ACT’s “Therapeutic Cloning” — Help or Hype?

[1] Our heated summer-time debates over human embryonic stem cell research were all but forgotten until we were jolted over the sleepy Thanksgiving weekend by an announcement from researchers at Advanced Cell Technology (ACT), a small biotech company in Massachusetts. On TV screens, in the pages of “U.S. News & World Report,” and online in “e-biomed: The Journal of Regenerative Medicine,” ACT staked its claim to the creation of the first “cloned human embryos,” tentative preludes not to cloned children but to tissues for transplant. ACT’s sojourn into so-called “therapeutic cloning”-an ambiguous term at best-is aimed at producing stem cells containing a patient’s own genetic material.

[2] ACT is searching for the miracle of regenerative medicine. Being able to develop stem cells that match a patient’s tissue type clears the formidable hurdle of immune rejection inherent in transplants that use cells or tissues the body identifies as foreign and subsequently destroys. Scientists hope to discover how pluripotent embryonic stem cells, capable of developing into all cell types of the adult human, can be chemically tweaked to give rise to perfectly matching tissues for transplant. The awaited miracle is the development of tissue-based treatments for a host of diseases-everything from diabetes to paralysis-absent rejection and damaging immunosuppressive therapy.

[3] The ACT team employed the same nuclear transfer technique used to create Dolly the sheep. The procedure requires a donor human egg from which the nucleus has been removed. Then, DNA from another person’s skin or other cell is slid into the egg. Following an electric jolt, the nuclear DNA is reprogrammed and the egg divides as if a sperm had just fertilized it. Division continues in culture until the ball of cells forms a small cavity containing a couple hundred pluripotent stem cells. This blastocyst forms in 5 days and is split apart when stem cells are obtained.

[4] ACT researchers added new genetic material to each of 19 donated human eggs. But, only three of the 19 eggs divided before dying-a paltry “success rate” of 16%. More importantly, this cell division stopped within a few hours at the 4 to 6 cell stage, well short of the 200-plus stem cell-rich blastocyst which the company claims is their goal-a “success rate” of zero. Why cell division stopped is unknown.

[5] “A critical stage of development is the kicking in of genes,” said Harry Griffin of the Roslin Institute, which cloned Dolly. “They didn’t get over this threshold.” The added genes may not have functioned at all.

[6] Although an ACT news release claimed that “this work sets the stage for human therapeutic cloning as a potentially limitless source of immune-compatible cells for tissue engineering and transplantation medicine,” many scientists were not impressed, calling ACT’s work “a complete failure,” a “nonevent” and “things not to do.” Under such circumstances, many researchers would head back to the lab to discover “what went wrong,” rather than to seek the international spotlight. Although ACT denies “any ulterior motives,” the company relies on major breakthroughs to attract investors.

[7] What are we to make of this? Has history been made by ACT’s creation of a “human clone?” I, for one, think not. At best, they have reported results that should be labeled as premature; at worst, they have grossly overstated the case.

[8] I continue to be struck by the sea change in how some scientists report experimental results since the birth of Dolly the sheep. Her creation first came to our attention on newspaper pages. While Dolly’s cloners published their work days after in a peer-reviewed journal, a troubling precedent was set that has since spawned such media events as ACT’s announcement. One wonders whether their report reflects solid science or a publicity pitch.

[9] Certainly, innovative and responsible science occurs in the private sector. Privately-funded science can often tackle problems more quickly and with greater efficiency than science dependent solely on government funds. At their best, both “public” and “private” science function in an arena of openness and methodological rigor. But, at its worst, science in the private sector can succumb to the lure of publicity and profit. ACT seems to have trumpeted a scientifically empty experiment in order to capture front pages and investor interest. Such much ado about nothing erodes the candor and trust so necessary to the pursuit of science in service to human health and threatens legislative retaliation in Washington.

[10] Prudence would dictate following the precautionary principle. In cases such as this, where the stakes are high and the unknown deep, we ought to go carefully and openly where no one has gone before. Research on stem cell biology and “therapeutic cloning” ought to be subject to prospective public scrutiny and debate irrespective of who foots the bill. Experimental results should weather peer review before the media blitz.

[11] ACT’s headline grabbing aside, the scientific potential to create stem cells bearing a patient’s genetic material raises what Ian Barbour calls “limit-questions”-questions that science alone cannot answer. Whether funded privately or publicly, the application of cloning technology to human beings challenges deep-seated beliefs about what it means to be created by God and the limits of human freedom and responsibility. The possibility of “therapeutic cloning” pushes the limits of our experience, raising serious ethical questions:

[12] What is the moral status of the blastocyst created in the laboratory? Is it protected human life or a cellular ball that may be used under certain circumstances in the pursuit of human health and well-being?

[13] Does the commandment to love the neighbor include pursuing “therapeutic cloning” in order to heal the neighbor?

[14] Is there reason to believe that “therapeutic cloning” will slide down the slippery slope to the birth of a cloned baby-a possibility that could commodify human life and that most Americans find morally repugnant?

[15] And, significantly, what does justice require of us? Like the rich man ignoring Lazarus suffering at the gate, we are often blind to questions of justice in our pursuit of the good life. Justice requires that society make certain that the benefits of medical research are distributed fairly-paying particular attention to those marginalized by the current health care system. The health benefits that stem cell research promises must not be bought at the expense of basic health care nor widen the gap between those who enjoy consistent access to quality health care and those who do not. Our penchant for long lives, quick fixes, and immediate gratification must be balanced with the costs and benefits to others, both now and in the future.