1.
If anything, the unhealthy levels of NPR that I ingested during the Summer of 2001 left me with one, lasting political aftertaste: Stem Cells. Knowing today what would transpire in the next few months, it's hard to believe that such a pastoral world ever existed. Hosts jabbered with guests about Bush and his upcoming Stem Cell Use ruling like it would be the thing that defined his presidency. After a certain point, the specialists weren't even defining words like "pluripotent" anymore; everyone already knew what they meant.

And so the rivalry of the summer ran up to its own veritable Super Bowl. On the evening of August 9th, 2001, President Bush spoke through America's Boob Tubes for the first time since his inauguration almost 8 months prior. He outlined his views, and thus the new laws, governing the controlled use of embryonic stem cells. Federal funding for stem cell research would be limited to the supposedly 60 unique lines that were already in existence, thus eliminating the "further destruction of human embryos that have at least the potential for life." The President's address constituted an Executive Order, an immediate measure often used during military operations that bypasses the more deliberate drafting of laws that take place in Congress. Many were expecting a congressional response to Bush's statement, but we now know that the plate of the American Government became very full, very quickly, exactly a month later.

The embryonic stem cell debate is a fascinating confluence of science, politics and ethics, and the legislation surrounding it has been unique. Due to the larger national issues facing the federal government, the stem cell issue receded from the national priority list almost immediately after it bubbled to the surface. The near instantaneous removal of this issue from the nation's political consciousness has resulted in a test period of sorts for the President's plan. Today, we can look back at the past three and a half years and once and for all inspect the effect of the embryonic stem cell guidelines on scientific progress. In addition, the Federal disinterest in the issue has spawned an interesting state-side response, concocting the next generation of stem cell legislation.

2.
In the years following the creation of the Bush Guidelines, the fallout has gone something like this: the mother has given the child access to the cookie jar, but placed it on top of the kitchen cabinet without giving the ladder necessary to get to the treats. All that the child can get is a few cookies that fell on the floor and are growing moldy. The child can either wait for the mother to bring the cookies down or buy a ladder, which of course the child can't afford. Neither option seems worthwhile, and the child begins the search for other sweets.

Shortly after Bush laid out his policy, things started to go off-track. Reports quickly surfaced revealing that only 22 approved embryonic stem cell lines actually existed, two-thirds less than initially promised. Scientists began developing more advanced methods of stem cell extraction and working with the federally approved lines seemed increasingly like using yesterday's technology to developed tomorrow's treatments. In a further blow, rumors started to circulate that many of the approved lines were contaminated. But these were only the beginnings of the problems facing scientists interested in stem cell research.

Journalists love to write about Embryonic Stem Cells in companion with their neurological disease pals, Alzheimer's and Parkinson's. These two debilitating conditions are caused by the death of neurons, a process that could hopefully be stalled by the innate ability of stem cells to transform into any cell-type in the body. However, at this stage of stem cell technology, this companionship is little more than an effective device for explaining what stem cells are. Scientists know that stem cells have the amazing potential to differentiate into any flavor of cell the body has to offer, but they are more preoccupied currently with getting them to successfully grow on culture dishes. They are more focused on the extraction and maintenance stage, rather than the differentiation and treatment stage. For this reason, the major stem cell advances of the past few years have been innovations in methods of extracting and growing stem cells rather than successfully turning them into the neurons that could treat a Parkinson's patient.

Understanding this facet is key to appreciating the true restriction of the federal policies. The limitation of research to only 60 (or 22) lines essentially freezes the technology at a stage that stem cell researchers are not yet prepared to deal with -creating treatment methods from stem cells. Instead, the true breakthrough research is isolated within a few centers - private companies (whose ulterior motives often sully the pure climate of "science for science's sake" that exists in most public labs,) and institutions that have enough private endowment to finance the research themselves. And even after potential advances and discoveries, the new stem cell science stays on these islands for the simple reason that mandate does not allow its transfer into the federally funded domain. A lab wishing to work with newly created cell lines would have to make sure that no piece of equipment, from the smallest beaker, to a cell incubator, to the lab building itself were ever funded by public money. It is this final hurdle - the child's inability to buy a ladder - which has truly stalled embryonic stem cell research.

Funding numbers from the National Institutes of Health (NIH) reflect the stagnant climate. In 2003, a paltry $30 million was granted to research organizations for the study of embryonic stem cells. To put this number in perspective, the average NIH grant for a primary investigator is roughly $1 million. Doing the math shows that under 50 labs received grants for embryonic stem cell research corresponding to the governments guidelines. Comparatively, the NIH allocated $5.5 billion towards cancer research and $2.8 billion to AIDS research in the same year. It is ironic that the Bush Administration is using these statistics to support their stem cell policy. The lack of funding, they say, shows that stem cell research has not hit its stride yet and is still too underdeveloped a field to deserve a more inclusive policy. Looked at more logically, however, the scant funding is a clear example of the scientific community's opposition to the Bush guidelines - the policy is so restrictive that its not worth seeking federal money.

3.
I met Elias Zerhouni on the grounds of Mass. General Hospital, a few months before Bush's reelection and a simultaneous shift in the stem cell story. Zerhouni holds the challenging task of being a Scientist working for the Bush Administration. As the Director of the NIH, he has overseen the completion of an effort to double the NIH budget and a transformation of the department's goals. The presentation I saw him give that day was an outline of the "NIH Roadmap," a forward thinking approach to anticipate the needs of life science research and keep abreast of new funding needs. My boss' boss, who was hosting Zerhouni during his visit, introduced me to him. He had an extremely solid handshake and I think he said something like "Its good to have young people excited about science." At Johns Hopkins, his former home, Zerhouni helped to create and run a $58 million stem cell research center. Even with this background, Zerhouni still has to be the voice-piece for the administration on all things Health. We didn't discuss his stance on the embyonic stem cell issue, but in the coming months, I would see his public statements display a subtle, but poignant shift in the administrations views.

Around the same time I was shaking Zerhouni's hand, stem cells returned from a long hiatus as a key issue in the Presidential campaign, making their biggest splash with Ronald Reagan Jr's speech at the Democratic National Convention. Also during that summer, legislators in California were finalizing a bill with the potential to change the direction of stem cell research, and in their minds, spark the Gold Rush of the 21st century. Proposition 71 was unique in many ways, only one of them being that it would be the largest allocation of state funds to scientific research in the history of the United States. $3 Billion would be distributed over 10 years to those in Industry and Academia wishing to study Stem Cells.

A passage of the bill would instate California as a haven for research- Investigators could write grants to the California Institute for Regenerative Medicine to fund the research prohibited by the federal government. The money would be generated from the sale of State Bonds, a pet project of California's republican Governator Arnold Schwarzenegger. Interestingly, this best explains his own support of the bill, correlating directly with his party's strategy of short term gain balanced with long term debt. Even so, the state justified the expenditure by the prospect of drawing many new top scientists to the Golden State as well as the potential to reap large dividends off of any Stem Cell patents created using state money. Even three months before the state would vote on the bill on November 4th, the overwhelming support almost assured its approval.

The fifth of November was a sad day for (still) Senator John Kerry, but California awoke on that (no doubt) sunny and warm morning full of bright prospects after their populace passed Prop 71 with a 59% majority. There were Institutes to set up, people to hire, and scientists to lure west. California's legislation is a step forward in a number of different ways. The bill is a 3 billion pound gorilla, sitting on the left edge of the United States forcing Washington to reevaluate its stance on the stem cell debate. In addition, it sets up potential competition between other scientific powerhouse states. There is suddenly a huge amount of money on the table, and state legislatures hoping to keep cutting edge research in their backyards have to think about their own stem cell bills. Since the legislative process of the states is somewhat speedier than that of the federal government, California's bill sets the stage for the landscape of stem cell research to change quite dramatically in a short period of time. Finally, the public approval of Prop 71 reflects the shift in sentiment surrounding stem cell debate. Granted, this bill was passed in California, not Texas, but the groundswell of support implies that the opinions of the general public may be aligning with those of the scientific community - restriction on embryonic stem cell research will need to be lifted if progress is to be achieved in this exciting, though controversial, field.

This past January, Bush's approved cell lines were dealt a near fatal blow. A group of scientists, reporting in the prestigious journal Nature Medicine, concluded that all 22 approved stem cell lines were contaminated. The current technique of growing human embryonic stem cells involves a bed of mouse feeder cells. It seems that the close interaction between these two cell types caused the human cells to become tainted with certain mouse proteins. Contaminated cells could not be injected into humans since the immune system would promptly reject them after recognizing the foreign proteins. The whole story makes working with the approved lines sound even less desirable.

In a brief editorial published in USA Today shortly after contamination story broke, Zerhouni tried to calm the storm by insisting that current techniques make contamination problems an issue for any stem cell line, not just the Bush approved lines. "The most basic scientific questions remain to be answered, and that's what we must concentrate on now. That's what the president's plan is meant to accomplish." Still, both the passively defensive argument and the greater scientific problems facing the approved cell lines foreshadow a crumbling of the Administration's stance.

4.
Robert Lanza, one of the super stars of stem cell research, was probably inquiring about real estate in California when he caught wind of some interesting legislation being discussed in his home state of Massachusetts. Lanza is the director of the Worcester based company Advanced Cell Technology (ACT) and also holds the illustrious title of Stem Cell Scientist Most Likely to be Quoted in a Newspaper. His company has researched extensively into Therapeutic Cloning, and recently developed the first technique of growing human stem cells without using the problematic mouse feeder cells. In early 2005, Massachusetts lawmakers began discussing a bill in the vein of Proposition 71. If the Bay State was going to hold on to companies like ACT, as well as the scientists at the Harvard Stem Cell Institute, they were going to have to respond.

The home of the 2004 World Champion Boston Red Sox is a much smaller state than California - just compare the number of baseball teams - but it is on par in the index of scientific impact. Massachusetts' $2.1 billion in NIH funding in 2004 is competitive with California's $3 billion for the same year. However, there is little chance that Massachusetts will be able to match California in the amount of state money allocated to stem cell research. For this reason, lawmakers have been wary to put exact numbers to the amount of money at stake with their own stem cell bill. The law qualifies state assistance in more task-oriented terms, like a charity auction consisting of leftover prizes - you win the off-season weekend at a vacation home, not the money it usually costs to rent it. Among other things, the bill would pledge to assist investigators in building lab space and acquiring equipment specifically for work on stem cells - buying the ladder for the child to finally get up to that cookie jar.

Massachusetts' Republican Governor Mitt Romney, eyeing a potential candidacy in the 2008 Presidential election, has been cautious about the bill, and has butted heads with the legislature over a key ethical issue. Romney is in support of lifting restrictions on the creation of new embryonic cell lines, but he is fiercely opposed to Therapeutic Cloning. Less controversially know as Somatic Cell Nuclear Transfer, this technique is the new crux of the stem cell debate. Though many understand that frozen embryos in storage at fertility clinics will probably be discarded eventually, cloning is a much harder idea for many to grapple with on the ethical plane. Therapeutic cloning uses an individual's DNA to make a special embryo allowing scientists to create stem cells that are genetic replicas of the individual. In a recent Massachusetts poll, 77% of those polled were in favor of creating new stem cell lines from discarded embryos, but only 42% supported therapeutic cloning. Thus far, a South Korean group has been the only team to successfully conduct the somatic cell nuclear transfer procedure, but ACT has come close on a number of occasions and only a few weeks ago, the Harvard provost cleared scientists at the Harvard Stem Cell Institute to begin research on the method. Notably, California's stem cell bill specifically allocated funds for research into Therapeutic Cloning. Despite the conflict, the Massachusetts bill passed both chambers with a veto proof margin in early April, making it unlikely that Romney will be able to stop the implementation of the new laws.

5.
Massachusetts and California are not the only states on the stem cell bandwagon. New Jersey has also pledged money, and bills are being discussed in Wisconsin and New York as well. In Illinois, lawmakers are looking to tax vanity treatments, like plastic surgery and Botox injections, to provide millions of dollars for stem cell research. The states have taken charge of the issue, and in the process are changing the way that money is allocated towards scientific research. The 117-year-old NIH is no longer the lone public financing option for life science research, and the injection of funds on all three coasts is sure to quicken the pace of stem cell discoveries.

The state-side legislation is providing a new pressure on the federal government to reevaluate their four year old standards as well - The child's friends are standing on each others shoulders to reach the cookie jar. The U.S. House is considering bringing the issue to the table in the next few months. Even though the stem cell debate is not neatly divided by party lines, and a number of key republican leaders are in support of modifications to the laws, it is unclear if any new federal guidelines will be instated while President Bush is in office - the conservative voice in Washington is still a strong majority, especially when the man at the top of the pyramid of power has the final word.

The unique nature of the politics surrounding the stem cell debate has created a situation where a vastly larger amount of money will be directed towards the research. In 2005, $300 million will be granted to researchers in California alone. There is no doubt that the funds will jump start stem cell research from its stagnant state, and install it as a hot scientific field for decades to come. Still, states do better when they provide for their citizens in concrete and direct ways, leaving the gamble of scientific research to those at the federal level. Thus far, the stem cell legislative logic at the federal level has been decidedly opposed to the most basic tenant of the scientific method: experimentation. Letting out only a fraction of a potentially long leash does not create a test phase to see if stem cells will fulfill their theoretical promise, it stifles the continuously expanding nature of science - the ability to constantly revise past methods while keeping a keen eye on the distant horizon.

In a recent interview with a senate panel, Elias Zerhouni stated that "from a scientific standpoint, there is no doubt that many scientists will tell you that there are questions they would like to be able to address, that more [stem cell] lines...would be helpful to them.'' It appears the Bush Administration is finally starting to trust the fact that the scientific community has a clear consensus on the stem cell issue. This community is hardly bound by a single, insular ethos; it is made up of people and institutions with morals and views sitting at both extremes and everywhere in between. When these myriad opinions align into a single trajectory, as is the case with the embryonic stem cell debate, politicians would be wise to take notice.

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