Regulating cloning

Introduction

Having helped block federal legislation that would ban human cloning for therapeutic purposes, the biotechnology industry is lobbying a handful of state legislatures to pass bills that would legalize the controversial techniques. Five states are currently considering nearly identical measures that the Biotechnology Industry Organization (BIO), the industry’s lobbying group, advocates; two other states, California and New Jersey, have already passed such measures into law.

The state bills faithfully duplicate word for word substantial portions of a BIO-backed bill that California adopted two years ago. Critics charge that the legislation is marked by “sloppy language” and ethical ambiguities. BIO’s intention in backing the bills was made clear in an unsigned memo to members of its state government relations committee dated March 4, 2003.

“BIO is circulating the [California] legislation as a means of promoting its solution to enabling therapeutic technologies,” the memo read in part. It goes on to note that opponents of unregulated cloning technology are battling state efforts to permit cloning human embryos to extract stem cells. “They understand the effort to create stem cell research at the state level.”

Since 1999, BIO has spent $12.7 million lobbying Congress and the executive branch on a number of issues, including its effort to block legislation on human cloning. The trade association and its state affiliates have also backed state bills that legalize embryonic stem cell research, permit with some restriction the sale of embryonic and fetal material, and allow researchers to create embryos for the purpose of medical research.

Some of the state bills that BIO is backing outlaw reproductive cloning. However, while they ban researchers from performing human cloning experiments that would result in the birth of a cloned human being, they allow the development of cloning techniques that might lead to new treatments for diseases.

Such experiments are ongoing. On Feb. 11, 2004, two South Korean scientists announced they had cloned human embryos and extracted stem cells from one of them, sparking fresh debate on the issue of human cloning. The accomplishment in what is called “therapeutic cloning” is hailed in scientific circles as a major breakthrough that will open the door for cell-based therapies.

Therapeutic cloning, the creation of embryos for the purpose of extracting stem cells—unspecialized cells that can develop into almost any human tissue or organ—could be used to treat patients suffering from diseases such as Parkinson’s and Alzheimer’s. It is believed that an embryo cloned using a cell from a patient will have genetically identical stem cells that could be grown into replacement tissues, or spare parts, to treat disease.

But it also brings human cloning close to reality. The techniques used to produce a cloned human embryo for therapeutic purposes could also be used to create a cloned embryo to be implanted in a woman’s uterus, and brought to term.

The embryos that the Koreans, one of whom was trained in the United States, created through cloning were not implanted—reproductive cloning is illegal in South Korea. But in the United States, there is no federal law or regulations governing such research.

Congress has been pursuing legislative measures to regulate the cloning research for more than six years. Since 1997, some 44 bills have been introduced in the House of Representatives and Senate seeking to ban or regulate cloning research. But despite such seemingly feverish legislative actions, congressional efforts failed because of the differences over whether to allow cloning for research purposes.

While there is an overwhelming consensus among members of Congress to prohibit reproductive cloning, or the creation of a genetically identical human being, lawmakers are almost evenly split on whether to allow the less controversial therapeutic cloning research, leading to a legislative stalemate.

State legislatures have entered the breach. Over the past two years state legislatures have considered nearly 100 bills on the cloning issue. Eight states have enacted laws addressing issues related to human cloning, and many more have embryonic and fetal research regulations, according to the National Conference of State Legislatures, a non-profit organization that tracks legislative activities in states.

The biotechnology industry has been tracking that activity as well.

Playing one state off another

States with a large biotech presence have moved toward legalizing the therapeutic cloning and stem cell research. California, the country’s largest biotech state, became the first to legalize therapeutic cloning in 2002, when it enacted a stem cell research law. The legislation was preceded by an executive order by President Bush in 2001 that limited the federal funding of stem cells to a few cell lines.

Once California had passed its law, BIO’s affiliates in other states began lobbying for similar measures. In 2002, a study funded by the Massachusetts Biotechnology Council, that state’s BIO affiliate, warned of increased competition among states for biotechnology jobs. The study warned that, “Competition for biotech jobs is getting tougher as rival states such as California and North Carolina, often with strong state-government support, organize to attract companies and jobs.”

Though California was the only state that adopted a law legalizing research into therapeutic cloning, the study claimed that rival states consistently offered “support of life-sciences research, both through funding and through the development of enabling regulations such as the California legislature’s.”

The study recommended 10 initiatives that the state could do “immediately” to help the Massachusetts biotech industry, including supporting “legislation (including legislation on stem-cell research and biodefense) that will enable life-sciences organizations to operate and innovate within a clear and predictable framework.”

It also warned that “burdensome regulations” can “deter companies from operating in a particular location. State regulatory agencies should review and reevaluate existing regulations for appropriateness.”

In the past two years, legislators in Massachusetts and four other states have introduced bills with language nearly identical to that of the California law. With a few variations, Illinois, Maryland, New York and Washington legislators have all authored bills with a preamble stating that, “An estimated 128 million Americans suffer from the crippling economic and psychological burden of chronic, degenerative, and acute diseases, including diabetes, Parkinson’s disease, cancer, and Alzheimer’s disease.”

Lawmakers involved in each of those legislative efforts have told the Center that the similarity in language was due, in part, to their reliance on the California bill, the same one that BIO actively encouraged states to adopt.

In New Jersey, home to more than 100 biotech companies, legislators copied more than the preamble from the California law. The first eight paragraphs of New Jersey’s Stem Cell Research law are nearly identical to the California counterpart.

New Jersey lawmakers told the Center that they modeled their bill after California’s. But Garden State legislators crafted a bill that was friendlier to the biotech industry than the one on which it was based.

The battle of New Jersey

In January 2004, New Jersey Gov. Jim McGreevey signed into law a controversial bill that authorized “research involving the derivation and use of human embryonic stem cells, human embryonic germ cells and human adult stem cells, including somatic cell nuclear transplantation.”

Somatic cell nuclear transplantation is the technique used to create an embryo that is an exact genetic duplicate of the cell donor—in other words, a clone.

The New Jersey bill permits the sale of embryonic and fetal material to researchers for “reasonable payment.” It bars reproductive cloning, defined as the “replication of a human individual by cultivating a cell with genetic material through the egg, embryo, fetal and newborn stages into a new human individual.”

Officially known as “Stem Cell Research Act,” it was introduced in the New Jersey Senate on Sept. 30, 2002, and sailed through the chamber within two months on a 25-0 vote.

When the bill reached the General Assembly, however, it ran into heavy opposition. Pro-life groups and other opponents argued that the bill’s ambiguous language and weak ethical safeguards could actually permit not just the cloning of an embryo, but its implantation. They were soon joined in their opposition to the bill by New Jersey Right to Life, the Catholic Bishops of New Jersey, and members of the President’s Council of Bioethics, which was created by President Bush in 2001 to advise him on bioethical issues.

In the Health and Human Services Committee, two members of the General Assembly, Charlotte Vandervalk and Samuel D. Thompson, criticized the “undue haste in releasing the bill without taking time to give full consideration to the practical and ethical questions.” They listed a number of concerns they had, including “the potential that this bill creates for the forced abortion of cloned embryos…the potential for medical abuses and exploitation of women and children; and the creation of a new class of human—one designated for the purpose of experimentation.”

The biotechnology industry countered with its own high level supporters. A number of patients’ groups backed the bill, most notably the Christopher Reeve Foundation, founded by the paralyzed former “Superman” star. Reeve testified in favor of the legislation and was present at the signing ceremony. But the main force behind the bill was New Jersey’s biotechnology and pharmaceutical industries, and its universities and hospitals, which mounted a formidable lobbying effort.

The Garden State is home to some of the largest pharmaceutical and biotech companies in the world, including Merck & Co., whose subsidiaries conduct stem cell research, and Johnson & Johnson, which is also involved in the research. New Jersey also has some state-of-the-art hospitals and universities that conduct stem cell research.

Other backers of legislation included University of Medicine and Dentistry of New Jersey and Saint Barnabas Medical Center, a top health care provider and the place where the first mammal was cloned from embryos. David Beck, president and chief executive officer of the Coriell Institute for Medical Research, a New Jersey-based, non-profit biomedical research institution, testified on behalf of the bill three times.

Leading the lobbying efforts for the industry was Biotechnology Council of New Jersey, a BIO affiliate which represents more than a hundred biotech companies. They hired one of their member firms, Princeton Public Affairs Group, the top lobbying firm in the state, which boasts Dale J. Florio, a former adviser to then-Gov. Christine Todd Whitman, John F. Russo, a past president of the New Jersey Senate, and Bradley Brewster, who served as executive director of the New Jersey General Assembly.

BIO itself pushed for passage of the measure. Testifying in its favor, BIO vice president Michael J. Werner raised the specter of competition from other states to pressure New Jersey legislators. “There are states that are aggressively pursuing legislation to attract biotechnology companies,” he said.

The General Assembly did not vote on the bill until after the November 2003 elections. In a lame duck session—the newly elected lawmakers would not be sworn in until January 13—the measure was passed into law.

Potential for abuses

Even though it explicitly bans reproductive cloning, most of the law’s critics are concerned about the law’s potential for abuses. “Using the language of the bill itself, you can conceivably harvest body parts,” Assemblyman Joseph Pennacchio, a Republican who voted against the bill, said. “Unless that language is tightened up, somebody could, in future, use that open-ended language and do a lot of nefarious things.”

Beck, of the Coriell Institute for Medical Research Institute, said the legislation represented a “public demonstration of support” to a very advanced branch of science. “Research on stem cell, whether embryonic stem cell or adult stem cell is the very cutting edge of cell biology, genetics and cellular engineering,” he said.

Beck, who testified in favor of the bill on three occasions, rejected the charge that the law was hastily written. “It went through a full political process, having been considered through all the various committees. I would say it went through a very deliberative process.”

Both supporters and opponents of the New Jersey law agree on one substantive point: it was intended to boost the biotechnology industry. The act itself makes this point explicitly: “The biomedical industry is a critical and growing component of New Jersey’s economy, and would be significantly diminished by limitations imposed on stem cell research,” it states.

“This [law] is driven by dollars and cents,” Pennacchio said. “They want… a lot of outside science money coming into the state, to do all those sorts of scientific experiments. Of course, now that they have an open door, they can.”

The experience in California shows how much money can flow. Since the state legalized stem cell research, California researchers have benefited as millions of private dollars were pumped into the research. Stanford University received a $12 million grant from one anonymous Bay Area donor alone. A private group, Californians for Stem Cell Research and Cures, is now trying to raise $3 billion for stem cell research over 10 years through state-issued bonds.

By putting a legal stamp on the research, New Jersey did become a favored place for biomedicine research, scientists and biotech executives say.

States with a large biotech presence are under pressure to enact similar laws legalizing stem cell research and therapeutic cloning, lest they risk losing research—and jobs—to the two pioneer states.

As in New Jersey, the biotech industry has tried to play states against each other in order to win concessions on stem cell research. Elected officials and biotech researchers have argued that they need to compete for the industry’s favor by passing laws like New Jersey’s.

“If I were a biotech company deciding to relocate, in any biotech now I wouldn’t want to foreclose the possibility of needing to do stem cell research, even if I weren’t a stem cell company—if I were choosing where to relocate on the East Coast, I sure might pick New Jersey over Maryland,” Curt Civin, a professor at Johns Hopkins University in Baltimore, told the Center. Civin worked with Sen. Orrin Hatch on a bill he introduced last year and is one of the architects of Maryland bill introduced by state Delagate Samuel I. “Sandy” Rosenberg. “I think university research will migrate too.”

“The biotechnology industry is very interested in [Massachusetts’ stem cell]… legislation,” state Rep. Peter Koutoujian, House chairman of the Joint Committee on Health Care, recently told the Boston Business Journal. New England has more than 250 biotechnology companies, more than any other region except California. “Massachusetts has so many great advantages in drawing and maintaining biotechnology companies to our state. But unless they feel we will be welcoming them to their next generation of research, we may start to lose some of that.”

Sara Feigenholtz, who sponsored a stem cell bill in Illinois, told the Center that her state is attracting researchers from the neighboring Iowa, where therapeutic cloning is illegal.

Free market in eugenics?

Iowa is one of at least four states—Arkansas, Michigan and North Dakota are the others—that have banned both reproductive and therapeutic cloning, laws that the biotechnology industry and others have lobbied against.

Research groups and patients rights organizations criticize what they see as a concerted effort from the right to ban therapeutic cloning. “We would support a prohibition on reproductive cloning,” said Sean Tipton, a spokesman for the Coalition for the Advancement of Medical Research, a group of patient rights organizations, universities, foundations and individuals. “There’s a broad support for banning reproductive cloning. But the problem is that there’s a group that wants to make the prohibition too broad and ban a promising science.”

Yet when an Alabama state lawmaker, Gerald Allen, a Republican from Tuscaloosa, introduced a bill in 2002 that would have made cloning a human being a felony under state law, BIO’s state affiliate opposed the measure.

“Our feeling is that this should be a federal issue and Alabama should be operating on the same playing field as other states,” Charles E. Bugg, then the chairman of the Biotechnology Association of Alabama, and CEO of BioCryst Pharmaceuticals, told The Birmingham News.

Allen’s measure did not pass.

“Just because we have the capability and the technology to do something does not mean it is the right thing to do,” Allen explained to The Birmingham News after introducing his bill. “Human cloning is a direction we should never go.”

As the technology progresses, there is no regulatory safeguard to prevent that direction from being pursued.

Researchers Agustín Armendariz and Alexander Cohen contributed to this report.