Transparency and Stem Cell "Hooey"

California's stem cell agency is suffering from a reality gap.

On one hand, its chairman and the prime voice of the agency, Robert Klein, promises the highest and best standards of transparency, openness and disclosure, as he did again just on Tuesday of this week.

On the other hand, the agency cobbles together transparency/disclosure regulations -- only under heavy legislative pressure -- that seem to be a far cry from those at John Hopkins University, the New England Journal of Medicine and the Journal of the American Medical Association.

On Tuesday, the stem cell Oversight Committee moved to tighten its transparency rules with the promise of more review to come – certainly a step in the right direction. One must acknowledge all this is difficult territory. Stem cell research remains an infant business with major unresolved, ethical issues. The stem cell agency itself is a bit of bureaucratic chimera –a quasi-business-scientific-governmental beast that has no real parallel.

Complicating the matter is the small and cozy nature of the stem cell community itself. Just how cozy? David Baltimore, a Nobel prize-winning scientist at age 37, is a member of the Oversight Committee of the California stem cell agency. He is also president of Caltech and serves on the boards of biotech firms Amgen and Med Immune Inc. Baltimore recently received a $14 million stem cell research grant from the Bill and Melinda Gates Foundation.

According to reporter Donald J. McNeil of the New York Times, the grant is for the "radical idea that stem cells could be created that could be safely injected into anyone, would populate the immune system and would contain the genetic instructions for initiating attacks on many diseases. If successful, they would make vaccines obsolete."

Baltimore told McNeil, "I imagined this proposal into existence, but I never imagined we could get money for it. It's not the kind of thing the N.I.H. would fund. It's too big, it's too chancy, it's too focused on a particular product. If this was 15 years ago in the biotech industry, this could be the basis of a company, but venture capitalists now are looking for a much quicker payoff."

Under the terms of the grant, the results of the research could be patented for commercial gain, although they would have to made available to poor countries at either free or at low cost.

Which raises a question about Baltimore and stem cell research grants before CIRM. There are legal restrictions on his potential conflicts, and we have no doubt he is a principled man. But persons with competing approaches will be before the agency with requests. Baltimore's stake in the issues will be well known to grant reviewers and fellow committee members. No one may violate the law, but members of the "club" are often unwilling to act in ways that might appear to be injurious to other members of the "club."

CIRM is an unusual agency in that conflicts of interests were built into it. Scientists, business executives and patient advocates are all directly involved as directors. Some even have personal health issues at stake.

Given that situation, it makes it even more important to have maximum disclosure of the economic interests of those who are making decisions, and that extends to members of the working groups.

So far, members of those groups will have to disclose their economic interests only to members of the "club" – in this case CIRM itself. CIRM contends that is necessary because scientists would not be inclined to serve as members of groups if they have to publicly bare their economic souls.

In two editorials earlier this week, The Sacramento Bee described that assertion as "hooey" and "malarkey."

The Bee dug into the current state of economic disclosure by scientists and reported:

"Throughout the scientific world, stem cell researchers are increasingly disclosing their corporate research relationships and stock holdings.

"Some must do so if they want to serve as faculty on Continuing Medical Education courses sponsored by the Johns Hopkins School of Medicine and other medical schools.

"Others must publicly disclose conflicts when their research is published in the New England Journal of Medicine, the Journal of the American Medical Association and other prestigious publications.

"Consider the recent meeting of the International Society for Stem Cell Research, held in San Francisco. Several of the world's top scientists disclosed their corporate ties there as part of the continuing education program."

Because of these disclosures, The Bee shared economic information with its readers about two members of CIRM's grant working group. The following information from The Bee would be secret if CIRM continues its policies or could control the policies of others:

"Let's examine," The Bee wrote, "the situations of Drs. Andrew Feinberg and Jeffrey Rothstein, two of 15 researchers appointed to the committee. Both work for Johns Hopkins, which owns stock in Geron and has a licensing agreement with the California company. According to an article in Scientific American this month, Geron is expected to be one of the main beneficiaries of a new California fund for stem cell research.' That means that Feinberg's and Rothstein's employer could benefit from any grants awarded to Geron."

While the stem cell agency moved forward this week with new transparency rules, several responsible California organizations said they did not go far enough. You can read two of their critiques at these locations: Foundation for Taxpayer and Consumer Rights. Calaware also advocated stronger rules.

One of the premises of Prop. 71 was that it is time to do business in a different way and throw off old, crippling constructs. Government can fund controversial research. And it can partner with scientists and business in innovative ways that benefit all. It is now time for the stem cell agency to fulfill the promise of Prop. 71. It should lead the way with new, forward-thinking transparency rules that enhance public trust, that provide maximum disclosure and that close the stem cell reality gap.