scholarly journals Regulatory oversight on the use of experimental therapies during a pandemic: the case of early access to convalescent plasma therapy in three LMICs

2021 ◽  
Author(s):  
Rosemarie Bernabe ◽  
Cristina Torres ◽  
Grace Wangge ◽  
Edlyn Jimenez ◽  
Juntra Karbwang
Keyword(s):  
Regulatory Oversight ◽  
Plasma Therapy ◽  
Early Access ◽  
Experimental Therapies

scholarly journals A Possible Role of Remdesivir and Plasma Therapy in the Selective Sweep and Emergence of New SARS-CoV-2 Variants

2021 ◽  
Vol 10 (15) ◽  
pp. 3276
Author(s):  
Philippe Colson ◽  
Christian A. Devaux ◽  
Jean-Christophe Lagier ◽  
Philippe Gautret ◽  
Didier Raoult
Keyword(s):  
Neutralizing Antibodies ◽  
Selective Sweep ◽  
Immune Escape ◽  
High Rate ◽  
Immunocompromised Patients ◽  
Plasma Therapy ◽  
Rapid Changes ◽  
Experimental Therapies ◽  
The Uk

Since summer 2020, SARS-CoV-2 strains at the origin of the COVID-19 pandemic have suddenly been replaced by new SARS-CoV-2 variants, some of which are highly transmissible and spread at a high rate. These variants include the Marseille-4 lineage (Nextclade 20A.EU2) in Europe, the 20I/501Y.V1 variant first detected in the UK, the 20H/501Y.V2 variant first detected in South Africa, and the 20J/501Y.V3 variant first detected in Brazil. These variants are characterized by multiple mutations in the viral spike protein that is targeted by neutralizing antibodies elicited in response to infection or vaccine immunization. The usual coronavirus mutation rate through genetic drift alone cannot account for such rapid changes. Recent reports of the occurrence of such mutations in immunocompromised patients who received remdesivir and/or convalescent plasma or monoclonal antibodies to treat prolonged SARS-CoV-2 infections led us to hypothesize that experimental therapies that fail to cure the patients from COVID-19 could favor the emergence of immune escape SARS-CoV-2 variants. We review here the data that support this hypothesis and urge physicians and clinical trial promoters to systematically monitor viral mutations by whole-genome sequencing for patients who are administered these treatments.

scholarly journals Free of charge medicine schemes in the NHS. A local and regional Drug and Therapeutic Committees (DTC) experience.

2021 ◽  
Author(s):  
Simon O'Callaghan ◽  
Robin Ferner ◽  
Andrew Barron ◽  
Katherine Saxby ◽  
Reecha Sofat (CURRENTLY UNAVAILABLE)
Keyword(s):  
Clinical Trials ◽  
Observational Studies ◽  
Phase 1 ◽  
Clinical Trial Data ◽  
Access To Medicines ◽  
Pharmaceutical Companies ◽  
Phase 3 ◽  
Regulatory Oversight ◽  
Early Access ◽  
Drug And Therapeutics Committee

Introduction: Free-of-charge (FoC) medicine schemes are increasingly available and allow access to investigational treatments outside clinical trials or in advance of licensing or NHS commissioning. Methods: We retrospectively reviewed FoC medicine schemes evaluated between 2013 and 2019 by a single NHS trust and a regional drug and therapeutics committee (DTC). The details of each locally reviewed FoC scheme, and any nationally available MHRA Early Access to Medicines Scheme (MHRA EAMS) in the same period, were recorded and categorised. Results: Most FoC schemes (95%) allowed access to medicines intended to address an unmet clinical need. Over 7 years, 90% were company-FoC schemes and 10% were MHRA EAMS that were locally reviewed. Phase 3 clinical trial data were available for 44% of FoC schemes; 37% had phase 2 data; and 19% were supported only by phase 1, retrospective observational studies, or pre-clinical data. Utilisation of company-FoC schemes increased on average by 50% per year, while MHRA EAMS showed little growth. Conclusion: Company-FoC medicine schemes are increasingly common. This may indicate a preference for pharmaceutical companies to independently co-ordinate schemes. Motivations for company-FoC schemes remain unclear and many provide access to treatments that are yet to be evaluated in appropriately conducted clinical trials, and whose efficacy and risk of harm remain uncertain. There is no standardisation of this practice and there is no regulatory oversight. Moreover, no standardised data collection framework is in place that could demonstrate the utility of such programmes in addressing unmet clinical need or allow generation of further evidence.

scholarly journals The Ethic of Access: An AIDS Activist Won Public Access to Experimental Therapies, and This Must Now Extend to Psychedelics for Mental Illness

2021 ◽  
Vol 12 ◽  
Author(s):  
Morgan Campbell ◽  
Monnica T. Williams
Keyword(s):  
Mental Illnesses ◽  
Public Access ◽  
Public Health Emergencies ◽  
Early Access ◽  
Experimental Drugs ◽  
Aids Pandemic ◽  
Experimental Therapies ◽  
The Face ◽  
Catch Up ◽  
The Right

If patients with mental illnesses are to be treated fairly in comparison with other categories of patients, they must be given access to promising experimental therapies, including psychedelics. The right of early access to promising therapies was advanced as an ethical principle by activist Larry Kramer during the AIDS pandemic, and has now largely been adopted by the medical establishment. Patients are regularly granted access to experimental drugs for many illness categories, such as cancer and infectious diseases. The need for expanded access is especially relevant during evolving crises like the AIDS and the coronavirus pandemics. In contrast to non-psychiatric branches of medicine, psychiatry has failed to expedite access to promising drugs in the face of public health emergencies, psychological crises, the wishes of many patients, and the needs of the community. Psychiatry must catch up to the rest of medicine and allow the preferences of patients for access to guide policy and law regarding unapproved medications like psychedelics.

Real-world experience of generalized and partial lipodystrophy patients enrolled in the metreleptin early access program

2019 ◽  
Author(s):  
Keziah Cook ◽  
Anna Stears ◽  
David Araujo-Vilar ◽  
Ferruccio Santini ◽  
Stephen O'Rahilly ◽  
...  
Keyword(s):  
Real World ◽  
Partial Lipodystrophy ◽  
Early Access ◽  
Access Program

Role of convalescent plasma therapy in new Coronavirus disease (nCOVID-19): A review

2020 ◽  
Vol 11 (SPL1) ◽  
pp. 546-549
Author(s):  
Shweta Dadarao Parwe ◽  
Milind Abhimanyu Nisargandha ◽  
Rishikesh Thakre
Keyword(s):  
Clinical Trial ◽  
Immune Responses ◽  
Indian Population ◽  
Preventive Treatment ◽  
The Body ◽  
Therapeutic Antibodies ◽  
Plasma Therapy ◽  
Host Immune Responses ◽  
Transparent Liquid

Hitherto, there is no proper line of treatment for the new (nCOVID19). The development of unique antiviral drugs has taken precedence. Therapeutic antibodies () will be a significantly beneficial agent against nCOVID-19. Here the host immune responses to new discussed in this review provide strategy and further treatment and understanding of clinical interventions against nCOVID-19. Plasma therapy uses the antibodies found in the blood of people recovering (or convalesced) from an infection to treat infected patients. When an infection occurs, the body begins producing proteins specially made to kill the germ, called antibodies. Those antibodies coat specifically plasma in the blood of survivors, the yellow transparent liquid blood portion for months or even years. research assesses plasma use from Convalescent patients of infected with nCOVID-19 as a possible preventive treatment. But it is not yet recommended as a line of treatment, and it is used as a clinical trial in the new in Indian population.

MANAJEMEN PENGAWASAN PERATURAN DAERAH DILAHAT DARI PERUNDANGAN-UNDANGAN

2017 ◽  
Vol 5 (3) ◽  
Author(s):  
Dr. Hotma Napitupulu, MM.
Keyword(s):  
Secondary Data ◽  
Empirical Method ◽  
Conceptual Approach ◽  
Regulatory Oversight ◽  
Secondary Data Source ◽  
Approach Method ◽  
Data Source ◽  
The Law ◽  
Harmonization Of Law ◽  
Legal Consequences

Management of regulatory oversight under the law, analyze the legal consequences with its use as a system of legal oversight mechanisms in order to create harmonization of law in the region. As for the method used in research by using empirical method that is by conceptual approach method with primary and secondary data source. As for the method used in research by using empirical method that is by conceptual approach method with primary and secondary data source.

Plasma therapy a possible hope to fight against COVID-19

2020 ◽  
Author(s):  
Ravikant Piyush ◽  
Aroni Chatterjee ◽  
Shashikant Ray
Keyword(s):  
Middle East ◽  
Severe Acute Respiratory Syndrome ◽  
Viral Disease ◽  
Plasma Therapy ◽  
Therapeutic Drugs ◽  
Wild Fire ◽  
The World ◽  
Short Span ◽  
Game Changer

The world is currently going through a disastrous event and a catastrophic upheaval caused by the coronavirus disease 2019 (COVID-19). The pandemic has resulted in loss of more than 150000 deaths across the globe. Originating from China and spreading across all continents within a short span of time, it has become a matter of international emergency. Different agencies are adopting diverse approaches to stop and spread of this viral disease but still now nothing confirmatory has come up. Due to lack of vaccines and proper therapeutic drugs, the disease is still spreading like wild fire without control. An Old but very promising method- the convalescent plasma therapy could be the key therapy to stop this pandemic. This method has already proven its mettle on several occasions previously and has been found to be effective in curing the pandemics induced by Ebola, severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV). The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) belongs to the same group of β-Coronavirus that has resulted in the above diseases. Therefore, the role of plasma therapy is being explored for treatment of this disease. In this review, we have mainly focused on the role of convalescent plasma therapy and why its use should be promoted in fight against COVID-19, as it could turn out to be a game changer.

The novel use of convalescent plasma in patients with COVID 19 in Basra governorate, Case series review

2020 ◽  
pp. 1-10 ◽  
Author(s):  
Saad Hammadi ◽  
Ali Hashim ◽  
Abbas Ali ◽  
Rafid Abbood ◽  
Hassanein Ali ◽  
...  
Keyword(s):  
Plasma Exchange ◽  
Case Series ◽  
Passive Immunity ◽  
The Novel ◽  
Efficacy And Safety ◽  
Off Label Use ◽  
Plasma Therapy ◽  
Off Label ◽  
Plasma Donation ◽  
Patient Series

Background: The idea of convalescent plasma usage is to give passive immunity to the patients, so their immune system stands a good chance of combating the virus.this study will review 6 cases of eligible covid 19 patients that had been treated with convalescent plasma therapy in Basra covid 19 quarantine Objectives: to demonstrate efficacy and safety of convalescent plasma in the patient series that had been enrolled . Method: this study had pioneered a new method to collect up to 3,000 mL in one session by an off-label use of Spectra Optia Apheresis systems by TerumoBCT /Exchange set to collect convalescent plasma. In this study 250 mL convalescent plasma had been given each of the 6 patients, from one donor. respose in spo2,dyspnoea and tachypnoea was observed ,any reaction to plasma also had been monitored . Result: Our case series have demonstrated both safety and effectiveness of convalescent plasma. This study was successful in reaching our primary and secondary outcomes in all 6 patients (improvement in SpO2 and symptoms). With negligible difference in time of post transfusion response Conclusion: convalescent plasma is apperantly safe and effective, In this study 250 mL convalescent plasma had been given each of the 6 patients, from one donor using Therapeutic Plasma Exchange (TPE) protocol by Spectra Optia Apheresis system/TerumoBCT. Keywords: convalescent plasma, COVID-19, SARS CoV-2, apheresis, plasma exchange, plasma donation

Sign in / Sign up

Export Citation Format

Share Document