A Scientist's Comment: Deal Directly with FDA Rather Criticizing It in the Media

The following comment on FDA regulation of stem cell research was submitted via email by a longtime scientist in the field, who asked to remain anonymous. 

"Many advertised  'stem cell' treatments use hematopoietic or blood stem cells which are run under a different set of regulations from pluripotent stem cells since they are umbrella-ed under regulations designed to cover blood transfusions and bone marrow transplants.  Pluripotent stem cells are very new, with many unknowns and the potential for triggering tumor growth.   In contrast, clinical use of blood stem cells has been ongoing for over 50 years with special regulations (or lack thereof) grandfathered in.   Unfortunately, the newly touted 'treatments' are not for homologous use of blood stem cells, are unlikely to be therapeutic and may even be dangerous. 

"The FDA has published new draft guidances addressing these issues that will be discussed in open forum this September.  I think it best to bring concerns about FDA regulations to these meetings and to initiate change by talking directly with the agency rather than criticizing them in the press or through Congress.  Like their oversight over the IRS and other federal agencies, Congress’s actions are counterproductive when they add broad, unfunded mandates while cutting funding at the same time.  But perhaps this is their way of shrinking the government and simultaneously dinging them for not doing their work.  A sure route to failure."

Recent Reader Comments on Randy Miller and SF Chron Editorial

The "recent comments" sidebar on this Web site has stopped functioning. While I attempt to repair it, here are some recent comments that have not shown up in that feature.

Anonymous has left a new comment on your post "San Francisco Chronicle: California Stem Cell Agen...":

What would you have expected to happen once the taxpayers funded scientist and PhD's associated with Big Pharma to do???? Build fancy administration buildings, laboratories, and sit around all day and discuss there. How many of these individuals who helped spend approx.. $2.4 Billion of taxpayers funds actually had patients in their care? Look at all the recent articles where scientist falsified data or their findings could not be replicated by others....physicians who actually care for patients have made greater strides in the field of regenerative medicine than CIRM could make in 30 years. CIRM will be another boondoggle where no one is held responsible for the waste of taxpayer funds. Gov't, Scientist, and PhD's should should move aside and allow actual doctors to care for their patients with the clinical advancements that have already been made in the field of regenerative medicine.

Anonymous has left a new comment on your post "Former Osiris President Chosen as New CEO at Calif...":

It is very disappointing that CIRM selected Randy Miller who backed obsolete mesenchymal stem cells (MSC), not someone with human embryonic stem cell (hESC) experience to back voter-approved Prop71. Randy Miller, together with CIRM vice president Ellen Feigal, are responsible for several multi-million CIRM disease team awards to MSC at UC Davis that have no commercial validation at all, and many anti-hESC and anti-Prop71 conflict of interest comments in CIRM undisclosed grant reviews. The only way for CIRM to revive and bring cures to patients is to publicly support Prop71 by giving out hESC research awards, do the right thing that CA voters and patients have waited for so long. If CIRM cannot even issue a RFA for hESC research, if CIRM cannot have a transparent grant review process to fund hESC research according to Prop71, if CIRM continues to take its anti-hESC position, as where all the money of CIRM awards so far have pointed to, it is hard to imagine anything is going to change except let a well-wished proposition down the drain.

Irv Weissman and Reader Comment

Stanford researcher Irv Weissman was mentioned in a comment on Jan. 3 on the California Stem Cell Report on the "Growing Stem Cells..." item.

It is the practice of this Web site to inform people who are mentioned in comments that something has been said about them and making it clear that they have an opportunity to add to the dialogue.

In this case, Weissman had difficulty in filing his comment directly via the “comment” function on the blog, so we are filing it here.

Among other things, the anonymous reader said, “Is it not clear that Irv Weissman is CIRM's puppet master?”

Weissman's response via email: “Anonymous need not remain anonymous.”

Reader Says Open Grant Reviews to Public

An anonymous reader this afternoon filed a comment on the “Prieto on Disclosure" item. Here is an excerpt from the comment from the reader, who has obviously been following the stem cell agency for some years,

“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 (stem cell board) if they think that will get them funded.”

You can read the entire comment by clicking on the word “comment” at the end of the Prieto item.   

Recent Comments

For unknown reasons, our “recent comment” function to the left on this page has ceased to work properly. Consequently, some recent comments have not appeared. We are attempting to fix the problem.

Meanwhile, here are some comments that have been posted in the last few days.

Anonymous has left a new comment on the post "CIRM Proposes $40 Million Stem Cell "Tools" Round;...":

"The 'disease in a dish' proposal combined with funding clinical trials seems like CIRM is trying to be everything to everyone.

"They will have to take care that the 'tools' aren't merely grantsmanship for more years of basic research funding going nowhere fast; a nice new grant stream for the universities, not so nice expenditure for the taxpayers and patients hoping for CIRM to help meet their medical needs. "

Brad has left a new comment on the post "CIRM Proposes $40 Million Stem Cell "Tools" Round;...":

"The meetings are on Wednesday and Thursday not Tuesday and Wednesday like your article states. Great blog and reporting I check things out at least once a week.

"Thanks,
Brad Bixby
www.BioSpherix.com"

The California Stem Cell Report said in response
"Brad -- Thanks for letting us know. We have posted a correction."

Gilly Newman has left a new comment on the post "CIRM Disagrees with Many Recommendations for More ...":

"Hi,
"I've been following up on your site quite regularly. My son plans to go for stem cell therapy early next year. I am worried that can CIRM's outburst have an effect on the therapy as a whole."

We ecourage comments and would like more.

Anonymous Comment Deleted; More Info Needed

An anonymous person posted a comment at 3:01 p.m. today containing serious allegations against a prominent California stem cell researcher. We have deleted, for the time being, the comment until we can gather additional information concerning the charges. If the anonymous poster is reading this, we would appreciate it if you would send an email with additional information about the matter to djensen@californiastemcellreport.com.

Operator Error on Loring Comment

A kindly reader pointed out that the Loring comment could not be found on "Obama Chapter Two." That was an error on the part of this operator. Her comment is now available.

Comments Update

We are again encouraging all who feel the need or who are inspired to comment on items on this report or on the comments of others. We have improved our "comment" function, enabling a "moderator" provision. We will examine each comment before it actually appears. This will avoid spam type comments and "flaming." The note on the comment pop-up, however, uses the word "approval." Google, which hosts this site, does not allow us to change that word. However, our function is to moderate -- not to endorse or approve of or disapprove of what you have to say. Your comments are yours and yours alone. The "approval" relates to spam and flames. Anonymous encrypted comments are still permitted. And we expect to publish the thoughts of many who disagree with positions of the California Stem Cell Report.

Good to See a Lively Debate

We would like to call your attention, once again, to the comments feature on this Web site, particularly the exchange on the "$100 Million Grant" a few items below. That exchange brings in new information and expands the discussion concerning the California stem cell agency, which is one of the goals of this particular Internet enterprise.

Making a comment is straightforward. Just click on the word "comment" at the end of each item and a form will pop up. You can even make your comments anonymously. Google, which is the site housing the California Stem Cell Report, encrypts the name of the sender so that it is not available to yours truly or others.