By Don C. Reed

On the 29th and 30th of this month, there will be a meeting of the Independent Citizens Oversight Committee, (ICOC), governing body of the California stem cell program. This one will be in San Francisco.

As always, you are invited.

When you come in, you will first see rows and rows of folding chairs, for interested citizens like you and I. And at the front? Great tables decked in white cloth, each place with its own microphone, water glass, and folded cardboard name tag. Here is where the ICOC sits: our 29 members, every one a champion of their field.

One nametag you will see that has been missing for more than a year: Dr. John Reed, M.D., Ph.D., chief executive officer of the Burnham Institute for Medical Research. (He is no relation, though I would be proud to call him kin.)

His scientific field is somewhat grimly-titled: apoptosis, cell death. Understanding how and why cells die is crucial in the battle for cure. If cells die too soon, you can have a stroke; not soon enough– cancer.

The Institute for Scientific Information identified Dr. Reed as the most frequently cited scientist in the decade 1995-2005. He has authored over 800 research publications, written more than 50 book chapters, and is the named inventor for more than 70 patents.

Why has he been gone for a year? That is the subject of this column.

Dr. Reed voluntarily absented himself from ICOC deliberations– while California’s Fair Political Practices Commission (FPPC) investigated something he did.

First, background: ICOC members like Dr. Reed are forbidden to participate in decisions affecting their home organizations. Preventing such conflicts of interest is crucial to the program: or board members could just use their vote to send the money to themselves.

A scientist who works with Dr. Reed’s organization, David Smotrich, applied for a grant through our California program. The proposal went through the usual process, was reviewed by a committee of scientists from out of state, then voted on by the ICOC— and, as is required by law, Dr. Reed took no part in that decision: so far, so good.

The project was judged excellent, receiving one of the highest scores given.

But– when the CIRM staff and legal department did their “due diligence”, making sure the grant fit every requirement, they found what they thought was a fatal flaw.

One of the requirements of this particular grant was that the recipient had to be a full-time employee of the institution making the request.

Burnham Institute was asking for the money, therefore Dr. Smotrich had to be a full-time employee.

Was he?

Maybe yes, maybe no—it depended on how you defined fulltime.

Smotrich had a “full faculty position and privileges at the Burnham… a small institution…(which) does not have a hospital, so it does not have full-time clinicians.”—Terri Somers, “Top Burnham Official accused of conflict of interest”, San Diego Union-Tribune, November 22, 2007.

He did not get a salary there, which would seem to disqualify him; but, on the other hand, with funding hard to get, many scientists at institutions have to pay their own way, bringing a grant with them, while they use the space and equipment of the Institute.

Suddenly, the whole project was dead—on a technicality– which might be a mistake.

What would you have done? Stayed silent and accepted it, watch an outstanding project go down, through a possible misunderstanding?

Remember, there was at this time no official review process for complaints.

Also, the decision had already been made… so was Dr. Reed allowed to voice his concerns now? It was clear he could not use his power of voting or discussion to influence the project’s chances when it was before the ICOC. But afterwards, when the decision was made, could he speak up then, like at a football game, where coaches do not interfere during the action, but may argue with the referee, after the play has been called?

Did the rulebook say anything about the timing of complaints? I visited the CIRM website, and could find nothing to clarify that.

Was this a new situation, which had not been considered, and therefore was not covered by the laws?

Also, there was something else:

“…executive officers of research institutions…who, as part of their responsibilities, oversee and advise researchers in their institution…shall not be deemed to have a conflict of interest under this provision. Recusal, however, is required…”
—“Conflict of Interest Policy for Members of the Independent Citizen’s Oversight Committee”, (footnote at the bottom of page 1-dr)

This is official policy, and it seems to me (admittedly a non-lawyer) to contain some wiggle room. On the one hand, the “recusal” part (not voting on money decisions affecting your outfit) had definitely been followed.

But did Dr. Reed’s legal right to “oversee and advise” allow him to explain his institution’s definition of a full-time employee?

That was a gray area.

With a brand-new organization like the California stem cell program, the rules are not always crystal clear. The process of making the laws began with the writing and passage of Proposition 71. After the voters said yes, there was an immediate major conference with the National Academy of Sciences to figure out best practices, and the ICOC (with the continual input of Sacramento) has been working hard on the rules ever since.

But despite the best planning, going first is not simple.

Dr. Reed felt a mistake was being made, so, he contacted ICOC Chairman Bob Klein, asking him what he should do.

Bob Klein said he “didn’t have the ability to evaluate the information in the administrative review, so if Dr. Reed thought there were errors, he should make them public by writing a letter to the scientific staff.” (ibid)

This was done. Dr. Reed wrote a six and a half page letter, detailing the problem, and sent it to Dr. Arlene Chiu, head of the science department.

It was a mistake.

The CIRM legal department caught the error immediately, stopped it cold. General Counsel Tamara Pachter pointed out there was no appeals process, and the matter would not be considered.

The grant did not receive funding.

But that was not the end of the matter.

Enter John Simpson of Consumer Watchdog, a frequent critic of our program. He filed a complaint with California’s Fair Political Practices Committee (FPPC), alleging a conflict of interest, and called for the resignations of both Dr. Reed and Chairman Klein.

To my mind, such a penalty is vastly out of proportion, like suggesting the electric chair for a parking violation, but Simpson feels otherwise.

As he puts it: “This is not trivial…When you hand out millions of dollars in public money, you have to play by the rules. He (Smotrich) didn’t meet the eligibility rules advertised for this grant and waiving them would have been unfair to everyone else.” –California Stem Cell Report, November 21, 2007

How did CIRM feel about it?

In an interview with David Jensen of the California Stem Cell Report, CIRM Acting President Dr. Rich Murphy said:

“It is important to remember that Dr. Reed sent his letter after the ICOC had approved the grant…At the time, Dr. Reed mistakenly believed that conflict rules would not prevent him from providing technical information regarding the status of a faculty member to CIRM staff. As soon as CIRM staff received the letter, counsel advised Dr. Reed that he must refrain from contacting the staff and board members regarding a grant to the Burnham and advised staff to disregard Dr. Reed’s letter. It therefore had no effect on CIRM’s process, and Dr. Reed now fully understands the conflict rules.”

The FPPC studied the accusation and background issues for more than a year.

Meanwhile, the rules were clarified, and a complaint process was established, whereby scientists denied grants could speak up, and be heard.

And Dr. Reed voluntarily took himself off the board, until the matter was resolved.

For me, as a patient advocate, the loss was painful, like a favorite football team being forced to play all year with one of our best athletes sidelined: In addition to being incredibly intelligent, Dr. Reed is passionate, clear, dedicated, and caring.

So, we all waited.

At last, the answer came.

A few days ago, the FPPC answer was delivered, in a public letter.

“In our view, by submitting a “letter of appeal” to CIRM staff, Dr. Reed intended to influence a decision that had the potential to affect his economic interests. However…it appears that Dr. Reed attempted to influence a prior-made governmental decision that could not be appealed… Thus, although this matter raises ethical concerns, we are closing this matter with a warning letter….Dr. Reed is advised that failure to comply with the provisions of the Act can result in an enforcement action against him, including monetary penalties of up to $5,000 for each violation…”
–Kourtney C. Vaccaro, Division Chief, Enforcement Division, Fair Political Practices Commission, January 7, 2009

That is harsh language, especially when you consider it took the FPPC itself, experts in the field, over a year to figure it out.

There was no penalty, because there was no violation of the law. Because Dr. Reed had objected to a decision which could not be undone, no crime had been committed.

But that does not mean Simpson was wrong in filing his complaint. Democracy depends on critics; like antibodies, their reactions are often painful to the body politic; yet they perform a vital function. Simpson’s fuss and furor made everybody really stop and think about the issue.

Above all, our system worked. California’s blend of public and private oversight found a problem, and dealt with it. Our legal department spotted the error, and immediately blocked it; while the transparent nature of our program (allowing and encouraging citizen involvement) made the blunder clear, accessible, and fixable.

The incident is done. As its letter states, “…the Fair Political Practices Commission… has closed its file…”

And Dr. John Reed? One of America’s greatest scientists is returning to the ICOC. His life goes forward, benefiting all: this molehill of controversy outweighed by his mountain of accomplishment.

Welcome home, Doctor Reed.

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