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J Am Acad Dermatol ; 82(2): 528-529, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30571991
Cutis ; 104(4): 213, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31774886


Management of nonmelanoma skin cancer (NMSC) in elderly patients carries a risk for morbidity; these patients frequently struggle to care for their biopsy sites and experience biopsy- and surgery-related complications. To minimize this treatment-related morbidity, we designed a knifeless treatment approach that employs reflectance confocal microscopy (RCM) in lieu of skin biopsy to establish the diagnosis of NMSC, then uses either intralesional or topical chemotherapy or immunotherapy (as appropriate, depending on depth of invasion) to cure the NMSC. By using this approach, the patient is spared surgery-related difficulties.

Rambam Maimonides Med J ; 10(4)2019 Oct 29.
Artigo em Inglês | MEDLINE | ID: mdl-31545703


United States (US) and European Union (EU) laws attempt to counterbalance the presumed discrimination of children in drug treatment and drug development. The US Food and Drug Administration (FDA)-rewarded pediatric studies with antidepressants triggered in 2004 an FDA black-box warning of suicidality in young patients. Fewer antidepressants were prescribed, and the number of completed suicides of young persons increased. The dilemma between this warning and the need to adequately treat young depressed patients remains unsolved. We analyzed the history of drug development, the evolving view of diseases in young patients, US/EU pediatric laws, and pediatric studies triggered by FDA/European Medicines Agency (EMA) in depression and other diseases on the background of developmental pharmacology; financial, institutional, and other interests; and the literature. The FDA/EMA define children administratively, not physiologically, as <17 (FDA)/<18 years old (EMA). But young persons mature physiologically well before their 17th/18th birthday. Depression occurs in young persons, has special characteristics, but is not fundamentally different from adult depression. Young persons are not another species. Regulatory requirements for "pediatric" studies focus on "pediatric" labels. Many "pediatric" studies, including those in depression, lacked and lack medical sense and harm patients by placebo treatment although effective drugs exist. The FDA has partially abandoned separate "pediatric" efficacy studies, but not in psychiatry. Clinicians, parents, institutional review boards, and ethics committees should become aware of questionable "pediatric" studies, should re-evaluate ongoing ones, consider to suspend them, and to reject new ones. The concept of separate "pediatric" drug approval needs to be abandoned.

Curr Ther Res Clin Exp ; 90: 86-91, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31388360


Background: US and EU pediatric laws promote industry-sponsored pediatric studies, based on the therapeutic orphans concept that claims discrimination of children in drug treatment and drug development. Objective: We investigated the medical validity of international pediatric studies with centers in Slovenia, an EU member state, and challenge their medical utility. Methods: We analyzed international industry-sponsored pediatric studies with centers in Slovenia, listed in, for their medical value. Results: Most pediatric studies triggered by the US Food and Drug Administration and by the European Medicines Agency were/are without medical or scientific value. They were/are formally and regulatorily justified, but lack medical sense and thus were/are unethical. Several even harm children and/or adolescents with serious diseases by exposing them to placebo or substandard treatment. Conclusions: Pediatric studies triggered by US and EU regulatory demands are a serious abuse of nonneonatal children and adolescents in Slovenia and worldwide. They are medically redundant at best and often deter patients from effective innovative personalized therapy. They also exclude young patients from reasonable studies. Institutional review boards/ethics committees should be alerted, should critically review all ongoing pediatric studies, should suspend those found to be questionable, and should reject newly submitted questionable ones.

J Cutan Pathol ; 46(11): 830-838, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31298761


Although histopathology is the time-honored gold standard diagnostic measure in dermatology, several factors may detract from an accurate microscopic diagnosis. Limiting factors include: human error, suboptimal biopsy-site selection or biopsy technique, and inherent restrictions of vertical tissue sectioning that lead to incomplete microscopic evaluation of the lesion. Reflectance confocal microscopy (RCM) is a non-invasive imaging tool that allows for the cellular-level examination of the lesion, at a horizontal plane, which may complement the subsequent vertical histopathological tissue examination. Herein, we report a case series whereby prebiopsy RCM examination enhanced the accuracy of histopathological diagnosis or allowed for a critical appraisal of initial histopathological misdiagnosis.

Rambam Maimonides Med J ; 10(3)2019 Jul 18.
Artigo em Inglês | MEDLINE | ID: mdl-31335307


BACKGROUND: United States (US) and European Union (EU) legislation attempts to counterbalance the presumed discrimination in pediatric drug treatment and development. METHODS: We analyzed the history of drug development, US/EU pediatric laws, and pediatric studies required by US/EU regulatory authorities and reviewed relevant literature. RESULTS: The US and EU definitions of a child are defined administratively (rather than physiologically) as being aged <17 years and <18 years, respectively. However, children mature physiologically well before their seventeenth or eighteenth birthdays. The semantic blur for these differing definitions may indicate certain conflicts of interest. CONCLUSIONS: Pediatric healthcare today is better than ever. Regulatory-related requirements for "pediatric" studies focus on labeling. Most of these studies lack medical usefulness and may even harm "pediatric" patients through administration of placebo and/or substandard treatment, despite the resultant publications, networking, patent extensions, and strengthened regulatory standing. Clinicians, parents, and ethics committees should be aware of these issues. New rules are needed to determine new pharmaceutical dose estimates in prepubescent patients, and when/how to clinically confirm them. Internet-based structures to divulge this information should be established between drug developers, clinicians, and regulatory authorities. A prerequisite for the rational use of pharmaceuticals in children would be to correct the flawed concept that children are discriminated against in drug treatment and development, and to abandon separate "pediatric" drug approval processes.