Stephen Lock, my predecessor as editor of The BMJ, became worried about research fraud in the 1980s, but people thought his concerns eccentric. Research authorities insisted that fraud was rare, didn’t matter because science was self-correcting, and that no patients had suffered because of scientific fraud. All those reasons for not taking research fraud seriously have proved to be false, and, 40 years on from Lock’s concerns, we are realising that the problem is huge, the system encourages fraud, and we have no adequate way to respond.
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Abstract
Knowledge of the antiseptic effects of hydrogen peroxide (H2O2) dates back to the late 19th century, and its mechanisms of action has been amply described. Globally, many physicians have reported using H2O2 successfully, in different modalities, against COVID-19. Given its anti-infective and oxygenating properties, hydrogen peroxide may offer prophylactic and therapeutic applications for responding to the COVID-19 pandemic. We report a consecutive case series of twenty-three COVID-19 patients (of 36 initially enrolled) who had been diagnosed by their primary care physician (mean age: 39, range: 8 months–70 years; 74% male) and twenty-eight caregivers in the Mexico City Metropolitan Area who received a complementary and alternative medicine (CAM) telemedicine treatment with H2O2 taken by mouth (PO, at a concentration of 0.06%), oral rinse (mouthwash, 1.5%), and/or nebulization (0.2%). We describe the treatment program and report the response of the COVID-19 patients and their caregivers. The patients mainly recovered well, reporting feeling “completely better” at 9.5 days on average. Two (9%) were hospitalized prior to joining the study, and one did not fully recover. Patients frequently reported nausea and sometimes dizziness or vomiting related to the oral treatment. None of the twenty-eight caregivers in close contact with the patients reported contracting COVID-19. Given its low cost and medical potential and considering its relative safety if used properly, we suggest that randomized controlled trials should be conducted. These should include both SARS-CoV-2-positive and SARS-CoV-2-negative participants, with single or combined modes of administration of H2O2, to study the benefits of this simple molecule and offer safe guidance regarding its use by health professionals.
Conclusions
Hydrogen peroxide is a widely used, highly accessible, and available chemical compound whose efficacy has been demonstrated on several human viruses, including coronavirus and influenza viruses. It is possible that hydrogen peroxide, by diverse routes of administration and mechanisms of action, could exhibit a therapeutic and/or prophylactic effect against SARS-CoV-2.
http://archive.today/2021.11.24-113821/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8289588/
Introduction
Severe COVID-19 illness in adults has been linked to underlying medical conditions. This study identified frequent underlying conditions and their attributable risk of severe COVID-19 illness.Conclusion
Certain underlying conditions and the number of conditions were associated with severe COVID-19 illness. Hypertension and disorders of lipid metabolism were the most frequent, whereas obesity, diabetes with complication, and anxiety disorders were the strongest risk factors for severe COVID-19 illness. Careful evaluation and management of underlying conditions among patients with COVID-19 can help stratify risk for severe illness.
http://archive.today/2021.10.25-144944/https://www.cdc.gov/pcd/issues/2021/21_0123.htm
Many governments have made nose and mouth covering or face masks compulsory for schoolchildren. The evidence base for this is weak. The question whether nose and mouth covering increases carbon dioxide in inhaled air is crucial. A large-scale survey in Germany of adverse effects in parents and children using data of 25 930 children has shown that 68% of the participating children had problems when wearing nose and mouth coverings.
The normal content of carbon dioxide in the open is about 0.04% by volume (ie, 400 ppm). A level of 0.2% by volume or 2000 ppm is the limit for closed rooms according to the German Federal Environmental Office, and everything beyond this level is unacceptable.
https://jamanetwork.com/journals/jamapediatrics/fullarticle/2781743
We report broad serological profiles within the cohort, detecting antibody binding to other human coronaviruses. 202(>99%) participants had SARS-CoV-2 specific antibodies, with SARS-CoV-2 neutralization and spike-ACE2 receptor interaction blocking observed in 193(95%) individuals. A significant positive correlation (r=0.7804) between spike-ACE2 blocking antibody titers and neutralization potency was observed. Further, SARS-CoV-2 specific CD8+ T-cell responses were clear and quantifiable in 95 of 106(90%) HLA-A2+ individuals.
https://www.sciencedirect.com/science/article/pii/S2352396421002036
Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.
The present assessment raises the question whether it would be necessary to rethink policies and use COVID-19 vaccines more sparingly and with some discretion only in those that are willing to accept the risk because they feel more at risk from the true infection than the mock infection. Perhaps it might be necessary to dampen the enthusiasm by sober facts? In our view, the EMA and national authorities should instigate a safety review into the safety database of COVID-19 vaccines and governments should carefully consider their policies in light of these data. Ideally, independent scientists should carry out thorough case reviews of the very severe cases, so that there can be evidence-based recommendations on who is likely to benefit from a SARS-CoV2 vaccination and who is in danger of suffering from side effects. Currently, our estimates show that we have to accept four fatal and 16 serious side effects per 100,000 vaccinations in order to save the lives of 2–11 individuals per 100,000 vaccinations, placing risks and benefits on the same order of magnitude.
Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism.
SARS-CoV-2 spike antigen-specific IgG and IgA elicited by infection mediate viral neutralization and are likely an important component of natural immunity, however, limited information exists on vaccine induced responses. We measured COVID-19 mRNA vaccine induced IgG and IgA in serum serially, up to 145 days post vaccination in 4 subjects. Spike antigen-specific IgG levels rose exponentially and plateaued 21 days after the initial vaccine dose. After the second vaccine dose IgG levels increased further, reaching a maximum approximately 7–10 days later, and remained elevated (average of 58% peak levels) during the additional >100 day follow up period. COVID-19 mRNA vaccination elicited spike antigen-specific IgA with similar kinetics of induction and time to peak levels, but more rapid decline in serum levels following both the 1st and 2nd vaccine doses (<18% peak levels within 100 days of the 2nd shot). The data demonstrate COVID-19 mRNA vaccines effectively induce spike antigen specific IgG and IgA and highlight marked differences in their persistence in serum.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0249499
Published 14 Dec 2020
Nanobiotechnology is emerging very promising to investigate novel methodologies for managing COVID-19 pandemic/endemic successfully. In this direction, experts have explored the opto-electro-magnetic nanosystem to detect the SARS-CoV-2 virus using a biosensing approach. Such optical, electrical, or magnetic biosensors function based on geno-sensing and immune-sensing has detected the SARS-CoV-2 virus selectively at a very low level. These efficient-miniaturized biosensors can be operated using a smartphone and promoted for clinical application for early-stage diagnostics of COVID-19 infection. The successful integration of these SARS-CoV-2 virus sensors with AI and IoMT enables virus detection at point-of-location and sharing of bioinformatics with the medical center at the same time for timely therapeutics decision. This approach is also useful for tracking tasks and managing COVID-19 infection according to patient infection profiling. To avoid human-to-human SARS-CoV-2 virus transmission, experts have developed stimuli-responsive nanotechnology enable which can not only trap aerosol of virus size but can eradicate viruses on applying external stimulation for example nanoenable photo-sensitive virus degradation. Various types of clothes containing nanoparticles have demonstrated SARS-CoV-2 virus trapping and eradication successfully [2,9]. However, significant attention is required to increase the production and distribution of these masks for public use.
https://www.tandfonline.com/doi/full/10.1080/17425247.2021.1860938
The introduction a Covid-status certification system would have a serious impact on businesses and individuals and has the possibility of infringing rights and being discriminatory in nature. In light of that, we believe that it would be inappropriate for a system with such a potentially wide adverse impact to be introduced by secondary legislation.
https://committees.parliament.uk/publications/6264/documents/69158/default/
If you do not want your patient data shared with NHS Digital, you can register a Type 1 Opt-out with your GP practice. You can register a Type 1 Opt-out at any time. You can also change your mind at any time and withdraw a Type 1 Opt-out.
Data sharing with NHS Digital will start on 1 September 2021.
The button will download a 42kB .docx file from the NHS website. If it is not available, you can download an archived copy from here.
The Authority seeks to procure a framework agreement for temporary body storage in the event of an excess deaths situation for the 32 London boroughs and the City of London, led by Westminster City Council. The framework agreement will appoint a single provider and will be for a period of 4 years. This will be a contingency contract, only called upon in the event that an excess deaths situation arises in the future and existing local body storage capacity needs to be augmented.
The over-arching aim of this tender is to provide a single framework supplier that will be able to provide temporary body storage facilities to house deceased in the event of an excess deaths situation. The deceased will be stored with dignity and respect, at locations to be determined based on local London needs at the time and will require some design elements to accommodate local site conditions and constraints, while being capable of rapid deployment, construction and commissioning to an agreed standard. This framework will be procured by the Authority as the pan-London lead, but all London local authorities may call-off against the framework.
This will be a contingency cover framework and as such there is no minimum guarantee of any level of spend or call-off under the framework agreement.
Scientists from the Cleveland Clinic, USA, have recently evaluated the effectiveness of coronavirus disease 2019 COVID-19) vaccination among individuals with or without a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
The study findings reveal that individuals with previous SARS-CoV-2 infection do not get additional benefits from vaccination, indicating that COVID-19 vaccines should be prioritized to individuals without prior infection. The study is currently available on the medRxiv* preprint server.
Published 15 December 2017
MHRA today announced a partnership worth over £980,000 to improve the safety monitoring of medicines in low and middle-income countries.
In the non-vaccinated group, out of the 30 individuals interviewed, the number of people showing attraction to the magnet was 0 (zero). Therefore the experiment ended there for this group.
In the vaccinated group, on the other hand, 29 of the 30 individuals interviewed showed attraction to the magnet. That is, the magnet adhered to their skin without difficulty.Of these same 29 individuals, 22 have the magnet adhering to only one shoulder and only to the injection area. These 22 individuals are those who received only one injection. The other 7 people in this same group have the magnet adhering on both shoulders.
Conclusions Individuals who have had SARS-CoV-2 infection are unlikely to benefit from COVID-19 vaccination, and vaccines can be safely prioritized to those who have not been infected before.
https://www.medrxiv.org/content/10.1101/2021.06.01.21258176v2
A Biological Safety Level (BSL 1, 2, 3, or 4) is assigned to a biological lab as a safeguard to protect laboratory personnel, as well as the surrounding environment and community.
With research into potential treatments, therapies and vaccines for the SARS-CoV-2 virus (known widely as the COVID-19 Coronavirus) exploding across the globe, many institutions and laboratories are wondering whether their equipment and lab are considered safe to contain samples of the virus. As discussed in our previous blog on biosafety levels, airborne transmissible diseases like COVID-19 are typically categorized as Biosafety Level 3 (BSL-3). BSL-3 laboratories are almost always purpose-constructed containment laboratories, outfitted with specialized equipment and HVAC systems designed to ensure no airborne particles can exit the contained space.
https://consteril.com/biosafety-level-guidance-covid-19-research/
Published August 2015
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products The Center for Biologics Evaluation and Research (CBER)/Office of Cellular, Tissue, and Gene Therapies (OCTGT) is issuing this guidance to provide you, sponsors of virus or bacteria-based gene therapy products (VBGT products)1 and oncolytic viruses or bacteria (oncolytic products)2 with recommendations on how to conduct shedding studies during preclinical and clinical development. For purposes of this guidance, the term “shedding” means release of VBGT or oncolytic products from the patient through one or all of the following ways: excreta (feces); secreta (urine, saliva, nasopharyngeal fluids etc.); or through the skin (pustules, sores, wounds). Shedding is distinct from biodistribution because the latter describes how a product is spread within the patient’s body from the site of administration while the former describes how it is excreted or released from the patient’s body. Shedding raises the possibility of transmission of VBGT or oncolytic products3 from treated to untreated individuals (e.g., close contacts and health care professionals). This guidance represents FDA’s current thinking on how and when shedding data should be collected for VBGT and oncolytic products during preclinical and clinical development and how shedding data can be used to assess the potential for transmission to untreated individuals. This guidance finalizes the draft guidance of the same title dated July 2014.
Levels of antibodies in the blood of vaccinated people that are able to recognise and fight the new SARS-CoV-2 Delta variant first discovered in India (B.1.617.2) are on average lower than those against previously circulating variants in the UK, according to new laboratory data from the Francis Crick Institute and the National Institute for Health Research (NIHR) UCLH Biomedical Research Centre, published today (Thursday) as a Research letter in The Lancet.
The results also show that levels of these antibodies are lower with increasing age and that levels decline over time, providing additional evidence in support of plans to deliver a vaccination boost to vulnerable people in the Autumn.
In the case of single-dose recipients, our data show that NAbTs are significantly lower against B.1.617.2 and B.1.351 VOCs relative to B.1.1.7, implying that although a single dose might still afford considerably more protection than no vaccination, single-dose recipients are likely to be less protected against these SARS-CoV-2 variants. These data therefore suggest that the benefits of delaying the second dose, in terms of wider population coverage and increased individual NAbTs after the second dose,7 must now be weighed against decreased efficacy in the short-term, in the context of the spread of B.1.617.2. Worldwide, our data highlight the ongoing need to increase vaccine supply to allow all countries to extend second-dose protection as quickly as possible.
In the longer term, we note that both increased age and time since the second dose of BNT162b2 significantly correlate with decreased NAb activity against B.1.617.2 and B.1.351—both of which are also characteristic of the population in the UK at highest risk of severe COVID-19 (ie, older and vaccinated earlier), independent of other existing factors such as compromised immune status or comorbidity, or geographic-specific responses to vaccination.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01290-3/fulltext