Ms. Roberts is a Ph.D. candidate in Neurobiology & Behavior at the University of Washington. Her laboratory receives funding from a $3.2M federal grant to UW for hESC research. She is the founder and co-director of the Forum on Science, Ethics and Policy, a multidisciplinary nonpartisan organization of students and postdocs that is committed to stimulating dialogue among local scientists, the public, and policy makers about the impact of science on society.

A piecemeal approach to stem cell policy
President Bush declared on August 9, 2001, that the federal government would fund research only on human embryonic stem cell (hESC) lines that had been derived before that time. Many scientists complain that the limited number and inferior quality of the twenty-two available lines that are eligible for federal funding hinder scientific progress and patient advocacy groups worry that treatments are being delayed.[1]

There are no indications that the second Bush Administration will revise its stem cell policy. Furthermore, even if the restrictions on federal funding of hESC research were relaxed, there are still two large regulatory gaps in the current U.S. policy that trouble both supporters and detractors of hESC research. The first gap is the absence of federal policies regulating stem cell research which is conducted with non-federal dollars. The second is that there is no ban on human reproductive cloning, even though such a ban is supported by a vast majority of Americans.[2]

State laws could potentially fill existing policy gaps and catalyze a change in federal policy.[3] However, not all are convinced that a state-by-state approach is the best method for modifying stem cell policy. US Representative Michael Castle (R-DE) believes that "we must continue to work to expand the current federal policy governing [stem cell] research, because a piecemeal [state] approach is not the solution".[4] Yet, dissatisfaction with the federal policy is leading to just such an approach. In 2004 alone, 32 states considered 106 bills involving hESC and cloning research.[5] The repercussions of state laws governing basic research must be carefully considered so that this piecemeal approach does not cause more harm than good.

State regulation of research
One result of most state legislative efforts would be a ban on human reproductive cloning. Although possibility of giving birth to a cloned baby is remote, such a ban would further decrease the likelihood. A ban on reproductive cloning would also benefit scientists, since blame for any attempt would belong to the rogue researcher and not to the scientific community as a whole.

Most scientists support a law that prohibits reproductive cloning but specifically allows a laboratory technique called somatic cell nuclear transfer (SCNT)[6] to produce new stem cell lines.[7] This technique, which replaces the DNA from a human egg with DNA from another person, is the first step in making either genetically matched hESCs for potential disease treatments or in making a blastocyst that might develop into a cloned baby if implanted into a woman’s uterus.

Three states have enacted a law that outlaws reproductive cloning and protects SCNT: California, New Jersey, and Rhode Island. However, most state bills have proposed a ban on SCNT along with reproductive cloning. Arkansas, Iowa, Michigan, and North Dakota already have passed laws prohibiting SCNT. Furthermore, 32 of the state bills considered in 2004 would have banned SCNT, whereas only 22 would have protected SCNT.

Some states are also attempting to regulate privately funded hESC research, since no federal policy does so. California and New Jersey’s current laws, which expressly encourage stem cell research, provide a regulatory framework for informed consent by blastocyst donors and for oversight of hESC research conducted with funding from any source. These laws also create an advisory committee composed of scientists, ethicists, law experts, and citizens to devise responsible hESC research guidelines. Other states considering similar laws include Washington, New York, Massachusetts, and Pennsylvania.[8]

State legislators hope that these regulatory laws will encourage private investment in hESC research.[9] Currently, few companies are openly conducting research on hESCs because 1) the controversy could be bad for business, and 2) potential cures and profits are too uncertain and too many years in the future to attract investors. It is possible that a well-written state policy that ensures transparency and oversight could help to move hESC research forward in the private sector by making the public and investors more confident that the research is progressing in an acceptable fashion. On the other hand, it is possible that legislation intending to promote hESC research may actually hinder it if the regulatory burden is too great. These purely regulatory policies are unlikely to stimulate hESC research in academic laboratories, which rely primarily on federal funding and must adhere to federal policies regarding hESC research.

A new experiment: State funding for basic research
Purely regulatory legislation apparently did not stimulate hESC research by an appreciable amount in either the public or private sector in New Jersey or California, since both states have recently dedicated state funds specifically to stimulate hESC research. New York and Wisconsin are also considering allocating state funding for hESC research. But it is California’s recently approved voter initiative – Proposition 71 - that could have a transforming effect on stem cell research, and possibly on our current model of basic research funding.

Last month, Californians voted by a convincing 59 to 41 percent to commit $3 billion in state funds over ten years specifically to hESC research.[10] There is no doubt that this financial investment will be an immediate boon to hESC research, since the proposed $295 million yearly investment is greater than the total 2004 expenditures of both the U.S. government ($25 million) and venture capital investments in private companies ($147.52 million).[11] California’s $3 billion experiment is sure to make a large impact on hESC research, but some of the repercussions could be both unexpected and possibly detrimental to basic science research in the long run.[12]

Supporters of Proposition 71 hope that the research breakthroughs of California researchers will lead to disease treatments. But a key justification for Proposition 71 was economic. Proponents assert that the revenue generated by job creating and royalties from scientific discoveries will more than pay for the initial investment.[13] If California funds lead to a treatment for a disease like Parkinson’s or diabetes, this may be true. But if the massive California effort does not lead to cures, not only may the public lose money, but they may also lose their optimism about the benefits of scientific research in general.

Critics also question whether Proposition 71 establishes the necessary oversight that is required to ensure that funded research adheres to high ethical standards.[14] [15] They argue that the “Independent Citizens’ Oversight Committee,” which is charged with governance of funding and research guidelines, is composed of researchers and patient advocates who may have a real or perceived conflict of interest in enforcing adherence to high ethical standards. Additionally, Proposition 71 takes the unusual step of amending the state constitution so that hESC research is a constitutional right and makes it nearly impossible for the state legislature to change the initiative. Thus, the citizens have little recourse if they feel that their investment is being used unwisely.

States: proceed with caution
State involvement in regulation and funding of basic research is relatively uncharted territory. Since World War II, basic research has been accepted as a charge of the federal government.[16] The recent bipartisan support for the NIH budget doubling suggests that most federal policy makers agree that this model is in the best interest of the United States. However, if individual states are willing to make large investments in basic research, the federal government may become less inclined to fund it. On the other hand, if investments move the research forward sufficiently to affirm the purported potential of hESCs to treat disease, then the federal government might feel compelled to loosen restrictions on federal funding for hESC research.

The most effective legislation will reflect a basic understanding of scientific findings, the research process, and existing research oversight procedures. Laws that contain inaccurate scientific wording or fail to consider existing federal policy will likely be ineffective or counterproductive. Therefore, it is important that experts in each state – including scientists, bioethicists, institutional review board members, fertility clinic doctors, and business leaders – are involved in discussing legislative efforts with both state policy makers and groups that support or oppose such legislation. In New Jersey and California, scientists were intimately involved in the policy process for legislation that provided both regulatory guidelines and funding for stem cell research.

Getting involved in the policy process
In my state – Washington – scientists were largely unaware that the state legislature considered six bills on cloning and stem cell research in 2004. But this will change in 2005. Inspired partly by Daniel Yankelovich’s call to action in “Winning Greater Influence for Science”,[17] a group of graduate students started a grassroots effort to stimulate dialogue among scientists, the public, and policy makers.[18] In October, we hosted a public forum on stem cells for our community and a roundtable discussion among policy makers, scientists, business leaders, and others to discuss “Stem cell policy in Washington State.”

The stem cell debate is an excellent opportunity to increase input of scientists in policy decisions. The most valuable lessons that scientists can teach are not about stem cell science specifically, but about the scientific process more broadly and about how to evaluate the credibility of scientific sources. Policy decisions, however, are not based on science alone. In a democracy, policy decisions require the support of the public. To maintain public trust in science, it is essential that research adheres to high ethical standards. Whether they come through the federal or state government, scientists should welcome further policies that prevent potential abuses while allowing promising research to move forward.

IN-PERSON ETHICS TRAINING REQUIRED OF ALL NIH EMPLOYEES
In the past, ethics training for NIH employees was required only for a select few and  could be completed via Internet learning modules.  This October, however, NIH changed its policy by mandating ethics training across the board, to be completed in-person by all NIH employees before midnight on December 31, 2004. 

In November, a county judge issued a preliminary injunction against SHAC, prohibiting anyone associated with the group from entering the property of any Valent employee or their family members.  In addition, specific names, addresses, and phone numbers must be removed from the SHAC website.  The attorney representing SHAC, Christine Garcia, said that the injunction violates free speech, and that the information posted on the website is already available in public phone books.  Garcia alleges that the names and addresses were posted only after the demonstrations had occurred.  A ruling on whether or not the injunction will remain permanent will be determined at a court hearing set for January 6, 2005.[2] 

Animal rights activism that borders on domestic terrorism is not a new phenomenon.  Animal rights groups have employed extreme tactics since the 1970’s.  SHAC U.S.A is an American affiliate of an organization started in England in 1999.  Its primary goal is to shut down Huntingdon Life Sciences, which contracts with many other companies, such as Chiron and Valent, to conduct animal testing services.  Recently, activists have adopted more violent and ruthless tactics to halt the use of animals in research and testing, placing many companies’ employees in danger of intimidation, vandalism, and harassment.[3]  The FBI has responded to increasing domestic terrorism by establishing the National Task Force and Intelligence Center to develop and implement a nationwide campaign to address the animal rights/eco-terrorism threat in the United States.[4]   

The Animal Enterprise Protection Act of 1992 (AEPA), in place to protect corporations and their employees from extreme activist tactics, only provides penalties against those who engage in physical acts against the industries.  It does not protect against the economic damage these industries suffer through threats and intimidation.  Senator Orin Hatch (R-UT) is expected to introduce an amendment to the current AEPA that will expand protections in the Act to encompass the economic damages industries experience. 

*TJ

In December 2004, the American Medical Association House of Delegates unanimously approved a resolution calling for the elimination of restrictive clauses in contracts between physician researchers and the industries that sponsor them.  The resolution is rooted in an A.M.A Council of Scientific Affairs report documenting how such clauses have limited the dissemination of clinical trial methodologies and results from others within the medical research community, and how they have inhibited physicians from disclosing information to patients. 

The resolution is intended to make it easier for medical researchers and physicians to discuss the process and outcome of their studies with their colleagues, without consulting first with their funders, and to enable them to uphold the ethical obligation they have to their patients to discuss all matters concerning their medical care.

In the spirit of the resolution’s mission “to protect the rights of physician researchers to present, publish and disseminate data from clinical trials,”[1] the AMA recommended creating a national registry of clinical trials.  In addition, the Pharmaceutical Research and Manufacturers of America, the American Academy of Pharmaceutical Physicians, and other organizations will work with the AMA to develop guidelines that would eliminate the use of confidential clauses that “interfere with scientific communication.”[2]

The one major concern voiced by the pharmaceutical industry is that data from only a few trials in a multi-trial endeavor would be discussed too early, which might not reflect an accurate final outcome and create false expectations among patients.

 *TJ