The role of advocacy in sustaining male contraceptive research and development.

Novel male contraceptives have been in development for well over half a century, and despite a robust predicted global market for new methods, funding for research and development has been extremely limited. While the pharmaceutical industry previously supported male contraceptive research and development, industry partners are only spectators in the current space, awaiting a product that has been de-risked by the public sector before re-entering the field. Current male contraceptive development efforts are thus primarily funded by nonprofit, non-governmental, and government agencies who also act as the primary advocates for the field. Specific organizations include the International Consortium on Male Contraception, the Population Council, the Male Contraceptive Initiative, the World Health Organization, and the US National Institutes of Health. The funding provided by these public agencies, alongside their social and policy-based advocacy efforts such as market research, public education, and calls to action have kept the male contraceptive product development space afloat, resulting in a pipeline of potential products advancing towards market approval. However, as these products mature into more expensive clinical stages of development, they continue to face significant funding challenges, which many programs may not overcome. To fully realize the benefits of novel male contraceptive options, it is incumbent on philanthropic entities, impact investors, venture capital, and/or the pharmaceutical sector to provide significant and timely support for male contraceptive research and development.

Smell Function in Schizophrenia During Acute Psychosis and Correlation with Clinical Symptomatology and Length of Hospitalization.

BACKGROUND: While several studies have noted smell impairment in schizophrenia, it is unclear whether this impairment extends to acute psychosis and whether it is associated with more severe illness as expressed in extended hospitalization. OBJECTIVES: To evaluate the olfactory function of patients in an acute psychotic state and correlate it with clinical symptomatology and length of hospitalization. METHODS: Olfactory function was assessed in 20 patients with schizophrenia in their first week of hospital admission for acute psychosis compared with matched controls. Olfaction was evaluated via three stages: threshold, discrimination, and identification of different odors utilizing the Sniffin' Sticks test battery. RESULTS: Schizophrenia patients scored significantly lower on total smell score, discrimination, and identification abilities. A significant association was observed between hospitalization duration and total smell score and smell discrimination. No significant associations between smell and clinical symptomatology were observed. CONCLUSIONS: Study observations confirm impaired sense of smell in schizophrenia patients and suggest that smell impairment may be a potential marker of more serious illness as expressed in longer hospital stay.

Efficacy, safety and acceptability of a benzalkonium chloride spermicide cream in women aged 40 years and over needing contraception: A prospective multicentre study.

OBJECTIVE: This multicenter prospective study (BZK40+) aims to determine the efficacy and tolerance of a benzalkonium chloride-containing spermicide as contraceptive among women aged 40 and over. PROCEDURE: Fertile women enrolled in this open single-arm study were instructed to systematically use the benzalkonium chloride spermicide before each intercourse. At the end of a 6-month mandatory period, participants were given the option of continuing the study for a further 6 months. The primary endpoint for contraceptive efficacy was the Pearl Index (PI) up to 12 months of typical use. MAIN FINDINGS: A total of 151 women (mean age: 45.9 years) were enrolled, 144 (95.4%) completed the initial 6-month period and 63 (41.7%) completed the optional 6-month period. The median number of intercourses ranged from 3 to 5 per month. The spermicide was applied before 96.3% of the 5,895 sexual intercourses. The PI up to 12 months of typical use was 0 pregnancies (95% confidence interval: 0-2.88). The cumulative treatment exposure was 1249.7 women-months. CONCLUSION: This first study in women aged 40 years and over shows that benzalkonium chloride spermicide (Pharmatex®) is effective, well tolerated and well accepted in this population. Although very interesting, these results with a PI equal to zero are surprising and not in accordance with the low efficacy of spermicides in the overall population according to the WHO. So, our results should be interpreted with caution and confirmed by future research. Clinical trial registration number (EudraCT): 2016-004,188-38.

Case report: Anorexia nervosa and unspecified restricting-type eating disorder in Jewish ultra-orthodox religious males, leading to severe physical and psychological morbidity.

Background: Young Jewish Ultra-Orthodox women usually show less disturbances in body image and eating in comparison to less religious communities. By contrast, problems with eating are highly unknown and unrecognized in Jewish Ultra-Orthodox males. Aim: To investigate whether in Ultra-Orthodox males, restricting-type AN (AN-R) with highly obsessional physical activity and unspecified restricting eating disorder (ED) in the context of obsessive-compulsive disorder (OCD) would lead to severe physical and emotional morbidity. Results: The study included two groups: the first, 3 adolescents with AN-R developing severely increased ritualized obsessional physical activity in addition to restricting eating, requiring inpatient treatment because of severe bradycardia. These youngsters ignored the severity of their obsessional physical activity, continuing with it in hospital despite their grave medical condition. One student began extensive training for triathlon, whereas another student, upon remitting from AN, developed severe muscle dysmorphia. These findings suggest that young Ultra-Orthodox males with AN may develop obsessional physical activity to increase their muscle mass rather than to lose weight Another four Jewish Ultra-Orthodox males developed malnutrition in the context of severe OCD, with no evidence of dieting or body-image disturbances. These individuals developed highly obsessional adherence to different Jewish religious rules, including prolonged praying, asceticism, and overvalued strict adherence to Jewish Kashrut rules of eating, leading in all cases to severe food restriction. They were highly unaware of their severe weight loss and required hospitalization because of severe physical disturbances associated with malnutrition. Moreover, most did not cooperate with their treatment, and their ED-related obsessionality was mostly resistant to psychopharmacotherapy. Conclusion: Owing to their highly ritualistic rigid way of life, combined with the need for excellency in studying, Jewish Ultra-Orthodox adolescent males with AN might be at a specific risk of developing severe physical disturbances if their illness is associated with highly perfectionistic obsessional physical activity. Second, Jewish Ultra-Orthodox religious males with OCD might be at a specific risk for severe undernutrition, as their rigid relentless observance of Jewish everyday laws might highly interfere with their eating.

First-episode psychosis in the ultra-Orthodox Jewish population.

Few if any methodologically robust studies of first-episode psychosis have been carried out in the ultra-Orthodox Jewish population. The opening of an inpatient psychiatry department within an ultra-Orthodox neighborhood in Israel offered the unique opportunity to study the specifics of first -episode psychosis in this subpopulation. Medical records of 60 ultra-Orthodox male Jewish patients with first-episode psychosis were examined over the first 18 months of the new department's operation. Data regarding the patients' demographical status, anamnestic information, clinical presentation, and psychiatric care were analyzed. Participants were 18-30 years old; 15 (25%) were already engaged or married. Most patients (37, 61.7%) had not been employed in any formal activity prior to their hospitalization, with 21 patients (35%) studying in a Talmudical school. Religion-related delusions were noted in 20 patients (33.3%), and community/rabbi-related delusions in 18 patients (30%). Only three patients (5%) reported suicidal attempts. Duration of untreated psychosis (DUP) ranged between 1-48 months (mean 10.4, SD 9.5). In contrast to other first-episode psychosis studies, this study highlights specific features of first-episode psychosis in the ultra-Orthodox Jewish population, which is characterized by a high marriage rate, short DUP, low rates of substance use and suicidal attempts, expression of religious- and community-related themes in delusion content, and limited cooperation with health care providers. A better understanding of the cultural specifics of first-episode psychosis in this subpopulation may enable earlier treatment, improve prognosis, and facilitate compliance with medications and rehabilitation programs.

Anxiety Reactions and Coping Modalities with the COVID-19 Pandemic: A Cross-Sectional Study Comparing a Population of Religious Patients with Mental Illness and their Health Caregivers.

This study evaluates the nature and intensity of anxiety, interpretations of the COVID-19 pandemic and coping modalities of hospitalized patients with mental illness compared with their caregivers. One hundred and fifty-one subjects were evaluated with a specially designed questionnaire. Psychiatric inpatients reported more anxiety and more negative feelings than staff members and healthy subjects, but inpatients felt protected by the hospital and Ministry of Health (MoH) measures. Despite this anxiety, inpatients reported a lower compliance with MoH instructions than staff and healthy subjects and gave more fatalistic interpretations to the pandemic. Haredi study participants reported less anxiety, more optimism and had a higher sense of control regarding the pandemic compared to non-religious participants.

Role of Religion in Psychotic Illness in the Israeli Ultra-Orthodox Jewish Population: Patient Beliefs and Expectations.

ABSTRACT: This study aims to describe the role that religion and belief may play in members of the Israeli ultra-Orthodox Jewish population hospitalized in the Mayanei Hayeshua Medical Center and diagnosed with a psychotic disorder. Religion was judged essential by the patients in the management of their illness. Forty percent of the patients perceive their illness as their destiny, 26.7% as an "affliction of love," and 33.3% as resulting from their sins. Sixty percent of patients explained that faith is a source of hope in their life, with 76.7% indicating that collective religious practices help them face their illness. Ninety percent expressed no conflict between consulting a psychiatrist and their religious beliefs. Collective religious practices were correlated with higher treatment credibility. The use of religious coping methods was correlated with lower anxiety and tension among women. Higher conflict between religion and consulting a psychiatrist was correlated with lower treatment credibility among men.

How are psychotic symptoms and treatment factors affected by religion? A cross-sectional study about religious coping among ultra-Orthodox Jews.

Religious coping is prevalent among individuals diagnosed with psychotic disorders, however its clinical relevance has been insufficiently studied. Thirty ultra-Orthodox Jewish patients experiencing current psychotic symptoms and receiving treatment in the inpatient and day-care units were administered measures assessing severity of psychotic symptoms, psychological distress/well-being, beliefs about treatment credibility/expectancy, and aspects of religious belief and coping. Among men, negative religious coping was associated with lower treatment credibility. Among women, positive religious coping was associated with increased treatment expectancy and greater quality of life; and trust in God was associated with reduced psychiatric symptoms and greater treatment expectancy. Study findings indicate that religious factors may promote treatment motivation and engagement, crucial factors for subpopulations facing culturally-based barriers to treatment, as well as boost more favorable outcomes. Sensitivity to religious factors in treatment appears to play an important role in the management of psychotic disorders and should be engaged when culturally appropriate in order to maximize treatment potential.

Minor gifts from pharmaceutical companies to doctors: A comparison between psychiatry and general medicine.

Pharmaceutical companies in countries that have community-oriented models of healthcare, unlike other countries with highly privatised healthcare systems, such as the United States, cannot legally advertise medications directly to patients. Thus, the physician is entirely responsible for choosing the right medication, and needs to take important professional and ethical concerns into consideration during this decision-making process. Pharmaceutical companies invest considerably in in marketing products to physicians. Often, this is in the form of "minor gifts" to the physician. This study examines variations in the number and type of such minor gifts present in the offices of psychiatrists and internists in various medical contexts in Israel. Our results showed that psychiatrists received more minor gifts than physicians in general hospitals. No significant differences were found between inpatient and outpatient psychiatric departments. It is important to increase awareness and highlight the impact of exposure to minor gifts as advertising products on doctors in order to avoid bias and maintain objectivity in clinical judgement regarding pharmacological management of patients. Keywords: Pharmaceutical, gifts, ethics, physicians.

Retrieval practice improves memory in patients with schizophrenia: new perspectives for cognitive remediation.

BACKGROUND: Schizophrenia is associated with severe cognitive deficits, particularly episodic memory deficits, that interfere with patients' socio-professional functioning. Retrieval practice (also known as testing effect) is a well-established episodic memory strategy that involves taking an initial memory test on a previously learned material. Testing later produces robust long-term memory improvements in comparison to the restudy of the same material both in healthy subjects and in some clinical populations with memory deficits. While retrieval practice might represent a relevant cognitive remediation strategy in patients with schizophrenia, studies using optimal procedures to explore the benefits of retrieval practice in this population are still lacking. Therefore, the purpose of our study was to investigate the benefits of retrieval practice in patients with schizophrenia. METHODS: Nineteen stabilised outpatients with schizophrenia (DSM-5 criteria) and 20 healthy controls first studied a list of 60 word-pairs (30 pairs with weak semantic association and 30 non associated pairs). Half the pairs were studied again (restudy condition), while only the first word of the pair was presented and the subject had to recall the second word for the other half (retrieval practice condition). The final memory test consisted in a cued-recall which took place 2 days later. Statistical analyses were performed using Bayesian methods. RESULTS: Cognitive performances were globally altered in patients. However, in both groups, memory performances for word-pairs were significantly better after retrieval practice than after restudy (56.1% vs 35.7%, respectively, Pr(RP > RS) > 0.999), and when a weak semantic association was present (64.7% vs 27.1%, respectively; Pr(weak > no) > 0.999). Moreover, the positive effect of RP was observed in all patients but one. CONCLUSIONS: Our study is the first to demonstrate that retrieval practice efficiently improves episodic memory in comparison to restudy in patients with schizophrenia. This learning strategy should therefore be considered as a useful tool for cognitive remediation programs. In this perspective, future studies might explore retrieval practice using more ecological material.

[TREATMENT ISSUES IN PSYCHIATRY IN THE MANAGEMENT OF THE HAREDI SUBPOPULATION].

INTRODUCTION: In recent years, the importance of cultural sensitivity and the adaptation of mental health services to diverse populations has been growing. Simultaneously, awareness of psychiatric illnesses and treatment is increasing, even among the Haredi (ultra-orthodox) population in Israel, with specialized services developing. Many studies have emphasized the central role of religion and belief in the coping styles of those with mental illness and their healing processes. These characteristics are especially evident among the Haredi population, where religion is present in behavior, in thought, both within the individual and in the community, and throughout life. In the encounter between a religious Haredi patient and the professional, many issues arise regarding religion and the patient's socio-cultural affiliation. Being familiar with this world, including unique concepts and sensitivity to these issues, can promote treatment that is provided to ultra-orthodox individuals with mental-illness in a manner that is culturally sensitive. These issues include specific expressions and manifestations of psychiatric illness in the religious Haredi patient, and issues related to the specific Haredi community to which the patient belongs. Discussions in the literature and halakhic rulings are divided into issues concerning the patient, religious law observance by the patient with mental-illness, issues regarding treatment coercion, pregnancy, and issues relating to therapy, such as "privacy" and "life and death" dilemmas. Unique expressions of psychiatric disorders in the Haredi patient may be noted in eating disorders, psychosis and OCD, both in clinical terms and in prognosis and disease processes. Factors related to society and the ultra-orthodox community to which the psychiatric patient belongs include issues of stigma and secrecy that are maintained by the community in relation to mental illness; interference by non-professional individuals involved in treatment; as well as the distinctiveness of treatment and rehabilitation adapted to the Haredi population and finally cultural sensitivity to the needs of the religiously observant patient (such as avoiding desecration of Shabbat, rehabilitation in unique areas such as Torah study, etc.).

Consensus of best practice in intrauterine contraception in France.

Objective: Our aim was to provide a consensus of best practice in intrauterine contraception (IUC) for French practitioners. Methods: A meeting of 38 gynaecologists was held to establish a consensus of best practice in IUC, using the validated nominal group (NG) method to reach consensus. Seventy questions were posed covering insertion, monitoring and removal of IUC devices. Two working groups were formed and all proposals were voted on, discussed and approved by the NG. Results: Of the 70 questions asked, answers to only four failed to reach NG consensus. While, in general, the IUC practices of French gynaecologists are in line with international guidelines, some notable differences were identified: for example, when to use the levonorgestrel-releasing intrauterine system versus the copper intrauterine device; practice recommendations in the event of upper genital tract infections; and immediate postpartum insertion. Clinicians are encouraged to inform women about IUC, irrespective of their age or parity. In general, the wishes and characteristics of the woman must be the main criteria informing the choice of IUC, once all potential contraindications have been excluded and information about IUC shared. Conclusions: This consensus paper is intended to update and standardise knowledge about IUC for health care professionals, to address any reticence about use of this contraceptive method.

The CORALIE study: improving patient education to help new users better understand their oral contraceptive.

OBJECTIVES: Combined oral contraceptives (COCs) are the most widely used contraceptive method in Europe. Paradoxically, rates of unintended pregnancy and abortion are still remarkably high. A lack of knowledge about COCs is often reported to lead to poor adherence, suggesting an unmet need for adequate contraceptive counselling. Our objective was to investigate the impact on the knowledge level of users of a structured approach to deliver contraceptive information for a first COC prescription. METHODS: The Oral Contraception Project to Optimise Patient Information (CORALIE) is a multicentre, prospective, randomised study conducted in France between March 2009 and January 2013. The intervention involved providing either an 'essential information' checklist or unstructured counselling to new COC users. The outcome measure was a questionnaire that assessed whether the information provided to the new user by the gynaecologist had been correctly understood. RESULTS: One hundred gynaecologists and an expert committee used the Delphi method to develop an 'essential information' checklist, after which 161 gynaecologists were randomised to two groups. Group I (n = 81) used the checklist with 324 new COC users and group II (n = 80) delivered unstructured information to 307 new COC users. The average score for understanding the information delivered during the visit was significantly higher in women in group I than in the women in group II, even after adjustment for age and previous history of pregnancy: 16.48/20 vs 14.27/20 (p < 0.0001). CONCLUSION: Delivering structured information for a first COC prescription is beneficial for understanding contraception. Our tool could ultimately contribute to increased adherence and should be investigated in a prospective study of long-term outcomes.

European society of contraception statement on contraception in obese women.

The obesity 'epidemic' continues to increase, mostly but not only in developed countries. As overweight and obese women are at an increased risk for venous thromboembolism (VTE) at baseline and at a much higher risk during pregnancy, it is essential to help these women to plan pregnancies carefully and to use contraceptives with a positive ratio of benefits versus risks. The Expert Group on hormonal and molecular contraception of the European Society of Contraception convened to review the existing evidence and propose recommendations to the prescribers in line with most recent studies and with the Medical Eligibility Criteria of the World Health Organisation.

The evolution of combined oral contraception: improving the risk-to-benefit ratio.

Since its introduction in 1960, the combined oral contraceptive (COC) pill has become one of the most widely and frequently used methods of contraception worldwide. Although highly effective, early COC formulations were associated with significant adverse effects and unacceptable cardiovascular risk. Improvements in tolerability and safety have been achieved, without compromises in effectiveness, primarily via hormone dosage reductions and the development of several new progestins. Multiphasic COCs and extended-/continuous-cycle COCs have also been introduced, although the clinical advantages of these formulations vs. traditional COCs have yet to be established. Inclusion of natural estrogens such as estradiol valerate and 17ß-estradiol with selective progestins in new combinations that maintain good cycle control is the most recent evolutionary step designed to improve COC tolerability and safety. Vigorous research needs to continue to help guarantee that the unmet need for safe and effective contraception is satisfied in future generations.