Maybe my imagination is getting the best of me, but I laughed out loud when I read last Thursday’s New York Times article about the minimal impact of a big hypertension study published in 2000 that compared various blood pressure drugs.

The study was called the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial, or ALLHAT. And while I’m sure the authors would never admit it, I desperately want to believe someone built that big ol’ clunky name around the classic cowboy insult “all hat, no cattle,” describing someone that’s all talk and no substance (in this case, the blockbuster drugs).

I do hope that’s what they had in mind, anyhow. It’s not just hilarious; it also makes sense, given what the Times article revealed about why the ALLHAT study had so little impact.

Its findings showed that cheap diuretics were at least as effective at treating high blood pressure as the expensive and heavily promoted drugs like beta blockers and calcium blockers — but that doctors were still prescribing the pricey stuff at a much higher rate.

One reason, according to Curt D. Furberg, a public health sciences professor who was the first chairman of the steering committee for the study, was that “The pharmaceutical industry ganged up and attacked, discredited the findings.”

The Times piece notes that Furberg eventually resigned “in frustration” from the steering committee, while another committee member went on to receive more than $200,000 from Pfizer, largely in speaking fees, the year after the Allhat results were released.

“There’s a lot of magical thinking that it will all be science and [there] won’t be politics,” Sean Tunis, a former chief medical officer for Medicare and an advocate for these kinds of comparative-effectiveness studies, told NYT.

I suspect there’s a lot more hat than cattle for a lot of the expensive drugs doctors are prescribing today to treat chronic conditions. And while of course drug companies are free to sell anything they’d like, I don’t really want to have to pay for the most expensive drug just because my doctor got seduced by the sales rep. Continue reading »

Earlier this week, I got a phone call from Steve Aldrich and Jim Newcomb, respectively CEO and director of research for Bio Economic Research Associates, a private research and advisory firm.

They’d read my paper on risk and synthetic biology and thought my characterization of their report on synthetic biology, “Genome Synthesis and Design Futures: Implications for the U.S. Economy,” was unfair.

The larger issue that our disagreement is based on — that is, how to pay proper fealty to scientific uncertainty — is at the core of my discontent with how technology innovations are assessed for risk and benefit.

So I told them I would write about our disagreement here. This way, they have an opportunity to respond, and maybe we can get a discussion going on the subject.

Here is what I wrote:

Of the most concern in the context of risk and governance are the reports that uncritically support synthetic biology, as they encourage development and commercial release with little or no acknowledgment of the degree of scientific uncertainty that surrounds the endeavor. A 174-page report on synthetic biology published by Bio-Economic Research Associates in 2007 and funded by the Department of Energy (which itself has invested heavily in synthetic biology research), contained but a single, three-quarter-page discussion of the limitations of the engineering paradigm as applied to living systems. Giving such short shrift to a topic that is still under deep consideration in the broader scientific community lends an air of certainty to a highly uncertain endeavor. Such under-representation has real significance from the perspective of investment and economic risk, as well as from that of health and the environment.

[Italics added by me; they aren't in the paper.] Continue reading »

I don’t know what kind of planetary alignment took place over the past week with regards to synthetic biology, but whatever it was, I like it.

Over the course of five days in November, from Thursday the 13th to Monday the 17th, four conversations about synthetic biology took place. They involved everyone from non-profit leaders to engineers, social scientists, biologists and government regulators. We need more open-minded, smart people from many sectors thinking and talking about this technology, and pronto.

What on earth am I talking about? If you’ve never heard of synthetic biology, you aren’t alone. According to the Project on Emerging Nanotechnologies, less than one in 10 (9%) Americans say they have heard some or a lot about synthetic biology — and a whopping 67% have heard nothing at all. [Edited in response to first comment. Never let it be said that I do not listen to my critics.]

But venture capitalists, multinational chemical, energy and “life science” companies, and just about every government agency you can name are already investing millions of dollars to develop commercial synthetic biology applications. According to one report, the research market in 2006 was already $600 million, and “the potential for growth in the next 10 years is projected to expand this market to over $3.5B.”

Proponents and opponents and everyone in-between agree these applications will have a direct and significant effect on our lives and on the planet. (I’ve put links to good/accessible background reading at the end of this post.)

The first event was on Thursday the 13th, a day-long “teach-in” in San Francisco, held by and for civil society groups and NGOs, which as far as I can tell was organized by the ETC Group in Montreal. It was private, so there’s not much else to say about it — I found a link about it on the Food First site. If you want more information, contact Jim Thomas at the ETC Group.

The second, on Friday the 14th, was hosted by the Wilson Center’s Project on Emerging Nanotechnologies, which was a conversation with — well, it was with me, actually, and Rick Weiss, a former senior fellow at the Center for American Progress (you may know him from his previous incarnation as the Washington Post science writer). The occasion was the publication of my paper on synthetic biology, which you can read or download here. Continue reading »

My next column in Strategy+Business (coming out in Winter 2009) will be about the need to rewrite our innovation policies from scratch. I strongly believe that we need to move beyond simplistic “greasing of the wheels” for corporations via tax credits and patent reform, and look more closely at how to create a whole new ecosystem in which innovation — and particularly, scientific and technological innovation — can flourish to everyone’s benefit.

In that regard, Barack Obama’s call for a return to scientific integrity is cause for tremendous hope for those who have spent eight long years battling the anti-science, anti-innovation era of the outgoing administration.

The very first item on the Obama campaign’s science fact sheet, which was published in September 2008, states that Obama’s science-friendly science policy will ensure that “decisions that can be informed by science are made on the basis of the strongest possible evidence.”

It goes on to say that the Obama administration will (among many other things):

• Appoint individuals with strong science and technology backgrounds to key positions;
• Take advantage of the work of the National Academies to identify the federal government positions that require a strong science and technology background;
• Ensure independent, non-ideological, expert science and technology advisory committees; and (last but certainly not least from Hybrid Vigor’s perspective);
• Actively encourage multidisciplinary research and education, noting that “innovation often arises from combining the tools, techniques, and insights from researchers in different fields.”

Yes! That’s what I’m talkin’ about! That last one even takes a page straight out of Hybrid Vigor’s mission statement.

But … I’m concerned that social scientists are not specifically mentioned anywhere in the policy fact sheet, either in spirit or in fact, not even in the last item. This is a serious omission as well as risky one, and unfortunately it is all too common in discussions of interdisciplinary, multidisciplinary or cross-disciplinary research.

Social scientists can — and should — provide a critical bridge between innovation and the people that the products of innovation purport to serve. They can help policy makers think about the social and cultural context for research priorities and decisions in a way that technologists cannot, making sure that the “strongest possible evidence” that scientists provide is also the evidence that is most relevant to the decision at hand. Continue reading »

I recently a story about software patents so goofy (to me, anyhow — YMMV) that I had to share it.The story was from the IT Examiner, titled, “US throws out most software patents.”

The hook was a decision by the US Court of Appeals for the Federal Circuit in Washington DC. Instead of automatically granting a patent for a business practice, the court decided there would be a specific testing procedure to determine how patentable is the process in question.

As the story put it, this is “a nearly complete reversal” of a judgment of 1998, which started the stampede for patenting business practices.
All I can say is, About damn time! Here’s the link to my extremely cranky New York Times column on this very same subject, written in 1999.

So here’s the goofy bit: The reporter wrote,

The decision is great for open source advocates. But it could mean a permanent change in the value of intangible assets, which comprise approximately 70 per cent of the average high-tech company’s market capitalisation. With the world’s economy sliding downhill at an increasing pace each day, this decision could cost US companies billions of dollars.

Oh, please. First of all, patents comprise only a fraction of that “70 percent” value for intangibles, and business practice patents are only a fraction of those.

And second, those patents should never have been granted in the first place, and everybody knew it. Continue reading »

It is not always happy-making to be ahead of one’s time.

On Tuesday, the New York Times published package of articles that explored new genetic research and new ideas of what a gene is.

Much of the package was based on the findings of the ENCODE study, which was sponsored by the National Human Genome Research Institute.

The upshot of ENCODE, which was published about a year and a half ago, in June 2007, was pretty straightforward: the human genome is not a “tidy collection of independent genes,” after all, with each sequence of DNA linked to a single protein, which in turn is linked to a single function, like the production of an enzyme.

Instead, genes appear to operate in a complex network, and interact and overlap with one another and with other components in ways will challenge scientists ”to rethink some long-held views about what genes are and what they do.”

The lead story in the package notes this perspective, writing that scientists “no longer conceive of a typical gene as a single chunk of DNA encoding a single protein,” and quoting one of them as saying, simply, “It cannot work that way.”

YES! I was so excited that this issue was finally going to get some attention. Not only was one of the central themes of my book, Intervention, but I too wrote a column about ENCODE for the New York Times — called “A Challenge to Gene Theory: A Tougher Look at Biotech” — right after the results were published, in July 2007.

In it, I asked what (to me) is the most obvious and important question, but it was addressed nowhere in the NYT package: Continue reading »

Managing Risk is Not Enough
Late last year, I sat in a meeting in which several bankers were present. During the meeting, one of the bankers said something that in retrospect belongs in the highlight reel of “famous last words.” The comment went something like this: “We’re bankers! We understand risk, because it’s our business. We know how to manage risk. That’s why industry and government are looking to us to solve risk-related problems.”

As ridiculous as this statement now seems (especially to those of us whose retirement funds have been decimated) I’d argue that the statement holds true—even in a grizzly market. Yes, good bankers do know how to manage risk—their own risk. Which is why the best investment bankers view a recession more like a sabbatical, while the rest of us have to figure out how to keep food on the table. And even as the government is coming to the rescue, the Fed won’t be doing the risk management part: they’re paying bankers to figure out how to get out of the mess they’ve created. Talk about a win-win!

Not that these guys aren’t suffering. Here’s a bit of anecdotal evidence of how bad things have gotten: Continue reading »

A story in today’s New York Times discusses how the media has struggled to explain the financial crisis to audiences. Admittedly, many industry experts are dumbfounded by the events of the last few weeks. Where the media has faltered, my good friend and former colleague Bob Blakley has succeeded with his down-to-earth post on “Wall Street’s Governance and Risk Management Crisis.” Thanks, Bob!

I particularly liked Bob’s phrasing of the “collective margin call” on the banks. It indicates that part of what’s happened is a failure in coordination: banks have cash on hand as long as only a few percent of their patrons want to withdraw their cash. This echoes a theme of a post I wrote about the credit crunch back in June. Here’s an excerpt from that post:

Clearly, a great crime has been committed. An entire nation has been robbed. World markets are shaken. But who’s responsible? Nobody. And everybody. The insidious nature of this crime is that we all collaborated to commit it and without a master plan. Can such collective action crimes be avoided? Or is the commons forever doomed to be the scene of tragedy?

Bob’s comments on risk management are also strongly reminiscent of Denise’s work on risk management in the biotech industry. Bob writes:

Risk management failures created the current financial crisis, and risk management failures have also created the personal information disclosure crisis, and the malware crisis, and a bunch of other problems which are not yet crises. We do risk management poorly in all disciplines. We do it poorly for a bunch of reasons: executives don’t understand their own businesses well enough to understand their risks; risk managers don’t know how to talk to executives about risk; incentives favor creating long-term risks in order to accrue short-term profits; the list goes on and on.

Denise’s main assertion in her book, “Intervention: Confronting the Real Risks of Genetic Engineering and Life on a Biotech Planet,” is that the biotech industry is similarly awash in poorly managed risk. Genetic engineering is another impending crisis that, once it reaches crisis levels, people will be dumbfounded to explain.

As an avalanche of new laws and regulations hit Wall Street over the next few years, I fear that we’ll lose sight of the most important learning to take away from this disaster. Again, Bob Blakley explains:

A final thought.  The financial crisis exists because of a failure of risk management. There will be a temptation to fix the problem using compliance mandates. Compliance mandates, however, don’t fix risk management problems. All they do is prevent specific risk management failures from happening over and over again. Organizations whose risk management is weak will find new ways to fail – and these new ways will circumvent compliance regulations. The right way to fix a risk management problem is to do a better job of risk management.

The latest (Spring 2008) issue of Strategy+Business magazine is on the newsstand and on the web — and in it, my piece whacking cost-benefit analysis, the bane of innovation and sane regulatory policy. I’m already getting letters …

(Free) registration is required to read the article online.

A friend just sent me a story from Monday’s Guardian U.K., on control of the net by corporations, a.k.a. “net neutrality.” I’ve been writing about this issue since the early ’90s, back when I was writing Inside Technology at the San Francisco Examiner. And then again at Digital Media. And again at Technology & Media. And then at NYT. And again, now, still, same as it ever d**m was.

Back before the days of AT&T deregulation, it wasn’t called Net Neutrality. It was called “conduit v content,” and AT&T — kind of the King God of conduit owners — had long been banned from controlling what traversed it.

You know, that pesky First Amendment and all that.

But deregulation shifted those sands as Judge Greene’s Modified Final Judgment that ruled who could do what after the breakup was slowly but surely modified to death in the courts.

Nicholas Johnson, a commissioner of the Federal Communications Commission from 1966 to 1973, was the only commish who was raising a ruckus about the importance of the issue back then. He called it “the No. 1 public policy issue confronting our nation,” critical for providing the “channels of communication for a democratic society.”

It makes me very cranky that we are still dealing with this fracking issue.

I’m on the advisory board of Public Knowledge, a tremendous organization run by the irrepressible Gigi Sohn, which does killer work in this area. Fight it. Hard. We won’t know what we’ve lost until it’s gone.