December 6, 2013
Genetic tester to stop providing data on health risks
Bowing to the Food and Drug Administration, the genetic testing service 23andMe said Thursday that it would stop providing consumers with health information while its test undergoes regulatory review. The decision was in response to a warning letter sent by the agency two weeks ago saying that the genetic test was a medical device that requires approval. (New York Times)
December 5, 2013
Dialysis raises hard questions for older patients
Researchers at Tufts University and the University of New Mexico underscored the disconnect in a recent review. Ninety-five percent of patients said they and their families want to be given information about life expectancy, the authors noted. But a 2010 survey cited in the study found that 90 percent of patients had never discussed the issue with their nephrologists. (New York Times)
‘Stem cell treatments’ mar trust
Many cases have emerged in which patients experience trouble after receiving treatment by private clinics under the name of regenerative medicine, which has been practiced without sufficient checks on their effectiveness and safety. Since the successful creation of induced pluripotent stem (iPS) cells was awarded the Nobel Prize in Physiology or Medicine, regenerative medicine has gained attention among the general public as a “dream treatment.” At some university hospitals and other medical institutions, clinical iPS research approved by the government has been steadily progressing. (The Yomiuri Shimbun)
Putting the breaks on home genetic testing: Four questions with geneticist Scott Diehl
Scott Diehl is director of the Center for Pharmacogenomics and Complex Disease Research at the Rutgers School of Dental Medicine, and a longtime critic of tests such as 23andMe, which derives its name from the fact that human cells contain 23 pairs of chromosomes. Diehl says ordering the test off the market was the right decision. (Medical Xpress)
December 3, 2013
Genetic testing should adhere to medical, not business, ethics: FDA’s regulation of 23andMe is a welcome move for consumers
The truth is that we still understand very little about how our genes interact with our environment, and our individual choices, to impact our health. Despite the many advances in genomics, we still don’t understand much about genomics at a most basic level. Even some of the most well-studied genes, such as the BRCA 1 & 2 genes discussed above, don’t tell a person if she’ll get cancer. After all, some women with these mutations never get cancer, and we don’t know why. (Huffington Post)
Medical technician sentenced in Hepatitis C outbreak
The technician, David M. Kwiatkowski, 34, pleaded guilty in August to 16 federal charges, including tampering with a consumer product and obtaining controlled substances through fraud. Prosecutors said that while he was working as a traveling medical technician in several states, including New Hampshire, Kansas and Maryland, Mr. Kwiatkowski injected himself with syringes of fentanyl, a powerful painkiller, then filled them with saline and put them back into circulation for patients. (New York Times)
A New Edition of The Journal of the American Medical Association is Available
The Journal of the American Medical Association (Volume 310, No. 20, November 27, 2013) is now available online by subscription only.
- “The 50th Anniversary of the Declaration of Helsinki: Progress but Many Remaining Challenges” by Joseph Millum, et al.
- “The Declaration of Helsinki, 50 Years Later” by Paul Ndebele
- “EBM’s Six Dangerous Words” by R. Scott Braithwaite
- “World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects” by the World Medical Association
- “Health Care Cost Control and Views of Physicians” by Janet Weiner
- “Health Care Cost Control and Views of Physicians—Reply” by Jon C. Tilburt, et al.
Child taken from womb by social services
A pregnant woman has had her baby forcibly removed by caesarean section by social workers. Essex social services obtained a High Court order against the woman that allowed her to be forcibly sedated and her child to be taken from her womb. The council said it was acting in the best interests of the woman, an Italian who was in Britain on a work trip, because she had suffered a mental breakdown. The baby girl, now 15 months old, is still in the care of social services, who are refusing to give her back to the mother, even though she claims to have made a full recovery. (The Telegraph)
December 2, 2013
Should your genetics be available to insurance companies?
Ontario is proposing a change to the Ontario Human Rights Code aimed at protecting people’s genetic information from being used by insurance companies and employers. This would allow more people to have genetic testing done, for health or research purposes — testing they would possibly not do if they had to disclose the test results to insurers. (Huffington Post)
November 29, 2013
Study unlocks trove of public health data to help fight deadly contagious diseases
In an unprecedented windfall for public access to health data, University of Pittsburgh Graduate School of Public Health researchers have collected and digitized all weekly surveillance reports for reportable diseases in the United States going back more than 125 years. The easily searchable database, described in the Nov. 28 issue of the New England Journal of Medicine, is free and publicly available. Supported by the Bill & Melinda Gates Foundation and the National Institutes of Health (NIH), the project’s goal is to aid scientists and public health officials in the eradication of deadly and devastating diseases. (Medical Xpress)
Surrogates often make call to deactivate heart devices
People who have implanted heart devices rarely have advance directives indicating whether they want them deactivated near the end of life, according to a new study. So the decision often has to be made by loved ones. So-called cardiovascular implantable electronic devices (CIEDs) are used to treat arrhythmias, conditions in which the heart beats too fast, too slow or in an irregular pattern. (Reuters)
November 26, 2013
Surgically implanted eyeball jewelry is the new piercing
Dr. Emil Chynn surgically implanted the eye jewelry a few weeks ago on Park Avenue in Manhattan for $3,000 as local news cameras captured the moment. Chynn operated in front of a floor-to-ceiling glass window so passersby could watch from the street. But Luckayanko didn’t mind. Chynn said he’d given her a Valium and some laughing gas to calm her nerves. (ABC News)
A New Edition of The Journal of Medicine & Philosophy is Available
The Journal of Medicine & Philosophy (Volume 38, No. 6, December 2013) is now available online by subscription only.
- “What Are Our Moral Duties? Critical Reflections on Clinical Equipoise and Publication Ethics, Clinical Choices, and Moral Theory” by Mark J. Cherry
- “The Ethics of Limiting Informed Debate: Censorship of Select Medical Publications in the Interest of Organ Transplantation” by Michael Potts, et al.
- “Reproductive Autonomy as Self-Making: Procreative Liberty and the Practice of Ethical Subjectivity” by Catherine Mills
- “Artifacts, Intentions, and Contraceptives: The Problem with Having a Plan B for Plan B” by Philip A. Reed
- “Rethinking Voluntary Euthanasia” by Byron J. Stoyles and Sorin Costreie
- “Comparable Placebo Treatment” and the Ethics of Deception” by Shlomo Cohen and Haim Shapiro
- “Paternalism in the Name of Autonomy” by Manne Sjöstrand, et al.
- “Pragmatism, Metaphysics, and Bioethics: Beyond a Theory of Moral Deliberation” by Matthew Pamental
- “The Journal Loses Its Founding Editor” by H. Tristram Engelhardt, Jr.
A New Edition of Genetics in Medicine is Available
Genetics in Medicine (Volume 15, No. 11, November 2013) is now available online by subscription only.
- “Finding common ground” by James P. Evans
- “Recommendations for returning genomic incidental findings? We need to talk!” Wylie Burke, et al.
- “Processes and preliminary outputs for identification of actionable genes as incidental findings in genomic sequence data in the Clinical Sequencing Exploratory Research Consortium” by Jonathan S. Berg, et al.
- “Genetic incidental findings: autonomy regained?” by Effy Vayena and John Tasioulas
- “Let us ask better questions” by Ellen Wright Clayton and Susan E. Kelly
- “Return of incidental findings in genomic medicine: measuring what patients value—development of an instrument to measure preferences for information from next-generation testing,” by Caroline Savage Bennette, et al.
- “Experiences and attitudes of genome investigators regarding return of individual genetic test results” by Rachel B. Ramoni, et al.
- “Researchers’ views on return of incidental genomic research results: qualitative and quantitative findings” by Robert Klitzman, et al.
- “Genetic medicine and incidental findings: it is more complicated than deciding whether to disclose or not” by Gillian Crawford, et al.
- “ACMG statement on access to reproductive options after prenatal diagnosis” by ACMG Board of Directors
- “ACMG Standards and Guidelines for constitutional cytogenomic microarray analysis, including postnatal and prenatal applications: revision 2013” by Sarah T. South, et al.
November 21, 2013
Making medical decisions for patients without surrogates
People who are decisionally incapacitated but haven’t provided advance directives for their health care and have no health care surrogates — sometimes called the “unbefriended” or “unrepresented” — are some of the most powerless and marginalized members of society. Most of the unrepresented are elderly, homeless, mentally disabled, or socially alienated. Yet medical decision making for these vulnerable patients often lacks even minimally sufficient safeguards and protections. Consequently, health care decisions made on their behalf are at risk of being biased, arbitrary, corrupt, or careless. (New England Journal of Medicine)
You’ve got mail…about STDs
A new free mobile app, the first of its kind, provides broader tools than the others, earning it praise from public health experts for promoting STD testing and awareness. The cutting-edge program, however, is also stoking some concerns about privacy, legality and what message its services send. (Scientific American)
November 20, 2013
Now, Dr. Rothberg and colleagues in Pennsylvania and Massachusetts have written a new paper on these little known, poorly understood medical directives. It is a small study of 16 health care proxies for patients with advanced dementia — largely their adult children, and some nieces and nephews. The key findings? Often, proxies are confused about how “do not hospitalize” orders work. Several proxies believed, mistakenly, that a such an order was equivalent to a request to withhold medical intervention altogether. (New York Times)
How doctors die
When it comes to dying, doctors, of course, are ultimately no different from the rest of us. And their emotional and physical struggles are surely every bit as wrenching. But they have a clear advantage over many of us. They have seen death up close. They understand their choices, and they have access to the best that medicine has to offer. (New York Times)
Doctors say heart drug raised risk of an attack
Cardiologists have accused a small drug company of withholding data from a clinical trial showing that the company’s drug, meant to reduce the risk of heart attacks, increased the risk instead. The cardiologists said that the company, Anthera Pharmaceuticals, did not turn over data to academic investigators, as it was required to do, for more than a year. (New York Times)
Many pediatricians uncomfortable providing care to kids with genetic conditions
Many primary care pediatricians say they feel uncomfortable providing health care to patients with genetic disorders. Also, many do not consistently discuss all risks and benefits of genetic tests with patients, according to research published today in the American Journal of Medical Genetics. (Medical Xpress)
November 19, 2013
Long-term oral contraceptive use may increase glaucoma risk
The study found women who used oral contraceptives, no matter which kind, for longer than three years were 2.05 times more likely to also report a diagnosis of glaucoma. Although the results of the study do not speak directly to the causative effect of oral contraceptives on the development of glaucoma, it indicated that long-term use of oral contraceptives might be a potential risk factor for glaucoma, and might be considered as part of the risk profile for a patient together with other existing risk factors, the researchers said. (UPI)