California Stem Cell Report

I think it may be an overstatement to say flat out...

2013-05-16T21:25:14.866-07:00

I think it may be an overstatement to say flat out that the Oregon style cloning would be illegal in California. The actual research of therapeutic cloning is in fact legal in California.

In addition, what about this bill: http://www.sacbee.com/2013/03/10/5250417/california-bill-seeks-pay-for.html ?

Hi David, Another important issue not getting need...

2013-05-13T10:10:40.122-07:00

Hi David,
Another important issue not getting needed attention is the huge issue of iPS cell patents. A patent war is brewing there and I don't know why people won't talk about it. Here's my post today on it: http://www.ipscell.com/2013/05/putting-the-ip-in-ips-cells-patent-war-looming/
Paul

Bob Klein is referring to the Translational grant ...

2013-05-05T20:45:09.900-07:00

Bob Klein is referring to the Translational grant award for Alzheimer's stem cell therapy. That grant was to a collaboration of academics who had already published their early success with this approach, and did not involve StemCells, Inc.

Thank you for bringing this to our attention. The...

2013-05-05T20:43:49.637-07:00

Thank you for bringing this to our attention. There are too many connections for the StemCells, Inc Alzheimer's disease team funding was not a coincidence.

To avoid the appearance of conflict, the NIH won't allow a grantee to even buy a cup of coffee for an NIH employee. Trounson at Wessman's ranch? What was he thinking?? What was Weissman's motivation? I'll believe that this was not lobbying when Irv invites ALL California stem cell scientists to spend 4 days at his ranch! And you too, Dave! And, Bob should also pay for you to visit Japan!

Hmmm- It may be appropriate to ask whether Irv We...

2013-04-11T16:06:25.925-07:00

Hmmm- It may be appropriate to ask whether Irv Weissman was awarded some extra stock to reward his efforts in persuading the ICOC to vote favorably.

The state does not really subsidize indirect costs...

2013-03-23T15:01:37.830-07:00

The state does not really subsidize indirect costs at the UCs. We do not have all the marble and perks of Salk. All indirects should be capped at 50% and the savings used to provide bridge funding for almost funded investigators to pay their own salaries at a reduced level.
The current R01 paylines are destroying the careers of many excellent midlevel scientists at a severe cost to them and to Science.

John Simpson had the answer to all of these vexing...

2013-02-27T14:37:27.465-08:00

John Simpson had the answer to all of these vexing conflict questions. Do the whole thing in public! Confidential peer review is just an excuse for secrecy. Any CIRM observer has seen that scientists are more than willing to discuss and argue about their grants before the ICOC if they think that will get them funded.
At some point, folks asking for millions of bucks should be willing to put the applications out into the public realm like most requests for funding. And, the analysis/review of those grants should take place in full public view. Then the ICOC members without conflict can vote the applications up or down in public. As Simpson noted, Connecticut conducts its reviews in public. We need to stop treating the research community like some delicate flower that will wilt if it is exposed to sunlight.

David: I love it that you pay attention to CIRM a...

2013-02-11T17:18:34.010-08:00

David: I love it that you pay attention to CIRM and am glad that you point it out whenever CIRM obfuscates.

But this is too much. CIRM- the staff, the ICOC, and the funded scientists are all human beings, and until there is a granting agency that is entirely staffed by robots, there will be potential for conflict of interest.

Yes, I am angered that Klein and Weissman were successful in using their personal powers of persuasion to get approval for grants that they favored--whether their motives were personal or financial is irrelevant--the board should not have rewarded this bad behavior.

Yes, I think that Reed was duped by his faculty into writing an inappropriate letter of support.

Yes, I am alarmed that ICOC members wrote letters of support for their young faculty members- they weren't trying to short-circuit the rules, they were just doing what they always do when a young faculty member writes a grant for the NIH. Stupid, but not wicked.

This is what conflict of interest is: conflict of interest is what happened in Texas when a cancer award was made to some friend of the administration, without any scientific review at all.

CIRM is an experiment, and almost all the time it has done the right thing. Sure, these non-robots make mistakes, but they learn from them. None of these bad things has become chronic, and although CIRM has not always moved swiftly enough, the unfair acts have usually happened only once. Wait- there is one thing- the extraordinary petition process: the applicants seem to have learned to ignore the instructions. But that's our fault, not CIRM's- the rules clearly state what constitutes a cause for a complaint. CIRM should just tell us to shut up and read the directions.

I'm certain that history will show that CIRM was a bold experiment that jump-started life-saving stem cell research as surely as the Susan G. Komen foundation brought to light the woefully inadequate funding for breast cancer research.

I'm not asking you to ease up- I'm just asking you to put CIRM into perspective- by writing about the good as well as the bad.

Almost no one is ever clear on the conflicts of in...

2013-02-06T14:38:16.864-08:00

Almost no one is ever clear on the conflicts of interest question. Here is one piece that sums it up:
http://www.hhs.gov/ohrp/archive/coi/korn.htm
Briefly, 1. Conflicts of interest are ubiquitous--we can never eliminate them. 2. It is the job of the institution to manage them, not eliminate them (that being impossible) and 3. Since conflicts of cannot be eliminated, only managed, the existence of a conflict of interest in itself is not misconduct.
The Council on Foundations illustrates exactly this muddied thinking. First it says that "members must represent unconflicted loyalty to the interests of the foundation," but then says that "this accountability supersedes any conflicting loyalty" --wait, you just said there can't be any conflicting loyalties! The proper formulation is to say that the loyalty to the foundation is superior, not to insist that the loyalty be unconflicted.

The IOM recommendations, if adopted, would have ma...

2013-01-30T13:21:43.891-08:00

The IOM recommendations, if adopted, would have made the California Institute for Regenerative Medicine (CIRM) a closed shop.

Supporters of open government should be glad we do not have a system where all substantive decisions were made behind closed doors, and the public had its rights of participation stripped away.

Under the IOM recommendations, the only public vote on stem cell research projects would be an up-or-down vote on a group of projects, perhaps 50 at a time.

Neither the publicly appointed board of directors, nor the public itself would be allowed to comment or vote on the projects themselves-- and that decision-- where the money goes-- is the most important job of the entire program.

Presently, the public can support various research projects. We can speak up, three minutes each of public comment, and then the board of directors will vote.

The ICOC bent over backwards to avoid even the appearance of a conflict of interest--every member whose organization had a chacne of getting a grant has now denied themselves the right to vote

LA Times columnist Mr. Hilzig may have a problem with the decisions of the California electorate, which overwhelmingly said yes to Prop 71 with its very specific requirement for a board of experts, but that is democracy.

I personally do not appreciate Mr. Hiltzig's eternally sneering invective against a program I regard as honorable and fine, good people working hard to solve chronic disabilities and diseases.

But that is also democracy. Mr. Hiltzig has a right to trashtalk Prop 71-- and California has the right to support it.

Don C. Reed

Hi David, You are quite right in your observations...

2013-01-24T07:57:36.180-08:00

Hi David,
You are quite right in your observations about the scant media coverage of CIRM. But where is the AP? It's AP's job to cover significant issues that its subscribers can't afford to.
One would think that would attend an especially important meeting of an agency such as CIRM. If reporters are searching for a way to provide information that readers care about, this would seem to be an example.
And given that CIRM does provide an audiocast, what prevented AP and other media outlets from using that for a story as we did?
Thank you for your detailed coverage of the meeting; your post stating that voting was near ensured I didn't miss it.

Above all, I hope that that Nelson & Miceli &#...

2012-12-12T19:36:42.333-08:00

Above all, I hope that that Nelson & Miceli 's work will help their own son and the many other boys affected by Duchennes Their work already brings
great pride to Cirm. I would like to point out that theirs was a casebook study on why the special petition is worthwhile. There
was indeed new and relevant information that only became available after grant review.Scientific staff and leadership flagged it. A sub- committee
reviewed the information and found it convincing.They advised the board to revise their funding decision which they did. There were some extra steps, tears were certainly shed when the board met the DMD families, but in the end, the extra care CIRM and the ICOC took is likely to have been well worth it.

The simple answer to the question from Wondering i...

2012-10-30T19:07:56.896-07:00

The simple answer to the question from Wondering is:
No, voters did not envision Prop. 71 as helping Big Pharma.
But if they had understood all the ramifications of the biotech business, stem cells and production of therapies, yes, they would have understood that the California stem cell agency could be of great benefit to Big Pharma

Is helping fund Big Pharma really what California ...

2012-10-27T11:42:13.842-07:00

Is helping fund Big Pharma really what California taxpayer's had in mind?

What is strange about the New Scientist article is...

2012-10-15T12:59:04.384-07:00

What is strange about the New Scientist article is it implies that the reason it took over 200 days for Yamanaka to get his paper p53 published in Nature is that Nature has a bias against non-US scientists. However in the data provided in the table, it shows Nature has virtually no bias against non-US scientists in terms of speed of acceptance and publication if reprogramming papers. Seems rather contradictory and unscholarly of Aldhous-- using anecdotal data to bolster his claim of unfairness by Nature, even when it is not supported by the more rigorous approach presented in the tables.

Apart from issues with peer review on journal publ...

2012-10-12T07:46:43.640-07:00

Apart from issues with peer review on journal publications, note the priority issue as to patent applications:

IPBiz: Yamanaka scooped on iPS (stem cell) patent ?!?

L. Ebert

I thought that there was to be another meeting in ...

2012-09-25T16:29:36.224-07:00

I thought that there was to be another meeting in the East? With all that has gone on over the past few months IOM REALLY NEEDS ANOTHER MEETING. Is this going to be another Little Hoover Commission waste of time and money? Whatever the IOM conclusions/recommendations will CIRM one more time ignore the outcome? I would bet the farm on it that they will ignore any possible change in structure and process.

From anonymous biotech exec

Re the item dealing with $1.5 billion to stem cell...

2012-09-24T16:12:45.174-07:00

Re the item dealing with $1.5 billion to stem cell agency directors' institution, a California biotech executive asked the California Stem Cell Report to post the following comment anonymously:
"This tops what the US government has been doing for the past 4 years. Criminal!"

first time CIRM handed out such historical large a...

2012-09-10T10:06:11.456-07:00

first time CIRM handed out such historical large amount (~ $200 M) exclusively to their conflicts of interest without any scientific merits and two-thirds of a quorum (e.g., at least 20 votes out of 29, > 10 members approval out of 15) required by Prop 71.

Re Ms. Allinquant's comment, the CIRM board a...

2012-09-06T07:27:01.283-07:00

Re Ms. Allinquant's comment, the CIRM board approved the award -- with conditions -- to StemCells, Inc., despite it being rejected twice by the agency's grant reviewers.

Congrat's StemCell ! Your research for Spinal ...

2012-09-06T04:57:50.946-07:00

Congrat's StemCell ! Your research for Spinal Injury and Alzheimer's disease Will allow for a new beginning for so many people.

DID THEY APPROVE THE FUNDING OR NOT THIS IS SONFUS...

2012-09-06T04:47:37.416-07:00

DID THEY APPROVE THE FUNDING OR NOT THIS IS SONFUSING

There is a misconception about indirect costs. CIR...

2012-09-05T15:58:37.126-07:00

There is a misconception about indirect costs. CIRM breaks out the costs for "indirects" from other items that include rent and libraries, so CIRM actually pays much more in overhead. In Salk's case, they provide the same amount of overhead costs that has been negotiated with the NIH-over 90%. You should know that no university or research institute can survive on 20% indirect costs. The UC's are subsidized by the state, giving them an artificially low indirect cost rate of about 50%. Salk, Burnham, Scripps, Buck, and other independent research institutes are not subsidized, so their indirect cost rate is closer to the actual costs of running the institution- around 90%. Stanford has a rate of 61%, subsidized by its endowment.

Re Salk's "near 100 percent" indirec...

2012-09-04T16:40:32.584-07:00

Re Salk's "near 100 percent" indirect costs, those would not have had an impact on the reviewers' decision because CIRM simply does not pay anything like. With some exceptions, indirect costs are limited to 20 percent. Here is the exact language from CIRM regulations:
"Indirect costs are currently capped at 20% for most awards (exceptions: RFA 05-01, 08-03, 08-04, and PA 08-06)."

http://www.cirm.ca.gov/our-funding/grants-management/grants-management#indirect_costs

Lanza filed a plan a while ago which does not have...

2012-09-02T03:15:19.589-07:00

Lanza filed a plan a while ago which does not have to be updated, but likely was, in which his BROKER sells his shares. He has no discretion. Because Lanza is PAID in shares, he owes ordinary income taxes on those shares immediately. His broker would have been unethical not to have taken an opportunity to get those tax dollars for him at the best price possible, rather than waiting for the price to come down and sell even more shares to make the tax payments. This story fails to tell the whole story.

http://www.sec.gov/Archives/edgar/data/1140098/000114420411034356/v225200_8k.htm

Key quote: "Except as may be required by law, the Company does not undertake to report on specific plans by the Company’s other officers or directors, nor to report modifications, terminations, transactions or other activities under the plan of Dr. Lanza or the plan of any other officer or director."

http://fairmark.com/execcomp/grants.htm