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FEATURE: Genomic Companies Assess the Role of Bioethics in Business

CANNES, France, Sept. 13 - Ask bioethicist Arthur Caplan what's at the top of his wish list and he'll tell you: an in-house bioethicist in every genomic, bioinformatic, and microarray company worldwide within the next 10 years.

And he defies those who say that traditional tool and technology makers needn't concern themselves with bioethics. "Just because you're not dealing with [patients], that doesn't absolve you from your responsibility from the application," said Caplan, the director of the Center for Bioethics at the University of Pennsylvania Health System in Philadelphia.

Caplan said that bioethics does not begin merely when research touches human subjects. Rather, he argues, information gleaned from human genomic data "which is facilitated by tool companies traditionally far removed from the clinic" can eventually be used for ill-gotten and potentially malevolent gains.

Take microarray developers, for example, he said. "They don't deal with [patients] on anything"--they just make chips. The question in the case of these companies becomes:  "Who do we sell [the chips] to? " Caplan asked, referring to the widely cited risk of insurance companies or employers that might use individual genomic data to vet applicants. "People will likely ask,  "Will they sell what they make to anybody?" and "Do they care? "

Speaking with GenomeWeb after a presentation he made here at the 9th annual Atlas Venture life sciences conference, which ended on Wednesday, Caplan cautioned that genomic firms "should be smarter, more innovative, and more alert to [bioethics] than their elephantine descendants." Compared with their larger and more established biotech and pharma counterparts, genomic companies have the advantage of being lithe and agile not only in the marketplace but also in their board rooms, where decisions on whether to enlist bioethics are made, he said.

Does he believe that the young genomic companies have embraced bioethics more than their predescesors? "Certainly." Why? "I think there's a more enlightened corporate leadership there."

"I'd say that big pharma is so established and set in their ways that they can' t get their hands around" the idea of bioethics, Caplan explained. "New bio probably can be more flexible and responsibility-savvy."

Several early-stage companies in the industry--"Affymetrix, Celera, Chiron, and Framingham Human Genomics, to name a few, he said--"have already approached him.

Celera, for example, asked: "We want to sequence the human genome. Whose should we sequence?" Caplan said.
Caplan said other firms may ask him about privacy and confidentiality issues. Specifically, should they share financial gains with the people whose DNA they studied to glean marketable and profitable data?

Ultimately, Caplan said, if biotech neophytes don't make bioethics a part of the culture of their business, "things may fall apart later when the rubber hits the road," or when human lives have entered the equation. And many industry analysts believe that more and more pure-play tool and technology companies are shifting their corporate focus to what they perceive to be the more attractive business models in the sector: drug discovery and diagnostics.

Indeed, there may be more potential for public and private investment in this realm of the industry,  analysts agree, but Caplan stressed that this also is an area in which companies with little patient experience must have fine-tuned bioethical antennae.

"Start-ups want to succeed and they want to make money," Caplan said. "It's fun to do what they do, and I know many of them want to "or should want to" do it in ways that are socially responsible."

"To make that happen, you have to have your feelers out in society to know what it thinks socially responsible is," Caplan suggested. "In other words, as a company, I can say, "Well, I think it' s socially responsible to do A, B, and C." But unless you made some clear efforts to speak with a community, how do you know what you' re doing?

"There is the direct business risk that [biotech firms] don' t understand social sensitivity," he went on. Part of the culture of our corporate evolution is that by the time you get to the point where others begin to challenge your efforts, "it' s too late" to look to bioethics for help.

Avoid this by building a well-rounded infrastructure, Caplan said. "You know, you hired a lawyer and an accountant to help you succeed. You should also put in a bioethicist in place and use him."

Michael Pellini, CEO of US-based Genomics Collaborative, said that he is in favor of running
ideas by a bioethicist. His firm has one, he said, and most decisions made by Genomics Collaborative that may eventually affect patients are brought first to its in-house ethicist.

"I'm surprised more companies don't do it," Pellini said atop the roof deck of a restaurant overlooking the Mediterranean Sea here. "It doesn't cost us anything, and in the end it may save us [money, time, or reputation]. I mean, the whole idea of it is so reasonable."

"We've always said that if we are going to be on the front page of the New York Times we'd better make sure we get it right," he said. Pellini said that bioethical questions raised by his company's research, which revolves around a library of proprietary DNA, sera, and tissue samples linked to certain medical data culled from more than 100,000 patients, mostly deal with privacy and confidentiality issues.

Mark Bodmer, CEO of Lorantis, a genomic drug-discovery company based in the UK, said he also agrees with the notion of bioethics in his end of the sector. "In fact, I think it's almost inconceivable to introduce this kind of science without first talking about the bioethics question," he said.

Is there room for the discipline in every part of the biotech sector? "Not only is there room for it, it's demanded. Bioethics must be treated on a proactive basis," Bodmer said.

One way in which bioethics may work for the biotech sector is to help companies better educate the public, Bodmer said in a telephone interview from his firm's offices in Cambridge. "In the public debate, all [the various biotech] issues got jumbled together, including agbio [and genetically modified foods], the [sequencing of the] human genome and personal privacy, and the rights of the individual," he said. "Someone has to tease these [issues] apart and find out what the ethical definitions of them are. There certainly needs to be more education, and bioethics can help this sector to do that.

"The point of the reluctance of the biotech industry to grasp bioethical issues in a proactive way tells me that we need to realize the possibility that we will wake up in an industry under threat," Bodmer said.

"At the end of the day, I'm a fan of the technology," Caplan concedes. "But I can say for sure that there is room for [bioethics] in every part of the industry, and in every kind of business within the sector. Ultimately, it will be, "You can talk to me now, or you will talk to me later." It' s up to you."

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