wings. To make matters worse, scientists are reporting numerous technical difficulties working with them. Adult stem cells rather than embryonic stem cells offer another alternative and avoid all ethical concerns, but also offer much less promising results.
As with IVF, enter entrepreneurship and privatization of a scientific industry; exit government oversight. And this time it is not just 5 million infertile couples that might be helped by the procedure. Stem cell research is not about cloning humans, which could be legislated against. It is about altering the course of serious chronic ailments. Potentially half the American population could be flocking for stem cell treatment. According to the New York Times (James Gorman, nytimes.com, 4-6-2004), the altered human is already here by virtue of the many medications we humans take to improve our lots. Last year retail drug sales worldwide were $317 billion of which U.S. consumers spent $163 billion. Why? Because we want a better quality of life as we live longer. People expect more from life and do what they can to achieve it. To afflicted and affected individuals and their families, stem cells appear to be the Holy Grail of treatment.
As a result, according to the Wall Street Journal (Laura Johannes and Antonio Regalado, March 4, 2004, B1), Harvard University is raising $100 million dollars for stem cell research and has already produced 17 new stem cell lines of its own. Harvard biologist Douglas Melton was motivated to create the stem cells for diabetes research because he has a young child with the disease. The Juvenile Diabetes Research Foundation is spending an additional $8 million over 3 years on this effort. The Michael J. Fox Foundation is spending $2 million on stem cell research for Parkinson's disease, a disease with which the founder is affected; Stanford University has a $12 million dollar initiative; University of California, San Francisco, received $5 million from Intel's Andy Grove for a future stem cell center; New Jersey's Democratic Governor James E. McGreevey aims to raise $50 million during the next 5 years for a new stem cell research facility; and the state of California seeks to raise $3 billion in private monies for a stem cell research initiative (Boston Globe, Bobby Caina Calvan, March 1, 2004, A3). Others are seeking private funding as well.
So here we go again. The United States begins the basic research, funding is restricted, other countries advance at a faster rate, privatization and entrepreneurship begins, America advances rapidly to keep pace with the rest of the world, and there is government concern of the industry's independence and need for regulation. This approach affects the staying power of physician–scientists (see Sharon Begley's article in this issue). Like IVF, stem cell research will not go away unless there is overwhelming success with an alternative (see article on fetal cord blood in this issue). There is an opportunity to learn from the IVF experience. Otherwise, it will be same song, second verse.
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