President Obama’s announcement today — that he is reversing Bush administration restrictions on research with human embryonic stem cells — comes as no surprise.
Still, it is a relief at the University of Minnesota’s Stem Cell Institute, where scientists have deployed these master cells in groundbreaking efforts to combat diabetes, cancer and other disorders.
“It will have a huge impact on my research and an even bigger impact on the research many other scientists are doing,” said Professor Meri Firpo, who is leading the diabetes studies. “The restrictions have really put a crimp in the number of scientists who can use this research tool.”
The Minnesota research has been slowed considerably since Aug. 9, 2001, when then-President Bush banned federal funding for work on any cell lines derived from human embryos after that date.
Obama cautioned at a White House ceremony signing his presidential order that the pace of stem cell research will be slow and careful even with the restriction lifted.
“But scientists believe these tiny cells may have the potential to help us understand, and possibly cure, some of our most devastating diseases and conditions,” he said. “To regenerate a severed spinal cord and lift someone from a wheelchair. To spur insulin production and spare a child from a lifetime of needles. To treat Parkinson’s, cancer, heart disease and others that affect millions of Americans and the people who love them.”
Obama acknowledged his order was controversial and he expressed respect for those who oppose the research on moral grounds. But he indirectly rebuked the Bush administration, saying his order was intended to ensure “that scientific data is never distorted or concealed to serve a political agenda — and that we make scientific decisions based on facts, not ideology.”
Healing power, heated controversy
While Obama’s order wins applause from millions of patients who have pinned hope on the research, it is unlikely to end controversy that has divided the nation for a decade.
Embryonic stem cells have amazing power to develop all of the mature body’s tissues, from a throbbing heart to a sturdy bone. Scientists predict they will be deployed to help repair malfunctioning organs and to step in where cells are damaged.
The cells also have opened new views into the process by which the complex human body, with its myriad of fine-tuned functions, grows from a few microscopic cells — how some cells specialize for the work of sending impulses through the brain while others take on the tasks of sheathing the body with skin capable of constantly renewing itself.
With knowledge about the process comes better understanding of what happens when something goes wrong — say, when cancer hijacks an organ.
But embryos must be destroyed to obtain the cell lines.
The Catholic League was among many groups denouncing Obama’s order even before he issued it, likening the stem cell studies to Nazi-era experiments in Germany.
League President Bill Donohue said in a statement that “it is immoral to destroy nascent human life,” especially when scientists have alternatives in the form of so-called adult stem cells.
“Obama has stepped on a slope so slippery that many of his supporters may eventually regret he did so,” Donohue said. “It is not for nothing that Germany has the most rigorous ethical guidelines on human research. Our model should be 21st century Germany — not 20th century Germany.”
Many other groups and many members of Congress objected vociferously to spending tax dollars on what they consider to be the equivalent of murder.
But most scientists and bioethicists see a distinction between an embryo in a dish and a fully developed baby.
“It is true that every human life begins at conception, but it is not true that every conception begins a life — huge numbers of embryos fail,” Arthur Caplan, who directs the Center for Bioethics at the University of Pennsylvania, said on CNN.
The University of Minnesota is a world leader in stem cell research because of pioneering studies done years ago with adult stem cells taken from bone marrow and cord blood.
Now, five laboratories at the University’s Stem Cell Institute experiment with the more versatile embryonic cells. And for nearly a year, they also have worked with so-called induced pluripotent stem (iPS) cells, which are created by inserting genes into skin cells to coax them to an embryonic state.
In one lab, Firpo works with all three cell types to develop lines of insulin-producing cells with the potential to help cure diabetes. At this point in the research, it would be a mistake to shut off the potential in any of the cell types, she said.
Firpi had derived two of her cell lines before Bush’s cutoff date, so they are eligible for federal funding, which is the lifeblood of scientific discovery at public research institutions. But 11 lines she derived after August 2001 were not eligible for the funding. (All were from embryos that would otherwise have been destroyed at fertility clinics.)
As a result of the Bush restrictions, Firpo has had to track every penny she spends, sorting the federally allowed projects from non-federal. She has done so by segregating all of her lab equipment and supplies — every pack of toweling, every microscope, everything.
“We had to label every piece of equipment, every box of pipettes,” she said. “And the University had to go to the extra effort to set up the policies and infrastructure and also monitor whether those procedures were being followed.”
She also spends a good share of her time raising private funds for the non-federal work.
No one knows how much research time was lost during the nearly eight years of the ban and how many scientists were discouraged from doing the studies in the first place.
But Obama suggested the setback was significant: “When government fails to make these investments, opportunities are missed. Promising avenues go unexplored.”
In Firpo’s case, the University recognized the need for her to push ahead with the new cell lines and took the considerable extra effort to make it possible.
“Many, many scientists around the country don’t have the benefit of a university that is this supportive,” she said.
Why reach so far? Why not simply settle for studies with the Bush-approved lines?
“When we were making those first lines, we had no idea — no idea — that these would be the only lines we could use for 10 years,” Firpo said. “We were just trying to figure out how to make them.”
As the studies progressed though, Firpo focused on potential patient safety, developing new lines of insulin-producing cells that could one day pass the scrutiny of the Food and Drug Administration and be accepted for use in hospitals and clinics.
“We kept track of every molecule, every reagent that came in contact with these cells with FDA approval in mind,” she said.
Obama’s order doesn’t entirely free Firpo of red tape. It will be up to Congress to decide whether to lift a separate ban on using federal funds to experiment with human embryos. Obama lacks the power to reverse that ban, which has been in place since 1996, but he did call upon Congress to “act on a bipartisan basis to provide further support for this research.”
Meanwhile, the upshot for Firpo is that she still will need private funding to derive new embryonic cell lines. Once she has the lines, though, she now can work with them far more freely.
“Most of our research will become much easier to do,” she said.
Killing cancer and stigma
Dr. Dan Kaufman, another scientist at the University’s Stem Cell Institute, sees an intangible benefit from Obama’s order.
Building on “natural killer” cells in the blood stream that help defend the body from infection and some cancers, Kaufman has coaxed embryonic stem cells to create cancer-killing cells in the laboratory.
While the findings have been hailed as groundbreaking, they also have been shadowed by Bush’s repeated claims that such research is immoral.
“As much as anything, it has given stem cell research a bit of a stigma,” Kaufman said. “It’s made it seem like something that maybe should not be allowed, sort of put it in a different category from other types of beneficial research out there.”
To comply with Bush’s order, Kaufman has restricted his studies to the cell lines Bush approved. Now he will be free to choose from more than 1,000 cell lines that have been derived since Bush’s restriction went in place.
And now, scientists can hold their heads high again.
Kaufman began his research at the University of Wisconsin-Madison, where the human embryonic stem cell lines first were isolated and where many scientists were vilified over the years. Today, five of the Wisconsin scientists were invited to Obama’s signing ceremony, the Chicago Tribune reported.
Also attending was Peter Agre, the Minneapolis native who shared a Nobel Prize in chemistry and now heads the American Association for the Advancement of Science.
“The American people are in favor of this; the sanctity of life has no political boundaries,” Agre told MinnPost shortly after the formal announcement. “This is going to make it much easier for the men and women in the laboratories to do their work. It’s still hard going … those scientists at the University of Minnesota and at the Mayo Clinic still have hard work to do.”
Research driven underground
One, perhaps unintended, effect of Bush’s policy was to drive the research into private laboratories, where it was beyond public scrutiny, said Jonathan Slack, who directs the University’s Stem Cell Institute.
“This has not been a ban on what people are allowed to do. It’s been a ban on what you could use federal funds for,” Slack said. “That has effectively driven the research underground into places like IVF [in vitro fertilization] clinics and private biotechnology companies. … One consequence is that nobody knows what is going on.”
Federal funding spent in public university settings comes with strict rules and ethics reviews. It also comes with expectations that scientists will publish their research and make the findings available so others can build upon them.
“If people have any ethical concerns at all about any aspect of this research, they should want to see it done in public universities like ours,” Slack said.
Cures likely a decade away
Now that a major hurdle has been cleared, the pace of the stem cell research will step up and possible treatments will get to patients more quickly.
The FDA recently approved the first clinical trial for human embryonic stem cells to be used to help repair spinal cord damage. And preliminary trials are under way in other countries. These first trials are small, intended for the most part to establish the safety of the treatments, Slack said.
“What is going to happen and when it is going to happen you never quite know because it is research,” Slack said.
But he predicted that over the next few years, we will see many more clinical trials worldwide, especially in new therapies for treating Parkinson’s disease, diabetes, spinal trauma and heart disease.
It will be a slow process, he said, given all of the scrutiny and necessary safety regulations.
“I hope in about 10 years we would have some things getting into the clinic for therapies that are known to be effective,” he said. “In the long run, the sky is the limit. I am very optimistic that we will be able to do just about anything we can contemplate.”
Meanwhile, Obama’s order will give the United States new standing to help lead the research, said Slack, who is from England.
“The image of the United States in scientific research has taken a bigger knock from Bush’s policy on human embryonic stem cells than from anything else,” he said.
Sharon Schmickle writes about national and foreign affairs and science. She can be reached at sschmickle [at] minnpost [dot] com.