Good morning and welcome to the WorldWatch booth at the World Congress on Information Technology in Fairfax. WashTech is here for a live chat with Dr. William Haseltine, CEO of Rockville-based Human Genome Sciences Inc.

Haseltine is a featured speaker at the World Congress this morning, but he arrived a bit early to chat with you first. We took your questions regarding HGS, its 27 gene patents, and the upcoming human testing of a new cancer drug.

The transcript of the live discussion follows.

Linton Weeks: Greetings, Bill. What do you hope to get out of the World Congress on Information Technology?

William Haseltine: I hope to learn what others creating the information revolution, both electronic and genetic, are doing now and plan to do in the future. I also hope to build links between what they are doing and our efforts to devise new means to treat and cure disease.

Washington, D.C.: Bill,
What do you think of this internet format as a medium for worthwhile Q&A.

William Haseltine: This is the first time I've used this format. It's too early for me to tell.

Cleveland, OH: Is our ability to understand genetics in a scientific way increasing faster than our ability to understand it in an ethical/moral way?

William Haseltine: I believe that we have a capacity to absorb technology rapidly and to incorporate it into existing moral and ethical structures. Western societies have built firm structures to ensure that new technologies are applied in moral and ethical ways. This includes the application of knowledge gained from gene-based studies. Although it is true that the pace of discovery of new genetic information has increased dramatically, the application of such knowledge is much slower. In the field of health, applications are carefully reviewed by government regulatory agencies worldwide. A review of moral and ethical questions is included in these analyses.

Washington, D.C.: To the uninitiated, the idea of cashing in on the medical and genetic problems of the nation seems a little mercenary. Do you feel a responsibility to return profits from your biomedical enterprises into further research? Does your company contribute to any public health charities and relief organizations?

William Haseltine: The pharmaceutical industry is a source of most new drugs and medical treatments. These companies invest in medical research almost twice the amount invested by U.S. taxpayers. My company, Human Genome Sciences, invests all of its resources in research, as we have not yet developed products which are approved for human use. I believe that the current system, in which corporations develop drugs, is a highly efficient system and one that assures the maximum use of new technology for finding new treatments and cures for disease.

Rockville, MD: The patenting of human genes--and eventually, the entire genetic code--would seem to have the potential to impede research-sharing. How do you justify that?

William Haseltine: To answer your question, let me first describe the patent system. Patents are a social contract between inventors and society, meant to benefit society as a whole. The fundamental principle of patents is that the ability to make and sell products that incorporate a new invention is protected for a limited period of time if and only if the inventor shares the full details of his invention with the world. The information in a patent is not secret. In fact, all details -- including the minute features that make an invention work -- must be disclosed. The purpose of such disclosure is to allow others to use this information to invent new and still better technologies. The alternative to patenting genetic information of potential medical value is secrecy.

No one can one a gene in its natural context. Therefore, no one can have rights of any sort to genes in a human being. However, gene patents are granted if the gene has been isolated from its natural context and rendered useful by human intervention. In practice, this means isolating a human gene, putting it into a test tube, placing it in a context where it can be used, describing the potential medical uses, and giving enough details so that anyone could follow the instructions to create a useful product. Even so, a patent does not confer ownership to the gene. It merely provides standing for an inventor to protect the fruits of his labor from exploitation by others for a limited period of time. It is not a license to sell or use the product in any way.

In my opinion, patents are the key technology advancement. Most technological know-how is communicated through the patent literature, not -- as is commonly supposed -- by the scientific literature. All technological details regarding a new invention must be disclosed by the patent literature, a requirement far beyond that for a scientific publication.

Stanford, California: What advice would you give to students and young people interested in your field?

William Haseltine: In my opinion, biology is going to be the most exciting scientific field for the next 100 years. There is now a new interface emerging between material sciences and the biological sciences. We are now engineering material substances at the level of individual atoms, the same scale on which the human body is engineered.

Students who wish to enter this field should first acquire a deep understanding of the natural sciences, including physics, chemistry, mathematics and computer sciences. Training in these fields must be done early as it is difficult to pick them up later. Biology is a much more accessible subject and can be learned later. My recommendation is for students to be trained in the hard sciences through first-year graduate studies at least, before embarking on a career in the biological and medical sciences.

Linton Weeks: Bill, what will be the first product off the assembly line at your new pharmaceutical plant? What's next?

Are you concerned that the new spate of chemical-based, prescription drugs…for impotence, hair loss, a wrinkle-free life…will undercut your efforts to develop gene-based drugs?

William Haseltine: Human Genome Sciences has been the first to reduce the notion of genomic medicine from concept to clinic. At present, we have three drugs based on our genomic discoveries in clinical trials. The fisrt drug, MPIF-1, is a natural human substance that negatively regulates the blood supply. It specifically inhibits growth of blood-forming tissues and prevents their destruction from cancer-causing drugs in our pre-clinical studies. We have recently concluded a preliminary safety trial with satisfactory results, and are now planning additional safety and preliminary efficacy test in cancer patients. We believe this drug has a potential to benefit the majority of patients undergoing cancer chemotherapy.

A second drug, KGF-2, is a substance that the body naturally uses to repair the inner and outer lining of the body, i.e. skin mucosal tissues and other tissues that line our internal organs. KGF-2 is currently undergoing preliminary safety trials in humans. This drug has the potential to dramatically accelerate wounds to the skin such as burns, pressure ulcers, diabetic ulcers and venous ulcers, and may also repair damage to mucosal and other tissues induced by chemotherapy and by other causes.

Separately, we are also developing, together with a new company we hoped to form called Vascular Genetics Inc., a gene-based therapy to grow new blood vessels in limbs and hearts to overcome the affects of clogged arteries without surgery. We hope that this drug will enter human trials this year.

Arlington, VA: Dr. Haseltine: You're one of the few Maryland tech executives featured on the World Congress program this week. Has your state's tech community had a chance to tell its story at the conference?

William Haseltine: It is a pleasure to be one of the representatives from Maryland at the World Congress on Information Technology held in Fairfax, Virginia. Virginia has long held a lead over Maryland in high-tech development. There have been recent efforts for Maryland to compete for location of high-tech companies. In our case, they were successful. Unless there is a sustained proactive program to encourage additional economic development in Maryland, Virginia will continue to dominate this region.

I can provide personal testimony to the effectiveness of the state and local government development agencies in Maryland over the past few years. Our senators, congressmen, governor and county officials have been extraordinarily helpful to us in building our company.

Arlington, VA: You've stated before that you want to cure diseases and make (and I'm paraphrasing) boatloads of money. The two goals seem diametrically opposed.

William Haseltine: I do not believe that there is an inherent conflict between for-profit companies developing drugs and a mission to treat and cure disease. Most new drugs and medical treatments emerge from the pharmaceutical industry. All new drugs are developed by the pharmaceutical industry. These companies, including our own, invest a very substantial part of their income in development of new drugs. It is the profit on sale of drugs that allows such an investment to be made.

Linton Weeks: Here's another couple from me: Why are you so critical of the Human Genome Project, the government's effort to locate and decode every gene in the human body?

Your former partner, J. Craig Venter, is hoping to beat the government to the punch. He is forming a new privately-funded company to finish the map project four years ahead of the National Human Genome Research Institute and for considerably less money.
Does Venter's company pose a competitive threat to yours?

William Haseltine: A response to your question on my critique of the government's effort to sequence the human genome: I support the international effort to determine the entire sequence of the human genome. The primary purpose of this endeavor is scientific and not medical. It was originally conceived and executed by the Department of Energy, not the National Insitutes of Health, as a scientific program equivalent to exploration of the universe by the Hubble telescope, or exploration of atomic structure using superconductor supercollider. The work should be done carefully, deliberately and cooperatively on an international basis.

The work to decipher the human genome should not be confused with isolating, characterizing and demonstrating the medical utility of individual human genes. Human Genome Sciences has already isolated greater than 95 percent of all human genes, using several different methods to calculate completion. Tens of thousands of newly-discovered genes are available in a form which can be readily used to facilitate medical discoveries. Others have done similar work and many thousands of new genes are available to scientists worldwide for their research.

I believe the current cost of the U.S. Human Genome Project is $250 million per year. There is a request to double this budget to compete both with international and other private initiatives. I believe that this is unreasonable, as $250 million is enough to fund almost 1,000 new projects to understand the medical utility of individual genes.

To explain further the difference between genes and the genome, let me use an analogy. The human genome contains over 3 billion individual base pairs which are equivalent to letters in a text. Only 150 million of these -- less than 5 percent -- specify individual genes. Therefore, 95 percent of the text deciphered by the Human Genome Project will not be useful for medical discovery. Most of the text consists of small repeated sequence -- some repeated over a million times in the genome -- which carry no functional information. This is a so-called junk DNA or selfish DNA that is almost certainly an information parasite, akin to a computer virus that is there not because it must be but because it can be. Human Genome Sciences uses a method that concentrates only on the text of the genes as they are used buy the body and not on the complete text of the human genome, most of which is nonsense. If the human genome was a song, it would most resemble the lyrics of the Doobie Brothers. Most of it would be "doo-wah, doo wah" -- very little would be actual words. I do not believe we should spend precious resources to decode genetic "doo-wahs."

Linton Weeks: Here's another couple from me: Why are you so critical of the Human Genome Project, the government's effort to locate and decode every gene in the human body?

Your former partner, J. Craig Venter, is hoping to beat the government to the punch. He is forming a new privately-funded company to finish the map project four years ahead of the National Human Genome Research Institute and for considerably less money.
Does Venter's company pose a competitive threat to yours?

William Haseltine: In answer to the second part of your question regarding competition: There is fierce competition between universities, private research agencies, big pharmaceutical companies, biotechnology companies and genomic companies to understand the medical utility of genes. In the end, I believe this competition will benefit humankind by providing speedier answers to urgent medical needs. In my opnion, the proposed new venture sponsored by Perkin-Elmer to provide a rough draft of the complete human genome text is not significant in context of the global effort to make medical sense of genetic information.

Fairfax, VA: Every once in awhile, I'll hear another news report indicating that we are inching closer to finding a cure for AIDS. However, I'm neither a scientist nor a doctor. How close are we really to finding a cure? Are these reports incremental, or indeed significant breakthroughs?

William Haseltine: As you may know, I was chief of the department of AIDS research at Harvard's Dana Farber Cancer Center. I am also an editor-in-chief of the Journal of AIDS Research. There have been great strides made in the treatment of AIDS using drugs that inhibit two critical enzymes of the AIDS virus. These drugs, used in combination, can reduce the growth of the virus in the body at least for some time. However, for most people, such treatments are not a cure, as the virus continues to linger, hidden in some tissues, and may eventually re-emerge in a form resistant to the drugs.

I believe that the pharmaceutical industry should increase its efforts to find new types of drugs, acting on different parts of the virus, that in combination with the two existing classes of drug, may supress the growth of the virus in the body for a lifetime. This may not be a cure, but it could be an effective lifetime treatment. We are not there yet, but I believe if the resources are properly marshalled that a person infected with the AIDS virus can live a near-normal life.

London - United Kingdom:
Once the mechanics of life are truly and inequivocably unlocked, what grand endeavours remain available to our species? (With life conquered, shall science then turn to pursue and decypher the face of that which some call God?)

William Haseltine: Vannevar Bush, One of the architects of America's technological infrastructure in the post-war period, called science "the endless frontier." There is no end to human curiosity and no end to scientific knowledge. Despite our recent rapid advances in understanding human genes, we are very far from understanding the complexities that go into creating even the most simple life forms, much less those of a human being. Consider that at present, we have no real understanding of what a memory is or what a thought is. I believe it will be many centuries before we approach a resonably complete description of a human being from fundamental scientific principles.

Linton Weeks: Bill, thanks for agreeing to this dance. And for taking a few hardball questions. And some curves. Linton

William Haseltine: Thank you for the opportunity to participate in an online question-and-answer forum. I believe this is a powerful and useful way to communicate.

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