Claim: adverse reactions in Covid vaccine trials are not being recorded

[Rory]

I'm looking for a solution to the liability issue.

Do you mean an explanation of how liability works?

From what I've read it probably varies from trial to trial. To know what Pfizer offered/required we'd have to see one of their consent forms.

My guess - based on reading about other trials - is that they would be liable if they had done something wrong but probably, outside of providing basic treatment in the immediate event, they don't need to do anything.

This is from an FAQ talking about Covid-19 vaccine trials:

If you feel sick, you should immediately get in touch with our staff to schedule an illness visit. Our medical staff will provide you with care and collect biomedical samples. If you require further care, we will direct you to the appropriate medical facility.

https://clinicalresearchassociates.com/frequently-asked-questions/

Also:

When a 54-year-old civil engineer broke out in a severe rash while in a clinical trial for a brain tumor treatment, Morris Groves, MD, JD, who was leading the trial [...] admitted the patient to the hospital, gave him steroids, and stopped the experimental drug. The man's insurance company paid for his care, and he recovered. This scenario is what researchers hope for if a study participant becomes ill as a result of an experimental intervention.

https://journals.lww.com/neurotoday...Trial_Liability__What_If_a_Patient_is.13.aspx

And:

Federal law recommends, but does not require, that consent forms spell out whether a patient will be compensated if injured as a result of a trial. (See "Federal Consent Guidelines.")

https://journals.lww.com/neurotoday...Trial_Liability__What_If_a_Patient_is.13.aspx

To be honest, I did some drug studies when I lived in New York in my early-twenties - as an illegal alien! - and I know I didn't read the consent form, didn't think for one second that something might go wrong, and had no idea about healthcare. All I thought about was the nice bed, the unlimited sorbets, and the check at the end of it. I'm sure there are still people like that today.

 

[econ41]

totally agree. but i'm going to assume clinical trials (esp this big) do cover that up front. the patient can release a copy of what they signed to us if this is not the case. now.. whether the patient actually understands what they are reading is another issue. but in U.S i bet the courts would side with the manufacturer in that case unless the language was excessively ambiguous.

Agreed all points. ESp "...whether the patient actually understands..." which is that foggy situation I hinted at when Isaid " informed consent >>a topic of some complexity for possible discussion at another time." It is a can of worms.

now, for people in the UK.. with National Health, i dont know. my above link says

Article:

Federal law also does not require states to cover routine patient care costs in clinical trials through their Medicaid plans.

Source: https://www.cancer.gov/about-cancer/treatment/clinical-trials/paying/insurance

medicaid is like our "national health" for poor people.

Yes, understood. There is wide diversity between countries. In AU Govt coverage of medical costs is Federal, not state - only 25million population. And a different approach to Fed/State relations to USA. Also AU has a "two tier" arrangement - basic Government coverage plus optional private insurance on top. I'm not sure If I would be covered for trials. Haven't checked and the issue has never arisen.

 

[econ41]

Do you mean an explanation of how liability works?

No - I comprehend the generic legal principles. My concern is about what specifically applies to the case under discussion. Was it:

a) Liability was accepted upfront by one side or the other >> then does the claim align with that pre-determined allocation of liability.
OR
b) Was liability NOT pre-defined or agreed >> then it should have been but that doesn't help sort out this instance.

AND - I'm betting it is very much as you describe:

.... and I know I didn't read the consent form, didn't think for one second that something might go wrong, and had no idea about healthcare. All I thought about was the nice bed, the unlimited sorbets, and the check at the end of it. I'm sure there are still people like that today.

AKA sort of a "caveat emptor" situation.

Hence my several references to "informed consent" which often isn't as "informed" as it should've because people rush to sign the paper and get things moving.

 

[Rory]

Gotcha.

Is there a relationship between the issue of liability and the claim of the thread though? Or are we going in a new direction?

 

[econ41]

Gotcha.

Is there a relationship between the issue of liability and the claim of the thread though? Or are we going in a new direction?

Your thread so mostly your call. But the topic is essentially a claim about "damages" from the side effects illness. i.e. meeting of medical costs and any associated tortious claims. The specific issue of "failure to report" as part of the trial MAY be a red herring. It depends on the status of the contract. The medical condition and associated compensation is a valid concern but at this stage we do not know where it should be addressed. i.e. within the contract for participation in that trial OR has it already been explicitly identified as outside the scope of trial management. Does it explicitly belong a different context? So we cannot discuss the claim without knowing where it fits in the agreement between the parties. And if it does not belong in trial management the non-reporting in detail will be perfectly valid.

 

[deirdre]

But the topic is essentially a claim about "damages" from the side effects illness. i.e. meeting of medical costs and any associated tortious claims.

the OP topic, if you read the full link he originally quoted is mostly about them wanting to be sure the FDA has the numbers of long term adverse effects so they can weight that into the "safety" determination of the vaccines.

which also maybe Rory can make a chart of each claimant he knows of and what the pool was. Because IS it a safety issue really? and how does it relate to long-haul covid [funky "abnormal" immune system responses] numbers (which is alot of the same type symptoms and seriously buggers people financially and emotionally as well)

Like Dressen was the astra zeneca trial which was something like 20,000 people who received the vaccine. so we know of 1 case in 20,000.
Maddie was i think Pfizer. how big was that trial? so her case would be 1 in x number.

the uk woman in the other thread was not in a trial , she was general population of vaccinated.

 

[Rory]

Your thread so mostly your call. But the topic is essentially a claim about "damages" from the side effects illness. i.e. meeting of medical costs and any associated tortious claims.

Yeah, it's about whether some people who had adverse effects were included in the data - now expanded to whether their effects were "underreported" (eg, "in a wheelchair and feeding through a tube" recorded as "functional abdominal pain"*).

Financial aspects I guess are part of some other conversation really, but I suppose interesting to know.

Maddie was i think Pfizer. how big was that trial?

2,260 12-15 year-olds

(*As Deirdre pointed out earlier, Pfizer were only reporting AEs up to 30 days after the trial, so it's very possible that adverse reactions that came later were legitimately ommitted.)

 

[Rory]

Report in the British Medical Journal about a 'whistleblower' who worked at a site testing Pfizer's vaccine and who listed a dozen concerns including:

• Participants placed in a hallway after injection and not being monitored by clinical staff
• Lack of timely follow-up of patients who experienced adverse events
• Protocol deviations not being reported
• Vaccines not being stored at proper temperatures
• Mislabelled laboratory specimens, and
• Targeting of Ventavia staff for reporting these types of problems.

A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer's pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Two [other] former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Both confirmed broad aspects of Jackson's complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a "helter skelter" work environment as with Ventavia on Pfizer's trial.

https://www.bmj.com/company/the-story-of-bmj-2/

 

[econ41]

Because IS it a safety issue really? and how does it relate to long-haul covid [funky "abnormal" immune system responses] numbers (which is alot of the same type symptoms and seriously buggers people financially and emotionally as well)

Those are the two real questions about safety rather than compensation and blame for a couple of exceptional cases. And whether or not it is a safety issue is a matter of risk probabilities related to the potential user population. Far too many of these discussions treat "safety" or "good enough" as yes<>no binary matters. "Yes - there has been a death - ban the medication" is the style of the common error of logic. Arguably the foundation error of much anti-vax propaganda. The wrong frame for the logic.

I forget the actual numbers but when I was scheduled - age priority - for Astra-zeneca the news broke about a couple of blood clot issues. In I think a couple of million usages. I didn't hesitate the protection offered still far outweighed the addition of the newly "discovered" risk. Not all people think so objectively and blood clots seemed to cause a significant slow down in Australian vaccinations. But the core issue on the probabilities - "How much do one or two exceptions shift the risk?" "Does the risk become unacceptable?"

Then - separate issue - the evidence being presented seems to indicate some cover-ups may be occurring. This raises two issues:

First - is it plausible, if there are "cover-ups", that the number of cases concealed would, if accounted for, significantly change the risk profile for the vaccine. And, if it is one or two cases in millions it probably won't. If it is one or two cases in a few thousand - it would need a more thorough assessment.

BUT base the decision on valid probability-based risk assessment NOT the emotion of a couple of individual scenarios. One whistle blower, one proven example is a possible warning sign. Not proof of guilt.

Second: If there is sufficient indication of deliberate cover-up then formal investigation is warranted. AND it is totally distinct from questions of vaccine efficacy or safety.

 

[Cryptic]

Even Reuters saying WTF

https://www.reuters.com/legal/gover...ss-foia-request-over-vaccine-data-2021-11-18/

 

[Rory]

Well, a Reuters commentator:

But, yeah, that story certainly raised a few eyebrows.

 

[Mendel]

The agency this week told a court that it had found about 329,000 pages of responsive information, but that it would like to release just 500 pages each month — giving it until 2076 to complete the request. The FDA took just more than 10 weeks, by contrast, to review the data before it approved the vaccine. Source: https://www.msn.com/en-us/news/us/critics-outraged-by-fda-request-to-hide-pfizer-vaccine-data-for-55-years/ar-AAQUufd?ocid=msedgntp

Article:

The Phase 3 clinical trial was designed to determine if the Pfizer-BioNTech COVID-19 vaccine is safe and effective in preventing COVID-19 disease. This trial began July 27, 2020, and completed enrollment of 46,331 participants in January 2021.

Source: https://www.pfizer.com/science/coronavirus/vaccine/about-our-landmark-trial

They have about 7 pages per participant, most of these probably include some kind of personal data which needs to be anonymized before being published. The FDA wouldn't need to review all of that in detail for the EUA; for example, they wouldn't check 46000 consent forms, or verify the age for each participant; if that was my job, I'd do spot checks. But to anonymize the pages, you have to go through and edit each one, which takes a lot more time.

Article:

The FDA proposes releasing 500 pages per month on a rolling basis, noting that the branch that would handle the review has only 10 employees and is currently processing about 400 other FOIA requests.

Source: https://www.reuters.com/legal/government/wait-what-fda-wants-55-years-process-foia-request-over-vaccine-data-2021-11-18/

The question the trial is going to answer is whether some people can force the government to spend more money to respond to this kind of request; or if these people should ask for a smaller, more specific set of documents to receive a timely answer.

If the court decides in favor of the plaintiffs, I expect future legislation to either limit the scope of FOIA disclosure for these studies, or limit the amount of information that needs to be submitted.

----

CICP covers Covid vaccine trial damages if you can prove the connection.

Generally speaking, insurance companies like vaccines bevause it lowers their costs, so in countries with a well-regulated health insurance, it covers trials because it encourages people to participate in them.

 

[deirdre]

The FDA wouldn't need to review all of that in detail for the EUA; for example, they wouldn't check 46000 consent forms,

i highly doubt the FOIA request included consent forms. you are trying too hard unnecessarily.

you could have just quoted the DOJ lawyer's response

Article:

The records must be reviewed to redact "confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials," wrote DOJ lawyers in a joint status report filed Monday.
.

Source: https://www.reuters.com/legal/government/wait-what-fda-wants-55-years-process-foia-request-over-vaccine-data-2021-11-18/

If the court decides in favor of the plaintiffs, I expect future legislation to either limit the scope of FOIA disclosure for these studies, or limit the amount of information that needs to be submitted.

No. I doubt anything will be done because it's been decades and noone bothered to do this before. But IF anything changes, my guess is that government agencies and/or clinical trials etc will be mandated to keep irrelevant information and "trade secrets" separate from patient safety result information. You know.. common sense changes, not transparency changes.

 

[Mendel]

i highly doubt the FOIA request included consent forms. you are trying too hard unnecessarily.

These CT FOIAs are often formulated in broad terms, i.e. something like "any and all documents pertaining to the FDA authorization process for the Pfizer vaccine". There's no way that a request generates over 300.000 pages unless there are patient-specific pages in there.

The records must be reviewed to redact "confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,"

Aka patient data.

 

[deirdre]

your Reuters link has the document ie. Complaint, which says specifically what they asked for :

Article:

ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e)[see footnote 5] with the exception of publicly available reports on the Vaccine Adverse Events Reporting System. 6 " (the "FOIA Request").

....
footnote 5: 5 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be made available for immediate disclosure absent extraordinary circumstances: "(1) All safety and effectiveness data and information. (2) A protocol for a test or study . . . . (3) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information . . . . (4) A list of all active ingredients and any inactive ingredients . . . . (5) An assay method or other analytical method . . . . (6) All correspondence and written summaries of oral discussions relating to the biological product file . . . . (7) All records showing the manufacturer's testing of a particular lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA]."

Source: 6. PHMPT therefore issued a request to the FDA pursuant to the Freedom of Information Act (5 U.S.C. § 552, as amended) (“FOIA”) for “[a

source fix: https://fingfx.thomsonreuters.com/gfx/legaldocs/klvykdlryvg/vaccine foia complaint.pdf

which is this (see section e):
https://www.law.cornell.edu/cfr/text/21/601.51

 

[Mendel]

yeah, I expect the bulk of the pages is going to be this

Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information,

(7) All records showing the manufacturer's testing of a particular lot, after deletion of data or information that would show the volume of the drug produced, manufacturing procedures and controls, yield from raw materials, costs, or other material falling within § 20.61 of this chapter.

They have a huge number of consumer reports, and a huge number of quality control reports, I expect.

 

[Rory]

Interesting to read that

Scientists believe they have found "the trigger" that leads to extremely rare blood clots after the Oxford-AstraZeneca Covid vaccine.

https://www.bbc.com/news/health-59418123

Seems like it's something to do with the chimpanzee adenovirus they use. In summary:

Interesting that point 2 seems to indicate that the issue is caused/compounded by the vaccine entering into the bloodstream. Perhaps it may turn out that the lack of aspiration, as some have been suggesting for months, really is to do with the problems people have experienced.

So not quite as safe as AstraZeneca assured us. But, as they're keen to stress, probably better than catching Covid.

 

[Mendel]

So not quite as safe as AstraZeneca assured us.

Are you sure? Because these blood clot issues are still very rare.

 

[FatPhil]

Are you sure? Because these blood clot issues are still very rare.

Indeed, and in terms of error bars, these cases may even reduce the upper end of the confidence interval.
Their initial not-very-sure assurance could have been 0-4 arbitrary badness units, and now they have more data it might be 1-3.
Looking at it another way - were they really "assurances" when the drug was new? As one old teacher used to say: "everything has error bars - even pi, historically" (doesn't need debunking, it's just an aphorism, a handy warning that I notice a lot of people don't seem to grasp).

 

[Rory]

Are you sure? Because these blood clot issues are still very rare.

Going by their reports quoted in posts 2 and 10.

 

[Mendel]

Conclusion: AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest;

That's still valid.

Going by their reports quoted in posts 2 and 10.

The language in the #10 quotes is "showed no evidence" or "found no increased risk", which technically doesn't say there isn't any, just that it's hard to find: like Bigfoot, we don't know if it's really rare or if it doesn't exist, until we find it. It's still safe to go hiking, though, because we know that even if Bigfoot exists, we're more likely to get hit by a falling branch than to meet the guy.

I haven't looked at the studies that "found no evidence", but what sometimes happens is that you can see some small effect, but you're not sure if it's just random sampling error: that's when the effect doesn't pass the significance test. That's kind of like the fuzzy bigfoot picture that could be Bigfoot or just a strangely shaped bush: you can't really say "we found evidence for bigfoot". You're still in that gray area where you know nothing except that it's very rare if it exists. And at that point, it comes down to the error you'd rather risk committing.

 

[Rory]

#2 in full:

Conclusion: AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group.

And #10:

A careful review of all available safety data of more than 17 million people [...] has shown no evidence of an increased risk.

 

[Mendel]

#2 in full:

119 serious adverse events occurred among 101 participants (0.5%) in the AZD1222 group and 59 events among 53 participants (0.5%) in the placebo group.

There were 20,000 people in the treatment group, and the thrombosis risk was so low it didn't show up.

And #10:

A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country.
So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of 8 March.

The incidence was 37/17 million = 0.2 per 100 000, and it randomly differed downward from the expected average, possibly because thrombosis in older people wasn't thought to be linked to the vaccine, and not all events had been reported.

Article:

So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination.

The Committee carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of 22 March 2021, 18 of which were fatal.

As of 4 April 2021, a total of 169 cases of CVST and 53 cases of splanchnic vein thrombosis were reported to EudraVigilance. Around 34 million people had been vaccinated in the EEA and UK by this date

Source: https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood

(62+24)/17 million = 0.5 per 100 000
(169+53)/34 million= 0.65 per 100 000
The number is likely rising because old people got vaccinated first.

In June, with more people vaccinated, Australia saw higher numbers, possibly because their thrombosis surveillance is better (they detected more mild cases). Or maybe Australians are just more susceptible to it.

Article:

Based on available international data at that time, the estimated risk of TTS was 4-6 per million cases following a first dose of COVID-19 Vaccine AstraZeneca.

From early April to 16 June 2021, 60 cases of confirmed or probable TTS have been reported in Australia. This includes an additional seven cases reported in the past week in people between 50-59 years, increasing the rate in this age group from 1.9 to 2.7 per 100,000 AstraZeneca vaccine doses. The revised estimates of risk associated with first doses of COVID-19 Vaccine AstraZeneca are listed in the table below.

Age​	Estimated risk of TTS per 100,000 AstraZeneca vaccine doses (first dose)​
<50 years	3.1
50-59 years	2.7
60-69 years	1.4
70-79 years	1.8
80+ years	1.9

TTS is a serious condition in a proportion of individuals who develop it. The overall case fatality rate in Australia (3%; 2 deaths among 60 cases) is lower than has been reported internationally. This is likely to reflect increased detection due to heightened awareness, as well as early diagnosis and treatment.

Source: https://www.health.gov.au/news/atagi-statement-on-revised-recommendations-on-the-use-of-covid-19-vaccine-astrazeneca-17-june-2021

BBC now:

Article:

These clots, known as vaccine-induced immune thrombotic thrombocytopenia, have been linked to 73 deaths out of nearly 50 million doses of AstraZeneca given in the UK.

Source: https://www.bbc.com/news/health-59418123

That amounts to 0.15 deaths per 100 000.
For comparison, the unvaccinated Covid case fatality rate for people under 40 is ~0.2% = 200 deaths per 100 000. (With a 7-day incidence of 50 per 100 000, the vaccine risk is offset in two weeks.)

If you have a choice between 2 vaccines with an otherwise similar safety profile, you obviously choose the one that doesn't have that thrombosis risk.

But compared to the incidence rates we've seen in Europe, the harm the AZ vaccine causes is still less than the harm it protects you from.

Australia has had fewer cases overall, and Covid is less severe in younger people, so for Australia with low incidence, AZ vaccine risk can actually balance with Covid risk, but if they get a big wave again, AZ would still have benefits.

So in most situations, the AZ vaccine is still safe (as in: clearly better than no vaccination), it's just worse than the mRNA vaccines, which are recommended instead.

 

[Rory]

Yes, but remember what I wrote?

So not quite as safe as AstraZeneca assured us.

What if I replaced the word "assured" with "told"?

 

[Mendel]

What if I replaced the word "assured" with "told"?

That doesn't change what they actually said.

"We found no evidence of Bigfoot" is different from "there is no Bigfoot".

 

[Rory]

I mean, we can agree to disagree on this, that's fine. But I think you're chasing red herrings by persisting in saying that "safe" equates to "it's better than no vaccination".

"Safe" to me means "it doesn't cause serious adverse effects". That a vaccine is better than no vaccine isn't argued, nor is it the issue. The issue is whether it causes SAEs or not.

In the beginning, AZ said it didn't; now they're saying it does. That's all I was saying when I wrote:

So not quite as safe as AstraZeneca assured us.

 

[Mendel]

"Safe" to me means "it doesn't cause serious adverse effects". That a vaccine is better than no vaccine isn't argued, nor is it the issue. The issue is whether it causes SAEs or not.

In the beginning, AZ said it didn't; now they're saying it does. That's all I was saying when I wrote:

Yes. In my opinion, AZ never said that; what they said is that they hadn't found any.

 

[econ41]

I mean, we can agree to disagree on this, that's fine. But I think you're chasing red herrings by persisting in saying that "safe" equates to "it's better than no vaccination".

"Safe" to me means "it doesn't cause serious adverse effects". That a vaccine is better than no vaccine isn't argued, nor is it the issue. The issue is whether it causes SAEs or not.

Therein is one of the fundamental problems in these COVID or similar epidemiological debates. The assumption that the situation has binary outcomes. "True or False" "Safe or Not Safe".

The whole topic is probability-based. The criterion is not "is it safe" it should be "is it safe enough". And the topic is not just about one aspect of probability. It is several and they're conflicting and interacting in various layers. Decisions are inherently a matter of risk management and selecting the best bets.

Probably the two most significant probability factors are:
(a) The over-riding position that the benefits far outweigh the downside risks.
(b) The downside risks which are typically order\s of magnitude lower than the
benefits.

So taking the AZ blood clots issue. It was not identified in the trials process but emerged once full-scale vaccination programs were underway.
In my case at age 70+ I was eligible for age-based priority under the Australian Federal program. My wife and I were scheduled for vax at the time the blood clot risk was discovered. With a couple of AU cases. We didn't hesitate - a chance of the order on one in a million is not much different than zero chance though that factor did seem to cause many older Aussies to hesitate.

In the beginning, AZ said it didn't; now they're saying it does. That's all I was saying when I wrote:

Both could be true if the argument is assumed to be "binary" - with no-one defining "safe enough". Most anti-vax "argument" relies on presumption of "binary" OR making the wrong choice for those who do recognise "probabilty" based.-

 

[Mendel]

The criterion is not "is it safe" it should be "is it safe enough".

Sure. Let's say I ask the question "will it put me in a wheelchair or kill me?"

"No" = safe

Rory's definition of "safe" is pretty radical, though I expect it is shared by many.

However, if we're evaluating what AZ means when they say that their vaccine is safe, we ought to use their definition (unless it is uncommon and misleading).

And that probably means not taking "safe" as an absolute, but considering "safe" in the context of feasible alternatives (e.g. remaining unvaccinated).

"Safe" is often not absolute, but relative: when we hear "safe", we need to ask, "compared to what?"

 

[econ41]

"Safe" is often not absolute, but relative: when we hear "safe", we need to ask, "compared to what?"

Which is nearly the same point I am making about "Binary" expectations on a system that is determined by probabilities.

Rory's definition of "safe" is pretty radical, though I expect it is shared by many.

It is implicitly a "global" expectation of absolute guarantees of perfection - the implied assumption that "safe" means there will NEVER be a single example of "not safe". Wrong paradigm. Wrong frame of reference.

And that probably means not taking "safe" as an absolute, but considering "safe" in the context of feasible alternatives (e.g. remaining unvaccinated).

Which is not the same emphasis I made in my comment but an equally important issue in the overall selection of risk-managed options or alternatives.

 

[Rory]

I can see where you guys are coming from but I don't think it quite applies in this case.

After the trials they observed that SAEs amongst the study group were the same as the placebo group and they concluded it was "safe" (which is fair enough).

After others had suggested there were issues to do with clotting they looked at the data from 17 million people and found "no evidence of increased risk". Presumably, they stayed with "it's still safe".

Now they have realised that there is an increased risk and are saying "it's safer than not having a vaccine" but presumably acknowledge "it's not quite as safe as we thought it was".

Note: "less safe" = non-binary. "Safe in the beginning and still safe now because it's not guaranteed dangerous" = binary.

I can understand why people go with the line of "it's safer than no vaccine" but to me that's a red herring and not answering the right question. I'm sure we can think of many things that are safer than other things but that aren't necessarily safe in and of themselves.

Also, Thalidomide was a drug that was initially thought to be safe in pregnancy and it was later discovered that it wasn't. Point being: issues that aren't spotted in the beginning are sometimes spotted later on, and definitions of safety change accordingly.

Rory's definition of "safe" is pretty radical

If we go with the top definition from the top dictionary (the OED) safe is defined as: "Free from hurt or damage; unharmed."

So not so radical really.

One final analogy to illustrate the point: imagine a building in a town and everyone in the town has always been told it's over 300 feet tall. It's by far the tallest building in the town but one day someone measures it accurately and finds it's only 296 feet tall. They tell everyone "it's not as tall as we were told" but others say "are you sure? Cos it's still the tallest building in the town."

Whether it's the tallest or not isn't the question. All he's saying is "it's not as tall as they said it was."

 

[Mendel]

Thalidomide was a drug

Its scandalous history notwithstanding, Thalidomide is a drug you can currently use. "It was approved for use as a treatment for cancer in the United States in 1998. It is on the World Health Organization's List of Essential Medicines. It is available as a generic medication." (Wikipedia)
Is it safe or not?

It might also be worth to mention that, as far as I can tell, just about 100% of Thalidomide (early?) pregnancies had "severe adverse effects" (with a 40% death rate) in an era with lax pharma control, which in no way compares to AZ blood clotting and today's oversight.

One final analogy to illustrate the point: imagine a building in a town and everyone in the town has always been told it's over 300 feet tall. It's by far the tallest building in the town but one day someone measures it accurately and finds it's only 296 feet tall. They tell everyone "it's not as tall as we were told" but others say "are you sure? Cos it's still the tallest building in the town."

Whether it's the tallest or not isn't the question. All he's saying is "it's not as tall as they said it was."

Yeah, but that analogy would only be true if the claim of safety by AZ would involve a lack of side effects, when it only involves a lack of evidence for them. And your BBC link showed that the mechanism for this side effect was previously unknown.

A proper analogy would be AZ saying "this is the tallest tower because it's approximately 300 ft tall", and then when you measure it more exactly and it's 296 ft, the conclusion doesn't change, except that we now have two other towers that are 298 ft tall, so everyone frequents them now.

There is no medication that is 100% free from harm that is also effective. Even sugar pills can give you diabetes and rot your teeth. I don't think there is anything in life that is 100% safe to your standard of "no hurt" except in retrospect.

 

[deirdre]

Even sugar pills can give you diabetes and rot your teeth.

thanks for the laugh.

 

[Rory]

Indeed. Citation required.

It might also be worth to mention that, as far as I can tell, just about 100% of Thalidomide (early?) pregnancies had "severe adverse effects" (with a 40% death rate) in an era with lax pharma control, which in no way compares to AZ blood clotting and today's oversight.

I wondered if you'd take the example of "something that was thought safe and was later discovered to be less safe" too literally. Perhaps I should have used Clobutinol instead.

I don't think there is anything in life that is 100% safe to your standard of "no hurt" except in retrospect.

As above, it's not my standard, it's the dictionary definition (OED, Collins, etc). Though you will find definitions along the lines of "unlikely to be harmed" too, which will help your side of the argument.

A proper analogy would be AZ saying "this is the tallest tower because it's approximately 300 ft tall", and then when you measure it more exactly and it's 296 ft, the conclusion doesn't change, except that we now have two other towers that are 298 ft tall, so everyone frequents them now.

You can't butcher my excellent analogy with a terrible analogy and then call it "a proper analogy".

Yes. In my opinion, AZ never said that [they've discovered it's not quite as safe as they initially believed]; what they said is that they hadn't found any [serious adverse effects].

You seem to be in denial that AstraZeneca have said it's less safe than they initially believed. But in their own very carefully considered words:

"[This] research further advances our knowledge about the potential mechanisms underlying the extremely rare condition. AstraZeneca is exploring ways to leverage these findings as part of our efforts to remove this extremely rare side effect."

https://www.washingtonpost.com/world/2021/12/02/scientists-trigger-blood-clots-astrazeneca-vaccine/

So very clearly - if seemingly reluctantly - they have accepted the existence of a serious side effect that they weren't previously aware of.

 

[econ41]

I can see where you guys are coming from but I don't think it quite applies in this case.

Good step. Recognise that the paradigm is relative, probabilistic, not binary. Then define which paradigm your case is if it is "binary". Or not.

So applying the wrong paradigm is inappropriate - no matter who does it. And calling something "safe" >> implying"absolutely 100% guaranteed" when it is not can lead to misunderstanding whatever the benefit in persuasion or "marketing".

My own preference is to simply not use the ambiguous term in situations where the ambiguity of meaning can cause misunderstanding. Especially when the debate is of a topic affected by conspiracy theories and the use of the term can be deliberate misleading mendacity.

So simply define what you mean. Avoid using the ambiguous word unless you explicitly identify the meaning you intend. Cumbersome it may be but whilst ever the word is used ambiguously some party is likely to cause confusion whether through unclear understanding or deliberate mendacity.

I can understand why people go with the line of "it's safer than no vaccine" but to me that's a red herring and not answering the right question. I'm sure we can think of many things that are safer than other things but that aren't necessarily safe in and of themselves.

"safer than other things" is relative. >> the appropriate paradigm. BUT "aren't necessarily safe" reverts to the other paradigm which is not appropriate. Do you want to mislead? Or do you want to be clear and rigorous in an argument? Then try either the negative weighted version "but are not guaranteed 100% safe" - OR the more positive slant "but are still safe enough for use with the low level of risk involved". (And I'm not saying any of those are"perfect". Choose your own words. But accept the principle that, when words have confusing ambiguities, you should define what YOU mean to avoid confusion.)

Also, Thalidomide was a drug that was initially thought to be safe in pregnancy and it was later discovered that it wasn't. Point being: issues that aren't spotted in the beginning are sometimes spotted later on, and definitions of safety change accordingly.

Yes. And the thalidomide example was a gross and intolerable excursion. Vastly different order of risk magnitude to - say - the AZ blood clot issue. And the definition of "safe enough" didn't change - the change was in knowing the actual level of inherent risk. Thalidomide was neither "safe enough " nor "safe". The problem was a previously unidentified risk. Not confusing word usage.

If we go with the top definition from the top dictionary (the OED) safe is defined as: "Free from hurt or damage; unharmed."

So not so radical really.

Whether @Mendel's use of "radical" was appropriate or not does not change the fundamental problem of the "wrong paradigm". And we should, now, be clear that we are not arguing with the OED or any other "D's" definition of the binary 100% guaranteed definition of "safe". We should be recognising that most factors in epidemiology are relative or probability based. "Safe enough" or "Not safe enough". (And I'll leave the definition of "enough" for later discussion once we get near enough agreement of the main issue. )

One final analogy to illustrate the point: imagine a building in a town and everyone in the town has always been told it's over 300 feet tall. It's by far the tallest building in the town but one day someone measures it accurately and finds it's only 296 feet tall. They tell everyone "it's not as tall as we were told" but others say "are you sure? Cos it's still the tallest building in the town."

Whether it's the tallest or not isn't the question. All he's saying is "it's not as tall as they said it was."

Adding more false analogies won't clear up the confusion. Whichever question may have been intended - some responses were answers to the wrong question. And neither question is about "probability" - both are about absolute determinable fixed physical quantities. One a single measurement - how high it is. The other is a comparison with other determinable fixed quantities - how high it is compared to how high other buildings are.

 

[Rory]

Nicely said. And it's interesting to contemplate that different people have different ideas about the word "safe", and especially to think about what a drug company means when they use that word.

To recap, pretty much everything I've said these last 20 posts is simply in reference to what I said in #55:

So not quite as safe as AstraZeneca assured told us.

and in reply to Mendel's response, which he seems to stick by:

Are you sure? Because these blood clot issues are still very rare.

To me the only question is: are they saying it's less safe than they first thought or not? Mendel seems to be saying they're not saying that. I say they are.

If I'm hearing you guys right you seem to be saying that going from zero in a million to five in a million doesn't mean going from "safe" to "safe but less safe" because "zero" and "five" are basically the same number when used on such a large scale.

Does that work as a way to simplify where you're coming from, all other points aside?

 

[Mendel]

Apropos butchering:

In my opinion, AZ never said that "it [the vaccine] doesn't cause serious adverse effects". What they said is that they hadn't found any serious adverse effects.

That was my intended meaning, directly referencing the quote I had included.

In your recent reply, you edited what I had written, and gave it a meaning I did not intend:

My core points are:
• AZ never stated that their vaccine has no serious side effects.
• AZ did state that they had not found evidence of serious side effects.

AZ now acknowledges the recent (well, June) evidence of this side effect, and works on changing their vaccine to eliminate it.

Your claim, as I understand it, is:
• AZ said there were no serious side effects.

So, to you, AZ acknowledging this means they changed their assessment.

But that is only true if AZ used your definition of "safe". However, they didn't.
For example, anaphylactic shock is also a well known risk for this vaccination. So the AZ vaccine was never "safe" with your definition.

From the WaPo article you quoted, it is clear that AZ use a comparison-based definition of "safe":

A statement from AstraZeneca, whose scientists joined the research, said the "preclinical research further advances our knowledge about the potential mechanisms underlying the extremely rare condition … which is treatable for the majority of people."
The pharmaceutical company based in England said the full reasoning behind why the clotting condition happens still needs to be determined, and noted that coronavirus infections were more likely to cause clotting than the vaccine. "Although the research is not definitive, it offers interesting insights, and AstraZeneca is exploring ways to leverage these findings as part of our efforts to remove this extremely rare side effect."

If you'd like me to accept that AZ said "no serious side effects" and not merely "no evidence of SAEs", please point out a quote that proves this point.

 

[Mendel]

I'm hearing you guys right you seem to be saying that going from zero in a million to five in a million doesn't mean going from "safe" to "safe but less safe" because "zero" and "five" are basically the same number when used on such a large scale.

Does that work as a way to simplify where you're coming from, all other points aside?

When "safe" means "quite healthier than not getting vaccinated", then that didn't change.
My contention is that they said "it's the tallest building" (and then 300 or 296 ft don't matter), while you claim they said "300 ft tall" (and then 296 does matter).

So it comes down to what they actually said.
And I won't accept AZ saying "it's safe" as evidence because I think we disagree on what AZ meant by that.

 

[Rory]

When "safe" means "quite healthier than not getting vaccinated", then that didn't change.

Can you really not separate "safe in and of itself" from "safer than catching Covid"? It seems for you that safety is very much intertwined with efficacy, whereas for me they're two separate matters - at least in the initial, 'pure' phase, before questions of "least worst" enter the discussion.

I won't accept AZ saying "it's safe" as evidence because I think we disagree on what AZ meant by that.

Okay, what do you think they meant by that? That it's "very unlikely to cause harm"?

If "yes", then I agree.

And then they realised it could cause clots and modified it to "very unlikely to cause harm but not quite as unlikely as we initially thought."

Agree?

If so, that's all I've been saying all along.

 

[econ41]

Nicely said. And it's interesting to contemplate that different people have different ideas about the word "safe", and especially to think about what a drug company means when they use that word.

Thanks. And my point is that there are two separate causes of confusion or disagreement subsumed in what you say about "different ideas".
First is the difference of opinions that may exist over the actual issue of fact. Whatever word is used to define it.
And,
Second, is in using the same word whilst ignoring or manipulating the reality of two conflicting definitions. Especially when the "two sides" of opposing debate are relying on the two different definitions of the word which is the subject of the contention. Some are talking about "apples" others are referring to "bananas".

Bottom line for this discussion > Stop using the single word "safe" unless you explicitly define which of the two ambiguous meanings you intend.

To me the only question is: are they saying it's less safe than they first thought or not?

Agreed because it is framed in the appropriate paradigm whether or not the earlier assertions about "safe" were framed more as marketing hyperbole rather than with rigorous accuracy. They should have said "safe enough for the purpose" which is lousy for marketing and begs the definition of "enough".

If I'm hearing you guys right you seem to be saying that going from zero in a million to five in a million doesn't mean going from "safe" to "safe but less safe" because "zero" and "five" are basically the same number when used on such a large scale.

I most definitely am not saying that. I am recommending that in situations like this discussion where the issue is contentious we need to be pedantically accurate in defining what we are talking about. "Glossing over" the key issue of difference doesn't satisfy me. It could be acceptable in a less critical scenario where it was not the central issue in contention.

Does that work as a way to simplify where you're coming from, all other points aside?

Not for me - glossing over the issue or conflating two different word usages is IMO too risky when a couple of extra words would avoid the risk.