Lawrence Technological University
College of Engineering
Department of Biomedical Engineering

Biomedical Engineering Seminar
Spring 2006

Handouts

The Human Genome: Ethics at the Frontier

Good afternoon. It is good to see you folks again as our second semester of Biomedical Engineering at LTU gets under way. I would also like to welcome our visitors. My plan is to talk about ethics: about ethics as a framework to govern human behavior, as a somewhat plastic framework at frontiers, and specifically as a framework for bioengineering with the human genome. Anyway, that is the plan. As many of you know, I often wander from the plan. One aspect of the plan I will adhere to is to stop talking after a while and allow time for your comments and questions. This is after all a seminar.

My favorite way to discuss ethics is to avoid abstract hypothetical questions until having looked at some real cases. The actual frontier situations for this talk will be the California Gold Rushes of 1849 and 2005.

I do not mean to imply that ethics is a young discipline. The author of the text for Intro to Biomedical Engineering, Domach, presented the 2500 year old Hippocratic Oath as still appropriate for biomedical engineers and entrepreneurs. Remember the part about sharing what you have learned for free. Later I want you to think about the difference between a pharmaceutical company selling a pill on which they have a patent and a physician in a teaching institution selling his instruction and also getting royalties from his students' use of his patented process.

There was a considerably looser set of ethics on the Western frontier in the gold rush following the discovery at Sutter's Mill in 1848. There is also a rather loose set of ethics in practice by those who have rushed to California after the passage of Prop 71 in 2004. So I would like you to think about the factors that caused people to suspend or disregard much of the biomedical ethics developed over millennia.

Before we take up the story of Drs. Wicha and Clarke who followed the gold to California. I will tell you about Sol Barth, the great-grandfather of Michigan physician, Charles Wolf M.D.. Solomon Barth was born in 1842, the son of a Jewish rabbi, perhaps in Prussia. He was a merchant and many other things. He was known for his fair and honest dealings. He did not cling to any particular organized religion. His faith, according to Dr. Wolf, "was in Arizona." In later years Solomon was addressed by the Spanish honorific "Don" and was buried in a Catholic cemetery after receiving Catholic Last Rites and a Mormon funeral service. In 1855 after visiting with his brother Jacob in Michigan, Sol fell in with a caravan of Mormons who were being driven West by intolerance. He arrived in California in 1856. Working for an ancestor of Senator Goldwater, Sol supplied miners. He followed successive gold rushes to Arizona.

While in Arizona he benefited from his reputation for fair and honest dealings. Sol Barth took nothing from the Indians. It was by formal treaty that the Navajos granted him trading rights in an area of Northern Arizona larger than Connecticut's entire Western Reserve. In 1868 he strayed into the hands of Cochise while that Chiricahua Apache chief was on the war-path. Because of Sol's good relations with with the other Apaches, he was allowed to walk home, 125 miles, with just cotton under-shorts and shoes. This does not seem like much of a privilege, except that during the decade Cochise was on the war-path, no other white American was known to have seen him and leave with his life.

In 1887 Solomon Barth was imprisoned after a dispute with the First National Bank of Prescott, which accused him of forgery. Two years later, the territorial governor pardoned Sol after hearing petitions from his many friends and stating his reservations about the legality of the original conviction. Sol went on to serve in the Arizona Territorial Assembly.

Let us return to Michigan 150 years later and read the story of Max Wicha and Michael Clarke, as told by Patricia Anstett of the Free Press.

At this point we should go back to General Sutter's description of his times. It was an interesting time. "Salting a claim" and "claim jumping" are just two new phrases for fraud, popularized then. General Sutter was not alone in feeling that the anarchy of the time was ruining him. California, weary of war and disorder, skipped being a territory and went on to become the 31st state in short order.

Again, fast forwarding to Prop 71. Whether the predictions of opponents of Prop 71 will happen, now that the attempts at federal regulation of stem cell research have been neutralized, is yet to be seen.

Where is the gold in the Human Genome? Of course some of it may be "fools' gold." Besides the billions in venture capital, there is the fame and fortune from just being a pioneer. Profits from products and royalties from patented processes are tempting. There is also the glitter of targeted advertising and the lure of savings to employers and insurers who can avoid unhealthy people. Additionally, there is profit in selling tools for criminal justice and anti-terrorism forces.

The ethical lapses in both gold rushes began with some concept of "Manifest Destiny." In 1840's America's destiny was to extend from shore to shore; in the 1990's to conquer disease. We began a war with Mexico for land and later a war on diseases with stem cells. War is a traditional tool to marshal all possible resources against a sworn enemy while suspending ethical judgment. You might be interested in Gilbert Meilaender's thoughts on the justness of the stem cell war … from before that war was eclipsed by the "war on terror."

Another ethical problem with both gold rushes is simply that the claims are staked on ground with unclear title. The 49ers staked their claims on land they thought belonged to the United States. The Treaty of Guadalupe-Hildalgo stated that the United States would respect the property rights of both the Mexicans who were now U.S. citizens and those of native Americans. General Sutter's land was deeded by Mexico. Sol Barth's was from the Indians by consensual treaty (and not by the sort of treaty often imposed by the United States' government on the Indians). Afterward, the United States Supreme Court was generally more favorable to claims by ex-Mexican citizens than the indigenous American citizens; even though, the Mexican land probably really belonged to the same indigenous Americans. The ownership problem in genome research is two related problems. First, the gene originally from an actual living human being is a body part never legally or ethically for sale. Second, the institution who receives patient genetic information and patient participation in research, owes something to the patient. Such was the argument made by the Texas Attorney General about the sale of not-for-profit, Baptist Christian, Baylor Medical to a for-profit chain.

In the more modern gold rush we encounter another rationale for suspending ethical considerations: economic necessity coupled with patriotic pride. This distills to the simple argument that without sufficient profit motive there will be neither innovation nor progress. This argument is simply not true. The Icelandic Genomic Database was created without a profit motive (although many have tried to co-opt this database for profit making purposes). The software that enabled sequencing of the human genome was Open Source and free. These economic arguments are advanced by entrepreneurs. This however is a digression from ethics to the wisdom of asking a fox to design a hen house.

Recent discussions of ethics on the frontiers of genetic research and engineering are found in the story of Dr. Hwang Woo-suk of S. Korea, and on the pages of last week's JAMA. The latter focuses on conflict of interest. Which treatments are used for a particular cancer problem are set by groups of cancer specialists, like SWOG, in meetings far away from the patient. Representatives from major institutions like University of Michigan and Stanford have considerable influence in this selection process.

As in the past, eventually the Prop 71 gold field will be less lucrative. Gold diggers will rush to places where the gold is closer to the surface and easier to mine. Perhaps like this database of British youth. Perhaps to the boxes in Lansing where each of you, that were born in Michigan, has stored a DNA sample.

Now I would like to stop and ask your opinions about where the "ethical" line in the sand should be drawn.

Thank you for your attention.

Respectfully submitted,
John M. Miller M.D.
January 31, 2006