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Sunday, March 18, 2001

Next Big Thing?
The Law of Digital Electronics.
Most Important Dynamic of 21st Century.
By Michael Malone

The Free Press Shall Be Free - Click to enlarge!CLOVIS - What's the next big thing? It's called bioinformatics, which is the application of computer technology to bioengineering.
     In particular, it is the use of computers to manage the massive streams of data emanating from the Human Genome Project.     Bioinformatics appears to be important because it will enable us to more easily manage that data, sift through it for useful encoded gene segments and then develop new drugs and therapies.
     But the real reason bioinformatics is important is because, as noted for the first time at a industry conference two years ago, it at last puts genetic engineering on the rocket sled of Moore's Law.
     The importance of that fact will be apparent in a few years. But keep in mind: Moore's Law, as applied to digital electronics, is the single most important dynamic in the modern world. More than demographics, the Dow, or the dreams of prognosticators, Moore's Law has been the single most accurate predictor of where society is headed since the late 1960s.
     Because it is a "geometric" law (i.e., the doubling of chip performance every couple years) it also acts like the proverbial grains of rice on a chessboard. It's impact, tiny at first, is cumulative--after a decade or so, it becomes a roaring, unstoppable freight train.
      The process has already begun for bioinformatics. There was an interesting, perhaps historic, moment that occurred in Silicon Valley's newspapers last weekend. It was as if the torch was being passed.
    The San Jose Mercury-News ran on its front page, as the lead feature, a story called "After the Gold Rush", describing the collapse of dot-coms and tech stocks.
    It discussed in lurid terms all of the fortunes that have been lost in the last few months, and profiled disillusioned and unemployed webbies as they packed up and moved away to cheaper climes.
     Meanwhile, the San Francisco Chronicle, splashed onto the front of its business section a feature about how the city's once-depressed Mission District was now becoming depressed again--after the brief renaissance of having hundreds of hungry dot-com companies crowd its empty buildings. |
     Being an old newspaperman, I know that papers have a built-in editorial flip switch. Months will go by in which they only run positive, upbeat business stories... and then one morning you wake up to the Daily Thanatopsis--months of falling economic indicators with your coffee, endless layoffs with your bran muffin.
     Even knowing this, I must admit this is some of the bleakest coverage I've ever seen. And yet there was one business section in the Sunday Chron that was like a ray of warm sunshine. It was called "Career Search", and it's usually one of those dreary advertiser-bait sections that feature exciting articles reminding you to update your resume and to be cheery during job interviews.
     But this time, the section had a feature headlined, ungrammatically, "Why Informatics Is Hot Career." The story proclaimed in its lead, "Move over Information Age. Make room for the age of bioinformation."
     You could picture bleary eyes opening all over the Bay Area. The story went on to note that a San Jose consulting firm was predicting a 10-percent annual growth in the bioinformatics market for years to come -- and that the National Science Foundation estimated that 20,000 new jobs in the field would be created in the field in just the next four years.
     If that wasn't enough, the rest of the section was filled with page after page of biotech firms listing job openings--in powerful juxtaposition to the endless lists of dot-com layoffs just a few pages earlier. Wow!
     Rewrite that resume to emphasize that biology course you took in college. Roll your Aeron chair down to the nearest lab. Trade that black turtleneck for a white lab coat. But hold on.
     You see, I've noticed something is missing from those stories in the same way that, a couple years ago, I noticed that all the glowing stories about e-commerce were neglecting to mention that selling retail on the Net was still an unproven idea.
     In the case of biotech, the missing piece is the fact that bringing a bio product to market requires an additional step not found with traditional digital: Food and Drug Administration approval. That may seem like a mere speed bump to the hundreds, even thousands, of new bio-startups that are about careen into this new market. But trust me, it isn't.
     As it happens, two years ago for a magazine story, I followed a biotech company as it ran the gauntlet of final FDA approval on a new heart drug. Now, in my career as a journalist, I've seen new product design teams sweat and fight and ruin their health trying to get a new model to market.
     I've seen chief executives with bad quarterly numbers get ripped to pieces by packs of howling analysts. I once watched a corporate chairman nearly collapse from a stroke while trying to drive a merger vote through any angry shareholders' meeting.
     But nothing prepared me for the FDA star chamber. The company I was watching had spent two years field-testing their drug, then weeks preparing its FDA presentation.
     Then the entire senior staff of the company moved to a hotel near Bethesda, Maryland, set up a full communications center in a conference room there, and spent four days running rehearsal after rehearsal, rewriting the entire presentation a half-dozen times.
     Meanwhile, back home, the company froze, knowing that its stock value and its future sales all depended upon what happened inside the FDA chambers at the National Institute of Health.
     The hearing itself had all of the elements of a nightmare: the terrified presenters, the panel of doctors on stage--each with their own prejudices and agendas. Eight hours of misery, until the final vote.
     The company gained approval by a single vote. General cheering and backslapping. The presenters went home to gigantic company party--only to learn a couple days later that one of the approving doctors had changed his mind.
     The company's stock collapsed, morale imploded and the company reeled under the shock for months. It is only now regaining its footing.
     My executive editor, who is an expert on biotech, tells me that, thanks to the Human Genome Project, it will soon be possible to develop drugs that are uniquely targeted at each individual's distinct DNA pattern.
     That, in turn, may result in the creation of thousands, even millions, of new drugs each year. And, for now at least, all will have to undergo the FDA star chamber. It won't work.
    All those digital types eyeing bioinformatics as their next career will tell themselves that its just a matter of using high-powered computation to gain the statistics the FDA needs. But they are wrong.
     This isn't about bandwidth or silicon gate speeds, but sick people in emergency rooms who can't quite describe what's happening to them, being treated by tired, harried doctors who don't remember to fill out drug response reports, and nurses who don't have the time to take vital signs at exactly the 20-minute intervals that the testing requires.
     All that human inaccuracy and, meanwhile, one stray anomalous data point can kill a $100 million product. Obviously, this is a situation that must be fixed. The FDA is going to have to give: looser requirements (but that may kill people), faster approval processes (but that may kill people), or more hearings (but that may lower standards--and kill people).
     Technology may someday provide the answer for the problem, via super sophisticated computer models that will mimic human body responses to drugs. But that's at least a decade away. In the meantime, the FDA will remain the great choke point.
     Because of that, there will be a great bioinformatics business boom, just like there was for e-commerce. And, like e-commerce, there will also be a nasty crash a few years from now.
     The only difference is that this time we won't be losing sock puppets, but perhaps the drug that would have saved our lives.

Letter to the Editor

©2001 Clovis Free Press. All rights reserved.

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