Category Archives: Stem Cell Therapy

The Los Angeles Times, California's largest circulation newspaper with more than 900,000 subscribers, today said the "Geron fiasco" raises questions about the conduct of business at the California stem cell agency and whether it "does a disservice to patients and taxpayers."

The comments came in a column by Pulitzer Prize-winning journalist and author Michael Hiltzik, who wrote about Geron's abandonment of its hESC trial only five months after the firm was awarded a $25 million loan by the stem cell agency. Hiltzik said,

"So we're talking at least about months of wasted effort by CIRM and Geron's researchers, crushing disappointment for those patients and conceivably a major setback for stem cell science generally. (CIRM Chairman Jonathan) Thomas observes that Geron said it made its decision strictly on financial grounds, not because of scientific reversals. But for an R&D company financial considerations always encompass scientific judgments, and Geron plainly concluded that the prospect for profits from stem cell therapies was receding.

"The Geron fiasco underscores the old questions, and raises new ones, about what CIRM is supposed to accomplish, how it does business and whether its addiction to hype does a disservice to patients and taxpayers."

Hiltzik's column contained brief remarks from Thomas. The columnist wrote,

"'There are going to be fits and starts,' its chairman, Jonathan Thomas, told me last week. Even so, he maintained, 'we remain unwavering in our commitment to pursuing the science.'"

Hiltzik has followed CIRM since the 2004 ballot initiative campaign that created the $3 billion enterprise. The effort was headed by real estate investment banker Robert Klein, who later served as CIRM's chairman for seven years. Hiltzik wrote,

"CIRM loves to compare itself to the federal government's biomedical research agency, the National Institutes of Health, but the two bodies are very different. The responsibilities of NIH are broad enough for it to make disinterested judgments about programs and scientific approaches. CIRM, however, was designed from the start (by Klein, who oversaw the drafting of Proposition 71) to focus on a very narrow field of biomedical science — embryonic stem cell research — and to promote that research in California as a sort of economic development tool.

"These two goals have always been ethically and scientifically incompatible, and the Geron case points to why."

Hiltzik said evidence exists to show that CIRM "downplayed legitimate questions about the state of Geron's science and the design of the clinical trial" in its efforts to fulfill the excessive promises of the electoral campaign. The issues, he said, included over-promising results, questions by other researchers about the trial and whether a spinal cord injury was the best subject for the first tests of stem cell therapies on humans.

Hiltzik continued,

"None of these issues were aired publicly in the run-up to the vote, because CIRM didn't disclose in advance that Geron was the loan applicant. Nor did it disclose that its own scientific review panel had awarded the Geron trial a scientific score of only 66 out of 100; that fact, along with other details of the board's consideration of the Geron loan, was pried out of CIRM later by David Jensen, the tireless proprietor of the indispensable California Stem Cell Report.

"CIRM told Jensen that although it customarily discloses its reviewers' scientific scoring of funding proposals, it didn't in this case because it was using 'new criteria' and thus the public might not find the result 'meaningful.' Call me a cynic, but I'd bet that if the score were, say, 90 out of 100, CIRM would have shouted it from the rooftops, rather than pleading that Californians were too dumb to understand what the number meant."

Hiltzik concluded,

"Another problem illuminated by the Geron case is that CIRM remains infected by the hype virus. Only a week after Geron parachuted out of the stem cell business, Thomas issued a statement bemoaning the public impression that CIRM isn't making any progress toward therapies. He declared: 'CIRM is turning stem cells into cures.'

"Well, no it isn't, not yet. Geron's now-halted project was the most advanced human clinical trial in CIRM's portfolio; yet it was at an extremely early stage, involved all of five human subjects and might still have been years away from showing that a cure was even possible. CIRM needs to take a good look at whether it pushed too hard for the Geron loan and overplayed the significance of the trial; otherwise its path toward building credibility with the public will only get longer."

The California Stem Cell Report has asked CIRM Chairman Thomas if he would like to respond in more detail to the Los Angeles Times column, with a commitment to carry his remarks verbatim.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

A second teleconference location has been added to where the public can participate in tomorrow's meeting of the directors of the California stem cell agency, which will be covered live via the Internet by the California Stem Cell Report.

The actual meeting will be in Los Angeles at Cedars-Sinai, but interested parties can weigh in from sites at Stanford and UC San Francisco. The meeting will also be audiocast on the Internet.

Here are specific addresses from the agenda for the teleconference locations.
Stanford School of Medicine
Li Ka Shing Center for Learning and Knowledge/291
Campus DriveLK3CO2 3rd Floor/MC5216/
Stanford CA 94305-5101

UCSF School of Medicine
513 Parnassus Avenue, Room S224
San Francisco, CA 94143

Here are instructions for the audiocast:
To access the live event or archive, use this URL:
https://im.csgsystems.com/cgi-bin/confCast
Enter Conference ID# 224434 then click Go.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Some connected to the California stem cell agency, notably its founding father Robert Klein, are fond of declaring that the $3 billion enterprise has an immutable mandate from voters to pursue its endeavors.

Well, mandates come and go.

That lesson was learned once again this morning with the results of a Field Poll that showed that another big ticket effort, the California high speed rail project which was approved by 53 percent of voters, has lost not only its luster but its support. According to the poll, 64 percent of voters would now like another chance to vote on it. And 59 percent would reject it.

The reasons for the change of heart? Severe economic conditions in California, increased mainstream media coverage of high speed rail's deficiencies and bungling by its management.

While a San Francisco Chronicle columnist last summer called CIRM "the high speed rail of medicine," the stem cell agency has not suffered from the same sort of heavy and critical media attention. CIRM is all but invisible to the public. But agency is now is embarking on an ambitious PR effort to raise its profile and to move forward to win voter approval of another multibillion bond measure. Otherwise it will run out of funds in 2017.

CIRM must tread carefully with its new communications campaign. It has a legitimate responsibility to better inform Californians, and its PR could be more robust(which is a sort of the word of the day at CIRM).

But downsides do exist. With a possible ballot measure coming up, some ungenerous folks might construe aggressive CIRM PR as electioneering at taxpayer expense, including its subsidies of patient advocate activities, such as attendance at conventions. Even without a looming election campaign, the high speed rail project's $12.5 million PR effort attracted negative attention in at least two major newspapers just this week(see here and here).

Klein, who led the campaign that created CIRM and served as its chairman for seven years, is now gone, but his footprints remain. The agency, however, cannot assume that voter support seven years ago, in a much, much different world, translates to support today.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

The California stem cell agency is readying a long list of changes that will affect all of its 453 grant recipients and all future awards.

Many of the changes are minor. Some have been requested by grantees. Others are aimed at dealing with issues posed by larger grants. Some reflect the agency's move to more streamlined reporting.

Amy Lewis, CIRM's grant management officer, has prepared an introductory memo along with the proposed changes for discussion at Thursday's board meeting in Los Angeles. She said the proposal is in its early stages and will not require a vote this week.But it would behoove those affected to carefully check the grant administration policy to see how it might alter their lives.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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