RSVP for the After-Life Party, or What to Do in the "Real" Retirement

A decade ago, the Kass court asserted strong support for planning well ahead of time with regard to the disposition of embryos by concluding that previous agreements ought to be presumed valid and binding, and what's more, the court found such contracts corral expensive and drawn-out litigation, provide a framework for the effective operation of IVF programs, and minimize misunderstandings between the parties. The forethought and execution of prior agreements fall, for all intents and purposes, in the same family as Consent Forms and other Release Authorizations, that take the guesswork out of an individual(s) intention as to what (s)he would want done with various biological by-product. The only major differences being that the previous contract addressed by the Kass court focused on the agreement of two parties and the by-product had the potential for procreation.
That is all well and good. However, recent developments in scientific techologies are giving new meaning to the Boy Scout motto, "Be Prepared," by pushing the ethical envelope and asking us to gaze a bit longer into the crystal ball before deciding what to do with our leftovers. Since our course on Bioethics and the Law has already touched, and will probably revisit, the many pre- and potential human life issues of stem-cell research, genetic engineering, and IVF programs, I would like to turn our attention to the darker side of donation consentment; not the viable, hopeful, endless potential of procreation and life-sustainment...rather the stiff gift of a dead body. Besides, during a ten-day stetch that has seen the deaths of DFW, Paul Newman, Summer, and the American Economic System, I am finding myself donning a tad more black than usual and think a meeting at the cemetery gates more apropos. So without further ado, let's let the wake begin...allow me to introduce...
Herr Doktor Gunter von Hagens is the real, modern-day Dr. Frankenstein who invented and patented a technique for preserving biological tissue and body specimens known as plastination. Since founding the Institute of Plastination in the medieval university fortress of Heidelberg in 1993, von Hagens has overseen other plastination centers in the most remote research areas of Bishkek, Krgyzstan (google earth that one) and Dalian, China. Herr Doktor has also performed televised autopsies and cadaver dissections while wearing his trademark costume: a black fedora and cape.
In spite of the creepy, Bela Legosi showmanship, von Hagen is most famous for his controversial Koerperwelten ("Body Worlds") exhibitions that show a circus of plastinated cadavers enjoying routine, everyday poses in their skinless, flayed and dissected honesty. Yours truly first witnessed the gruesome cabinet of curiousity in 2002 in London, where mile long lines waited outside an Art Gallery in Bankside to see what most didn't really want to see...what the body looks like while it does what it does everyday. That is, one cadaver is playing chess (...and winning), another equestrian cadaver is mounted atop a hideless horse, there's a cadaverina pirouetting, and still another cadaverunner finishing a marathon in all his veiny glory. The morbid absurdity runneth over however, when attendants come face to face with a cadaver, fist under chin, assuming the position of Rodin's Thinking Man. The subsequent sick smile is quickly wiped off every face with teutonic precision around the next wall as a room full of plastinated pregnant women cadavers at varying trimesters and jarred fetuses showing one week olds, four week olds and so on were displayed. Leave it to the Germans for a real party faux-pas.
Having lasted longer than I would ever had expected, I left shaking my head with the full realization that Body Worlds would never make it across the Atlantic.
I was wrong. It has toured the States, and on limited publicity, haunted the halls of Chicago's Museum of Science & Industry. I went again, this time with my own students at the U of C and couldn't help thinking that it was a toss-up between the exhibition and the U of C campus as to which had more signs of life.

How does any of this relate to consent forms or Bioethics or the legal implications surrounding previous contractual agreements?

Well, for the past four years, our von Hagen has been dogged by a slew of legal proceedings that started as a result of his showmanship getting the better of him; he photographed plastinated corpses late at night all over Hamburg, including the Reeperbahn (the red-light district). Is it still necrophilia when the dead are doing the come-hithering? The charges in Hamburg included the serious offense of disturbing the dead. Additional proceedings against the good doctor were lodged in Siberia regarding a strange shipment of 60 corpses to Heidelberg that had little in the way of paperwork. 2004/2005 brought legal accusations that von Hagen had illegally received and plastinated several hundred corpses from prisons, psychiatric institutions and hospitals from China and Kyrgyzstan, most if not all without the notification of the respective families.

After some ridiculous google searching, during which I actually typed, "plasticate my dead, rotting body," I found the following consent form:

http://www.bodymobil.de/Downloads/Englisch/BD_Consent_ENG_euro_120208.pdf

Surprisingly, I found the consent form inclusive in that it reasonably addressed the inevitable concerns brought by family members, or others who would rather not know their loved one is touring the world as the resident? piano player in von Hagen's traveling band. In fact, it's the most interesting and bizarre consent form I could find that carried at least the pretense of being legally binding. Still, it raises the question that if plastination is going to claim the bodies of fellow humans, do it bear the responsibility not to make a mockery out of their situation by posing them in often ridiculous and laughable poses? Should GvH include a checklist of the types of activities the future dead would care to be engaged in? "No" to mixing guacamole, "Yes" to playing the guitar..."Yes" to Giacometti..."No" to the Statue of Liberty.

There was a better piece published in the Reader but here's a link to the basic premise:

http://www.newyorker.com/archive/2006/10/09/061009ta_talk_friend

Del Close, a fixture of the Chicago theatre-scene, wanted desperately to donate his skeleton, and more importantly, his skull, to the stage. Of course, the greatest gig for a skull would have to be Hamlet's Gravedigger Scene but really, how picky is a skull going to be?

For those of you familiar with the story, you know Close's intentions and wishes were not fulfilled due to legal obstacles and the absence of proper consent and authorization forms. I don't know about you, but I am definitely going to make sure I get my papers in order so my great-grandkids can see my onstage for the Mastodon (Reunion) tour in 2058 as a stage-prop, the best plastinated drummer in rock'n'roll history!

JWD

Gene Patents: Hindering Research or Promoting Genetic Discovery?

Background:

Over three million gene patents have been filed in the United States alone. A gene patent is a patent on a specific gene sequence, its usage, or its chemical composition. The general rule is that naturally occurring products are not patentable. Therefore, it is only after a DNA product is isolated, purified, or modified that a patent is considered.

Currently, the United States’ patent policy allows for gene patents when an inventor can (1) identify a novel gene sequence, (2) specify the sequence’s product, (3) specify the use for the product, and (4) enable one skilled in the field to use the sequence for its stated purpose. Examples of typical gene patents include genes and gene fragments, single nucleotide polymorphisms (DNA sequence variations that occur when a single nucleotide in the sequence is altered), gene tests developed to screen for disease genes in humans; specific gene binding proteins, and stem cells.

Controversy:

There is a controversy over whether gene patents advance technology by providing scientists with an incentive to create new and medically useful gene sequences, or whether gene patents actually hinder research by making it too costly.

Privately funded researchers generally advocate for gene patents, arguing that they would be unwilling to make the substantial investment in research without the ability to prevent competitors from making or using the invention without a license. Additionally, patents allow private-sector researchers to make inventions public without losing exclusive rights; thus, avoiding secrecy and promoting the dissemination of knowledge regarding genetic discoveries.

On the contrary, many research scientists who work in public institutions strongly oppose gene patents. Public-sector researchers argue that science will advance more rapidly if researchers can enjoy free access to knowledge. Those against gene patents also argue that patents could impede the development of diagnostics and therapeutics by third parties because of the costs associated with using patented research data. Furthermore, patent stacking (allowing a single genomic sequence to be patented in several ways) is a problem because researchers who want to use such a gene have to pay royalties to multiple patent owners for the use of one gene. Moreover, public-sector researchers argue that patent filings are replacing journal articles as places for public disclosure.

Another concern is that any research facility that gets federal grants (such as state universities) should not be able to patent, because they used tax-payer money to fund their research.

Potential solutions:

HUGO intellectual property committee recommends the European statutory model of a mandatory exemption from license fees for researchers, which includes all forms of research for the purpose of improving or developing knowledge. Second, HUGO suggests the establishment of a clearing house to expedite rapid and low cost licensing of patented DNA sequences which have potential applications in clinical diagnosis (such as the BRCA1 breast cancer susceptibility gene).This suggestion would be especially beneficial for companies and researchers who are developing technologies for rapid diagnosis of multiple gene variants who may need to acquire patents for large numbers of patented DNA sequences. (Some genetic testing companies, such as Navigenics, Inc., have already adopted such policies. Navigenics licenses gene patents used for risk assessment on a non-exclusive, non-discriminatory basis.)

The Sex Question

My wife is a medical student who recently worked in a reproductive endocrinology and infertility (REI) clinic at which many in vitro fertilizations occur. The usual process for these fertilizations is:

1. Extracting eggs from the potential mother
2. Fertilizing the eggs to make a set of embryos
3. Optionally karyotyping the embryos
4. Selecting 2-3 embryos for implantation
5. Implanting the selected embryos into the potential mother

The optional third step of karyotyping the embryos is a process in which many attributes of the embryos can be determined including its sex and possibly any defects. The ethical issue arose in the situation where a couple asked for karyotyping to occur and further asked to know the sex of the embryos. At this point at the clinic, there had been many ethical issues that had been addressed through different policies but this particular issue had not been discussed on whether or not the doctor should tell the patient. This particular doctor made it his personal position to tell patients because he felt that it was not in his power to deny them this information, but another doctor could have easily made the exact opposite decision. This doctor did say that he wished there was a policy stating the correct course to be followed.

The further issue could possibly occur at the selection step. The karyotyping of embryos does give some information about the embryo; however, the overall makeup of most embryos is very similar and one embryo cannot be differentiated from another. Therefore, when choosing what embryo to implant, there really is not an objective test to follow. The selection could easily be influenced by outside knowledge of whether a patient prefers a boy or a girl. Furthermore, the idea that the sex of an embryo can be determined before implantation raises the possibility of a patient choosing if they want a boy or girl. The clinic did not have a policy dealing with this issue either. The overall concern stated by the doctor was that the clinic’s policies were inadequate guidance for doctors in the in vitro fertilization field. Further, there did not seem to be any state or national regulations to these particular questions either. In the end, more law and policies need to exist governing these and other ideas if there is going to be any consistency going from one clinic to another or even one doctor to another.

The Human Genome Mapping Project: Failure?

The New York Times yesterday published an in-depth article about the projected realization of actual benefits from the human genome project. The goal behind the $3 million project was to isolate and eliminate "variant" genes, which predispose people to disease. The basic hypothesis that the research was predicated on was the common disease/common variant hypothesis.
The idea is that the varient genes are only around because they have not been eliminated by natural selection becasue they only harm people later in live after reproductive years are over. We are just starting to learn how wrong this hypothesis is.

The article quotes David B. Goldstein of Duke University, a leading young population geneticist who says the effort to nail down the genetics of most common diseases is not working. “There is absolutely no question,” he said, “that for the whole hope of personalized medicine, the news has been just about as bleak as it could be.”

All of this has develped a split between researchers who want to continue to do huge, nation-wide studies to find these common variant genes, and those, like Goldstein, who think it is a pointless, needle-in-the-haystack exercise. Goldstein says that the genetic burden of disease lies in rare variants. It takes large, expensive trials with hundreds of patients in different countries to find even common variants behind a disease. Rare variants lie beyond present reach.

Yet, we hear so much about the successes of the project. It seems like we hear in the news all the time about a new gene that has been identified for a disease. Apparently, some of this publicity is well-founded, we are identifying precise genetic differneces in humand that contribute to variation in disease susceptibility. "But while the media trumpet the successes of genome scans, little attention is paid to their failures. The fact remains that despite the hundreds of millions of dollars spent on genome-wide association studies, most of the genetic variance in risk for most common diseases remains undiscovered. Indeed, some common diseases with a strong heritable component, such as bipolar disease, have remained almost completely resistant to GWAS."

Is it just going to take time for the science to use biotechnology to solve problems? Is it a funding problem? Is the US falling further and further behind in the math and science fields. It seems like we are due for a breakthrough, right?

Live or Let Die?

My friend Tom's father-in-law, Frank, was admitted to a hospital a few years ago after suffering a massive stroke from a cerebral hemorrhage. Frank was elderly and already in poor health before suffering the stroke. The blood clot in his brain was quite large and, no matter what course of treatment was selected - medical or surgical - Frank was not expected to fully recover and his already frail health was likely to deteriorate.

Frank was unconsciousness by the time he arrived at the hospital, so it was up to his wife and family to decide how to proceed. Given his very poor prognosis, the family started thinking about Frank's attitudes about life support. They knew that he unequivocally believed that a life hooked up to machines was not a life worth living - and so began their consideration of foregoing surgical intervention and adding a "do-not-resuscitate" (DNR) order to his chart.

But their deliberation was a short one.

All discussion ended when Frank's surgeon simply announced that the plan was to move ahead with surgery. His stated reason: "I am in the business of saving people's lives, not killing them." Since Frank's vulnerable and conflicted family really didn't think they were in the killing business either, they agreed to a highly aggressive course of treatment. Frank survived the procedure and lived another year - bed-ridden and never fully regaining consciousness.

Ed's family takes full responsibility for making treatment decisions they ater came to regret. Still, they have never been quite comfortable that they made the right choices. They don't blame the doctor for 'forcing' them to do anything, but do wonder what they would have decided had he not been so certain about how to proceed.

Is it a problem when a physician equates a choice not to agressively treat a patient with killing that patient? Did the balance between Ed's values (as understood by his family) and his doctor's judgment tip in favor of the doctor's biases? If patient and families can be willingly coerced in a crisis, is patient "choice" more of an illusion than a reality?

PJM