Saturday, April 30, 2005
The piece said that while stem cell chairman Robert Klein pays lip service to NIH standards, he does not seem ready to go along with the latest that have resulted in the resignation of some NIH scientists.
“Thus we have a sad situation. Weak standards in California are attracting scientists who don't want to deal with new ethics standards in Washington. This wasn't the magnet effect voters envisioned when they approved Proposition 71."
Reporter Steve Johnson of the San Jose Mercury News wrote:
“Oleg Kaganovich, chief executive of the Sacramento Area Regional Technology Alliance, which helped put together that city's bid, wouldn't talk in detail about what Sacramento's backers have planned for the visiting board members. 'It's going to be somewhat of a surprise,' he said. 'We're going to wow the pants off of these people.'''
It's not clear whether he was talking about the Sacramento Kings' smashing victory over Seattle Friday night in the NBA playoffs.
Reporter Carl Hall also had an account of the site selection committee's visit to San Francisco on Friday.
“There was free Hetch Hetchy bottled water. The Giants scoreboard at SBC Park signaled a welcome. And the bus ran more or less on time,” Hall wrote.
“San Francisco officialdom did everything but hire Tony Bennett to melt the hearts of state officials shopping this weekend for a headquarters city on behalf of California's Proposition 71 stem cell program.”
Were the decision makers impressed? “Side talk among members was also ruled out,” Hall wrote. “If anyone gave a clue as to how he or she was leaning on Friday, it was well out of the earshot of the mayor and the media.”
By the way, the next Kings-Seattle game is Sunday night at 7:30 p.m. West Coast time.
Friday, April 29, 2005
Ken Garcia wrote a “personal perspective” in the San Francisco Chronicle on the behind-the-scenes tittering in San Francisco.
“No one I spoke with would comment on the record, but it's fair to say that San Francisco officials are not exactly saddened by San Diego's woes. It certainly can't help if the future capital of the world's biggest private stem- cell program is mired in scandal. With San Diego reeling from another mayor-go- round -- (Mayor) Murphy was re-elected in November after a judge threw out thousands of write-in ballots that would have elevated surfer/councilwoman Donna Frye to the post -- it's hard to see how the selection committee wouldn't at least consider it a factor.
"'It does raise some interesting questions,' one City Hall official said. 'But it's not our place to raise them.'''
Garcia skated over San Francisco's own rather checkered political history. Another minor note: Frye is not a surfer; she ran a surf shop.
Reporter Terri Hardy of The Sacramento Bee wrote that local officials there staged a “cheesy” news conference Thursday to support the Sacramento bid but were quite unified when they did it. She quoted Sacramento Mayor Heather Fargo as saying, "Sacramento is in fact the best location, and location should be critical. The Capitol is where stem cell decisions are made."
Reporter Rachael Gordon of the Chronicle covered the perspective from all four cities. The San Diego Union Tribune did not appear to carry a story on the matter this morning.
Thursday, April 28, 2005
“So cautious is the (selection) committee that cities were warned they could provide no food or gifts during site visits. Said one staff member, 'Only coffee or water can be served,'" wrote reporter Terri Hardy in The Sacramento Bee.
Reporter Carl Hall of the San Francisco Chronicle pretty much says Baghdad-by-the-Bay has it in the bag. But he also reported, “San Francisco officials made it clear they are not yet ready to start celebrating -- and not only because they want to avoid looking too smug in advance of the key votes.
“The reason the subcommittee is recommending a runner-up city is that a separate group from the institute is now searching for a permanent chief executive. Officials want a couple of possibilities in the event that person has a strong preference on location.”
Reporter Laura Mecoy weighed that question in a story on the competition for the site. She wrote that Sacramento “is closest to state government and has the lowest cost of living.
“Problem is, neither point is getting much attention from the site selection panel that will visit Sacramento and the three other finalists over the next four days.
“The panel plans to use the site visits to help advise the full stem cell board when it picks the headquarters city on May 6.
"'We are working against the notion that the Legislature should have no role in the stem cell program,' said Sen. Deborah Ortiz, D-Sacramento.
“Tom Zeidner, Sacramento's senior economic development project manager, said the stem cell agency's chairman also told him 'rather curtly' that cost of living didn't matter.
“Most of the employees at the California Institute for Regenerative Medicine are expected to earn more than $100,000 a year. Its board is considering paying up to $600,000 to hire a president.”
The Sacramento News and Review offered up an editorial touting the Big Tomato's bid. But the editorial may have actually been a disincentive. “What better location than Sacramento--with its taxpayer attentiveness, watchdog organizations and capital press corp--to keep this agency above reproach in its role to safeguard the public's interest in all things stem-cell?” the newspaper wrote. Given the agency's sketchy relations with Capitol denizens, it may not want to be any closer than San Francisco, at the very least.
Wednesday, April 27, 2005
Their actions follow last fall's approval of Prop. 71 in California, which had major support from some venture capitalists in that state. Robert Klein, chairman of the California stem cell agency, told thedeal.com that his venture capital supporters had personal reasons for supporting the measure.
One venture capitalist, Michael Goldberg, sits on the Oversight Committee of Klein's agency. The entry of successful business men and women into public life is to be lauded. They bring much energy, talent and a different perspective to difficult issues. Nonetheless venture capitalists make their bones by flinty attention to their economic self-interest. As in any business deal, it behooves public officials to exercise equally flinty attention in dealing with venture capitalists.
Here is more on what writer Alex Kash of thedeal.com had to say about venture capitalists and stem cells and their effort in Massachusetts:
“It marked the second time VCs have rallied at the state level to support
the controversial research, which creates human embryonic stem cells as
a research tool and, proponents hope, eventually as a treatment for chronic diseases such as diabetes, Alzheimer's and Parkinson's. Researchers and VCs scored a big win in California last November with the adoption of California's Proposition 71, protecting research there and providing a $3 billion state research fund. A good portion of the $24 million or more raised to support the measure came from VCs such as Brook Byers, John Doerr, Vinod Khosla and Joseph Lacob (all of Kleiner Perkins Caulfield & Byers of Menlo Park, Calif.), Gordon Gund and Amgen founder William Bowes of U.S. Ventures.
“Campaign chairman Robert Klein, a real estate investment banker, was the main political and financial force behind Prop 71. Klein, whose teenage son has juvenile diabetes, said through a spokeswoman that the VC contributors all had personal reasons for getting involved in Prop 71. The law creates a state board, chaired by Klein, that will dole out $3 billion in public funds mostly to research institutions, although startups will be allowed to apply for grants.
"'It was a role model for me,' (Massachusetts VC Chris) Gabrieli says. Prop 71 backers not only made their point about the research potentially saving lives, Gabrieli says, but also the campaign was "the first time effective arguments were made" in the stem-cell debate about economics, jobs and innovation.”
Monday, April 25, 2005
It tells us that if the top candidate likes opera, San Francisco could become the new headquarters for the stem cell agency. But if surfing and a truly wonderful climate are what matters, San Diego could get the nod. If it is professional basketball (Go Kings!) and skiing in the Sierra, Sacramento looks better.
We remarked on Jan. 27(“The CEO Reality”) that the most important factor in corporate location decisions is the desire of the CEO.
Walter Barnes, chief administrative officer of the stem cell agency, reinforced that in a letter to Julie Wright, president of the San Diego Regional Economic Development Corp. He was responding to some of Wright's concerns about the site selection process.
“At the most recent meeting of the ICOC on April 7, 2005,” Barnes wrote, “several members expressed the opinion that a decision on the headquarters site was a critical element of the recruitment for a permanent president. Your comment that the 'location of the job should not matter to the right candidate and that all postings should be viewed as interim' is disputed by Spencer Stuart – the presidential search firm hired by the ICOC. They have told the ICOC that a mid-May decision is needed. For example, a candidate with school-aged children will be able to relocate his or her family without inconvenience that might prevent him or her them from accepting an offer made at a later date.
“The Presidential Search Committee has adopted a plan of its own to make a decision on a recommendation at a meeting planned to be held on May 18, 2005. A decision on the headquarters site by May 6, 2005 will allow that Committee to ensure that uncertainty of location will not affect the finalist recommendations for the presidency of the CIRM.”
Perhaps the competing cities should plug themselves into the presidential search process for a little lobbying with the job candidates. However, some might think that would be unseemly.
On another recruitment note, some experts believe it is better to move children during the school year as opposed to summer. During the summer, displaced children have less to do – no school, etc. So they have more time to whine as they contemplate the loss of their old friends and environs.
As for the site selection subcommittee meeting, the finalist cities are seeking to have their scores changed. The recommendation to the committee was to alter the scores slightly, but that did not change the pre-meeting rankings that left San Francisco No. 1 and Sacramento No. 2.
Friday, April 22, 2005
Red Gate Communications, which handled PR for Prop. 71 and some of the early months of the agency's existence, has resigned the account. Edelman, the world’s largest independent public relations firm with 1,800 employees, has been retained.
Also on board as a state employee is Nicole R. Pagano, senior communications specialist, and formerly with the Brookings Institution in Washington, D.C. She is listed at the top of the two-person contact list on the CIRM web site. Below her is Adam Silber, who is head of Edelman's Sacramento office.
In response to questions, Fiona Hutton, president of Red Communications in Studio City, CA., said in an email, “Red Gate Communications recently resigned its representation of the California stem cell agency. As you might imagine, we are very proud of the communications and outreach efforts we so successfully orchestrated during Prop 71 and during the first few, formative (albeit challenging) months of the Institute. It has been our pleasure to have worked closely with the Institute and so many passionate stakeholders throughout both these efforts. The firm continues its stem cell research expertise and advocacy in other regions throughout the nation.”
The change at CIRM came suddenly nearly two weeks ago, leading to a certain amount of speculation and rumor. The agency put out no advisory to the media about the change, merely altering the contact names on its web site.
Only on Thursday did the agency confirm that Edelman had been hired. That was after multiple queries by this blog to the agency and, on Wednesday, to the chief of staff nationally for Edelman
In an email, Pagano said, “CIRM has engaged Edelman to assist the Institute in fulfilling its public education and media relations duties, and was selected after a competitive search process.
“The mission of the Institute is to make grants and provide loans to advance stem cell research. Edelman will assist the Institute in its mission by making its progress as transparent and understandable as possible – both to the voters of California who have funded it and to the medical research communities who share its commitment.”
Pagano did not respond to questions concerning Edelman's compensation or whether it was required to file any economic disclosures in connection with possible conflicts of interest.
The contract is not insignificant. Red Gate's contract provided for as much as $70,000 for work from Jan. 18 to April 18, which was its entire term. While it is not yet known how much Red Gate was paid, the $70,000 figure is not unreasonable given the scope of the work, which went far beyond fielding phone calls from reporters. If Edelman is working under similar terms, a year contract could mean $250,000-$300,000 compensation. However, the agency now has on staff at least one fulltime person, Pagano, so that could affect Edelman's package.
Skilled public relations, information dissemination and public education are valuable assets for any organization. It is even more important for CIRM, which has virtually no track record and which is delving into areas new to medicine and public policy as well as to the public at large. However, PR is dependent on reality. To build a great reputation and keep faith with the people of California, CIRM must demonstrate accomplishment and accountability.
Recently he commented on the flap about federal government contracts for public relations. He said the PR business basically is “accused of foisting government propaganda on the American people, in direct violation of the law.”
To counter that sort of bad PR, he told his readers (others in the business) “let's start by revealing the size of our US government contracts.” Edelman also said, “The industry “ should commit to providing full disclosure on exactly what we do for Government contracts.”
“It is possible that this level of transparency will make it less attractive to the US Government to hire PR agencies. So be it,” Edelman blogged
Other advice for PR people “trying to adapt to a fast-changing environment.”
“We have to be operating in parallel universes, continuing to do a great job with traditional media, while engaging with new media,” Edelman wrote.
“We should help our clients create original content, and advise them to engender conversations on-line but be honest about our inability to control outcomes. We must be on top of the breaking news in companies, because news is being filled by the person who has the newest information. The coverage of tsunami initially came from survivors with cell phones or mini-cams, and delivered across the Web. Our tone in new media must reflect the different expectations of the audience, which is to demand authenticity, individuality and transparency.”
Thursday, April 21, 2005
California legislative action on measures to tighten oversight of the state's stem agency attracted little interest in the media today.
Reporter Laura Kurtzman of the San Jose Mercury News appeared to be the only reporter who attended Thursday's meeting of the Senate Health Committee and wrote a story on the legislation, which was approved 10-0.
The Associated Press filed a story, but did not actually attend the session. Instead it relied on a statement from the office of the Sen. Deborah Ortiz, D-Sacramento, chair of the committee.
It is not uncommon for news outlets to write stories on such a basis when they deem the subjects not to be compelling. In this case, passage of the measure seemed assured since it was co-authored by Ortiz and the Republican vice-chair of the committee, George Runner of Antelope Valley.
Kurtzman fleshed out her story with additional reporting. She wrote,“The proposal would require the California Institute for Regenerative Medicine, which was created by Proposition 71, to abide by National Institutes of Health standards that were recently revised to bar employees from holding biotech or pharmaceutical stocks.”
“While refusing formally to take a position, representatives of the Institute for Regenerative Medicine said in interviews after the hearing that the rules were too restrictive. The head of the National Institutes of Health's human stem-cell program recently cited the (NIH) rules in announcing his retirement.”
Kurtzman quoted Ortiz as saying, “There is a higher level of accountability. This is a hybrid. This is a new model. In the end, it is the taxpayers who either benefit or lose in that equation.''
The AP story appeared on the web sites of the San Diego Union Tribune, San Francisco Chronicle and The Sacramento Bee, but not on the Los Angeles Times. Here is a link to the AP story and a link to the press releases on the two measures, which now move to the appropriations committee.
Wednesday, April 20, 2005
As a result the conference, sponsored by Political Pulse in Sacramento, was cancelled.
CIRM's withdrawal left some in Sacramento bemused, given the agency's pledge of openness. One insider said the action was “very unfortunate, and does not bode well for the ICOC creating an open dialogue with the public, much less maintaining public confidence in the institute.”
Political Pulse is an independent source of Capitol items and has been around for 20 years. It scheduled the teleconference for April 27, promising that it would explore issues and information about the agency and its startup progress.
Scheduled to be heard at the teleconference event were State Sen. Deborah Ortiz, D-Sacramento; Dr. David Gollaher, president of the California Healthcare Institute of La Jolla; Marcy Darnovsky, associate executive director of the Center for Genetics and Society in Oakland, and Dr. Phyllis Preciado of Fresno, a member of the Oversight Committee.
It was Darnovsky's presence that apparently triggered the withdrawal of Preciado. Darnovsky's organization has been a vociferous critic of the stem cell agency on issues ranging from the stem cell medical questions to conflicts of interest.
Political Pulse did not respond to questions about the cancellation nor did CIRM, including whether this was a onetime action or reflected an agency policy.
Tuesday, April 19, 2005
The best bet is the legislative staff analysis which can be found on the Web(here and here). It states what the law is, what is being changed and summarizes some of the issues. It doesn't, however, deal with Robert Klein's contention that the legislation is thwarting the will of the people, a dangerous political argument that goes beyond the purview of staff analysis.
The analysis of that dubious assertion can be found in a couple of items on this blog: “The Fallacy of the Will of the People” (3-23) and “Will California Vote Again on Stem Cell Research” (4-15).
Instead Sen. Deborah Ortiz, D-Sacramento, is going to ask the agency to fund a study of the impact of hyperovulation on women's bodies, said Hallye Jordan, director of communications for the lawmaker, who is chair of the Senate Health Committee.
Ortiz has teamed with a conservative Republican, Sen. George Runner of Antelope Valley, to co-author measures, including a proposed constitutional amendment, to require the State Auditor to audit Prop. 71 expenditures. The legislation would also require written informed consent procedures and limits on compensation for women who wish to donate eggs for medical research, among other things.
The legislation will be considered by the Senate Health Committee in Sacramento Wednesday afternoon. For more on this, see the item on this blog April 15, “Will California Vote Again on Stem Cell Research?”
Monday, April 18, 2005
“Dude, you obviously don't know Emeryville!” -- Inclusion of the little city of 10,000 among the finalists for the permanent stem cell agency HQ left some folks in Los Angeles mystified. Columnist Chip Johnson of the San Francisco Chronicle explained why, at least in his view. Among the reasons is a certain vision. “In the early 1980s, when few people had ever heard the term biotechnology,” Johnson wrote, “Emeryville gave the thumbs up to three UC Berkeley professors who wanted to open a lab in Emeryville. Those men, William Rutter, Edward Penhoet and Pablo Valenzuela, are the founders of Chiron Corp., one of the largest biotech firms in the world.” Penhoet is now vice chairman of the stem cell agency.
Now Hiring – Just posted on the stem cell agency's Web site are new hiring plans. Over the next six to nine months, it will bring on as many as 15 full time scientists who will be responsible for reviewing and managing its scientific programs. The agency is looking for a strong background in basic or clinical biomedical research, including a Ph.D. and/or an M.D., post-doctoral experience as well as relevant experience. More information is available here, but it doesn't tell job seekers they might have to live in Sacramento to afford housing and commute to the pricey Bay Area.
Brownback's Ban – Local Liberty, the blog of the Center for Local Government at the Claremont Institute, notes how doings in Washington, D.C., could affect this state. “More threatening” than lawsuits against CIRM in California “is United States Senator Sam Brownback's bill to ban all human cloning, even if the cloned embryo is prevented from growing in a womb, as California law requires. The CIRM plans to spend lots of its $3 billion to research human cloning in this manner.”
All Laid Out – The stem cell agency has posted its approved conflict of interest policies on its web site. The Sacramento Bee commented critically on the standards for working group members. “Unfortunately, institute leaders have proposed a deeply flawed policy, one that doesn't pass the good-government smell test....Institute staff will instruct the reviewers to recuse themselves from considering any grant decisions with which they have a conflict. No disclosure forms will be required. As a result, the institute's staff will have no ready mechanism for ensuring that reviewers are acting ethically. Nor will the public.”
Friday, April 15, 2005
Sen. Deborah Ortiz, chair of the Senate Health Committee, has authored both a bill and a proposed constitutional amendment that will come before her committee in Sacramento. Co-authoring the proposals by the Sacramento Democrat is conservative Republican Sen. George Runner of Antelope Valley, vice chair of the committee.
Ortiz supported Prop. 71. Runner opposed it. She proposed her measures “to maintain the public’s confidence, the integrity of this important research and California’s significant financial investment.”
“We must make sure meetings are open to public scrutiny, strict conflict-of-interest and economic disclosure standards are developed, patients’ rights are protected and the state receives a fair financial return on its generous investment,” she said.
Runner said, “The voters of California did not vote for Proposition 71 so that biomedical companies get a windfall of billions of tax dollars with little or no accountability. It’s critical that we establish the highest ethical conflict of interest standards, true operating transparency, and a direct benefit to Californians from their $6 billion investment.”
Ortiz introduced an early version of the legislation last December. It was toughened up following an informational hearing in March. Robert Klein, the chairman of the stem cell agency and the prime mover on the ballot measure, refused to appear before the hearing of both the Assembly and Senate Health committees, despite the fact that he is a state employee, albeit one who is independently wealthy.
While promising publicly to cooperate with the committees, he lobbied behind-the-scenes to have the hearing put off. His efforts also came at the same time that his allied nonprofit organization, Cures for California, sent out emails across the country to generate pressure on the legislature. The messages solicited recipients (presumably disease sufferers) to send emails to the Legislature or call seeking postponement of the legislative hearing because of the possibility it would generate bad press.
Legislators later privately called Klein his “own worst enemy” and described him as a “meglomaniac and liar(see Roiling Undercurrents 3/16 on this blog).”
The Health Committee seems certain to approve the bill and constitutional amendment, but that is only the first step on their legislative journey. Should the constitutional amendment win approval of the legislature, it must appear on a statewide ballot. If it does, it is likely to become a referendum on all that the agency has done – not just the contents of the measure.
Such a ballot fight would give stem cell opponents a huge, fresh target, one that is likely to bring in major national anti-research campaigns from the Christian right, among other players. That would be a serious distraction for the agency, to put it mildly.
The task facing Klein is to scuttle early on at least the constitutional amendment. If he fails, it will gain momentum and become increasingly difficult to kill.
Here are links to the bill and the constitutional amendment. Earlier blogs on the legislation and related matters included: Robert Klein: The Missing Man (3/15), “Roiling Undercurrents (3/16), Litany of Losses (3/17).
We welcome and will publish comments on CIRM or the failings of this blog. Please send your comments to firstname.lastname@example.org.
Thursday, April 14, 2005
One is the appropriate way to present complex material for quick and sound decisions. Second is the old cliché about the devil in details.
The background agenda material for the site selection subcommittee was very late in coming. But when it did come it was clear, complete and concise. The decision points were identified and the rationale was coherent. We suspect that was largely the influence of the State Department of General Services, which has eons of experience in making such presentations. By contrast, the stem cell agency's agendas are often muddled and confused, which bog down the meetings and make it difficult to make good decisions.
Failure to mind the details savaged the losers in the bidding process for the headquarters. One wonders how supposedly accomplished executives and their staffs managed to omit simple documents from their applications. It is not as if the selection panel overlooked the missing information. Calls were made to the losers to verify that they failed to send in their coupons, so to speak.
The fiasco does bring to mind March's meeting of the Oversight Committee and the fracas over the missing information on the presidential selection criteria(see Fumbling the CEO Search April 4 on this blog).
The tale of the permanent headquarters is not yet finished. There is talk of appeals by the disgruntled to the Oversight Committee. Ratings could change as a result of site visits and other considerations. One can only imagine the lobbying and political pressure that will come the way of the Oversight Committee members, who probably should take their phones off the hook.
Here are links to this morning's stories on the HQ affair: Sacramento Bee, San Francisco Chronicle, San Diego Union Tribune.
Wednesday, April 13, 2005
The plan was tucked away in the criteria for the headquarters, along with a couple of other tidbits illuminating the agency's thinking and expectations.
“The CIRM is currently the single most important source of stem cell research funding in the world,” the document said. “As such, it will be a draw for researchers and clinicians around the world for conferences and other knowledge sharing activities. CIRM leadership plans to hold at least one international conference a year.”
“Additionally, the CIRM plans to host numerous events to gather government officials and patient advocacy personnel together on topics relevant to the CIRM mission,” which means, among other things, a bunch of business for meeting planners.
The agency also said it will be busy tending its political fences in Sacramento, regardless whether that city wins the bid. “CIRM business in Sacramento—meeting with elected officials and legislators as well as government personnel—has already required numerous staff trips in the last several months. This travel frequency is estimated to continue.”
Coming up on Thursday will be a look at the leavings from today's meeting on HQ location. Here are links to Wednesday's stories on the HQ: San Francisco Chronicle, Sacramento Bee, San Diego Union Tribune, Los Angeles Times, Los Angeles Daily News, San Jose Mercury News.
Tuesday, April 12, 2005
The San Francisco Business Times said San Francisco scored highest in a point system that examined eight categories, such as cost, the availability of no- or-low cost hotel and meeting space and the size of the surrounding biomedical community.
San Francisco chalked up a total of 158 points followed by Sacramento with 133, San Diego with 116 and Emeryville with 113.
The stem cell agency posted details of ratings sometime this afternoon on its web site in the agenda of the subcommittee considering the matter. That theoretically allowed members of the subcommittee less than 24 hours to study the issue before their meeting.
The agency did not respond to queries about whether the subcommittee members had been given copies any earlier.
Here are some excerpts from the article by Antonio Regalado:
“Stepping gingerly into a politically charged arena for the first time, some large companies in the U.S. are pursuing plans to study stem cells drawn from early-stage human embryos.”
“Among companies that have initiated research programs or have plans to are Becton, Dickinson & Co., Invitrogen Corp., Johnson & Johnson, General Electric Co. and the U.S.-based research operations of Swiss drug giant Novartis AG. Their interests range from using the cells to test drugs to developing new transplant treatments.”
“A survey by The Wall Street Journal of 12 of the world's largest drug firms by sales, as well as leading U.S. biotechnology concerns and medical-device makers, found several previously undisclosed research programs involving human embryonic stem cells. But many companies said they weren't using stem cells, and several had policies forbidding the research.
“In no case is a major U.S. company working directly with human embryos. Instead they are turning to small companies and universities to obtain supplies of the cells. Johnson & Johnson, for instance, is backing cutting-edge research on the cells at a biotechnology company in California. Becton Dickinson received supplies from the University of Wisconsin. Other companies declined to say where they obtained cells or where they planned to get them.”
Such creatures are called chimeras, a word derived from the monstrous beast of Greek mythology -- part lion, part serpent and part goat.
Author Jamie Shreeve wrote about the 2005 versions of chimeras in the New York Sunday Times Magazine. Some of his examples are located here in the west, such as experiments involving implantation of human stem cells in sheep.
Esmail Zanjani, a hematologist in the College of Agriculture, Biotechnology and Natural Resources at the University of Nevada at Reno, says he has sheep with livers that are 40 percent humanized. Shreeve, in discussing the ethics of such situations, asks the rhetorical question, “What if, instead of internal human organs, Zanjani's sheep sported recognizably human parts on the outside -- human limbs or genitals, for instance, ready for transplant should the need arise?”
Shreeve's article also discusses experiments by Irving Weissman in California. “Several years ago, Weissman and his colleagues at Stanford and at StemCells Inc., a private company he helped to found, transplanted human neural stem cells into the brains of newborn mice.” Weissman is now considering the possibility of making a mouse brain composed entirely of human neurons.
Taking it a step further, Shreeve wrote about possibilities involving primates. '''One could imagine that if you took a human embryonic midbrain and spliced it into a developing chimpanzee, you could get a chimp with many of our automatic vocalizations,''' says Terrence Deacon, a biological anthropologist at the University of California at Berkeley and a member of the Johns Hopkins committee. 'It wouldn't be able to talk. But it might laugh or sob, instead of pant-hoot.'''
Which brings us to the possibility of an ape that laughs like Phyllis Diller” and what some in the stem cell field call “the yuck factor.”
Recommended reading, especially for those of us less versed in the science of stem cells.
Monday, April 11, 2005
Here is one quote from the article:
"If there's one thing that I would say about Bob, it's that he makes things happen when other people are trying to stop them from happening," said Chris Miller, a New York marketing executive who has been a friend of Klein's since they both worked on John Tunney's successful 1970 Senate campaign.
"When he decides to help you, you get helped," she said.
The piece notes the criticism that has been directed at Klein.
“Some of the attacks seem motivated as much by discomfort with Klein's hard-charging style as they are by unhappiness with the program. Characteristically, none of it seems to faze Klein.
“During two interviews and many briefer encounters since the November election, Klein makes it clear he has no time for distractions, little patience for Prop. 71 opponents and seemingly infinite faith in his own ability to get the job done,” Hall wrote.
The piece also reported that Klein's grandfather supported Upton Sinclair's California gubernatorial campaign during the Depression, which is a fascinating story by itself.
Profiles like Hall's are quite useful and all too rare in newspapers. They help provide insight into what makes public figures tick. Too often there is an excessive but understandable focus on tangible rules, procedures and actions while the real action is more ambiguous and based on relationships and motivations.
By most measures, Battey appears to be qualified to head CIRM. He is head of the National Institutes of Health's stem cell program, but is retiring in September.
He is not alone. Three other high level researchers are leaving the NIH because of the new rules.
The case of James Battey, his colleagues and the NIH illuminates some of the conundrums of conflicts of interest. The situation suggests that conflict policies should start out very restrictive and be eased later, if necessary. It illustrates the very real personal burdens that can laid on top researchers and others. And it demonstrates some of the difficulties in controlling the most insidious sorts of conflicts, the ones arising from a lifetime of belonging, so to speak, to the same club.
Battey said he is leaving the NIH because “the new rules imposed an insurmountable problem for me,” according to a piece in the Washington Post by Michael S. Rosenwald and Rick Weiss.
“I manage a family trust...which supports the education of my father's seven grandchildren, and it contains assets I'm told I'd have to divest. That would cost a lot of money, and I can't do that to my family,” Battey was quoted as saying.
Quite justifiably he may think that the situation is not fair. He once operated under the rules, but then the rules changed through no fault of his own. As a result, the NIH is losing a valued executive and scientist.
An identical situation could occur in California if it has to toughen its conflict standards someplace down the road. It could lose valued employees as a result and then waste time, energy and money replacing them. Better now to be more restrictive than face embittered staff later.
The NIH situation shows how individuals can personally feel the burden of complying with conflict standards, something critics do not always seem to fully understand. It goes beyond consulting arrangements that yield hundreds of thousands of dollars in compensation.
One cancer researcher with the NIH was recently told she could not accept a $200 train ticket to present a paper at a conference for a physician's education group, according to the Post. The researcher said it was embarrassing to cancel her appearance.
The newspaper quoted a legal opinion prepared for a group of senior agency scientists that laid out the scope of the new conflict policy.
"Basically (it) means anything NIHers do outside -- whether getting paid for it or not, from singing in a jazz group to selling art or jewelry, from volunteering at charity organizations to membership in a school or community organization to developing their own small business completely unrelated to biomedical science -- requires prior NIH approval," the memo says.
"We find this very disturbing,” the scientists said. “It is intrusive and scary. It suggests the NIH owns our lives away from work."
The NIH rules additionally touch on the web of relationships that nearly all successful persons build during their careers. The Post said that many NIH employees are barred from holding executive positions with trade or professional organizations, even on a volunteer basis.
One NIH researcher said it could lead to an unpleasant backlash. “We will be cut off, disenfranchised from our academic colleagues.”
Most conflict codes, including the ones now in place at CIRM, can't deal with the ambiguous issues that can arise from the relationships that are built during a career. Sometimes they are formal as in leadership positions in professional organizations. Other times they involve informal or past connections to men and women who have assisted a person during his professional or business life, either financially or with advice or friendship. Sometimes it is training and shared experiences that create a way of thinking that imbues a person's approach to business or science.
The California stem cell agency has built into it a reliance on persons you might call “members of the club” who dominate the Oversight Committee. They bring special expertise, experience and skills to the effort, which is to be valued. They also bring a lifetime of comfortable relationships with other accomplished persons, people they have worked with, rely on and trust. It would be unrealistic not to expect them to go back to these people to seek their help and to help them.
It is also unrealistic to expect codes to catch all of the subtle conflicts and abuses that can and do come up involving such relationships. The best watch dogs, in fact, are other members of the Oversight Committee and CIRM employee peers. They may be the only ones who can stop a breach before it becomes serious enough to become a scandal.
We welcome and will publish comments on CIRM or the failings of this blog. Please send them to email@example.com.
The agency has persevered under much pressure and cranky public attention, dating back to its first meeting only last December. Critics have pummeled the panel. The press has been sharply critical. But rules are now place.
Yes, they are not perfect, but no such effort ever is. More hearings on conflict issues are scheduled for later this year, allowing possibilities for changes and fine-tuning. This is marathon for the Oversight Committee – not a 40-yard dash.
Saturday, April 09, 2005
There is a certain amount justifiable self-interest as well.
Millionaire Ed Penhoet, vice chairman of the Oversight Committee, told Terri Somers of the San Diego Union Tribune, "I'm spending an enormous amount of time and effort purely in the public interest. I'm not willing to sacrifice the entire rest of my life, which has been in the biotech world, because it doesn't make any sense."
However justified Penhoet's statement may be, it demonstrates one of the differences between the private sector, which has provided many of the Oversight Committee members, and government. A skilled practitioner in the public sector would not have said what Penhoet did. It's impolitic and can be misconstrued. It sems to indicate that he would place his private business above his public responsibilities. And it implies a petulant belief that it is wrong even to ask questions about possible conflicts.
The stem cell agency is continuing its drumbeat that the charges of the critics are meritless because they fly in the face of the will of the people as expressed in November's election. This is a dangerous argument that is not in the best interests of the agency. It places the agency on a collision course with all critics, however warranted their criticism. It has already pushed stem cell agency supporters into hostile positions in which they have formed alliances with those whose greatest desire is close down the agency.
The objectivity vs. expertise argument was also engaged last week as part of the reaction to charges by the Center for Genetics and Society. Somers' story and one by Steve Johnson in the San Jose Mercury News touched on the subject.
Friday, April 08, 2005
A quick check showed only two major newspapers with their own stories and no story from The Associated Press, which feeds coverage to thousands of outlets worldwide.
The San Diego Union Tribune (Terri Somers) and The Sacramento Bee (Laura Mecoy) had staff written stories on the approval of the conflict of interest codes. The Los Angeles Times, the San Francisco Chronicle and the San Jose Mercury News carried none, based on a look at their web sites. A search of the Internet turned up no other stories in California newspapers, although there may have been some.
There are a couple of reasons for this. One could be deadline problems. Reporters may have been there but filed stories too late to be placed in the paper. The other may be that the novelty is wearing thin. Newspapers only skim the top of most events. They turn away from issues that seem to be getting old, even if they are fundamentally important. And the conflict of interest flap has been written about repeatedly since the agency's first meeting in December.
We may yet see additional stories from this week's meeting, perhaps on Saturday or Sunday.
Wednesday, April 06, 2005
The Center for Genetics and Society noted that seven members of the committee have significant business connections with companies connected to stem cell research.
“Managing $3 billion in taxpayer money is an enormous responsibility, and it should not be done by those who have a personal financial stake in how it is used,” said Marcy Darnovsky, associate executive director of the center.
“The proposed conflicts policy sounds good on first reading, but all it really requires is disclosure and self-recusal,” said Jesse Reynolds, the center's program director.
“Because of mutual understandings among board members based on longstanding relationships and financial interests, real oversight would be almost impossible. That’s why we support divestment, not disclosure,” he said.
The center's press release said that Oversight Committee vice-chair Edward Penhoet and members David Baltimore, Tina Nova, Gayle Wilson, Keith Black, John Reed and Brian Henderson have investments and/or leadership positions in companies which are or have been involved in stem cell research.
The center's research can be found here.
Both policies appear straight forward and relatively strong, given that the Prop. 71 has inherent conflict of interest problems written into it. What is mainly different is language in the code for employees that declares the agency must “conduct its activities in a way that is perceived to be open, fair and free from bias.”
“CIRM employees must be free from both real and apparent conflicts of interest,” the code says.
The code for the bosses -- the CIRM Oversight Committee -- makes no mention of perceptions or “apparent conflicts of interest.” In fact, it specifically exempts deans of medical schools from situations that appear to raise perception issues.
“Deans of medical schools and executive officers of research institutions oversee and advise researchers in their institutions and sign off on all grants as part of the basic duties of their position. This activity shall not be deemed to be a conflict of interest,” the policy states. But it does require such oversight committee members to recuse themselves from decisions on such grants.
One wonders why the “perception” language was not included in policy for the Oversight Committee. It may be that the code writers came to the conclusion that the committee members could never avoid the possibility of perception problems.
Another interesting aspect of the employee code is the ban on financial interests in a organizations with a “substantial” interest in stem cell therapy.” That is defined as “one in which more than 5% of the research budget is known to be devoted to stem cell therapy.”
Could the “known-to-be” language be construed to exempt investments in privately held enterprises, whose budgets are secret?
The policy for employees also presumably applies to consultants to the agency, such as attorneys and computer security analysts. However, there is a provision in the language approved at the last meeting that gives vast leeway to an aide to the chairman (not the president) to exempt consultants from the type of disclosure that ordinary employees would have to make.
Not dealt with in the two codes are perceptions involving entities seeking the permanent headquarters of the agency. Earlier the agency said one of the requirements of the lease is a "letter signed certifying that the owner does not have and will not have in the future any ownership interest in any firms or agencies competing for grants to be awarded by the Institute."
We raised questions on Feb. 28 about the definition of “ownership interest.”
If the employee standard is applied to landlords, it will mean investments of more than $10,000. One might wonder whether the landlord ownership ban would also apply to the principals of a firm that the landlord hired to do janitorial work at the permanent headquarters.
Under the best circumstances, it is impossible to write a conflict of interest code that covers all possibilities. It is particularly difficult with CIRM because some of the Oversight Committee members have longstanding and deep ties with parties that could stand to benefit from actions by CIRM. All that is legal but some critics have raised questions whether it is right.
Given that situation, it would behoove the agency to act with an abundance of discretion in matters involving perception and appearance, whether in the case of Oversight Committee members and employees or consultants and landlords.
We welcome and will publish comments on the conduct of CIRM and the failings of this blog. Please send them to firstname.lastname@example.org.
Tuesday, April 05, 2005
Currently she is a developmental neurobiologist and Associate Director of the Office of Research Administration of the National Institute of Biomedical Imaging and Bioengineering – one of the National Institutes of Health.
She is the first appointment of interim stem cell agency president Zach Hall. Her new title is director, scientific programs and review.
"Recruiting Arlene Chiu as our first scientific appointment is a major coup for the Institute," said Hall. "She is undoubtedly the most knowledgeable scientific program director at NIH about stem cell research world-wide. Of the many candidates who applied, Arlene's strong research background and administrative experience made her a clear first choice for this position."
The CIRM announcement said, “At NIH, Dr. Chiu was a leader in organizing stem cell research programs, serving on both the NIH Stem Cell Task Force and on the NIH Stem Cell Implementation Committee. She organized the first NINDS workshop on stem cells, as well as an international meeting in Sweden to promote collaborations between investigators in the US and abroad. She also represented the United States at stem cell conferences in England, Korea, Sweden and China. At NINDS, Dr. Chiu also led efforts to promote cooperation with the U.S. Food and Drug Administration in expediting the use of stem cells in therapies. She has co-edited, with Mahendra S. Rao, a leading book on stem cell research entitled Human Embryonic Stem Cells.”
Reports, minutes and background material are finally beginning to appear as links in the full agenda. On the site are such things as a list of names of persons being considered as ethicist members of the Scientific and Medical Accountability Standards Working Group.
That item also shows that some members of the Oversight Committee continue to be unhappy about the agency's processes for making important decisions.
The minutes from the Scientific and Medical Accountability Standards Working Group Search Subcommittee said that Joan Samuelson, head of the Parkinson's Action Network, “felt very strongly that she did not have enough information on the candidates other than those which were on her list to vet and felt insufficiently informed to make a final decision on candidates at this meeting.”
Jon Shestack, vice president of Cure Autism Now, also was displeased. “Shestack echoed Joan Samuelson’s concerns about this committee’s process of identifying candidates and the compressed timeline in which the subcommittee was asked to carry out this task,” the subcommittee report said.
The upshot was that the “subcommittee (was) divided in terms of how to proceed and (slowed by ) persistent resistance to moving forward with voting on another ethicist candidate.”
Monday, April 04, 2005
The subject comes up again this week – and again on a tight schedule, which seemed to play a role in generating frustration and complaints from Oversight Committee board members. The conduct of the search firm, Spencer Stuart, also came under fire. Chairman Robert Klein promised to hold a “very significant discussion” with the firm.
The problems arose when the search subcommittee held a meeting to discuss criteria for the position, which is expected to pay about $400,000 annually. Although a quorum was not present, the group made suggestions that were to be forwarded to the full Oversight Committee the next day.
But when the time came to discuss the recommendations, none of them had been included in the material provided to the full board by Spencer Stuart, giving board members an unpleasant surprise.
Klein initially pushed to keep the selection process moving forward, which some board members favored. But he finally agreed to take the whole matter through the subcommittee process again, according to a transcript of the meeting.
That was after several Oversight Committee members including Phyllis Preciado, a Fresno, Ca, physician, and Joan Samuelson, president of the Parkinson's Action Network, expressed displeasure with how the matter was being handled.
“I would much rather do this in a deliberate way that allows the entire committee to be able to weigh in on the specifics of the job description and the other details,” said Samuelson.
“This is an enormously important decision. And it's not only that the wrong document is here, but there wasn't any time for anybody to review it. We got tens of pages."
Francisco J. Prieto, a Sacramento, Ca., physician, said, “I think we have to appreciate that, as a public enterprise, we are sometimes going to have to sacrifice efficiency for openness."
David Baltimore, president of the California Institute of Technology, said he was surprised by the absence of the search firm from the Oversight Committee meeting.
“They should understand the various concerns around the table.... If they were running a search for me, they would have been here.”
At one point, the discussion degenerated into talk about the logistics of running more teleconferencing sites so Oversight Committee members could more easily weigh in remotely at subcommittee meetings.
“Isn't there a simpler way to do this?” asked Committee member Sherry Lansing, a Hollywood entertainment executive, concerning the subcommittee's suggestions.
It is not clear exactly what is on the table for this week. The presidential search subcommittee has only one item on its agenda for Wednesday, a closed door executive session. The next day the Oversight Committee is scheduled to take up a status report from the subcommittee and criteria for selection. It has also scheduled an executive session on the presidential search.
The status report of the presidential search subcommittee was not available online at the time that this item was posted on the Web, two days before the Oversight Committee meeting.
We welcome and will publish comments on CIRM or the failings of this blog. Please send them to email@example.com.
Sunday, April 03, 2005
What kind of privacy protections should be in place for cell donors? If they are guaranteed anonymity, what happens when later research turns up information that could be medically important to the donor?
In the international world of stem cell research, how are conflicting standards reconciled between nations?
When does the FDA become involved?
These are just a few of the questions facing California's stem cell agency. Alta Charo, a bioethicist from the University of Wisconsin, last month briefed the CIRM oversight committee on these and other legal, ethical and practical issues facing the agency.
Her comments are now available online in a transcript from that meeting. While they are looser than a formal text might be, they give a valuable overview and some insight into a few of the concerns of committee members.
Charo's subjects included protection of human subjects, privacy, reimbursement of donor expenses, international and conflicting patient and research standards, international collaboration, FDA involvement, stem cell banking, underlying medical conditions of donors and more. Some of her comments were brief but all illuminated one or another subject and are worth reading.
Here are samples from her presentation:
“Just working with cell lines, just collecting the embryos functionally means you are in a position to be studying the donors and not just their materials, and it's the ability to study the donors as people that triggers the need to treat them as research subjects.”
“How much should be told to your potential donors about the range of research uses? There are research uses that are coming down the pike that are probably going to sound very alarming to most members of the public. These might include genetic manipulation of the embryonic stem cells. That is already going on if only to just insert markers so that one can actually observe where the cells are differentiating.”
“Even the context of reimbursement has some ambiguities built into it,” Charo said. She cited examples of preferential medical treatment for donors or in-kind benefits such as fertility treatment, in addition to the possibility of donors requesting reimbursement for “outlandish” travel expenses. “You may find it worthwhile to simply make (language in Prop. 71) that much more explicit so there's no possibility for confusion.”
The piece included an interview with Zach Hall, interim president of the stem cell agency.
“He estimates it will take about 20 eggs to produce one successful nuclear transfer. About 10 eggs can be harvested from a woman at a time, he said. That means fewer than 1,000 donors would be needed for 300 new stem cell lines, which should be enough for the next few years, Hall said.
Kleffman continued, “The Bedford Research Foundation near Boston is believed to be the only place in the nation now collecting eggs for research purposes.
“It has paid about 20 women an average of $4,000 each to be donors. Participants tend to be young women who have a family member with a disease they hope can be cured with treatments based on stem cell research, said foundation director Ann Kiessling.”
Perhaps this may sound callous, but that price sounds like it does not reflect true market value. I am sure there some economists out there who could tell us what occurs when prices are artificially low or high.
The measures are authored by Sen. Deborah Ortiz, D-Sacramento, chair of the Health Committee. Often hearing dates change, so keep in mind that this could be rescheduled. The measures are SB18 and SCA 13, which is a proposed constitutional amendment.
Friday, April 01, 2005
Nominally the agency has posted its agenda on the Internet. The brief document provides some general hints on matters to be discussed, such as its first step towards issuing $3 billion in bonds (see item below).
However, most of the agenda consists of ambiguities that are of little help to members of public, businesses, academicians or scientists about whether it is worth their time to attend the session.
“Consideration” is the key word. Virtually all of the agenda items that might appear to be substantive are listed for “consideration,” such as “consideration of conflicts policy for ICOC (oversight committee) members.” Other subjects to be “considered” are:
- Working group policies, including confidentiality, meeting format, conflict of interest, compensation and chair positions
- A report from the standards working group search subcommittee, including but not limited to consideration of appointment of members (5 ICOC patient advocates, 9 scientists, and 4 medical ethicists) to the standards working group
- Conflicts policies for the CIRM staff
It is impossible to tell whether the matters will be voted on, amended, written, proposed or merely discussed at the meeting. In fact, it is next to impossible to determine their specific nature.
For example, a report to be considered from the grants subcommittee, which is a key group for dispensing hundreds of millions of dollars, is not available online. Nor are either of the latest versions of the conflicts policies. Last month, a draft of the conflicts policy for the oversight committee was available online, but it is unclear whether that document is the one to be discussed or whether it has been altered.
As for the staff conflict policy, the oversight committee approved a “statement of incompatible activities” at the last meeting. It is unclear whether that is up for amendment or reconsideration or whether entirely new restrictions are up for approval.
While the lack of information is troubling for members of the public, it is even more so for members of the committee, busy people who have other issues before them besides the stem cell agency. If they do not have sufficient time in advance of the meeting to read background material and reports, it makes it difficult for them do their jobs properly.
As for the public and other interested parties, it is nearly impossible to make informed comments to the agency during its three-minute comment periods unless background material or texts of proposals are provided in advance. Most of the matters the agency is dealing with are complex and deserve careful thought as opposed to something generated on-the-fly at a busy meeting.
Chairman Robert Klein has promised the highest and best standards for the stem cell agency. However, even local school districts in California do a better job of making background material available to the public in advance of meetings.
The stem cell agency is still young and understaffed, but there is no doubt that it can do a better job at maintaining openness.
We welcome and will publish comments on the stem cell agency or the failings of this blog. Please send them to firstname.lastname@example.org.