Kuehl On the Big Lie, Aging Porsches and Politics

California State Senator Sheila Kuehl, author of the latest legislation to intervene in California stem cell matters, talks about her politics and personal life in a lengthy interview in California Conversations magazine in Sacramento.

Writer Aaron Read opens the article by commenting that Kuehl, a Santa Monica Democrat, has "a Cagneyesque, spit-in-the-eyes willingness to engage in consequential discussion on how we are allowed to live our lives–a real world concept that public policy im­pacts Californians in elemental ways."

The interview is remarkably revealing. Few politicians, businessmen or women or stem cell scientists would be so open. Here are sample quotes from Kuehl, who once played Zelda on the Dobie Gillis television series, concerning the more pedestrian matters of politics and policy:

Why did she seek a legislative seat:

"I was working with a small group of people framing a domestic violence law in California. And, because I was a law professor, I was asked to come up and testify at the Capitol, where I had only been once as a teenage tourist. And I would sit and wait while committees rambled on and watch everybody and after a while I thought, 'I could do this.'"

Her major legislative accomplishments?

"There are three I’m most proud of. One is the protection of students in school against harassment or discrimination or violence on the basis of real or perceived sexual orientation. It protects all the kids, even if they’re not gay and others just think they are. The second is nurse-to-patient staffing ratios, which I’m very proud of. And the third is paid family leave."

On political lies:

"I think the right-wing philosophy of starving the beast is so detrimental to 90% of the people. They’ve got the people fooled that somehow if rich people do okay, then every­body does okay. That’s the big lie."

She tells readers that she still has her 1964 red Porsche convertible, a model we have admired over the years. She attended and worked at UCLA for a number of years before getting a law degree at Harvard. But she does not mention UCLA basketball (tonight the Bruins play Florida in the final four). She discusses her love life, but she does not mention stem cells or the California Institute of Regenerative Medicine. Perhaps because the interview was conducted some time ago. Magazines usually have lengthy prepublication schedules. Or perhaps because the topic was not as interesting as other matters. (Hard to believe, I know.)

Los Angeles Times blogger Robert Salladay reports that the magazine is produced by some folks at Aaron Read & Associates, a Sacramento lobbying firm that represents the California Association of Professional Scientists, the California Medical Association, AT&T, PG&E, among many others. Read, head of the firm, conducted the interview with Kuehl.

CIRM Lab Grant Programs Coming Up in April

The agenda for the April 10 meeting of the Oversight Committee of the California stem cell agency is now available on the institute's web site, well ahead of the actual date of the meeting.

It is still quite shy of background material but that is likely to fill in as the date of the meeting at the Sacramento Convention Center approaches.

Topics to be considered include SB771 (see item below), an update on the search for a person to replace CIRM President Zach Hall, who is leaving in three months, and discussion of procedures for considering the upcoming round of laboratory grants. A goodly number of the members of the Oversight Committee represent institutions that are likely to be applying for the grants.

Also on the agenda is a "presentation of survey description and concept plan for large facilities," meaning grants for buildings and laboratories. CIRM has about $300 million allotted for various building projects.

SB771: CHI Takes 'Not-So-Subtle Jab'

California's biomedical industry has already begun its lobbying campaign against legislation to guarantee the state shares in the potential bounty from products developed from its $3 billion stem cell research effort.

Writing on Law.com, reporter Cheryl Miller said members of the California Healthcare Institute were pounding the hallways in the Capitol a few days ago armed with a "not-so-subtle jab" at SB771, which does not face its first legislative test until April 11.

Miller said that their talking points included the following:

"Recent legislative proposals that focus on revenue-sharing thresholds and pricing and access requirements place direct financial return ahead of the far greater benefit to all Californians (and people everywhere) from the development of innovative technologies. Such provisions are sure to discourage the private investment needed to bring state-funded science to market."

Miller also quoted the author of the bill, Sen. Sheila Kuehl, D-Santa Monica, as saying,

"I expect that there will be people who are not going to praise this bill. But they're going to have to find a way to critique it without saying we don't want the state to get any money."

CHI members have a number of legislative fish to fry so it is not clear how widely their stem cell message was distributed.

Clarification

The "Eggs" item below makes a reference to CIRM regulations concerning reimbursement of expenses for egg donors involving "lost wages" vs. direct expenses. Some persons contend that lost wages should not be reimbursed, arguing that creates a disparity between well-paid and less well-paid women. In California, CIRM regulations include reimbursement for lost wages. So does the proposed policy for ESC research that is not connected to CIRM funding, which is regulated by another state law.

Eggs and Absurd Inconsistencies

Writing in the New England Journal of Medicine, a Harvard business professor says the "politics of egg donation" have obscured the real issues concerning the market for human oocytes.

Debora Spar discusses the scene nationally and internationally, using the case of woman she calls "Anna Behrens," who Spar says is not a real person. Spar wrote in the March 29 edition of the NEJM:

"The United States, by contrast, maintains the absurd inconsistency illustrated by the case of Anna Behrens: $20,000 for an egg used for reproduction; nothing for the same egg used for stem-cell research. Such a policy would make sense only if we deemed assisted reproduction socially more valuable than research. But this argument is not being made and perhaps could not logically stand, given that the alternative to assisted reproduction would often be adoption. Instead, opponents of egg selling tend to refer to the fears of commodification and the risks to donors — all of which, if valid, apply equally to the reproductive and research uses of eggs.

"What we need, therefore, is a fresh debate on egg donation and a new set of policies. We need to consider the health risks and ways of identifying and mitigating them. We need to ensure that all potential donors are fully informed of these risks and fully protected against them. We need to make clear that the benefits of egg donation, for reproductive or research purposes, are complicated, and that few of these benefits will ever flow directly to the donor. At the moment, though, the politics of egg donation have blinded us to these real issues. We have not thought deeply about what makes sense for science, for women, and for society. Instead, we are only fighting about the price."

Spar, author of "The Baby Business: How Markets are Changing the Future of Birth," does not discuss in her NEJM article the possible growth of a black market for human eggs, which seems certain to arise if eggs have real monetary value and there is a shortage.

As far as California is concerned, Spar reports that researchers using state funds are prohibited from compensating egg donors for anything beyond direct expenses.

The actual language of the CIRM regulations is slightly different. It says that "permissible expenses" are "necessary and reasonable costs directly incurred as a result of donation or participation in research activities. Permissible expenses may include but are not limited to costs associated with travel, housing, child care, medical care, health insurance and actual lost wages."

NEJM has also posted an interview with Spar and Emily Galpern of the Center for Genetics and Society in Oakland on the subject of egg donations.

Comments

John M. Simpson has posted a response on the "Sacbee and Cha" item. Den has posted a commento on "Fairness and Cha."

Fresh Comments

We have two anonymous comments today. One is on the question of the costs included in CIRM grants(see the "CIRM Grant Oversight" item). The other is a comment on the "FTCR and Sacbee" item.

Governmental Camels and Stem Cell Swag

Is it good business for a drug company to charge – let's say $47,000 for a 10-month cancer treatment – or will such pricing hurt the industry long term?

But forget the business issue. Is it good public policy to allow a company to charge those fees – labelled egregious by some? Especially if the treatment was partially financed with public funds?

Questions such as those stand close to the center of the debate over the intellectual property that will be produced by $3 billion in research funded by California's stem cell agency. Intellectual property policy is the vehicle because that's where CIRM sets its requirements for royalties and revenue-sharing connected to its research. That is also where it sets its requirements for affordable access to stem cell cures that it helps to finance.

The $47,000 treatment cost is not hypothetical. It involves Genentech and its drug, Avastin, which was developed with the help of some clinical trials that were subsidized by the federal government.

On March 15, the Wall Street Journal examined the case of Avastin in a front page story. Reporter Geeta Anand began her piece like this:

"Two years ago, Steven Harr urged Genentech Inc. to lower the price of a key drug that was helping buoy its stock price. He was an unlikely messenger because of his job: a Wall Street research analyst whose investing clients crave profits.

"In a conference room with 30 senior managers from the biotech company, Dr. Harr said he feared patients wouldn't be able to afford the drug Avastin, which costs about $47,000 for the average 10-month course of treatment for colorectal cancer. He warned that Congress 'will get involved when its constituents can't get drugs.' Genentech later capped Avastin's price, acknowledging the influence of Dr. Harr, among many others."

Harr also pointed out an interesting bit of blowback from oncologists detected during a survey he conducted. According to the WSJ story,

"He says most physicians surveyed weren't prescribing the drug in breast and lung cancer for fear of not being reimbursed. Avastin and Erbitux are given to patients intravenously in doctors' offices. Doctors buy the drug ahead of time, infuse it into patients and then wait to be reimbursed. Any refusal by insurers to reimburse would leave doctors thousands of dollars in debt."

Harr, an analyst with Morgan Stanley, sees high prices as bad for business.

"He says soaring cancer-drug prices, generating fat profit margins, aren't sustainable."

That is a message that is sometimes hard for business executives to accept. They rail at governmental fiddling with their enterprises. They froth at bumbling regulators. But at the same time, many seek government assistance for research, favorable regulation, tax benefits or laws restricting their competitors. Contrary to popular belief, the vast majority of legislative activity nationally and in California does not involve such things as gay marriage or sex offenders or drivers licenses. It involves "filthy lucre" and crass commerce. Most of it is instigated by those advocates of free markets – the top executives of the finest companies in America. It is why business spends tens of millions of dollars and more annually lobbying lawmakers.

Folks such as those at the California Healthcare Institute, which represents the state biomedical industry, want the grants from CIRM. But they don't want to pay the piper that provides the basis for the plenititude. Or they don't want to pay as much as some watchdog groups and legislators would like. But like any other investor, the state wants its slice and does not want to be treated a whole lot differently than, say, the venture capitalists at Kleiner Perkins Caufield & Byers, if they had laid out a $3 billion investment. When you invite governmental camels into your tent, it is sometimes hard to get them to leave.

Biotech, however, has valid points concerning writing what are basically the terms of a business deal into state law and regulation. Both are difficult to change and can impair development of cures if they are riddled with restrictive minutia. Likewise, biotech firms must see a strong likelihood of making money. If they don't, the cures will not be developed unless the government is ready to pay for the whole process, which is not likely to happen in our lifetime.

Obviously, the state of California is not a venture capital firm. Perhaps not so obviously, the stem cell industry is not the most shining example of private markets at work. The finest risk-takers in America(venture capitalists) run for the back exits, for the most part, when they see a stem cell executive come through the front door. The result is that with embryonic stem cell research in California, we have an amalgam of business, government and science. That means that compromises must be made by all the players. If one of the partners gets too greedy, the whole endeavor – the California stem cell experiment -- can fail.

Finally we should note that a group actively engaged with CIRM on IP issues was mentioned in the WSJ article but not by name. That organization is the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca. Here is what the WSJ wrote about FTCR.

"In the spring of last year, a taxpayer group in California began publicly condemning Genentech for charging too much for Avastin, noting that the federal government's National Institutes of Health had subsidized some clinical trials of the drug. Not long after, Genentech said it was considering capping the price of Avastin."

FTCR on Sacbee and Cha

John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumers Rights, sent along the following comment on today's Sacramento Bee editorial on CHA RMI.

"What the Foundation for Taxpayer and Consumer Rights has said is that there are enough red flags associated with CHA's leadership and corporate affiliations as to warrant a thorough vetting of an application from its researcher.

"Precisely because we raised our concerns, CIRM's staff is now on the record in public in response as promising a thorough review of all applications -- including this one -- before any checks are issued.

"We did our job. The editorial board of the Sacramento Bee did its job. Now it's up to CIRM to do its job."

See the item below on the Bee editorial.

Sacramento Bee: Fairness and Cha

The Sacramento Bee today said today that the California stem cell agency should "resist calls to rescind or freeze" a $2.6 million grant to CHA RMI, whose founding president is embroiled in an international plagiarism scandal.

The medical director of an allied organization, CHA Fertility, is also under investigation by the state Medical Board in connection with an allegation that he seduced her and lied to her about the number of eggs he extracted from her.

The Bee said in an editorial:

"Both allegations are serious. But the CHA scientist who applied for and received the $2.6 million stem cell grant, Dr. Jang-Won Lee, hasn't been implicated in either incident. Unless someone can demonstrate otherwise, the California Institute for Regenerative Medicine should resist calls to rescind or freeze the $2.6 million grant.

"The issue is a simple one of fairness. Over the years, medical scandals have rocked several university medical centers, including one at UC Irvine that was forced to close its transplant center. These revelations were shocking, but they don't mean that all scientists affiliated with UC Irvine should be disqualified from government research funds. Nor, by itself, should Lee's affiliation with CHA prevent him from receiving a state grant, which he hopes to use in the development of stem cells that can be used to study Amyotrophic Lateral Sclerosis, also known as Lou Gehrig's disease."

For more details on this issue, see: "CHA Example," "Grant Recipient." You can also use the "search blog" function at the upper left hand corner of this page to find all the items on CHA. Use the search term "Cha."

Stem Cell Snippets: Financial Challenges, Kuehl and Presidential Search

CIRM's Governance -- The stem cell institute's governance committee will meet April 5 in San Francisco to consider "CIRM merit and professional development programs," "key financial challenges and opportunities" and travel rules for the Oversight Committee. Public teleconferencing locations are available: Two different sites in Los Angeles, three different locations in San Francisco and separates at Stanford, Sacramento, La Jolla and UC Irvine.

Kuehl and the Mayor – State Sen. Sheila Kuehl, author of legislation to guarantee the state a return on its stem cell investment, is a member of Los Angeles Mayor Antonio Villaraigosa's inner circle, according to the Los Angeles Times. The story by Duke Helfand says the mayor has offered her a job more than once. She says she wants to be on the ride when he goes for governor.

CIRM Presidential Search – A meeting scheduled for today of the CIRM presidential search subcommittee has been cancelled. Do not expect fresh information until the April 10 Oversight Committee meeting in Sacramento.

More Response from CHA RMI

CHA RMI and its California stem cell grant surfaced on the web site of The Scientist magazine with more details about the company's response.

The report by Kirsten Weir contained the following:

"According to a statement released by CHA RMI, the organization was incorporated in California in 2005 and 'has been engaged in adult and embryonic stem cell research at its Los Angeles laboratory...None of the member companies belonging to CHA Health Systems have any ownership interest in CHA RMI and none of the companies have any voting rights on CHA RMI's Board.'

"According to the statement, Jang-Won Lee earned his PhD from the University of Connecticut and has held positions at Wake Forest Institute for Regenerative Medicine and Children's Hospital & Harvard Medical School. Lee could not be reached for comment."

Most of the other information in The Scientist report is familiar to readers of this web site.

Correction:

The SB771 item from last night (3/25/07) incorrectly said that the CIRM Oversight Committee was scheduled to meet April 11 in Sacramento. The meeting is actually scheduled for April 10.

LA Times Piece on CHA RMI Has Response from Researcher

The Los Angeles Times Monday ran its story concerning CHA RMI and its $2.6 million California stem cell grant, including a statement from the main researcher on the project.

The Times story was picked up the KNBC television station in Los Angeles, which did not add any new information to the account.

The Times piece by reporter Mary Engel began by noting that the grant went to a research center whose founding president is "embroiled in an international dispute over authorship of a medical journal article." Then it listed the ethical allegations concerning an associated fertility clinic.

Engel's story also had this from the researcher involved:

"In an e-mail to The Times, the lead scientist for the grant, Jang-Won Lee, said he was not involved in any of the allegations. The research, he said, will undergo thorough scientific and ethical review, and is aimed at developing therapies for a devastating neurodegenerative disease."

She also had this quote from John M. Simpson, stem cell project director for the Foundation for Consumer and Taxpayer Rights, concerning the secrecy involved in the grant review process.

"'Had everyone known that a grant was being discussed to that organization, things would have gone slower and questions would have been raised then.'"

We have a query into CHA for a response on the issues that have been raised and have promised that we will run it verbatim when we receive it.

For previous items on this see: "Grant Recipient," "Little Notice" and "CHA Example."

The SB771 Debate: White Knights vs. Greedy Big Pharma?

"Mom and Apple Pie" – that's one way to look at the latest legislation to step into the affairs of the uniquely independent California stem cell agency.

The bill is crafted in such a way that it is difficult to oppose. In other words, it is virtually a "motherhood" bill. After all, who can be against the state of California receiving a fair share of the perceived bountiful booty from the $3 billion in state-financed research? Oppose that and you can be tarred with the brush of greedy Big Pharma.

We are not talking about the details of SB771. That involves the nitty gritty of intellectual property, a daunting and dense subject for the media, not to mention your average reader. It is easier to cast this as battle between avaricious Big Business and the White Knights who protect the public. Lawmakers do not want to be seen as voting in favor of $100,000-a-year treatments that would not have existed without state-financed research.

Whether or not Sen. Sheila Kuehl, D-Santa Monica, and lead author of the bill will choose to play it that way, some of the other interests involved may do so. We cannot say what Kuehl's strategy is, but all accounts, she is a very smart woman (Harvard grad and former law professor) and politically astute. As chair of the Senate Health Committee and veteran activist and politico, she knows what it takes to succeed with legislation.

Previous legislation involving CIRM was more complex, giving more people more reasons to oppose it. That's not to minimize the complexity of Kuehl's measure, but at its heart it is quite simple – give the people of California a share and help out the ailing poor. Wasn't that the promise in the Prop. 71 campaign?

The opposition is likely to be led by the California Healthcare Institute, which represents the biomedical industry. The industry is not a minor player in the Capitol and can use its resources well. But it will have to step smartly to avoid being tagged as greedy.

The scenario begins to play out in the second week of April with the first hearing on the bill by the Health Committee on April 11, the day after the Oversight Committee of the stem cell institute meets in Sacramento. As part of the day's activities, members of the 29-member panel are expected to visit some legislators to discuss areas of mutual interest.

In a case of adroit timing, California stem cell chairman Robert Klein is scheduled to speak to the Sacramento Press Club on April 9, two days ahead of the April 11 hearing. CIRM has also scheduled its own hearing into IP issues on April 9 in Sacramento. We say adroit because Klein's talk and the hearing will help frame the issues in the media ahead of the Senate hearing, if the events are covered. That is a big if. IP is a boring news topic in the minds of most editors and reporters. CIRM issues are a third tier media matter at best in the Capitol. Witness the extremely light coverage of CIRM this past year with the rare exceptions of occasions when buckets of money were rolled out (grant approvals by the CIRM Oversight Committee). Arnold's contretempts with Rush are much higher on the California news agenda, although nearly meaningless.

With four stem cell events in one week in Sacramento, news editors are likely to cover one and not the rest. The earliest may get the media worm.

With a super, super-majority vote (70 percent) required in both houses, Kuehl's bill likely will find tough sledding. On March 16, in Los Angeles at the Oversight Committee meeting, we asked Assembly Speaker Fabian Nunez about the measure. He was there for a news conference touting CIRM's good works. But he said he knew nothing about Kuehl's bill. To win a 70 percent vote in the Assembly, he will have to know more.

For those of you interested in the real stuff of IP, CIRM has posted some advance material concerning its IP hearing April 9. Among the issues CIRM wants to address are the following:

"Is there a reference or scheme in another body of law that would provide a workable formula to price drugs purchased in California that have been developed with CIRM-funded patented inventions?

"What mechanisms exist that can be used to formulate the price of non-drug therapies provided to Californians?

"Is the term 'public funds' sufficiently precise to capture the universe of purchasers intended in the scope of regulation 100406?

"What comparables would be used by which the “access plans” referenced in regulations 100406 and 100408 be assessed?

Written comments may be submitted directly to CIRM if you are unable to attend the hearing.

Here are links to additional background on the legislation. "Tall Hurdle," "Open Kimono," "CIRM IP Legislation."

(Editor's note: An earlier version of this item said the Oversight Committee meeting was April 11. It is scheduled for April 10.)

CIRM Grant Oversight Question

Lawrence Ebert has posted the following question:

"Of the procedure on grants given by CIRM, I was wondering "who" has the authority to conduct oversight. Directly, this comes up as to "who" might have been responsible for vetting the Cha proposal. Down the road, "who" would conduct any investigation of alleged research impropriety. In a different research area, this issue is currently looming large. See
http://ipbiz.blogspot.com/2007/03/more-about-congress-reviewing-purdue.html

"Separately, how much of the CIRM grants are going directly to the conduct of research, and how much are going to overhead of the respective institutions?"

Here is what we know. Re the questions of oversight of grants given by CIRM, it is CIRM itself that has oversight and the agency vets the proposal and monitors its execution. It is unclear who might conduct an investigation of research impropriety beyond CIRM, although the state Department of Justice has wide authority to investigate and prosecute violations of state law. CIRM's research regulations have the force of law.

We can't tell you the split on overhead vs. actual research, but we learned at the March 15 meeting of the Oversight Committee that comparing size of NIH grants and CIRMs for the same project is not accurate. CIRM grants apparently include funds that are not usually included in the announced figures for equivalent NIH grants.

Fresh Comment.1

Lawrence Ebert is onboard with a comment on the correction below and is a little puzzled. We have posted an comment/explanation that should clarify the matter. John Simpson has a comment on the "CHA Example" item. An anonymous comment has been posted on the "Plagiarism, prayer" item.

Fresh Comments

Jonathan Eisen has posted a new comment on the "CHA Example" item below in which he proposes a Journal of Rejected Grant Proposals. We suspect his suggestion is a bit tongue in cheek, but he makes some interesting points. Also new is an anonymous comment on the "Plagiarism, Prayer" item that involves a patent matter and Cha.

Correction

On Friday March 23, we incorrectly reported that the California Stem Cell Report was the first to pull together the plagiarism allegations and other ethical concerns involving CHA RMI and its allied organizations and link it to the CIRM grant. In fact, the Bodyhack blog on Wired.com carried much of the same information on March 17. We simply missed their earlier report. Our apologies to the folks at Bodyhack, particularly Steve Edwards, who wrote the March 17 item.

Fresh Comments

Jonathan Eisen has posted a comment on the "CHA Example" item below. We have posted a response to his comment. Click on the word "comments" at the end of the item to see the little pearls.