CA: Stem cell enterprise under scrutiny

SAN FRANCISCO — Last fall, a group of pioneering scientists, venture capitalists and entrepreneurs sold Californians on the ultimate startup, one with shoot-for-the-moon ambitions. The men and women pitched the state's residents on a new science that they said might one day lead to cures for humankind's worst diseases. "Save Lives with Stem Cells!" campaign posters urged.

Today, however, a little more than three months after state voters approved a measure allocating $3 billion in public funds for stem cell and related research, organizers are struggling with more down-to-earth concerns.

The initiative has been tainted by accusations that those who pushed hardest for the money stand to benefit from it the most. Advocates question the pell-mell pace organizers have set to get the program up and running; they worry that in their haste, program leaders are taking too many shortcuts, leaving the initiative vulnerable to being taken advantage of by private profiteers and unscrupulous scientists.

"I appreciate that people feel a sense of urgency. But it has to be done right rather than be done fast," said Susan Berke Fogel, co-founder of the Pro-Choice Alliance for Responsible Stem Cell Research, a coalition of scientific and legal groups that have raised concerns about the initiative.

The stakes surrounding California's initiative have only grown higher in recent weeks with the discovery that much of the most promising research probably cannot be conducted with federal funds because President Bush has restricted the money to certain lines of stem cells which now appear contaminated.

California's experiment is being watched closely by other states. Maryland this month became the most recent state, joining Connecticut, Florida, New Jersey, New York and Wisconsin, to allocate or consider allocating their own money to stem cell research.

Proposition 71's creators thought the best way to tackle stem cell research was to create a government agency in a very non-government-like way. The California Institute of Regenerative Medicine would be run like a corporate startup, with the state's populace effectively serving as shareholders. Elected state officials, including Gov. Arnold Schwarzenegger, appointed a panel of 29 scientists, businessmen and university administrators to oversee the effort, in hopes of issuing the first grants in May.

To streamline and speed things along, the state decided to exempt parts of the organization from many of the traditional rules that government entities must follow, including some regulations governing how agencies spend money.

It didn't take long for controversy to ensue, starting with the man selected to lead the effort: Robert Klein II, 59, a Silicon Valley real estate developer and lawyer who wrote much of Proposition 71 and created a nonprofit group to campaign for it. One of his sons has juvenile diabetes and his mother has late-stage Alzheimer's.

Public-interest groups worried about his investments in the biotech industry and his ties to various interest groups. Some even called on him to resign.

Critics also expressed concern that other members of the oversight group might have conflicts of interest: More than a few own stakes in biotech firms or other businesses that could stand to benefit from the research bonanza.

They noted that the first batch of jobs for the institute were not advertised and went to friends or allies of the members and came with lucrative annual salaries, many in the $100,000s.

So loud is the opposition that Democratic state Sen. Deborah Ortiz, one of the strongest supporters of the proposition, expressed concern with how things are proceeding and suggested that new legislation might be needed to guarantee there's no abuse of the funds and that the neediest benefit.

A spokeswoman for the institute, Fiona Hutton, vehemently disagreed with the notion that there is anything fundamentally wrong with the program or that new legislation is needed. She said the committee has been working "cautiously and carefully" and that some issues have been resolved.

Klein, for example, has taken a number of steps to minimize any appearance of improper relationships, leaving his post at the nonprofit organization that led the campaign and divesting himself of millions of dollars in biomedical stocks he once held. He has said those actions should be sufficient to resolve concerns over possible conflicts.

"I don't think there has been any rush to judgment on any front thus far," Hutton said. "The board is keeping the challenges that patients have day in and day out in their minds, but they are taking logical, prudent steps as to how they move this forward."

Human embryonic stem cells are one of the great medical hopes of this century. Extracted from fertilized eggs in their first days, these cells have an ability to "grow" into many different types of cells that make up the human body, be they muscle cells, brain cells or something else. Even though no single treatment has resulted from this research, some think that scientists will one day be able to engineer these cells so they can be used to cure all kinds of life-threatening diseases, from heart disease and diabetes to cancer and HIV/AIDS. The research, however, has been opposed by some religious groups, women's rights advocates and others because the eggs are donated by fertility clinics and the embryos are destroyed during the laboratory work.

Proposition 71, approved by 59 percent of California voters on Nov. 2, allocates $295 million a year for 10 years for stem cell research and outlines a streamlined bureaucratic structure for how the program will operate. In contrast, the federal government spent $25 million on similar research last year.

The initiative is being governed by a citizens' oversight committee and three working groups focused on specific topics. Members of the oversight committee must adhere to state rules regarding financial disclosures, open meetings, and civil service laws. The working groups, which act in an advisory capacity, are exempt — a source of concern to many public-interest groups.

"If you don't know what people are saying in the meetings, then you have no way of telling whether their declared interests are playing an undue role and influence in what they are recommending," said Terry Francke, general counsel of Californians Aware, which advocates open government.

Of the 29 members of the committee, at least nine serve on boards of biotech or pharmaceutical companies or have financial holdings, according to disclosure forms they filed. Only a handful of these companies currently conduct stem cell research, but critics contend that the potential of the science is so large that it is not hard to imagine that the firms could one day be involved in the work.

The board's vice chairman, Edward Penhoet, is the co-founder of two prominent biotech firms, Chiron Corp. and Renovis Inc. He has said he owns at least $3.36 million in stocks and stock options in biotech firms. Tina S. Nova is chief executive of biotech firm Genoptix Inc. And Ted Love is president, chief executive and director of biotech venture Nuvelo Inc. He has more than $1 million in stock in Nuvelo and another $1 million in Theravance Inc.

Penhoet, Nova and Love have declined to follow Klein's lead in divesting their holdings. Hutton said the committee considers such steps a "personal decision."

The Jan. 31 meeting of a subcommittee of the oversight group, held in a windowless room at one of the University of California-San Francisco medical school buildings, illustrates the mammoth challenges members of the oversight group face. Panel members briefly discussed complex issues such as how to handle intellectual property rights for discoveries made with state money and what protections should be put in place for patients. They talked about conflict of interest rules and ways to address minority health disparities.

The longest discussion concerned the appointment of members of the Scientific and Medical Accountability Standards Working Group. They agreed they wanted scientists, economists, lawyers and ethicists.

Joan Samuelson, an advocate for patients with Parkinson's Disease, suggested they add someone with an expertise in religion to the mix. "The public looks to theologians for guidance," Samuelson said.

Many of the others nodded. But it wasn't long before the implications of the seemingly simple suggestion sunk in.

Were they looking for someone who was a specialist in Catholicism, Protestantism, Judaism, Islam, Buddhism or what? What about other sects and subsects? They wondered what kind of statement it would make if they chose someone with one belief system over another. And what about separation of church and state?

In the end, everyone agreed it was too complicated. An explicit call for theologians was left off the list.

Fetal Stem Cells 0 - Adult Stem Cells 1000s

It doesn't even sound like a game worth watching, does it?

No Not One

With all the promising talk about the future of fetal stem cell research, there is little, in reality, to cheer about. To date, there has not been a single benefit to any human.

Because everyone, on both sides of the issue, is in awe of the amazing development of those first few cells after conception, the implications of being able to control the process has boggled many minds. This has led to many empty promises. When the many laboratory failures come into the full light of scrutiny, one is left with little immediate hope. Persistent mutations have "dogged" most of the results. But we are told to be patient with these consistent failures, give more money and not complain when the voting public is misled because they will make it so we can live forever. (You do know that curing disease is the first hurdle, but immortality is the next, don't you? There is already intense interest - and investment money - in cloning duplicates for spare body parts.)

So what is the side of this discussion that both sides, amazingly, are not talking about?

There Is an Alternative

It is one that has a long track record of success that no one can argue about. It is totally non-violent and ethical. The list of successes total in the thousands—so many that there are no arguments over statistics.

There is another, somewhat misleading, classification called Adult Stem Cells or, more accurately, post-birth stem cells. They are taken from umbilical cord blood, bone marrow or extracted from fat cells. Most often these stem cells are taken from the patients’ own body. This insures against rejection, which is half the risk. Even donated cells properly matched don’t have the associated mutation issues.

But in the midst of the current debate over stem cell research, we find that the adult stem cell discussion is mysteriously absent. Why is that?

And The Lame Shall Walk

The successes are, in a word, amazing:

In Germany, a paraplegic South Korean woman was treated with stem cells from umbilical cord blood. At a news conference in Seoul on November 25, 2004, she walked (with the help of a walker). Only a little impressed? She had been paralyzed for 20 years!

Over two years ago a young girl in Germany fell and destroyed over 19 square inches of her skull. After several other procedures were attempted, all of which failed, a "paste" of extracted pelvic bone and her fat cells was mixed together and administered. On December 20, 2004 a press conference was held to report that the skull bone, although thin, had re-grown. The girl, after having worn a helmet for some two years, formally took it off.

At The Heart Institute in Houston, Texas, four out of a group of five severely sick Brazilian heart patients were taken off the heart transplant list. Doctors harvested some of the patients' own bone marrow and injected it into their hearts. The patients had such an increase in blood supply after the procedure that, in October of 2003, they were no longer in need of a transplant. The four were part of a larger group of 14 that were reported to have improved heart function.

Researchers in Texas say they have developed a method of delivering cancer - fighting Interferon Beta through the use of stem cells taken from bone marrow. Because stem cells have a "duty" to aid growth they are attracted to tumors. Once the stem cells have been "manipulated" with the Interferon Beta gene they become targeted "missiles" aimed at the cancerous tumor, leaving healthy cells untouched. This is still in the animal research stage but should get approval for human testing this year. Since the patient's own cells are used, with proper screening there is little danger.

These are only a few of the "miraculous" strides that are occurring with the use of adult stem cells. Others include degenerative blindness, diabetes, muscular dystrophy, Parkinson's disease and leukemia. While time and energy (and much money) is being spent on fetal stem cell research, which has only a hope of some future benefit, the field of adult stem cell research is having an affect today on real people.

This lack of practical success is the weak spot of the fetal stem cell debate. With such successes in adult stem cell applications, the majority of research monies should be going to furthering these programs. It makes no sense to not fully support the therapies that are having such dramatic effects on real patients.

The debate on stem cell research shouldn't be over the ethics of using fetal stem cells but on whether they are even necessary to solving our medical needs. If we are truly attempting to do away with paralysis, genetic disease, and systemic deficiencies, adult stem cell therapy appears to be the answer. If we are looking for something more far-reaching, such as immortality, then we have much more grave concerns and issues to discuss.

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