Recalling a 2012 California Alzheimer's Effort: A Case of 'Clutching at Straws'Says LA Times Columnist

California’s stem cell agency, which is working mightily to develop a commercially viable stem cell treatment, popped up this week in the heated national debate about federal approval of a treatment for Alzheimer’s.

The therapy in question is Aduhelm. Here is how Michael Hiltzik, author of “Big Science” and business columnist for the Los Angeles Times, yesterday summarized the controversy concerning it. 

“Medical experts’ doubts about whether Aduhelm works at all should have stayed the FDA’s (Food and Drug Administration’s) hand in issuing its approval. Despite the experts’ doubts, however, the FDA went ahead, effectively giving Biogen the green light to set the drug’s price at $56,000 a year.”

Hiltzik’s column in the Times was headlined: 

“The FDA’s hasty approval of an unproven Alzheimer’s drug is bad news for everyone”

As part of his commentary, Hltzik recalled the case of a proposed Alzheimer’s treatment that was financed by the $12 billion California stem cell agency. Hiltzik said,  

“This (week’s FDA action) is not the first time that the promotion of a potential treatment for Alzheimer’s has resembled clutching at straws. California’s stem cell program, known formally as the California Institute for Regenerative Medicine (CIRM), fell into the same trap in 2012, when its governing board approved $19.3 million in funding for an experimental treatment that was to be tested on mice.

I (Hiltzik) reported at the time that the funding was based on an application that had been repeatedly rejected by CIRM’s scientific review panel, largely because the reviewing experts considered the data supporting the application less than ‘compelling.’

“The applicant was the very well connected firm StemCells, Inc., which was supported in its quest by the Northern California real estate man Robert Klein II, who had drafted Proposition 71, the ballot measure that created CIRM, and served as the program’s first chairman. But the fundamental rationale for the approval was that the larder of potential treatments for Alzheimer’s was otherwise bare.

“‘Everybody says it’s a huge unmet need,’ Leeza Gibbons, a former television personality placed on the CIRM board as an advocate for Alzheimer’s patients, said at a board meeting in July 2012. ‘This is a sixth-leading cause of death, the only one in the top 10 for which there is nothing, nothing, nothing, zilch.’

“As it happens, the company ended the research program in 2014, after spending $8.9 million of its grant and ‘without seeing a significant change in memory performance’ among the test animals. The company returned $679,166, to CIRM after abandoning the project; the $10.4-million balance of the grant had never been disbursed and was redirected to other recipients.”

(See the final conclusions/report from the company under the topic “year two” report here.)

The California Stem Cell Report covered the Stem Cells, Inc., saga in considerable detail, ranging from the initial, dubious award process to complaints of arm-twisting from CIRM’s board members. 

It should be noted that a different CEO was in charge of CIRM operations at the time. CIRM’s now 35-person board (formerly 29) also has a number of new members as well.

Gibbons, for one, has been replaced as an Alzheimer’s advocate by Lauren Miller Rogen.

Here are links to a few of the Stem Cells, Inc., stories on the California Stem Cell Report.

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