Monday, August 12, 2013

A $6 Billion Question: Progress of the California Stem Cell Agency

The headlines march like legions across the Internet and throughout the world.
But then there is this extraordinarily rare headline that sounds a harshly different note:
All these headlines go to address, in one form or another, a request/question posed last month by an anonymous reader of the California Stem Cell Report. The comment came on an item about the California stem cell agency's $70 million plan to establish a network of “Alpha” stem cell clinics in California.

The reader said,
“It would be nice to have an overall update on how much as been spent on California's stem cell research project and what progress has been made.”
On the surface, the answer is easy. The agency has given away $1.8 billion. The agency says it has made tremendous progress and expects to make even more with the about $600 million it has left. The prestigious Institute of Medicine has said the agency has “achieved many notable results.”

However, no thorough, rigorous evaluation has been made of the details of the agency's scientific contributions, specific grant awards or its impact on the field of regenerative medicine. No one has attempted to genuinely assess whether the work of the agency is or will be worth the roughly $6 billion(including interest) that California taxpayers will have paid for the agency's ambitious efforts.

Then there is the question of “progress towards what?” Is the progress to be measured against the promises of the 2004 ballot campaign that resulted in creation of the stem cell agency or more modest goals that eschew the hype of the campaign?

The stem cell agency is burdened in a way that most science is not. The 2004 campaign created a sort of contract with voters. They were led to believe nine years ago that the cures for diseases that the campaign said afflict nearly one-half of all California families were, in fact, right around the corner. Few, if any California stem cell researchers were publicly warning that a hard and long, long slog remained before therapies reached patients.

Last week, however, Simon Roach of the British newspapers, The Guardian and Observer, shed some light on the early, rosy promises of stem cell science compared to the world as it exists today.

He wrote that in 1998,
“(B)iomedical engineer Professor Michael Sefton declared that within 10 years, scientists would have grown an entire heart, fit for transplant. 'We're shooting big,' he said. 'Our vision is that we'll be able to pop out a damaged heart and replace it as easily as you would replace a carburetor in a car.'

“Fifteen years on, however, we've had some liver cells, eye cells, even a lab-grown burger, but no whole human organs. We could be forgiven for asking: where's our heart? It does seem strange that a field stoking so much excitement could be so far off the mark. Speaking last week about the vision that he and his colleagues outlined in 1998, Sefton said they had been 'hopelessly naïve.' As time plodded on and an understanding of the biological complexity increased, the task seemed bigger and bigger. Even now, a cacophony of headlines later, we are not much further ahead.
Chris Mason is a professor of regenerative medicine at University College London and believes that concentrating on organ regeneration is missing a trick. 'These organs are immensely complex,' he said. 'They've got nerves, blood vessels, in the case of the liver, a bile system – there are huge degrees of complexity. These things take a long time to grow in humans, let alone in the lab without all the natural cues that occur in the growing embryo.'"
The final paragraph in Roach's article said,
“There's a tension in medical research between the glory of the big discovery and the assiduous commitment to real application. 'We're hoping the scope and possibilities of this project will catch the public's imagination,' Sefton concluded in 1998. It did, but perhaps the public's imagination isn't always what science should be vying for.”
Little doubt exists that the California stem cell agency has made a significant contribution to stem cell science, although the size of that contribution – beyond dollars – remains to be measured. For now, the key for the agency and the public is to focus on activities that will generate the greatest value over the next few years and advance the science that has already been financed by the agency.

As the $700,000 Institute of Medicine report said,
“The challenge of moving its research programs closer to the clinic and California’s large biotechnology sector is certainly on CIRM’s agenda, but substantial achievements in this arena remain to be made.”

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