Category Archives: Ethics

Minnesota Families Sue Minnesota Department of Health, Allege that Newborn Screening Violates Informed Consent for Genetic Testing

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Tim WelchBy Tim Welch

A group of families is suing the Minnesota Department of Health (MDH) for violating a 2006 genetic privacy statute that includes an informed consent provision for collecting genetic information.  The plaintiffs allege that MDH has taken blood samples from their newborn babies without their consent, tested the blood for various disorders, kept the blood samples in storage instead of destroying them, and shared the samples with various private entities and hospitals.  The plaintiffs allege that Minnesota state law (Minn. Stat. §13.386) prohibits MDH from "collecting, storing, using, and disseminating blood and genetic information."  In collecting and testing these blood samples, MDH is complying with another Minnesota law (Minn. Stat. §144.125) that requires the mandatory testing of newborns (called "newborn screening") for certain genetic diseases.

Minnesota is not the only state to require the genetic testing of newborn babies for hereditary diseases.  In fact, all states require testing for phenylketonuria (PKU) and congenital hypothyroidism.  Testing for PKU is generally considered justified, since a newborn diagnosed with PKU must immediately follow a strict diet, or suffer irreparable brain damage.  The number of diseases tested for ranges across the country from 4 to 32.  States decide which diseases to test for based on several criteria, including benefit to the newborn, validity and reliability of the test results, and safety and effectiveness of treatment.

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Embryo Stem Cell Research–Politics and Science are Still Entangled

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Lori Andrews by Lori Andrews

On Monday, President Obama gave the green light for federal funding of embryo stem cell research. Stem cell research provides potential new treatments. Embryonic cells can develop into all the types of cells in the body. In the future, doctors might be able to repair damaged hearts by inserting new heart cells or help people walk with the use of embryonically-derived nerve cells.

Prior to Obama's actions, the existing Bush position reflected a pro-life religious belief that an eight-cell embryo is a person and stem cell research, which of necessity destroys the embryo, is murder. In August 2001, Bush addressed the nation and said that he would only allow federal funding for research on existing embryonic cell lines. Bush did not want to be a party to the termination of any further embryos, but he would allow research on cell lines where the embryos had been terminated in the past.

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Coerced Korean Egg Donor Loses Case

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JulieBergerBy Julie Burger

Debate over embryonic stem cells heats up once again, between proponents claiming the technology will be a panacea to cure the world's ills and opponents contesting the hype and raising ethical and legal issues.  One such issue hit the Korean courts on February 18—the coercion of egg donors.  The saga began when Hwang Woo-Suk, a South Korean researcher, was hailed for his groundbreaking research after he reported in Science in 2004 that he had successfully cultivated human embryonic stem cells from cloned embryos.  One year later, he reported the creation of patient-specific stem cells.  Both articles were retracted after reports surfaced that much of Hwang's work had been fabricated.  As the story unraveled, more ethical and scientific violations were revealed.

Hwang submitted duplicative photographic images of cells to Science which he falsely claimed supported his creation of different cell lines in 2005.  He also manipulated the DNA testing of the cell lines to support his desired results.  Allegations abound that Hwang switched samples to cover up the falsification of data and potentially embezzled research funds.

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Enhanced Privacy, Improved Health through Research: In Today’s World, Does the HIPAA Privacy Rule Do Enough to Ensure Both?

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Tim WelchBy Tim Welch

In February 2009, the Institute of Medicine (IOM) released a report, "Beyond the HIPAA Privacy Rule:  Enhancing Privacy, Improving Health Through Research," which outlines the IOM's evaluation of the effectiveness of the 1996 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in the context of today's electronically-intertwined world.  The report, by the IOM's Committee on Health Research and the Privacy of Health Information, assessed the impact of the HIPAA Privacy Rule on health research in the United States and made recommendations to encourage health research while preserving and improving the privacy protection of personally identifiable health information.

Every American doctor's office contains endless rows of file cabinets which house the confidential medical records of the office's patients.  Modern technology offers us the time- and space-saving convenience of storing, organizing, accessing, and transmitting these records electronically.  However, such a free flow of information—in a less-tangible and more easily-shared form than classic paper records—raises privacy and security concerns.  Medical records often contain personally identifiable information that could be damaging to a patient's dignity and lead to discrimination in other aspects of a patient's life.

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The Octuplets: A Medical Mistake Needing More Regulation?

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Bruce PatsnerGUEST BLOGGER Bruce Patsner, M.D., J.D.

The spotlight and the story line have been shifting continuously since the news of the delivery of octuplets by Nadya Suleman was first announced by Kaiser Permanente Medical Center in California on January 26, 2009.  Staged photo shoots of the smiling faces of dozens of physicians and nursing staff involved in the historic Cesarean delivery of the eight premature infants (only the second known living set of octuplets in the U.S.) were quickly replaced by interviews with family members and efforts to secure multi-million dollar contracts for morning talk show appearances.  However, public amazement quickly turned to consternation and in some cases outrage when it was revealed that the birth mother was divorced, unemployed, disabled, on food stamps and already the mother of six previous children.  Kaiser Permanente is asking California taxpayers to foot the bill for the octuplets' seven-figure hospital bill.

Infertility specialists almost immediately began to question the rationale for implanting all eight embryos, and a noted medical ethicist immediately labeled the conduct of all parties concerned "unethical."  A determined but unsuccessful effort began to keep the identity of the infertility specialist who implanted eight embryos from becoming known in the face of mounting public and medical criticism.  Two weeks after the octuplets' birth, the California Medical Board announced that it would investigate the infertility specialist for potential violations of the standard of care.  Ms. Suleman asserted in an interview with NBC News that "Those [the embryos] are my children, and that's what was available and I used them. So, I took a risk. It's a gamble. It always is."

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Genetics and Race: Will New Technologies Reopen the Old Book of Racial Inequality?

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Tim WelchBy Tim Welch

In 1883, Sir Francis Galton—a cousin of Charles Darwin—released his book Inquiries into Human Faculty and Its Development, in which the term "eugenics" is used for the first time.  In his book, Galton advocates the need for a term that "takes cognizance of all influences that tend in however remote a degree to give to the more suitable races or strains of blood a better chance of prevailing speedily over the less suitable than they otherwise would have had."  In the 1930s and 1940s, the Nazi party in Germany used eugenic principles as a basis for systematically exterminating millions of people.  In the United States, racial segregation was permitted and practiced until the 1960s.  In South Africa, legally enforced racial segregation lasted until 1994.

Over the past century, civil rights activists have successfully challenged claims that natural or inherent differences between races can be used to justify unequal treatment of certain ethnic and minority groups.  In many countries, racial equality has improved by a vast degree.  The days of attempting to justify racial hierarchies on scientific grounds seem to be in the past.  However, new applications of genetic technologies could come dangerously close to reopening a chapter of human history that many would rather leave closed.

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Octuplets: Medical Miracle or Medical Mistake?

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Lori Andrews by Lori Andrews

When octuplets were born at Kaiser Permanente Bellflower Medical Center in California, the doctor overseeing the 46 health care professionals in the delivery room called the event "marvelous" and described the mother as "courageous."  But was the event really marvelous?  Or was it a public health nightmare of fertility treatments gone awry?

Between 1980 and 2003, the number of higher-order multiples (triplets or more) increased four-fold.  The prime culprits responsible for this rise in multiples are fertility drugs and in vitro fertilization (IVF).  While other countries regulate the number of embryos that can be transferred to a woman during an in vitro fertilization treatment, the U.S. does not.  As a consequence, one in three in vitro fertilization births involves multiples. 

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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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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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