This is part one of a two part post. The image is from the opening sequence of Raiders of the Lost Arc and shows Indiana Jones being chased by angry natives with the shakiest of means of escape – like trying to escape in a Ford Pinto which risked bursting into flames. A Fireser 747 Max 8 might have been more up to date option. Part two next week.
When vaccines and drugs are approved, these days, regulators state they have a favourable Benefit-Risk ratio. Regulators have only made statements like this for approximately two decades. Prior to that, treatments were approved on the basis of an established treatment effect with some evidence for a likely acceptable safety profile.
Benefit-Risk ratios are now, according to regulators, established in Randomized Controlled Trials (RCTs), also called clinical trials. RCTs are now, and have been since 1962, essential to approval, but there has been a shift from using them to establish a treatment effect to viewing them as laying the basis for a Benefit-Risk ratio.
Approval is not granted on the basis that this drug acts on the serotonin system or that vaccine produces Spike proteins. These biological effects may be true but the observed effects on people in RCTs in the real world are given primacy. The biology may help explain those observations but is not a basis for approval, other than in exceptional cases.
The approval process requires pharmaceutical companies to run RCTs, the results of which are submitted to regulators (FDA, HealthCanada, EMA, MHRA, and TGA). These bodies may regulate Food and Drugs, as FDA does, or medical drugs and devices but not food (MHRA).
The pivotal (key) RCTs are ordinarily published in medical journals, usually a prestigious journal if the treatment is noteworthy. These publications are the primary means of conveying key details of a drug to doctors who as learned intermediaries are entrusted with responding to queries from patients about their conditions and possible treatment benefits and risks.
For both drugs and vaccines, the RCTs that lead to an approval are viewed as offering a favourable Benefit-Risk ratio. Individuals clearly can opt not to consent when the taking of a particular drug like an SSRI. Regulators believe that across a population the benefits will outweigh the risks and since a set-piece pitching Company RCTs against convincing Case Reports of Treatment Induced Suicidality on SSRIs in 1991, they invoke a fear of deterring people from seeking a benefit that RCTs promise to explain their caution about warnings about hazards on the basis of Case Reports.
Companies rather than regulators decide whether to warn about a hazard. They may do so because the hazard is serious, or because it is one that can be avoided if warned about, or when it is one that induces a frisson that might increase sales. Companies write drug labels. Regulators review these for wording that is not supported by evidence, but do not write them.
RCTs have developed a reputation as a good way to manage all potential sources of bias or confounders that may compromise the evaluation of a treatment. This reputation is misplaced according to Sir Austin Bradford Hill, who developed and ran the first RCTs, and Dr. Louis Lasagna, who introduced RCTs to the regulatory apparatus in 1962 to help establish whether treatments are effective. From the start, companies have been to the forefront in encouraging doctors to practice in accordance with evidence that only they have the resources to produce.
RCTs can manage some confounders in very limited settings. This management, however, involves a trade-off. A drug or vaccine can have a hundred or more significant effects. Selective Serotonin Reuptake Inhibiting (SSRIs) antidepressants, for instance, have multiple actions other than just their action on the serotonin system. In addition, they affect every bodily system – eyes, ears, skin, bones, muscle, gut, blood, heart, sperm, hormones, allergic responses, urinary system, genitals and other aspects of sexual function, as well as the peripheral and central nervous systems, where they affect appetite, sleep, libido, anxiety levels, memory and mood.
Similarly, it was hoped the Spike proteins, that mRNA agents generate, might lead to immunity but in addition they affect most bodily systems in a manner that does not happen with traditional vaccines.
An RCT necessarily focuses on the effect of primary therapeutic interest, called the primary endpoint. Does this drug affect mood? Does this vaccine produce immunity? For the purposes of a trial, we are not interested in whether an SSRI also has antibiotic properties as several do or whether an antibiotic inhibits serotonin reuptake and might affect mood as some do.
Most (90%) examinations and measurements in an RCT centre on the primary endpoint, with investigators having little time, or space, to record other effects.
For more on RCTs, see
People are the Data in Clinical Trials
Ideally in this case the Indiana Jones image above would have some role reversal as in the following Professor Pi image to really hit the nail on the head.
From Model to Mandate?
A model in which companies are required to prove a treatment benefit through an RCT has some utility when the task is one of establishing whether a treatment has an effect of possible therapeutic value, where those effects are uncertain because of natural variation or placebo effects. The intention was to hold companies seeking to make money out of us at our most vulnerable to a higher standard than charlatans.
It was once thought that a positive result in one RCT of a medicine would invariably make for positive results in other RCTs of that medicine, but this has not been borne out.
The model however also has a bureaucratic function. It gives regulators a box to tick, or process to adhere to. They can approve a drug where there are two positive RCTs, even if the majority of RCTs done have been negative.
The Primary Endpoint Problem
The model when introduced was not viewed as providing a basis for a Benefit-Risk claim. It does not now provide such a basis.
The basis for a possible claim of a favourable Benefit-Risk hinges on the primary endpoint in a trial offering a significant benefit and being by far the commonest effect of that treatment. Other effects may occur, but they are viewed as rare or events that only appeared after the trial period was over and therefore not missed deliberately.
For instance, in the case of a parachute, saving a life is significant and the life-saving effect is the commonest effect of that device. Limbs might break in the process, but these injuries are less important and less common.
A positive Benefit-Risk balance in other words is obvious. RCTs are not needed. If the primary endpoint in a trial is less common than other effects and less beneficial than the harm these other effects entail, the basis for a positive Benefit-Risk claim disappears. In these cases, RCTs are deployed for their rhetorical value; evidence is used to persuade us something is evident when it’s not.
For instance, SSRIs have been licensed for their effect on mood. This effect is marginally more common than the effects of natural variation or response to placebos on mood. About 1 person in 10 has a benefit from an SSRI that they would not have had from natural variation or placebo factors and this effect may only be apparent after six to eight weeks of treatment.
This might offer the basis for a positive Benefit-Risk claim, provided there were no other more common significant effects. In the case of the SSRIs, there are many more common effects. The most common effect is a numbing of, or irritability effect on, genitals. This happens close to universally (9 out of 10 at least) within 30 minutes of a first pill but was missed in all RCTs of these drugs because of their focus on a primary mood endpoint.
This genital effect can significantly affect sexual functioning. Over time libido falls. These drugs also cause dependence, so a person may be trapped on them unable to make love for years, having to risk withdrawal induced suicidality in order to make love again.
Even if the person stops treatment, the ability to make love and their libido may never return. This is termed post-SSRI sexual dysfunction (PSSD).
These drugs also cause an emotional numbing in about 8 people out of 10. This change can be obvious enough within a day or two of starting treatment to be observable by others – nearly as obvious as the effects of alcohol. This is the effect through which SSRIs mediate the benefit for which they were licensed. But this effect was not detected in RCTs.
The failure to detect this emotional numbing, a ‘chill’ factor, introduces an incoherence into treatment. We give these drugs to treat a mood disorder but do not tell people how they will help bring about this change in mood and so people cannot monitor whether the right things are happening or not. Even if an emotional numbing is present, rather than the irritability or agitation which happens to 1 person in 5, this numbing may be unwelcome to the person on treatment who may opt to stop this treatment and turn to other options and could do so much earlier if properly informed.
SSRIs also cause nausea in up to 1 person in 3, more commonly that is than the hoped-for therapeutic endpoint. In the case of people who stay on treatment, SSRIs double the rates of miscarriage in pregnant women and double the rates of birth defects and behavioural problems in the children born from those pregnancies, and agonisingly for women cause a dependence that can be so severe that women aware of the hazards to a child are unable to stop treatment.
Regulators proclaim these SSRIs have a favourable Benefit-Risk ratio, despite the fact that they can make people suicidal and homicidal, and even though sexual dysfunction, emotional numbing, nausea and other effects are more common than a beneficial mood effect and some of these may be more significant to individuals than even a realized benefit.
Thalidomide offers a striking symbol of the Primary Endpoint problem. It was put into a placebo-controlled RCT, before marketing in the USA, perhaps the first drug to be assessed in this way. It proved efficacious at putting people to sleep and appeared to have fewer side effects than other sleeping pills then available. Regulators and companies, behaving as they do now, would point to the scientific grounds for stating thalidomide has a favourable Benefit-Risk ratio.
mRNA Primary Endpoint
In the case of mRNA vaccines, the primary endpoint of the trial was whether the person caught a Covid infection. If catching significant Covid infections was almost universal and the difference between being treated or not was clear, this might offer the basis for a positive Benefit-Risk assessment.
The commonest effect following dosing is an action of the mRNA agent on the cells. Apparently, the hope is that this will produce Spike proteins which will generate an antibody response which will bring about immunity and that in turn will prevent death or other serious injury.
MRNA may in its own right act as a drug rather than simply as an agent to generate Spike proteins. If mRNA drug effects could be optimised to produce helpful effects such as tackling Covid pneumonia without producing Spike proteins, such a treatment might have a clear Benefit Risk ratio.
(The effects of mRNA agents are more consistent with a treatment than a vaccine model. These agents do not induce immunity or stop transmission as a vaccine ordinarily would).
More speculatively, mRNA agents may change our genetic disposition so that enduring effects occur that may or may not be helpful or that may be transmitted to the next generation of children. Earlier this month an article appeared confirming transgenerational effects for the anticonvulsant valproate. Only time will tell whether such effects are realized but they are a significant possibility and Benefit-Risk ratios that discount such effects are incautious. In addition if these agents provide a treatment rather than a vaccine effect, many people like pregnant women might opt not to be treated.
MRNA agents do produce Spike proteins, in greater amounts and from more bodily locations than expected, with a wider range of actions than just generating an antibody response.
Generating an antibody response moreover is more complex than most of us once thought. The antibodies the Spike protein generates can be neutralising or enhancing antibodies and they are IgG antibodies rather than the IgA antibodies found in the lung in respiratory infections, which would on the face of it be a better bet.
Like SSRI induced emotional numbing, Spike proteins have significant effects, other than a hoped-for immune effect. They cause many deaths, and injuries like myocarditis, pericarditis, thromboses and neurological problems after vaccination. Our focus on a hoped-for immunity means that the full range of effects of these proteins, like the full range of effects of emotional numbing, remains unknown and commonly missed in clinical practice as a result. Because these effects were not reported in the clinical trials, they are not therefore on clinician’s radars.
In summary, there are many more common effects than the apparent benefit on the hoped-for primary endpoint. As with SSRIs, therefore, it is not possible to say that the RCTs for the current Covid vaccines offer a favourable Benefit-Risk ratio. There are grounds for concern that there are more common, or at least as common, serious effects than there are benefits but these have not been and are not being looked for.
There are more deaths in the active treatment arm of these trials than in the placebo arms.
In contrast, Pfizer are claiming an 89% reduction in deaths and hospitalisations for their protease inhibitor nirmatrelvir-ritonavir combination compared to placebo in a trial that only had to recruit 2,246 patients to demonstrate this benefit.
While there may be a treatment rather than a vaccine effect from mRNA agents that can be of benefit in cases that develop serious complications, there are also several times more reported deaths from these agents in one year than from all vaccines combined over a twenty-year period. These are reports to a system that heavily under-reports serious events like death – at best 1 death in 10. No-one is putting these mRNA deaths in a benefit-risk scale to see where the balance lies.
Besides death, the other key index of benefit for a ‘vaccine’ would be sustained immunity to infection and a greatly reduced risk of transmission to others. Even Messrs Gates and Fauci agree these agents do not give us these outcomes.
The Surrogate Outcome Problem
In SSRI trials, there is a higher death rate in the SSRI arm of trials than in the placebo arm and a higher suicidal event rate on active treatment than on placebo, when one might have expected a licensed treatment with a positive Benefit-Risk ratio to save lives and get people back to work.
The answer to this conundrum is that SSRIs were licensed on the basis of rating scale changes. Rating scale changes are surrogate outcomes, which we expect to reflect processes that will lead to the benefits we hope for such as lives saved, or people restored to functioning.
In similar fashion, we license statins on the basis of lowered cholesterol levels rather than any benefit on mortality. We license hypoglycemic agents on the basis of an ability to lower glucose, even though this commonly leads to more hospitalizations than diabetes. The drugs for osteoporosis are licensed on the basis of an ability to thicken bones rather than reduce fractures with the result that there are now more serious fractures of abnormally thickened bones in the elderly after falls than there ever were before these drugs were introduced.
We have the same situation with the mRNA trials. The ability to reduce infection rates would not ordinarily be thought of as a surrogate marker but reducing the risk of death or of infection severe enough to lead to hospitalization are the hoped-for outcomes. If these do not happen, then reducing apparent infection rates may even be a bad thing. Abolishing symptoms like cough may make infected younger people more likely to kill their elderly relatives.
The hoped-for outcomes on hard endpoints like death were not measured systematically because they are too rare even for a trial with 40,000 entrants to pick up differences, which is an ironic comment on the severity of the infection. Covid is not Ebola.
Between the primary endpoints and surrogate outcomes that trials need, as Bradford-Hill recognised RCTs are almost by definition not a good way to evaluate a drug or vaccine. They can establish that there is a potential for benefit. They do not provide a basis to establish a Benefit-Risk ratio. When there is a benefit in terms of lives saved as clear as there is with parachutes, there is no need to run RCTs.
Trials can be run for two reasons. One is to demonstrate that we know what we are doing, in which case, as with parachutes, we would expect to get the same result every time. There is no treatment that regulators approve that meets this criterion.
The other reason to run trials is when we do not know what we were doing. In this case, even with 40,000 patients recruited and trial designs that enable a lot of deaths to vanish, we still ended up with more dead bodies in the treatment arm of mRNA trials than in the placebo arm.
Not knowing what we are doing, and not getting a clearly favourable result, we nevertheless mandated the administration of these agents because of their favourable Benefit-Risk ratio.
The Conduct and Publication of Trials
As of the 1980s, companies began to outsource the running of their clinical trials to Contract Research Organizations (CROs) and the medical writing of reports of what those trials showed to medical writing companies. The medical writing side of the business is regularly called ghostwriting because the authorship line of these papers will list academic physicians but not the writers who wrote the drafts and even wrote the cover letter for the submission of the paper to a medical journal.
The upshot of this outsourcing was that in the interests of speedy completions CROs took trials to Eastern Europe, India, Africa and South America. The pressure to get trials done quickly meant that the patients didn’t always exist. North American academics nevertheless remained the named authors on these trials although they had never collected a scrap of data or met a single patient.
Trials also became larger and multinational. Larger does not mean better. Weaker medicines need larger trials to demonstrate an effect. It only takes a trial of 12 people to show that the genital numbing SSRIs cause can make them a treatment for premature ejaculation, whereas it takes several hundred people to have a hope of finding an antidepressant effect. Even snake oil can demonstrate a benefit with large enough numbers and the right outcome measures.
The running of trials required CRO personnel to shuttle between an increasing number of increasingly far-flung centres. This created a natural drift to store the master copy of all records in one location. An academic investigator, who was increasingly unlikely to have seen the patients anyway, no longer had the records from the whole trial that s/he could analyse. At best s/he had copies of a small subset of files.
The CRO transcribes the data from the master files into spreadsheets. For instance, in Study 329, where paroxetine (Paxil) was compared to placebo in depressed adolescents, there were 77,000 pages of records, Clinical Report Forms (CRFs), with each subject in the trial having 300 or so pages of trial records. The data from CRFs, along with various protocols took up 5000 pages of appendices, accompanying an 800 page Clinical Study Report (CSR). In many instances, data goes missing in the transcription process. Particular problems can end up effectively concealed under esoteric coding rubrics, such as emotional lability for suicidality.
The 800-page CSR gives a company view of what this trial has shown. The final medical journal publication from this trial may then amount to 10 pages.
Company submissions to regulators centre primarily on the Clinical Study Report. The 5000 pages of appendices will almost certainly accompany these but are rarely looked at by regulators. The 77,000 pages of Clinical Report Forms may be notionally available to regulators but are never looked at by them.
If a problem blows up about a drug, regulators will ask the company to review their material and report back to them. They will not go to their own archive and see what they make of what is there. Even if the 77,000 pages were there all names are redacted so the regulators can never contact the person behind the record to find out what in fact actually happened – or even establish if they actually existed.
Regulators never see the bedrock data from RCTs. They do not have access to either the figures in the CRFs behind the figures appearing in the appendices or the people from whom those figures come. The regulators of medicines have for three decades depended on the integrity of company submissions. The apparent success of this practice may underpin the recent turn of air safety regulators to depending on Boeing’s submissions on its planes as the sole basis for approval.
Prior to the 1980s, clinical trials of medicines had usually been run in a small number of university hospitals, and the clinicians involved knew the patients and had access to and analysed the data. When an RCT was brought into a legal setting as evidence, the Court could bring an expert into the proceeding to answer questions about the effects of a drug on real patients who could potentially also be called to testify. This understanding made it sensible to grant the evidence from RCTs a Hearsay exemption. It no longer makes sense.
The changes that were taking place from 1990 onwards led New York State to lodge a fraud charge against GlaxoSmithKline in respect of an RCT of paroxetine done in depressed teenagers. This trial, Study 329 was carried out in the mid-1990s and published in 2001. It claimed the drug worked well and was safe. Documents emerged that made it clear that GSK knew the drug did not work but the company intended to pick out the good bits of the study and publish them. This laid the basis for a fraud charge and later a $3 billion fine from the Department of Justice.
It transpired that the entire literature on the results of the use of antidepressants in RCTs for depressed children at that point was ghostwritten,
There was a complete mismatch between what the ghostwritten articles said and what the data showed when accessed.
GSK told FDA that Study 329 was negative, as were their other two studies. FDA acknowledged this and still issued an approvable letter for paroxetine for the treatment of depressed adolescents, and in addition agreed to GSK’s request not to mention that these studies were negative in the label of the drug. Other regulators almost certainly did exactly the same thing.
Study 329 was not a bad study. It was conducted to a higher standard than the recent vaccine trials. What this points to is that, quite aside from the limitations of RCTs, fraud is the de facto company modus operandi when it comes to their RCTs.
(What companies have been doing is not fraud in terms of business processes. No business rules are intentionally broken. In terms of the norms of science, however, the company trials are fraudulent. The practices adopted are designed to maximise commercial advantage rather than adhere to scientific norms, but the marketing rhetoric summons us to follow the science and as doctors to prescribe and as patients to take).
In the case of the RCTs for the Pfizer mRNA agent, this was run by a CRO – ICON. There is a published BMJ article on how shoddy some of the recruiting centres were. There is every chance this shoddiness, already put on the record in the BMJ, and uncontested, is nothing compared to what has happened in other centres in which this trial was run that have not yet been looked at.
The published articles reporting the trials of mRNA and related agents were ghostwritten. These published reports are patently misleading in terms of the conduct and findings of these trials. The harms that occurred in these trials have been egregiously written out of the script.
As things stand these agents cannot be given or taken with informed consent.
Mandates vitiate consent. If mandated to take a treatment we have to trust the authorities. In this case, the authorities never had the data and never will have it. In terms of what has been submitted to FDA and other regulators (company reports of what their trial has shown and correspondence between regulators and companies in respect of the trial), FDA have blocked access to this for 55 years and are trying to have that period extended.
Were the material that FDA is blocking from release available we still would not have the raw data. The bedrock information on which consent should be based is not available to anyone. The authorities have not been able to review this material before instituting mandates.
They have not mandated a recording of or assessment of the hazards of treatment following the requirement for all of us to be treated. See Mandates Yes and No.
Consent can be given on the basis of trust but with a track record of fraud and regulatory willingness to turn a blind eye to that fraud, there are no grounds for trust either.
Re Ghostwriting see
The New England Journal of Misinformation
Pre-Vaccine Summary
- Clinicians do not have access to clinical trial data on medicines or vaccines.
- Close to all of the medical literature reporting trial results for on-patent drugs and vaccines is ghostwritten, hyping the benefits and hiding the harms.
- Clinical trials of these treatments that are negative on their primary or their most common outcomes are often published in prestigious journals as positive.
- Clinical trials have their harms airbrushed out of ghostwritten publications.
- Regulators (FDA, Health Canada, MHRA, EMA) do not get to see the full trial data.
- Regulators approve treatments as working even when more people die on active treatment than on placebo.
- Regulators approve medicines on the basis of negative studies and agree not to let the wider world know about this.
- Regulators say nothing when companies publish negative studies as positive and make adverse effects of treatment, including death, vanish.
- For many trials there are more deaths on active treatment than on placebo, but this does not lead regulators to warn about hazards as to do so would in their stated view deter people from seeking a benefit (even when the benefit is better characterized as a commercial benefit to a company rather than a benefit to the individual in terms of a life saved or a restoration of function).
This pre-vaccine summary and the entire document, along with the material next week has been sent to
- Joe Biden – Love in a Time of Covid,
- the BMA,
- Sajid Javid, Minister for Health in Wales, threatening mandates
- Eluned Morgan, Minister for Health in Wales,
- Robin Swann, Minister for Health in N Ireland,
- MHRA,
- NICE,
- Daniel Sokol, lawyer with an interest in ethical issues, who has written in favour of mandates,
- Jeff King, lawyer who has written in favour of mandates,
- the Canadian Health Minister,
- the Chief Public Health Officer for Ontario
- the Ontario Human Rights Commission
- the College of Physicians and Surgeons of Ontario (CPSO)
- the President of McMaster University
- the Dean of Medicine at McMaster University
There have been others. Some of the above have responded at various points (4,5,6,7,9). No-one has demurred on any of these points (except perhaps JK). The CPSO (13) did however make a marvellous contribution that will feature in Part 2 of this post.
There is an ironic background here. In 1979 Peter Medawar coined the term Conspiracy of Goodwill to indicate that pharmaceutical companies, governments, doctors and we who take medicines all want them to work. He was explaining that RCTs were our best antidote against being seduced into this conspiracy.
Charles Medawar and Social Audit resurrected the idea of a Conspiracy of Goodwill around 2004 but pointed to the ambiguities in the term that were more obvious by then. Even he however did not get to the idea that far from being an antidote, RCTs might be the key that locks the Iron Cage around us.
CONSPIRACIES OF GOODWILL?
Paroxetine, Panorama and user reporting of ADRs: Consumer intelligence matters in clinical practice and post‐marketing drug surveillance
https://content.iospress.com/articles/international-journal-of-risk-and-safety-in-medicine/jrs286
Authors: Medawar, Charles; | Herxheimer, Andrew | Bell, Andrew | Jofre, Shelley
Abstract: We systematically analysed two complementary samples of emails relating to patients’ problems with the popular SSRI antidepressant, paroxetine. These mainly concerned serious mood disorders and drug withdrawal symptoms. 1,374 emails were immediate responses to a major BBC‐TV documentary programme. These were contrasted with 862 messages on similar themes sent to a website discussion forum over a period of nearly three years. Despite the limitations of most individual email reports, we judged their collective weight to be profound. We also suggest that the value of “immersion” in a large body of such data may be greater than continuing exposure to a variable trickle of reports. We discuss the significance of these data in relation to the patient–prescriber relationship and pharmacovigilance. We suggest that the Internet offers unparalleled opportunities for soliciting and monitoring patients’ reports of adverse drug reactions, and propose practical initiatives to capture peoples’ experiences and thereby promote safer and more effective drug use.
Journal: International Journal of Risk and Safety in Medicine, vol. 15, no. 3-4, pp. 161-169, 2002
A comparison of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behaviour with paroxetine
Authors: Medawar, Charles; | Herxheimer, Andrew
https://content.iospress.com/articles/international-journal-of-risk-and-safety-in-medicine/jrs295
Abstract: We have previously described the value of patients’ reports relating to withdrawal problems and dependence, and violent or suicidal ideation or acts, and their linkage with paroxetine [1]. Here we describe how Yellow Card reporters – health professionals – perceived and reported suspicions of the same kinds of harm. This analysis was made possible only because the organisers of the Yellow Card scheme – the Medicines and Healthcare Products Agency (MHRA) and Committee on Safety of Medicines (CSM) – agreed to release data. National drug regulatory agencies rarely do so, and we believe this to be the first such analysis of the operation of the scheme. This analysis had two main objectives: to compare the value of professionals’ reports with patients’ reports of the same suspected adverse drug reactions (ADRs), and to learn more about the effects of paroxetine. Our analysis was limited for many reasons, but sufficient to form a robust preliminary view. In this particular case, the overall quality of professional reporting and interpretation of data seemed poor, providing intelligence that was in some ways inferior to that provided in spontaneous reports from patients. We give new evidence to suggest that miscoding and flawed analyses of Yellow Cards have led to under‐estimation of the risk of suicidal behaviour, and have impeded recognition of what appears to be a close relationship between suicidal behaviour and changes in drug concentration. An increased risk of suicidal behaviour during the first few days of treatment with an SSRI has been suspected for some years: we suggest that comparable risks may also exist outside this ‘window’, when drug dosages are either increased or lowered (during withdrawal). The implications for dosing strategies are discussed. Our analysis relates only to one drug and to two suspected ADRs, but suggests that the Yellow Card scheme is, in important respects, both chaotic and misconceived. Further research is essential.
Sen. Johnson asks FDA, CDC for information related to adverse COVID-19 vaccine reactions
https://www.ronjohnson.senate.gov/services/files/F564153D-89FD-40C9-A1B1-8663C22D2F0A
Led by Donkeys
https://www.youtube.com/watch?v=AkPwfcCzF54&t=2s
A Work Event – all fair-game for Andrew Witty and Patrick Vallance who must have celebrated the ignominious results of RCTs…
It’s all still so shadowy and completely unknown to most people even after you and others have dragged them out of the shadows to expose how dodgy are the authorities we are necessarily dependant upon . Many of us don’t trust them but are forced to suspend our disbelief including in un -evidenced coerced medication if needing to avoid sanctions on employment and so on when it comes to mandates. The consequences of un-informed often covert coercive consent to SSRIs and other medications have the same effect when adverse effects kick in leading to loss of employment ,social ostracisation, increased mental physical disabilities and so on. The rxisk to our lives is serious and unknown yet in UK we are being urged at every opportunity to accept another vaccine (booster) while no presenter. no journalist presses for aswers to the points raised in DH post And politicians seem willfully ignorant at best ,of the seriousness what they are promoting. That we should all be forced in one way or another by hook or by crook(ed) to do what they say because they have the power – but not the evidence.
Till Bruckner
2 days ago
Call for medical journals to support clinical trial transparency
Six health groups including TranspariMED today call on medical journals to help patients, doctors and scientists to rapidly access data from recently completed clinical trials.
In a joint open letter, they ask the International Committee of Medical Journal Editors (ICMJE) to issue a statement clarifying that any trial data contained in official documents can later also be published in scientific journals.
Data from recently completed clinical trials is often rapidly assessed by governmental bodies, while publication of the same data in medical journals can take several years. Government bodies often redact such data in public assessment reports, leading to long delays in data availability.
This seemingly obscure issue has recently been identified as a barrier to clinical trial transparency.
As the letter explains:
“A research article published in BMJ Open in 2021 showed that over 80% of appraisals by NICE contain redacted data, including data on clinical trial outcomes that are of importance to patients, clinicians and researchers. Health Technology Assessment (HTA) agencies in other countries also routinely redact data.”
“A significant portion of these data are redacted as being “academic in confidence” (as opposed to “commercially confidential information”) based on widespread concern among researchers that disclosure of data in a public HTA report could prevent them from later publishing the outcomes of the trial in a peer-reviewed journal.”
“We are currently advocating with HTAs to discontinue their “academic in confidence” redactions so that patients, clinicians, and researchers can access all relevant elements of HTA reports.”
The letter asks the Committee to issue the following statement:
“The ICMJE will not consider results data contained in assessment reports published by HTAs, medicines regulators, medical device regulators, or other regulatory agencies to be prior publication.”
One Committee member, the BMJ, already takes this approach, but many government agencies and medical researchers are not aware of this.
The Committee has traditionally been very supportive of trial transparency, benefiting patients worldwide. In 2005, it issued a statement that led to a dramatic increase in clinical trial registrations.
Today’s open letter was coordinated by Consilium Scientific and is supported by five other groups:
Cochrane
Health Action International
International Society of Drug Bulletins
Transparency International Global Health
TranspariMED
The full letter can be downloaded below:
Consilium Scientific
LL@consilium-scientific.org
17 January 2022
ICMJE statement on clinical trial data contained in assessment reports
Dear Editors,
A research article published in BMJ Open in 2021 showed that over 80% of NICE appraisals
contain redacted data, including data on clinical trial outcomes that are of importance to
patients, clinicians and researchers. Health Technology Assessment (HTAs) agencies in other
countries also routinely redact data.
A significant portion of these data are redacted as being “academic in confidence” (as
opposed to “commercially confidential information”) based on widespread concern among
researchers that disclosure of data in a public HTA report could prevent them from later
publishing the outcomes of the trial in a peer-reviewed journal.
Several medical journals, including the BMJ, have informed us that researchers’ fears in this
regard are unfounded, and that trial data contained within reports published by HTAs and
regulatory agencies (including EMA and FDA assessment reports) does not constitute ‘prior
publication’ and would not compromise researchers’ ability to later publish trial outcomes in
peer-reviewed journals. However, not all journals share this position.
We are currently advocating with HTAs to discontinue their “academic in confidence”
redactions so that patients, clinicians, and researchers can access all relevant elements of
HTA reports.
In this context, it would be extremely helpful for ICMJE to highlight, clarify and support
journals’ existing position by formally issuing the following statement:
“The ICMJE will not consider results data contained in assessment reports published
by HTAs, medicines regulators, medical device regulators, or other regulatory
agencies to be prior publication.”
By eliminating the putative rationale for “academic in confidence” redactions, such a
statement by ICMJE would put an end to the current misguided redaction practices of HTAs.
Please do not hesitate to contact us if you require additional information, or if you would like
to discuss this issue further with us.
Could you please let us know by when you expect to reach a decision on this issue?
Thank you for your time, we look forward to hearing from you,
Leeza Osipenko, PhD
London, UK
Signing on behalf of six medical and health groups:
• Cochrane
• Consilium Scientific
• Health Action International
• International Society of Drug Bulletins
• TranspariMED
• Transparency International Global Health
Open Letter to ICMJE_20220117
Let’s go a bit further down the covid vaccine rabbit hole.
With 21 deaths in the vaccine arm v. 17 deaths in the placebo arm, that means that the trend was towards harm and we don’t know because of mathematical significance issues whether the trend towards harm was either merely due to chance or was, in fact, understated.
There was a 6 month safety paper about the Pfizer data that showed that in the vaccine arm there was one covid death v. two covid deaths in the placebo arm. Let’s consider that baseline pre-covid mortality for each arm is 15 deaths (17 all-cause deaths – 2 covid deaths in the placebo arm). In the covid vaccine era, that means that we may have traded five all-cause deaths likely caused by the Pfizer covid vaccine in order to prevent one covid death. And perhaps those five deaths trended younger while the prevented covid death trended older, so that there was a net harm to man-years lived and reproduction potential.
But those advocating for vaccines will point to hospital statistics after the rollout showing benefit. However, accurate statistics for covid vaccine deaths aren’t being kept. Accurate statistics for covid deaths are being kept, so the comparison fails. We have no numbers for covid vaccine deaths because covid vaccine deaths are new and nobody knows what to look for in order to investigate a possible covid vaccine death. No pathologist was trained in how to investigate this covid vaccine death in fellowship. There are no continuing education courses teaching pathologists how to investigate such a thing.
There is no official guidance about how to investigate covid vaccine deaths and official FDA codswallop about the deaths in the covid vaccine arm not considered to have been caused by covid vaccines are without evidentiary support nor an explanation of the method used to rule out covid vaccines as the cause of death. So that statement is merely an unsubstantial gloss and may be disregarded.
Now Arne Burkhardt over at doctors4covidethics has published an article containing guidance on how pathologists may investigate covid vaccine deaths. And Burkhardt is being studiously ignored by public health officials.
There is a document over at doctors4covidethics which provides some details about autopsies performed by Burkhardt and his pathologist associates on 17 corpses. Fifteen of the deaths were determined by the team to have been caused by covid vaccines. Yet the official cause of death for all seventeen was NOT covid vaccines. Which means that doctors/coroners/others missed the cause of death more than 90% of the time on these 17 corpses. Which implies that covid vaccine deaths are being missed, generally. And we have no good way to estimate how many covid vaccine deaths are missed nor at what rate relative to the number of vaccinations given.
So, we have a lot of uncertainty. We may be certain of that, which is a good thing because in order to learn something, you have to have questions and know about the uncertainty.
Dr. Healy writes in a far more entertaining manner than your humble servant, who is rather pedantic. I hope that I at least write clearly.
Are you saying I’m entertaining but not very clear?
D
I enjoy your blog very much. The figures of speech are delightful and my mood becomes lighter.
I think that maybe you write for doctors. And maybe your writing takes some getting used to–you seem to pivot off of SSRIs a lot. So things maybe seem clear to you in the moment they are written. My own writing is sometimes obtuse and leaves a lot of dots unconnected, so I know how difficult it can be to communicate one’s thoughts and ideas.
When I first read one of your posts–the first time I found your blog, I had to read it three times to get all of the points. Especially where you discussed the confounding between SSRI treatment effect and symptom–suicide.
I haven’t had any difficulty since with understanding your posts.
Now, I have a question for you. Was my rambling rabbit hole comment clear to you? Did you spot any major errors or holes in logic? Did it add to your knowledge or give any insight or prompt any new questions? Was it of benefit?
————————-
Oh, I just thought of another point. We could say that there is no significant benefit as regards reducing the risk of covid death from the Pfizer covid vaccine. One more death from covid in the placebo arm isn’t significant.
Pilot
Your comments have been good and welcome. And I know from feedback they are appreciated by others who don’t comment. There’s no expectation here that everyone should be on the same page or have the same thinking style.
We definitely can say the RCTs don’t show a benefit re Covid deaths – at least not one that is compatible with the claimed benefits in the real world. This gives rise to a very real Real World issue- how do we reconcile the mismatch. What’s going on to produce such an apparent differential between a treatment that doesn’t look like it should be of much benefit for things that count and the genuine observations of people working in ICUs.
D
I think that the observations depend on which ICU you are discussing and when…there’s much variance with time and there’s much variance with hospital and country…and there’s also variance between medical and surgical ICUs. I have a buddy who is a vascular surgeon and he tells me about a lot of new onset clotting and ischemia issues that he sees in his low-BMI middle-aged vaccinated patients. He also sees a few covid patients with clotting issues as well, but that seems to have died down. It looks like a Sword of Damocles situation. With boosters, it seems that damage will increase.
There is an issue with the definition of “unvaccinated” because it includes the partially vaccinated. The trick is that people will assume that the numbers are all fully unvaccinated. So that will skew how medical staff in ICUs see their “unvaccinated” patients where there is a binary choice of “unvaccinated” and “vaccinated” on the chart. So harms from covid will accrue in their minds to the “unvaccinated” group even though some of the people in the “unvaccinated” group are actually partially vaccinated and perhaps in the highly-vulnerable two-week waiting period after vaccination. The problem is that different immunological categories ought to be tracked separately instead of using a binary system. Of course, the binary system is rigged to favor the vaccination narrative and the ICU staff has been fooled repeatedly.
Because of travel/work/family pressure, people will continually leave the fully-unvaccinated group over time and this will lead to ongoing skewed statistics and fuel for covid vaccine propaganda as they become highly vulnerable in the two-week waiting period and perhaps become part of the “unvaccinated” statistics.
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🚨 Covid passes DITCHED 🎉
Inbox
Nobody could have predicted that authorites might use threats to coerce unproven vaccinations on zillions of people. In UK There is constant friction and mud slinging between the UK government based in London England ,which has some controls over the whole of the UK, (Wales, Scotland ,N Ireland and England)and the devolved nations one of which is Wales .Partly because the UK Parliament vetoes some policies Wales wishes to decide itself. This has gone on all through the pandemic resulting in people being used as political pawns where disagreements over laws/guidelines have had huge impacts on peoples’ lives. This is a big win for England while Wales , both part of the UK, is still in limbo .
Big Brother Watch, Erlend Evans via gmail.mcsv.net
Wed, Jan 19, 7:14 PM (5 hours ago)
to me
Dear friends,
Today Boris Johnson announced that mandatory Covid passes are to be scrapped from next Thursday in England.
Covid passes are a huge threat to civil liberties. They discriminate, they create a checkpoint society, they make a mockery out of our medical privacy and they don’t even work!
April 2021: We launched our Access Denied report setting out the case against a two-tier Britain under Covid certification
April 2021: We brought MPs and Peers from all parties as well as numerous rights groups together to sign a joint pledge against Covid passes, this was covered across the whole media.
July 2021: We scuppered plans for mandatory Covid Passes
September 2021: We scuppered plans for mandatory Covid Passes a second time
September 2021: We projected our Stop Covid passes message onto Parliament
September 2021: We hired an ad van to remind ministers of the lies they fed us about Covid passes and sent the Health Secretary running
September 2021: We brought Labour MPs together at party conference to discuss the left case against Covid IDs
September 2021: We brought Conservative MPs together at party conference to discuss the conservative case against Covid IDs
October 2021: We held a Stop Covid Passes protest outside the Senedd and should’ve won the vote(It was passed in one of the most shameful acts of the Senedd( Welsh parliament)
December 2021: We organised a Stop Covid Passes protest outside Parliament
December 2021: We organised a Stop Covid Passes billboard campaign around the country
December 2021: We hired an ad van reminding MPs that Covid Passes are a failure
December 2021: Following our lobbying of MPs there was the biggest backbench rebellion of Johnson’s premiership with 126 MPs, 99 of whom are Conservative MPs, voting against Covid passports.
December 2021: We launched legal action against the Government
2022: The fight continues
We also wrote multiple briefings to Parliamentarians, contributed to Parliamentary business, appeared in the media more times than you can count and so much more.
This really is a day to celebrate the reversal of this appalling scheme that has taken the world by its grip.
The Big Brother Watch support base has been phenomenal and it is no doubt down to our solidarity and mobilisation that we have changed the course of history today, together.
Without our strong opposition from very early on, this scheme would no doubt have been in place earlier and evolving into something much greater.
The price of liberty is eternal vigilance
The Covid pass is still available for businesses to make use of in England.
It is important that we boycott these places and educate them on the damages they are causing by continuing with these draconian health IDs.
We will be continuing our campaign and fighting back against Covid passes in England under every single circumstance.
Checkpoint Cymru legal latest
Today we have revealed that we have issued a legal claim against the Welsh Government.
This challenge follows weeks of correspondence between our lawyers and the Welsh government who are continuing to silence us.
We’ve seen the reasons the Welsh Government have given to justify its Covid pass scheme… It doesn’t stand up to scrutiny and is unsurprisingly, remarkably weak!
We want YOU to see them too!
And that’s why we are pursuing this legal challenge.
“In maintaining the Covid Pass Scheme, the Welsh Government is exercising an unprecedented level of control over the rights and freedoms of the public. In these circumstances, it is essential that the Welsh Government is transparent about what evidence they have relied upon to impose the scheme.” – Shirin Marker, Solicitor at Bindmans who is representing Big Brother Watch
Thankfully David H has been clearly pointing out the issues raised in this article, on the DH and Rxisk blogs and elsewhere for n number of years, including in theBMJ Without coming across them many of us wouldn’t have been alerted by his making the information freely and openly accessible often with links to follow up further. The level of generosity and respect for the relationship with contributors/readers input is quite rare still.
Thebmj also encourages comments as r.r’s from a wide variety of readers.
Covid-19 vaccines and treatments: we must have raw data, now
BMJ 2022; 376 doi: https://doi.org/10.1136/bmj.o102 (Published 19 January 2022)
Cite this as: BMJ 2022;376:o102
Responses
Peter Doshi, senior editor, Fiona Godlee, former editor in chief, Kamran Abbasi, editor in chief
Correspondence to: P Doshi Pdoshi@bmj.com
Data should be fully and immediately available for public scrutiny
In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.1234
The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data.56 Public battles for drug company data,78 transparency campaigns with thousands of signatures,910 strengthened journal data sharing requirements,1112 explicit commitments from companies to share data,13 new data access website portals,8 and landmark transparency policies from medicines regulators1415 all promised a new era in data transparency.
Progress was made, but clearly not enough. The errors of the last pandemic are being repeated. Memories are short. Today, despite the global rollout of covid-19 vaccines and treatments, the anonymised participant level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come.16 This is morally indefensible for all trials, but especially for those involving major public health interventions.
Unacceptable delay
Pfizer’s pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial hold all the data.17 And Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, 24 months after the primary study completion date, which is listed on ClinicalTrials.gov as 15 May 2023 (NCT04368728).
The lack of access to data is consistent across vaccine manufacturers.16 Moderna says data “may be available … with publication of the final study results in 2022.”18 Datasets will be available “upon request and subject to review once the trial is complete,” which has an estimated primary completion date of 27 October 2022 (NCT04470427).
As of 31 December 2021, AstraZeneca may be ready to entertain requests for data from several of its large phase III trials.19 But actually obtaining data could be slow going. As its website explains, “timelines vary per request and can take up to a year upon full submission of the request.”20
Underlying data for covid-19 therapeutics are similarly hard to find. Published reports of Regeneron’s phase III trial of its monoclonal antibody therapy REGEN-COV flatly state that participant level data will not be made available to others.21 Should the drug be approved (and not just emergency authorised), sharing “will be considered.” For remdesivir, the US National Institutes of Health, which funded the trial, created a new portal to share data (https://accessclinicaldata.niaid.nih.gov/), but the dataset on offer is limited. An accompanying document explains: “The longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives.”
We are left with publications but no access to the underlying data on reasonable request. This is worrying for trial participants, researchers, clinicians, journal editors, policy makers, and the public. The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data. In our view, there is no dilemma; the anonymised individual participant data from clinical trials must be made available for independent scrutiny.
Journal editors, systematic reviewers, and the writers of clinical practice guideline generally obtain little beyond a journal publication, but regulatory agencies receive far more granular data as part of the regulatory review process. In the words of the European Medicine Agency’s former executive director and senior medical officer, “relying solely on the publications of clinical trials in scientific journals as the basis of healthcare decisions is not a good idea … Drug regulators have been aware of this limitation for a long time and routinely obtain and assess the full documentation (rather than just publications).”22
Among regulators, the US Food and Drug Administration is believed to receive the most raw data but does not proactively release them. After a freedom of information request to the agency for Pfizer’s vaccine data, the FDA offered to release 500 pages a month, a process that would take decades to complete, arguing in court that publicly releasing data was slow owing to the need to first redact sensitive information.23 This month, however, a judge rejected the FDA’s offer and ordered the data be released at a rate of 55 000 pages a month. The data are to be made available on the requesting organisation’s website (phmpt.org).
In releasing thousands of pages of clinical trial documents, Health Canada and the EMA have also provided a degree of transparency that deserves acknowledgment.2425 Until recently, however, the data remained of limited utility, with copious redactions aimed at protecting trial blinding. But study reports with fewer redactions have been available since September 2021,2425 and missing appendices may be accessible through freedom of information requests.
Even so, anyone looking for participant level datasets may be disappointed because Health Canada and the EMA do not receive or analyse these data, and it remains to be seen how the FDA responds to the court order. Moreover, the FDA is producing data only for Pfizer’s vaccine; other manufacturers’ data cannot be requested until the vaccines are approved, which the Moderna and Johnson & Johnson vaccines are not. Industry, which holds the raw data, is not legally required to honour requests for access from independent researchers.
Like the FDA, and unlike its Canadian and European counterparts, the UK’s regulator—the Medicines and Healthcare Products Regulatory Agency—does not proactively release clinical trial documents, and it has also stopped posting information released in response to freedom of information requests on its website.26
Transparency and trust
As well as access to the underlying data, transparent decision making is essential. Regulators and public health bodies could release details27 such as why vaccine trials were not designed to test efficacy against infection and spread of SARS-CoV-2.28 Had regulators insisted on this outcome, countries would have learnt sooner about the effect of vaccines on transmission and been able to plan accordingly.29
Big pharma is the least trusted industry.30 At least three of the many companies making covid-19 vaccines have past criminal and civil settlements costing them billions of dollars.31 One pleaded guilty to fraud.31 Other companies have no pre-covid track record. Now the covid pandemic has minted many new pharma billionaires, and vaccine manufacturers have reported tens of billions in revenue.32
The BMJ supports vaccination policies based on sound evidence. As the global vaccine rollout continues, it cannot be justifiable or in the best interests of patients and the public that we are left to just trust “in the system,” with the distant hope that the underlying data may become available for independent scrutiny at some point in the future. The same applies to treatments for covid-19. Transparency is the key to building trust and an important route to answering people’s legitimate questions about the efficacy and safety of vaccines and treatments and the clinical and public health policies established for their use.
Twelve years ago we called for the immediate release of raw data from clinical trials.1 We reiterate that call now. Data must be available when trial results are announced, published, or used to justify regulatory decisions. There is no place for wholesale exemptions from good practice during a pandemic. The public has paid for covid-19 vaccines through vast public funding of research, and it is the public that takes on the balance of benefits and harms that accompany vaccination. The public, therefore, has a right and entitlement to those data, as well as to the interrogation of those data by experts.
Pharmaceutical companies are reaping vast profits without adequate independent scrutiny of their scientific claims.33 The purpose of regulators is not to dance to the tune of rich global corporations and enrich them further; it is to protect the health of their populations. We need complete data transparency for all studies, we need it in the public interest, and we need it now.
NoGracias Retweeted
Ramón Nogueras #Vacunado
@RamonNogueras
Una nueva revisión confirma que los sesgos de publicación distorsionan la efectividad de los antidepresivos, dado que los estudios negativos muchas veces no se publican, aunque son el 50% de los casos. De nuevo.
A new review confirms that publication bias distorts the effectiveness of antidepressants, since negative studies are often not published, although they are 50% of the cases. Again.
Erick Turner
@eturnermd1
Out today in PLOS Medicine: Our update on publication bias with antidepressants.
https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003886
Erick Turner
@eturnermd1
Former reviewer of psych drugs for FDA, back when they had backbone vs Pharma. User of FDA reviews to sort out truth vs lies in publ’d articles on clin trials.
Erick Turner
@eturnermd1
·
Thus, RR makes it WAY more difficult to hide negative trials or to “put lipstick on a pig” and transform a negative trial into an apparently positive one.
https://twitter.com/eturnermd1
GSK’s top scientist quits to help make billionaires live forever: Hal Barron joins Jeff Bezos-backed anti-ageing start-up Altos Labs
By CALUM MUIRHEAD FOR THE DAILY MAIL
PUBLISHED: 21:50, 19 January 2022 | UPDATED: 09:01, 20 January 2022
https://www.thisismoney.co.uk/money/markets/article-10420033/GSKs-scientist-quits-join-Jeff-Bezos-backed-anti-aging-start-Altos-Labs.html
GSK, Hitting the Rocks…
MHRA to reframe the UK legislation for clinical trials.
I watched yesterday’s UK Column (my expression 😳🥺 )
https://www.ukcolumn.org/ukcolumn-news/uk-column-news-19th-january-2022
The links are on this page.
Charles Medawar’s forum was of great help when I was tapering.
Unfortunately the forum is no longer available.
High Covid death rates skewed by people who died from other causes, admits Sajid Javid
Health Secretary reveals daily government figures might be unreliable as ONS data show fewer deaths registered to Covid
By
Sarah Knapton,
SCIENCE EDITOR
19 January 2022 • 8:37pm
Daily reported Covid death figures are too high because people are dying from conditions unrelated to the virus after testing positive, Sajid Javid has admitted.
On Wednesday, there were 359 deaths reported in Britain, but the Health Secretary said that “many” people were being included in the count who “would not have necessarily died of Covid”.
His comments came after death data from the Office for National Statistics (ONS) show a large discrepancy in weekly death registrations compared to the figures released on the Government dashboard.
For the week ending Jan 7, the UK Health Security Agency reported 1,282 deaths of people who had died within 28 days of testing positive for coronavirus.
However, ONS data show there were just 992 death registrations with Covid mentioned on the death certificate in that week.
For deaths where Covid was the primary cause, the difference is even starker, with just 712 registrations, meaning that 44 per cent of the Government’s daily reported figures in that week may not be true Covid deaths.
At a Downing Street press conference on Wednesday, Mr Javid warned that the daily figures are no longer reliable because of the surge in omicron infections.
“We estimate that around 40 per cent of the people with Covid in hospital are there not because they’ve got Covid, but they happen to have Covid, so it’s what you might call an incidental infection,” he said.
“That’s almost double the percentage that we saw with delta, and that’s important because the deaths that are being reported of people who were Covid-positive within 28 days of passing away, many of those people would not have necessarily died of Covid.”
Before omicron hit, the number of deaths reported by the ONS was consistently higher than the Government dashboard data because their figures include people who have died at hospital and in care homes.
However, the trend has since changed, with dashboard figures way higher than those published by the ONS.
The ONS has warned that the new year bank holiday will have pushed some deaths, which would usually be registered in the first week of January, into the second week.
However Susan Hopkins, the chief medical adviser at the UK Health Security Agency, confirmed that people were being swept up in the daily death figures who would not be classed as true Covid deaths.
“Deaths within 28 days, we regard as a leading indicator and we monitor this very carefully. But it doesn’t take into account people who have died with Covid,” she said.
“Given the very large number of cases that we’ve diagnosed in the last number of weeks, we will sadly see some people, particularly the very elderly, who die within 28 days of a case of Covid.”
Warnings about skewed death figures
In December, experts predicted that such a steep rise in omicron cases would lead to skewed death figures because a certain number of people testing positive would be expected to die naturally anyway.
The January death rate is about 0.09 per cent, according to the ONS. So on a day of 244,000 infections as we saw at the peak, we may expect 219 of those people to die naturally over the next month, yet currently all would end up in the Covid data.
Most of these natural deaths will occur in hospitals or care homes where patients and residents are being regularly tested, and where there have often been outbreaks of omicron.
Latest figures for England show that 44 per cent of all Covid patients currently in hospital were admitted for reasons other than the virus, and are “incidental” cases.
However, people may also now be included in the death figures who cleared the virus weeks before their death.
Dr Raghib Ali, a consultant in acute medicine at Oxford University Hospitals NHS Trust, warned last week that the death data was likely to be inaccurate because of the high omicron case numbers. On Wednesday, he said that the discrepancy was starting to become apparent in the data.
Medicine and the Media
Facebook versus The BMJ: when fact checking goes wrong
BMJ 2022; 376 doi: https://doi.org/10.1136/bmj.o95 (Published 19 January 2022)
Cite this as: BMJ 2022;376:o95
……….Kamran Abbasi, The BMJ’s editor in chief, said, “We should all be very worried that Facebook, a multibillion dollar company, is effectively censoring fully fact checked journalism that is raising legitimate concerns about the conduct of clinical trials. Facebook’s actions won’t stop The BMJ doing what is right, but the real question is: why is Facebook acting in this way? What is driving its world view? Is it ideology? Is it commercial interests? Is it incompetence? Users should be worried that, despite presenting itself as a neutral social media platform, Facebook is trying to control how people think under the guise of ‘fact checking.’”
……
The BMJ is brave to fight against a company as powerful as Facebook.
“Facebook is trying to control how people think under the guise of ‘fact checking.’”
Hiding evidence can be useful in changing people’s perceptions and preventing them from understanding. It has been effective so far.
“Jan 7 – Score one for transparency.
A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer’s COVID-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months.”
…from Reuters…
Why a Judge Ordered FDA to Release Covid-19 Vaccine Data Pronto
Jan. 18, 2022, 9:00 AM
Bloomberg Law
https://news.bloomberglaw.com/health-law-and-business/why-a-judge-ordered-fda-to-release-covid-19-vaccine-data-pronto
This has never been done before. Typically adult vaccine mandates have been limited; even the seminal U.S. Supreme Court vaccine mandate decision, Jacobson v. Massachusetts, only involved a state-imposed $5 penalty, and school vaccine mandates have historically had liberal religious or personal belief exemption policies.
Even more problematic is that Americans, if injured, cannot sue Pfizer. There is virtually no other product where a consumer is prohibited from suing the company that manufactures, markets, and profits from the product.
It would be laughable ……….
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Press Release: On The Eve of Washington March, COVID Declaration
Inbox
Robert W Malone MD, MS from Who is Robert Malone <rwmalonemd@substack.com
Jan 21, 2022, 11:27 PM (1 hour ago)
to me
Now Backed by More Than 17,000 Doctors and Medical Scientists Around the World
Robert W Malone MD, MS
Jan 21
On The Eve of Washington March, COVID Declaration Now Backed by More Than 17,000 Doctors and Medical Scientists Around the World
Following Dr. Robert Malone’s appearance on The Joe Rogan Experience, more physicians and medical scientists have joined with their colleagues from around the world in signing the Physicians Declaration. Now with more than 17,000 signatures confirmed through a rigorous validation process, these physicians and scientists are represented by Dr. Malone as he speaks at the march to Defeat the Mandates on Sunday, January 23 in Washington, D.C.
The over 17,000 signers to the declaration have reached consensus on three foundational principles:
Healthy children should not be subject to forced vaccination: they face negligible risk from covid, but face potential permanent, irreversible risk to their health if vaccinated, including heart, brain, reproductive and immune system damage.
Natural Immunity Denial has prolonged the pandemic and needlessly restricted the lives of Covid-recovered people. Masks, lockdowns, and other restrictions have caused great harm especially to children and delayed the virus’ transition to endemic status.
Health agencies and institutions must cease interfering with the physician-patient relationship. Policymakers are directly responsible for hundreds of thousands of deaths, as a result of institutional interference and blocking treatments proven to cure at a near 100% rate when administered early.
Led by Dr. Malone and staying loyal to the Hippocratic oath, the declaration’s signers have resisted financial inducements, threats, unprecedented censorship, and reputational attacks to remain committed first to patient health and well-being. After 23 months of research, millions of patients treated, hundreds of clinical trials performed and scientific data shared, and after demonstrating and documenting their success in combating COVID-19, the 17,000+ physicians and medical scientists who signed the declaration support the core principles Dr. Malone and many other doctors have been speaking out about since late last year.
The 17,000+ signatures of the declaration are authentic and must pass a screening process before being officially identified as signing the declaration. Signatories are required to supply their affiliation and a link to their medical organization, facility, or profile. Nurses, non-MD practitioners and non-medical scientists are removed from the list signatories, as are duplicate entries and “bot” emails. The emails of the signatories have been separately and repeatedly tested and verified by a 3rd-party provider.
As the number of signatures to the declaration continues to rise, we have published a select group of world famous, highly credentialed physicians and scientists who authored the
declaration. Many other doctors who have spoken out against the corruption, censorship and hypocrisy by authorities have been threatened, fired, censured, lied about, intimidated, and harassed – all while saving patients’ lives daily. Never has the public been forced to become lab rats, for a vaccine 5 years away from adequate testing, violating basic principles of informed consent. Moreover, the medical and scientific evidence on the efficacy and safety of the COVID- 19 vaccine do not support mandating its use for anyone, especially healthy children.
January 23 March on Washington
The over 17,000 signers of the declaration will be represented on Sunday, January 23, when Dr. Malone stands with fellow doctors and scientists on stage in Washington DC, as part of the Defeat the Mandates march Sunday, January 23, 2022. At the Lincoln Memorial, they will be joined by a wide range of featured guests for a series of inspiring talks and musical performances. Join us!
About the Global COVID Summit
Global Covid Summit is the product of an international alliance of doctors and scientists, committed to speaking truth to power about Covid pandemic research and treatment.
Thousands have died from Covid as a result of being denied life-saving early treatment. The Declaration is a battle cry from physicians who are daily fighting for the right to treat their patients, and the right of patients to receive those treatments – without fear of interference, retribution or censorship by government, pharmacies, pharmaceutical corporations, and big tech. We demand that these groups step aside and honor the sanctity and integrity of the patient- physician relationship, the fundamental maxim "First Do No Harm", and the freedom of patients and physicians to make informed medical decisions. Lives depend on it. More information here: https://globalCovidSummit.org
Dr. Peter McCullough: Vaccines Failed in Stopping COVID-19 and Mandates Have to Be Dropped
By Harry Lee and Steve Lance
January 21, 2022 Updated: January 21, 2022
https://www.theepochtimes.com/dr-peter-mccullough-vaccine-failed-in-stopping-covid-19-and-mandates-have-to-be-dropped_4227159.html?utm_source=morningbriefnoe&utm_campaign=mb-2022-01-22&utm_medium=email&est=ym%2BQgLymdqjq5%2B8A%2BbNBVBM4Qu3qnLtFqdYR42t8PO%2FfLNBjGaLxoWqkC%2FNCxMwwQlE%3D
The COVID-19 vaccines have largely failed in stopping the transmission of the CCP (Chinese Communist Party) virus, especially for the most recent Omicron variant, so the vaccine mandate should be thrown away, according to Dr. Peter McCullough.
“The vaccines themselves have basically now become obsolete as the virus has continued to mutate,” McCullough told NTD’s “Capitol Report” in an interview broadcast on Wednesday. “So at this point of time, the vaccine mandates have to be dropped across the board.”
McCullough said some recent studies have shown the effectiveness of the COVID-19 vaccines dropped significantly with the new variants.
VIDEO – CAPITAL REPORT – ON THE STAGE
“There’s a paper by Young-Xu in JAMA, the prior Delta strain that was only about 20 percent covered by the vaccines. Vaccines were very ineffective against Delta,” McCullough said.
The study, which is peer-reviewed and published on the Journal of the American Medical Association (JAMA) last month, found that during the high-Delta period, the estimated vaccine effectiveness was 62.0 percent in the first month and decreased to 57.8 percent by month three. The decrease in vaccine effectiveness accelerated after month four, reaching a low of approximately 20 percent in months five through seven.
“And now a paper from Hansen from Denmark, and from the UK public health security report indicated, against Omicron the vaccines are basically ineffective,” McCullough continued.
The Danish study, a preprint and has not been peer-reviewed, found that vaccine effectiveness against Omicron was initially 55.2 percent and 36.7 percent for Pfizer and Moderna vaccines, respectively, but waned rapidly over time. By comparison, vaccine effectiveness against Delta was significantly higher and better preserved over the same period.
The UK Health Security Agency report released on Dec. 31 also found that vaccine effectiveness against the Omicron variant is significantly lower than compared to the Delta variant and wanes rapidly.
“Among those who had received 2 doses of AstraZeneca, there was no effect against Omicron from 20 weeks after the second dose. Among those who had received 2 doses of Pfizer or Moderna, effectiveness dropped from around 65 to 70 percent down to around 10 percent by 20 weeks after the second dose,” the report (pdf) states.
The Centers for Disease Control and Prevention (CDC) has been saying the COVID-19 vaccines are “safe and effective,” and serious adverse events are rare.
“The only thing the vaccines could have done is reduce the chances of getting COVID-19. … So many millions of Americans who have taken the vaccines have been disappointed to find out they contracted COVID-19 anyway,” McCullough continued.
On Wednesday, the CDC published a study showing protection from prior infection, or so-called natural immunity, was better than the protection from COVID-19 vaccines against the Delta variant.
McCullough also said the vaccine mandates lack the ethical or legal standing in the first place because the COVID-19 vaccines are “investigational.”
“All the vaccines are still investigational and in research. Mandates had no ethical or moral or legal standing from that perspective. No one can be forced into research against their will or be coerced into it.”
A spokesperson from the Food and Drug Administration (FDA), didn’t answer directly whether COVID-19 vaccines are investigational, but told The Epoch Times that “all of the vaccines are under an EUA except for Comirnaty, which is fully approved.”
In a guidance (pdf) issued last year, FDA said emergency use authorizations (EUAs) are issued for investigational vaccines to prevent COVID-19 during the pandemic.
“We can’t have Americans have fear about losing their job or school or travel related to a failed vaccine,” McCullough said. “But even more so we need to re-examine what we’ve done with respect to our public health priorities and COVID-19.”
McCullough said that in March and April 2020 America should have had large randomized trials and moved very quickly into studying multi-drug treatment. However, the federal authorities refused to do so and made a big push for vaccines.
McCullough also shared the treatment for COVID-19 patients with the Omicron variant.
“Fortunately with the Omicron variants very mild, the main treatment is oral nasal virucidal washes with dilute povidone-iodine or hydrogen peroxide 12. Clinical trials show the biggest benefit of that is more than any other form of treatment,” McCullough said.
Occasionally patients may need additional oral drugs and Pfizer and Merck pills could be featured, the renowned cardiologist and epidemiologist added.
“And for severe cases we can use Sotrovimab, which is the GSK monoclonal antibody, may be in a high-risk senior or special case,” McCullough said.
“The vaccines aren’t treatment, they offered no hope of treating a patient once they contracted COVID-19. And we knew with respiratory virus they were very unlikely to be effective,” said the doctor.
The CDC has been saying that the COVID-19 vaccines could reduce severe illness and death, and vaccinated people should get a booster to keep up the protection.
Shame the College of GP’s hasn’t spoken out before on behalf of everone’s right to have or decline vaccinations. Bearing in mind of course that many GPs and a whole army of healthworkers and volunteers have been vaccinating people themselves without informed consent .
Javid and co need to decide whether to lose healthworkers who are not going to be coerced or lose face and find a weasel way around this.
Published1 hour ago BBC
NHS England staff must be fully vaccinated by 1 April under government rules
The deadline for health workers to have a Covid vaccination should be delayed to prevent staff shortages in England, the Royal College of GPs has said.
NHS staff must have a first jab by 3 February and be fully vaccinated by 1 April to continue in frontline roles.
The Department of Health said there were no plans to delay and it was “the right thing to do to protect patients”.
NHS workers who oppose the government’s mandatory vaccination policy have staged a protest in central London.
Demonstrations were also held in other cities across England including Manchester, Birmingham and Leeds.
The UK recorded 76,807 coronavirus cases and 297 deaths within 28 days of a positive Covid-19 test, daily government figures show.
Martin Marshall, chairman of the Royal College of GPs, said compulsory vaccination for health professionals in England was “not the right way forward”.
He said the vast majority of staff were vaccinated but some 70,000 to 80,000 were not and they accounted for 10% of staff at some hospitals or GP surgeries.
Some 94.3% of NHS trust health care workers in England have had a first dose of vaccine and 91.5% have had a second dose, figures to 31 December show.
If unvaccinated staff were taken out of frontline roles by 1 April there would be “massive consequences” for the NHS, Mr Marshall told BBC Radio 4’s Today programme.
He said a delay would allow time for booster jabs and a “sensible conversation” about whether vaccines should be mandatory at all.
Response to Daniel Sokol
Re: Why mandatory vaccination for healthcare workers should not be scrapped Daniel Sokol. 376:doi 10.1136/bmj.o206
Dear Editor
Quite the opposite to causing ‘reputational damage’ as described by Daniel Sokol, the stance taken by healthworkers themselves, rather than the colleges who have come lately, who know better than most from first hand two years’ experience of actually dealing with Covid has enhanced the opinion of many who value their expert judgement regarding risk versus benefit of vaccines whether individual decisions are the same or not. Crucially their opposition to coercion and mandates in a ‘civilised’ society is vital to enhancing trust in the idea of informed consent by at least a section of the medical profession and their supporters who are standing up to the values of democracies during dark times.
The countries Daniel Sokol mentions which are imposing mandates in extremely dictatorial and dangerous ways have a troubling history of destructive scapegoating of groups for political and idealogical ends with horrific consequences. It is heartening that the voices of all sections of our populations are finding ways of being heard despite the incredible level of ‘cancellations’ decided by unaccountable individuals working to silence open discussion. Including the BMJ. Nobody has the crystal ball. We will have to see what the legacy of covid and its bizarre impact on open society and the ethics of our health services will be.
The vaccinated who are in the two-week waiting period go into the “unvaccinated” statistical bucket. I have a new post with a hypothesis that some of those in the waiting period are at high risk for severe covid.
Those in the waiting period aren’t tracked separately and may account for a disproportionate share of the “unvaccinated” numbers.
I can’t get my head around this.
Imagine if Space Shuttle Manufacturers and Safety Regulators, thought it was perfectly scientific and ethical to send four billion people (7 billion people being the desire number apparently) including healthy young people and children, on a hastily launched one-way space shuttle built with novel technology the manufacturers only two years before thought would never be approved.
Imagine, despite how taking the journey into the unknown was sold, the Space Shuttle Manufacturers and Safety Regulators, never actually checked if taking the journey would do anything particularly great for humanity as a whole. Rather, it might (if we care to overlook many passengers dying immediately, within a few days, or within a few weeks, by perhaps shuttle induced sickness that may not otherwise have died), reduce the symptoms of a disease which presented the most risk to a particular demographic: the world’s vulnerable elderly people.
Or at least for 6 weeks, or two months, or so.
Imagine if Space Shuttle Manufacturers and Safety Regulators had the audacity to do this without asking questions (eg. questions we have now: where does the spike protein end up? The LNPs go) you wouldn’t need a scientist to ask, which even (or perhaps especially) a chemically labotomised or iatrogenically impaired SSRI causality would ask if required to read the information thoroughly, and in light of the fact that the lives or long term health of perhaps up to seven billion people, were in their hands. Further, without allowing independent scientists to access the data and who may have taken the Space Shuttle Manufacturers to task where the Safety Regulators didn’t.
But, you know, if healthy young people at little to no risk hadn’t taken the one-way journey, it could have been worse?
By golly, just imagine! Right after I start mentioning how maybe covid deaths are occurring in the two-week waiting period after receiving a clotshot, the Alberta government posts data showing that most covid deaths in vaccinees occurred within the two week waiting period.
Then, giving fuel to conspiracy theorists, the government deleted the post. But someone had already archived the post.
“Alberta Canada Inadvertently Published (and Quickly Deleted) Health Data Exposing that MORE THAN HALF of VACCINATED DEATHS Have Been COUNTED AS UNVACCINATED”
…because they were in the two-week waiting period.
https://www.thegatewaypundit.com/2022/01/alberta-canada-inadvertently-published-quickly-deleted-health-data-exposing-half-vaccinated-deaths-counted-unvaccinated/
Robert Malone’s FULL Speech (1/23/22)
https://rumble.com/vt54k5-robert-malones-full-speech-12322.html?mref=lzerp&mc=3ifeq
Anti-vaxx rally – latest: Outrage at RFK Jr Holocaust comments at vaccine mandate opponents gathering in DC
https://www.independent.co.uk/news/world/americas/anti-vaccine-mandate-rally-live-washington-b1998969.html?page=3
Senator Ron Johnson Retweeted
One America News
@OANN
Sen. Johnson: Monday’s panel to give ‘different perspective on COVID response’ https://rumble.com/vt15k4-sen.-johnson-mondays-panel-to-give-different-perspective-on-covid-response.html… #OANN
https://rumble.com/vt15k4-sen.-johnson-mondays-panel-to-give-different-perspective-on-covid-response.html?mref=lzerp&mrefc=3
Live streamed on Rumble
‘Different viewpoints were being crushed’ – S.RJ
A Second Opinion – Watch Here
https://rumble.com/vt62y6-covid-19-a-second-opinion.html
Discussion begins around 40 minute mark. Sen. Ron Johnson moderates a panel discussion, COVID-19: A Second Opinion. A group of world renowned doctors and medical experts provide a different perspective on the global pandemic response, the current state of knowledge of early and hospital treatment, vaccine efficacy and safety, what went right, what went wrong, what should be done now, and what needs to be addressed long term.
…..provided the study shows the tweaked shot is safe and effective, he added.
Pfizer Begins Study Evaluating COVID-19 Vaccine That Targets Omicron Variant
https://www.theepochtimes.com/pfizer-begins-study-evaluating-covid-19-vaccine-that-targets-omicron-variant_4234939.html
It is probably safe and effective to assume this is an FDA Done Deal – without – A Second Opinion…
Yesterday I attended the panel discussion “COVID-19: A Second Opinion” sponsored by Senator Ron Johnson of Wisconsin. We heard from a nurse who treated a ten-year-old boy who suffered a heart attack after getting the shot. Before she could get an EKG done she had to argue for half an hour with the attending physician, who sagely informed her “Ten-year-old don’t get heart attacks.”
Neal Jacobson was not the first to kill on antidepressants. Here are 10 other cases.
https://www.palmbeachpost.com/story/news/2022/01/21/ten-murder-cases-besides-neal-jacobson-where-people-ssri-antidepressants-killed/6460798001/
Neil Young is ‘very upset’ Beyond farcical
‘They can have Rogan or Young. Not both,’ writes musician in an open letter to his management that has since been taken down from his website
Neil Young has demanded that his music be removed from Spotify due to vaccine misinformation spread by podcaster Joe Rogan on the streaming service, saying: “They can have Rogan or Young. Not both.”
In an open letter to his manager and record label that was posted to his website and later taken down, Young wrote: “I am doing this because Spotify is spreading fake information about vaccines – potentially causing death to those who believe the disinformation being spread by them. Please act on this immediately today and keep me informed of the time schedule.”
Young specified that his decision was motivated by The Joe Rogan Experience, which is currently Spotify’s most popular podcast and one of the biggest in the world. Rogan signed a US$100m deal in 2020 giving Spotify exclusive rights to the show.
“With an estimated 11 million listeners per episode, JRE, which is hosted exclusively on Spotify, is the world’s largest podcast and has tremendous influence. Spotify has a responsibility to mitigate the spread of misinformation on its platform, though the company presently has no misinformation policy,” he wrote, adding: “I want you to let Spotify know immediately TODAY that I want all my music off their platform … They can have Rogan or Young. Not both.”
The letter was addressed to his manager Frank Gironda and Tom Corson, the co-chairman and chief operating officer of Warner Records, which releases Young’s music through its Reprise Records imprint.
Gironda confirmed the letter was authentic to The Daily Beast. “It’s something that’s really important to Neil. He’s very upset … we’re trying to figure this out right now.”
Last month, 270 doctors, scientists and healthcare professionals signed an open letter requesting that Spotify implement a policy for dealing with misinformation because of Rogan’s “concerning history of broadcasting misinformation, particularly regarding the Covid-19 pandemic”.
The letter cited an episode in which Rogan interviewed Robert Malone, a virologist who was involved in the mRNA vaccine technology that led to some of the leading Covid-19 vaccines but has since been criticised for spreading vaccine misinformation. Both men were criticised for promoting several baseless conspiracy theories, including the false claim that hospitals are financially incentivised to falsely diagnose deaths as having been caused by Covid-19, and Malone’s assertion that world leaders had hypnotised the public into supporting vaccines.
Reviews…
Sen. Ron Johnson Hosts “Second Opinion” Panel on America’s Problematic Pandemic Response
Media promptly smears it as a panel of “vaccine skeptics and promoters of unproven early treatments.”
Posted by Leslie Eastman
https://legalinsurrection.com/2022/01/sen-ron-johnson-hosts-second-opinion-panel-on-americas-problematic-pandemic-response/
This discussion on the special “Second Opinion” panel that Senator Ron Johnson (R-WI) hosted is a perfect example of one of the root problems in the American response to the covid pandemic: The press.
Johnson organized world-renowned doctors and medical experts to offer a different perspective on the pandemic: global pandemic response, the current state of knowledge of early and hospital treatment, vaccine efficacy and safety, what went right, what went wrong, what should be done now, and what needs to be addressed long term. The panel discussion was held this Monday, and the 5-hour discussion is via the link HERE.
I strongly encourage anyone interested in the scientific challenges to the pandemic response that have been suppressed under the guise of “misinformation” to watch as much as they can, if not all, of qualified medical experts who are disturbed by the approaches developed by Dr. Anthony Fauci and the rest of the federal health bureaucracy.
Sen. Ron Johnson’s Latest Covid Panel Reveals 800,000 People And Counting Want ‘A Second Opinion’
BY: KYLEE ZEMPEL
https://thefederalist.com/2022/01/25/sen-ron-johnsons-latest-covid-panel-reveals-800000-people-and-counting-want-a-second-opinion/
A second opinion is long-overdue, and the hundreds of thousands who tuned in to Johnson’s panel proved people are starving for it.
Perhaps that’s why just 24 hours after Johnson’s panel, the video had more than three-quarters of a million views on Rumble — the platform the sitting U.S. senator uses since having been censored five times on Google-owned YouTube.
Americans have witnessed this with masks, the lab leak theory, vaccines, mandates, schools and the wellbeing of children, and natural immunity. So it’s only logical that hundreds of thousands would flock to a video of a more than five-hour discussion allowing different perspectives to surface.
FACT CHECK: Ron Johnson’s ‘COVID-19: A Second Opinion’ panel
https://madison.com/wsj/news/local/govt-and-politics/fact-check-ron-johnsons-covid-19-a-second-opinion-panel/article_fce1e2cc-974d-5693-8e58-d90d7c967bac.html
Immediately after Johnson’s panel, the Committee to Protect Health Care, an advocacy group aligned with Democrats, held a Zoom call with Wisconsin doctors to criticize the senator for spreading misinformation.
FACT: “I don’t think the process was rushed,” Sethi said. “The only thing that was cut from the process was red tape, but the science that was carried out was the same science that would be carried out with the approval process for any new biologic vaccine or treatment.”
Fact-Check…..?
And Yet More Fragging
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Robert W Malone MD, MS from Who is Robert Malone Unsubscribe
2:55 PM (3 hours ago)
to me
And Yet More Fragging
People who want to act like journalists need to behave responsibly.
Robert W Malone MD, MS
Jan 26
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“In the United States military, fragging (from fragmentation grenade) refers to the act of murdering members of the military, particularly commanders of a fighting squad. Additionally, the term can be applied to manipulating the chain of command in order to have an individual, or unit, deliberately killed by placing the personnel in harm’s way, with the intended result being death. An example would be to order a soldier to perform a particularly hazardous task, and continue to repeat the order until the soldier met his demise. Originating among United States troops during the Vietnam War, the term was most commonly used to mean the assassination of an unpopular officer of one’s own fighting unit. Such incidents have been documented in European military history back to the 18th century.
Current usage could apply to murder of any other member, enlisted or officer, and has nothing to do with rank. Initially, the killings were effected by means of a fragmentation grenade,[1] making it appear as though the killing had been accidental, or the result of combat action with the enemy, thereby obscuring the assassin’s true intentions. The term now encompasses any means of deliberately and directly causing the death of fellow military members.”
From: Fragging
As if my life were not complicated enough, yesterday I received emails from colleagues in Spain and on Maui regarding a recent newsletter publication by an organization I had never heard of, “Health Freedom for Humanity” The email from Spain had been forwarded by my friend Dr. Geert Vanden Bossche, who lives in Belgium. Apparently this newsletter post has gone globally viral. The article was written by Jeff Witzeman (Instagram profile linked)
Here is the version of the hit piece text, forwarded to me from both Maui and Belgium, and put out by this mysterious organization:
From Jeff Witzeman’s Health Freedom for Humanity newsletter:
In a shocking development, we are discovering that Dr. Robert Malone, viewed by so many as a hero for saying nobody should get the Pfizer and Moderna vaccines, is actually developing his OWN COVID VACCINE! And it allegedly has Darpa (graphene oxide) Hydrogel in it. No mention of this vaccine was ever made on the Joe Rogan interview, bringing the question of conflict of interest. Malone also stated in the Rogan interview that he collaborated with the CIA on a project. (For more on Graphene Oxide Hydrogel read here.)
We had a lively discussion among the podcast team of HFFH whether we wanted to interview Malone and if that would have any value. Dr. Stanton Hom asked the question of where we draw the line with who we interview and I was fascinated by his answer. He said that anyone who is willing to admit the vaccine schedule for children (72) is evil or at the very least seriously off, is one of us and fair game for speaking on our platform. We are still inclusive and welcome all beliefs, but when it comes to our stage, that is where we have to draw a line.”
So, who is Stanton Hom?
He is a Chiropractor, who practices here
So, hoping to find out what the heck is going on here, I look for someone affiliated with this group that I have had contact with, and find Dr. Ben Tapper, another Chiropractor. I write to him, and receive the following reply:
“Hey Doc,
I am not on the board anymore. :/ I passed on the info to the board. I’m hopeful they will respond. I apologize this is happening. “
Then I reach out through my network to find out if anyone knows about this organization, and am put in touch with Mr. Alec Zeck, who self-identifies as Executive Director of “Health Freedom for Humanity”. Mr. Zeck calls me while I am having dinner with colleagues here in Nashville, TN, and gives me a series of excuses for how this happened but fails to take ownership and responsibility for the defamation and slander, and after I hear him explain that he is only 29 years old (as if that is an excuse), I hang up. When I called him this morning, as I am writing this article instead of enjoying a peaceful morning preparing for recording an interview with Candice Owens Show, he informed me that his organization will publish a retraction and apology later today.
But let’s be very clear, a retraction of the newsletter at this point will get read by a tiny, tiny fraction of the people who have seen this slanderous article – as it has literally gone global. The damage to my reputation is real.
So, lets walk through this “Shocking Development”, claim by claim:
Statement #1- “Dr. Robert Malone, viewed by so many as a hero for saying nobody should get the Pfizer and Moderna vaccines, is actually developing his OWN COVID VACCINE! “
I am not developing “my own vaccine.” The vaccine product (Relcovax) is being developed by Reliance Life Sciences, not me. I used to consult for Reliance. I no longer do. I have no ownership, stock, or any ongoing consulting or contractual relationship with Reliance at this point. This is a sub-unit vaccine, not a genetic vaccine. I was very glad (and honored) to assist, coach and mentor the Reliance Life Sciences when I was serving as a consultant. They are highly experienced and fully committed to developing safe and effective vaccines in full compliance with international and Indian government standards. Which is probably why this vaccine is still not in clinical testing at this point, despite briefing about two years into development. Of relevance is that the Indian national regulatory authority guidance for vaccine development and licensure is more rigorous than that of the FDA, consequent to the various prior transgressions of Merck Vaccines and the Bill and Melinda Gates Foundation when doing business in India.
This is not my vaccine, and never has been (below is a presentation at a vaccine conference about this vaccine).
Statement #2- “it allegedly has Darpa (graphene oxide) Hydrogel in it”.
Hydrogel, and other alum-based adjuvants, are among the best characterized of the traditional adjuvants. DARPA had nothing to do with developing Alum or Alhydrogel adjuvants. Alhydrogel has nothing to do with Graphene Oxide. This “Relcovax” vaccine product using Alum + CpG for its adjuvant system. The vaccine candidate is designed to be a very low cost, traditional alternative to the genetic vaccines, and employs much more traditional methods than, say, the Novavax product.
This statement clearly demonstrates the profound ignorance of the author, and his willingness to use the same fearporn and hyperbole which I find so offensive in so many of the attack articles that seek to damage my reputation.
Statement #3- “No mention of this vaccine was ever made on the Joe Rogan interview, bringing the question of conflict of interest”
This is not my vaccine, I am not engaged as a consultant by Reliance, and I have no financial interests in this vaccine. Another example of the author and organization seeking to damage my reputation using classic yellow journalism smear tactics.
Statement #4- “Malone also stated in the Rogan interview that he collaborated with the CIA on a project. “
Another false statement designed to smear my reputation. I have co-published with Dr. Michael Callahan on manuscripts relating to the Zika virus. You can find those articles here. You can find information regarding Dr. Michael Callahan here.
I have not collaborated with the CIA. I do have a (currently inactive) secret DoD clearance. I have actively collaborated with USAMRIID, and I am proud of our work together repurposing drugs for Zika and Yellow Fever (which included ivermectin, Hydroxychloroquine, Niclosamide, Nitazoxanide, and many others).
Statement #5- “He said that anyone who is willing to admit the vaccine schedule for children (72) is evil or at the very least seriously off, is one of us and fair game for speaking on our platform. We are still inclusive and welcome all beliefs, but when it comes to our stage, that is where we have to draw a line.”’
I just do not know where to start with this word salad. Is Stanton Hom saying that I am evil or seriously off? On what basis? So, if I am able to interpret this correctly, the justification for not speaking to me prior to sending out this little nasty piece of work into the internet is that I am evil based on ???.
In conclusion, I regret having to take my morning to write this retort and apologize for having to send it into your inbox.
Now, there are the various attack articles written by hostile press outlets, and typically are composed by junior writers seeking five minutes of fame and pieces of silver by denigrating me (The Atlantic Monthly and Washington Post articles being among the most egregious). These mostly serve to illustrate the bias of the Atlantic (owned by a Biden megadonor and Bill Gates), and the Washington Post (owned by Biden megadonor Jeff Bezos).
And then there is the fragging, like this piece of work from “Jeff Witzeman’s Health Freedom for Humanity newsletter” that I have discussed above.
What I run into, again and again, is frightened people who do not understand the science, and jump to conclusions about what they see as nefarious activities. In some ways, this is even more dangerous to the cause of truth and transparency, because it injects false issues into the discussion. This is not science, it is just paranoia.
So, please. If you have concerns about anything that I have said or done, or the technology I created or the scientific research that has been accomplished in my laboratory over the years, please do me a favor and contact me before you send some defamatory text out onto the internet to go internationally viral. In the interest of respect for integrity, human dignity, and community, if for no other reason.
And in the meantime, please do not hesitate to contact Alec Zeck, Stanton Hom, Jeff Witzeman and “Health Freedom for Humanity” and let them know what you think about all of this. And for any who know me personally and want to call Alec Zeck directly to get his take on this, please get in touch and I will gladly forward his V-card so that you can discuss your point of view directly with him.