Five Ways to Kill the Biotechnology Industry
and One to Help It Prosper)

By Lorraine Ruff and David Gabrilska, Partners
Milestones, the critical thinking company
Seattle, WA

There are at least five good ways to kill the biotechnology industry, according to John Rennie, only the seventh editor-in-chief in the nearly 155-year history of Scientific American, and they aren’t necessarily related to companies not being able to raise investment dollars to keep their companies going.

Addressing an international audience of biotechnology executives, policymakers and scientists as keynote speaker at the Hannover Fairs first U.S.-based 2003 Biotechnica conference in Monterey, CA, Rennie’s observations, while humorous, hit squarely home.

Method #1: Ignore the fears of the public, because it clearly doesn't know what it's talking about.

"The public is horribly ignorant about biology and biotechnology, and this ignorance breeds fear," he said. "Let's face it, the three people who have probably done the most to raise public awareness of DNA in the past 50 years are James Watson, Francis Crick, and O.J. Simpson - O.J., because his high-profile case brought DNA fingerprinting to everybody's attention. Suddenly, everybody knew at least vaguely what DNA was."

Public education is not sufficient to solve the near-term problem from the perspective of those managing scientific research and development.

"Education is hard, and it is slow, and you have businesses to run now," he said. Rennie pointed out that a good example of this predicament is what’s happening with genetically modified crops.

"If we go to Europe, we'll have no difficulty at all finding people who will tell us that GM crops that have cleared years of extensive study are just too much of a menace. And they will then puff on their unfiltered Gauloise cigarettes and zip down the autobahn at 120 mph," he said. "20/20 hindsight now makes so clear, people have certain unreasonable fears about anything that smacks of somebody tampering with their food.

"In the short term, industry and government need to demonstrate that there are checks and balances in place and that they have taken redundant measures to stop potential problems before they get out of control, he said.

"Unfortunately, establishing credibility as a sentinel can be tough, and it's a credibility that is easily shattered," Rennie said. "When GM corn plants are allowed to accidentally infiltrate other lots, or when pollen from GM fields drifts onto other supposedly pristine fields, it really doesn't matter that the demonstrable level of harm done is zero. Your credibility as trustworthy custodians of a scary technology suffers," he said, adding, "however, as medical biotechnologies grow and contribute benefit to society, other genetic-based technologies may benefit as well," he said.

Method #2: Let fear of terrorism squash research progress.

Rennie said that he recently had dinner with a group called the Science Coalition in New York, at which 20 university presidents spoke with clear agitation about how new "homeland security" measures were causing them major problems by interfering with the ability of foreign-born students and faculty to travel across the border and be involved in sensitive projects.

"The problem sapped at manpower, it sapped at administrative resources, and of course it slowed down the work itself. Biomedical research was very much at the center of these new security concerns," he reported.

Very specific events frame our current view of tensions between biomedical research and security: the Al-Qaeda coordinated attack on the World Trade Center and the Pentagon, and the mailing of weapons-grade anthrax, which took place on the heels of 9/11 and which has never been attributed to any culprit. And there have been "acts of research."

In 2001 Australian researchers were genetically modifying mouse pox virus with the intention of developing a contraceptive vaccine to curtail the rodent population explosion. Rennie pointed out that to their amazement and dismay, researchers found that inserting an interleukin gene inadvertently converted relatively mild mouse pox into a mouse super pathogen.

"The publication of that work prompted worries that some would-be bioterrorist who couldn't obtain a sample of smallpox might create his own disease instead," Rennie said.

In 2002, Eckard Wimmer of SUNY Stonybrook published a paper showing that it was possible to synthesize poliovirus from scratch, using the publicly available viral genome.

Most recently, there’s been an act of policy on scientific communication, Rennie said.

"In mid-February 2003, the editors of more than 30 journals publishing biology research announced that they would adopt a voluntary policy of self-policing papers for information that might be useful to terrorists," he said. "Nobody likes to talk about this as self-censorship, but it is in many ways a matter of semantics."

"My own perspective on the new journal policy is that in practice, this is not going to interfere much with scientific communication and I'm not going to wring my hands about how this journal policy will wreck or cripple science," he said.

"Before government's protective iron hand closes too tightly on research, it should do more to sensibly govern the commercial availability of actual materials that could be put to malicious ends.

In November 2001, we at Scientific American arranged a vivid demonstration [Special Report: Better Killing through Chemistry: Buying chemical weapons material through the mail is quick and easy] of how easy it was to obtain dangerous chemicals. At a time when the whole country was on alert against terrorists, Rennie and his staff picked up the phone, called a chemical supply company, and conspicuously ordered all the ingredients needed to make the nerve gas sarin.

"These chemicals were delivered through the mail to an office in midtown Manhattan, no questions asked," he pointed out. "Theoretically, I had enough material in my office to kill thousands of people. but disposing of the materials was considerably more challanging!"

Method #3: Let intellectual property skirmishes squash research progress.

Patents and other forms of intellectual property protection are crucial for providing incentives for innovation in biotech and every other part of industry. In the short run they serve the individual interests of the innovators, but in the long run they serve everyone's interests, both as economic drivers and as inducements to add to general knowledge. But we also shouldn't let the leverage provided by patents become a stranglehold on progress, Rennie advised.

For instance, since 1997 Jeremy Rifkin and Stewart Newman have repeatedly filed for a patent on a method of combining embryonic cells to create chimeras, organisms that would be part human and part animal, a patent that is still pending.

"Rifkin and Newman don't want to use their technique to produce useful chimeras: quite the opposite," he explained. "They want ownership of the patent so that they can stop anyone else from making chimeras, no matter how useful they might be, because Rifkin and Newman consider such organisms to be ‘unnatural abominations.’"

Rennie pointed out that when self-designated enemies of biotech do something like this, it's easy to see it as Luddism, as opposition to reasonable scientific progress.

"But what about when biotech innovators themselves do it? Harvard University, MIT, and the Whitehead Institute for Biomedical Research jointly hold a very broad patent on methods of treating disease by regulating the activity of the protein Nuclear Factor Kappa B, which is involved in the genetic regulation of inflammation, cell division, and many other processes," he posed? [See Razing the tollbooths, Scientific American, April, 2003].

"Those institutions have informed more than 50 companies that they are seeking licensing fees or royalties for research or commercialization of drugs that act on this pathway," he said. "For example, they have filed suit against Eli Lilly, charging that its drugs for treating osteoporosis and sepsis infringe on that patent. In effect, the patent now serves as a tollbooth blocking the way of anyone who wants to work on a biochemical pathway involving Nuclear Factor Kappa B," Rennie explained.

The journal Law and Contemporary Problems (Winter/Spring 2003) observed that in the case of the Nuclear Factor Kappa B protein intellectual property that "upstream patents issued to academic institutions serve as a tax on innovation, diluting rather than fortifying incentives for product development."

While Rennie said he wasn’t specifically knocking Harvard or MIT. or the Whitehead because they were granted the patent and they are acting within their rights, he pointed out that the first place to find fault is with the patent office itself for granting a patent that is perhaps just too broad for the common good. Interesting to note is that Stanford has done a credible job of facilitating licenses, especially in the computer software business at reasonable terms that accelerate the introduction of innovations, whether by design or simply because patents don’t afford a great deal of market exclusivity to those engaged in the IT industry.

The Bayh-Dole Act of 1980 helped spur universities to seek patents and commercialize their research. The law has had an overwhelming effect in pouring the fruits of academic research into industry-between 1979 and 2000. The number of university patents increased 14-fold, and about half of those were for biomedical discoveries. [See Bayh Dole Reform and the Progress of Biomedicine: Allowing universities to patent the results of government-sponsored research sometimes works against the public interest, by Arti K. Rai and Rebecca S. Eisenberg, American Scientist, Jan-Feb, 2003].

"It's hard not to see the general effect of the law to have been good," he said. "But if bad administration of patents is now going to start choking off whole lines of progress, then we need to somehow fix the system before serious damage is done," he said.

Method #4: Let the crazy nanotechnology people do all the talking

While articulating a crucial distinction that not all nanotech researchers are crazy, Rennie pointed out that there are nanotechnologists, often touted as "leading visionaries" of nanotechnology, whose "vision" includes fleets of microscopic robots that will cruise through the body, fixing damaged cells as they go, ensuring eternal life. Or that trillions of these "molecular assemblers" will settle like clouds onto junk heaps and rearrange the atoms into Porsches while you wait.

"I don't know, but to me this sounds farfetched," he said. "Still, these "visionaries" do a great job of getting press for themselves, and when Scientific American has criticized them in the past; their reply has been that since we haven't proved they someday can't do it, they must be right," he said.

Rennie said that the issue isn’t about whether the visionaries are right or wrong, but rather if the biotechnology industry allows the talk about "micro-robots" get ahead of the game, or the industry will inadvertently contribute to terrifying the public with the possibility that nano-biotech will run amok and destroy the world.

There have been a number of shots over nanotechnology- and nanotechnology-biotechnology’s bows recently.

"See Bill Joy’s famous essay a few years ago, or more recently, Michael Crichton's bestselling novel Prey [REVIEWS]," he pointed out, warning, "you face a possibility of severe backlash...and biotech has enough PR problems already."

Rennie said that that it is all well and good for the biotechnology promoters to say that biotechnology has the potential to change the world.

"But never forget that some people out there like the world just fine as it is, and they don't trust you to ‘retailor’ it for them. In short, fear your own hype—someone may take it seriously!" he warned.

Way #5: Hand stem-cell and human-cloning technologies to other countries without a fight.

In the U.S., work on human embryonic stem cells and on human cloning are both mired in a political, religious, ethical struggle that has its roots far outside any of the concerns that biologists and biotechnologists commonly address.

"It's a struggle that I think goes right to the heart of what the U.S. is supposed to stand for, including the balance between separation of church and state but also our sense that we have a good, moral society," he said.

"From an economic standpoint, it would be disastrous for the U.S. to lose its natural lead in the development of these technologies to other countries," Rennie stated. "Stem cells and cloning really ought not to be lumped together so often in a single breath because, of course, for all that they have connections, they are very different. And in the interest of maintaining perspective, it's worth reminding ourselves that so far we don't really know how much we can do with either one of these technologies," he said.

Opponents are calling for ethical debates now before the technology overtakes our ethical deliberations.

"But we have really put the cart ahead of the horse. The biomedical community keeps stressing that it is only interested in cloning to generate cell lines, while the public discussion always slips over into reproductive cloning, and the almost unhinged level of fearful speculation about what that would mean," he pointed out. Scientists have loudly said that they would accept a ban on reproductive cloning as long as it allowed therapeutic cloning, but some lawmakers insist the only way to prevent reproductive cloning is to ban any kind of cloning.

"Scientific American supports the scientists’ position, but lately I've begun to wonder whether this argument shouldn't be turned on its head. Maybe no kind of human cloning should be banned. Maybe it should all be kept expressly legal so that it can be," he said.

One Method to Help Biotech Prosper: Make It Disappear.

"When I talk about the disappearance of biotechnology, I'm making an analogy to the stated goals of some of the information technology guys who talk about ‘invisible computing.’ They are referring to a time when computers are so much a ubiquitous part of life that they fade into the background:

• You’ve got a computer on your desktop, a PDA in your pocket.
• You probably carry a sophisticated cell phone that does things only a computer could do some years ago.
• Your car is full of microchips. So is your microwave oven, along with most of the rest of the appliances in your house.
• You may have chips in your clothes, or embedded in your pet's ear as I.D.

"Computers in the form of microprocessors are on a steady, unstoppable rise, and why? Because you don't even think of them as computers anymore," he said.

As biotech grows and becomes a more ubiquitous part of life, that "bio" suffix will matter less and less because it will say less and less that's distinctive.

"Products of biotechnology cease to exist when everything starts to contain elements of biotechnology," he said. "And assuming that the biotechnology industry can safely navigate all the ways in which it might wreck itself, the time will come when biotech will be integrated into every aspect of manufacturing and services, just like plastics and alloys," he said.

"There is so much opportunity to turn the capabilities of living things and their components to our further advantage. I can't imagine an industry that has more potential, and I wish you all the very best success in realizing it," he said.

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