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Goods and consumer issues
Published in Michael Weir, Law and Ethics in Complementary Medicine, 2023
‘Therapeutic use’ is defined widely in section 3 to include use in preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons, or influencing, inhibiting or modifying a physiological process in persons.
The Convergence of Digital Health Technologies: The Role of Digital Therapeutics in the Future Healthcare System
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Joris van Dam, Justin Wright, Graham Jones
Designing a device that is engaging is one critical step forward. However, deployment for therapeutic use, safety, and efficacy needs to be considered and addressed, and the requirements for such include quality control measures and regulatory standards. These requirements are typically beyond the comfort zone and capacity of many consumer products developers, and the use of consumer products in bona fide clinical applications has lagged. WellDoc is among the companies demonstrating their commitment to quality control and regulatory standards through regulatory review of their digital therapeutics products, going back to clearance of their first DiabetesManager® product in 2010.8 In 2017, Pear Therapeutics made headlines with FDA clearance of their Computerized Behavioral Therapy Device (a software application) for treating psychiatric disorders.9 And in recent years, the number of regulatory clearances and applications for regulatory review is steadily increasing.10
Conclusion: Rationalizing drug markets in the Global South
Published in Carine Baxerres, Maurice Cassier, Understanding Drugs Markets, 2021
Maurice Cassier, Carine Baxerres
The seven regulatory tools and powers that we have just laid out are largely interdependent. Drawing up a list of essential medicines can guide a policy of local production and serve as a basis for setting up health coverage; strengthening drug agencies and quality control laboratories strengthens local production and monitoring of pharmaceutical supply and distribution networks; and intervention by consumers and citizens is likely to promote the expansion of health coverage and price vigilance to make treatments accessible. These technical, financial, and political instruments and mechanisms could create market governance that is more favorable to public health, patients, and the populations to be protected, and a better balance between the drug's therapeutic use value and the market value. This contrasts with the waves of “commodification” that have occurred since the origin of the pharmaceutical industry, extensively explored in this book at currently at work today.
The current status of gene therapy in bladder cancer
Published in Expert Review of Anticancer Therapy, 2023
Côme Tholomier, Alberto Martini, Sharada Mokkapati, Colin P. Dinney
The US Food and Drug Administration (FDA) defines gene therapy as a technique that ‘seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use’ [1]. To accomplish this, nucleic acids, either DNA or RNA, are packaged within a vector. The goal is to either inhibit, replace, or manipulate a dysfunctional gene, or even to introduce a new or modified gene [2]. Therefore, gene therapy has the potential to alter tumor biology for therapeutic benefit [3]. This idea was originally described 50 years ago by Theodore Friedmann [4]. Following a brief description of the genesis of gene therapy, we will review the mechanisms by which gene therapy works, and then focus on landmark studies in bladder cancer and its current role in this disease space.
Advancing elite athlete mental health treatment with psychedelic-assisted psychotherapy
Published in Journal of Applied Sport Psychology, 2022
Courtney C. Walton, Paul Liknaitzky
Perhaps even more so than in the general population (Sellers & Leiderman, 2018), conducting research with these substances will be complex, given the many additional regulations that athletes must adhere to. Whether psychedelic medicine might be considered a form of doping in sport will need to be determined by regulatory bodies like WADA. As highlighted by Mazzoni et al. (2017), classical psychedelics are unique among most other illicit drugs in that they are not currently listed by WADA among “Prohibited Substances”2 (WADA., 2020). However, WADA also make reference to “Non-Approved Substances”, which include those which are unlisted but have “no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development)” (WADA, 2020). We envisage that Therapeutic Use Exemptions would be required for currently active athletes to engage in any clinical trial investigating psychedelic-assisted psychotherapy.
Substance use in the Norwegian general population: prevalence and associations with disease
Published in Journal of Substance Use, 2021
Tore Bonsaksen, Laila Skogstad, Tine K. Grimholt, Trond Heir, Øivind Ekeberg, Anners Lerdal, Inger Schou-Bredal
Clearly one must be careful when considering possible causality between substance use and the occurrence of diseases. While substances such as alcohol may cause disease directly, as argued in a range of studies (Briasoulis et al., 2012; Parry et al., 2011; Rehm, 2011; Rehm et al., 2010; Shield et al., 2014), disease processes may also make people more prone to use substances in an attempt to gain comfort, distraction and relief from physical or psychological pain. Indeed, some of the substances investigated in this study are commonly prescribed drugs for therapeutic use among persons with diseases, rendering causes and effects intertwined. Moreover, cultural and socioeconomic factors impossible to control may constitute common risk factors for substance use and adverse health outcomes alike.