Showing posts with label ethics. Show all posts
Showing posts with label ethics. Show all posts

Monday, May 05, 2008

Klein, Zeal and CIRM's No-Contact Rule

The chairman of the California stem cell agency, Robert Klein, has apparently violated his agency's bylaws by contacting applicants for $262 million in stem cell lab construction grants scheduled to be approved this week.

CIRM, however, contends Klein did nothing wrong. One non-longtime CIRM observer called the violations "technical." And Klein's actions are not likely to have any significant impact on funding or result in sanctions on him personally.
According to the San Francisco Business Journal(see item below), Klein has been dickering with applicants in an effort to convince them to reduce the size of their grant requests by 10 percent if they receive the money sooner rather than later. CIRM's board of directors is scheduled to take up the grants in Los Angeles tomorrow.

Bylaws for CIRM's Facilities Working Group, of which Klein is a member, forbid him from contacting applicants. Article Seven, section four, states:
"Members of the Facilities Working Group shall not communicate with an applicant about an application to CIRM."
In response to a query about Klein's actions, Don Gibbons, chief communications officer for CIRM, said,
"Chairman Klein was specifically authorized by the Facilities Working Group at its last public meeting to work with the institutions on this project in his capacity as board chair. This supersedes the language you cite."
However, our review of the transcripts and a grant administration policy document from the April meeting showed no such authorization. A possibility exists that the authorization is somewhere in the 418 pages, and we asked Gibbons to provide a citation.

Gibbons said he was too busy with other matters today to provide a citation. He said,
"The Facilities Working Group approved the Facilities Grant Administration Policy with the understanding that Mr. Klein, in his role as chair, would carry out the negotiation."
It is not clear what sanctions, if any, might apply if Klein is found to be in violation of the bylaws. As for the grants themselves, in our view, it is unlikely that any might be affected by Klein's contact with applicants.

We queried John M. Simpson, stem cell project director for Consumer Watchdog, on Klein's actions. Simpson, who was at the Facilities meetings on April 4 and 5, said,
"Given the working group's bylaws it would have been better if Bob Klein hadn't been the one to contact grant applicants about taking less CIRM money if the entire grant were paid up front. I think the idea is a good one and supported it enthusiastically at the working group meeting as a way to avoiding making more cuts. I still do.

"Based on the discussion at the meeting, I understood that Klein was one of those that would be contacting applicants. I thought that as long as all applicants were treated equally and offered the same discount in return for taking the money up front there was no problem.

"Re-reading the the working group's bylaws today, I reluctantly conclude that in his zeal to maximize the impact of CIRM's $262 million, Klein may have technically broken the rules."
The no-contact clause in the bylaw has existed since 2006 and was drafted by James Harrison, outside counsel to CIRM. During the meeting when the language was adopted, Klein said,
"The purpose of having a committee here is that we are able to gather information generally; but once there's an application in, you can't discuss anything with them...there has to be a bright line created here."
CIRM board member David Serrano Sewell also commented in 2006 on what he described as "ex parte discussions." He said,
"It sort of just goes without saying and common sense that an applicant doesn't have a one-on-one conversation about their particular application. Should that discussion happen, a, it's inappropriate, it's unethical, and, c, it's going to have to be disclosed on some level."
However, the 2006 meeting, which we attended, was mainly considering the process prior to facilities group action. No one at that meeting discussed a situation where the chairman of the CIRM would negotiate some terms of a grant privately following the facilities group action, but before the grant came before the full CIRM board, which has final authority on funding.

At this year's April meeting of the facilities group, attorney Harrison presented language that would permit the reduction in the size of grants if applicants agreed to take the lesser amount up front. He did not mention the no-contact rule in the bylaws involving members of the facilities group. It appears, however, that no restriction exists on staff negotiating a hold-back on funding with grant applicants.

One final note on yesterday's item below, which was written before we turned up the no-contact rule. We raised a series of questions about whether Klein had contacted members of the CIRM board who had lab grant applications pending this week. We asked CIRM to respond to those questions. Here is Gibbons' response:
"The discount proposal was discussed at the April 5 public meeting of the Facilities Working Group, at which time Citizens Watchdog's John Simpson said it 'bordered on brilliant,' per the transcript on the CIRM web site.

"All discussions on the proposal subsequent to that time have been conducted in collaboration with CIRM legal counsel in full compliance with all regulations governing CIRM, so the chair did not negotiate with any board members."
We have queried members of the CIRM Oversight Committee who have applications pending concerning contacts with Klein. We will report on their responses tomorrow, but so far it appears that none had contact.

(The actual discussion of the "hold-back" or "discount" plan begins on page 45 of the transcript of the April 5 meeting.)

Tuesday, October 30, 2007

Stem Cell Freeze Flap: Ethics, UC San Francisco, Stanford Involved


"Modern day frankenstein story," "undeniably creepy," "trying to improve the quality of life." Some of the comments on a story in the San Francisco Chronicle involving a firm that offers "to create 'personalized' stem cells from the spare embryos of fertility clinic clients."

The article Monday by Bernadette Tansey said the idea is to freeze the stem cells for possible later use – "insurance for the future" – in the event that medical breakthroughs could make use of them.

The company is StemLifeLine Inc. of San Carlos, which is located south of San Francisco. It charges as much as $7,000 to create and freeze the stem cells with storage costs of $350 currently. Additional fees of up to $2,000 could be charged.

Tansey said the firm's proposal has set off a "flash fire of protest" from both supporters and foes of stem cell research.

Forty-seven comments were filed by the public on the story(they can be read at the end of the Chronicle story). The wide range offers some insight into the magnitude of the public education challenges that stem cell research still faces. Particularly since the Chronicle audience presumably consists largely of stem cell supporters.

The story also reported that the firm's business has triggered something of a tussle involving folks from UC San Francisco and Stanford.

The head of StemLifeLine is Ana Krtolica(see photo), a former researcher at UC San Francisco. On the firm's advisory board is Susan Fisher, who heads the UC San Francisco stem cell program. Olga Genbacev, a member of the firm's board, is a scientist in Fisher's lab. Tansey also reported that "the company's staff and boards include present and former research collaborators of Fisher's."

One of the folks from Stanford arrayed against the firm's proposal was David Magnus, director of that university's Center for Biomedical Ethics. He told Tansey,

"These companies are essentially taking advantage of people's ignorance and fears to make a buck,"

Also commenting negatively from Stanford were Rene Reijo Pera, director of Stanford's stem cell program and formerly of UC San Francisco, and Chris Scott, director of the Stanford program on Stem Cells in Society.

In addition to the comments on the Chronicle site, Monya Baker in Nature's stem cell blog, The Niche, said that it is "troubling" that the company has failed to make any of its customers available for interviews and refuses to provide a copy of the contract that customers sign.

Friday, March 23, 2007

RHA RMI Issues Receive Little Notice in Media

The flap over the $2.6 million California stem cell grant to a Los Angeles enterprise linked to ethical lapses involving a Korean scientist received scant attention today in California newspapers.

Only one story appeared in a newspaper, and one online. Neither contained much new information. Reporter Carl Hall of the San Francisco Chronicle did carry a comment from CHA Health Systems, the parent company for CHA Regenerative Medicine Institute, which was approved for the grant last week by the CIRM Oversight Committee. Hall wrote:
"Jason Booth, a spokesman in Los Angeles for CHA Health Systems, said the research unit is a bona fide California nonprofit whose status was not at issue, and that its 'grant was based on a thorough scientific review that speaks for itself.'"
Rob Waters of Bloomberg.com, who was the first to point out the connection between CHA Health Systems and CHA RMI, also reported on the calls for an investigation. He said a representative of CHA in Korea said the company would respond later.

The Californa stem cell agency said it was in the process of conducting a routine review of all the grants approved last week, which will include an examination of whether each recipient is eligible for the award. Waters quoted the agency as saying that the review could take six weeks.

The Bodyhack blog on Wired.com was the first (on March 17) to pull together the plagiarism allegations involving the head of CHA Health Systems along with other ethical concerns involving CHA and point out that a CHA subsidiary had been approved for the $2.6 million state grant. The California Stem Cell Report on the matter appeared Wednesday night and led to the calls for the investigation.

We have emailed CHA several times seeking a comment on the matter, including a promise to run their comments verbatim. We will do so when we receive a response.

(Editor's note: An earlier version of this story incorrectly said that the California Stem Cell Report was the first to link the CIRM grant and the ethical concerns involving CHA.)

Thursday, March 22, 2007

Advisory

The press release by the Center for Genetics and Society concerning the CHA grant has now been posted on its web site. Here is the location.

CGS: CIRM Grant Recipient Has 'Shadowed' History

The Center for Genetics and Society today said "troubling questions" have arisen in connection with California's $2.6 million stem cell research grant to CHA RMI, adding another voice to the call for an investigation.

Marcy Darnovsky, associate director of the Oakland-based center, said in a press release:
"The leadership of CHA Health Systems (a Korean firm) has a shadowed recent history, including a lawsuit that alleges the director of its fertility center lied in order to obtain a woman’s eggs, The CIRM needs to live up to its oft-stated commitments to transparency and responsibility by freezing this multi-million dollar award while a thorough investigation is undertaken. If questions cannot be satisfactorily answered, the grant should be rescinded.”
Jesse Reynolds, a policy analyst at CGS and who has attended many CIRM meetings, said:
"Did CHA Health Systems establish this subsidiary in order to pursue California public funding, at a time when South Korea government funds were unavailable because of the Hwang Woo Suk cloning scandal? Given the recent record of unethical conduct in this field, the CIRM should have known to exercise greater scrutiny."
The press release continued:
"The medical director of the CHA Fertility Center is the subject of a lawsuit filed by a woman who says that he lied about the number of eggs that had been collected from her, causing her to continue seeking treatment from him. The CHA Fertility Center and the CHA Regenerative Medicine Institute are located in the same Los Angeles office building.

"'The lawsuit suggests that CHA’s leadership placed a woman at unnecessary risk by misleading her into undergoing repeated cycles of egg retrieval,' Darnovsky said. 'Women’s health advocates have warned about the health risks of egg retrieval, as well as about likely conflicts of interest between fertility doctors conducting egg retrieval and researchers who want the eggs for their experiments.'"
Asked for a comment, Dale Carlson, chief communications officer for CIRM, said CGS' comments were "another uninformed reaction." He used similar language concerning statements by the Foundation for Taxpayer and Consumers Rights.

We have asked CHA for comment on these matters and will carry them when we receive them.

The center's press release was not posted on the Internet at the time of this writing. We will carry an advisory when it is posted.

Tuesday, January 30, 2007

MSU Clears Cibelli of Misconduct

Stem cell scientist Jose Cibelli, a member of one of the working groups of the California stem cell agency, has been cleared of misconduct by Michigan State University but it is not known whether he will return to his advisory work with CIRM.

Cibelli asked for the MSU investigation as a result of his connection with the Korean stem cell scandal. He was the co-author of the fraudulent March 2004 paper that reported the first-ever closed human stem-cell line.

A letter signed by the university intellectual integrity officer was provided by Michigan State University to the California Stem Cell Report. The letter said in part:
"The excerpts below summarize the findings of the IC(investigative committee):

'After considering all the testimony and evidence available to it, the IC finds that the Respondent did not commit Misconduct.'

"The report further states:

'His support for, and participation in, the 2004 manuscript were motivated by his natural enthusiasm for NT cloning and human ES cell research, his hopes that the field will progress and his well-meaning desire to participate appropriately in that overall effort.'"
Dale Carlson, spokesman for CIRM, told the California Stem Cell Report:
"Cibelli was an enthusiastic, valuable member of the group and we'd like very much to see him back."
Carlson added that further information would have to wait until CIRM President Zach Hall returns from a trip to Singapore.

Cibelli voluntarily withdrew from active participation in the standards working group after the Korean scandal erupted.

Below is the full text of the MSU letter concerning Cibelli. We have asked the university for a complete copy of the report that is referred to in the letter.

Text of Cibelli Letter

Here is the complete text of the letter supplied by Michigan State University concerning Jose Cibelli:

January 26, 2007

This letter is to inform you that Michigan State University has just completed its Investigation into the Allegation of Misconduct in Research against Dr. Jose Cibelli, Professor, Department of Animal Science and Physiology, under MSU’s Procedures Regarding Allegations of Misconduct in Research and Creative Activities. The Investigative Committee (IC) found that no Misconduct in Research occurred.

Immediately after learning that the paper he co-authored, “Evidence of a pluripotent human embryonic stem cell line derived from a cloned blastocyst”, Science 303:1669-1674, reported data from fraudulent research, Dr. Cibelli voluntarily went to MSU’s University Intellectual Integrity Officer (UIIO) seeking an evaluation of his contributions to the manuscript. Dr. Cibelli’s review included a Preliminary Assessment by the UIIO, an Inquiry conducted by three colleagues of an Inquiry Panel and a formal Investigation conducted by three colleagues who comprised the IC. Review of Dr. Cibelli’s case took approximately one year.

The excerpts below summarize the findings of the IC:

After considering all the testimony and evidence available to it, the IC finds that the Respondent did not commit Misconduct.

The report further states:

His support for, and participation in, the 2004 manuscript were motivated by his natural enthusiasm for NT cloning and human ES cell research, his hopes that the field will progress and his well-meaning desire to participate appropriately in that overall effort.

Please consider this finding of no misconduct in future interactions with Dr. Cibelli.

Sincerely,

James M. Pivarnik, Ph.D.
University Intellectual Integrity Officer

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