For the Patient's Good or the Company's Profit?

"For the patient's good" has been a governing axiom of moral medicine for centuries. Many contemporary business arrangements in medicine threaten this axiom and, thereby, threaten patient well–being.

The brouhaha among the collaborators on the Human Genome Project is a case in point. If mapping the human genome—all the genetic material in the human blueprint of life—is to ultimately prove beneficial in treating and perhaps curing human diseases, then it is imperative that the effort be completed as expeditiously as possible and that the information be disseminated as widely as possible.

Craig Venter, president and CEO of Celera Genomics, has been the only private researcher involved in the collaborative effort to sequence the human genome. His for–profit laboratory is just one of six centers working on the project. All six centers—the others at university–based labs—were committed originally to the practice of making the results of each day's work available on the internet so that researchers around the world would have access to the data.

The rationale for the collaboration revolves around several important points:

1. the human genome is the common property of humanity and should not be the subject of private ownership
2. the benefits of genome mapping are potentially so great that those benefits should not be held hostage to proprietary interests, and
3. with the exception of Celera's work, the public has funded the human genome project through the National Institutes of Health and through university–based labs, therefore, the benefits of the project should accrue to the public, not to private biotechnology companies.

Everyone should have known that including Craig Venter in the collaboration was risky, if not downright foolish. After all, Venter is the quintessential entrepreneur. On more than one occasion he has filed for patents on so–called Express Sequence Tags (ESTs). ESTs are segments of DNA, as they occur in the human body, but without known function. That is, ESTs are ordered segments of the As, Cs, Ts, and Gs, that form the language of genetics, but the precise function of these ordered segments within the genome is unknown. Once Venter's group was able to identify these segments, they sought to patent them—6,000 at one time—so that Celera would be able to control the market on any future use of the ESTs. Venter's efforts to exploit the human genome for profit has thrown the U. S. Patent and Trademark Office (USPTO) into a tizzy. Heretofore, organisms as they appeared in nature have not been patentable. And it's unclear that isolating ESTs constitutes any so–called "improvement" which is also a requisite of a successful patent.

So, what's the moral of the story? If we are going to keep the human genome from being held hostage by entrepreneurial interests, we must avoid entanglements with private research companies like Celera Genomics. That will mean that if we are to realize the benefits of the human genome project and the therapeutics spun off the project, we will have to devote more research dollars to basic research. Furthermore, we will also have to direct the USPTO to refuse to grant patents on human genes, tissues, cells, and cell lines. This, of course, will require legislators who are familiar with and committed to funding basic scientific research.

The human genome is given to us all, not for the company's profit, but for the patient's good.

C. Ben Mitchell is Senior Fellow at The Center for Bioethics and Human Dignity
Commentary Date: March 10, 2000

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