scholarly journals Adverse events related to unapproved stem cell products and other regenerative interventions: recommendations for more robust regulation of the direct-to-consumer marketplace

2021 ◽  
Author(s):  
Farzana Akkas ◽  
Leigh Turner ◽  
Elizabeth Richardson

Tweetable abstract Adverse events continue to occur in the direct-to-consumer market for unapproved regenerative interventions and US FDA alone cannot adequately address the problem. Other public health strategies are needed to provide better patient protection.

2020 ◽  
Vol 15 (1) ◽  
pp. 1238-1249
Author(s):  
Catherine Waldby ◽  
Tereza Hendl ◽  
Ian Kerridge ◽  
Wendy Lipworth ◽  
Tamra Lysaght ◽  
...  

The prevalence of businesses selling autologous stem cell-based interventions to patients in Australia has raised serious concerns about how weaknesses in regulation have enabled the emergence of an industry that engages in aggressive marketing of unproven treatments to patients. Little is known about how patients experience this marketing and their subsequent interactions with practitioners. This paper reports results from 15 semistructured interviews with patients and carers, and also draws upon discussion conducted with patients, carers and family members (22 participants) in a workshop setting. We explore how Australian patients and carers understand and experience these interventions, and how their presumptions about the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments.


2021 ◽  
Vol 14 (6) ◽  
pp. 560
Author(s):  
Pietro Brunetti ◽  
Raffaele Giorgetti ◽  
Adriano Tagliabracci ◽  
Marilyn A. Huestis ◽  
Francesco Paolo Busardò

The rising use of designer benzodiazepines (DBZD) is a cat-and-mouse game between organized crime and law enforcement. Non-prohibited benzodiazepines are introduced onto the global drug market and scheduled as rapidly as possible by international authorities. In response, DBZD are continuously modified to avoid legal sanctions and drug seizures and generally to increase the abuse potential of the DBZD. This results in an unpredictable fluctuation between the appearance and disappearance of DBZD in the illicit market. Thirty-one DBZD were considered for review after consulting the international early warning database, but only 3-hydroxyphenazepam, adinazolam, clonazolam, etizolam, deschloroetizolam, diclazepam, flualprazolam, flubromazepam, flubromazolam, meclonazepam, phenazepam and pyrazolam had sufficient data to contribute to this scoping review. A total of 49 reports describing 1 drug offense, 2 self-administration studies, 3 outpatient department admissions, 44 emergency department (ED) admissions, 63 driving under the influence of drugs (DUID) and 141 deaths reported between 2008 and 2021 are included in this study. Etizolam, flualprazolam flubromazolam and phenazepam were implicated in the majority of adverse-events, drug offenses and deaths. However, due to a general lack of knowledge of DBZD pharmacokinetics and toxicity, and due to a lack of validated analytical methods, total cases are much likely higher. Between 2019 and April 2020, DBZD were identified in 48% and 83% of postmortem and DUID cases reported to the UNODC, respectively, with flualprazolam, flubromazolam and etizolam as the most frequently detected substances. DBZD toxicology, public health risks and adverse events are reported.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
V Bellisario ◽  
R Bono ◽  
G Squillacioti ◽  
M Caputo ◽  
I Gintoli ◽  
...  

Abstract Background Childhood obesity is an important public health issue worldwide and includes different risk factors, such as environmental pollutants exposure or physical activity. Neighborhood composition and green spaces availability could contrast obesogenic lifestyles and promote healthy habits, whereas, urbanization and traffic volume exposure are inversely associated with physical activity and worsen effects on childhood health. Methods This project analyzed students involved in the HBSC survey from the Piedmont Region. Data were collected in 2018, following the protocol. All the subjects were georeferenced within buffers around schools. Green-spaces availability was measured by Normalised Difference Vegetation Index (NDVI-satellite images) while urbanization was calculated by population density, traffic intensity (satellite measurements) and air pollution concentration (sampling stations). Results Overall, the sample included 3022 subjects, with amount 50% male/female and 30% for each age group (11-13-15 years old). Concerning weight status, above 14% of the all sample is obese or overweight, with, respectively, 20% among boys and 11% among girls. Preliminary analyses showed an association between weight status and population density (rural vs urbanized areas). Currently, we are analyzing the association with greenness and the other measures of urbanization. Conclusions Our preliminary findings suggest that high urbanization levels impact health implementing weight in children. We are testing the hypothesis that greenness positively influences weight status and reduce negative effects of urbanization and air pollution. The managing of these risk factors must be deepened and corroborated by active preventive Public Health strategies for improving children health. Key messages Urbanization and greenness may influence weight status in children. Public Health strategies must be improved for children health.


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043421
Author(s):  
Rae Thomas ◽  
Hannah Greenwood ◽  
Zoe A Michaleff ◽  
Eman Abukmail ◽  
Tammy C Hoffmann ◽  
...  

ObjectivePublic cooperation to practise preventive health behaviours is essential to manage the transmission of infectious diseases such as COVID-19. We aimed to investigate beliefs about COVID-19 diagnosis, transmission and prevention that have the potential to impact the uptake of recommended public health strategies.DesignAn online cross-sectional survey.ParticipantsA national sample of 1500 Australian adults with representative quotas for age and gender provided by an online panel provider.Main outcome measureProportion of participants with correct/incorrect knowledge of COVID-19 preventive behaviours and reasons for misconceptions.ResultsOf the 1802 potential participants contacted, 289 did not qualify, 13 declined and 1500 participated in the survey (response rate 83%). Most participants correctly identified ‘washing your hands regularly with soap and water’ (92%) and ‘staying at least 1.5 m away from others’ (90%) could help prevent COVID-19. Over 40% (incorrectly) considered wearing gloves outside of the home would prevent them from contracting COVID-19. Views about face masks were divided. Only 66% of participants correctly identified that ‘regular use of antibiotics’ would not prevent COVID-19.Most participants (90%) identified ‘fever, fatigue and cough’ as indicators of COVID-19. However, 42% of participants thought that being unable to ‘hold your breath for 10 s without coughing’ was an indicator of having the virus. The most frequently reported sources of COVID-19 information were commercial television channels (56%), the Australian Broadcasting Corporation (43%) and the Australian Government COVID-19 information app (31%).ConclusionsPublic messaging about hand hygiene and physical distancing to prevent transmission appears to have been effective. However, there are clear, identified barriers for many individuals that have the potential to impede uptake or maintenance of these behaviours in the long term. We need to develop public health messages that harness these barriers to improve future cooperation. Ensuring adherence to these interventions is critical.


2021 ◽  
Vol 150 ◽  
pp. 112072
Author(s):  
Jose Alejandro Romero Herrera ◽  
Sofie Theresa Thomsen ◽  
Lea Sletting Jakobsen ◽  
Sisse Fagt ◽  
Karina Banasik ◽  
...  

1990 ◽  
Vol 18 (1-2) ◽  
pp. 20-28
Author(s):  
Jonathan Mann ◽  
Marjorie Dam ◽  
Kathleen Kay

2012 ◽  
Vol 9 (3) ◽  
pp. 275-282 ◽  
Author(s):  
Joy Samuels-Reid ◽  
Brenda Lawrence ◽  
Courtney Millin ◽  
Judith Cope
Keyword(s):  

2021 ◽  
Vol 24 (7) ◽  
pp. 7
Author(s):  
E.B. Shapovalova ◽  
E.V. Indukaeva ◽  
G.V. Artamonova

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