In an article dated September 22, 2016, it was revealed that a Swedish scientist has become the first known researcher to begin attempts to modify genes in healthy human embryos—a practice which has been, and for many still is, considered “taboo.” Critics are concerned that people will begin to use such technology to create “designer” babies, or that such research could unintentionally create a new genetic disease; however, the scientist involved says he plans to use the embryos for no more than 14 days, in which time he may be able to discover new ways to treat infertility, prevent miscarriages, and use stem cells to treat various diseases.
From NPR.org, “Breaking Taboo, Swedish Scientist Seeks to Edit DNA of Healthy Human Embryos”
Excerpt from article:
“Lanner is planning to methodically knock out a series of genes that he has identified through previous work as being crucial to normal embryonic development. He hopes that will help him learn more about what the genes do and which ones cause infertility.”
A new study published by BMJ (formerly the British Medical Journal) in May 2016 suggests that medical errors may cause more deaths than lower respiratory diseases. This would make medical errors the third leading cause of death (following heart disease and cancer) in the United States. The study indicates that at least 251,454 deaths each year are due to medical error. This number is much higher than that reported by previous studies. One reason for such discrepancy may be the lack of accurate data regarding deaths caused by medical error. Causes of death listed on death certificates are based on insurance billing codes, which “are designed to maximize billing rather than capture medical errors.” As a result, death certificates fail to address human errors or other system failures.
The doctors who completed the study hope that their analysis will “lead to real reform in a health care system [that] is letting patients down.” They suggest that better reporting mechanisms must be put in place to address medical errors that lead to death. Some proponents believe that a space should be added on death certificates to indicate whether death was related to a medical error. However, to avoid legal implications when a doctor indicates such a cause of death, legislation would need to attach some protection or privilege to this information (for example, by prohibiting the information to be used in a lawsuit). Such legal protections would encourage accurate reporting by doctors and, in turn, would help establish a course of action for minimizing the most common medical errors that lead to patient death.
An alternative to open-heart surgery, transcatheter aortic valve replacement (TAVR) is a less-invasive heart-valve procedure for the treatment of severe aortic valve stenosis. The procedure, which involves threading a catheter through patients’ arteries to implant new aortic valves, has received high praise as a “technological leap” in treatment.
TAVR has been used as an alternative for patients where open-heart surgery is too risky. Despite the early success of the procedure, TAVR has higher rates of some serious complications, including blood vessel damage and stroke than traditional treatments.
Despite its initial praise, some doctors worry that the early excitement regarding TAVR can lead physicians to rely on the procedure even when it is not the best option. Currently the FDA requires that before patients can undergo the TAVR procedure, they must show that they “are not the right candidate” for traditional surgery. However, recent data show that more than half of Medicare patients who received catheter valves did not meet the FDA threshold for the procedure.
Within the next two years British scientists are confident that they will be able to prevent mitochondrial disease which effects 1,000 to 4,000 children in the U.S. However, the treatment would result in babies with three biological parents.
The procedure would allow doctors to use material from two women and one man with the goal of producing healthy embryos. Mitochondria mutations are inherited maternally, and scientists believe that they can help women who carry mutated genes by using the target couple’s “nuclear DNA” while substituting healthy mitochondrial DNA from another female donor.
There are legal and ethical questions that must be addressed before this type of procedure would be allowed in Britain. But the outlook for approval is bright considering the Human Fertilization and Embryology Authority group has reported that evidence “does not suggest that these techniques are unsafe.”
Pentobarbital was used, primarily, for the purpose of lethal injection in America. However, the principal manufacturer of pentobarbital, Hospira, Inc., halted its production of pentobarbital in 2011. As a result, states that allow the death penalty are experiencing a shortage of lethal injection chemicals. The shortage has caused states, such as Ohio, to modify their lethal injection protocols, which has led to new quandaries that implicate the 8th Amendment of the U.S. Constitution.
Counsel for the convicted murderer, Dennis McGuire of Ohio, argued recently on Mr. McGuire’s behalf in the U.S. District Court for the Southern District of Ohio. McGuire’s counsel claimed that the new, untried drug substituted for pentobarbital could leave Mr. McGuire conscious and suffering from “air hunger,” thereby posing “a substantial risk of severe pain” which would violate the 8th Amendment’s prohibition against cruel and unusual punishment. However, the Court ruled that the defense did not offer sufficient evidence to support a finding that the new drug poses a substantial risk of severe pain, and did not delay the execution proceedings.
The World Health Organization (WHO) recommends artemisinin-based combination therapies (ACTs) to treat malaria. Artemisinin is extracted from a plant. However, in April, 2013, a consortium led by the international, nonprofit organization for global health, NGO Path, announced that it had used synthetic biology to produce “semi-synthetic artemisinin.” The consortium claimed that the breakthrough would help increase global access to affordable anti-malarial drugs.
However, Sanofi, pharmaceutical firm and member of the consortium, will charge a price comparable to that of the original agricultural product. In addition, Sanofi intends to produce enough semi-synthetic artemisinin to meet only 1/3 of the world’s demand for anti-malarial drugs. Sanofi received $50 million dollars from the Bill and Melinda Gates Foundation for research and development of the product, and does not have to pay royalties on the patents—which are held by other members of the consortium.
“Redressing Past Wrongs: Changing the Common Rule to Increase Minority Voices in Research” (forthcoming, American Journal of Public Health) states that the underrepresentation of minorities in human subject research is particularly alarming because many diseases are more prevalent in minority populations, irrespective of age, gender or income. The article suggests that minority underrepresentation reflects minorities’ mistrust of the government, due, in part, to cases of abuse of minorities in human subject research; and, minorities’ comparative lack of access to health care, leading to fewer opportunities for minorities to participate in research.
The article was co-written by Bill Rencher, the health access program director of the nonprofit, Georgia Watch, and Leslie Wolf, Professor of Law at Georgia State University, and it appears in a special issue on the Ethics of Human Subjects Research in Minority Populations. The authors suggest that federal regulations be changed to protect minority populations as they protect prisoners, children and pregnant women.
This week in San Diego, California, plastic surgeons will meet to discuss the future of their industry. The head of the American Society of Plastic Surgeons, Dr. Bob Murphy, states that stem cell therapy can be used in elective procedures, as well as reconstructive procedures. Dr. Murphy went on to say that perhaps, one day, stem cells might make it possible for patients to regrow breasts after mastectomies.
On September 27, 2013 the National Institute of Health (NIH) announced that it is seeking public comment on draft proposals regarding how researchers should share data from genomic research projects. The goals of the proposal are: to protect the privacy of participants in human subject research; to protect intellectual property rights; and to promote data-sharing in order to advance genomic research. Under the proposal researchers would be able to combine data from various projects, which would enhance the value of the scientific data collected. The public may submit comments to the NIH until November 20, 2013.
Dengue fever is a tropical disease that is transmitted to humans via mosquitos, and it is prevalent in 100 countries worldwide. Dengue fever may have serious consequences and can be fatal. There is no vaccine or cure, and because the virus is only transmitted to humans and no other species, there were no animal models available to study the disease. To address this problem, researchers from MIT and the Singapore-MIT Alliance for Research and Technology have created a “humanized mouse.” These mice have features of the human immune system and may be infected with Dengue fever. As a result, the researchers discovered that a major symptom of the virus is blood platelet depletion. The study has been referred to as a major breakthrough in discerning how Dengue fever operates.