The Silence of the Scientists

Consumer Watchdog, the Santa Monica, Ca., group that has spent more time and money than any other organization monitoring California stem cell matters, today chastized a trio of major researchers for their failure to speak out on an issue that some contend is holding back not only the science but the industry.

Writing on his organization's blog, John M. Simpson, stem cell project director for the group, discussed the dispute that involves Irv Weissman of Stanford, Fred Gage of the Salk Institute and David Anderson of Caltech and indirectly their institutions.

StemCells Inc. of Palo Alto, Ca., which was founded by the three researchers, is "thwarting noncommercial neural stem cell research" at Children's Hospital of Orange County as part of the company's zealous protection of its patents, Simpson said.

The springboard for Simpson's latest commentary was an article about the matter by Michael Hiltzik in the Los Angeles Times. It pointed out that some experts believe that over-protection of IP is hampering stem cell science and even the high tech industry.

Simpson's piece was headlined "A deafening -- and embarassing -- $ilence" and substituted a "$" for the "S" in silence.

Simpson wrote,

"This is a situation that should have been settled easily in a month, if not a week. After a two-year stalemate the silence is deafening."

The three researchers have not responded to requests for comments from Hiltzik nor from earlier ones from the California Stem Cell Report. We are renewing our queries and have promised the men that we will carry their comments verbatim.

You can read our earlier item on the Hiltzik piece here.

The Riddle of the Stem Cell Trinity

Can science, business and government work together in a win-win combination in a unique endeavor involving arguably the most controversial research in the world and billions of dollars in funding?

That is the key question ultimately for the California stem cell agency. Now we have some help in seeking answers to at least two-thirds of the riddle.

The aid comes from an analysis by Harvard business professor Gary Pisano in his new book: "Science Business: The Promise the Reality and the Future of Biotech." Pisano examines the sometimes difficult mix of business and science and their conflicting cultures. He omits the hefty government component represented by an agency such as CIRM, which has deeper hooks into science and business than the NIH.

Pisano, who has a Ph.D. from UC Berkeley, has studied the biotech business for years and has served as a consultant to some biotech companies.

We ran across his book as the result of a review in the Wall Street Journal by Andy Kessler, author of "The End of Medicine." Kessler wrote:

"Can science and business mix? ...The problem, according to the Harvard Business School professor, is that today's corporate structures are allergic to the uncertainty and risk inherent in science."

Kessler noted:

"Cumulative profits for the entire biotech industry are meager. The whole lot of them probably drip red ink if you take out Amgen, a 26-year-old company with $14 billion in annual sales and -- like Genentech and just a handful of others -- real profits."

Kessler continued:

"Mr. Pisano notes that 'drug R&D is a highly complex process; it is expensive, time consuming, and fraught with risk. In these respects, drug R&D is not too different from, say, the development of a new airliner, a new microprocessor, or even an epic movie.' The key word is risk. While an Airbus plane, Intel's Core Duo or 'Apocalypto' may have market risk, their development is undertaken with confidence that the products will at least make it to market; drug companies begin work on a new product with no idea whether it will even make it out of the lab, much less progress through clinical trials and onto drugstore shelves. A new drug might have the potential to be a blockbuster, but, then again, only one drug out of 6,000 newly developed compounds actually goes on sale. 'Productivity' is not a word used often in the drug business.

"'Drug development is a gamble in itself simply because of the hit-or-miss nature of the science -- or the 'profound and persistent uncertainty,' as Mr. Pisano calls it, 'rooted in our current limited knowledge of human biological systems.' But it becomes a staggeringly expensive gamble -- like playing blackjack at a table with a billion-dollar minimum -- because of the facilities required and the legions of experts in chemistry, biology, genomics and other fields who pour their time and energy into research. The 'nature of this process is integral,' Mr. Pisano points out. 'It cannot be broken neatly into different pieces.'"

Kessler's review prompted us to purchase the book, which appears to be very much worth reading. You can find a lengthy excerpt here or purchase it by clicking on one of the Amazon ads at the top of this blog.