Ethical considerations of cellular immunotherapy for cancer.

With the rapid development of immunology, molecular biology, and associated technologies such as next-generation sequencing, cellular immunotherapy has recently become the fourth major cancer treatment. Immunotherapies based on T cells, natural killer cells, and dendritic cells play key roles in cancer immunotherapy. However, their application in clinical practice raises several ethical issues. Thus, studies should focus on proper adherence to basic ethical principles that can effectively guide and solve related clinical problems in the course of treatment, improve treatment effects, and protect the rights and interests of patients. In this review, we discuss cellular immunotherapy-related ethical issues and highlight the ethical practices and current status of cellular immunotherapy in China. These considerations may supplement existing ethical standards in cancer immunotherapy.

Ethical Implications in Vaccine Pharmacotherapy for Treatment and Prevention of Drug of Abuse Dependence.

Different immunotherapeutic approaches are in the pipeline for the treatment of drug dependence. "Drug vaccines" aim to induce the immune system to produce antibodies that bind to drugs and prevent them from inducing rewarding effects in the brain. Drugs of abuse currently being tested using these new approaches are opioids, nicotine, cocaine, and methamphetamine. In human clinical trials, "cocaine and nicotine vaccines" have been shown to induce sufficient antibody levels while producing few side effects. Studies in humans, determining how these vaccines interact in combination with their target drug, are underway. However, although vaccines can become a reasonable treatment option for drugs of abuse, there are several disadvantages that must be considered. These include i) great individual variability in the formation of antibodies, ii) the lack of protection against a structurally dissimilar drug that produces the same effects as the drug of choice, and iii) the lack of an effect on the drug desire that may predispose an addict to relapse. In addition, a comprehensive overview of several crucial ethical issues has not yet been widely discussed in order to have not only a biological approach to immunotherapy of addiction. Overall, immunotherapy offers a range of possible treatment options: the pharmacological treatment of addiction, the treatment of overdoses, the prevention of toxicity to the brain or the heart, and the protection of the fetus during pregnancy. So far, the results obtained from a small-scale experiment using vaccines against cocaine and nicotine suggest that a number of important technical challenges still need to be overcome before such vaccines can be approved for clinical use.

En niños alérgicos con asma o rinitis, ¿es útil la inmunoterapia? / In allergic children with asthma or rhinitis, is immunotherapy useful?

Conclusiones de los autores del estudio: en niños y adolescentes con rinoconjuntivitis alérgica, la inmunoterapia no ha mostrado beneficio para disminuir los síntomas o la utilización de medicación. En el asma alérgica la inmunoterapia subcutánea parece reducir los síntomas y el uso de medicación, pero la evidencia es limitada en cuanto a la magnitud del efecto. Además, no está exenta de efectos secundarios. La inmunoterapia sublingual en dosis altas produce mejoría sintomática y disminuye el uso de medicación en niños con asma y alergia a polen de gramíneas. Comentario de los revisores: la prevalencia de las enfermedades alérgicas está aumentando, generando importante morbilidad. El tratamiento con inmunoterapia no ha demostrado su eficacia, ya que produce mejorías estadísticamente significativas pero clínicamente poco importantes y con riesgo de efectos secundarios. Por ello no debe generalizarse su uso, reservándolo solo para casos concretos evaluados detenidamente (AU)

Authors’ conclusions: There is at present insufficient evidence that immunotherapy in any administration form has a positive effect on symptoms and/or medication use in children and adolescents with allergic rhino conjunctivitis. In allergic asthma, the subcutaneous immunotherapy appears to reduce symptoms and use of medication but the evidence is limited concerning the size of benefit. It is not free of side effects. High dose sublingual immunotherapy produces symptomatic improvement and decreases the medication use in children with asthma and allergies to grass pollen. Reviewers’ commentary: The prevalence of allergic diseases is increasing, and its burden is substantial. The efficacy of the treatment with allergen-specific immunotherapy has not been demonstrated; although the improvement has statistical significance, the clinical relevance is poor, with an increased risk of adverse reactions. Due to that, the use of immunotherapy should not be generalised, reserving it for cases thoroughly evaluated (AU)

Provenge: revolutionary technology or ethical bust?

Sipuleucel-T (known by the trade name, "Provenge") is the first prostate cancer vaccine approved by the Food and Drug Administration (FDA), and represents a new type of cancer therapy termed, Autologous Cellular Immunotherapy (ACT). This therapy has been described as a revolution in technology by clinicians and researchers alike. However, policy-makers and health economists question the efficacy of such treatment given its costs, while mainstream media often bemoan Provenge as yet another example of a healthcare system gone awry. This paper examines the debate for and against Provenge, and discusses why Medicare adoption of payment protocols for the vaccine may violate the egalitarian and feminist principles of distributive justice theory. The paper also acknowledges the larger context of the Provenge debate within the bioethical community; that is, how much should society be willing to invest to prevent death? The paper concludes by arguing for a more thorough ethical review of such new technologies by policy-makers prior to the adoption of funding protocols.

The role of health technology assessment in the comprehensive evaluation of the impact of immunotherapy on real practice.

The increasing development of new health care technologies, along with the ageing of the population and the increasing patients' expectations, cause a significant raise in medical costs, inducing in policy makers the need for well-funded information to support their decisions. The development of Health Technology Assessment (HTA), which is the systematic evaluation of properties, effects or other impacts of health technology and can be considered as a bridge between the world of research and the world of policy-making, reflects this high level of demand. HTA requires a multidisciplinary approach, that covers many different disciplines, in order to assess various aspects of health technologies, as technical properties, safety, efficacy/effectiveness, economic aspects, social, legal, ethical and political impacts. Allergic diseases show a worldwide increasing prevalence and consequent increasing costs, which result very high in recent evaluations. Specific immunotherapy is the only treatment able to alter, differently from drugs, the natural course of allergic diseases, exerting a long-lasting therapeutic effect, that persists also after stopping the therapy. This has a potential great impact in the cost of disease, which only recently was considered in properly designed studies. These issues claim for a larger use of HTA, which may provide a more comprehensive approach to the evaluation of the impact of immunotherapy on allergic patients.