From time to time, there are dubious studies that pop up that I mean to discuss and, for whatever reason, never get around to or, having failed to discuss them in a timely fashion, decide that no one cares any more and don’t come back to. On the other hand, sometimes there are studies like what I just described that keep bugging me, that keep coming back in a niggling fashion in such a way that eventually I just say, “WTF?” and discuss them, even though I probably should have done so a week or two ago. A new study by Peter Doshi and colleagues that purports to be a reanalysis of the adverse events data from the original phase 3 clinical trials of the Pfizer and Moderna mRNA-based COVID-19 vaccines that the companies used to gain Emergency Use Authorizations (EUAs) for their products over a year and a half ago is one such study, and last night I just gave in.
The study was published as a preprint in early June, but, as often happens with studies antivaxxers widely share as evidence that vaccines don’t work or are dangerous, it took at least a couple of weeks before it started to gain traction on antivax Twitter. Personally, I trace its real takeoff to when Jordan Peterson cited it a week ago:
Much was also made of Peter Doshi’s status as a senior editor at The BMJ, one of the oldest and most respected journals in the world:
As of this morning (when I decided to make one last check before publishing this post), this is what the analytics for the preprint look like:
Unfortunately, the manuscript, entitled Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials, authored by Joseph Fraiman, Juan Erviti, Mark Jones, Sander Greenland, Patrick Whelan, Robert M. Kaplan, and corresponding author Peter Doshi, is making a splash.
The first thing I wondered when I read this study for the first time is more of a meta issue, specifically: Why was this study done? First, let’s look at the introduction to Doshi’s paper:
We sought to investigate the association between FDA-authorized mRNA COVID-19 vaccines and serious adverse events identified by the Brighton Collaboration, using data from the phase III randomized, placebo-controlled clinical trials on which authorization was based. We then use the results to illustrate the need for formal harm-benefit analyses of the vaccines that are stratified according to risk of serious COVID-19 outcomes, as well as contextualize the findings against post-authorization observational data.
What is the Brighton Collaborative? (I’m actually surprised that I hadn’t heard of it before.) It’s a group dedicated to vaccine safety and improving the scientific rigor of vaccine science. Learning that, to be honest, made me a bit annoyed at some criticisms of the study that the serious adverse events (SAEs) had been pulled out of someone’s nether regions. That the Brighton Collaborative doesn’t absolve Doshi for his chicanery in this paper, but we should be careful regarding criticisms we make.
Back to my meta question, though: Why does this study exist? I’ll preface my answer by pointing out a simple observation. It’s been well over a year and a half since the randomized clinical trial (RCT) results for the Pfizer and Moderna vaccines were first reported. Both of them involved only ~43K and ~30K participants, respectively. Next, I will point out that even large randomized clinical trials used to approve drugs and vaccines miss less common adverse events (AEs), including SAEs. That’s why we do postmarketing surveillance studies, particularly for vaccines. Less common AEs sometimes don’t show up until after a vaccine is rolled out and distribution goes from a population of tens of thousands to administration to millions, tens of millions, hundreds of millions, and even billions, as has happened with the Pfizer and Moderna COVID-19 mRNA vaccines during the more than a year and a half since EUAs were granted. In other words, if you are interested in the safety and efficacy of COVID-19 vaccines right here, right now, in mid-2022, over a year and a half after the EUAs were granted, the original RCT data are not the best data to use to estimate rates of adverse events. Over 10 billion doses have been administered since then, and numerous countries have safety and efficacy data.
So, given that background, why reanalyze the original RCT results from Pfizer and Moderna at all? There’s one reason, and one reason only, that scientists might want to reanalyze data from a completed and published clinical trial, specifically if they think that there was something wrong with the original RCT or how it was analyzed. The subtext, of course, is that they might do it if they suspect some sort of serious flaw in the RCT design or how the RCT was carried out. They might even suspect outright fraud. Doshi and his colleagues don’t explicitly say this, but if you know Doshi’s history you’ll understand that the real reason he undertook this analysis was almost certainly because he thought that the RCTs for the Pfizer and Moderna vaccine didn’t show what they claimed to show and were analyzed in such a way to exaggerate efficacy and hide adverse events. It’s not as though he’s made a secret of this belief, given that he’s a senior editor at The BMJ who’s been allowed to use the journal as his own soapbox.
Before I discuss this paper, let’s look at a bit of Doshi’s history on this issue, which is pretty clear. He’s argued in editorials for The BMJ that the vaccines aren’t as effective or safe as advertised, starting in January 2021, when he outright tried to argue (using truly awful methodology) that the efficacy of the Pfizer was much lower than reported because a large number of COVID-19 cases were missed. He was wrong. In fact, he was worse than wrong. Doshi’s methodology turned into an antivaccine meme that still circulates today, albeit in a somewhat different form. It’s similar to a technique that he’s used to attack influenza vaccines going back at least to 2006 and continuing for years and years after that, with his articles being approvingly cited by antivaxxers as prominent as Robert F. Kennedy Jr. This preprint is nothing more than the latest in a long line of articles by Doshi calling the safety and efficacy of vaccines into doubt and asking “Do we need more evidence?” Unsurprisingly, his conclusions are always that the vaccines aren’t safe and effective as the studies claim and that we do need more evidence. While no vaccine advocate would ever dispute that more data are a good thing, Doshi’s calls for “more data,” more than anything else, resemble JAQing off, rather than an honest call for more information and study.
It turns out that Doshi isn’t the only author of the paper known for misinformation about COVID-19 and COVID vaccines. The first author is Joseph Fraiman. The name sounded very familiar to me, but I couldn’t place him, although he’s billed as an emergency medicine physician in Louisiana. So I searched the blog, and it turns out that I’ve mentioned him before. He was a speaker at antivaxxer Steve Kirsch’s quackfest in which he claimed that COVID-19 vaccines have killed a half a million people. It further turns out that Fraiman has no expertise in vaccines, infectious disease, epidemiology, or pandemics, which is probably why he appeared on an “Urgency of Normal” panel organized by Florida Gov. Ron DeSantis to argue against vaccinating children. Dr. Fraiman, it turns out, is the first author of the paper. In papers in the biomedical literature, the two most important authors are the first author and corresponding author, the latter of whom is the senior author under whose supervision all the research is carried out and who is the point person for submission of the manuscript, answering peer review issues, and postpublication contact. Under “Author Contributions,” it’s noted that Fraiman and Doshi drafted the manuscript, which makes a lot of sense given how bad it is and how it tries to promote an antivaccine narrative.
Fraiman and Doshi aren’t the only COVID-19 contrarians on the author list either. Another author, Patrick Whelan, has popped up before in my reading. He’s a pediatric rheumatologist who was referred to in a positive light all the way back in February 2021 and before that supported the fear mongering of Human Noorchasm in a positive light by Lynn Redwood on Robert F. Kennedy Jr.’s Children’s Health Defense website for having claimed that the spike protein in the Pfizer and Moderna vaccines can cause heart attacks and strokes. Meanwhile, Robert Kaplan is Stanford faculty who, interestingly, expressed disbelief that antivaccine sentiments were more widespread than expected. Now, by being a co-author on this study, which is designed to imply that COVID-19 vaccines do more harm than good, he’s contributing to them.
No doubt at this point Doshi’s defenders (and there are a significant number of them, unfortunately) will claim that I’m basing my criticism on an ad hominem attack. Such claims misunderstand the nature of ad hominem. If I dismissed this study solely because Doshi had served as corresponding author on it, then that would be an ad hominem. It is not, however, an ad hominem to point out Doshi’s history and how the methodology of this study is consistent with his history of doing everything he can to portray vaccines as less effective and safe than accepted based on current evidence and then to discuss the problems with this study.
Enough about the authors. Let’s get back to the paper, which is yet another example of what I like to refer to as weaponizing the medical literature to spread disinformation. Here’s one big “tell” regarding what this is really about:
The Pfizer and Moderna trials are expected to follow participants for two years. Within weeks of the emergency authorization, however, the sponsors began a process of unblinding all participants who elected to be unblinded. In addition, those who received placebo were offered the vaccine. These self-selection processes may have introduced nonrandom differences between the vaccine and unvaccinated participants, thus rendering the post-authorization data less reliable. Therefore, to preserve randomization, we used the interim datasets that were the basis for emergency authorization in December 2020, approximately 4 months after trials commenced.
Here Doshi is echoing a common antivax talking point, in which it is claimed that the unblinding was carried out to hide AEs and much lower efficacy than reported based on the data used to obtain EUAs for the vaccines. Of course, the question of whether or not to unblind a clinical trial is a complex issue and depends on the intersection of bioethics and science. In the case of COVID-19 vaccines, after efficacy and safety were demonstrated in the first analyses, it became unethical to leave the control groups of those studies unprotected against COVID-19, which was surging around the world and causing mass illness, disability, and death. I won’t go into more detail, as I discussed the issue of unblinding the trials in detail over a year ago. Moreover, multiple assessments of the trials have concluded that both were rigorously conducted.
As I read this study, the first thing that came to mind was p-hacking. This study reeks of it. In brief, p-hacking (also known as data dredging) is a technique in which multiple analyses are done by exhaustively searching and comparing the variables alone and in combination, until a “statistically significant” result is found, regardless of whether that result is scientifically or clinically meaningful. Basically, p-hacking is a technique to make nonsignificant results seem “significant.” Basically if you compare enough things or combine and then compare enough things, you can almost always find a spuriously “statistically significant” result.
So let’s look at the paper.
Instead of looking at all AEs, as the papers and reports analyzing the data from the clinical trials did, Doshi and his colleagues decided to focus on “serious adverse events of special interest” (SAESIs, sometimes use called AESIs in the manuscript, something that at times confused me about what the authors meant in any one section). The first version of this list was published early in the pandemic based on five reports from China and has undergone a total of four updates, the most recent of which was published last September. These SAESIs were determined, as described by Doshi:
This effort created an AESI list which categorizes AESIs into three categories: those included because they are seen with COVID-19, those with a proven or theoretical association with vaccines in general, and those with proven or theoretical associations with specific vaccine platforms. The first version was produced in March 2020 based on experience from China. Following the second update (May 2020), the WHO Global Advisory Committee on Vaccine Safety (GACVS) adopted the list, and Brighton commenced a systematic review process “to ensure an ongoing understanding of the full spectrum of COVID-19 disease and modification of the AESI list accordingly.”7 This resulted in three additional AESIs being added to the list in December 2020. The subsequent (and most recent fourth) update did not result in any additional AESIs being added to the list.
We matched SAEs recorded in the trial against an expanded list of AESIs created by combining Brighton’s SPEAC COVID-19 AESI list with a list of 29 clinical diagnoses Brighton identified as “known to have been reported but not in sufficient numbers to merit inclusion on the AESI list.”7
So right away, I wondered how these diagnoses were being combined, mixed, and matched. If you look at the Brighton Collaborative document, you’ll see a lot of unremarkable standard AEs and SAEs, but you’ll also find ones that require intepretation. Here is the table defining its AESIs in Brighton’s Safety Platform for Emergency Vaccines (SPEAC):
The AESIs included because they have a theoretical or proven association with specific vaccine platforms are interesting, mainly because none of them are associated with the mRNA platform, but rather platforms that existed before the mRNA-based COVID-19 vaccines were released. Also note how the AESIs are (mostly) listed as broad categories, rather than specific diagnoses. Exceptions include, of course, myocarditis, which is associated with COVID-19 and has been associated in safety data with COVID-19 vaccines, but mapping the AEs in the clinical trials to these categories requires some subjectivity. There are more than just what’s listed above, delineated in a number of charts under each organ system. Colitis is listed in Annex 6, which encompasses the gastrointestinal system.
Indeed, here’s a passage that jumped out at me as a surgeon (who was well trained in dealing with abdominal pain, for instance) and clinician and suggested the subjectivity to me:
For SAEs that described symptoms, not diagnoses, the clinician reviewers independently judged whether each SAE type was likely to have been caused by an AESI. For example, the SAE “abdominal pain” is a symptom based diagnosis, which was judged as fitting within the SPEAC clinical diagnosis of “colitis/enteritis.” Disagreements were resolved through consensus; in two cases, consensus could not be reached and were resolved by the judgment of a third clinician reviewer (PW) to create a majority opinion. For each included SAE, we recorded the corresponding Brighton Collaboration AESI category and organ system.
Here’s a hint: Not all abdominal pain is due to colitis (inflammation of the colon) or enteritis (inflammation of the intestines). True, these are common causes, but there are so very many others. Similarly, what mapped to myocarditis and pericarditis? There are lots of causes of chest pain other than myocarditis and pericarditis.
For completeness, let’s look at the list (taken from Supplemental Table 1) of the included AESIs:
Included SAE types (matching AESI list): Abdominal pain, Abdominal pain upper, Abscess, Abscess intestinal, Acute coronary syndrome, Acute kidney injury, Acute left ventricular failure, Acute myocardial infarction, Acute respiratory failure, Anaemia, Anaphylactic reaction, Anaphylactic shock, Angina pectoris, Angina unstable, Angioedema, Aortic aneurysm, Aortic valve incompetence, Arrhythmia supraventricular, Arteriospasm coronary, Arthritis, Atrial fibrillation, Atrial flutter, Axillary vein thrombosis, Basal ganglia haemorrhage, Bile duct stone, Blood loss anaemia, Bradycardia, Brain abscess, Cardiac failure, Cardiac failure acute, Cardiac failure congestive, Cardiac stress test abnormal, Cardio-respiratory arrest, Cerebral infarction, Cerebrovascular accident, Chest pain, Cholecystitis, Cholecystitis acute, Cholelithiasis, Colitis, Coronary artery disease, Coronary artery dissection, Coronary artery occlusion, Coronary artery thrombosis, Deep vein thrombosis, Dermatitis bullous, Diabetic ketoacidosis, Diarrhoea, Diplegia, Dyspnoea, Embolic stroke, Empyema, Facial paralysis, Fluid retention, Gastroenteritis, Gastrointestinal haemorrhage, Haematoma, Haemorrhagic stroke, Hemiplegic migraine, Hepatic enzyme increased, Hyperglycaemia, Hyponatraemia, Hypoxia, Ischaemic stroke, Laryngeal oedema, Multiple sclerosis, Myocardial infarction, Noncardiac chest pain, Oedema peripheral, Pancreatitis, Pancreatitis acute, Pericarditis, Peripheral artery aneurysm, Peritoneal abscess, Pleuritic pain, Pneumothorax, Post procedural haematoma, Post procedural haemorrhage, Postoperative abscess, Procedural haemorrhage, Psychotic disorder, Pulmonary embolism, Rash, Rash vesicular, Respiratory failure, Retinal artery occlusion, Rhabdomyolysis, Rheumatoid arthritis, Schizoaffective disorder, Seizure, Subarachnoid haemorrhage, Subcapsular renal haematoma, Subdural haematoma, Tachyarrhythmia, Tachycardia, Thrombocytopenia, Thyroid disorder, Toxic encephalopathy, Transaminases increased, Transient ischaemic attack, Traumatic intracranial haemorrhage, Type 2 diabetes mellitus, Uraemic encephalopathy, Uterine haemorrhage, Vascular stent occlusion, ventricular arrhythmia.
And now let’s compare to the list of SAEs that were excluded by Doshi because they didn’t match the AESI list:
Excluded SAE types (not matching AESI list): Abdominal adhesions, Abortion spontaneous, Abortion spontaneous incomplete, Accelerated hypertension, Adenocarcinoma gastric, Adrenal gland cancer, Alcohol abuse, Alcohol poisoning, Alcohol withdrawal syndrome, Animal bite, Ankle arthroplasty, Ankle fracture, Anxiety, Anxiety disorder, Aortic stenosis, Appendicitis, Appendicitis perforated, Arteriosclerosis, Asthma, Atelectasis, Autonomic nervous system imbalance, B-cell small lymphocytic lymphoma, Back injury, Back pain, Benign prostatic hyperplasia, Bipolar disorder, Breast cancer, Breast cancer stage I, Breast hyperplasia, Bronchitis, Cartilage injury, Cellulitis, Cervical radiculopathy, Cervical spinal stenosis, Cervical vertebral fracture, Choroidal neovascularisation, Chronic kidney disease, Chronic lymphocytic leukaemia, Chronic myeloid leukaemia, Chronic obstructive pulmonary disease, Clostridium difficile colitis, Clostridium difficile infection, Colon cancer stage III, Colon injury, Colorectal cancer, Completed suicide, Complicated appendicitis, Concussion, Confusional state, Constipation, Cough, Craniocerebral injury, Dehydration, Depression, Diplopia, Diverticular perforation, Diverticulitis, Dizziness, Drug hypersensitivity, Duodenal ulcer, Duodenal ulcer haemorrhage, Emphysema, Facial bones fracture, Fall, Feeling hot, Femoral neck fracture, Femur fracture, Fibromuscular dysplasia, Flail chest, Flank pain, Food poisoning, Foot fracture, Foot operation, Forearm fracture, Fracture nonunion, Gastric cancer, Gastric perforation, Gastrooesophageal reflux disease, Gout, Gun shot wound, Head injury, Heart disease congenital, Hepatic cancer metastatic, Hepatic mass, Hepatitis A, Hernia, Hiatus hernia, Hip arthroplasty, Hip fracture, Humerus fracture, Hypertension, Hypertensive emergency, Hypertensive urgency, Hypoglycaemia, Hypokalaemia, Hypomagnesaemia, Hypotension, Idiopathic intracranial hypertension, Immunisation anxiety related reaction, Incarcerated hernia, Incision site pain, Influenza like illness, Intentional self-injury, Interstitial lung disease, Intervertebral disc degeneration, Intervertebral disc protrusion, Intestinal obstruction, Intestinal perforation, Intraductal proliferative breast lesion, Invasive ductal breast carcinoma, Invasive lobular breast carcinoma, JAMMED RIGHT INGUINAL HERNIA@@, Jaw operation, Joint injury, Knee arthroplasty, Large intestine perforation, Lead dislodgement, Leiomyosarcoma metastatic, Leydig cell tumour of the testis, Ligament rupture, Loss of consciousness, Lower limb fracture, Lung cancer metastatic, Lymphadenopathy, Major depression, Malignant melanoma, Meningioma, Mental disorder, Metabolic acidosis, Metastases to central nervous system, Migraine, Multiple injuries, Musculoskeletal chest pain, Nausea, Neck pain, Nephrolithiasis, Neutropenia, Obstructive pancreatitis, Oesophageal carcinoma, Oesophageal food impaction, Organising pneumonia, Orthostatic hypotension, Osteoarthritis, Osteochondritis, Osteomyelitis, Ovarian cyst, Ovarian mass, Overdose, Pancreatic mass, Papillary thyroid cancer, Paraesthesia, Pelvic neoplasm, Penile cancer, Penile neoplasm, Peritonitis, Pharyngitis streptococcal, Pleural effusion, Pneumonia, Pneumonia aspiration, Pneumonia staphylococcal, Pneumonitis, Polymyalgia rheumatica, Postoperative wound infection, Precancerous condition, Prostate cancer, Prostate cancer metastatic, Pulmonary mass, Pyelonephritis, Pyelonephritis acute, Rectal prolapse, Renal cancer, Renal cell carcinoma, Renal colic, Retinal detachment, Retinal tear, Rib fracture, Road traffic accident, Salivary gland calculus, Salpingitis, Sepsis, Septic shock, Sexual abuse, Shoulder injury related to vaccine administration, Skin laceration, Small intestinal obstruction, Speech disorder, Spinal cord injury cervical, Spinal fusion surgery, Spinal stenosis, Staphylococcal infection, Streptococcal sepsis, Suicidal ideation, Suicide attempt, Suspected COVID-19, Swelling face, Syncope, Systemic inflammatory response syndrome, Tendon rupture, Thoracic vertebral fracture, Thyroidectomy, Toxic shock syndrome, Toxicity to various agents, Transient global amnesia, Traumatic liver injury, Ulna fracture, Umbilical hernia, Unevaluable event, Urinary bladder polyp, Urinary tract infection, Urosepsis, Uterine leiomyoma, Uterine prolapse, Vertigo, Viral pharyngitis, Volvulus, Vomiting, Wound infection, Wrist fracture.
Note: I’m not sure why “jammed right inguinal hernia” is in all caps. I’ll presume it’s a typo.
A lot of the SAEs in the second list make sense given that they include fractures, gunshot wounds, head injuries, and the like, but a number do not, such as viral pharyngitis, volvulus, vomiting, and others. Dr. Susan Oliver has posted a video discussing the problems with this preprint. She didn’t really so much discuss the meta problems with it and Doshi’s history, but she did note many of the same things that I did, in particular the odd choices of what was and wasn’t included as SAESIs. For example, Doshi included diarrhea, but not vomiting (or, as the surgeon in me can’t help but note, intestinal perforation or volvulus, the latter a known complication of a certain vaccine); hyperglycemia (high blood sugar) but not hypoglycemia (low blood sugar); gastrointestinal hemorrhage but not duodenal ulcer hemorrhage (which is a form of gastrointestinal hemorrhage); and coronary artery disease but not atherosclerosis (which causes coronary artery disease). It’s all very curious. Perhaps the most important issue is that “events related to COVID-19” were excluded, which on the surface makes sense, but, given that COVID-19 cases were much more common in the placebo controlled group, automatically biases the results for the remaining SAEs to the vaccine-group.
That’s not all, though. Instead of comparing the number of people who had SAEs, they did this:
In their review of SAEs that supported the authorization of the Pfizer and Moderna vaccines, the FDA concluded that SAEs were, for Pfizer, “balanced between treatment groups,”14 and for Moderna, were “without meaningful imbalances between study arms.”15 In contrast to the FDA analysis, we found an increased risk of all cause SAEs in the Pfizer trial. While our analysis excluded SAEs related to COVID-19 (because it is an efficacy outcome), this exclusion did not explain the difference given the low risk of SAEs attributed to COVID-19 (0 in the vaccine arm, 1 in the placebo arm). Instead, the difference in findings may in part be explained by the fact that the FDA analyzed the total number of participants experiencing any SAE, whereas our analysis was based on the total number of SAE events. Given that approximately twice as many individuals in the vaccine group experienced multiple SAEs than the placebo group (there were 24 more events than participants in the vaccine group, compared to 13 in the placebo group), FDA’s analysis of only the incidence of participants experiencing any SAE would not reflect the observed increase in multiple SAEs in the vaccine group.
To put it briefly, they compared number of SAEs, not the number of patients who suffered an SAE. This sort of analysis is guaranteed to double count SAES—at least!—because some of the SAEs or groups of SAES will be linked. For example, as Dr. Oliver points out, abdominal pain often goes along with diarrhea, to which I would add that colitis or enterocolitis can lead to gastrointestinal hemorrhage. Moreover, formal reporting systems for clinical trial AEs require that all AEs be entered, even when they are related, which is why analyses are usually done at the patient-level, as in “number of patients who suffered this AE,” rather than in total AEs reported in each group independent of the number of patients. I’d be willing to bet that if the same statistical analysis were done using per-patient-level data rather than SAE-level data the statistical significance would likely disappear. At the very least, if I were reviewing this paper, I would refuse to publish it until such an analysis was included for comparison.
The “money” chart that antivaxxers are sharing is Table 2:
First of all, this chart demonstrates the power of cherry picking. Notice first the huge confidence intervals. Next, notice how for the combined data for all SAEs there is no statistically significant difference. Now notice how, even for the SAESIs, for the individual trials there is no statistically significant difference until you combine the two. Moreover, all they could find was an additional 12.5 SAESIs per 10,000 participants (with, I can’t help but adding, a 95% confidence interval of 2.1 to 22.9, again a huge uncertainty).
But that’s not all. Perhaps the most dubious—dare I say dishonest, even?—part of the paper is a comparison that Doshi makes between the number of SAESIs reported and hospitalizations due to COVID-19 observed in the placebo control group:
In the Moderna trial, the excess risk of serious AESIs (15.1 per 10,000 participants) surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group (6.4 per 10,000 participants).3 In the Pfizer trial, the excess risk of serious AESIs (10.1 per 10,000) surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group (2.3 per 10,000 participants).
Think of it this way. You can only hospitalize patients, not SAESIs (or AESIs or AEs). An individual patient in the vaccine group could suffer more than one AE, but a a patient in the placebo control group could only be hospitalized once (in the context of the limited timeframe of the clinical trial) for COVID-19. Here Doshi is comparing apples and oranges in order to make it look as though the vaccines were more dangerous than actually getting COVID-19, which is a ridiculous contention given what we know. Moreover, in clinical trials in general a lot of the “serious adverse events” are not serious enough to warrant hospitalization. In fact, according to the standard terminology used to rate SAEs in clinical trials grade 3 events and above (on a five-point scale) are rated severe. If you look at the list of specific AEs, you’ll see that some grade 3 AEs require hospitalization; some don’t. Grade 3 is defined as an AE that:
- Is severe or medically significant but not immediately life-threatening; OR
- Requires hospitalization or prolongation of hospitalization indicated; OR
- Limits self care/activities of daily living (ADL)
For completeness, I’ll mention that grade 4 AEs are by definition life-threatening events that require urgent intervention and that grade 5 events are by definition AEs that result in death. Any rigorous evaluation would compare hospitalizations due to AEs in control versus hospitalizations due to AEs in the vaccine group, not AEs (regardless of whether they are AESIs or just AEs). Again, Doshi’s comparison is deeply intellectually dishonest. The only thing Dr. Oliver didn’t consider in her discussion was AE grades.
There’s another issue here as well. The rate of hospitalizations in the placebo control group would be expected to be highly dependent on the level of COVID-19 that was circulating in the populations tested during the time period in which the clinical trial was carried out, as these trials were not challenge trials, in which subjects are intentionally exposed to the virus. As a result, most people in the placebo and vaccine groups were not exposed to COVID-19, because these trials were carried out in the summer and early fall of 2020, before the really big winter surge hit.
Here’s a graph of COVID-19 cases in the US in 2020:
Enrollment for the Moderna trial ended on October 23, 2020; for the Pfizer trial, November 14, 2020. Note that this was before the winter surge took off. Had the trial started a few months later and ended in, for example, February 2021 or later, you can bet that the rates of hospitalization for COVID-19 would have been much higher in the placebo control group.
The bottom line is that this study is deeply misleading based on what sure looks like p-hacking combined with misleading comparisons, further combined with a low enough risk of COVID-19 in the two populations to allow for a low rate of hospitalization when normalized to the entire population in the control group.
This brings me back to Peter Doshi. If you didn’t know Doshi’s history, you might very well take this study at face value. Sadly, The BMJ hired Doshi, who is now a senior editor, despite his long history of playing footsie with the antivaccine movement since at least 2009, amplifying antivaccine conspiracy theories, downplaying the severity of influenza and thus feeding antivaccine narratives, using sleight-of-hand to downplay the effectiveness of flu vaccines, and generally playing the role of a false skeptic with respect to vaccines, as well as having signed a petition in 2006 “questioning” whether HIV causes AIDS. It continued to employ him even after he’d fallen for a conspiracy theory that the Vaccine Adverse Events Reporting System (VAERS) database was being made inaccessible to suppress report. Even worse, Doshi has also served as an expert witness for the plaintiffs in antivaccine leader Robert F. Kennedy Jr.’s lawsuit against the University of California’s influenza vaccine mandates and taken part in a “roundtable” organized by Sen. Ron Johnson to go dumpster diving in VAERS to find “vaccine injuries” due to COVID-19 vaccines, whether the injuries were caused by them or not.
In his testimony at Sen. Johnson’s quackfest, Doshi denied that COVID-19 at the time (November 2021) was a “pandemic of the unvaccinated”, citing a report from July from the UK that most hospitalizations are among the fully vaccinated. It turned out that this report was in error, substituting “vaccinated” for “unvaccinated” and the majority of hospitalizations were among the unvaccinated, even though they made up only 31% of the population at the time. He even cited cherry-picked tables to claim that the vaccine wasn’t saving lives in what was basically an updated rehash of the nonsense he had peddled a few months earlier in which he claimed that there was “no biodistribution data” for COVID-19 vaccines and made a number of other negative false claims about the vaccines (also deconstructed by Dr. Hilda Bastian). In a truly risible moment, Doshi even cited the Merriam-Webster definition of “antivaxxer” as opposed to those supposedly opposed to vaccine mandates to argue that he and his fellow COVID-19 contrarians were “not antivaccine” and that large numbers of people would qualify as “antivaccine”. He even parroted the antivaccine talking point that mRNA vaccines are not really vaccines and therefore shouldn’t be mandated like vaccines.
I’ll conclude by scratching my head and wondering why Sander Greenland signed on to Doshi’s “study,” which was predestined to find something bad about mRNA-based COVID-19 vaccines. For those of you who haven’t heard of him, Greenland is a giant in the world of statistics, and I myself have cited his work on Bayesian statistics and reasoning when giving talks about the differences between science-based medicine and evidence-based medicine to support my argument that science-based medicine is superior and, in fact, necessary. Given that Greenland apparently had no role in deciding which AEs were included (at least not as far as I can tell) and Doshi is listed as having been the investigator solely responsible for data acquisition, I can only conclude that Greenland mistakenly trusted Doshi and did his standard skilled statistical analysis on a fatally flawed dataset. At least, I hope that that’s what happened. Unlike, for example, John Ioannidis, for now I have to give Sander Greenland the benefit of the doubt.
Unfortunately, Peter Doshi has spent his career amplifying antivax narratives, either wittingly or unwittingly, disguised as demanding more rigor in scientific trials. Even worse, The BMJ continues to employ him, thus providing him with a platform that gives him the appearance of scientific authority that allows him to attract respected academics to help him spread dubious studies custom-made for weaponization by antivaxxers, making its leadership complicit in his spreading misinformation.
97 replies on “Peter Doshi vs. COVID-19 vaccines, the latest round”
This dude, again. When he went to talk at Hopkins, I got up and left. As I’m leaving, he tells the audience, “Well, we know how he feels about vaccines.” No, my dude… My friends and colleagues know how I feel about you. Self-aggrandizing amateur epidemiologist.
Yeah he made the rounds in the PNW, too. Many of us were “backed up in clinic” or “stuck in surgery.”
@Orac: Did you try asking Sander Greenland about it? I’ve had some luck asking a few other scientists, but I’d bet that Greenland just allowed his name to be used with little knowledge of what Doshi was doing. Most likely Greenland won’t respond now that he knows what Doshi was up to.
I find it a bit odd that Orac refers to this as Doshi’s paper, and attributes the pulled quotes to Doshi, when the paper has seven authors, and Doshi is listed last. I don’t know enough about the conventions of med science research and publishing to interpret these multiple-author things get any idea of who’s responsible for what. If I just dropped in on this, I might think that the focus on Doshi in the OP to the exclusion of the other authors is indeed evidence of a strong dose of ad hominem. Why not use language like “the authors” and “they” instead of “Doshi” when referring to the paper? The fact he’s involved still makes any continuities between issues with this paper and his prior work relevant.
E.g. I wouldn’t know how to quickly find out, as Orac reports, that Sander Greenland probably just crunched the numbers he was given, or that Doshi was solely responsible for data acquisition. It might be helpful for other non-specialist readers if Orac provided a bit more background on what, if anything, we can conclude from the info provided about authorship in these papers. Is the first-listed author the “senior” or “lead” researcher, and if so what does that mean? Is there any significance to the order of the rest of the list?
IOW: who is Joseph Fraiman, why might he be involved in questioning vaccines, how did he get hooked-up with Doshi, what aspects of the study were his responsibility directly, and what might, if nothing else, show lack of due diligence on his part (or the others) before signing on to this paper? Etc. ?
Doshi is the corresponding author, and the corresponding author is the main author responsible. Usually in biomedical research papers, the corresponding author is the faculty member responsible for a paper, while the first author is often the trainee who did much of the work under the supervision of the corresponding author, who is usually listed last in the author list (although sometimes the corresponding author and the first author are one in the same). The corresponding author is the point person for everything about the paper, from submission to answering peer reviews, to postpublication contact. It’s primarily Doshi’s paper, without a doubt.
As for Fraiman, I looked him up (which I should have done before). I knew the name sounded familiar. He’s one of Ron DeSantis’ “experts” who opposes vaccinating children:
https://www.floridahealth.gov/newsroom/2022/03/20220308-FDOH-covid19-vaccination-recommendations-children.pr.html
My bad. This is Fraiman AND Doshi’s paper. I’ll probably add a paragraph later this evening to reflect that. The exaggeration of vaccine side effects and downplaying of efficacy appear to be Doshi’s joint, while the bogus “risk-benefit” analysis might be Fraiman’s joint, although Doshi has certainly been JAQing off about that too for quite a while, as I’ve blogged about. In addition, Patrick Whelan has promoted antivax misinformation. Now I’m going to have to look all of these guys up. I’ll still say that this is almost certainly primarily Doshi’s joint, given that he’s the corresponding author (which means a lot), but Fraiman is clearly either second or co-equal. There rest come below that.
Finally, here’s a pro tip: At the end of the text right before the reference list, the preprint helpfully lists who was responsible for what tasks, which is how I know that Doshi was responsible for the “acquisition of data,” as the preprint puts it.?
In the same section: Fraiman and Doshi drafted the manuscript, which makes a lot of sense if it’s Doshi’s paper, which it is.
This seems to be many med bloggers’ standards.
Doshi’s standards are very very well known, now. His work against influenza vaccines identified his biases, as well as his attempts to publicly attack vaccines while using false credentials (John Hopkins scientist). It’s VERY easy to lay this kind of paper at the foot of Doshi, given his proclivities.
I’d like to see a lot more attempts from bloggers like Novella and Orac to obtain statements and comments from some of the co-authors of these pathetic papers. I’d also like to be kept abreast of attempts to retract their shoddy works. I’ve personally reached out to a handful of authors of papers like this to try to find out their motivations, but given my lack of a PhD and public history (bibliographies, etc) I don’t get very far.
Perhaps we need a group of “scientific skeptics” to spearhead real investigations as to why some credible scientists will sign their names to papers that clearly lack robust methodologies and intentions. Would such attempts have clarified the Wakefield disaster if someone like Brian Deer had obtained statements and comments from the co-authors prior to the hearings?
Let’s just say that learned this morning that one skeptic did indeed contact Sander Greenland. We shall see.
@Orac
I’ve emailed Dr. Greenland and he doesn’t seem to think Doshi is an anti-vaxxer. I’ve linked him to a few of the takedowns of his previous influenza anti-vax takes and how there is no way he could be unaware of how anti-vaxxers would use his opinions and papers. We’ll have to see if he accepts that Doshi’s intentions are clearly not academic.
There’s nothing “odd” about singling out Doshi, given his evident leading role in producing this paper based on the order in which authors are listed, Doshi being last.
From science org:
“The last author is the lead PI, who has supervised, financed, or otherwise been the main person responsible for the project.”
This convention has been referred to here on other occasions, so it’s odd you wouldn’t know about it, or at least have had the curiosity to look it up.
And…an update. Yesterday, I learned from Steve Salzberg something about Sander Greenland that I hadn’t known before. He was an expert witness for the complainants in three of the test cases the Autism Omnibus Proceedings, specifically the group who claimed that autism was caused by the mercury in the thimerosal preservative that used to be in several childhood vaccines until around 2002.
http://genome.fieldofscience.com/2010/03/vaccine-court-ruling-thimerosal-does.html
I should have realized that this is not new.
Thank you for this thorough analysis and thank you for mentioning my video, although I think you may have inadvertently referred to me as Dr. Richards a couple of times. I would hate to think nice Dr. Richards is now being trolled.
Sorry about that. It’s fixed.
There’s a funny story behind that brain fart (maybe). I had actually been reading some Fantastic Four comics during a break in editing the post, and I suppose I had Sue Richards on the mind…?
Thank you for this – I’m very grateful for the time and effort you put into this stuff, I learn a lot (and then forget it, so I’m glad I can come back!). One little possible correction – is ‘Dr. Richards’ supposed to be ‘Dr. Oliver’?
I hope those long lists of SAEs and AESIs don’t catch the attention of recalcitrants on the Boston Red Sox roster who have declined Covid-19 vaccination.
Their absence, especially that of the team’s closer, Tanner Houck was felt during the just-concluded series in Toronto (Canada bans entry of players who haven’t been vaccinated against Covid-19), in which the Red Sox blew a ninth-inning lead and lost, then almost repeated the feat last night when Houck’s substitute gave up two runs in the bottom of the 10th and had the winning runs in scoring position before getting the final out of the game.
It’s unclear whether SAEs and AESIs are worrying the holdouts, or if it’s fertility and/or corruption of precious bodily fluids, but manager Alex Cora seems to think they’ll change their minds.
“I do believe when we come to [Toronto in] September, it’s going to be different,” said Cora. “Let’s leave it at that. I bet you a dollar it’s going to change.”
I’d take that bet. I don’t know of a single publicized vaccine holdout in sports where the refuser changed his mind.
Chicago doesn’t. If the Cubs didn’t habitually forget what bats are for, they could have swept that series.
Doshi’s counting of AEs rather than patients who had an AE has that “new untested metric” stench used by antivax p-hackers (eg Lyons-Weiler’s “relative incidence of office visits” metric). Doshi snuck it unnamed into his paper which shows sneakiness at a higher level than L-W.
Indeed it does. I wonder where they submitted this travesty. Hopefully, it’s a journal that actually does decent peer review.
One of our faculty doesn’t like the term p-hacking. She refers to it as <p-hucking around
Supposing each AE that was counted as a comparison against the covid hospitalization was at the level of hospitialization as well it wouldn’t be misleading. .
“In other words, if you are interested in the safety and efficacy of COVID-19 vaccines right here, right now, in mid-2022, over a year and a half after the EUAs were granted, the original RCT data are not the best data to use to estimate rates of adverse events.”
Where are those “better data”, exactly? You’re deep in denial about VAERS, and no one is funding long term studies. It is hilarious that a person claiming to support “science-based medicine” runs in the opposite direction whenever evidence is presented that might challenge their beliefs. “Science” is skeptical to be sure, but when new evidence is introduced, it needs to be tested. If it holds up, we must iteratively adapt our conclusions to best fit the available evidence. All I’ve seen you do is performative gymnastics to avoid dealing with data that proves your faith in untested (ok, barely tested) mRNA therapies to be misplaced. I would respect the skepticism more if it were accompanied by calls to fund research (by neutral parties with no conflicts of interest) designed to prove or disprove the causality of the mRNA products in connection with adverse events. You cannot state with confidence that there is no causality in the absence of evidence to back the claim, and it seems you do not WANT to know.
It’s amazing that the guy poo-pooing Robert Malone’s position on the bioethics of forced injections suddenly cries “Ethics!” to defend the unblinding of the Pfizer study. Even that study barely demonstrated efficacy and the incidence of cardiac events were higher in the Pfizer arm. You could just as well assert that it was unethical to give the placebo arm an injection with higher risk of heart complications. Arguably, the ethical thing to have done–in light of willing participants and an outcome impacting billions of people–would have been to continue monitoring and collecting data in both arms to verify the long-term safety of these products. But now we can’t do that, which apparently impresses you for some unfathomable reason.
“[Doshi] even parroted the antivaccine talking point that mRNA vaccines are not really vaccines and therefore shouldn’t be mandated like vaccines.”
The mRNA products neither confer immunity nor stop transmission. They introduce foreign genetic material that lingers in the body for an unspecified period of time. What are they then? They do not fit the traditional understanding of what a “vaccine” does, and the redefinition is quite obviously deceptive marketing with the intent to trick people into attributing qualities to the mRNA products which they do not have, which makes a gullible and scared populace more compliant. “Misinformation” indeed.
You’re in the wrong place, non-scientist.
“You’re deep in denial about VAERS, and no one is funding long term studies.”
Evidence, little one. You forgot evidence.
“All I’ve seen you do is performative gymnastics to avoid dealing with data that proves your faith in untested (ok, barely tested) mRNA therapies to be misplaced.”
Phase 3 trials aren’t testing? How effing funny you are! These were some of the largest RCTs carried out on a developing vaccine.
“The mRNA products neither confer immunity nor stop transmission.”
Thank you for showing everyone here that you’re nothing but an anti-vaxxer.
doi: 10.1016/j.vaccine.2021.08.060
I doubt you’ll be back, you’re probably just a standard uneducated drive-by troll.
“They introduce foreign genetic material that lingers in the body for an unspecified period of time.”
mRNA lasts for hours, not even really “days” in the human body. The generation of spike proteins does create an immune response, thus this is a vaccine.
What an uneducated clown.
Yeah this is the one I keep hearing. Kids in basic bio should know how valuable those neucleotides are and how quickly the body scavenges them.
Agreed. Yet I hear this hundreds of times from alties.
“The various vaccine technology strategies generated non-identical immune responses to provide protection against SARS-CoV-2 infection4. For instance, the LNP-mRNA vaccine, mRNA-1273, induces spike (S)-specific IgG, high TH1 cell responses, low TH2 cell responses and CD8+ T cell responses5,6, whereas the inactivated virus vaccine, CoronaVac, elicits robust CD4+ and CD8+ T cell responses to the structural proteins, including S, nucleocapsid (N), envelope (E) and matrix (M), in addition to humoral responses7,8. ”
DOI: 10.1038/s41591-022-01877-1
Definitely not a vaccine, right? Just clearly generates immune responses like a … ?
Sigh. You really don’t know what you are talking about and it shows. Everything you say is wrong and you haven’t provided evidence to show anyone you are right. You can’t even comprehend what a vaccine is. I’m just a regular guy and I understand what VAERS does and doesn’t do. Guess I’m in denial. Lol.
I feel well immunized and am glad I took the vaccine to minimize transmission. I even wore a mask under mandate and no mandate.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4257027/
https://www.cdc.gov/vaccines/hcp/conversations/understanding-vacc-work.html
Do you understand that SARS-CoV-2 essentially ismRNA and that when it infects your cells it causes those cells to make 10 more subgenomic mRNAs so your cells can make the 29 proteins required by the virus?
Name any vaccine used for a human viral disease that is considered to elicit long-persistent protection against infection. The list is remarkably short.
Hi everyone. You’ll be pleased to hear that yesterday I completed what the pharmacist called “the trifecta”: Johnson & Johnson, Moderna, and Pfizer. The first one was an end of the day leftover at an event in a seniors’ complex. Neither special freezers nor a return for second doses were available. I was thrilled to get it, and thrilled that the local health department was able to protect a vulnerable community.
I wasn’t able to find any real evidence that the trifecta is better, but I’m pretending it is so I can gloat. 🙂
I was able to get J&J for my second shot in early November after the CDC recommendation became official. I got the Moderna in early May. It’s an odd combo, but I’ve remained covid free.
Meanwhile, my Pfizer vaxxed and boosted co-workers have all had covid, and two of them have had it twice. Pure luck of the draw I’m sure, but…..I’m leaning toward Moderna for a fall booster. Depends on what they and Pfizer come up with.
There are a better way to measure vaccine efficiency than listening tales of your friends.
You’re right that counting EVENTS rather than SUBJECTS is inappropriate. You’re also right that it’s fishy to revise the AESI event list after the fact. There’s a potential shenanigans synergy in doing both – after the dataset is unblinded, adjusting the AESI event list and then counting events is a recipe for fraud.
OT ( but is outlining the inner mechanics of charlatanry ever TRULY OT at RI? )
How this works
Mikey revealed a few aspects of his grift so clearly on today’s broadcast that I feel obligated to point it out ( first 30 minutes)
— after endless stories about future food shortages, starvation, hyper food inflation, etc Mike offers his emergency meals ( Ranger Buckets) today with a limited supply of only 1000 at a holiday discount of only 358 USD
I looked at the contents of these miracle buckets at his site and discovered that they are mostly rice and beans and include about 19 lbs each. ( organic, GMO free)
That’s it.
I could do much better buying storable foods at my local store but then I’m not crazy
— Mike earned a 50K affiliate fee from the Bollingers’ site and is donating 100% to “worthy” alties/ organisations such as Andy’s film funder, Del’s ICAN, Tenpenny’s new Christian group, ANH, Green Med Info and possibly a truther type investigatory website.
— Dr Madej and her BF were in a plane crash and Dr Zelenko is in ICU for metastatic cancer: donate to them too
— Mike is from Kansas and is asking followers to donate to a group that wants to limit abortions there by a state measure
His instructions are heavily laced with religious tripe.
Some of my friends in Kansas are having weekly rallies until August to encourage people to vote no and block this change in the state constitution.
https://www.washingtonpost.com/opinions/2022/06/29/kansas-abortion-referendum-womens-lives-are-ballot-kansas/
Skimping on jimmies is one thing, but I’d expect at very least a dental dam than can be converted into a lean-to.
@ Everyone
In a BMJ article Peter Doshi wrote: “None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths (Doshi, 2020 Oct 21).”
So, I went to the FDA website and downloaded both Moderna and Pfizers Clinical Study Protocols (2020 Aug 20). I’ll just quote from Moderna’s:
Secondary Efficacy Assessments:
To be considered a severe COVID-19, the following criteria must be
met: a confirmed COVID-19 as per the Primary Efficacy Endpoint
case definition, plus any of the following:
• Clinical signs indicative of severe systemic illness,
Respiratory Rate ≥ 30 per minute, Heart Rate ≥ 125 beats per
minute, SpO2 ≤ 93% on room air at sea level or PaO2/FIO2 <
300 mm Hg, OR
• Respiratory failure or Acute Respiratory Distress Syndrome
(ARDS), (defined as needing high-flow oxygen, non-invasive
or mechanical ventilation, or ECMO), evidence of shock
(systolic blood pressure < 90 mmHg, diastolic
BP < 60 mmHg or requiring vasopressors), OR
• Significant acute renal, hepatic or neurologic dysfunction, OR
• Admission to an intensive care unit or death.
The secondary case definition of COVID-19 is defined as the
following systemic symptoms: fever (temperature ≥ 38.C) or chills,
cough, shortness of breath or difficulty breathing, fatigue, muscle
aches or body aches, headache, new loss of taste or smell, sore throat,
nasal congestion or rhinorrhea, nausea or vomiting or diarrhea AND a
positive NP swab, nasal swab, or saliva sample (or respiratory
sample, if hospitalized) for SARS-CoV-2 by RT-PCR.
Death attributed to COVID-19 is defined as any participant who dies
during the study with a cause directly attributed to a complication of
COVID-19. . . The investigator, in consultation with the Sponsor’s medical monitor” [Note. I was in the study. We gave permission to contact our primary care physician and get access to our medical records. Basically, if they lost contact with us, they could contact our PCP.]
The first of several peer-reviewed papers on the Moderna study was published on December 30, 2020:
“A key secondary end point evaluated the efficacy of mRNA-1273 at preventing severe Covid-19. Thirty participants in the trial had severe
Covid-19; all 30 were in the placebo group (indicating vaccine efficacy of 100% [95% CI, could not be estimated to 1.0]), and one death among
these participants was attributed to Covid-19 (Baden, 2020 Dec 30).
So, did Doshi bother to check out on the FDA website the study Protocols?. If he did, then how could he have claimed “none designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths?” Note, for instance, the Moderna Protocol was posted August 20, two months before Doshi’s BMJ opinion piece
And given the NEJM articles, no follow-up admission he was wrong.
References:
Baden LR et al. (2020 Dec 30). Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. New England Journal of Medicine;
Doshi P (2020 Oct 21). Will covid-19 vaccines save lives? Current trials aren’t designed to tell us. BMJ
Moderna (2020 Aug 20). A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and
Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older.
“Doshi P (2020 Oct 21). Will covid-19 vaccines save lives? Current trials aren’t designed to tell us. BMJ”
A fabulously bad-faith title. The purpose of P3 isn’t to determine “number of lives saved”; it’s to determine safety and efficacy of the product in a large-scale trial to ensure it’s fit for market.
“Number of lives saved” is for the epidemologists to determine, once safe and effective vaccines are in widespread use and the disease is brought under control. So will Mr Doshi provide an update once those figures are in? And will it be anything but yet more weasel-worded smears, with the BMJ now apparently only too happy to serve as the antivaxxers’ ass-in-the-air bitch?
Doshi repeatedly phrases the questions or the premises in misleading ways. You gave an example from the trials, let me give another example. In an article attacking vaccine advocacy organizations, Doshi criticized them from not being “independent” from CDC and not acting as watch dogs. https://www.bmj.com/content/359/bmj.j5104
But these organizations are not designed to be watch dogs. These are lay organizations that draw on expert bodies for what to recommend, and simply work on translating recommendations, explaining information, and improving access. They’re not scientific organizations overseeing CDC.
In other words, Doshi’s criticism misrepresented what the organizations do and was simply giving BMJ affirmation to an attack on these organizations that could have been written by any (other) anti-vaccine activist.
And it was all in the framing of the question.
“In an article attacking vaccine advocacy organizations, Doshi criticized them from not being “independent” from CDC and not acting as watch dogs.”
LOL, Doshi clearly learns from the best.
It is funny that so many of these free-market/anti-regulation, libertarians are suddenly advocating for raising taxes to create a more independent FDA/CDC. They now see the main danger being a regulation funded by fees from those who wish to obtain approval. .
“libertarians are suddenly advocating for raising taxes to create a more independent FDA/CDC”
Nope. Your Libertarians’† singlular goal is, as before, to destroy the FDA and CDC completely, and return ’Murica to the Good Ole Days of enjoying Independence Arsenic and Freedom Formaldehyde in everybody[ else]’s drink and food.
Anything else they say is just silly theatrics to keep their enemies off-balanced and confused, chasing after their tales. And, credit to them where due: the tactic clearly works.
—
† As in, “Freedom for me, and fuck y’all.”
Nah. Free market anti-regulation libertarians want to neuter or even eliminate the FDA and CDC. At the very least, they want to drastically diminish their power and reach. It’s long been a goal. Have you not paid attention to what Peter Thiel and his acolytes have advocated? Back during the transition between Obama and Trump, I wrote a lot about the Thiel acolytes being considered for FDA Commissioner. One didn’t believe that the FDA should require evidence of efficacy to approve drugs. Another thought that drug evaluation and safety monitoring could be done through a “Yelp for drugs.” The guy who ultimately got the job, Scott Gottlieb, was a bona fide actual pharma shill, and, as bad as he was, was actually the “least bad” of the candidates considered.
https://www.respectfulinsolence.com/2016/12/09/fixing-the-fda-by-appointing-a-commissioner-who-doesnt-believe-in-the-fdas-mission/
https://www.respectfulinsolence.com/2017/01/16/next-up-on-the-trump-fda-crazy-train-a-man-who-thinks-that-a-yelp-like-system-will-do-better-than-the-fda-at-maintaining-drug-safety/
Back in 2014, Nick Gillespie was writing articles in Reason like Kill the FDA (Before It Kills Again). It’s been a longstanding theme among libertarians that the FDA supposedly harms more people than it protects through bureaucracy and keeping new drugs from the people with all those pesky regulations about how drugs should be proven safe and effective. Some even argue that the FDA is unnecessary because its drug testing and approval process could be better carried out by private labs like UL.
It seems that the irony is missed on them as well.
The BMJ has published a new investigation in the problem is having pharma companies fund the FDA via user fees
(https://www.bmj.com/content/377/bmj.o1538).
@ Orac
So they would like to wait for another Thalidomide?
Because if you think the market will solve everything, we have to wait till the nasty side-effects occur, and consumers react and if something has a nasty effect on the foetus, it will defenitly take some time before a link between the product and the side-effect will be proven.
Yesterday, I learned something about Sander Greenland that I hadn’t known before. Basically, he was an expert witness for the complainants in the three test cases (Dwyer, King, and Mead) for the Autism Omnibus Proceedings who used the “theory of causation” that mercury in vaccines causes autism. Steve Salzberg contacted me and referred me to one of his contemporaneous blog posts.
http://genome.fieldofscience.com/2010/03/vaccine-court-ruling-thimerosal-does.html
I looked up the Special Masters’ final decisions and the testimony. (Greenland’s testimony was featured on day one.) Not good. It might even be worth a blog post.
First Ioannidis, now Greenland.
@ Everyone
Three years ago I began submitting BMJ Rapid Response. Given it was a medical journal, I was much more careful in my choice of words, no swear words, and no attacking other Rapid Responders; however, I did refute point by point what antivaxxers, especially John Stone from Age of Autism wrote. A number of my Rapid Responses were posted up to 10 days after I submitted them; but posted on the submitted date so that if anyone wanted to find them they would have needed to scroll down several pages. I have had OpEds and Letters-to-the-Editor published/posted in Newspapers, Online Magazines, and various Blogs. They were posted the day they were published, NOT when submitted. I have had articles published in peer-reviewed journals, again, not published on date submitted; but on date published/posted.
Even worse, eight of my Rapid Responses were NEVER posted. Below is an example so you can judge for yourself if there is anything wrong with it. So, I finally stopped submitting Rapid Responses; but continue to follow them and over the past three years John Stone has had probably 50 or more and many others from antivaxxers; e.g., Allan Cunningham, Elizabeth Hart, etc.
Peter Doshi was and still is the Senior Editor at BMJ. Does anyone think he had a hand in delaying several of my submissions and not even publishing eight of them? I can’t be sure; but . . .
“Response 2 to John Stone’s “I would not start from here” (2019 Jun 24).
As I explained in my previous RR (Harrison, 2019), Stone is just plain WRONG when he predicts increasing vulnerability to measles as those with natural immunity die out. Those with natural immunity would be overwhelmingly those born before the introduction of the vaccine in 1963, probably around 10% of the current U.S. population. However, measles was declared ended in U.S. in 2000. So what happened? Antivaccinationists.
“There are basically two things you need to make a measles outbreak in the U.S. The first is a local community with a low vaccination rate. Although 91 percent of Americans nationally are vaccinated against measles, isolated pockets can have much lower rates — 70 percent, 50 percent, or even less. Insular communities connected around shared culture, religion or a single school provide a place where measles can incubate and spread . . . If a measles outbreak is a fire, you can think of this as the tinder. . . But you still need a lit match, and thatʼs where international travel comes in. Measles outbreaks no longer start on their own anywhere in the Americas.” (Koerth-Baker, 2019; see also: Sarkar, 2019, Skeptical Raptor, 2019). And as I wrote previously, despite measles being highly contagious, thanks to vaccinations, these were contained locally.
Stone writes: “It seems that for Harrison (and for most health officials) it is important to hide from the public the limitations of the technology while introducing ever more products which in total may have other effects on our not too healthy community, but I have doubts whether this is either wise or ethical.”
I’ve already shown how wrong he is about the “waning effects” of vaccines. As for the wisdom of introducing new vaccines, he ignores all the suffering, disabilities, and deaths caused prior to the introduction of vaccines and the fact that over 90% of children experienced most, if not all of them. Even polio, which antivaccinationists downplay, actually affected a much larger percentage of children and adults (Harrison, 2018). Yep, vaccines don’t confer 100% immunity and though they either prevent or lessen the effects of disease in most individuals, there are rare serious adverse events, exponentially fewer than the suffering, hospitalizations, disabilities, and deaths from the natural diseases. Stone would sacrifice the many for the few. If we could conduct inexpensive accurate labs to determine which individuals would develop an adverse event from a vaccine, then we would. Herd immunity would protect them.
Stone would also have people believe that health officials are hiding the risks from vaccines. In the U.S., by law going back over 30 years, prior to receiving a vaccine, a Vaccine Information Statement (VIS), must be given to each patient or parent for each vaccine given. What is on a VIS (CDC, 2019ab). The VIS for MMR explains each disease, the schedule, an extensive list of who should not get the vaccine, and risk of a vaccine reaction, minor events, moderate events, AND “Severe events occur very rarely”: Deafness, Long-term seizures, coma, or lowered consciousness, brain damage.” Followed by: “What if there is a serious problem?” which includes information on reporting to the Vaccine Adverse Events Reporting System AND The National Vaccine Injury Compensation Program (CDC, 2019c, MMR). One can find the effectiveness of various vaccines, e.g. MMR: “About 3 out of 100 people who get two doses of MMR vaccine will get measles if exposed to the virus. However, they are more likely to have a milder illness, and are also less likely to spread the disease to other people. . . Two doses of MMR vaccine are 88% (range 31% to 95%) effective at preventing mumps. Mumps outbreaks can still occur in highly vaccinated U.S. communities, particularly in settings where people have close, prolonged contact, such as universities and close-knit communities. During an outbreak, public health authorities may recommend an additional dose of MMR for people who belong to groups at increased risk for mumps. An additional dose can help improve protection against mumps disease and related complications.” (CDC, 2019 e). So, what are we hiding?
I would love for vaccines to confer 100% protection and 0% serious adverse events; but I live in the real world where the benefits of vaccines exponentially outweigh their risks. Even a single child harmed by a vaccine is a tragedy; but until we can test who can and who can’t be vaccinated, the risks from the natural diseases far outweigh those from the vaccines. The vast majority of children would suffer the natural diseases if vaccines didn’t exist. If more and more parents decide to not vaccinate a child herd immunity disappears as we are seeing in current measles outbreaks.
Why does a child experiences an adverse reaction? The answer is they probably have a genetic predisposition and if exposed to the natural disease would have a high likelihood of the same reaction. What about additives in vaccines? Aluminum is the 3rd most abundant metal on the planet. It is in breast milk, the air we breath, water we drink, etc. Albumen is the protein in egg whites. Formaldehyde is a natural byproduct of our own body’s metabolism. All are in trace amounts in vaccines, much lower than the amounts we are exposed to on a daily basis.
What angers me most is Stone’s impugning the honesty and integrity of myself and others. I have spent over 40 years reading/learning immunology, microbiology, epidemiology, biostatistics, and the histories and current status of infectious diseases in the world. However, if valid research should find that any of the vaccines and/or components caused more harm than good, I wouldn’t hesitate to support changes. I’ve NEVER had a problem changing my position if strong valid evidence supports such a change. I am a mere mortal and recognize that I could be wrong as opposed to Stone who is absolutely certain he is right, despite lacking even the basics of any of the sciences and history underlying vaccines. A perfect example of the Dunning-Kruger Effect (Murphy, 2017).
References:
CDC (2019a Apr 5). Vaccine Information Statements. Available at: https://www.cdc.gov/vaccines/hcp/vis/index.html
CDC ((2019b Apr 5). Current VISs. Available at: https://www.cdc.gov/vaccines/hcp/vis/current-vis.html
CDC (2019c Apr 5). MMR (Measles, Mumps, & Rubella). Vaccine Information Statement. Available at: https://www.cdc.gov/vaccines/hcp/vis/vis-statements/mmr.html
CDC (2019d Jan 31). Vaccine Safety. Available at: https://www.cdc.gov/vaccinesafety/index.html
CDC (2019e Mar 28). Measles, Mumps, and Rubella (MMR) Vaccination: What Everyone Should Know. Available at: https://www.cdc.gov/vaccines/vpd/mmr/public/index.html
Harrison, JA (2018 Nov 9). Wrong About Polio: A Review of Suzanne Humphries, MD and Roman Bystrianyk’s “Dissolving Illusions” Part 1. Science-Based Medicine. Available at: https://n1s1t23sxna2acyes3x4cz0h-wpengine.netdna-ssl.com/wp-content/uploads/2018/11/Part-1-Joel-A.-Harrison-2018-Oct-28.-Wrong-About-Polio-A-Review-of-Suzanne-Humphries-MD-and-Roman-Bystrianyk-“Dissolving-Illusions”-long-version.pdf
Harrison JA (2019 Jul 1). Response to John Stone’s “I would not start from here (Stone, 2019 Jun 24). BMJ Rapid Responses. Available at: https://www.bmj.com/content/365/bmj.l2359/rr-23
Keorth-Baker M (2019 Jun 24). We Can Predict Where Measles Will Happen. Why Donʼt We? FiveThirtyEight. Available at: https://fivethirtyeight.com/features/we-can-predict-where-measles-will-happen-why-dont-we/
Murphy M (2017 Jan 24). The Dunning-Kruger Effect Shows Why Some People Think They’re Great Even When Their Work Is Terrible. Forbes. Available at: https://www.forbes.com/sites/markmurphy/2017/01/24/the-dunning-kruger-effect-shows-why-some-people-think-theyre-great-even-when-their-work-is-terrible/#5a8e3845d7c9
Sarkar S, Zlojutro A, Khan K, Gardner L. (2019 May 9). Measles resurgence in the USA: how international travel compounds vaccine resistance. Lancet Infectious Diseases. Available at: http://www.thelancet.com/retrieve/pii/S1473309919302312 [OR]
https://ksltv.com/wp-content/uploads/2019/05/PIIS1473309919302312.pdf
Skeptical Raptor (2019 Jun 25). Predicting US measles outbreak – vaccine uptake and international travel. Available at: https://www.skepticalraptor.com/skepticalraptorblog.php/predicting-us-measles-outbreak-locations-vaccines-travel/#more-13311
Stone J (2019 Jun 24). I would not start from here. BMJ Rapid Responses. Available at:
https://www.bmj.com/content/365/bmj.l2359/rr-21
Stone is just a blogger at Age of Autism. There is no reason to treat him as a peer in any way.
Fun tidbit: I know a doctor who once ended up charting “abdominal pain” in an adolescent with blue balls so bad that his mother had taken him to the emergency room. Because what else are you going to write?
“Abdominal pain” could cover anything from gas to labor, from appendicitis to Chron’s, from allergies to food poisoning. (There’s a lot of stuff in the average human abdomen, and a lot of ways for all of it to be painful.) To take a symptom that broad and arbitrarily decide that it’s “colitis/enteritis” feels at best lazy and at worst dishonest.
I tried to find out more about Carrie Madej’s plane crash, but there are conflicting reports from a variety of dubious websites and YouTube videos. The maverick trailblazing osteopathic vaccine muckraker* was apparently involved in a small plane crash near an airport in Woodbury, Georgia earlier this week, was injured and wound up in an ICU, or died, or maybe was admitted to an ICU after death (reports and timelines are confusing).
Naturally it’s being theorized that the plane was sabotaged, her being a holistic doctor and all, and Erin Elizabeth is on the case.
*Madej is noted for her objections to Covid-19 vaccination. When viewing a vial of the Moderna vaccine under a compound microscope, she reported seeing an “object or organism — I’m not sure what to call it — that had tentacles coming from it. And it was able to lift itself up…This isn’t supposed to be injected into human beings, especially children.” This explains a lot – I’ve had Moderna shots and in the weeks and months following have occasionally felt itchy, which…well, connect the dots. Let’s hope Dr. Carrie is well and back on the road exposing vaccine dangers real soon.
My search page yields several reports that she ” almost died”/ one death. It seems she was in Florida for a conference of health freedom advocates and her partner, a pilot with 20 years experience, crashed his small plane soon after takeoff. They are both in ICU: she has a broken leg ( needed surgery) and several broken vertebrae ( not in need of surgery) and he is in worse shape with neck and head injuries. She wrote up a little summary of the event so I guess she is awake and well enough despite her injuries.
In other news:
Dr Zelensky died today ( NN; Times of Israel). He was 49.
If I include an altie news source about real world events, I try to also find reliable sources.
FYI: Zelenko. Zelensky leads you down a whole different reason to doubt the future of humanity.
Sorry about that.
It’s doubly bad because I do actually know something about the structure/ meaning of Eastern European names.
“They are both in ICU”
Why? Waste of perfectly good beds. Slap some homeopathy on it, and a nice cup of char up the ass, and they’ll be good as gold by tomorrow. Or don’t they believe in the miracle healing power of their own damn products?
Ha ha!
But you see. alties want to have it both ways: their incredible natural medicine is pure, effective, without side effects** and not based on greed BUT
SBM is ONLY useful for emergency medicine.
Gary Null says this too because who can deny lifesaving surgery, re-attached limbs, stopping deadly bleeding, starting a stopped heart.
Alties claim that SBM fails at care for chronic conditions.
Madej needed surgery because two bones in her leg were broken and her foot pointed 120 degrees from normalcy. I think she’s a chiropractor: she can’t fix that!
Neither can herbs, vitamins or yoga. What they misunderstand is that some conditions can be managed with lifestyle changes whilst some need meds or surgery. Medicine is not neatly compartmentalised into emergency and chronic care but is based upon physiology and biochemistry that underlie both.
Alties also dismiss how much patients do not follow the best regimes because regimes are hard to keep up and that SB physicians recommend lifestyle changes often.
** or primary effects either
“Medicine is not neatly compartmentalised into emergency and chronic care but is based upon physiology and biochemistry that underlie both.”
QFT. You really should frame this.
The alties’ claim that acute medicine works but chronic medicine doesn’t, when both are built on the same thing, is such an blatant double-standard that we know altmed is a grift. (Their every accusation is a confession. SOP for abusers.) What they’re really admitting is they want to steal all those chronic patients for themselves, so they are the ones who profit from all that reliable repeat business for months and years to come.
And yes, several major chronic conditions nowadays are primarily self-inflicted; sedentary western culture being the unhealthy animal it is it is. But doctors can talk till they’re blue in the face about the importance of lifestyle changes for health, and many patients simply choose not to listen because they don’t want the inconvenience; and then demand a pill to magic away the entirely predictable, and predicted, consequence of their own bad decisions. Magic pills that altmed grifters, of course, will also be delighted to sell them at vast markup, along with the same damn lifestyle changes that said doctors couldn’t give away before. But as modern mainstream medicine drops the old paternalistic doctor-as-god rope, the shameless pretenders are only too happy to pick it up and productize that too, and their market falls over itself to buy it too, now it’s tarted to feed their egos.
Is it any surprise we now see altmed openly embracing authoritarianism? Sadly a lot of people today just want to be lied to, and are only too eager to pay real coin for it. Cowards all. But perhaps this reveals what altmed (and every other irrational belief system) is ultimately selling them: not an end to their diseases but an end to their fear.
What could be a greater Product to market to millions of frightened and insecure overgrown infants, lifelong repeat sales guaranteed? (Just ignore the side-effects; they’re a killer.)
Of course, it’s a common claim among quacks that science-based medicine is just fine for trauma and serious injuries. (After all, how could they claim otherwise when operating on fractures fixes them and surgery is often the only way to save someone from bleeding to death from a gunshot wound?) To them, SBM is just no good for everything else, particularly chronic illnesses like diabetes, hypertension, etc.
The paper is not an example of p-hacking. It does not use p-values and, despite what Susan Oliver and David Gorski keep parroting, they make no claims at all of statistical significance. So this critique is garbage.
Explained in full:
https://probabilityandlaw.blogspot.com/2022/06/response-to-susan-oliver-video.html
Silly. p-hacking doesn’t require that p-values be used as the test of statistical significance. That’s why the term preferred now is often “data dredging,” a term that I also used. it’s also utter bullshit to claim that they made no claims of statistical significance. If they weren’t, why on earth would they include 95% confidence intervals?
You should look at that silly blog he linked, it’s full of anti-vax nuttery and paranoia.
https://probabilityandlaw.blogspot.com/
Go back through their posts, it’s nothing but failures. They keep “publishing” papers that never get through peer-review.
True, it’s disturbing. The specific post linked to above seemed to me to have been written simply so the author could talk about Bayesian work while sprinkling anti Covid-19 crap along the way. But he also nit-picked on language, saying basically “Ha, it’s not p-hacking because there is no mention of a p-value”, while ignoring completely the real issues.
I guess if his only problem with your post is that it’s not, strictly speaking, p-hacking – then it’s all good…
Interesting comment: they say in the paper
What is that based on? If they are only looking at the point estimates then they can say that about their samples, but there is no way to determine whether the size difference is due to chance or something else. If they rest the statement on their confidence intervals then they are essentially using p-values, despite the denials by you and Norman Fenton (who is on record as “questioning” covid vaccine effectiveness and safety).
“Richard Querrey is a technology writer and webmasters.”
You need to stop thinking you know anything, and stop trying to bother the EU with false requests for records on COVID, you’re not a scientist.
“If the authors had been “p-hacking” they would have chosen a p-value like 0.05 and would have added, for each comparison of vaccine v placebo”
So you admit you don’t know what a CI is. Stay in your lane, which is NOT science.
[…] mRNA-based vaccines actually showed more serious adverse events than the placebo group. Of course as I discussed, it took p-hacking, cherry picking of data, and comparing apples and oranges to reach that […]
An incredibly disastrous political event of consequence for public health happened yesterday: the SCOTUS decision in West Virginia vs. EPA. On the surface, this merely further bakes-in the inevitability of accelerating climate catastrophes crescendoing toward social apocalypse. But that was pretty much the status quo anyway. Just underneath that though, is legal “reasoning” that, like the Dobbs decision on abortion, has far ranging implications. What the Court has done here is establish the “major questions doctrine” as precedent, which undermines the ability of ANY government agency to regulate ANYTHING absent specific direction from Congress. Right…included in that would be OSHA, the FDA, the FTC, the CDC… While media coverage of The Federalist Society’s policy program focused almost exclusively on it’s intent to overturn Roe, the broader top agenda point of the conservative legal movement — yes, heavily indebted to the funds provided by the Koch network — has been nothing less than the dismantling of “the administrative state,” returning business activity to unfettered laissez faire. That version of ‘Libertarianism’ has now been enshrined here in the US.
One major theme here at RI and over at SBM is the role scientific expertise should play in public policy, widening out to lament attacks on expertise generally — one reason why evocations of the (so-called) Dunning-Kruger effect are so resonant to this audience. As Charlie Savage points out in the NYT [https://is.gd/AZOFDs] social/economic groups began to rely on experts as a result of the complications accompanying the Industrial Revolution and related developments — urbanization, rapid technological advances, mass media, etc.
So ever there’s been a concerted campaign to get the experts off the backs of the businessfolk and their drive to maximize profits in the next quarter, and now, some 50 years down the pike they’re getting their wish.
It remains to be seen how far court-ordered de-regulation will go, and how exactly it will proceed. It’s clear the Federalist Society’s Six will rule for whatever outcome suits their ideology, and back-fill the legal ‘reasoning’ [aka gaslighting] after the fact. So any regulation the oligarchs find beneficial is no doubt safe. It will likely require a certain high measure of power, influence and cash to get a regulation overturned, in the form of developing and maintaining an exemplar case that can brought up through the lower courts until it finally gets to the SCOTUS — like Palin’s defamation suit against the NYT as a vehicle to (potentially) overturn Sullivan, or the praying football coach case used to unbalance the First Amendment view of religion. So it’s not like some random quack can undermine the FDA or FTC with a legal challenge unless they can find a coalition of very well-healed power-brokers with some parallel interest who would benefit from the precedent. I don’t expect we’ll see any big changes related to medical science anytime soon, though the lesson on recent events would seem to be “anything’s possible”, but I certainly wouldn’t expect the federal government to be able to be much of a factor if, say, we have another serious pandemic.
I’m betting an attack on the CDC by the activist judicial branch, next. October is going to be a scary month. I know who I’ll use as a template for my scary pumpkin this year.
I’m thinking that my post on SBM will be about what this means for the CDC Anna FDA.
But what about the other half of the FDA? The Blue Bell ice cream guy is still trying to dodge a trial (for knowingly releasing listeria contaminated ice cream to the public), and I bet other major food manufacturer CEOs would like to be able to change the law and avoid ending up like the peanut butter guy (salmonella, he’s in jail).
There’s a lot of money in Big Food, and there would be more if they could just ignore FDA and USDA and go back to the “Gilded Age” of feeding us all rotten crap full of arsenic and formaldehyde. And as soon as you say “agriculture” you’ve got a dozen politicians in your pocket.
This session of the Supreme Court has been the worst since Citizens United (worse than that really) and the best I can hope is that this is the nadir.
It’s not the nadir. This supermajority is just getting started.
In the past 2 weeks, I noticed that several governors are taking steps to limit the effects of the court’s decisions. A while ago, I speculated jokingly that the progressive parts might split off and become “Bi-coastia” – the NE and West Coast**.
Maybe it’s not such a joke but a good idea. We’d be very rich with great universities, commerce, fashionable cities and trendy restaurants.
** CA, OR, WA and NY, NJ, CT as abortion havens for a start
Bi-costia leaves Illinois as an enclave in the United States of Repression.
Can we expect airlifts of good California wine?
I only wrote it that way because it’s easy to envision on a map and the governors have acted to protect women’s rights ( as well as civil rights and LGBTQIA issues)
OF COURSE there are enclaves like Illinois and Colorado – I’m less sure about the others, like Michigan.
So we have the wine ( even NY does… although slightly) and the pizza.**
** my SO’s cousin visited from the Mountain West : she used to live here. She immediately requested pizza and chose two REALLY old timey ( but not in a good way) places. Obviously, she wasn’t aware of important developments in pizza over the past 40-50 years .
Much as I would like to say “shoot them all”, I’m pretty certain they’re just angling now for some grandstanding Berniebro to conveniently Reichstag Fire it for them; so best demolish these absolute fuckers at the ballot box come November or you can kiss worldwide democracy goodbye.
(Also, you really need to eject those Schumer and Pelosi dinosaurs who still think it’s 20th-century political business as usual, and bring up your Gang of Four and other young street brawlers who understand where it’s at. Ask the Polish cavalry how well elite 19th-century battle tactics worked 50 years too late—not only a waste of perfectly good infantry and infantry food, but a great PR coup for a mendacious machine that knew how to sell it. Because successful abuse isn’t nearly as much about abusers and their victims as it is about their enablers. And those are the ones who really need cut off if you’re going to break them, because our children’s future really is now on the line.)
“undermines the ability of ANY government agency to regulate ANYTHING absent specific direction from Congress.”
I have direct experience with this. However it is not in relation to medicine, pharma or anything like that. Many years ago as part of my job working for a certain megacorp, I frequently flew to Washington to meet with the regulator for our industry in regards to our US operations. There were also many public comment processes that we needed to respond to in writing.
It was very strange. Unlike every other country I had experience with the US regulatory process was almost entirely run by lawyers. Statutory direction to the regulator was very strict and was often crafted to limit their flexibility in addressing policy directions. All the lawyers were needed, by all sides, to interpret the laws passed by Congress and justify every regulation by strict adherence to the laws. Written submissions had to be crafted by lawyers because of the need for extensive footnotes to established laws and regulations and interpretations, whether straight-forward or forced.
There was little trust between Congress and regulators and the agency had to tread carefully to be sure they were on a solid legal footing.
In other countries the regulators are typically given far greater flexibility within the laws, including the ability to set policies and intervene in regulated companies’ affairs without requiring legislative action. Usually the government only intervenes when those actions are seriously contradictory to their political objectives. In parliamentary systems the government and the legislative body are almost always in accord so there is less friction.
Instead of lawyers, regulated companies needed people who knew people, and especially those with excellent political connections to get things done. I stayed out of those interactions whenever possible.
Which approach is better? I’m not sure. The US method of aligning government policy with the laws and industry regulation isn’t so bad. At least in my limited experience.
Take Michigan and you can get Ontario wine.
Michigan is odd. There are a lot of old-school Republicans who wouldn’t vote for a Democrat if their lives depended on it, yet they don’t support the MAGATs and RWNJs who are trying to make inroads in rural areas.
On the other hand, the number of homegrown “militias” keep rising. I don’t know if the state is saveable.
[Ontario ice wine is a particular favorite. Pairs well with strong cheese and dark chocolate.]
Michigan has long been a hotbed of right wing militia activity going back at least to the 1980s-1990s. So I don’t know if militias are the reason to judge Michigan too far gone. A better reason is that those old school Republicans have thrown in their lots with the MAGA crowd and gone all-in with Stop the Steal conspiracy theories and CRT/indoctrination nonsense.
I have a hard time reading Michigan on a local level.
My brother lives in a very red township. A coalition of people, mostly those who owned property but didn’t live in the township and those who didn’t even live in the township, came in breathing fire about how the township council was a bunch of socialistic traitors who wanted everyone to get high. Even though they’re all Republicans.
[The township voted to allow three marijuana companies to set up growing and processing facilities a few years ago. The people who live in the township don’t mind because JOBS.]
So they managed to get a recall vote on the ballot in May. And were soundly trounced — they only got about 25% of the vote. In a solidly Republican township. So maybe the locals simply don’t like carpetbaggers.
Brother says their next target is the school board.
Sorry this is getting way OT. I’ll stop.
Michigan is a very large state if you take into account that you can’t travel from one end to the other without detouring around some very large lakes.
There is, and always has been, a city/black-rural/white divide, and changes in rural America are felt rather intensely. Both the farms and the factories are going away.
Look up information about the republican candidate for our Sec. of State: she believes the presidential election was stolen, that demonic possession is real and can be spread by “intimate contact”, pushes the QANON line hard, thinks birth control should be banned — and you’ll get a good feel for how the republican side of the state looks.
Isn’t the believe the presidential elections are stolen mandatory for Republican candidates at this moment?
Renate said:
It seems to be here in MI, yes. We even have one guy running ads here in West Michigan attacking our governor, listing all the things he’ll fix, including re-opening Line 5 (an oil pipeline that runs under the straights of Mackinaw. It’s been in the news for a couple years because various groups want it shut down due to the obvious risk of a major oil leak in the Great Lakes). The kicker is that Line 5 is still operating — it’s never been shut down. I was eating in downtown Kalamazoo this weekend and a guy at the table next to me said he couldn’t believe our governor had shut down Line 5 without it making the news, but “that’s the liberal press for you”.
We are so screwed.
@ Idw56old:
You’re right.
Plus they’re working overtime to solidify their current positions via misinformation, voting restrictions and conservative laws/ courts as soon as they possibly can because
even their less-addled brained leaders can read the writing on the wall:
the country is becoming LESS white, less conservative and less religious.
Younger people are fine with ethnic diversity and LGBTQIA issues and aren’t thrilled with guns. They support Roe and other women’s rights issues.
They are more liberal than their parents and grandparents.
Of course, if righties can make these voters disgusted with politics or feel that they can’t do much to change the status quo, maybe more progressive youngsters and their like-minded older relatives will sit out elections.
[…] pflegte seine Schlussfolgerungen zu ziehen. DR. David Gorski sprach auch über Dr. Doshis Tricks hier. Beide Dr. Oliver und Gorski bemerkten, dass Dr. Doshi stellte sicher, dass die potenziellen […]
[…] seinen Schlussfolgerungen zu gelangen. Dr. David Gorski sprach auch über die Tricks von Dr. Doshi hier. Beide Dr. Oliver und Gorski stellten fest, dass Dr. Doshi bei der Bestimmung, „wie diese […]
[…] pour parvenir à ses conclusions. Le Dr David Gorski a également discuté des astuces du Dr Doshi ici. Les deux Drs. Oliver et Gorski ont remarqué qu’en déterminant «comment ces dommages sont […]
[…] Dr. Doshi used to reach his conclusions. Dr. David Gorski also discussed Dr. Doshi’s tricks here. Both Drs. Oliver and Gorski noted that by determining “how these harms are counted,” […]
[…] Dr. Doshi used to reach his conclusions. Dr. David Gorski also discussed Dr. Doshi’s tricks here. Both Drs. Oliver and Gorski noticed that in determining “how these harms are counted,” […]
“Had the trial started a few months later and ended in, for example, February 2021 or later, you can bet that the rates of hospitalization for COVID-19 would have been much higher in the placebo control group.”. If indeed this is true, doesn’t that also indicate an issue with the efficacy data as well? (One that appears in the real world with apparent seasonality? Otherwise and this may shock you – I’m inclined to agree with the analysis that the data categorization re adverse events seems sloppy as you describe. But also the CDC categorization seems so narrow as to not compile enough ‘coincidences’ to ring the bell.
[…] conclusion est provocante. Alors que certains ont critiqué l’étude pour avoir alimenté le sentiment «anti-vax», beaucoup […]
[…] you may have heard of a new study claiming the vaccines do more harm than good. This study is garbage. In fact, vaccines may have saved 31 million lives making them one of the most effective public […]
[…] conclusion is provocative. While some have criticised the study for fuelling ‘anti-vax’ sentiment, many have welcomed the independent scrutiny of the […]
[…] conclusie zet tot denken. Terwijl sommigen het onderzoek hebben bekritiseerd omdat het ‘anti-vax’-sentimenten zou aanwakkeren, hebben anderen dit onafhankelijke onderzoek […]
[…] een aparte blogpost aan wijden. Er zijn wel een aantal goede Engelse debunks van verschenen: van Orac (David Gorski), van HealthFeedBack, van Harriet Hall van Jonathan Howard en een video van Susan […]
[…] which already has been heavily criticized online because of methodological flaws, e.g. by David Gorski, Harriet Hall, and Jonathan Howard, who bluntly […]
[…] conclusie zet tot denken. Terwijl sommigen het onderzoek hebben bekritiseerd omdat het ‘anti-vax’-sentimenten zou aanwakkeren, hebben anderen dit onafhankelijke […]
[…] unzulässig. Andere Wissenschaftlerinnen und Wissenschaftler bezeichneten sie als "dubios", "völligen […]
[…] transmission’ reminds me of Peter Doshi’s obsession—shared by many antivaxxers—with the original clinical trials used to license the Pfizer and Moderna vaccines. How? This line of disinformation intentionally completely ignores what we have learned during the […]