Divorce, Bioethics Style: Can a Kidney Donor Get His Organ Back From His Ex?

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Lori Andrews by Lori Andrews

New options in medical therapies, including reproductive technologies and organ donation, provoke heated debates among philosophers and physicians.  But these therapies also create disputes in the unlikeliest of places:  divorce courts.

When a man has an infertility problem, his wife can be inseminated with donor sperm to create a child for the couple.  But what if the couple later split?  Initially, some ex-wives tried to deny their ex-husbands visitation rights, saying the men had no biological bond to the children.  And some ex-husbands tried to shirk child support, saying “I’m not that baby’s daddy.”  Courts initially fumbled (with a 1956 Illinois court decision holding that donor insemination constituted adultery, even if the husband consented).  But ultimately, courts and most state legislatures came to a solution that benefited the child: a man who consented to the insemination of his wife has the rights and responsibilities of a legal father.

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Could that Bottled Water Be Raising Your Risk of Diabetes?

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JulieBergerBy Julie Burger

Bisphenol A (BPA) is a chemical that is used in most plastic food and beverage containers.  BPA is also found in dental sealants, the resin lining of cans, carbonless paper (often used for receipts), pizza boxes, and other common household products.  A recent study published in the Journal of the American Medical Association (JAMA) looked at possible associations between BPA levels in adults and their health status.  The study concludes that there is a significant link between BPA and diabetes, cardiovascular disease (including coronary heart disease and heart attacks), and liver-enzyme abnormalities.  According to the Center for Disease Control (CDC), as of 2007 (the most recent data available), nearly 24 million children and adults, approximately 8% of the population, have diabetes.  Diabetes contributed to 233,619 deaths in 2005 alone and in 2006 was ranked as the seventh deadliest disease in the United States.  Diabetes related deaths have increased by 45% since 1987.  Diabetes is a serious, growing health concern.

Previous studies have also demonstrated adverse effects of BPA on the brain, reproductive system, and metabolic processes (including insulin resistance).  These studies tested the effect of BPA on animals using BPA levels that were less than what federal agencies have determined is an acceptable daily intake dose.

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Handheld Laboratories? Ability to Conduct “Instant DNA Tests,” Could Be Available to Physicians, Crime Scene Investigators

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Tim WelchBy Tim Welch

The ability to conduct DNA tests in the palm of your hand might sound like something out of a science fiction movie, but the technology could be available for widespread use sooner than you thought.  Research scientists at the University of Virginia are developing a device about the size of a microscope slide that could pave the way for handheld DNA tests that would produce results in minutes, perhaps eliminating the need for a central laboratory.  Such devices could be crucial to doctors in diagnosing infectious diseases in minutes rather than days, as well as to crime scene investigators in gathering forensic information on scene.  While handheld DNA tests would have many useful applications, they would also raise important questions.

If doctors were able to receive DNA test results in minutes, rather than wait days to hear back from a laboratory, their response time in diagnosing and treating infectious diseases would be shortened dramatically.  This would be extremely useful with diseases that worsen quickly when left untreated, such as meningitis.  In addition, a cheap and effective handheld DNA test could reduce the cost of treating patients with "personalized medicine," or a therapeutic regime based on a patient’s own genetic code.

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Space Elevators and Carbon Nanotube Patents

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Jake Meyer by Jake Meyer

Space elevators are a simple idea that could make transporting passengers or cargo into space relatively easily and inexpensively as compared to our current method of space transport – igniting millions of pounds of fuel to blast a rocket out of our atmosphere.  Most concepts for a space elevator involve a tether anchored to the earth, for example on a floating platform somewhere in the Earth’s oceans.  The tether would stretch 100,000 kilometers or so from Earth, past the Earth’s atmosphere and into space where the tether would be attached to a large counterbalance.  This counterbalance would orbit the Earth while the centrifugal forces from the earth’s rotation would keep a constant tension on the tether.  Under a constant tension, the tether could be used as a rail for a lift or “climber” that could ascend the tether into space carrying with it a payload of cargo or passengers.

Besides making space transport inexpensive, space elevators could also solve our need for environmentally friendly energies.  Space elevators could be used to install large solar power satellites in space that could provide us with inexpensive and continuous energy.  These types of projects are not feasible with our current rocket technology.

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Who’s Peeking at Your Genes? Direct-to-Consumer Genetic Tests and Your Privacy

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JulieBergerBy Julie Burger

If you want to get a peek at your own genes, there are now several companies that will help you look: 23andMe, Navigenics, and deCODEme offer direct-to-the-consumer genetic testing. For a not-so-nominal fee combined with a sample of your DNA (spit, a cheek swab) the companies will tell you whether you are more or less likely to get a certain disease, or (less helpfully) what kind of ear wax you have and what color your eyes are. Questions over what the company will do with the information, what the consumer will do with the information, the quality of the information and the test, and whether this is a good use of a health resource have all been raised.

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Genentech Files Petition with FDA Urging Regulation Over All In Vitro Diagnostic Tests Aimed for Use in Therapeutic Decision Making

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Tim WelchBy Tim Welch

The biotechnology company Genentech filed a 31-page citizen petition on December 9, 2008 urging the Food and Drug Administration (FDA) to regulate all in vitro diagnostic tests aimed for use in therapeutic decision making.  Under the current regulatory system used by the FDA, there are two types of in vitro diagnostic tests: those that are developed by device manufacturers and sold as diagnostic test "kits," and those that are developed by clinical laboratories for use within the laboratory ("in-house").  The FDA has regulated the former, while it has not regulated the latter.  This allows developers of "in-house" diagnostic tests to make claims about the accuracy, validity, and effectiveness of their tests which are not subjected to the same scientific scrutiny from the FDA that is required of similar test "kits."  Genentech argues in the petition that this regulatory inconsistency poses a serious threat to patients’ health because "the future of personalized medicine depends on the development of pharmacogenomic tests," and "it is critical that they are accurate, reliable, and clinically valid (i.e., effective)."

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Testing Children for “Sports Genes”

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Lori Andrews by Lori Andrews

While some of us might be heading to the gym as we start the new year, certain parents are making another sort of resolution.  They are dialing up Atlas Sports Genetics and plunking down their credit cards to have their infants and toddlers tested for genes supposedly related to sports ability.  One woman who was considering such a test told The New York Times, “What if my son could be a pro football player and I don’t know it?”

As the denizen of a city famous for sports highs (Michael Jordan’s Bulls) and lows (the Chicago Cubs’ near misses), I am cautious about making predictions about a current team, let alone betting my hopes that a three year old will grow up to be the next Tom Brady or Peyton Manning.  And caution in this field should be the word of the day.  The proposed test raises both scientific and social issues.

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Happy Holidays from the ISLAT Team

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Everyone here at the Institute for Science, Law & Technology wishes you all Happy Holidays! We will be back with new posts on Tuesday, January 6, 2009. In the meantime, send us your New Years Resolutions that have to do with genetics. We would like to thank all of our readers, and we look forward to continuing our blog in the new year.

NIH Pulls Genetic Information from Internet after Research Shows Info Can Be Linked to Individuals

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JulieBergerBy Julie Burger

For years, scientists have raced to unlock the mysteries hidden in the human genome. Relatively recent research methodologies, used in genome wide association studies (GWAS), are allowing scientists to much more rapidly uncover genes that may be linked to diseases. In GWAS, genetic and health information from thousands of people is compared to locate mutations or gene variants for diseases like breast cancer, diabetes and heart disease.  (For a scientific viewpoint as to why this research theory might not be successful, click here.)  Because this type of research calls for genetic and other information from thousands, or even tens of thousands of people, researchers are increasingly trying to tap into existing bodily tissue samples and private medical data from blood or biopsy samples taken at a physician’s office or hospital.  Researchers are also asking to share information from other researchers’ studies.  What many people don’t realize is that information about them and their genes could be taken and shared among researchers or even posted on the internet.

Researchers’ quest to correlate genes with disease has encouraged government agencies to implement policies to increase the sharing of genetic samples and genetic and health information even where the individual has not explicitly consented to the secondary use. The National Institutes of Health (NIH) has implemented a plan to increase access to genetic and associated health information. Starting in January 2008, researchers who received government funding for GWAS were required at the end of the study to submit the genetic profile and associated information about the health of the people whose tissue was used. The health information might be blood pressure or weight, or it might be information about drug use, mental health, and it could include information about family relationships.

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Five Major Intellectual Property Offices to Share Work

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Jake Meyer by Jake Meyer

On October 31, 2008, the U.S. Patent and Trademark Office announced a work-sharing initiative between five major intellectual property offices.  The initiative is the result of a meeting on October 27 and October 28, 2008, at Jeju, Korea, between the heads of the five major intellectual property offices to discuss collaboration among the offices.  The Korean Intellectual Property Office, the European Patent Office, the Japan Patent Office, the State Intellectual Property Office of the People’s Republic of China, and the U.S. Patent and Trademark Office stated that they were creating an initiative with the goal of: “The elimination of unnecessary duplication of work among the offices, enhancement of patent examination efficiency and quality, and guarantee of the stability of patent right.”

The five intellectual property offices established 10 “Foundation Projects,” such as creating a common application format or standardizing the training of patent examiners, to further the initiative’s goal.  The projects are designed to harmonize the examination process and searches for prior art and to standardize the information-sharing process.  Each office will oversee two of the “Foundation Projects.”  The offices agreed that by the end of April 2009 they would exchange detailed proposals on each “Foundation Project.”

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