The Lancet, The BMJ, The NEJM and RxISK

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June 10, 2020 | 14 Comments

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    • Its just a cleaned up and shortened version of the post. There was nothing controversial added – quite the opposite. We went out of the way to flatten the tone – Kansas flat

      D

  1. David I have protracted symptoms from antidepressants and benzodiazepines now for over twelve years. I have also had the protracted ‘long tail’ version of Covid19. What may be of interest is how many of the symptoms are similair. Covid is now being recognised increasingly as a blood vessel disease and I have noticed your hypotheses regarding withdrawal symptoms being blood vessel based. I was beset with neurological symptoms, parasthesia, tremors, seizures, tinnitus, fatigue, weakness, heart and BP problems. Granted I have these but many people report the same.
    Regarding medications worsening symptoms I occasionally take Codeine for Arthritis and had to discontinue due to it worsening my breathing so in an older person one can only imagine the huge detrimental effect it would have.

  2. There are hundreds of research volunteers being recruited into upteen trials Wonder how rigorously they are screened in the rush to get a product on the market.even if deemed to be in a healthy group as surely at least some will have adverse reactions due to their individual physiology? Would they just be pulled out of the trial and not investigated further? That seemed to happen in some cases in Study 329 -or at least the ones who dropped out weren’t mentioned again. When a vaccine becomes mass produced how would they weed out those who shouldn’t be given it? Could we have a list similar to the one you and Juan drew up ie of things to look out for such as what is in the vaccine not just a fob off bare minimum of info but where to look for more detail;; would we be given a copy of the progress and the results, would we be allowed to add to the dissemination /publication; would we be equal shareholders of the trial not just ‘participants’. Issues of insurance if harmed etc Journals are also getting away with stating that studies are published with inclusion of ‘expert by experience’ or something as vague as ‘patient involvement’ or advice and assistance from particular patient groups in drawing up protocols when these are often massively funded and can be biased . If a vaccine or test is produced, including the thousands of tests which are being used already on a conveyor belt system with no public info as to whether some people have had adverse effects – would you be able to give us some advice as to whether you would accept it yourselves?

  3. Unprecidented (sorry) surveillance of those who question;oppose or refuse vaccines Possibly only China could match this level to match this level
    Katrina.Megget@googlemail.com for thebmj
    Will covid-19 finally vanquish the anti-vaccination movement or will it fuel the fringe community? ….. (biased from the start)
    During a pandemic, you might expect everyone to say they want a vaccine—but that’s not what a study of 1000 people in New York over 24-26 April found.
    “Only 59% of respondents said they would get a vaccine and only 53% would give it to their children,” says Scott Ratzan, distinguished lecturer at the New York based CUNY Graduate School of Public Health and Health Policy.1Tufts University School of Medicine

    A little snipett she left out re distinguished Scott –
    Scott C. Ratzan
    Clinical Associate Professor of Public Health and Community Medicine
    Vice President Global Health, Johnson & Johnson
    Editor-in-Chief, Journal of Health Communication: International Perspectives

    Dr. Scott C. Ratzan is Vice President, Global Health, Johnson & Johnson. In this role, he is charged with promoting communication, innovation and programs that focus on health literacy and public health policy. He is a pioneer in the areas of health literacy and mHealth communication, having co-authored the definition that serves as the basis for U.S. health literacy

    Since the project began in March, Ratzen’s group has asked the question three times, and each time the proportion is low. “It’s concerning. I would have thought numbers would go up. I didn’t expect to see it so negative.”

    In their first poll on 27-29 March, 62% said they would have a coronavirus vaccine, with 19% saying they would decline it and 19% unsure. The latest poll, conducted at the start of May, found that 31% would have a vaccine immediately with 48% saying they would if their doctor recommended it; 12% would reject a vaccine outright. Ratzan also asked if they would volunteer for a coronavirus vaccine clinical trial. Just 31% expressed an interest.

    He attributes much of the negativity in his surveys around a coronavirus vaccine to a small but incredibly vocal movement. “The anti-vaccination movement is going to make covid-19 more difficult to get under control,” he told The BM
    While relatively small, the anti-vaccination movement actively uses social media to amplify its messaging and target people who are unsure about vaccines, particularly parent groups. A study of more than 500 Facebook ads between December 2018 and February 2019 found that 145 featured anti-vaccination sentiment, reaching audiences of between 5000 and 50 000 people. Researchers found that 54% of anti-vaccination ads came from just two organisations: the World Mercury Project and Stop Mandatory Vaccinations.4

    Facebook told The BMJ that it rejects ads that include vaccine misinformation and has removed hundreds of thousands of posts containing harmful misinformation relating to covid-19 and a potential vaccine while also directing people to articles with accurate information. Yet despite concerted efforts by social media companies, WHO has “seen anti-covid-19 vaccine sentiment in social media,” says Katherine O’Brien, director of the department of immunization, vaccines, and biologicals at WHO. “We don’t have a vaccine yet and already there is an anti-vaccination voice on it
    Fuel to the fire
    “Covid-19 will die out before the anti-vaccination movement,” says Barry Bloom, research professor of public health at the Harvard TH Chan School of Public Health. Rather than being cowed, he says the movement has been invigorated by the pandemic.
    Since the outbreak began, there has been an influx of more extreme views, especially from those who are suspicious of government control, says Dorit Reiss, a law professor at University of California Hastings College of the Law, who monitors the anti-vaccination movement. With vaccine hesitancy at record rates, coupled with economic hardship, scepticism of government, and growing annoyance at lockdown measures, there are opportunities for anti-vaccination campaigners to target those vulnerable to anti-vaccination sentiment, she says.

    Reiss is particularly concerned about the fast tracking of vaccines. “The anti-vaccination community will latch on to anything that goes wrong and will use that to create fear. We should expect that.”
    Indeed, an analysis of more than three million social media posts a day from January to mid-March 2020 found most comments keen on a vaccine.6 But, says Heidi Larson, director of the Vaccine Confidence Project (VCP) at the London School of Hygiene and Tropical Medicine, “one of the more dominant concerns is that new covid-19 vaccines will be developed too quickly—that they won’t be safe enough.”

    Bloom has no doubt the movement will resist any forced implementation of a covid-19 vaccine. “These are new vaccines, never been used before. There will be lots of possibilities to sow doubt,” he says. A jab based on the measles vaccine—a particular area of hate for the movement—would immediately be a target. Any rush to roll out a new vaccine will be used as ammunition and evidence of a loss of civil liberties. And the movement will not hesitate to point to political corruption and big pharma conspiracies if those with money have priority access when a vaccine becomes available.
    This sentiment is reflected in early findings of an 18 month study tracking online conversations and conducting global polls to measure attitudes about the coronavirus. Led by the VCP, one poll in mid-March found around 7% of Britons would decline a covid-19 vaccine if it existed. This dropped to 5% when a second poll was conducted in early April—although this wasn’t a trend in all countries. March polling found 18% of French people would refuse a coronavirus vaccine.
    He calls for a vast advocacy campaign led by respected individuals alongside mass screening of social media with harmful misinformation removed.

    Getting communication right is critical, says Ratzan. “The pandemic is showing our vulnerabilities when it comes to vaccines and vaccine hesitancy—and it raises the matter of how we protect for future pandemics.
    ”2 of 5 Responses: one from John Stone and one from a GP – (so if the %48 who would rely on their GP were consulting her – what would they do then?)
    Even covid-19 can’t kill the anti-vaccination movement
    Dear Editor
    After a succession of powerful responses to Katrina Megget’s article [1] I would just like to point out when considering the safety of products how unscientific and prejudicial labels such as “the anti-vaccination movemement” and “misinformation” are [2]. In a correspondence involving Dr Paul Offit last year [3] some of us remained unsatisfied about the evidence for the existence of double blind placebo safety trials for the routine schedule, but even Dr Offit has criticised the dangerous race for a COVID-19 vaccine warning among other things [4]:

    “Even if a vaccine generates antibodies, it does not prove that the vaccine is effective at preventing infection; it only makes it more likely that the vaccine would be effective…Even with the initial trials, we are likely to have scant data on whether older people will mount an immune reaction and be protected…”

    Politicians and journalists totemise vaccines but perpetually fail to acknowledge the scientific limits of the technology and the fallibility of institutions (just as they denigrate critics), and there is a real public danger. A prerequisite for having safe, effective products is allowing people to talk about them, and there is no reason why vaccines should not be like anything else.

    10 June 2020
    John Stone
    UK Editor
    AgeofAutism.com
    London N22
    @JohnStone32
    Vaccine science and Copernicus
    Dear Editor
    In 1543, ‘De revolutionibus orbium coelestium’, described the heliocentric model of the universe as established by Copernicus (1). The Church objected to the, “false Pythagorean doctrine, altogether contrary to the Holy Scripture,” and issued a decree suspending the work so that the knowledge would not, “creep any further to the prejudice of Catholic truth.”

    In 1633 Galileo Galilei was convicted of grave suspicion of heresy for, “following the position of Copernicus, which is contrary to the true sense and authority of Holy Scripture”, and was placed under house arrest for the rest of his life (2).

    Had the Church been able to prove its point by engaging in objective, scientific discussion rather than relying on a rigid belief system, it might not have had to employ censorship and authoritarianism to establish its superiority in the eyes of the people.

    In parallel today, were the vaccine industry and its proponents willing to engage in an unbiassed, evidence-based, scientific discussion with those who question the safety and efficacy of vaccines, they would surely establish the superiority of their position more successfully? One must therefore ask why such an open discussion has not taken place?

    Has belief in the safety and efficacy of vaccines now become such an ingrained doctrine that the only course of action open to industry and its supporters is to attempt to denigrate and silence dissenting voices? If so, what does that say about the perception in the eyes of the public of industry’s confidence in its own science?

    Book-burning does not seem to be achieving the desired result.

  4. Richard Smith
    @Richard56

    Peer review won’t save us [from fraud] by itself. Even back in 1983, Relman understood that the standard system for evaluating manuscripts was a blind watchman in the fight against scientific fraud.

    https://www.wired.com/story/just-how-historic-is-the-latest-covid-19-science-meltdown/

    When The Lancet and The New England Journal of Medicine pulled an influential pair of Covid-19 papers last Thursday, it was a rare event in scientific publishing. For medical researchers, this was like seeing The Washington Post and The New York Times take down related news stories at the same time—a confluence of editorial failures that raises dire questions about what went wrong and why. But how surprising is this scandal, really?

    Could these be among “the biggest retractions in modern history,” as one observer described the news about the paper in The Lancet? That depends entirely on how you read history. Science meltdowns of this type—and the “biggest” retractions that ensue—occur with shocking regularity. Again and again, over decades, scientists and the public have had their confidence in the enterprise shaken by these sorts of disturbing revelations; and then, again and again, over decades, everyone has been surprised. Cue Casablanca.

    https://www.youtube.com/watch?v=SjbPi00k_ME

    Vampire Medicines

    https://davidhealy.org/vampire-medicines/

    BMJ’s lawyers made it clear that if the journal had anything to do with Healy and Jureidini they would be providing GSK or other companies with grounds to claim bias and to sue. This is even though BMJ and GSK are partners in AllTrials and BMJ had a short while before featured Andrew Witty on its front cover as the acceptable face of pharma, helping GSK put a $3 billion fine behind them. Partnership?

    There is an excess of suicidal events on antidepressants in every one of these 30 trials. In the only notionally non-company trial, the investigators in 7 major publications in leading journals from this trial “managed to conceal” the 34 suicidal events on Fluoxetine versus 3 on placebo – this requires an Editorial Nelson to be not just blind in one eye but very short-sighted in the other.

    Cue Casablanca…

  5. We are doing a three part review of CHILDREN OF THE CURE this week on Olly’s Friendship Foundation Facebook page. The first, showing the back cover and blurb, with our campaign to spread this book as widely as possible and particularly to all our followers’ GPs, went on at 8 am today. There will be two more posts before Thursday. We hope the authors will approve. Hats off to them for a magnificent book, which we have also reviewed last week on Amazon U.K.

  6. Shouldn’t Jeff have published this sooner?
    The BMJ
    Jeffrey Aronson: When I Use a Word . . . Benefits, harms, and three tales of retractions
    June 12, 2020
    Here are three tales of retractions and a puzzle.
    A tale of apparent benefit
    In a tweet on 16 April, the prolific Professor Mandeep R Mehra, whose 2020 PubMed record already runs to 44 papers, announced a forthcoming paper. The preprint reported the results of an “observational propensity-matched case-controlled study” in 1408 patients with covid-19; 704 received a single dose of ivermectin 15 micrograms/kg and 704 did not. The in-hospital mortality rates were 1.4% versus 8.5% respectively (hazard ratio = 0.2; 95% CI = 0.11–0.37). The patients were said to have come from 169 hospitals in three continents, but a table in the preprint identified them as having come from North America (n=923), South America (69), Europe (227), Africa (66), Asia (121), and Australia (2).

    Many comments on Reddit were enthusiastic. Only a few were skeptical. None questioned the provenance of the data. The preprint was later withdrawn as “not ready for peer review”.

    A second tale of apparent benefit
    On 1 May the New England Journal of Medicine published another paper by Mehra and four colleagues (Figure 1). They described an apparent beneficial effect of ACE inhibitors in covid-19 but no effect of angiotensin receptor blockers (ARBs). Their registry study was in 8910 patients in 169 hospitals in Asia, Europe, and North America, whose data had been gathered in an observational database called the Surgical Outcomes Collaborative (Surgisphere), described as “an international registry”, whose director is co-author Sapan Desai.

    However, following an expression of concern on 2 June, all five authors wrote a letter to the journal: “Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article.” They therefore asked that the article be retracted.
    Figure 1. Source https://pubmed.ncbi.nlm.nih.gov/32356626/

    A tale of apparent harm
    On 22 May The Lancet published another paper from Mehra and three colleagues (Figure 2) describing a registry study of data from 671 hospitals worldwide in more than 96 000 patients with covid-19, of whom 16% been treated with a 4-aminoquinoline, chloroquine or hydroxychloroquine. The reported mortality was 7530/81144 (9%) in patients who received neither drug and 3168/14888 (21%) in those who received a 4-aminoquinoline; those who received azithromycin or clarithromycin in addition were at higher risk of dying (2318/10004, 23%) than those who received a 4-aminoquinoline alone (850/4884, 17%).
    Figure 2. Source https://pubmed.ncbi.nlm.nih.gov/32450107

    Suddenly the floodgates opened. Australian hospitals reported that they had not given permission for any data to be released, and hospitals elsewhere reported likewise. Unusual features of the paper were highlighted—the small number of authors for such a large database study and the lack of ethics committee approval, from which the data collection and analyses were, according to the authors, “deemed exempt”. Following an expression of concern on 3 June, three of the authors retracted the paper. They were unable to complete an independent audit of the data underpinning their analysis and concluded that they “can no longer vouch for the veracity of the primary data sources.”
    The puzzle
    The responses to the first two papers were warm, often enthusiastic, with some skeptical reservations. Appropriate doubts emerged only when the third appeared. Why the delay?
    It was Australian researchers who first pointed out the problems with the third paper, and, apart from two patients, Australian data were not apparently involved in the first and second. Could that be relevant? But there is something else. The first two papers reported benefits, fulfilling everyone’s hopes for effective interventions. The third reported harms and no benefits, dashing the hopes of all those who were expecting the latter.
    Realistically we should pay equal attention to benefits and harms, and gauge the balance between them. But do we prefer to believe beneficial outcomes and not harmful ones?

    Jeffrey Aronson is a clinical pharmacologist, working in the Centre for Evidence Based Medicine in Oxford’s Nuffield Department of Primary Care Health Sciences. He is also president emeritus of the British Pharmacological Society.

  7. From STATS
    FDA revokes emergency use ruling for hydroxychloroquine
    The Food and Drug Administration on Monday said it had withdrawn an emergency approval for use of the malariadrug hydroxychloroquine as a Covid-19 treatment. The agency said the drug, along with chloroquine, is “unlikely to be effective in treating Covid-19,” and highlighted its “serious side effects.”

  8. Just to say, our trilogy of CHILDREN OF THE CURE posts are up now on wwwollysfriendshipfoundation.org.uk Facebook page. We think the expression on face of the ‘Spirit of Indifference’ hobgoblin, who symbolises Pharma, MHRA, FDA, and NICE, as well as the medical journals, gets the point across, with the dead and dying daisies falling across his legs, like so many unfortunately fell across the paths of the above organisations. Please buy the book and do your GP and enormous kindness by presenting them with a copy, saving lives in the process.

  9. Back in April David H (who doesn’t ‘shy away’) contacted Sue Jordon to suggest a collaboration using the project she and colleagues had developed at Swansea University. She was not helpful seeming to be more interested in grabbing Kudos than tackling the over prescribing of drugs to vulnerable elderly people in care homes. Since April maNY thousands of people have died of course. She declined to collaborate when deaths were much lower but beginning to escalate

    re Rxisk Blog Medications compromising Covid Infections
    April 2, 2020 | 58 Comments
    Joan-Ramon Laporte, M.D.
    Emeritus Professor of Clinical Pharmacology, Department of Pharmacology, Therapeutics and Toxicology
    Universitat Autònoma de Barcelona.
    Fundació Institut Català de Farmacologia. WHO Collaborating Centre for Research and Training in Pharmacoepidemiology.
    jrl@icf.uab.cat
    David Healy MD FRCPsych
    Professor Dept of Family Medicine
    McMaster University
    Hamilton, Canada.
    david.healy54@googlemail.com

    April 17, 2020 at 2:40 pmRxisk Blog
    Susan Jordon hasn’t found herself able to respond to a letter asking whether she might enable her project to be used to investigate the Covid crisis, Not altogether surprising admittedly. But she was also contacted by somebody else though reading the Rxisk blog and was keen to get involved with his PhD project. Now or never, is not the time to be precious about owning projects which could be used or adapted to help .S Jordan could still claim kudos for her and her colleagues but the idea of collaboration is not a mind set established in institutions sadly.Sue and her colleagues had been busy publishing…

    BMJ Open. 2018; 8(9): e023377.
    Published online 2018 Sep 28. doi: 10.1136/bmjopen-2018-023377
    PMCID: PMC6169755
    PMID: 30269073
    Nurse-led medicines’ monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the adverse drug reaction (ADRe) profile for mental health medicines
    Sue Jordan,1 Timothy Banner,2 Marie Gabe-Walters,1 Jane M Mikhail,1 Jeff Round,3 Sherrill Snelgrove,1 Mel Storey,1 Douglas Wilson,1 David Hughes,1 and the Medicines Management Group

    And In Eureka Alert
    Academics call for structured drug monitoring in care homes
    A structured approach to medicine monitoring leads to positive impacts on patientss

    Professor Sue Jordan from the University’s College of Human and Health Sciences led the research which is newly published in the PLOS ONE journal. The study showed how care home residents’ adverse side effects were picked up more effectively by their nurses and carers when a structured monitoring system was used alongside administration of mental health medicines.
    The over-use of mental health medicines in care homes has long been a cause for concern, and insufficient patient monitoring has been seen as an important cause of medicines-related harms.
    The new study examined the nurse-led medicines’ monitoring system known as the Adverse Drug Reaction (ADRe) Profile which identifies and addresses the adverse effects that mental health medicines can have on patients.
    This study worked with ten care homes caring for people prescribed mental health medicines to investigate:
    The clinical impact of ADRe.
    How to ensure the routine and continued use of ADRe in care homes.
    How ADRe might enhance pharmacists’ medication reviews.
    The study found that nurses using ADRe picked up issues which resulted in nursing care being changed for 27 of 30 residents and medication for 17 patients being reviewed.
    Other key findings were that nurses using ADRe found:
    Antipsychotic medicines were reduced.
    Eight of 30 residents were identified as being in pain, and ADRe helped to resolve this e.g. by recommending review of painkillers.
    Six of 30 residents were short of breath and were referred for medication review.
    Care plans were changed for five of nine residents that had suffered falls.
    Residents were ‘brighter’ or less agitated or less aggressive when care changed to reduce antipsychotic medicines.
    The research team also interviewed key people such as prescribers, pharmacists, nurses and care staff in the homes, residents, service users and relatives as well as policy makers and a care homes inspector. The responses were mainly favourable, because without ADRe treatable problems might be left unattended, but healthcare professionals said that time, understaffing and work demands were potential barriers to regularly using ADRe.
    However patients and service users said continued monitoring was needed to avoid people becoming ill, their conditions deteriorating, mistakes being made or valuable information about a patient’s condition not being picked up.
    The study concluded that when ADRe is used routinely, it improves the lives of patients, helps to identify problems quickly, and results in better care and medication reviews. It also shows that as ADRe fully records a list signs and symptoms, it makes reviews by pharmacists easier and helps them make better decisions when changing, reducing or stopping medicines.
    Professor Sue Jordan said: “Our study shows how simply checking patients for the signs and symptoms of possible adverse drug reactions improves the lives of the most vulnerable in society. It also shows that bringing patients’ perspectives into medicines optimisation is complex, and the very complexity means that professionals may shy away from this potentially difficult task. The positive impact on patients’ lives should persuade managers, service leaders and guideline developers to adopt ADRe – after all who wouldn’t want to be checked for pain, breathlessness, sedation and tremor?”
    Timothy Banner, study pharmacist, said: “ADRe is needed to meet the recommendations of Welsh Government for medicines optimisation Use of Antipsychotic medication in care homes, and these findings need to be implemented by healthcare professionals, policy makers and sector regulators to ensure patient safety and minimise any harm caused by adverse side effects.”
    Dr. Jeff Round, health economist, said: “This study shows how a simple and inexpensive tool in routine care can minimise preventable adverse side effects. There are significant resource and cost implications in failing to tackle the problem.”

    This week in thebmj
    https://blogs.bmj.com/bmj/2020/06/18/reduction-of-polypharmacy-by-electronic-decision-support-less-is-more/
    https://www.bmj.com/content/369/bmj.m2023
    and
    Editorials
    Inappropriate medication use and polypharmacy in older people
    BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m2023 (Published 18 June 2020)

    Less has certainly resulted in more deaths for elderly people .They don’t have time for yet more research of what is known already

  10. A long article in the Paris ‘Le Monde’ refers to the Surgisphere scandal.

    This is an example of how peer review, even in journals such as the Lancet, can fail.
    This is an indication that data can be manipulated in the digital, ‘Cloud’ context. The amounts of data were huge, indeed elephantine, from hospitals all over the world, for the study in question.
    This is a sign of how a journal may favour a result, a conclusion, that it wants a priori. The ‘hope’ was that the controversial drug for Covid-19, hydroxychloroquine, could be categorically rejected.
    The Le Monde article does not refer only to what it terms ‘Lancetgate’. It adds also that France finances researchers according to their number of articles and citations. It cynically adds that ‘autocitations – citing one’s own papers – is a means to take a part of the one and a half billion euros given annually by Paris to scientists in line with the ‘citation count’.

    The Le Monde article has something verging on brutal sarcasm about how today’s science works. The paper implies that data, citations, papers, peer review, and so on, can all be ‘cooked’, manipulated.

    The COVID-19 crisis has not been much of a victory for Big Pharma. Testing with the adequate sensitivity and specificity has not been guaranteed. The diagnostic industry has let down the NHS. As for a vaccine, none exists to forestall any coronavirus. Big Pharma is probably not going to provide the necessary vaccine soon.
    ith the arrival of a Biblical plague, Big Pharma has hopelessly dithered, ducked, and disappointed.
    The Surgisphere disaster possesses a grim, frightening resonance with regard to how science can be corrupted, just like society in general.

    Dossier: Covid-19: le , un incident editorial revelateur. Sandrine Cabut, et al. Le Monde. 17 June. 2020.
    25 June 2020
    Zekria Ibrahimi
    psychiatric patient
    West London Mental Health Trust

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