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Location: Northern California
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I don't think I have ever witnessed sooner or later being on any "attack," but I do not spend a lot of time reading all of the threads and posts.
Many here have me beat by a large number in terms of posts. However I would surmise that few here have as much experience with the regulatory system overseen by FDA. And how it has evolved... Somewhere I have an xray of the former CEO of GE Healthcare who came down and got imaged on a prototype digital xray system. I remember wearing my film badge. I did some "student design work" on that system. I remember when regulatory requirements for SW development for medical equipment was quite simpler than it is today. Do you folks realize that a tongue depressor is a regulated medical device? Here is what the US CFR says about them: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.6230 In any case... "...the inaccuracy in the FDA/Pfizer's characterization of the risk." I think it is more likely FDA came up with their conclusion based on information, and Pfizer came up with their conclusion based on information. Their conclusions may have been related, different, identical, et cetera. If this is true, just because some different folks got something published and came to a different conclusion does not mean that either Pfizer or the FDA or both were "inaccurate." Disagreements happen. Mistakes happen. Products are recalled. Labeling changes. New types of safety risks are identified... "strength" of efficacy changes... All of these things are inherent in our systems. And lawyers make money. And folks benefit from new and improved drugs, vaccines, medical devices and medical equipment each and every hour of each and every day. Globally. And other folks do not benefit or are actually harmed. The world is not perfect... humans are part of that!
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Mike PCA Golden Gate Region Porsche Racing Club #4 BMWCCA NASA |
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06-29-2021, 03:54 PM
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Speaking of imperfection, I'll chalk it up to a little spillover from another arena ... Happens. Quote:
I'm listening. Last edited by pmax; 06-29-2021 at 04:19 PM.. |
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06-29-2021, 04:15 PM
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06-30-2021, 05:03 AM
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Back in the saddle again
Join Date: Oct 2001
Location: Central TX west of Houston
Posts: 55,778
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Steve '08 Boxster RS60 Spyder #0099/1960 - never named a car before, but this is Charlotte. '88 targa  SOLD 2004 - gone but not forgotten
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06-30-2021, 05:15 AM
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Back in the saddle again
Join Date: Oct 2001
Location: Central TX west of Houston
Posts: 55,778
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__________________
Steve '08 Boxster RS60 Spyder #0099/1960 - never named a car before, but this is Charlotte. '88 targa SOLD 2004 - gone but not forgotten
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06-30-2021, 05:23 AM
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Join Date: Apr 2002
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06-30-2021, 05:26 AM
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Posts: 15,530
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I linked your study. The study that questioned the methodology of that study that shows risks at half.of your study. And two other studies that showed no additional risk. Mahler also posted one of those 2 links. Here it is from post 136. Study about the study above https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00076-1/fulltext Here, we offer a different interpretation of their findings and statistical consideration of risks associated with mRNA and non-mRNA SARS-CoV-2 vaccines. |
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06-30-2021, 07:13 AM
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That's what I posted ! PIIS1473-3099(21)00076-1 
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06-30-2021, 05:32 PM
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My bad. I posted the wrong link.
Try this one. I have now corrected the original post. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184125/ |
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06-30-2021, 05:47 PM
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OK the article spells out two points of argument. First, given the vaccine consists of 2 doses, the Bell's palsy rate per dose is half that per patient aka recipient ... to which my response is well, that's a big fat duh. Comparing the expected rate per recipient (column 1) to the rate per dose (column 3) is a sleight of hand, apples to oranges so to speak, won't you agree ?  The second with regards to extending the time interval from 2 months to 12 weeks from the 1st dose, I will give them that but that doesn't change the conclusion that much namely there being an obvious causation signal here, just reduced to ~2.5 to 5x from 3.5-7x . BTW the placebo matches the expected cases the last time I looked. 
Last edited by pmax; 06-30-2021 at 06:55 PM.. |
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06-30-2021, 06:52 PM
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I am not saying that any are right or wrong. Some state higher risks while others state no higher risk.
As I said earlier, I would guess it is higher than non vaccinated folks. I would also guess it could be similar to cases in people that were infected. Also, the actual rate in a normal population is estimated in a wide range which can bring in more questions about actual increases in the closely tracked vaccines. That fact is mentioned in the Medpage article. There is far too much difference in the various studies to claim any are definitive. To me you must look at both sides. Rate vs non vaccinated and rate vs those that have been infected. Eventually, everyone would be infected without the vaccine. Here is the latest info on Bells palsy after infection. This is the first info I have found making a comparison. There may be others.. I would hope we see more. Also, the study below could under report actual vaccine cases due to the time frame. Released on 6/24/2021. More info at link. https://www.medpagetoday.com/infectiousdisease/covid19vaccine/93274 People with COVID-19 were more likely to develop Bell's palsy (peripheral facial nerve palsy) than people who were vaccinated against the virus, an analysis of medical records showed. Matching COVID-19 patients with vaccinated individuals showed that people with COVID-19 were nearly seven times more likely to have a diagnosis of Bell's palsy than those who were vaccinated (OR 6.8, P<0.001), reported Akina Tamaki, MD, of University Hospitals Cleveland Medical Center, and co-authors in a research letter in JAMA Otolaryngology-Head & Neck Surgery. When Pfizer-BioNTech and Moderna revealed adverse events in their trials, concerns about Bell's palsy and the vaccines grew, observed C. W. David Chang, MD, of the University of Missouri in Columbia, writing in an invited commentary accompanying the two papers. "Epidemiologically, linking the vaccine with an adverse event requires accurate estimation of event incidence in association with the vaccine, comparison with a nonvaccinated group, and understanding of the background incidence," he explained. Historical background rates for safety surveillance offer some context, but come with caveats, Chang added: Many publications cite an incidence of 11.0 to 51.9 per 100,000 person-years, but these rates can vary widely. "Further confounding background rates, the COVID-19 pandemic itself has been theorized to affect the incidence of Bell palsy, with mixed findings," he noted. Tamaki and co-authors searched a large database of records from 41 healthcare organizations from Jan. 1 to Dec. 31, 2020, to determine the rates of Bell's palsy in patients with a COVID-19 diagnosis. Of 348,088 people with COVID-19, 284 had a Bell's palsy diagnosis within 8 weeks of COVID diagnosis, including 153 people with new-onset Bell's palsy. "The authors translate this to an 8-week incidence of 82 per 100,000 patients with COVID-19," Chang said. "However, if using a crude analysis and assuming a pre-pandemic rate of 40 per 100,000 person-years and no seasonality, Bell's palsy would be expected to naturally occur in only 21 of 348,088 patients during an 8-week period." A comparison of patients with 63,551 matched individuals who were vaccinated from Jan. 1 to March 31, 2021, showed that the incidence of Bell's palsy was lower among people who received COVID-19 vaccines. In the second paper, Shemer and colleagues evaluated the COVID vaccination and facial nerve palsy risk in a case-control study. Israel is a leading country in vaccination rates per capita, exclusively using the Pfizer-BioNTech vaccine. All residents are part of the national digital health registry system. From Jan. 1 to Feb. 28, 2021, a total of 37 people were admitted to the emergency department of a tertiary referral center in central Israel. Of these, 21 people (56.8%) had received the vaccine. The researchers compared these people with a group of 74 matched controls and found no difference in vaccination rates (59.5%; adjusted OR 0.84, 95% CI 0.37-1.90, P=0.67). An analysis of the number of patients with acute-onset facial nerve palsy during January and February in the preceding 5 years showed that the volume was about the same, with an average of 26.8 cases from 2015 to 2020. This figure may have been biased by unmeasured factors such as referral patterns, Shemer and co-authors noted. The mRNA COVID-19 vaccines also showed no higher safety signal for facial paralysis than other vaccines in VigiBase, the World Health Organization pharmacovigilance database, earlier this year. Underreporting may be a factor in both JAMA Otolaryngology-Head & Neck Surgery studies, Chang noted, explaining that adverse effects of COVID vaccines were studied for only a short period; some patients would not have had 8 weeks of observation after vaccination. Last Updated June 25, 2021 |
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06-30-2021, 07:29 PM
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I'll give you an analogy.
It's generally agreed that cigarette smoking increases the risk of lung cancer. How about we compare the incidence of lung cancer per cigarette over 10 years versus the rate per person in the population over the same 10 years ? That would be asinine, wouldn't it ? But it's the same line of "reasoning" that rebuttal paper takes. |
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06-30-2021, 08:06 PM
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Black Label
