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WASHINGTON INSIDER
Summer 2004
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The National Catholic Bioethics Quarterly
introduces, in this issue, our quarterly political review.
Richard M. Doerflinger
Deputy Director
Secretariat for Pro-Life Activities
United States Conference of Catholic Bishops
Washington, D.C.
will alternate this column with
William L. Saunders
Director and Senior Fellow
Center for Human Life and Bioethics
Family Research Council
Washington, D.C.
Mr. Doerflinger is this issue’s contributor.
Congressional Impasse on Human Cloning
Human cloning has been a serious public policy issue in the U.S. since the birth
of “Dolly” the sheep in 1997. However, despite the introduction of several federal
bills, considerable congressional debate, and approval of a human cloning ban by one
chamber, Congress adjourned at the end of 2003 without taking final action on the
issue.
A Human Cloning Prohibition Act (H.R. 2505) was overwhelmingly approved
by the House of Representatives in 2001, but the Senate took no action, and the bill
died when the 107th Congress adjourned at the end of 2002. In February 2003 the
House again approved a similar bill (H.R. 534); but again the Senate took no action
on this bill or its Senate companion (S. 245). These 2003 bills carry over into 2004,
the second session of the 108th Congress, so only Senate approval (and the signature
of President Bush, who supports a ban on cloning) would be needed for enactment.
Senators remain divided over two very different approaches to human cloning.
S. 245, sponsored by Senators Sam Brownback (R-KS), Mary Landrieu (D-LA),
and twenty-seven others, would ban use of the cloning procedure known as “somatic
cell nuclear transfer” to create human embryos for any purpose. This is the policy
now approved twice by the House. However, some senators instead support S. 303,
a Human Cloning Ban and Stem Cell Research Protection Act, sponsored by Senators
Orrin Hatch (R-UT), Dianne Feinstein (D-CA), and nine others. This bill would
authorize use of the cloning procedure to mass-produce human embryos for research
purposes, while seeking to prevent pregnancy and live birth involving cloned humans.
Specifically, the Hatch/Feinstein bill would prohibit placing a cloned human
embryo into “a uterus or the functional equivalent of a uterus.”
A number of scientific and patient advocacy groups oppose S. 245, claiming
that it would block potentially promising medical research. The Catholic bishops’
conference, pro-life groups, and others opposed to human cloning oppose S. 303,
seeing it as a case of two wrongs claiming to make a right: The bill would authorize
human cloning itself, then prohibit the actions (implantation and gestation) needed to
allow a cloned human to survive. In effect, S. 303 would mark the first time a federal
law defined a class of human beings it is a crime not to discard or destroy.1
This congressional debate has run largely, but not entirely, along lines already
familiar from the abortion debate and from an earlier debate on federal funding of
embryonic stem cell research. Some ethicists (including some members of the
President’s Council on Bioethics) and members of Congress favor some funding of
research involving “spare” embryos from fertility clinics, but oppose specially creating
human embryos solely to destroy them in research. Citing concerns similar to
those expressed by environmental groups and watchdog groups that are critical of the
biotechnology industry, some House members who claim a “pro-choice” position on
abortion, such as Denis Kucinich (D-OH) and Bernie Sanders (I-VT), voted for the
House-approved cloning ban; and Senator Mary Landrieu (D-LA), who generally
opposes abortion restrictions, is an original co-sponsor of the companion Senate bill.
At the other end of the spectrum, S. 303 is co-sponsored by Senator Orrin Hatch (RUT),
who has generally supported pro-life legislation. Senator Hatch has publicly
argued that human embryos have no moral status as human beings unless they have
resided in a mother’s womb, and also that humans arising from the cloning procedure
may not have the status of human beings even if they are born.2
While S. 245, the outright ban on human cloning, has more supporters than the
rival bill, neither bill has acquired clear majority support in the Senate—not to mention
the sixty votes needed to overcome a filibuster. The result is an impasse that
may not end until events in the outside world convince Congress that it can no longer
delay addressing this issue.
While federal action on cloning may be stalled, this has not stopped Congress
from addressing the closely related issue of patents on human embryos. Nor has it
put an end to legislative action on cloning in the states.
Federal Action on Human Patenting
While many researchers have long wanted to use cloned human embryos to
obtain genetically matched stem cells for possible future therapies, some have cited
other uses for these embryos. For example, genetic material from patients with certain
diseases might be used to mass-produce cloned embryos as “models” for those
diseases, to be marketed to researchers in the same way that genetically tailored
laboratory mice are now. To make such avenues commercially viable, some researchers
would like to be able to patent cloned human embryos—or other embryos
that have been created, or genetically modified, to have traits deemed useful by
researchers.3
The U.S. Patent and Trademark Office (USPTO) has denied applications for
patenting members of the human species, citing the Thirteen Amendment’s ban on
owning human beings. Its policy is to refuse patents on living organisms unless the
adjective “nonhuman” is added. But an earlier USPTO policy against patenting living
organisms in general was overturned in 1980 by the U.S. Supreme Court, which
found no distinction between animate and inanimate inventions in the relevant federal
statute.4 And the current patent office has dropped its guard at least once,
granting a patent on cloned organisms in 2001 that failed to add the qualifier “nonhuman.”
5 In light of the growing pressure for marketable advances in cloning and
genetic engineering, the policy against patenting humans could be highly vulnerable
to a court challenge launched by biotechnology firms.
Responding to the challenge this summer was Congressman David Weldon (RFL),
a physician and prime sponsor of the House-approved cloning ban. On July 22,
he offered an amendment to the Commerce/Justice/State appropriations bill for fiscal
uear 2004. The Weldon amendment, which was approved on the House floor by
voice vote, reads: “None of the funds appropriated or otherwise made available
under by [sic] this act may be used to issue patents on claims directed to or encompassing
a human organism.”6
The full Senate did not act on this bill. Instead, this and several other appropriations
bills were combined into a Consolidated Appropriations Bill (H.R. 2673) near
the end of 2003. Despite efforts by Senate conferees to derail or weaken the Housepassed
human patenting amendment, that provision remained in the final consolidated
bill, which was approved by the House on December 8; the Senate will take up
this bill when it resumes deliberations in January 2004.
The Biotechnology Industry Organization (BIO), a Washington-based umbrella
group representing hundreds of biotechnology companies nationwide, led an unsuccessful
effort to scuttle the Weldon amendment. In a September 2nd “fact sheet”
attacking the amendment, for example, BIO claimed: “Investment and research into
developing biotechnology products would halt if the amendment were enacted into
law.... Treatments for tissue regeneration for burn victims, bone marrow regeneration
after chemotherapy, and growth hormone deficiency are some conditions for
which lifesaving biotechnology therapeutics would not be available.”7 Of course,
none of these research areas rely on the ability to patent human embryos (or on the
ability to use human embryos for research in general).
BIO’s fact sheet also claimed that the term “human organism” has no clear
meaning and might be interpreted to encompass stem cells and tissues that are currently
eligible for patenting. On this point, BIO apparently forgot that leading members
of its own coalition had formerly stated that exactly the opposite is true. When
Congress began considering federal funding of embryonic stem cell research in 1998,
it had to decide whether funding of such research was prohibited by a federal law
against funding experiments on human embryos (defined in that law as “human
organisms” at a very early stage of development). At one hearing centering on this
question, the most prominent embryonic stem cell researchers, NIH Director Harold
Varmus and Thomas Okarma of the Geron Corporation (a leading member of BIO),
testified that a stem cell is clearly not an “organism” and therefore not covered by the
ban on funding embryo research.8 BIO’s new claim that embryonic stem cells might
be “organisms” in their own right ran directly counter to that testimony. Ironically, if
BIO’s new claim were true, it would mean that federal funding for embryonic stem
cell research violates federal law (because the research involves experimenting on
stem cells which cannot clearly be distinguished from human organisms)—surely an
unintended policy result of BIO’s new argument.
The real reason for BIO’s opposition to the Weldon amendment was that BIO
does indeed want to treat some human beings as patentable “inventions.” This was
apparent in a footnote to the BIO fact sheet, explaining the organization’s own stance
on human patenting:
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Only things that have been specifically altered in their physical make up through
human intervention, and as a result differ from the corresponding products in
their natural states, may be the subject of a U.S. patent claim. For example, a
bacterium discovered in the wild may not be patented as a “thing,” but a purified
composition containing the bacterium in a form distinct from how it is
found in nature may be patented. Similarly, an animal or human produced by
conventional reproduction—with no intervention by an “inventor”—would not
qualify as a patentable “manufacture” because it is a product of nature. Living
organisms that possess physical characteristics resulting from human intervention
qualify for protection because such living organisms are no longer
“products of nature.”9
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The chilling implication of this policy stance is that any human created in ways other
than “conventional reproduction,” and any human whose physical characteristics
have been changed by technological intervention, should be seen not as a fellow
member of the human race but as a “manufacture,” a commodity to be licensed,
marketed, bought, and sold by the biotechnology industry. Groups lobbying in support
of the Weldon amendment needed only to place BIO’s own language before
members of Congress to prove that the amendment is urgently needed.
In a further irony, BIO enlisted the aid of patient groups that support embryonic
stem cell research in its campaign to defeat the Weldon amendment. At BIO’s
urging, the Coalition for the Advancement of Medical Research (CAMR) sent out
alerts to the parents of children with devastating diseases, warning them that treatments
for their children may be blocked by the amendment. These groups were still
lobbying against the amendment even after BIO itself stopped opposing it ostensibly
due to assurances by congressional sponsors that the amendment would not interfere
with patents on stem cells. Yet the implication of BIO’s stance on human patenting
was that biotechnology companies may want to assert an enforceable property interest
in any human patient whose “physical characteristics” they have modified to
prevent or cure disease. Patient groups lobbied vigorously for what they thought was
an opportunity to have their children cured, never having been told that the real issue
is whether their children may in effect be owned by a for-profit company. This was a
new chapter in the continuing and tragic saga of patient groups lobbying against their
own interests on this issue, by believing hyped promises for embryo research while
ignoring or downplaying the real advances coming forward from morally noncontroversial
cell therapies.
As of this writing, the fate of the Weldon amendment was tied to the ultimate
fate of the end-of-year omnibus spending bill, which the U.S. Senate may or may not
approve in January. If the omnibus bill falls, many federal programs will likely be
funded by means of a continuing resolution that maintains 2003 spending levels and
policies through September 2004, and this amendment would not go into effect.
Human Cloning Developments in the States
The impasse on cloning in Congress has allowed individual states to set their
own policies. In 2003, Arkansas and North Dakota approved complete bans on
human cloning for any purpose, joining three other states that had already taken this
approach (Iowa, Michigan, and Virginia). In addition, South Dakota, since 2000, has
banned harmful experiments involving human embryos, including cloned embryos,
and several other states may restrict research using cloned embryos depending on
how their laws on embryonic and fetal research are interpreted.10
Beginning in 2002, states in several parts of the country began to consider
strikingly similar bills to authorize human cloning for research purposes. What all
these bills had in common was a commitment to allow the development of cloned
human embryos into the fetal stage if that is demanded by the needs of research.11
The California bill, for example—the only one of these bills to be enacted into law in
2002—stated that “research involving the derivation and use of human embryonic
stem cells, human embryonic germ cells, and human adult stem cells from any source,
including somatic cell nuclear transplantation, shall be permitted.” Since embryonic
germ cells are obtained at about eight weeks of fetal development, and adult stem
cells are generally obtained near or after birth, the implication of this bill was that
researchers’ efforts to exploit cloned humans for their stem cells may move well
beyond the embryonic stage. California’s chief restriction on cloning is that one may
not use a cloned embryo to initiate a pregnancy that can result in “the birth of a
human being.”12 BIO was instrumental in promoting the California law as a model
for other states in 2002 and 2003—ignoring its own June 2003 testimony to the
President’s Council on Bioethics insisting that BIO does not support maintaining
cloned human embryos past fourteen days of development.13 This ever-expanding
legal agenda may be partly due to recent scientific findings—several studies have
found that “therapeutic” use of cloning to treat diseases in animals may require
sustaining the cloned animals past the embryonic stage to harvest usable tissues.14
The end of 2003 saw further action along these lines. In December, the Massachusetts
State Senate attached a provision, similar to the California law, to its version
of a year-end budget bill, but the provision died when conferees from the state’s
House of Representatives refused to accept it.15 Finally, on December 15th, the New
Jersey State Assembly gave final approval to a cloning bill that had already been
approved early in 2003 by the State Senate, giving New Jersey the most extreme
official policy on human cloning in the country.16
The New Jersey bill had been withdrawn from Assembly consideration in February
2003, after columnist Robert Novak and other observers publicly pointed out
how potentially sweeping the bill’s language is.17 Yet the bill was revived without
change in December and passed, after sponsors assured their colleagues that the bill
is simply a show of support for “stem cell research.” In fact, the New Jersey law has
the same expansive language as the California law regarding the commitment to
obtain embryonic, fetal, and adult stem cells from cloned humans. Potentially it is
more extreme than California’s law, because its only legal restriction on cloning is
that researchers may not sustain a cloned human “through” the fetal and newborn
stages to produce “a new human individual.”18 The implication here was that cloned
fetuses may be aborted for their stem cells right up through the ninth month of
pregnancy and that even a cloned newborn infant may not yet have the status of a
human individual. On January 4, 2004, Governor McGreevey signed the bill into
law.
The national leadership of BIO had gone out of its way to testify in support of
the New Jersey bill.19 This, and BIO’s stance in support of patenting human beings
who have been created or modified with technological assistance, should help clarify
the issue that faces Congress. It is increasingly clear that the debate on human cloning
is not just about the human embryo—it is not about disagreements on “when life
begins.” It is about an agenda for treating some classes of human beings, potentially
at any stage of development, as “manufactures” and thus as mere commodities in an
age of biotechnology. The prospect raised by these developments is nothing less than
a new form of slavery, in which one class of humanity can produce and exploit
(perhaps even buy and sell) other humans for profit, all in the name of human
progress. It remains to be seen how many members of Congress will realize what
kind of Brave New World is on the horizon—due in part to their own inaction.
Richard M. Doerflinger
Deputy Director
Secretariat for Pro-Life Activities
United States Conference of Catholic Bishops
Washington, D.C.
Notes
1
See testimony of Richard M. Doerflinger on behalf of the U.S. Conference of Catholic
Bishops before the Senate Commerce Subcommittee on Science, Technology, and Space,
March 27, 2003, http: //www.usccb.org/prolife/issues/bioethic/cloning/test327.htm.
2
“I believe that human life begins in the womb, not in a petri dish.” Statement of the
Honorable Orrin Hatch, hearing before the U.S. Senate Judiciary Committee, March 19,
2003, http://judiciary.senate.gov/member_statement.cfm?id=622&wit_id=51. “No doubt
somewhere, some—such as the Ralians [sic]—are trying to make a name for themselves
and are busy trying to apply the techniques that gave us Dolly the Sheep to human beings.
Frankly, I am not sure that ‘human being’ would even be the correct term for such an
individual heretofore unknown in nature.” Statement of the Honorable Orrin Hatch, Hearing
before the Senate Judiciary Committee, February 5, 2002, available at http://
www.senate.gov/~hatch/index.cfm?FuseAction=Topics.Detail&PressRelease_id
=180430&Month=2&Year=2002.
3
See Neil Munro, “The New Patent Puzzle,” National Journal (March 2, 2002): 628–629.
4
Diamond v. Chakrabarty, 447 U.S. 303 (1980). See testimony of Karen Hauda on
behalf of the U.S. Patent and Trademark Office before the President’s Council on Bioethics,
June 20, 2002, http://www.bioethics.gov/transcripts/jun02/june21session5.html.
5
Andrew Pollack, “Debate on Human Cloning Turns to Patents,” New York Times (May 17, 2002), A12.
6
See Congressional Record (July 22, 2003), H7274.
7
Biotechnology Industry Organization, fact sheet, “New Patent Legislation Sets Dangerous
Precedent and Stifles Research,” September 2, 2003, http://www.bio.org/ip/
cloningfactsheet.asp.
8
Stem Cell Research: Hearings before a Subcommittee of the Committee on Appropriations,
U.S. Senate, S. Hrg. 105-939 (Washington, D.C.: U.S. Government Printing
Office 1999), 3, 7, 29, 71.
9
See BIO “New Patent Legislation,” note 1.
10
See USCCB Secretariat for Pro-Life Activities, fact sheet, “Current State Laws on
Human Cloning,” http://www.usccb.org/prolife/issues/bioethic/statelaw.htm.
11
See Americans to Ban Cloning, “State Bills on Human Cloning,” March 26, 2003,
http://www.cloninginformation.org/info/ABC-State-Laws.htm.
12
Ibid.
13
See Illinois Biotechnology Industry Organization, “BIO State Government Relations
Committee Meeting,” March 4, 2003, http://www.ibio.org/upload/notesMarch4
BIOlegismtg.doc (reporting that national BIO was circulating the California law to its
state affiliates as a model for other states); remarks of Michael Werner of BIO before the
President’s Council on Bioethics, session 4, “Biotechnology and Public Policy: Embryo
and Related Research,” June 12, 2003, http://www.bioethics.gov/transcripts/jun03/
session4.html (BIO claims to support a fourteen-day legal limit on development of any
cloned human embryo).
14
See Robert P. Lanza et al., “Generation of Histocompatible Tissues Using Nuclear
Transplantation,” Nature Biotechnology 20.7 (July 2002), 689–96. Regarding this effort
to use cloning to produce functional kidney tissue for cows, the authors noted: “Because
the cloned cells were derived from early-stage fetuses, this approach is not an example of
therapeutic cloning and would not be undertaken in humans.” Ibid, 689. Lead researcher
Robert Lanza later reversed his stand, insisting that this study in gestating and aborting
cloned animal fetuses to obtain stem cells is indeed a model for human “therapeutic cloning.”
See Do No Harm: The Coalition for Research Ethics, press release, “Reality Check:
Proof of ‘Therapeutic’ Cloning?” March 10, 2003, http://www.stemcellresearch.org/pr/
pr_2003-03-10.htm. Another study, seeking to use cloning to correct an immune deficiency
in mice, ultimately required developing the cloned mouse to the newborn stage to
obtain therapeutically beneficial stem cells. See William Rideout et al., “Correction of a
Genetic Defect by Nuclear Transplantation and Combined Cell and Gene Therapy,” Cell
109.1 (April 5, 2002), 17–27. For a critique of this study, see Americans to Ban Cloning,
“Why the ‘Successful’ Mouse ‘Therapeutic’ Cloning Really Didn’t Work,” April 2002,
http://cloninginformation.org/info/unsuccessful_mouse_therapy.htm.
15
See Paul Nowak, “Mass. Budget Bill Passes without Embryonic Stem Cell Funding,”
LifeNews, November 20, 2003, http://www.prolifeinfo.com/bio148.html.
16
Robert Schwaneberg, “Stem-Cell Research Bill Squeaks through Assembly,” Star-Ledger (Newark), December 16, 2003.
17
See T. Hester and K. MacPherson, “Stem Cell Bill Pulled after Flood of Dissent,”
Star-Ledger (Newark), February 11, 2003; R. Novak, “Christopher Reeve Republicans,”
February 5, 2003, http://www.townhall.com/columnists/robertnovak/printrn20030205.shtml.
18
See Americans to Ban Cloning, “State Bills,” note 11 above.
19
Testimony of Michael J. Werner on behalf of the Biotechnology Industry Organization
in support of New Jersey Senate Bill 1909, November 4, 2002, http://www.bio.org/bioethics/tst200211.asp.
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