Biotechnology companies specializing in stem cell research stand to reap huge financial windfalls from successful therapies developed via this science. To ensure that their research can continue and perhaps accelerate, some of the companies have teamed up with patients rights groups against certain religious and pro-life groups in the fight over federal regulation of this controversial field. As a result, what was once a debate between science and religion has become, in part, a clash between profits and ethics. New guidelines from the National Institutes of Health, released yesterday, mark the first hard-fought victory for patients rights groups and biotechnology companies interested in this issue. President Clinton took the occasion to voice his support for the guidelines, noting the "potentially staggering benefits" of this technology.
Geron Corporation and Advanced Cell Technology (ACT) are the two companies most interested in NIH funding for research involving stem cells derived from human embryos. Stem cells are indifferentiated, and can develop into brain, heart, or any number of more specific cells. They form within the first eight days of an embryo's life, and develop into almost all of the human body's various tissues and organs.
Since Geron's successful isolation of these types of cells in 1998, scientists and patients rights groups have jubilantly theorized about the extraordinary possibilities in developing treatments for a whole range of diseases and ailments. For example, depending on the future success of stem cell research, scientists might be able to grow stem cells into the neuron cells of the brain, which could provide treatments to those suffering from Parkinsons and Alzheimers disease, or heart cells for those suffering from cardiac ailments.
Yet as exciting as these potential medical advancements are, embryonic stem cell research presents plenty of tough ethical dilemmas. The most accessible supply of human stem cells is found in human embryos, which both pro-life advocates and many religious groups consider to be human life. Scientists must harvest the stem cells from the inner cell mass of the blastocyst, the embryonic phase that begins after eight days of development; in so doing, they destroy the embryo itself. According to the new NIH guidelines, scientists will be able to use federal funds for research on embryonic stem cells, but not for the derivation, or harvesting, of those stem cells from the embryos. Even after the first grants are awarded under the new guidelines, they will still have to pay for the stem cell derivation with their own money.
The companies that stand to benefit from federal funding for embryonic stem cell research are not sitting idly by as the battle rages between patients' rights groups and the religious/pro-life community. One of the patients' rights groups most active in the legislative debate on federal oversight of stem cell research is the Alliance for Aging Research, which bills itself as "the nation's leading citizen advocacy organization for improving the health and independence of older Americans through public and private research," according to their mission statement.
The Alliance also happens to receive funding from private sector biotechnology companies that have a financial stake in the outcome of the stem cell debate, including Geron, which gave the organization $25,000 in 1998, according to Alliance tax returns. (When contacted for this article, the Alliance had not completed its 1999 tax returns.) Ronald Eastman, the former CEO of Geron, also sits on the Alliances board.
Some of the world's biggest biotech and pharmaceutical companies are also counted as some of the Alliances top funders. Among them are Pfizer, which contributed approximately $200,000 to Alliance in 1998, Eli Lilly and Company ($130,000), GlaxoWellcome ($43,781), Merck & Co. ($49,154), Warner-Lambert ($41,000), SmithKline Beecham ($35,000), Bristol-Myers Squibb ($35,000), Johnson & Johnson ($35,000), Procter & Gamble ($25,000), Schering-Plough ($10,000), Amgen ($5,000), and Genentech ($5,000). In 1997, according to the organizations tax filings, Hoechst Marion Roussel, now part of Aventis Pharmaceuticals, gave the Alliance $465,000.
The Alliance also has a friend in Merrill Lynch & Co., Inc., whose executive vice president, John L. Steffens, chairs the Alliances board of directors and personally contributed $25,000 of his own money to the organization in 1995. Merrill Lynch itself also gave $53,000 to the Alliance in 1998. A representative from the companys media relations department told The Public i that "Mr. Steffens has a keen personal interest in gerontology and all things related to aging. This is reflected in studies that Merrill Lynch has done for many years."
One of Steffen's fellow board members is Allan Fox, a former senior partner at Fox, Bennett, Turner, which split into two separate law firms in September of 1999. Mr. Fox is currently a senior partner at FoxKiser. According to Daniel Perry, executive director of the Alliance, Fox joined the Alliances board after the breakup of Fox, Bennett, Turner and was not involved in lobbying for stem cell research. But, until last year, other members of the firm had been registered lobbyists for Geron, including Samuel D. Turner, a senior partner. Mr. Turner served previously as the deputy general counsel at the Department of Health and Human Services. At Fox, Bennett & Turner he worked primarily with patient advocacy groups and pharmaceutical and biotechnology companies, according to his official biography.
Fox, Bennett & Turner also funded the Alliance, chipping in $20,000 from 1997 to 1998. The firm declined to comment on the extent of its lobbying activities for Geron, though its federal lobbying reports list "stem cell issues" as a description of its lobbying work for the biotech company.
Embryos are not involved
A large part of the Alliances attention has been focused on ensuring that federal funds can be used for embryonic stem cell research. In that regard, it created the Patients Coalition for Urgent Research (Patients CURe) in May of 1999. Perry, who is also chair of Patients CURe, said in an interview that the Coalition was formed in part to support the controversial finding by NIH and the Department of Health and Human Services that federal funding for stem cell research did not violate a 1996 congressional ban, renewed every year since, on research harmful to embryos.
On January 15, 1999, Harold Varmus, director of NIH, received an official legal opinion that federal funds could be used for stem cell research. NIHs general counsel concluded that such use of federal funds did not violate the 1996 congressional ban on "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death" (section 128 of Public Law 104-99).
In a letter dated February 23, 1999, to members of Congress who oppose the NIHs determination, HHS Secretary Donna Shalala stated that "research on existing...stem cell lines is both legal and appropriate," and that "there is nothing in the legislative history to suggest that the provision was intended to prohibit funding for research in which embryos - organisms - are not involved." In other words, because stem cells are technically not embryos, companies and NIH scientists should be able to use government funds for embryonic stem cell research as long as they derive the stem cells from the embryos at their own expense.
This is exactly what Geron and ACT are doing, but at a considerable cost, according to one official at the NIH familiar with the agencys policy on stem cell research. The official, who wished to remain anonymous, told The Public i that the fledgling stem cell industry would profit tremendously from federal funding that would cover embryonic stem cell research. In fact, complementary federal funding of private sector research has been shown to increase private sector pharmaceutical research productivity by as much as 40%, according to a study done by the National Bureau of Economic Research, a nonprofit research organization. Other studies have shown that public funding of biotech research also leads to increased investment in private sector companies engaged in similar research.
"We knew that the research would be controversial and difficult for Congress to wrestle with," says Perry when explaining the reasons for creating Patients CURe. The Coalition represents thirty-four major patients rights groups, including the Alliance, and is, according to Perry, "a vehicle for bringing into contact media, politicians, and patients who are facing devastating diseases." Among the groups in the coalition are the American Parkinson Disease Association, the Christopher Reeve Paralysis Foundation, and the Juvenile Diabetes Foundation International.
HHS findings did not go unnoticed. Many lawmakers, pro-life organizations, and religious groups felt the Departments determination was a sneaky attempt to circumvent the 1996 federal ban on research harmful to embryos. In a letter addressed to Secretary Shalala on February 11, 1999, seventy members of the House of Representatives, including Tom DeLay (R-Tex.), Jay Dickey (R-Ark.) Henry Hyde (R-Ill.), and Christopher Smith (R-N.J.), protested the HHS findings. "While the act of destroying or injuring an embryo would certainly be ineligible for Federal funding, the law has a broader application. It also bars the use of tax dollars to fund research which follows or depends upon the destruction of or injury to a human embryo," they wrote. The lawmakers who signed the letter believe that federal funding indirectly but inevitably influences how many embryos are killed based on the need for stem cells. Therefore, they believe, the NIH would be partly responsible for the death of embryos, and would be in violation of the 1996 ban.
Richard Doerflinger, associate director for policy development at the Secretariat for Pro-Life Activities of the National Conference of Catholic Bishops, believes that the NIH is eager to reverse the 1996 federal ban on embryonic stem cell research, and sees the HHS determination on stem cell research as a wedge to open up federal funding for other controversial research initiatives. He mentions genetic engineering and embryonic cloning as examples of such initiatives. In an article posted on the National Right to Life Committees Web page, Doerflinger suggests that Geron and the NIH hope to use federal funds in the near future to clone embryos containing the same genetic material as the patient being treated, thereby decreasing the probability that the patients body will reject the therapeutic embryonic stem cells. He states the following:
"Geron and NBAC [the presidents National Bioethics Advisory Commission] know that the much-touted use of spare embryos may well fail to produce the promised results. But they also know that the unconscionable step of using taxpayers funds to create human embryos for destruction could doom the entire enterprise in the eyes of public opinion. So expect them to proceed with spare embryos, perfecting the art of culturing stem cells and directing them to differentiate in the lab. And when they stand on the threshold of transplantation into humans, expect them to announce that they could save many lives, if only we will allow this one last step."
Thomas B. Okarma, president and CEO of Geron, responds that the company, as well as the scientists from NIH, would require only a limited "bank" of embryos from which to derive stem cells. "Once you have the bank of [stem] cells you need for the market you are entering, you are done," Okarma told The Public i. He explains that the regenerative qualities of embryonic stem cells make the acquisition of an endless supply of embryos unnecessary. When asked how many embryos Geron has used in its research, Okarma said he could not make a guess.
Interestingly enough, Geron recently purchased Roslin Bio-Med, Ltd., the Scottish company that cloned "Dolly" the sheep. Geron thereby acquired Roslins cutting-edge cloning technologies, including a technique known as somatic cell nuclear transfer, one of Roslins most important technologies. Both Roslin and ACT have been developing this technique, which can be used to create embryos (ACT officials did not make themselves available to be interviewed for this article). While creating human embryos is prohibited in the United States, the British government recently agreed to initiate legislation that would amend the ban on human cloning in that country.
While the new NIH guidelines clarify the right of companies to use federal funds for stem cell research in general, a new bill introduced in Congress, the Stem Cell Research Act of 2000 (S. 2015), would allow companies to use federal money to derive the stem cells from embryos, as well as use them in subsequent research. As noted by the NIH official, such a windfall of federal money would greatly benefit private companies like Geron.
S. 2015 was introduced in the Senate on January 31, 2000, by Senator Arlen Specter (R-Pa.), who chairs the Senate appropriations subcommittee on Labor, Health and Human Services, and Education. The bill goes a step further than funding embryonic stem cell research by proposing to federally fund the derivation of stem cells from human embryos as long as "the research involved shall not result in the creation of human embryos [or] the reproductive cloning of a human being."
A spokesperson from Specters office said that the bill was introduced because "there is no oversight of the private sector regarding embryonic stem cell research." The spokesperson added that the bill would allow NIH researchers to draw from a controlled source of embryos and perform their research in an ethical manner. "The goal of the bill is not to urge couples to donate more eggs than necessary or create a bank of embryos," the spokesperson said, "but to allow federal researchers, who are the best in the land, to research embryonic stem cells."
However, those who are adamantly opposed to the bill, such as Senator Sam Brownback (R-Kans.), believe that the bill will have a much different effect. When Specters Senate subcommittee held a hearing on stem cell research on April 26, 2000, Brownback, a member of the subcommittee, made his position regarding the research quite clear:
"In brief, the Stem Cell Research Act of 2000 would allow federal funding for researchers to kill living human embryos. This research is problematic because it would use federal tax dollars to allow the government to procure, and therefore own, a vast supply of living human embryos. The notion of ownership, particularly by the Federal government, of other human beings is deeply disturbing. The bill defines a new class of human beings who, under the law, will simply not be allowed to live."
Biotech and pharmaceutical companies are not standing by while opposition to the research grows. Specters second-largest campaign patron during the 2000 cycle is Amgen, whose employees have given the Senator at least $42,000. The bulk of that money was donated on August 10, 1999, by dozens of Amgen executives, according to the Center for Responsive Politics. During the current election cycle, according to CRP, the "Health Professionals" and "Pharmaceuticals/Health Products" industries have contributed almost $800,000 to the senator. The "Health Professionals" industry has contributed $31,500 to congresswoman Carolyn Maloney (D-N.Y.), who introduced a resolution in the House supporting HHSs decision to uphold federal funding for embryonic stem cell research.
Besides the companies themselves, the Biotechnology Industry Organization (BIO), which represents over eight hundred biotech and pharmaceutical companies (including Geron and Advanced Cell Technologies), is also actively engaged in trying to push federal funding for embryonic stem cell research through Congress. According to a letter written from BIO to Harold Shapiro, chairman of NBAC, BIO does not take an official position on "whether federal money should be used to fund research to derivestem cells or to study these cells once they are derived." However, BIO "believes additional funding, including the use of public monies, will expedite progress in development of new stem cell treatments." Last year, OBrien Calio, a major lobbying firm, raked in more than $100,000 for lobbying lawmakers on BIOs behalf. They focused their attention on "embryonic stem cell legislation" and other issues, including human cloning, according to federal lobbying records.
BIOs own lobbying records show that they spent a portion of their in-house lobbying expenses, which totaled $1,715,896, pushing their views regarding the "Stem Cell Report" that NBAC would issue to the President on September 7, 1999. NBAC was asked by President Clinton to examine ethical issues involved in stem cell research shortly after Gerons successful isolation of stem cells in 1998. According to Eric Meslin, executive director of NBAC, the Commission supports federal funding for embryonic stem cell research and "concluded that for purposes of public policy, there was no ethical distinction between the derivation of embryonic stem cells from embryos remaining after in vitro fertilization on the one hand, and the use of those stem cells." However, Meslin did mention that the Commission did not find the creation of embryos for the sole purpose of acquiring stem cells ethically acceptable.
The Alliance, the Coalition, and organizations within the Coalition have also been active in lobbying members of Congress to support federal funding for stem cell research. Some of their activities have included bringing patients facing serious illnesses to meet with congressional members involved in the stem cell debate, and arranging letters in support of stem cell research to be sent to the Hill.
Reacting to the activities of the major religious groups opposing the research, the Alliance sent a letter addressing the controversial issue, signed by university professors of various faiths (Jewish, Muslim, Protestant, and Catholic), to House Speaker Dennis Hastert (R-Ill.). The letter gives support not only to federal funding for stem cell research, but also to funding for the derivation of stem cells from human embryos. They acknowledge that "all human life must be protected," but make a clear distinction between the level of protection that should be given to an embryo and to that of a fetus. "There is a significant difference between an embryo suspended in liquid nitrogen that will never be implanted inside a womb, and an unborn child who is already in the womb. We support embryonic stem cell research because it would use these frozen or otherwise discarded embryos to help ease the suffering of those with catastrophic disease."
According to the Alliances Perry, the Juvenile Diabetes Foundation has also been an important player in lobbying Congress on the issue. The Foundation refused to confirm this. However, according to their 1999 annual report, the organization has been very influential in securing federal funding for NIH projects. The literature states that they "successfully advocat[ed] a fifteen percent increase in the NIH budget to $17.9 billion." It also mentions that Sen. Specter and Rep. John Porter (R-Ill.), who chairs the Labor, Health and Human Services, and Education appropriations subcommittee in the House, were "instrumental in working with JDF in advocating this large increase." Patients CURe also believes that the U.S. public supports its position on stem cell issues. To prove this point, the Coalition points to a survey, which it commissioned, in which seventy-four percent of the people polled favored federal funding for embryonic stem cell research. Perry says that the NIH funding decision "reflects the publics support for the research."
However, the definition of "federal funding for stem cell research" used in the poll perhaps oversimplified the issue; it failed to alert the survey participants that a human embryo is killed in the process of deriving the stem cells, and that stem cells can also be derived from other parts of the body, though not as easily.
At the moment, S. 2015 remains in Senator Specters subcommittee. According to Charles Robbins, Specters press secretary, there is a possibility that the bill will go to the floor for debate this September.
"Embryos are a part of the human family. Because of that, we should not legislate in such a manner that it becomes common course to experiment or destroy a human embryo," says Laura Echevarria, director of media relations at the National Right to Life Committee. NRLC is one of the groups crusading against federal funding for both embryonic stem cell research and the derivation of stem cells from human embryos. Both the Christian Coalition and the National Right to Life Committee are spending hundreds of thousands of dollars lobbying Congress on these issues, and are coordinating their efforts with those of the National Conference of Catholic Bishops and the National Convention of Southern Baptists.
In 1999, NRLC spent a portion of its more than $340,000 of in-house lobbying expenses opposing Specter's legislation, which they say would "allow federal funding of embryo-destructive experimentation." They also lobbied for new legislation sponsored by Rep. Dickey that would "protect living human embryos."
Since 1997, the Christian Coalition has spent almost four million dollars in lobbying expenses on various issues, including opposition to "medical research on a human fetus or embryos." The Coalition has joined forces with NRLC in an attempt to cut off federal funding for stem cell research, including Specters bill. In fact, Susan T. Muskett, director of legislative affairs for the Christian Coalition, was formerly a policy analyst for NRLC and lobbyied on stem cell research for that organization in 1999, according to NRLCs lobbying records.
The National Conference of Catholic Bishops, one of the two organizations comprising the American Catholic hierarchy, shares the same position as NRLC regarding stem cell research funding, and has been outspoken on the issue. Four of Richard Doerflingers articles, all opposing federal funding for embryonic stem cell research, have appeared on NRLCs Web page, along with a letter issued by the National Conference of Catholic Bishops addressing the same issue. While the National Conference of Catholic Bishops does not spend money on political campaigns or hire lobbyists, it has been influential in other ways. According to Doerflinger, his organization has sent letters, signed by various organizations opposing funding for embryonic stem cell research, to members of the Senate, and was partly responsible for encouraging approximately 50,000 people to send Congress statements of opposition to funding for embryonic stem cell research. He also said that the NCCB focuses most of its lobbying on senators who are "on the fence" regarding stem cell research. On that list he included Sens. Joe Biden (D-Del.), Orrin Hatch (R-Utah), and Gordon Smith (R-Ore.). Senator Smith, a conservative Republican who normally votes to tighten abortion laws, has family members who have died or who are suffering from Parkinsons disease. According to his deputy press secretary, Rebecca Wilder, "he supports the concept of federal funding for stem cell research. However, he has not put his support behind a specific proposal."
Of all the members of the Senate, "Brownback has been our champion," says Doerflinger. Sen. Brownback has been the most outspoken opponent of Specters bill, as well as of federal funding for any embryonic stem cell research. He has held public forums on the issue and is "looking at legislative options to make sure that the ban on embryonic stem cell research is not overturned," according to Eric Hotmire, Brownbacks press secretary. According to Ben Mitchell, a consultant to the national Southern Baptist Convention, "Sam Brownback has been interested in providing a voice to those who have no voices."
Both Doerflinger and Mitchell criticize the government for taking the moral high ground in banning federal funding for embryo research, yet allowing funding for stem cell research that, they believe, encourages private companies to destroy embryos. "When someone does something really good, people want to be complicit. When something is morally problematic, complicity stops," says Mitchell. Conversely, Tom Okarma of Geron also finds the governments actions "a little bizarre from an ethical perspective."
Irresponsible Scientific Talk
"There is a lot of irresponsible scientific talk that this is the magic bullet that will solve all of these problems," says Doerflinger, referring to the diseases that many patients rights groups and some biotechnology companies say will be cured by stem cell therapies. "Stem cells do promise certain benefits. However, it has to be underscored that they are theoretical," says Mitchell.
According to Annemarie Moseley, CEO of Osiris Therapeutics, a privately held biotechnology company that focuses on the development of cellular therapeutic products via adult stem cell research, embryonic stem cell technology is still in its early stages, and treatments for related diseases might not be available for another fifteen years. "While we support the continued research in the field, we do not think it would be fair for groups to believe that therapeutic strategies based on embryonic stem cells will be readily available in the near term. In that vein, we believe that the government should view embryonic stem cells as an early and potentially very beneficial developmental tool," she says.
This years leading presidential candidates have generally avoided public discussion on stem cell research. The Gore campaign provided The Public i with this statement of the Vice Presidents position:
"The medical benefits of using stem cells for research purposes are compelling and hold great promise for treatments of Parkinsons disease, heart disease, and other illnesses. However, because of sensitive ethical issues and social considerations raised by the derivation of human stem cells, he does not request any change [to] current law [to] permit federal funding for the derivation of stem cells from human embryos."
While Gore disclaims support for any a change in the ban on human embryo research, some skeptics say that the Administration has already endorsed a change in the law, without admitting its a change. "The Clinton-Gore Administration and certain members of Congress have been looking for ways to fund human embryonic stem cell research without violating the letter of the congressional ban," states an article published on the NRLC web page. "To this end, administration officials offered several inventive readings of the statutory language."
Governor George W. Bush's campaign did not return repeated calls from The Public i, and his Web site makes no mention of the Republican candidates position on stem cell research. Several media reports have indicated that Bush is opposed to stem cell research.
While it seems likely that biotech companies will soon cash in on the revised NIH guidelines, it is unlikely that Specters bill will be signed into law and reverse the 1996 congressional ban on stem cell derivation, according to Doerflinger. Although the National Conference of Catholic Bishops is active on Capitol Hill in their opposition to embryonic stem cell research, he acknowledges that the organization is facing very powerful opponents. When asked if the battle between the pro-life/religious coalition, and the biotech companies and patients rights groups was one of money, he laughed. "If it were a question of money, they could buy and sell us if they wanted to."