Do Fair and Just Systems Require Compensation for the Disadvantages of the Natural Lottery? A Discussion on Society's Duties on the Provision of Gene Therapy.

Genetic diseases have been thought to be acquired as a result of sheer bad luck. However, recent advances in medical science have demonstrated the mechanisms of genetic disorders, which enable us to intervene with their occurrence and treatment. Today, gene therapy, once considered too risky, has become safer and can save the lives of patients with previously untreatable and lethal genetic diseases. However, the positive expectations from gene therapy are overshadowed by their extremely high prices. Thus, the duty of society in the provision of gene therapies has been frequently discussed. The discussions mainly focus on how to meet the genetic treatment needs of patients without violating the notion of justice and fairness in society. This study discusses the theoretical grounds for society's duty to compensate for genetic disease patients' disadvantages by providing them with appropriate genetic treatment. The main question is whether a fair and just system requires society to provide available lifesaving gene therapy to patients in need. The discussion is constructed on the crucial notion of the fair equal opportunity principle in a just system and the plausibility of including disadvantages emerging from bad luck in the natural lottery in the domain of justice.

Inconsistencies in institutional review board decisions: A proposal to regulate the decision-making process.

Medical sciences and medical technologies are developing in an enormous pace. The number of multi-site and multi- cultural clinical trials is increasing in line with this development. Yet, the increase in number brought about a problem, namely that of inconsistencies in institutional review board (IRB) decisions. The efforts to develop a comprehensive and systematic framework for the decision-making procedure of IRB members were ineffective and ended up in form of lists containing general principles of research ethics. The increase in multi-site, multi-cultural clinical research together with the initiation of new institutional review boards in countries involved in these researches emphasize the importance of defining the sine qua non criteria for considering a proposed research study to be ethical, as well as for avoiding inconsistencies in institutional review board decisions. The aim of this study is to prepare a toolkit for IRB members to regulate the ethical decision-making process while minimizing inconsistencies in institutional review board decisions. The objective is to minimize the effect of subjective factors and to ensure that all issues in key international documents and guidelines are covered prior to the point of reaching a conclusion for the proposed research protocol. By providing a comprehensive review of the Declaration of Helsinki, Council For International Organizations of Medical Sciences Guidelines, International Conference on Harmonization Guidelines, Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants of World Health Organization, and Medical Ethics Manual of the World Medical Association, this study aims at developing a standard evaluation sheet for institutional review board members to evaluate the ethical appropriateness of proposed trial protocols (Tab. 1, Ref. 35). Keywords: clinical research, ethics review committee, human subjects, informed consent, institutional review board, research ethics.

MAIN ETHICAL BREACHES IN MULTICENTER CLINICAL TRIALS REGULATIONS OF TURKEY.

Turkey has been a growing market for multicenter clinical trials for the last ten years and is considered among the top ten countries in terms of potential study subject populations. The objective of increasing the share of Turkey in multicenter clinical trials is strongly supported. This ambitious goal of Turkey raises the need to have regulations in compliance with other leading countries conducting clinical trials. The latest published Turkish regulations on clinical trials are structured in compliance with the International Conference on Harmonization (ICH) Guidelines and in harmony with the regulations of other leading countries in clinical research, such as the US. There are still flaws in Turkish regulation with the risk of violating human subjects' rights and issues with responsible conduct of research. The aim of this article is to compare Turkish clinical trials regulations with those of the US, to determine if there exists any incompatibility between the countries' regulations and, if so, how to ameliorate these. The main flaws in Turkish clinical trials regulations are identified as follows: lack of definition of the term "human subject; absence of explicit referral to the unacceptability of Conflict of Interest (COI) and taking measures to avoid it; exiguity of emphasis on plurality of the IRB members; nonexistence of a clear expression that this is research; and clinical equipoise, regarding the treatment of the existing clinical problem and lack of integration with international accreditation systems for Institutional Review Boards.

Hyperbaric levobupivacaine in anal surgery : Spinal perianal and spinal saddle blocks.

BACKGROUND: An ideal anesthetic technique for anal surgery on an outpatient basis should permit early mobilization without pain or residual complications of anesthesia. The aim of this study was to analyze the reliability and efficacy of spinal perianal and spinal saddle block by using two different doses of levobupivacaine for perianal surgery and their effects on voiding, first analgesic requirement and hospital discharge times. METHODS: A prospective, randomized, double-blinded study was conducted on 78 ASA I-II patients scheduled for elective perianal surgery. Patients were randomized into two groups, the spinal perianal group and the spinal saddle group. Hyperbaric levobupivacaine 1.5 mg (perianal) or 6 mg (saddle) was administered intrathecally through the L4-5 intervertebral space by a 25-gauge Whitacre spinal needle with the patient in the sitting position. Sensory block was evaluated using a surgical toothless clamp until satisfactory block reached the S4 sensory level and motor block was evaluated using a modified Bromage scale. Patient and surgeon satisfaction were recorded for each patient. Ambulation, voiding and hospital discharge times were assessed. RESULTS: There was no statistical difference between the two groups demographically. Perianal low dose levobupivacaine use resulted in no motor block (Bromage=0, p=0.006) and a sensory block limited to the S4 level. The low and conventional doses of levobupivacaine provided sufficient anesthesia during the surgical procedures. The sensory block regression time in the perianal block group was shorter than the saddle group (p=0.048). Time to first analgesic requirement was significantly longer in the saddle block group (p<0.05). The times of first ambulation, the first voiding and hospital discharge in patients with the perianal block were significantly shorter than patients in the saddle block (p<0.05, p<0.01, p<0.05, respectively). CONCLUSION: The results of the study showed that the use of 1.5 mg hyperbaric levobupivacaine provides sufficient and satisfactory anesthesia in ambulatory perianal surgery.

Cutaneous, pulmonary and hepatic sarcoidosis associated with autoimmune complications during interferon-alpha treatment for hepatitis C virus infection.

A patient with hepatitis C virus (HCV) infection was diagnosed with cutaneous, pulmonary and hepatic sarcoidosis following interferon alpha therapy. There are only a few cases of sarcoidosis associated with this treatment. This is the first case who not only developed sarcoidosis, but also autoimmune hypothyroidism and thrombocytopenia during interferon alpha therapy due to the immunomodulatory effects of the drug.

Chemical matricectomy with phenol for the treatment of ingrowing toenail: a review of the literature and follow-up of 172 treated patients.

There are many options for the treatment of ingrowing toenail, ranging from simple conservative approaches to extensive surgical procedures. Although conservative treatment modalities are helpful in patients with stage 1 disease, stage 2 and 3 ingrowing toenails are best treated surgically. The aim of this study was to evaluate the efficacy of chemical matricectomy with phenol for the treatment of ingrowing toenail. A total of 350 phenol ablations were performed on 172 patients with stage 2 and 3 disease. Each patient was reviewed weekly until full wound healing was achieved and afterwards, to assess the long-term efficacy of the treatment, they were followed up for a mean period of 25 months. The healing period after the operation ranged from 2 to 4 weeks and no postoperative complications were seen. Only two recurrences (0.57%) were observed, after 9 and 17 months, respectively, and nail spikes had developed in only two toes (0.57%). The success rate was found to be 98.8%. We conclude that phenol cauterization is an excellent surgical method for the treatment of ingrowing toenail because of its simplicity, low morbidity and high success rate.

A painless subungual osteoid osteoma.

BACKGROUND: Osteoid osteoma is a benign bone tumor. Its etiology is not fully understood and the role of trauma is still elusive. OBJECTIVE: Osteoid osteoma mostly presents with a poorly localized pain that is worst at night and characteristically relieved by salicylates. It usually occurs on the weight-bearing bones of the lower extremities, but toe location is quite rare. Here, we present a case of painless osteoid osteoma located subungually on the dorsum of the great toe. RESULT: A 29-year-old woman presented with a painless subungual mass on the dorsum of her great toe. Subungual exotosis, osteochondroma, and osteoma were considered in the differential diagnosis and the lesion was totally excised. Histopathologic examination showed characteristic findings of osteoid osteoma. CONCLUSION: A painless osteoid osteoma is rarely seen and it can be easily misdiagnosed if it occurs in an atypical location such as the subungual area.

Subungual osteochondroma: a case report.

Osteochondromas are among the most common bone tumors of the foot. However, they rarely occur in subungual locations. Clinically they appear as slow-growing masses causing deformity of the overlying nail. Here we present a case of subungual osteochondroma with characteristic clinical, radiologic, and histopathologic features. The lesion was successfully treated by total excision.

Multiple basal cell carcinomas developed after radiation therapy for tinea capitis: a case report.

Development of skin neoplasms is the most important complication of radiation therapy. There are contradictive reports about the type of these neoplasms. Squamous cell carcinomas are considered the most frequent tumors arising on chronic radiodermatitis areas, but recent studies have demonstrated that the type of neoplasm occurring in response to ionizing radiation exposure depends on several factors. Herein we report a patient who had received low-dose radiation for the treatment of tinea capitis and developed multiple basal cell carcinomas in the radiated areas after a long latent period of 53 years.