Text of McCormack and Loring Emails on Stem Cell Board Meeting

Here is the text of the Sept. 9, 2015, email message to Sherrie Gould, executive director of Summit4stemcell, from Kevin McCormack, senior director of communications for the California stem cell agency, along with one from Jeanne Loring, head of the stem cell program at Scripps, to McCormack.  Loring sent her email to McCormack after she received a copy of his email to Gould.

The Gould-McCormack email comes first with the Loring-McCormack email following.

“Dear Sherrie
“I just wanted to let you know that there has been a change in plans for our September board meeting. As you know, it was originally scheduled to be held in San Diego, however, that has changed and it is now simply a telephonic meeting. The reason is that the agenda is going to be lighter than originally anticipated and it didn’t make sense to incur the cost of an in-person meeting for one hour’s worth of business. 

“I know you were planning to have many of the Parkinson’s group attend the meeting so I wanted to let you know so you can alert them to the change.
 “Our next in-person meeting will now be in Los Angeles on December 17th.
“Cheers,
“Kevin McCormack”

Loring’s email to McCormack:

“Hi Kevin:
 “Two in a row??  CIRM has rather pulled the rug out from under the patient advocates -these meetings are supposed to be public, so how is the public going to participate if there is no access?  Does CIRM have a plan to give access?  More importantly, is CIRM doing this to avoid having public access?
 “I'm disappointed and the Parkinson's patients are exceedingly disappointed.  The Parkinson's group is trying to find out the resolution, if any, of the timing of the grant applications.  Has anything been done in that regard yet?
 “In addition to the advocates, my students will be disappointed.  I always bring my interns and my CIRM fellows to the meetings so they can meet their benefactors.
 “Any plans for access to the public would be welcome.
 “Jeanne”

Text of Comments by Sherrie Gould, Executive Director, Summit4stemcells

Here is the text of comments by Sherrie Gould, executive director of Summit4stemcell of San Diego, made in connection with changes in the stem cell agency board meeting Sept. 24. Gould made the remarks in response to a query from the California Stem Cell Report.

“We are both confused and disappointed that this PUBLIC meeting has
been essentially cancelled.  We were prepared to talk with the ICOC (the stem cell agency) board and answer all questions about our patient advocacy
(Summit4stemcells) movement and our research. The Summit4stemcell
project has been faithfully attending public meetings every other
month for the last two years.  We have flown in numbers to make sure
our voice is heard.  We have spoken to board members, and to the media
about our plight.  This San Diego meeting, now cancelled, was an
opportunity attend to discuss the funding possibilities for
Parkinson's disease and whether funding might be appropriate for our
project.  Our science is sound and we have a clinical arm to this
project. We believe CIRM could take ownership of this very exciting
translational research if we were indeed funded.

“Unless we can be present in front of the CIRM board, Summit's strong
voice is diminished.  Being physically present in human form is always
more effective than a teleconference. Delays, which we realize are a
part of any government associated agency, are devastating to people
suffering from the progressive symptoms of Parkinson's disease. And
although hope springs eternal, we are saddened by the repetitive
delays.”

Text of Remarks by David Higgins, Stem Cell Agency Board Member

Here is the text of comments by David Higgins, a member of the governing board (the ICOC) of the California stem cell agency, in connection with changes in the September meeting of that board. By law, Higgins is appointed as a patient advocate for Parkinson’s disease. He made his comments in response to questions from the California Stem Cell Report.

“It is my understanding that the September ICOC meeting was switched to a phone format because the modest agenda planned made the cost associated with having this meeting ‘on the road’ questionable.

“In my year at CIRM I have only encountered enthusiasm and support for patient advocacy - both from the staff as well as the board. Patient and patient advocate participation in the process is welcomed. CIRM is first and foremost about patients. There will be differences in opinion on how best to allocate CIRM’s financial resources, but there are no difference of opinion on the importance of patient advocacy and the value of interactions between the public and the ICOC.”

Text of McCormack's Response to Questions

Here is the text of remarks today from Kevin McCormack, senior director of communications for the California stem cell agency, concerning changes involving this month's governing board meeting. He made the comments in response to questions by the California Stem Cell Report.  One of the questions involved the agency's strategic plan, which was scheduled to be discussed at the meeting this month.

"The reason we switched from an in-person to a teleconference Board meeting is simple, the agenda for this meeting consisted of just a few items that could probably be handled in one hour. We can’t justify the cost of an in-person meeting in San Diego – which includes transportation for all those going there, plus hotel rooms, meals and the cost of the ballroom for the day - for one hour’s worth of business. As a state agency we are always mindful of how we spend our money so we made the change.

 "The elimination of the dates in the Discovery and Translational programs is simply to give the CIRM Team more flexibility. As we say in the documents that will be presented to the Board – available on our website here https://www.cirm.ca.gov/sites/default/files/files/agenda/150905_Agenda_4_DTConcept%20Amendments%20--%20FINAL%20%2800256870xAEB03%29.pdf
  

"In  order  for  CIRM  to  operate  efficiently  and  to  respond  to  changing  circumstances  and  needs,  CIRM  must  be  nimble  and  flexible.   To  ensure  that  the  CIRM  team  has  the  ability  to  make  adjustments  to  the  program  schedule  to  meet  these  needs,  we  propose  to  eliminate  the  specificity in  the translation  and  Discovery  Program  concept  plans  regarding  the  schedule  for  the  submission  of  applications  in  response  to  program  announcements  issued  under these programs.”  (McCormack's boldface) 

"As for the Strategic Plan, we have already conducted extensive outreach, through both on-line surveys and in-person meetings, with Patient Advocates (including meetings in San Diego, Los Angeles and San Francisco), researchers, Board members and the public. We are now working on bringing all those thoughts and suggestions together in order to be able to present them to Board. 

"And the Board agenda will be posted ten days ahead of the meeting as usual." 

California Stem Cell Agency Seeking to Fill High Level Positions

The $3 billion California stem cell agency is looking for a handful of new employees, including a top level executive who could be paid as much as $250,000 a year.

Openings for four positions are currently up on the Web site of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known.  

They are a grants management specialist, systems engineer, science officer/senior science officer and associate director/director of therapeutics. They would join the 51 employees currently at the agency.

The listings with two different titles are for one job only.  The ultimate title of the successful candidate will depend on their level of prior experience, according to the agency.

The director of therapeutics position carries a maximum salary of $250,065.   The job would involve managing budgets of $600 million plus. The job listing also said candidates should know “what ‘great’ looks like and (use) that vision to set clear direction that is fully understood by the therapeutic team.”

The position would report to the vice president for therapeutics, Ramona Doyle, a former Genentech executive who joined CIRM in July.

The agency is currently based in San Francisco but will be moving its headquarters to Oakland this fall.

The New York Times, the California Stem Cell Agency and the San Francisco Warriors

California’s $3 billion stem cell research effort made one of its rare appearances in the New York Times this weekend in a long article on the front page of the newspaper’s Sunday business section.

The piece, however, carried not a word about the agency’s accomplishments. Instead the story by Matt Richtel talked about a proposal to build an 18,000-seat arena for the Golden State Warriors basketball team.

The arena would be located a short walk from the current headquarters of the stem cell agency as well as the UC San Francisco Mission Bay complex and the biotech enterprises that surround it. The proposal has triggered a major flap in the city involving the biotech industry, among other issues. A former vice chancellor of UCSF, Bruce Spaulding, is leading a move to block the project.

The stem cell agency, known formally as the California Institute for Regenerative Medicine(CIRM), popped up in the article as a result of its decision to transfer its headquarters to Oakland. The California Stem Cell Report wrote about the move on Aug. 17, triggering a spate of articles in the Bay Area media. (See here and here.)

Richtel wrote,

Jeff Sheehy -- Sheehy photo

“’San Francisco has always been that other city with a different set of values,’” said Jeff Sheehy, a governing board member of the California Institute for Regenerative Medicine, the largest stem cell funding agency in the world. The institute is moving to Oakland after the expiration of a free-rent deal on its space near the proposed complex; it discovered that office rents in San Francisco were prohibitively high. He sees the arena, which he opposes (he would like affordable housing on the land), as suggestive that San Francisco secretly wanted mainstream credibility all along.

“'We should have an arena because New York has Madison Square Garden. We should compete for the Olympics and the Super Bowl,' he says, mocking the pro-arena attitude. He describes the new San Francisco as 'just another capitalist, consumerist, profit-driven, money-motivated Disneyland.'” 

Sam Hawgood -- UCSF photo

Another CIRM board member was mentioned in the piece, Sam Hawgood, chancellor of UCSF, which also employs Sheehy as a communications manager.

Richtel wrote that Hawgood “has offered qualified support for the Warriors, as long as the owners and the city address his big concerns about traffic, including creating dedicated lanes for health emergencies and increasing public transportation options and the number of parking lots.”

Joe Lacob -- Kleiner photo

In another stem cell/biotech-related linkage, Joe Lacob is one of the majority owners of the Warriors. He also contributed $759,017 to the campaign for Proposition 71, the ballot measure that created the stem cell agency in 2004. He is a partner in the Kleiner Perkins Caufield & Byers venture capital firm, which pumped nearly $6 million into the campaign and which is a major investor in biotech.

Openness and Transparency: Backsliding at California Stem Cell Agency

Highlights
$34 million Alpha Clinics involved
Information failure on proposal
Discourages public/researcher participation
California’s stem cell agency this past couple of weeks skidded significantly backwards in its efforts to improve clarity and transparency in its $3 billion operation.

The latest example came this week and involved its ambitious, $34 million Alpha stem cell clinic program at four major California institutions: the City of Hope, UCLA and UC Irvine and UC San Diego. 

A proposed, multimillion dollar project involving the effort was scheduled for action next Tuesday by the Science Subcommittee of the agency’s governing board.  As of early this morning -- only one full business day from the meeting -- the agency had released only nine words about it to the public. Here is the full text:

“Consideration of concept plan for Alpha Clinics Accelerating Center.” 

Opaque is the only way to describe the process. And it was bound to create issues with affected parties, which it has in this case.

Such cryptic notices make it impossible for the public to comment intelligently or otherwise, given the lack of information. The failure to provide the information in a timely fashion also feeds suspicion and distrust.

Clarity is one of the watch words that Randy Mills has invoked in his 15-month tenure at the California Institute for Regenerative Medicine(CIRM), as the agency is formally known. He has done much to sharpen CIRM’s focus and provide additional clarity through his analysis of the agency’s work.  

But failing to provide material in a timely fashion removes more than the shine on his efforts. The meetings of the agency’s directors are CIRM’s most important public events.  They are where patients, advocates, researchers, biotech executives and even the unwashed public can come together to hear and see the board in action and discuss issues informally with directors and the CIRM staff. Attendance should be encouraged – not discouraged. Which is what happens when important information is withheld from the public.

Last Friday the California Stem Cell Report carried an item on another mysterious agenda item, one that involved forgiveness of agency loans and potential royalty revenue, something that was promised in the election campaign that created the agency in 2004. 

That too was a case of missing information until it was much too late for the public or affected parties to make thoughtful comments. (See here and here.)

CIRM can and should do better than this. 

(The California Stem Cell Report this morning asked CIRM for comment on the failure to provide information on the Alpha proposal scheduled for Tuesday.  About ninety minutes later, CIRM spokesman Don Gibbons responded, saying that the item was now being postponed "to allow more time for refinement and consideration.")

(By this afternoon, the agency had also posted the first explanation of another cryptic item on the Tuesday agenda for the Science Subcommittee. This one would eliminate the specific schedule for RFAs in the upcoming basic research (discovery) and translational RFAs. The reason for the change is to provide more flexibility.)

(Editor's note: The last paragraph of this item was added several hours after the original posting.)

Moderate Media Coverage of California's New, $32 Million Stem Cell Bank

The California stem cell agency this week scored moderately well in media coverage of the announcement of its $32 million stem cell bank, the world’s largest such public effort.

Most of the coverage was based in California but, of course, all of the stories can be read globally. The San Francisco Chronicle, The Sacramento Bee and a chain of newspapers in the Bay Area carried articles, among others.

Missing was coverage from major national outlets, such as the New York Times. Also absent was coverage by television news outlets, according to a search this morning on Google. A spokesman for the agency said the Buck Institute, which houses the bank, has restrictions on video coverage.

Ron Leuty of the San Francisco Business Times called the bank opening a “big win” for the $3 billion agency.  

A story by Stephanie ONeill of  KPCC  carried a factoid missing from all other stories – the cost of the cells from the bank in Marin County, north of San Francisco. O'Neill reported,

"The cost of each vial will range from $750 for researchers affiliated with nonprofit research organizations to $1,500 for those who work  for-profit companies, says (California) Institute for Regenerative Medicine spokesman Kevin McCormack."

The Bee story reported much larger figures, which the stem cell agency today said are incorrect.

Jeff Buchanan, who is based in Wisconsin for xconomy, wrote a story with a headline that reflected his focus on the Wisconsin firm involved,

“Cellular Dynamics Launches ‘World’s Largest’ Public Stem Cell Bank”

Buchanan also wrote that the company’s executive vice president, Chris Parker, said that the bank offers more than other banks. Buchanan reported,

“’The diseases, the demographic information that’s associated with them, the clinical data, the genetic and genomic data available—that’s what’s really making these lines valuable,’ (Parker) says. Donors gave consent for their tissue samples to ‘be used for a variety of research purposes,’ giving investigators considerable latitude, says Parker.”

Here are links to the other stories that turned up in the Google search this morning: San Francisco Chronicle, San Jose Mercury News and other papers in its chain, KGO, California Healthline, Philadelpha Business Journal and Latino Health.

$32 Million Project: California Opens Largest Public Stem Cell Bank in World

Stem cell storage tanks at new stem cell bank -- Coriell photo

Highlights
300 different stem cell lines
3,000 donors
Coriell, CDI operating, supplying
Stanford, UCLA, UCSF and UCSD involved

Thanks to the taxpayers of California, the Golden State is now home to the largest publicly available stem cell bank in the world.

The state’s $3 billion stem cell agency this morning announced that the bank, located in Marin County north of San Francisco, is open for business.

The project is backed by $32.3 million from the California Institute of Regenerative Medicine (CIRM), as the agency is formally known.

In a news release this morning, CIRM said the bank is “offering the first 300 different stem cell lines for researchers interested in gaining a deeper understanding of, and developing treatments for 11 common diseases and disorders.”

The agency said the bank, housed at the Buck Institute in Novato, is collecting samples from as many as 3,000 donors. CIRM said,

“Those samples will then be turned into high quality stem cell lines – known as induced pluripotent stem cells or iPSCs – which are available to researchers throughout California and the rest of the world.” 

CIRM Chairman Jonathan Thomas said,

“We believe the bank will be an extraordinarily important resource in helping advance the use of stem cell tools for the study of diseases and finding new ways to treat them.” 

As of this writing, the announcement had received coverage on the San Francisco SFgate Web site and on other sites in the San Francisco Bay Area that are owned a news media chain and another site in Pennsylvania.  The coverage is likely to grow throughout the day, which is important to the agency. It is hard-pressed to generate news coverage for its achievements. 

The bank was funded by awards from California in 2013 and is operated by the non-profit Coriell Institute of Camden, N.J.  Generation of the cells is performed by Cellular Dynamics International, Inc., of Madison, Wisc.

CDI was formed by stem cell pioneer research Jamie Thomson of the University of Wisconsin. It was sold to Fujifilm of Japan earlier this year for $307 million at double its stock price.

Also involved in securing the initial adult cells are researchers at UC San Diego, Stanford, UC San Francisco and UCLA.

Here are links to the press releases at Coriell and CDI. Here is a link to a summary of the CIRM banking initiative and a link to a progress report on the effort. Below is a list of participants and amounts of awards. Click on it to see it in a larger format.

Sunlight on California's Stem Cell Loan Effort; Info Missing on Changes in $127 Million Research Programs

Highlights

Some details on loan changes

New Alpha clinic center proposed; no details

Unspecified changes upcoming in $93 million award programs

A little sunshine popped up over the weekend on a bit of fiscal alchemy at the $3 billion California stem cell agency, and a little clarity emerged.

The matter involves the agency’s loan program, which affects multi-million awards to businesses. The awards are called loans but are forgiven if no viable product emerges.

The matter surfaced as a result of a cryptic agenda item for Thursday’s meeting of the agency’s directors’ Intellectual Property Subcommittee. Here is what happened:

About a week ago, the agency posted the agenda for the meeting. The agenda contained a 24-word line that said that it was going to change its policies “to permit existing loan recipient whose loan has been forgiven to convert its award to a grant.”

The need for change and its financial impact on the agency was not discussed. The specific language being changed was not spelled out. The timetable for the changes was not specified. Nor was it discussed whether the move was desired by any recipients of the agency’s largess.

Given the opaque nature of the agenda item, the California Stem Cell Report carried an item Friday morning that said,

“In just four business days, the $3 billion California stem cell agency is going to perform a bit of financial alchemy. But like most alchemists, its methods are less than transparent.” 

Much later that day or possibly early Saturday, the agency posted a brief memo and regulatory language that provided a better look at the loan rule changes, which could have an impact on royalties the state might receive on a successful stem cell therapy.

Based on what is now on the agency’s Web site, the proposal would clarify what happens if a loan-financed therapy is dropped and then revived, leading to actual revenue. Under existing rules, such a situation could trigger an ambiguous financial burden that would have to show on the company books. And business executives and investors do not like ambiguous financial burdens. 

The memo from the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, said,

“To provide clarity regarding future obligations, CIRM proposes giving existing loan recipients whose loan has been forgiven by CIRM the option to convert their loan to a grant and forego reinstatement of a forgiven loan. In this way, loan recipients will be automatically governed by the revenue sharing (and other) principles of the agency’s intellectual property regulations in the event future revenue streams are realized. This will be particularly important in the event future revenues are realized after CIRM has exhausted its funding.” 

The directors’ subcommittee is likely to approve the change on Thursday. It would then go to the full board at its Sept. 24 in San Diego for action before it enters the state’s regulatory process, which will open it to further public comment.

The Thursday meeting will also take up changes in the “loan election policy” for this year’s $100 million clinical award program. Details on that are still not available as of this morning, but one assumption would be that they are an extension of the proposed loan changes to that particular program.

The weekend’s memo on the loan changes was dated  Aug. 20.  One can only assume that it was lingering on some CIRM executive’s desk for eight days until it was made available to the public, researchers and likely affected businesses.  

Problems with timely posting of agenda material are not new to the agency. In the more distant past, they were significant but have diminished. That is, until this case and others earlier this year.

The agency also has another directors’ subcommittee coming up in just five business days. The session involves two significant, multimillion dollar programs. One proposal calls for creation of an “Alpha Clinics Accelerating Center” in connection with the $34 million Alpha clinics effort.

The other proposal before the Science Subcommittee deals with unspecified changes in the agency’s upcoming, $93 million “discovery and translational” award rounds.

This morning, no additional details were available on those two matters.

The Science Subcommittee teleconference session on Sept. 8 will be based in San Francisco. Interested parties can weigh in at public locations in Irvine, La Jolla, Los Angeles and Duarte. Addresses are on the agenda.

The meeting Thursday of the Intellectual Property Subcommittee is also a teleconference session based in San Francisco. Public locations are available in San Diego, Hawaii, Woodside and Redwood City with two in San Francisco.

The only public access to these meetings is at their physical locations. No participation is available via the Internet.  However, comments may be submitted in advance or later by emailing them to mbonneville@cirm.ca.gov.

The California Stem Cell Agency and its Mysteries of Fiscal Alchemy

In just four business days, the $3 billion California stem cell agency is going to perform a bit of financial alchemy. But like most alchemists, its methods are less than transparent.

The case in point involves a session of the intellectual property subcommittee of the agency’s board of directors. The committee is scheduled to meet next Thursday to deal with an unknown amount of cash that the agency has given to an unidentified recipient.

According to the very limited information on the meeting agenda, the cash was once a loan. But that loan has been forgiven by the agency. Now the plan is to turn that forgiven loan into a grant.

Why? How much money is involved? What is the rationale? What is the benefit to the people of California, if any? It is all something of a mystery.

Also on the agenda are unspecified changes in the “loan election policy” for clinical awards, a program that is budgeted for $100 million this year. Again, no rationale or explanation is publicly available as of this morning.

One of the favorite words of agency’s president, Randy Mills, is clarity. He reminds folks regularly that the agency should have clarity in what it does.

Mills has indeed improved the clarity of the organization in his one-year tenure at the California Institute for Regenerative Medicine, as the agency is formally known. He has brought analytic and presentation skills that have opened new insights into how the organization spends the taxpayers’ billions.  The result has been an improvement in the way the agency operates.

But in this case, the agency is falling short. Its rules call for notifying the public about meetings 10 calendar days in advance of the sessions. However, cryptic agendas that raise more questions than answers do not add up to clarity. Instead, they are opaque and can generate suspicions about the conduct of the agency on the part of the public and interested parties.

Trust in government – and the stem cell agency is part of our government – is at all-time lows. It behooves the California stem cell agency to do what it can avoid feeding that distrust and to make its operations as transparent and open as possible.

California Stem Cell Agency Up to State Snuff on Cyberspace Security

Highlights

Most state departments deficient

Agency says it's okay

Foreign stem cell collaborations

The California state auditor this week warned that a host of state agencies are poorly secured and vulnerable to intrusion, but the California stem cell agency is apparently not now one of the miscreants.

In a report released yesterday, State Auditor Elaine Howe said that 73 of the 77 state departments answering a recent security standards survey said that they were not in compliance with security standards.

A story by Jon Ortiz and Jim Miller in The Sacramento Bee said that most departments “have not planned for interruptions or disasters” and five departments audited more closely all had “security deficiencies.”

The Bee story said state departments’ databanks are “stuffed with Social Security numbers, medical records, tax return data and other sensitive information.”

The $3 billion California stem cell agency is one of those departments filled with sensitive data, including proprietary information that is submitted as part of applications for the billions that the agency is handing out.

Responding to a query today from the California Stem Cell Report, Kevin McCormack, senior director of communications for the agency, said that the agency was surveyed by the auditor and now meets state standards. He said,

“We were one of those 77 departments.  We did not have security deficiencies as such – in that we put confidential information at risk – but some aspects of our site were not in full compliance with the state standards, for example not having a link to all previous privacy policies and the dates they were in effect. So we put together a plan of action on how to correct the problems, that plan was approved by the state and those changes have been implemented.”

McCormack continued,

“The question of proprietary information was one of the things we had to address, namely showing all the protections we have in place in our Grants Management System which is the only place that any kind of proprietary information is kept. Because that system already requires separate log in and password protections those met the state standards without any changes being necessary.” 

The agency has awarded tens of millions of dollars to a variety of businesses. It also has relationships with researchers in a number of countries, including China. 

Periodically news surfaces about Internet theft of business information by Chinese interests, including in the world of biotech and pharmaceuticals (See here, here and here.)

China is also widely believed to have ambitious stem cell research aspirations, although current specifics are scarce.  In May, however, Reuters skimmed off a quick look at Chinese biotech. Earlier this month, China announced regulations aimed at both clearing the way for human research and regulating rogue stem cell clinics. (See here also.)

The California research involving a Chinese collaborator does not allow the collaborator password access to the stem cell agency’s grant management system, McCormack said.

“None of the collaborative funding partners, foreign or domestic, can access our (grant management system). We explicitly make clear in the rules for these collaborations that we take care of the California portion of the funding and their respective agency/government/institution, etc., takes care of their portion. The California researchers would have access to our (system)  through a protected log in and password but not their collaborative funding partner.” 

The collaboration involving the China research is connected to a $1.5 million grant to Holger Willenbring, associate director of the UCSF Liver Center, who has received a total of $4.7 million from the stem cell agency. 

The latest progress report on his research on the agency’s Web site said,

“The objective of this project is to establish the feasibility of liver cell therapy with human induced hepatocyte-like cells (iHeps). As proposed we established the feasibility of generating iHeps from several expandable, potentially autologous human cell types. We identified transcription factors effective in inducing hepatocyte differentiation as well as further maturation of these cells. We also identified small molecules and culture conditions (extracellular matrix composition and stiffness) that promote proliferation and hepatocyte-specific differentiation. The next steps are to investigate the genomic integrity and therapeutic efficacy of these cells.”

Here is a link to 2014 information about Willenberg’s research.

A Tale of Two Stem Cell Stories, Plus Reading the Entrails of the Media

Last week, two interesting stories popped up involving California’s $3 billion stem cell research effort.

One of the stories dealt with a matter that could affect as many as 27 million people. The other involved less than 100.

One story involved creation of important linkages that could help speed up the transformation of stem cells into cures. The other concerned little more than a change of address. 

The story about the change of address was displayed on the front page of the largest circulation newspaper in Northern California, the San Francisco Chronicle, and appeared in many other outlets. (See here and here.) Not a word was reported in the mainstream media about the development that could affect the 27 million people afflicted with arthritis in this country.(See here and here.)

For many persons, such disparities in news are puzzling and frustrating, not to mention disturbing. Sort of like trying to find meaning by reading the entrails of animals. 

Stem cell research is exceedingly important, the reasoning goes, and how can those dolts in the press ignore it? More specifically, the situation poses a continuing challenge for California’s stem cell agency, which has a hard time breaking into ink except when it moves its headquarters a few miles from San Francisco to Oakland.

So how do editors and reporters make the decisions that lead to such disparities? The first thing to remember is that -- like of all us -- the news media are most comfortable doing the things they have always done. The treatment of these two stories follows a pattern that has been established over many decades.  Newsies like “horse race” stories – ones with clear winners and losers. In this case, San Francisco "lost" the headquarters of the stem cell agency and Oakland "won" it.

The move also fit with an ongoing news theme – skyrocketing office space costs in San Francisco – coupled with high housing costs and the current conflict between the impact of high tech on the city vs. the desire to return to a past that is perceived by many as more benign.

Additionally, the stem cell agency headquarters story is fundamentally local as opposed to the arthritis research, which is not solely about the San Francisco Bay Area.

The tale was easy to report. It did not require weeks of digging or lengthy interviews to understand the science. The story was basically handed to the news media as a result of the Aug. 17 item on the California Stem Cell Report, although the move has been around publicly at least since July 23.

At our request, one longtime observer of the California stem scene, who must remain anonymous, elaborated on the situation. 

“Well, you write a blog that catches the eye of a reporter/editor. It concerns a state agency that was lured to the city to help kick start biotech, to be a lynch pin, if you like, for a new regional research base. Ten years after arriving the agency is a victim of its own success, or the city’s success, or just the economy (choose your story line here), so you have a story about a state agency moving, a city that is experiencing soaring rents losing businesses like this, and another neighboring city that stands to benefit. You can then focus on the biotech angle - 'is the city doing enough to keep businesses here' - or the people angle or any angle except the only one that really matters, the science.
 “That results in a front page article on the local newspaper – they love to put local stories on the front because it is more attractive to potential readers, and put all the national/international wire stories inside – which then leads other local news outlets to follow along. Why the delay? Because most media outlets don’t have specialist reporters anymore so they rely on some other news outlet, usually newspapers, to dig up something interesting, and they can then follow along. Radio first usually, they are rapid responders and can get stories on the air very quickly, followed by other online media and then TV.”  

We should add that the treatment of the two stories has lessons that apply to dealing with the media generally.  If researchers want to get their stories out – as they should – the first thing to consider is the needs of the media. Work into the existing framework. Don’t try to create a new one. That may take longer than getting a stem cell treatment approved by the FDA.

Find a compelling angle, one that can be summarized in a couple of sentences. Speak English. Avoid jargon and technical-speak. Talking about a “chondrogenic drug candidate targeting resident mesenchymal stem cells” will never make the front page. Talking about a relatively simple therapy, the first of its kind for arthritis, has a much better chance.

Don’t expect to find relatively well-informed science reporters at news outlets. The few that once existed are mostly gone. Be a guide for editors and reporters and help them along by providing material that answers all their basic questions.

Finally, lower your expectations. The financial crunch on the news media means less space for science stories and fewer reporters to write them. But don’t be discouraged. A good story, properly presented can find a home at some point in the media. But it may not be tomorrow.

The StemExpress Controversy and Collateral Damage

Back in July, after the Planned Parenthood, anti-abortion controversy erupted and entangled a California firm, one Internet headline read,

“Fetus Miner’s Friends in High Places”

The site that posted the headline was the American Conservative. The item referred to Charlotte Ivanic, the older sister of Cate Dyer, CEO of StemExpress LLC of Placerville. It is the stem cell and human tissue firm that was named in the videos involving Planned Parenthood.

In July, Ivanic was the highly regarded top health policy aide to House Speaker John Boehner, who denounced Planned Parenthood and approved House committee investigations into Planned Parenthood and StemExpress.

Dyer once said that her sister is “one of her biggest inspirations.”

Now she is gone from public service. She left on Aug. 5 and has become a Capitol Hill lobbyist. In a press release, Boehner said, 

“Charlotte has spearheaded some of our most significant accomplishments on behalf of the American people. She is one of the best I’ve seen at bringing people together to find common ground, and she leaves Boehnerland with the deepest respect — and best wishes — of her peers as well as lawmakers from both parties.” 

The news about her resignation was slow to ripple out. It was only yesterday that one anti-abortion Web site caught up with the news. Fireandreamitchell.com had this to say, 

“It took three weeks for Charlotte Ivancic to resign from John Boehner’s staff after the videos went public. This yet again shows that John Boehner is just a progressive like liberal Democrats. Why else would he have a leftist like Charlotte Ivancic on his staff in the first place? John Boehner is not only mentally unstable but a progressive hack too. Boehner has to go, NOW!”

StemExpress: Anti-Abortion Activists Telling "Long Series of Lies"

A beleaguered California company caught in the national, anti-abortion controversy involving Planned Parenthood late today said its foes were engaged in a “long series of lies.”

The company, StemExpress LLC of Placerville, made the charge in a statement that included the unedited portions of the latest anti-abortion video along with a transcript of what was said.
(If you would like the video, please email djensen@californiastemcellreport.com. It is a large file.)

The firm said,

“David Daleiden and the Center for Medical Progress today released their latest heavily edited, highly-deceptive video in which they claim StemExpress “admitted” to receiving fully intact fetuses from Planned Parenthood….

“During the video, the parties refer to 'cases,' which is a term of art referring to livers in this conversation. CMP’s accusations that this conversation somehow refers to 'intact fetuses,' which were never mentioned at any point during the entirety of the illegally recorded conversation, are false.

“StemExpress has never requested, received or provided to a researcher an “intact fetus.” CMP’s and Daleiden’s claims to the contrary are unequivocally false.”

The statement and release of the transcript reflected a more aggressive posture on the part of StemExpress, which has lost business as a result of the activists’ efforts. Its employees have also been threatened with violence.

Here is the full text of the StemExpress statement.

“StemExpress today released the following concerning CMP’s 8th video:

“David Daleiden and the Center for Medical Progress today released their latest heavily edited, highly-deceptive video in which they claim StemExpress ‘admitted’ to receiving fully intact fetuses from Planned Parenthood. Accompanying this document is a link to the unedited part of that video where this supposed admission discussion occurred, as well as a transcript of what was actually said.

“As anyone can see and read, the entire discussion was in fact about ‘intact livers.’ Livers are among the most urgently needed of medical tissues by scientists and medical researchers working to cure cancer, diabetes and Alzheimer’s disease.

“During the video, the parties refer to ‘cases,’ which is a term of art referring to livers in this conversation. CMP’s accusations that this conversation somehow refers to ‘intact fetuses,’ which were never mentioned at any point during the entirety of the illegally recorded conversation, are false.

“StemExpress has never requested, received or provided to a researcher an ‘intact fetus.’ CMP’s and Daleiden’s claims to the contrary are unequivocally false.

“Earlier today, a court found that this footage was likely obtained in violation of California criminal law prohibiting the illegal recording of private conversations. In a different court later this afternoon, Daleiden and his CMP co-defendants invoked the 5th Amendment rather than answer questions about their ongoing illegal activities in a related case in federal court. The release of today’s video and CMP’s claims about it are just another in a long series of lies.”

California's StemExpress Loses Bid to Block Anti-Abortion Videos; Appeal Being Considered

A Los Angeles judge today rejected a bid by a California stem cell/human tissue firm to halt the release of an anti-abortion video that the firm said is harming its business and endangering the lives of its employee.

The firm, StemExpress LLC of Placerville, said, however, it is considering appealing the ruling.

Brian Melley of The Associated Press wrote,

“Los Angeles Superior Court Judge Joanne O'Donnell rejected efforts by StemExpress to block the videos, though she said the company likely will prevail in its lawsuit claiming its privacy was violated by an anti-abortion activist posing as a biomedical company employee.”

Melley continued,

“StemExpress won a temporary restraining order last month, but O'Donnell said Friday that the center's First Amendment rights to release the videos trumped the company's right to block them under their privacy claims.

“The judge said she couldn't tell who was telling the truth about how confidential the May meeting was, but she said the fact (David) Daleiden concealed his identity and secretly recorded the conversation made his account less believable.

“O'Donnell rejected the center's argument that the secret recordings were legal under an exemption that allows such subterfuge if someone believes they are gathering evidence of a crime.

"'Defendants' apparent ideological conviction that fetal tissue procurement is a violent felony does not, without more (evidence), rise to the level of a 'reasonable belief,' O'Donnell wrote.”

California Firm Says Anti-abortion Activists Misleading Courts, Endangering its Employees

A California stemcell/human tissue company this morning renewed its efforts to halt distribution of a video by anti-abortion activists that it says will endanger its employees and damage its business.

The firm, StemExpress LLC of Placerville, said in court filings that it was only seeking to stop the distribution of the video, not the information contained within it.

It said that the activists, the Center for Medical Progress of Irvine, Ca.,  and David Daleiden, have misled the judge in the case. The firm said the activists want to distribute the video to “inflame” the public against the company and provoke a “hostile reaction.” The company has already received death threats against its president.

StemExpress also said its request for a preliminary injunction does not violate the First Amendment of the Constitution.

The firm argued that such orders have been upheld in other cases “where anti-abortion protesters were constitutionally enjoined not in what they wanted to say, but how, where, and when they wanted to say it.  Such injunctions are simply not subject to strict constitutional scrutiny.”

The activists have argued that they did not violate state law barring recording the conversations without the permission of all parties because the discussions involved a crime -- “harvesting and killing live babies for resale.”

StemExpress noted that the activists did not report any alleged crimes to authorities during a two-year investigation.

The court filing said the activists’ belief that StemExpress is

“…‘harvesting and killing live babies for resale’ is neither objectively reasonable nor credible from a subjective standpoint.  First, abortion before viability is not murder in California…. While defendants may wish that abortions were illegal and constitute murder, that is simply not the law.  This alone precludes defendants’ purported ‘defense’ of their illegal conduct.  Second, defendants have no evidence that would even remotely support the claim that plaintiffs participated in any abortion procedure involving a viable fetus.  To state the obvious, StemExpress does not perform abortions.  And contrary to Daleiden’s hearsay statements, StemExpress has never received a living, fully-intact fetus from an abortion clinic.”

Here is the full text of this morning's filing.

  StemExpress filing 8-21-15 for preliminary injunction

Correction

The arthritis spending item yesterday incorrectly stated that the California stem cell agency was spending $17 million on arthritis research. The correct figure is $19.5 million.  The lower figure was based on erroneous numbers on the agency's "arthritis fact sheet," which did not include a $2.3 million award to Schultz in March.

Solid Hook-Up: California Stem Cell Agency and Calibr Connection

Highlights

Creating pathway to clinic

The Calibr approach

Problematic pharma-academic ties

As of today, the California stem cell agency has a $4 million hook into a San Diego research enterprise that also has ties to a glittering array of partners, ranging from Merck to Bristol-Myers Squibb. 

The connections fit with the state stem cell agency’s new goal of creating a clear pathway from the basic research bench to the use of stem cell cures in clinics for millions of people.

The signal event came routinely and quickly this morning when directors of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, approved a $1.7 million award.

The cash is going to the California Institute for Biomedical Research (Calibr) and its director, Peter Schultz.

The funds will be used for pushing into clinical trials a treatment that would -- for the first time -- modify the progress of osteoarthritis, which afflicts 27 million Americans. The therapy could also be used to treat damaged cartilage in knees and elbows.

CIRM has now invested $10 million in Schultz, a reknown chemist and biotech entrepreneuer. Six million of that went for research that was performed at Scripps. All of the funds involve the proposed arthritis therapy. Including today’s award to Schultz and funds to other researchers, the agency has now handed out $19.5 million to find a therapy for arthritis.

Schultz founded Calibr three years ago with up to $90 million, promised over seven years by Merck. The Big Pharma firm has first refusal rights on treatments developed by Calibr. If Merck passes, then other enterprises can make an offer. Calibr has additional partnerships, including a $28.9 million, five-year relationship with the Gates Foundation.

Peter Schultz, catching a big one

Schultz says “our mission is a little bit arrogant.” In a lengthy piece in March by Bradley Fikes of San Diego Union-Tribune, Schultz said Calibr has “a very broad spectrum of interest and we hope to have a significant impact on a number of diseases."

Fikes wrote,  

"'There are a lot of discoveries being made in life science, and many of these discoveries are made in academic institutions and basic research institutions,’ Schultz said. ‘The process of translating those discoveries into new medicines has become somewhat difficult.’

“These institutions have trouble collaborating with big pharma because of differences in culture and regulatory challenges of for-profit and not-for-profit collaboration.

"'That's left the universities try to do drug discovery themselves,’ Schultz said. ‘The problem there is they don't have the knowledge, experience or even the processes to do drug discovery, which is a lot different than a cottage industry approach to basic research."

Fikes continued,

“Meanwhile, big pharma is becoming more risk-averse, looking for validated drug targets and in-licensing compounds. That makes pharma collaboration with basic research centers even more problematical, Schultz said.

"’We have to come up with other ways to really facilitate and accelerate the translation of new research into new medicines,’ Schultz said. ‘Universities are trying to set up their own drug discovery units. Scripps has done that in Florida, Vanderbilt, we see Cornell, Rockefeller and Sloan-Kettering teaming up to do that. They're building something from scratch, and usually without having the experience of having been there and done that. And in some cases what they wind up doing is hiring a lot of people from pharma industry and recreating a pharma-like process.’"

Calibr has 110 employees, Fikes reported, including 60 postdocs. Its annual operating budget for 50 projects totals $25 million. Calibr is still busy hiring with seven positions open on its Web site as of this afternoon.

California Stem Cell Agency Awards $1.7 Million to Help Treat Arthritis

Directors of the California stem cell agency, as expected, this morning approved $1.7 million to help push an arthritis treatment into clinical trials. The funds went to Peter Schultz, director of the California Institute for Biomedical Research. We will have more details later today.

California Spending More than $19 Million on Search for Stem Cell Arthritis Therapy

Stem cell agency summary of Peter Schultz proposal

Highlights
First in class therapy
Avoids risks, costs
Uses drug-like kartogenin
The California stem cell agency tomorrow is set to boost its spending on arthritis to $19.5 million with a new grant to a San Diego researcher who is preparing a clinical trial for his possible therapy.

The agency’s governing board is all but certain to approve a $1.7 million award to Peter Schultz of the Scripps Research Institute in La Jolla on top of the $6 million he has already received.

Meeting behind closed doors, the agency’s blue-ribbon scientific reviewers earlier this summer approved the application on a 12-0 vote. The agency board almost never overturns a positive decision by its reviewers.

The review summary said the proposed therapy would be “first in class regenerative medicine” for osteoarthritis as well as cartilage injury. Currently no disease-modifying drugs are approved for clinical treatment of arthritis, which afflicts 27 million people in the United States. The award is to assist in preparation for a federally approved clinical trial. 

Peter Schultz -- Scripps photo

Schultz, who has close ties to Merck and who is also director of the California Institute for Biomedical Research, laid out some details of his approach in an earlier progress report to the stem cell agency.

He said,

“Because limited joints are affected in most (osteoarthritis) patients, intra-articular drug injection is an attractive treatment approach that allows high local drug concentration with limited systemic exposure. Targeting resident stem cells pharmacologically also avoids the risks and costs associated with cell-based approaches.”

 Schultz continued,

“Cartilage contains resident mesenchymal stem cells (MSCs) that can be differentiated in vitro to form chondrocytes. This observation suggests that intra-articular injection of a small molecule that promotes chondrogenesis in vivo will preserve and regenerate cartilage in OA-affected joints. Using an image-based screen, we identified a drug-like small molecule, kartogenin (KGN), that promotes efficient and selective chondrocyte differentiation from MSCs in vitro. Intra-articular injection of KGN also shows beneficial effects in surgery-induced acute and enzyme-induced chronic cartilage injury models in rodents, as well as positive effects in incapacitance pain models.”

The agency has already pumped in around $17 million for arthritis research, including funds given earlier to Schultz.

As usual, the award tomorrow involves an institution that has a representative on the agency board. About 88 percent of the money that the agency has handed out since 2005 -- $1.9 billion -- has gone to institutions that have ties to agency directors, according to calculations by the California Stem Cell Report.

The stem cell agency does not identify the winning applicants for awards until after the board acts. However, based on information on the agency's Web site, the California Stem Cell Report was able to verify that Schultz was the applicant up for approval tomorrow.

Tomorrow’s teleconference meeting is scheduled for only one hour beginning at 9 a.m.. The main session will be in San Francisco, which has another location there as well. Other locations where the public can participate include Irvine, San Diego, Napa, Redwood City, two in Sacramento, Los Gatos, San Francisco, Elk Grove, Beverly Hills, Fresno, Los Angeles, Cambridge, Ma., and Ballard, Ca., in Santa Barbara County. Specific addresses can be found on the agenda.

The public can also make comments  on any issue during the board session.

(Editor's note: The figures on CIRM's total spending for arthritis have been increased from an earlier version of this story. The previous figures were based on erroneous numbers on the agency's "arthritis fact sheet," which did not include a $2.3 million award to Schultz in March.)

'Terrorized' -- The LA Times on the StemExpress Story

Highlights
Juggling threats to business
Realistic response by StemExpress

The Los Angeles Times today said anti-abortion activists have  “terrorized and harassed” a small California stem cell/human tissue firm in a heated, national campaign that threatens important medical research.

Pulitzer Prize-winning columnist Michael Hiltzik took on the issue in a column published this morning.

The piece began:

“Last week a small California company that provides human blood, cells and tissues to research scientists bailed on one of its partners, Planned Parenthood.

“Placerville, Ca.-based StemExpress, which had worked with Planned Parenthood to distribute fetal cells and tissues following abortions at the organization's clinics -- with the full consent of the patients undergoing the procedure -- ended its relationship with the healthcare provider ‘due to the increased questions that have arisen over the past few weeks.’ “These aren't questions about the legality or ethics of Planned Parenthood's activities, which haven't been legitimately challenged. They're questions about whether the organization's activities can survive a full-scale political onslaught.”

The headline on the article read:

“A terrorized and harassed corporate partner abandons Planned Parenthood”

 Hiltzik continued,

“StemExpress isn't terminating its relationship with Planned Parenthood because it thinks the relationship led it to do anything wrong. The firm doesn't think Planned Parenthood has done anything wrong, either. We know this because the company says so in a lawsuit it filed last month against the Center for Medical Progress. That's the anti-abortion group that has been releasing edited undercover videos of meetings it conducted, apparently under false pretenses, with Planned Parenthood officials and others.”

He wrote,

“One might think of StemExpress' action as cowardly. But it's more fair to regard it as realistic. In any controversy involving private enterprise, corporate self-interest is the soft underbelly for attack, because economic interest almost always trumps moral steadfastness; the smaller the company the less its defenses against bad publicity, no matter how ill-informed.”

Hiltzik said,

“Among the most disturbing aspects of this affair is its effect on the legal and often necessary use of fetal tissue in biological research. It's true that advances in science have made this less important than it used to be, but it's also true that it's still needed in work toward cures of muscular dystrophy, diabetes, degenerative eye disease and other conditions. CMP's campaign threatens this whole line of inquiry, because any business or nonprofit that serves these researchers will have to ask whether it's worth trying to resist political pressure or the threat to employees' safety.”

For more on StemExpress' problems, see here.