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ASRM BULLETIN
Volume 3, Number 13
July 3, 2001

July Will Be Crucial in Stem Cell and Cloning Debates

The Bush administration is facing an enormous amount of pressure to make a decision on federal funding for embryonic stem cell research. The issue, and the President’s indecision on it, has generated reams of media coverage.

Thanks in part to the excellent work of the Coalition for the Advancement of Medical Research (CAMR) of which ASRM is a member, there has been a strong tide of pro-research momentum. Papers all over the country have editorialized in favor of stem cell research, and many conservative and anti-abortion Republicans have started to speak out in favor of stem cell research.

Late last week Senator Orrin Hatch (R- UT) released a letter to the President urging him to allow NIH funding for embryonic stem cell work.  On talk shows over the weekend Hatch stated he felt the Senate was close to having enough votes to overturn any Bush decision not to fund the research.

Meanwhile, GOP leaders in the House, attempting to blunt the pro-stem cell research momentum, released a statement yesterday urging Bush not to give in to the “industry of death.”

Cloning

The high profile action on stem cell research has driven cloning policy from the front pages. However, the House is expected to continue its efforts to pass legislation prohibiting human cloning when it comes back into session following Independence Day.

There are two bills competing for attention in the House. ASRM is supporting H.R. 2172, introduced by Representative Jim Greenwood (R-PA). This bill would prohibit attempts to initiate a pregnancy via human cloning, but allow research into therapeutic cloning to continue.

The other bill, H.R. 1644, is a very broad bill that prohibits any use of somatic cell nuclear transfer, even if done for non-reproductive purposes.

The Independence Day recess would be an excellent time for you to contact your Representative to express your support for H.R. 2172 and your concern that H.R. 1644 is overly broad and could have a chilling effect on important research. If you can make a call this week, then simply look up your Representative’s number in your local phone directory. Or you may call the Capitol Switchboard at 202-224-3121 and ask to be connected to your local member’s office. (If you need help determining who your member is, contact our office or go to the “find your member” section of the CAMR website at http://www.stemcellfunding.org/.)

Below is the text of a document the ASRM public affairs staff has developed for Congressional staff on the issue. Feel free to borrow from it to use in your communications.

H.R. 2172, the Cloning Prohibition Act of 2001
Prohibits Cloning Babies, Protects Medical Research!

H.R. 2172, introduced by Representative Jim Greenwood (R-8th/PA) and co-sponsored by Representatives Peter Deutsch (D-20th/FL) and Diana DeGette (D-1st/Co), takes the necessary steps to prohibit human reproductive cloning, while preserving the promising medical and scientific possibilities offered by the technique of somatic cell nuclear transfer SCNT). Doctors, legislators and the American people agree that at this time we do not have the expertise to clone a normal, healthy human child. The risks of reproductive cloning to the individual and to society are too great and any present attempt to produce a human child through cloning technology must be stopped.

H.R. 2172 makes it illegal to use or attempt to use human SCNT with the intent to initiate a pregnancy, and to transport the product of human SCNT with the knowledge that it will be used to initiate a pregnancy.

H.R. 2172 protects the possibilities of medical progress offered by SCNT by allowing doctors and scientists to clone molecules, DNA, cells, or tissues; to clone or otherwise create animals other than humans; and to pursue other possibilities (biomedical, microbiological, or agricultural) not expressly prohibited.

We must keep our freedom to allow important scientific discoveries to be made.

  • Somatic Cell Nuclear Transfer Technology holds promise for developing treatments for a myriad of diseases: Alzheimer’s, Parkinson’s, diabetes, heart disease, stroke and spinal cord injury, to name a few.

  • Therapeutic cloning from somatic cells may help repair tissues and create new autologous tissues (tissues that are produced from a patient’s own cells, genetically identical to him or her), thereby eliminating the problems of transplant rejection, the side effects of immune-suppressant drugs, and donor-organ availability.

  • Through the study of newly created cloned embryos, the process of genetic reprogramming could be better understood, contributing to our understanding of the workings of adult stem cells and the development of new therapies.

  • Cloning techniques could provide an initial source of embryonic stem cells, which are pluripotent (can be induced to develop into any type of specialized tissue) and are thought to be immortal (capable of being cultured indefinitely). Our scientific community is still in the beginning stages of this exciting research on stem cells. Until more studies have been completed and more discoveries made, we will not know whether adult stem cells will prove to be as useful as embryonic cells.  Until we know more, we must pursue all areas of research open to us.

Competing Bill

We are concerned that a competing bill presently before Congress, H.R. 1644, in its broad prohibition against human SCNT, might chill research into new fertility therapies and embryo development, since it is difficult to discern whether an embryo has been created via sexual (in vitro fertilization) or asexual (cloning) methods. H.R. 1644 prohibits not merely the creation of a cloned human child, but any use of human SCNT technology for any other purpose, including scientific and medical research.

H.R. 2172 recognizes that using SCNT in the development of medical treatments is not the equivalent of reproductive cloning. 

Additionally, H.R. 2172 explicitly does not apply to in vitro fertilization (which involves the combination of gametes, sperm and egg, to form an embryo), the administration of fertility-enhancing drugs, or the use of other medical procedures to assist a woman in becoming or remaining pregnant. It also explicitly does not apply to the use of mitochondrial, cytoplasmic or gene therapy.

Enforcement

Difficulty in enforcing the law and the fear that any use of human SCNT would open the door to reproductive cloning have persuaded many people to advocate a complete ban as provided for under H.R. 1644. But whether or not all human SCNT is made illegal, it is still scientifically and practically possible. However, the prospects under H.R. 2172 of serious fines, jail time, and the accompanying losses of professional licensure and the right to practice medicine are powerful disincentives to doctors who might attempt to create a cloned pregnancy.

Registration

  • H.R. 2172 requires all individuals who intend to perform human SCNT to register with the Secretary of Health and Human Services and to sign a statement that they are aware of the law's prohibitions and will not violate them. 

  • H.R. 1644, since it bans all use of human SCNT, provides no such requirement.

Civil Penalties

  • H.R. 2172: the penalty for violating the law, including failure to register, shall not exceed the greater of $1,000,000 or two times the amount of the gross pecuniary gain derived from violation.

  • H.R. 1644: the penalty for violating the law, if violation involved pecuniary gain, would be at least $1,000,000 but not more than two times the amount of the gross pecuniary gain derived from the violation, if that amount is greater than $1,000,000. No penalty is specified for violations that do not involve pecuniary gain.

Criminal Penalties 

  • H.R. 2172 and H.R. 1644 provide for a criminal penalty of imprisonment for up to 10 years as an alternative to, or in addition to civil penalties.

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