Should direct-to-consumer personalized genomic medicine remain unregulated?: a rebuttal of the defenses.

Direct-to-consumer personalized genomic medicine has recently grown into a small industry that sells mail-order DNA sample kits and then provides disease risk assessments, typically based upon results from genome-trait association studies. The companies selling these services have been largely exempted from FDA regulation in the United States. Testing kit companies and their supporters have defended the industry's unregulated status using two arguments. First, defenders have argued that mere absence of harm is all that must be proved for mail-order tests to be acceptable. Second, defenders of mail-order testing have argued that there is an individual right to the tests' information. This article rebuts these arguments. The article demonstrates that the direct-to-consumer market has resulted in the sidelining of clinical utility (medical value to patients), leading to the development of certain mail-order tests that do not promote customers' interests and to defenders' downplaying of a potentially damaging empirical study of mail-order genomic testing's effects on consumers. The article also shows that the notion of an individual right to these tests rests on a flawed reading of the key service provided by mail-order companies, which is the provision of medical interpretations, not simply genetic information. Absent these two justifications, there is no reason to exempt direct-to-consumer personalized genomic medicine from stringent federal oversight.

[Internet pharmacies and counterfeit drugs]. / Versandhandel und Arzneimittelfälschungen.

Counterfeit drugs are mainly distributed via the internet. On statement of the World Health Organization (WHO), one medicine out of ten ordered on the internet is counterfeit. Fighting against counterfeits needs close and international cooperation among manufacturers, wholesalers, pharmacies and agencies.

Ethical issues in transnational "mail order" oocyte donation.

The rising demand for donor oocytes in developed countries has led to what is referred to as transnational or international oocyte donation, or the outsourcing of oocyte donation to poorer countries. In a further twist, frozen sperm from a recipient's partner can also be mailed to a foreign clinic to fertilize donor oocytes, and the resulting embryos are mailed back, cryopreserved, for transfer to the recipient. Among the numerous ethical concerns raised by this practice of mail order oocyte donation, the most obvious are that underprivileged women from poorer countries are often exploited; fertility physicians from richer counties abdicate responsibility for the welfare of donors; and responsibility could become an issue of contention if transmission of disease to the oocyte recipient or congenital defects in offspring born from such oocyte donation were to occur. Moreover, savings from utilizing donors from poorer countries ought to be shared with oocyte recipients.

Folie a trois in a multilevel security forensic treatment center: forensic and ethics-related implications.

Shared (Induced) Delusional Disorder commonly occurs in close relationships and involves a varying number of participants who may be nonconsanguineous. The disorder has been associated with forensic and fatal consequences. Its occurrence in three nonrelated, incarcerated individuals is described in this article. This case of folie à trois has forensic implications and raises several questions of ethics that relate to autonomy, confidentiality, safety, and risk estimation. The presentation, management, and outcome of the patients suggest that a high index of suspicion is needed to detect cases in similar settings. The report concludes that the rarity of the disorder in a forensic mental health population may be the result of underdetection, given that conditions are conducive to the development of the disorder. Telltale signs of its manifestation are hypothesized as being responsible for some events in incarcerated populations. Physical separation and antipsychotic medications remain the mainstay of treatment.