Tuesday, January 10, 2006

Hwang Reaction: Research Needs More Care

In the first of what is likely to be a series of comments about the impact of the Korean stem cell fraud findings, a top Stanford researcher says they show that researchers must "work more deliberately."

Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine, released a statement that included the following:

"With the dollars provided by California's Proposition 71, Stanford intends to recruit scientists who will find ways to do nuclear transfer research, first in animal models and then with human cells, using the safest and most effective methods.

"The Stanford Institute for Stem Cell Biology and Regenerative Medicine is committed to advancing the field through the creation of new stem cell lines, research to further understand stem cell biology and the development of treatments for disease. Proposition 71 will play a significant role in helping Stanford researchers as well as other California institutions achieve the full therapeutic potential of stem cells."

Weissman called the Korean scandal a "personal tragedy" for Hwang and his scientific colleagues.

"While the announcement is a disappointing setback for nuclear transfer stem cell research, we are all making significant progress in the fields of adult tissue stem cell research, embryonic stem cell research and cancer/leukemia stem cell research. We must work more deliberately on nuclear transfer stem cell research, but we must go forward ethically and responsibly, as the future potential applications for the diagnosis and treatment of human diseases using these tools is so great," Weissman said.

CIRM Promises Open Search on General Counsel

After we posted the item below, the California stem cell agency emailed the following comment on Bedford's position at CIRM.

"CIRM will engage in a full and open recruitment process for the position of General Counsel when our funds become available."

Update on CIRM's General Counsel: An Orrick Connection

The California stem cell agency may have found the man who will be its new general counsel once the money really starts rolling in.

He is Daniel R. Bedford who is working fulltime pro bono at CIRM while he winds up affairs at Orrick, Herrington & Sutcliffe LLP of San Francisco.

It is our understanding that Bedford will fill the general counsel slot at a later point, but neither he nor CIRM would confirm that. Currently CIRM has put a hold on new hiring because of its budget crunch.

Bedford is assisting "CIRM generally on its many legal matters," says Nicole Pagano, a spokeswoman for CIRM. "At the moment most of his time is devoted to helping CIRM put together its Grants Administration Policy and advising on internal governance questions."

According to Orrick's web site, Bedford focused his practice on complex asset-based and lease financing, with an emphasis on agribusiness, domestic and international project financing, and tax-advantaged leasing."

His work has included representation of John Hancock Life Insurance in areas concerning equity and debt direct private placements. Other clients included public transit districts and Banc of America Securities. Much of his work involved various kinds of debt, which would seem to be a good fit with the needs of CIRM in connection with the issuance of state bonds.

Bedford has also participated in complex negotiations for natural gas pipelines involving government agencies, both in the US and involving Argentina, Chile, Brazil and Bolivia. Orrick's site did not list any involvement with biotech firms.

Orrick is bond counsel to California, but Orrick's site does not show any work by Bedford for the state.

Bedford received a B.S., M.B.A. and J.D. from Stanford University, where he was a member of Phi Beta Kappa.

Monday, January 09, 2006

Time for a Stem Cell Sunshine Vaccine

The international scientific conference that was sponsored last fall by the California stem cell agency had an interesting sidelight that is now surfacing in the Korean research scandal.

It was in San Francisco at the time of the conference that Gerald Schatten, the University of Pittsburgh scientist who co-authored the fraudulent Korean stem cell paper, met with Hwang Woo-suk and asked for a 50 percent share of the patent, according to Merrill Goozner, director of the Integrity in Science project at the Center for Science in the Public Interest.

Hwang rejected Schatten's request. About six weeks later Schatten publicly broke with Hwang, helping to set in motion a string of events that culminated in Hwang's disgrace.

The rejected request by Schatten has been reported previously (Nov. 29), although we had not seen the location of the meeting. But as Goozner notes, it has received little notice in American media. Goozner also points to a story on Saturday by reporter Jennifer Bails of the Pittsburgh Tribune-Review, who wrote that Schatten "is seeking to patent technology to create embryonic stem cells without crediting his now-estranged colleagues in South Korea."

The 50-percent request is not the only allegation about Schatten that has received little scrutiny. Totally overlooked by most newspapers was a report Dec. 16 by Associated Press writer Paul Elias. He wrote that Schatten, who was listed as "senior author" on the Hwang paper, could also become a victim of the Korean scandal.

"At the very least, Schatten faces a formal reprimand once an internal school investigation is concluded," Elias said.

He quoted Arthur Levine, dean of Pitt medical school, as saying:
"One should only be the senior author of a scientific paper when one has prepared and was responsible for all the data in that paper. It also implies the senior author is the chief of the lab where the experiment took place."


Other allegations concerning Schatten have also received short shrift in this country. They include aKorean statement that Hwang rejected Schatten's request to serve as chair of the once-vaunted World Stem Cell Hub. Hwang also reportedly rejected a Schatten request for a payment of $200,000 to help start the US operations of the World Stem Cell Hub, according to Digital Chosun.

Schatten and Pitt have generally not responded to the allegations. Pitt is conducting its inquiry behind closed doors, a process Goozner called outrageous.

Bails wrote:
"The rush to file biomedical patents for early-stage technologies creates roadblocks to research that do a disservice to the public by requiring scientists to dish out licensing money whenever they have an idea that might be worth pursuing, Goozner said.
"'It sets up arbitrary financial roadblocks to research,' Goozner said. 'We need new systems that make these technologies open to all scientists at the lowest possible price, and when the government funds them, it should be the government insisting that's how they are managed.'"

In his blog, Goozner wrote that Hwang was also attempting to patent the same research without mentioning Schatten.
"Ownership disputes over key stem cell patents have been simmering since the field emerged in the late 1990s. The University of Wisconsin, whose researcher James Thomson used Geron Corp. funding to isolate the first embryonic stem cell lines, charges $100,000 to commercial concerns and $5,000 to academics for access to those lines. It also granted Geron exclusive rights to pursue therapies in the most promising fields. Last May, San Diego-based stem cell researcher Jeanne Loring told Nature magazine her start-up firm collapsed because it couldn’t get access to the Wisconsin patents at reasonable rates," Goozner said.
In the case of Hwang, however, one wonders why someone would want to patent bogus research results.

Aside from the San Francisco meeting between Hwang and Schatten, what does all this have to do with CIRM? Much of it goes right to the point of the hottest issues before CIRM this year. The agency, as well as the legislature, is in the midst of wrestling with the question of ownership of state-funded research results and sharing access to those results. The fallout is likely to build support for more sharing rather than less. The Korean scandal also reminds us that the stakes are huge and people are tempted by riches and fame. It tells us that more disclosure is better than less about the economic interests of those associated with the $3 billion California effort. Call disclosure a kind of sunshine vaccine. Without some protections such as could be provided by a pending state constitutional amendment, the CIRM program would not likely survive a scandal of even a fraction of the magnitude of the Korean affair.

Why Whales Migrate

When two U.S. scientists decided to take their research to Singapore last fall, one Stanford stem cell researcher called it a "loss for America."

The two are Neal Copeland and Nancy Jenkins. They left the National Institute of Cancer in Maryland and rejected a pitch from Stanford as well before deciding to depart for Asia.

They said they would have moved to California if funds were available from the state's stem cell agency. Writers Sara Webb and Mia Shanley of Reuters recently explored more of the couple's reasons for leaving the Home of the Free and the Land of the Brave. They included "restrictions on government funding for stem cell research, shrivelling grants and curbs on commercial spin-offs from their work such as consulting and other fees," the scientists told Reuters.

The news agency reported:
"'The amount of money going towards research is going down. It doesn't have a high priority (in the United States). In Singapore it does," said Copeland, adding that they would like to exploit some of their Singapore-funded research commercially.
"Copeland and Jenkins said they had been won over by Singapore's scientific freedom, deep pockets and interest in commercial applications, at a time when the U.S. government's National Cancer Institute in Maryland -- where they worked for 20 years -- began a clamp down on consulting work by its scientists."
The story continued:
"In an era where funding is critical -- even a microscope can cost half a million dollars -- wealthy Singapore has the money.
"That, say scientists, has been Singapore's attraction, along with speedy grant approvals and lack of burdensome paperwork.
"'We don't want to spend the rest of our lives writing grants,' said Copeland, adding that Singapore's quick access to funding was key. The couple's colony of 20,000 mice costs some $1 million a year to maintain."

Singapore is currently engaged in a major recruitment drive to attract top scientists – "whales"-- as part of a multi-billion dollar biomedical research effort. Last fall reporter Lisa Krieger of the San Jose Mercury News wrote about the couple's decision. Irving Weissman, director of Stanford's Institute for Cancer/Stem Cell Biology and Medicine, told Krieger:

"'It is a loss for Stanford and a loss for America,' Weissman said. 'Without a doubt, they are the best people I know to find out which genes are altered to cause cancer.
"'When they do their work, it will be for Singapore,' he said. 'They'll conduct their clinical trials in Singapore. The first place their work will be patented and used will be Singapore.'"

Sunday, January 08, 2006

Studying the Science of Surfing

It's just like science say the biotech "dudes" who combine business and surfing in the Pacific Ocean near San Diego.

"In San Diego's booming biomedical industry, opportunity tends to come in waves — the kind found at La Jolla Shores or Black's Beach or Scripps Pier. Surfing has become a way to make contacts, get face time with the boss and arrange deals," wrote reporter Denise Gellene in the Los Angeles Times on Sunday.

They call them "board" meetings and report that "it's where the best business gets done." One surfer, Steve Mayfield, named his company, Rincon Pharmaceuticals Inc., after a surfing spot somewhat farther north on the California coast. Mayfield is also an associate professor of cell biology at the Scripps Research Institute.

Laura Shawver, chief executive of Phenomix Corp., said riding the waves has something in common with biotech.

"This is just like science. You must be very persistent. You can have spectacular wipeouts followed by the high of your life. And you are always looking for the next one."

We should report that we surfed a spot in La Jolla early in December but did not see any major stem cell breakthroughs or deals being hatched. But again it is about being in the right place at the right time.

California Researchers Forging Ahead with SCNT -- Among Others

Newsweek had something to say in its most recent edition (dated Jan. 16) on the impact of the Korean scandal on stem cell research in California as well as elsewhere.

Here are the most pertinent paragraphs in the item written Claudia Kalb and B.J. Lee:
"The Hwang debacle isn't stopping U.S. scientists. Nor are they starting from scratch. Somatic cell nuclear transfer (SCNT)—the technique Hwang claimed to have mastered in humans—has already been accomplished in mice. If researchers can move it to people, they say SCNT will allow them to watch complex diseases develop in the petri dish, spot problems and then test drugs to fix them.
"The procedure, which requires human eggs, is technically daunting and only a handful of U.S. scientists have said they have plans to try it. Three from Harvard, who specialize in diabetes and brain and blood diseases, hope to start experiments soon. The biotech firm Advanced Cell Technology, in Worcester, Mass., says it's moving ahead again after shutting down in the wake of South Korea's supposed advance. Stanford says it's recruiting scientists to work on the procedure. And last week, Larry Goldstein of the University of California, San Diego, went public, telling NEWSWEEK that he and several colleagues now plan to pursue SCNT as well. A politically active stem-cell researcher—he fought hard for California's $3 billion initiative—Goldstein wants to use the technique to focus on the genetic underpinnings of Alzheimer's: 'It's a unique approach to understanding disease.'"

Thursday, January 05, 2006

Correction

On Jan. 4 in the "eggs and ethics" item, we made an incorrect reference to the "Center for Policy and Genetics." The correct reference is to the Center for Genetics and Society. We are told that we have done this in the past, much to our regret -- the error -- not the criticism. We can only attribute it to a synapse breakdown.

Our policy is to correct all errors. We do not want to repeat them. If you see a mistake, please call them to our attention by sending an email to djensen@californiastemcellreport.com. Or you can post it directly online by clicking on the word "comment" at the end of each item.

San Diego Voice: Don't Tar California Stem Cell Effort

From San Diego, one of the hotbeds for stem cell research, comes an appeal to the public to not paint California's efforts with a Korean brush.

The pitch was made by Elie A. Shneour, president of Biosystems Institutes, Inc. and research director of Biosystems Research Institute of San Diego

Writing in the Voice of San Diego, an online news outlet in that area, he said,
"California in general, and San Diego in particular are directly affected by the fallouts of this debacle. It has to do with damage to the credibility of the stem cell enterprise, and the trust of the public in the funding of scientific research. But it should not be."
He continued:
"What happened in South Korea unjustifiably reverberates in California, but it should not create one more unmerited impediment to an already charged situation."
Shneour went on to praise the work of the agency and said:
"Unfortunately, this grand project is now mired in legal conflicts generated by politically and religiously motivated antagonism that mirrors the resistance of Washington to stem cell research."
"Disappointingly, California, a state that has always been at the forefront of progress, is allowing the uninformed and the fearful to deny it the opportunity to take one of the first steps."



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Wilson Cites Other Commitments

According to CIRM, Gayle Wilson left the Oversight Committee of the California stem cell agency because "her other commitments have shifted in the last year and she is unable to devote the full time and attention necessary to participate fully as a member of the ICOC."

That was the response from Nicole Pagano, spokeswoman for the agency.

Wednesday, January 04, 2006

Gayle Wilson Leaves Oversight Committee

Gayle Wilson, the wife of former California Gov. Pete Wilson, has resigned from the Oversight Committee of the California stem cell agency.

Wilson's resignation took effect last Sunday, according to a press release from CIRM. The statement said she will "continue to advise CIRM leadership on state and federal legislative matters." The reason for her departure was not disclosed in the press release, but we have a query into the agency.

Wilson was appointed to the board by Gov. Schwarzenegger as a representative to a committee slot for "an executive officer of a commercial life science entity." She is serves on the board of Gilead Sciences, as biopharmaceutical company.

Stem cell chairman Robert Klein said, "Her outreach efforts to fully inform the stem cell debate in Washington D.C. have been invaluable-especially in moving pro-stem cell legislation forward and with advancing a scientific understanding of stem cell research and its promise for treating chronic disease."

Wilson is the second person to leave the Oversight Committee. Phyliss Preciado left in the middle of 2005 to take a job in Oregon.

Eggs, Ethics and Cash: What about Singapore?

What is the price for a woman's egg? Is it more or less than a man's sperm? Is an egg worth more than the $30 paid to the donor of a pint of blood? Is it worth more than a kidney, for which the official price is zero?

Some of the questions that are being discussed by the California stem cell agency as it develops rules for securing eggs for its taxpayer-funded research.

Prop. 71 prohibits paying women to provide eggs, beyond direct expenses. But the agency is trying determine whether eggs can be used that come from sources outside of California that may involve some sort of additional payment. The Center for Policy and Genetics says that many members of the CIRM's Standards Working Group have "advocated seizing on a potential loophole in Prop. 71," asserting that "compensation for egg providers would be legal as long as the funds for these payments came from a source other than the CIRM."

The topic of cash-for-eggs came up at the group's meeting in December. The meeting received no coverage in the media but was attended by a staffer from the Center. The Korean scandal, which involved payments of $1,400 for a human eggs, was discussed during the meeting, although the flap was in its early stages.

The transcript of the meeting shows a free-ranging and loose discussion of some of the considerations involving the use of human eggs. Often in such discussions, the beginning question is phrased as "should we pay women to donate their eggs?" Rarely is it phrased as "should women be allowed to sell their eggs?" The different starting points could lead to different conclusions.

Here is a semi-random sampling of some of the partial comments from members of the Standards Group as carried in the transcript of the meeting.

Ann Kiessling, director of the Bedford Stem Cell Research Association and associate professor of surgery at Harvard Medical School
"I think that in the consenting process itself, you cannot establish guidelines for people in Singapore or other parts of the world who may actually view this as a way for women to get together and actually create a small business to donate eggs. I don't think that should be absolutely prevented. What you want to prevent is having somebody go through this procedure who was not fully informed and not doing it of their own free will."

Zach Hall, president of CIRM
"The question is do we want to exclude cell lines that are made by well-meaning, thoughtful, responsible people who happen to come to a different conclusion for whatever reasons than we do on this particular issue?"

Kiessling, again
"Lots and lots of women are going to be willing to do this because they're going to be willing to do it. It's going to be a select group. You are not going to recruit people who can't afford to take off two weeks to do it... Plenty of women...are going to volunteer to donate eggs because women do things like that. That's not the issue. The problem is whether you ought to accept lines from other parts of the world or other parts of the country that have different guidelines."

Marcy Feit, president of ValleyCare Health Systems
"(Say)there's a cell bank in Singapore. What assurances do we have that even if we get paperwork that says informed consent was given, how do we validate the process of informed consent? Many times cultures work under different understandings of processes than we do. And so I think we have to give really careful consideration to lines that were derived before our standards were set in. And I'm not saying I have the answer of how we're going to go about that because I hear the plea from the scientists that you really want to include as many lines as possible that are usable for research. But given that, the attack on CIRM would be vicious internationally if we accepted one cell line that wasn't properly handled in another country. So to validate that process, to really understand, as much discussion as we had this morning regarding protecting women, and we know what we want, how do we validate that with cell lines that were created prior to this understanding this morning?"
The discussion turned to the value of eggs in dollars and cents.


Kevin Eggan, assistant professor of molecular and cellular biology at Harvard and a founding member of the Stowers Medical Institute

"The problem here is that...eggs somehow lie somewhere between blood and sperm
and a kidney. "
Robert Taylor, associate professor of medicine at Emory University
"So I'm having trouble following this argument. So the liver donor gets nothing.The kidney donor gets nothing. The sperm donor get $75 or something like that.The blood donor who has probably a slightly higher risk of injury than the sperm donor, which I would say is probably relatively minimal risk last time I thought about it, gets compensated to the tune of $30. I'm just -- I'm starting to -- so cost and risk clearly are either dissociated or inversely related. I can't figure this."
The topic of eggs and ethics is expected to be revisited later this month at a two-day meeting of the Standards Working Group.

Tuesday, January 03, 2006

CIRM President On Cyberspace Airwaves Jan. 4

Set your Internet radio Wednesday Jan. 4 to Science and Society at 1 p.m. PST to catch the president of the California stem cell agency discussing the latest doings at the institute.

Zach Hall is scheduled to be interviewed on a program called Science and Society by David Lemberg. The program's website says it provides "direct access to primary sources of change in science and technology." It is also a public service of the Hopkins Capital Group, a St. Louis venture capital firm focusing on high tech health firms.

California Universities Not Waiting for CIRM Cash

California universities are plunging ahead with multimillion dollar stem cell programs despite the failure – so far – of the California stem cell agency to deliver on promised grants.

That's the report in the Los Angeles Times this morning by writer Rong-Gong Lin II.

According to the story:

"'We are … not waiting,' said Arnold Kriegstein, director of UC San Francisco's stem cell institute, which has also hired faculty and started preparing research facilities. 'We are moving ahead with what we can with private funding.'"
The Times said that UC San Francisco officials are using private fundraising to renovate about 7,000 square feet of lab space, expected to be ready in 10 to 11 months for new embryonic stem cell lines not approved by the federal government.

The story also said, however:
"Some (UCSF) researchers who had been eager to compete for grants for embryonic stem cell research have had to look for other sources of funding or areas of emphasis. Programs to train scientists in developing and maintaining human embryonic stem cells have stalled."
Here is the Times look at other schools:
"USC has lured a top scientist from the Australian Stem Cell Centre to head its new research institute and has committed $10 million this year to hiring faculty and renovating lab space." He is Martin F. Pera, whose lab was the second in the world to isolate embryonic stem cells from the human blastocyst, a developing embryo.

"UCLA has said it will spend at least $20 million over five years to recruit scientists and set up laboratories. It has already hired three young researchers for faculty positions, two from Harvard University and the other from Massachusetts Institute of Technology." The Times identified three of the hires as Hanna Mikkola, who is focusing on leukemia; Kathrin Plath, who was at the Whitehead Institute for Biomedical Research at MIT and is studying the biology of how stem cells differentiate; and Amander Clark from UC San Francisco, who wants to see how stem cell research can help improve human fertility

"Stanford University has made several prominent hires, including two in May from Harvard and the University of Michigan. UC Irvine has begun planning a $60-million facility to house its program, and on Friday hired Peter Donovan, a prominent Johns Hopkins University professor, as an interim co-director."
Separately from the Times article, John Simpson, stem cell projector director for the Foundation for Taxpayer and Consumer Rights in Santa Monica, commented on the hiring of Pera, but his remarks apply to the others as well:
"This just shows that Prop. 71 is having worldwide impact and that California is becoming the model for publicly funded stem cell research. If the ICOC is to fulfill the promises made to the voters, CIRM polices need to be grounded on three principles: affordability, accessibility and accountability."

Sunday, January 01, 2006

Stem Cell Matters Moving Into Gubernatorial Campaign

You might call him Stem Cell Steve. He is the only major candidate for governor of California with a section of his website devoted to stem cell issues.

He is Steve Westly, the elected controller of the state of California. Westly is running for the Democratic nomination for governor against Phil Angelides, who is the elected state treasurer.

The position of controller is pretty much a ho-hum office, hardly worth more than the proverbial bucket of warm spit, as a former vice president of the United States once described his own office. It is difficult to electrify the electorate when your main responsibilities as controller are primarily printing state payroll checks and dealing with "fiscal year-end procedures."

Only one California controller has managed to make it into the governor's office, Gray Davis, who was a colleague of ours some 30 years ago.

We ran across Westly's interest in stem cell matters when we saw a Google ad bearing his name on this web site. That means the Westly campaign is paying Google to place ads on sites that deal with stem cell issues.

(For the record: We -- the California Stem Cell Report -- do not have any control over which ads Google places on our pages. We do not receive any revenue from Google unless someone happens to click on Westly's ad or any of the others that may appear. Even then the amounts are inconsequential or less. Since Google ads began appearing on this blog in early 2005, we have not received one cent from the advertising. We hesitate to speculate about what that means.)

Westly's ad makes a pitch. "Stem cell research – why it's held up and how you can help," it reads. The ad contains a link that takes the curious to a section on Westly's campaign website called "Stem Cell Research Now!" It targets Gov. Schwarzenegger as allied with opponents of stem cell research who have sued the stem cell agency. Here is what it says:

"Right-wing troublemakers Ted Costa and Lew Uhler are behind the lawsuit. They also happen to be - surprise, surprise - two of Governor Schwarzenegger's biggest backers. Costa led the recall and Prop. 77 drives. Uhler was behind the union dues initiative, Prop. 75.

"So why doesn't the Governor call off his conservative cronies? Millions of people are waiting for cures. Stem cells may be the fastest way to get those cures. And Arnold's buddies are holding up the research."

The pitch includes an electronic petition that is designed to be sent to the governor with the electronic addition of a signature and email address from whomever may be viewing the site, whether they live in Korea or South Dakota. Our suspicion is that the petition, if it ever gets delivered, would contain no names from Korea. The Westly effort is undoubtedly designed to identify probable Westly supporters who are interested in stem cell research. Once identified, they can be targeted later for more specific pitches in support of Westly.

Westly's rival for the Democratic nomination, Angelides, does not have a similar focus on stem cell issues. One can only speculate on the stem cell strategy in Westly's campaign. But here is one theory: Westly's people read polls that say the public supports stem cell research. If the public knows Westly supports the research, that will generate voter approval. It will generate even more voter approval if the evil Gov. Gropenator is linked with the Luddites who oppose stem cell research and are suing to prevent it. Further, attacking the governor at this stage could also help weaken him in next fall's general election. Or so the reasoning may go.

We should note that Westly is a former top executive at eBay and has close links to the Silicon Valley financial community, which was a big supporter of Prop. 71. California stem cell chairman Robert Klein also donated $27,695 to Westly's campaign for controller, according to one report.

More Cash for CIRM This Month?

The financially hard-pressed California stem cell agency hopes to get a boost this month with the sale of bond anticipation notes to philanthropic investors.

Reporter Laura Mecoy of The Sacramento Bee quoted Zach Hall, president of CIRM, as saying that the agency hopes to secure enough funding by the end of January to move forward on some of the training grants it approved in September.

No money has been available for grants because litigation against the agency has made it unable to issue the $3 billion in bonds that voters authorized more than a year ago. The lawsuits are not expected to be resolved until 2007.

Mecoy's story Sunday morning also reported that the agency is "trying to determine whether state-funded research can use stem cell lines developed by other agencies that allow larger donor payments" than permitted under Prop. 71, which limits egg donor payments to reimbursement for expenses.

"There are other entities in other countries that operate in other ways. If we insist everybody do as our regulations say, our scientists will not be able to work on (stem cell) lines that deviate from our standards," Hall said.

The main focus of Mecoy's story was on the impact of the Korean scandal on legislation by State Sen. Deborah Ortiz, D-Sacramento, to tighten oversight of the stem cell agency, which we discussed on Dec. 20 (Christmas Comes Early for Sen. Ortiz).

Mecoy wrote:
"'The South Korean scandal makes it more difficult for opponents to allege this is a plot by the right wing,' Ortiz said of her legislation. 'It shows the best and the brightest in the scientific community couldn't catch these instances of fraud and overstated research.'"

Mecoy continued:

"'If their industry can't sufficiently police themselves and root out fraud, then government should step in,' the senator said. 'California would be leading the nation if we did the right thing.'

"Hall said the South Korean scandal 'emphasizes the importance of just the type of apparatus we are putting together' at the stem cell agency.

"But he said fraud is not unique to stem cell research: It has happened in various fields of scientific endeavor.

"'These things happen,' he said. 'The more intense the interest, the more likely they are to happen, and the more likely they are to be found out.'"

Regarding the sale of the bond anticipation notes, agency officials earlier said they hoped for funding last fall so we will have to wait and see whether the current expectations materialize. Agency officials have been circumspect on any pending deals, but on Oct. 31, an official from the state Treasurer's office said there was no interest from investors in purchasing the notes. However, that was two months ago and that official may not have been fully informed on efforts by stem cell chairman Robert Klein to peddle the notes. He seems to have taken on the sale as a personal project.

A sale of the notes in amounts that would not fully fund the first year of all the authorized grants raises interesting questions about which institutions would receive cash and in what amounts. Presumably that would be a decision that would be made by the stem cell Oversight Committee, which does not meet again until February. A politically astute grant recipient might promptly begin discreet lobbying of Oversight Committee members to assure that its programs receive favorable consideration.

Thursday, December 29, 2005

A Korean Lesson: 'Money Breeds Corruption'

The California stem cell agency needs to start asking more questions about the Korean scandal and how it may relate to stem cell research in the Golden State, The Sacramento Bee said today in an editorial.

The Bee said CIRM can learn from the Hwang affair but only if the agency takes "the time to publicly grapple with this scandal. So far, they have acted as if Hwang is a distant aberration whose fabrications don't affect them. Nothing could be further from the truth."

The editorial continued:
"While California's institute can do only so much to combat scientific fraud - the responsibility lies largely in the hands of peer-reviewed journals - it can set standards for obtaining eggs and other biological material, and ensure those rules are enforced. The institute's medical standards working group is now preparing such regulations. Yet at their last meeting, on Dec. 1, the committee's members went out of their way to avoid any discussion of Hwang's mounting troubles."
In a separate opinion piece, Associate Editor Stu Leavenworth wrote that it is easy to learn the wrong lessons from Korea.

It is, he said, "laughable to hear people insinuate that this debacle could have been avoided if American researchers, and not the South Koreans, were leading the way.

"The annals of U.S. science are filled with researchers who faked findings, exploited human test subjects and enriched themselves while extolling their supposed ethics. Indeed, it is interesting that Hwang's fraud was exposed not because of scrutiny from U.S. researchers, but because his colleagues in South Korea had the courage to go public with questions about their 'supreme scientist.'"
He continued,

"The only lesson is an old one: Money breeds corruption. Rightly or wrongly, embryonic stem cell research is seen as the next big rainmaker in the biomedical field. With so much money riding on the outcome, some people are going to lie, cheat and steal.

"To combat such fraud, editors of science journals - and those of us in the media - need to be much more skeptical than we were in this case."

Monday, December 26, 2005

California Stem Cell Director Stresses Speed

One of the members of the Oversight Committee of the California stem cell agency spoke of the need for "urgency" in finding stem cell therapies in an interview with a newspaper printed today.

The quest for speed is one of the problems at the heart of the Korean stem cell scandal, according to some scientists.

Joan Samuelson of Healdsburg, CA, an attorney and president of the Parkinson's Action Network, is the committee member who did a Q&A with the Santa Rosa Press-Democrat. Given the nature of such Q&As, it is likely that she actually made her comments anywhere to a few days to a few weeks prior to their publication, probably at a time when the scandal was not as hot. The topic of Korea did not even come up in her printed remarks.

Nonetheless, one of the refrains heard from the patient advocates is the crying need for cures. Some, such as Samuelson, are living with diseases that could be alleviated through the results of stem cell research.

Here are a couple of excerpts from the interview:
"Prop. 71 seeks something that may be a first in biomedical history: not just research advances, but actual treatments and cures resulting from the investment of funds, and in a tight time frame. The National Institutes of Health, for example, spends about $30 billion each year in federal tax dollars to fund research, but requires no particular results.

"My 15 years of watching this process causes me to side with the scientists who believe that if every step is treated with great urgency, sharing of information, collaboration in approaches and adequate funding, that will start translating into the first treatments far sooner than they will if this process is left to chance."

"Several forces delay finding cures. For example, you might not get a cure for decades because researchers don't stick to the problem. They move on to something else, because they lose interest, because it's too hard, because there's no funding.

"But this won't happen at the institute because 10 of us wake up every morning saying, 'Please, God, let this succeed.' My vision is that the institute will be available to fund any piece of remaining research needed. We're going to have to work with the whole world."

The reference to "10 of us" is to the number of patient advocates on the board.

Friday, December 23, 2005

CIRM Scientific Conference Expenses Disclosed

The California stem cell agency's international scientific conference last October cost $128,489, coming in nearly $87,000 under budget.

The event drew a fair amount of news media attention (see "Everything" and "Clues" items on this blog) and was praised by editorially by at least one newspaper as one of the wisest expenditures CIRM has made. That said, the agency was a bit balky at releasing the budget figures.

The largest single expenditure was $48,643 for rooms, facilities and equipment at the PARC 55 Renaissance Hotel in San Francisco. Rooms were discounted 30 percent for the 32 persons that the agency picked up expenses for. CIRM paid $45,200 to Mosaic Event Management to run the event. Travel expenses for speakers and others ran an estimated $20,000. Another estimated $9,000 is slated to go to science writer Kelly LaMarco, who is preparing an executive report of the meeting.

The event generated $23,450 in registration and other fees.

The expenses do not include a reception for attendees that was hosted at the St. Francisco Hotel by the California Healthcare Institute, a biomedical industry group.

Wednesday, December 21, 2005

Why Do Scientists Cheat?

"If you're not in first place, you're no place," says one bioethicist in an article in the Christian Science Monitor about what it calls "a year of research ethics challenges."

The springboard for the piece by reporter Peter Spotts is the Korean affair. But Spott recounted scientific scandals at the Veterans Administration, MIT and the University of Vermont.

He also dealt with dubious dealings at NIH.
"In a survey of NIH-funded scientists, released in June, only 1.5 percent of 3,000-plus respondents acknowledged having falsified or plagiarized information. But 15.5 percent admitted to altering their research approach under pressure from funding sources, and 12.5 percent admitted to looking the other way when colleagues used flawed data."
The comment about "first place" came from Thomas Murray, president of the Hastings Center, a bioethics institute in New York state. He noted that scientists have the usual human failings but work in an intense environment where only the best ideas rise to the top. He did not say "perceived" best ideas, but he should have.

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