We are living in the golden era of medical research. Almost every week a major advance is announced in the scientific journals, and just a few months ago researchers reached a watershed in human history when they published the complete human genome, a catalog of our DNA. Despite the promise of breakthroughs in the near future that could help all of us lead longer and healthier lives, medical research is not immune to political pressure. The Progressive Policy Institute (PPI) recently released a report detailing the political pressure being exerted by President Bush to halt research into stem cells -- the "universal clay" of biology that can turn into any type of tissue and potentially cure a number of diseases, from Alzheimer's to diabetes, that kill 3,000 Americans every day. Now President Bush and Republican leaders in Congress are indicating that they want to interfere with another line of research that could save millions of lives: therapeutic cloning.
It is important to distinguish between two distinct kinds of cloning: therapeutic cloning and reproductive cloning. Therapeutic cloning is not cloning in the sense most people use the term, namely using technology to create a person who is a genetically identical copy of someone else. That type of cloning is reproductive cloning, and is rightfully subject to a moratorium. Therapeutic cloning, on the other hand, seeks only to derive stem cells from a cloned embryo. The embryo is created by cloning DNA taken from a donor, which can be gathered by simply swabbing the inside of one's cheek, and transferring it into an unfertilized donor egg.1 The embryo then divides into a tiny clump of about 100 cells, and the stem cells are then derived to be used to create any kind of tissue, from nerve cells to arteries to organs.
The potential therapies that may be developed from therapeutic cloning are significant. Under current medical technology, patients who need organ transplants face two grave dangers: that a matching organ from a donor will not be found in time, and if an organ is found, that it will be rejected by the patient's immune system as a foreign invader. To get around the rejection risk, patients must have their immune systems suppressed, which in itself presents a grave danger, as it leaves the patient susceptible to any number of infections that people with normal immune systems do not need to worry about. (Indeed, suppression of the immune system is what makes AIDS such a lethal disease.)
Therapeutic cloning has the potential to change all of that. Since embryonic stem cells are capable of becoming any kind of tissue, researchers hope to learn to grow entire organs from scratch in a laboratory, eliminating the need to wait for organ donors. If the stem cells that create the organ are cloned from the patient, medical researchers believe that the patient's body will not recognize the organ as a foreign object; with no risk of rejection, there would be no need for dangerous immunological suppression. Therapeutic cloning, therefore, may significantly reduce the risks involved with stem cell therapies derived from non-related embryos, and save millions of lives.
Federal funding for therapeutic and reproductive cloning is currently banned by the Dickey amendment,2 which specifies that funds cannot be used for "the creation of a human embryo or embryos for research purposes." Though this language applies to therapeutic and reproductive cloning, it is not specific to cloning; it also bans federal funding for any other methods of creating an embryo, including combining a sperm and an egg in a laboratory setting, if it is done for research purposes. In March 1997, President Clinton extended the Dickey amendment ban on cloning [which applied to the Department of Health and Human Services (HHS)] to all federal agencies, without distinguishing between reproductive and therapeutic cloning.3 He also called for a voluntary moratorium on cloning by privately funded researchers. Despite the media attention surrounding the issue in the wake of Dolly, the famous sheep that was the first live clone, the National Bioethics Advisory Commission in June 1997 supported a temporary moratorium on reproductive cloning, but did not recommend against therapeutic cloning and did not recommend a permanent ban.4
There are a number of bills in Congress that address the issue of human cloning. The House Energy and Commerce Committee's Subcommittee on Health held a hearing recently on the two leading proposals. H.R. 1644, authored by Reps. Dave Weldon (R-Fla.) and Bart Stupak (D-Mich.), would ban all human cloning under any circumstances. H.R. 2172, authored by Reps. Jim Greenwood (R-Pa.) and Peter Deutsch (D-Fla.), would ban reproductive cloning, but allow therapeutic cloning as long as researchers register with the federal government and attest to their understanding that cloned embryos are not to be implanted for pregnancy. The Greenwood-Deutsch bill would also place a ten year ban on reproductive cloning. At the hearing, HHS Deputy Secretary Claude Allen did not take a position on the two bills, but made clear that President Bush supports a total ban on all cloning. Following the hearing, House Republican Conference Chairman J.C. Watts (R-Okla.) declared a total ban on all cloning to be a top priority for the party.
The reasons for having a moratorium on reproductive cloning are fairly clear. Changing the way humans have reproduced for millions of years raises a host of ethical questions which society is only now beginning to consider. Moreover, reproductive cloning is still an unproven and extremely unsafe technique. Though a small number of animals have been successfully cloned, for every clone that is born there are dozens more unsuccessful clones that are either miscarried or seriously malformed.5 It is unclear at this stage whether even those "successful" clones are truly successful; there is evidence to suggest that cloned organisms suffer from significant developmental and health problems. The temporary moratorium on reproductive cloning, therefore, is entirely appropriate.
Therapeutic cloning, on the other hand, does not engender the same safety and ethical concerns.6 While therapeutic cloning does involve the creation of an embryo, the derivation of stem cells from cloned embryos is the same as the derivation from leftover embryos, and any cloned human embryos would be created with the express permission of the donor and the express understanding that the embryo would be used for stem cell derivation only, not for implantation. Many prominent scientists (such as Rudolf Jaenisch) and bioethicists (such as Arthur L. Caplan) who oppose reproductive cloning still strongly favor therapeutic cloning for research based on its tremendous potential to ease human suffering.7
Some critics of therapeutic cloning contend that the temptation to implant cloned embryos will be too great, and the birth of a human clone would be inevitable. The Greenwood-Deutsch legislation addresses that concern by providing severe criminal penalties -- up to 10 years in prison -- for researchers who implant embryonic clones. This safeguard should be sufficient to deter those who can be deterred; for those who are determined to create a human clone despite the legal impediments, even a total ban on creating embryonic clones will not stop them. (And no ban passed by Congress can stop scientists in other countries from reproductive cloning.) The potential reward in advanced therapies for dreaded diseases more than justifies the risk.
Though cloning is still a new science and caution is warranted, there is no need to close off a promising avenue of scientific inquiry because of justified fears of reproductive cloning. Therefore, PPI recommends the following steps to let this vital research go forward:
1. Congress should pass, and President Bush should sign, the Greenwood-Deutsch bill (H.R. 2172) to ban reproductive cloning for 10 years.8 This bill is a well-considered compromise that gives us time to contemplate the medical and ethical implications of reproductive cloning without delaying research into the lifesaving breakthroughs that could be made as a result of deriving stem cells from cloned embryos. The safeguards written into the legislation -- a requirement for researchers who work with cloned embryos to register with HHS and attest to the ban on implantation, criminal penalties for implantation, a mandated study on the progress of the research -- adequately address the risks involved in cloning human embryos.
2. President Bush should revise the executive ban on federal funding for cloning to allow funding for therapeutic cloning while continuing to ban funding for reproductive cloning. When President Clinton issued his order barring federal agencies from supporting human cloning, he acted out of prudent intent to slow the scientists until bioethicists and policymakers had a chance to consider the implications of cloning. In the accompanying legislation Clinton sent to Congress, he asked for a five-year sunset period on the ban in order to force reconsideration of cloning when more information was available. That was four years ago, and we now know that stem cells from cloned embryos could lead to tremendous medical breakthroughs. With legal prohibitions and funding bans firmly in place against reproductive cloning, there is no reason to continue the ban on federal funds for research into therapeutic cloning.
3. Congress should repeal the Dickey amendment and allow HHS and the National Institutes of Health (NIH) to fund research in therapeutic cloning. While Clinton's ban extended the Dickey amendment to all agencies, repealing that ban would not benefit researchers unless the Dickey amendment is repealed. The primary source of funding for biomedical research is NIH, a division of HHS, and the Dickey amendment is a rider on the HHS appropriations bill. To ensure that scientists have the resources they need to conduct their important research, the Dickey amendment must be repealed. NIH could then change their guidelines to allow funding for research using stem cells derived from embryos created through asexual cloning for research purposes (somatic nuclear transfer), while still confining funding for research on stem cells derived from embryos created sexually (by combining eggs with sperm) to those derived from excess in?vitro fertilization embryos which would otherwise be discarded.
It is entirely appropriate to be skeptical about powerful new technologies, and to take a collective pause to consider the next step. The United States did so with cloning. But now that we have a clearer picture of the risks and a firm understanding that reproductive cloning should not take place now, if ever, we should move forward cautiously with therapeutic cloning to see if it can live up to its promise. Moreover, if the Weldon-Stupak bill is passed, it is likely that therapeutic cloning could be banned for decades, delaying promising research into medical treatments and advances in cloning technology. We must not close the door on this important medical research because of fears about reproductive cloning. With the safeguards provided by the Greenwood-Deutsch bill, and the oversight inherent in federal funding, research into therapeutic cloning can go forward under the bright light of public scrutiny and perhaps, one day in the future, save lives.
