All the people in England today being given the Pfizer BioNTech covid vaccine are necessary guinea pigs. They are guinea pigs because they are participating in the early post marketing surveillance of a vaccine that, at this stage, we know very little about. We will come to just how little we know soon enough, but for now we should note that they are necessary guinea pigs, because, given that an effective vaccine against covid–19 is a common good, the only way we are ever going to know more about the vaccine is by giving it to lots of people. That, bluntly, is how it has to be. But this context, of participating in a mass trial, means that informed consent, always of paramount importance, is, in this particular context, of dominant importance. The distinction here between paramount and dominant, which both mean supreme, is that paramount merely describes a position, whereas dominant adds an element of dominion: that which is dominant is not only above all else, it also rules over all else.

Which brings us to the rule of law over informed consent. All doctors are familiar with the Bolam test, the long-standing legal test for medical negligence. The test is disarmingly simple — and, some might say, equally disarming to a patient alleging negligence — if a doctor can produce a body of responsible medical opinion — it doesn’t have to be many doctors, just a small number will do — that would have acted as the doctor said to be negligent did, then the doctor has not been negligent. It is a low bar, but on the face of it, it is fair enough — if other responsible contemporary doctors would have done the same thing, then that is fair enough. But it has one huge great gaping hole. It relies solely on medical opinion — the doctors know best — and takes no account at all of the patient. The patient is merely the passive recipient, and has no say on what is or is not reasonable in his or her particular case.   

Bolam (Bolam v Friern Hospital Management Committee [1957]) was chiefly about a procedure, and the harms it caused, but it was also about consent, though the consent part has been largely eclipsed by the procedural part. Bolam was a voluntary mental patient who consented to electro-convulsive therapy (ECT). It was common but not exclusive practice in those days to give ECT without anaesthetics, muscle relaxants or restraint, and the patient had a full blown convulsion, which could cause serious injuries. This happened to Bolam, who suffered fractures of both hips. He subsequently sued for negligence, on the grounds that he was not given muscle relaxants, not restrained, and that, had he been warned of the risks, he would not have consented to the treatment. Directed by the judge that a medical man “is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”, the jury returned a verdict in favour of the defendant: the doctors knew best, and, inter alia, it was for the doctor to decide how much to tell, or not tell, the patient.

Bolam, and in particular the question of who decides how much to tell, or not tell, the patient, was reaffirmed in Sidaway v Bethlem Royal Hospital Governors [1985]. The patient claimed that she would not have consented to a neurosurgical operation, had she been warned about the risks, which subsequently came to pass. The point at issue here was not the competence of the surgeon, which was not in doubt, but whether, by withholding information, the surgeon had impaired the patient’s ability to give fully informed consent. The case was muddied by the fact the surgeon had since died, so that his account could not be heard, and there was a glimmer of dissent from one of the lords hearing the case, but at the end of the day, the judges unanimously dismissed the appeal. Four of the five judges relied almost exclusively on Bolam: if a responsible body of medical opinion was of the view that the best interests of the patient were not best served by providing her with an alarming catalogue of rare and catastrophic complications, then so be it, and therefore a surgeon acting in such a way could not be said to be negligent.    

By 2015, however, the tide had finally turned. Bolam got the boot. Ms Montgomery, a short (small pelvis) diabetic (big baby) nulliparous (no previous births, so more of an unknown) highly intelligent (not medical, but her mother and sister were) woman nearing delivery, was nudged towards vaginal delivery by a caesarean averse obstetrician who chose not mention a rare but serious risk of vaginal delivery (obstruction, and subsequent cerebral palsy for the child), believing if she did, it would cause the patient to want a caesarean section. The labour went ahead, the outcome was calamitous, and the bady was born with cerebral palsy. Ms Montgomery subsequently sued, claiming that had she known of the risks, she would indeed have resisted vaginal delivery, and asked for a section. The issue at stake here was not the appalling conduct of the labour itself, but was the patient sufficiently informed to make the right decision for her over how her baby was delivered? More generally, the question here is who controls the final decision: the doctor, by manipulating the flow of information, in what they believe to be the patient’s best interests, or the patient, in full possession of all the relevant information.

Recall that the Bolam/Sidaway principle is doctor knows best: it is for the doctor to decide, in the patient’s best interests, how much information to give, and how much to withhold. The Supreme Court judges hearing Montgomery’s final appeal came to a different conclusion. After a comprehensive review of the law (the judgment runs to 38 pages), the key finding comes in paragraph 87 (emphasis added):

“An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.” Montgomery v Lanarkshire Health Board [2015]

How does this affect gaining informed consent to administer the Pfizer BioNTech vaccine? In the past, under Bolam and Sidaway, the doctor or indeed any other suitably trained person obtaining consent had considerable largesse to decide how much information to reveal. If a responsible body of medical opinion had it that there was no point in frightening the person contemplating being vaccinated with a raft of unknowns and uncertainties, then so be it. Today, Montgomery has turned that on its head. Instead of it being for the doctor to decide on a doctor knows best basis, the doctor now has to ensure that the patient is aware of any risk that a reasonable person is likely to consider significant. This is a fundamental shift: the frame of reference has moved from what the doctor thinks is best, to what a reasonable person is likely to consider significant. The locus of control has shifted from the doctor to the reasonable person, and with that, it is no longer the case that doctor knows best.

Dr No takes the view that the fact we know very little about the vaccine means that having the vaccine entails a significant risk, of unknown unknowns. Under Montgomery, it is no longer good enough for us to say that we believe it to be in the patient’s, and, more controversially still, in the population’s, best interests to have the vaccine, and therefore there is no need to bother with all that complicated unknown unknowns nonsense. Instead, we have a duty to ensure that the patient is aware of any risks that a reasonable person is likely to consider significant.

All we really know about the Pfizer vaccine, chiefly from ad hoc press releases, an MHRA ‘agency knows best’ announcement and an ‘Information for healthcare professionals’ leaflet, is that, based on a small number (less than 200 cases), the vaccine appears to be effective in preventing PCR confirmed symptomatic covid–19, and that, based on around 22,000 recipients, mild to moderate but self-limiting adverse reactions are common. On the other hand, the list of what we do not know is considerable and significant. We do not know: how long immunity will last; whether the vaccine reduces transmission; whether the vaccine protects especially the more vulnerable against serious and fatal covid; what, if any long term serious adverse reactions will occur, or what the long term effects of injecting mRNA are. Nor do we know — and this is of particular significance given that many of the first recipients will be women of child bearing age — anything about the effects of the vaccine on pregnancy and the foetus.

When asked what kept him awake at night, Harold Macmillan the prime minister famously replied, ‘Events, dear boy, events.’ Donald Rumsfeld’s famous ‘unknown unknowns.’ All of these unknowns are by definition risks. None of them is necessarily a reason not to have the vaccine, and perhaps more to the point, we, as a society, need these necessary guinea pigs to have the vaccine, to discover more about these risks. But, in this new Montgomery world, it is not for doctors to decide whether a person should have a vaccine, or to attempt to nudge the patient into consenting by holding back information on risk. Instead, the job of doctors is to tell the person contemplating the vaccine of these unknowns, these risks, and then let the person, not the doctor, decide.     


  1. Tom Welsh Reply

    “…given that an effective vaccine against covid–19 is a common good…”

    But it isn’t!

    “Covid-19” (if any such disease exists, which is far from certain) has caused little or no excess mortality in 2020.

    If it does exist, it assuredly offers no threat to children, and very little to adults under, say, 65.

    Those whom it harms (and sometimes kills) are the very old and those who are already seriously ill. There is reason to believe that age, itself, is not a very important risk factor; old people are at risk only because so many of them are already ill.

    Thus the young and middle-aged have no need of a vaccine, as their risk is exceedingly low.

    And the seriously ill might well be harmed by the vaccine itself – if they are even judged fit enough to undergo it.

    I have never seen a more perfect example of a cure for which there is no disease.

  2. dearieme Reply

    I’m ruled out by being on anti-coagulants.

    Is my wife ruled out because of two serious allergies? I take it that nobody can yet have any evidence that would help her decide.

  3. Tom Welsh Reply

    “… the vaccine appears to be effective in preventing PCR confirmed symptomatic covid–19…”

    And then there is this:

    It has seemed all along that the use of PCR to “diagnose” “Covid-19” was like a blind person searching for black cat in a darkened room = when the cat is actually elsewhere.

    As we should know by now, Dr Kary Mullis warned in terms that PCR could never be a suitable diagnostic test for any disease – by its very nature. As he got the Nobel Prize for inventing PCR, he should know.

    And now at least ten separate reasons for not relying on PCR have been reported and published. (Informally as yet, but one hopes formally soon).

  4. dr-no Reply

    dearieme – as you know, we docs can’t give personal medical advice online on an open blog. Dr No can however observe, because it is in the public domain, that the first reported side effects after the vaccine ‘went public’ were allergic reactions in two people each of whom had a history of serious past reactions.

    Tom – Dr No thinks SARS-CoV-2 and covid-19 are real, but they amount to just another seasonal flu like illness, and, though there was a spike in the Spring, the ‘pandemic’ is now a testdemic. Only yesterday Dr No was talking to a friend and we concluded yet again, like many others, that PCR testing is the epidemic – take it away, and then there is no epidemic, just another seasonal flu like illness.

    Just as we have a vaccine for flu (awkward because the virus keeps changing and not very effective in use) it is not unreasonable to have a covid-19 vaccine if it turns out to have useful real world effectiveness without burdensome side effects. It’s use, as with flu vaccines would be to protect the vulnerable, partly by vaccinating them (caveats about effectiveness agreed) and through herd immunity.

    All that said, there is another axis running through all this, an axis of evil: the use of vaccination status for social control. Even if the government don’t make vaccine cards mandatory, lots of businesses may simply take it upon themselves to apply a vaccine code. The last time a nation tried singling out a chunk of its population and marking them as different ended very badly. We should be extremely resistant against anything that moves us even a hair’s breadth in that direction.

  5. Tish Farrell Reply

    Thank you for further illumination re Bolam and Montgomery. Doesn’t the latter now put doctors in a potentially sticky position if they’re expected to carry out vaccinations with all the unknown and unknowns. Not at all good for future doctor-patient relations I would have thought.

    From my personal perspective, thinking I may have had the virus, what about all the people who had it, probably without knowing (as per Whitty press conference May 11 in which he said the majority would probably either not know they had had it, or were not ill enough to consult a doctor; while the lack of subsequent excess mortality shows nothing has changed since this statement). If they/I have immunity why would I have vaccine or, more crucially as per your last point, be excluded from public life for refusing to be vaccinated. This whole psyops herding process has been about control, obedience, social shaming and isolation right from the start. The big question is why.

  6. dearieme Reply

    Sorry, doc, that I inadvertently asked a question of you when I had intended to direct it at the Gods of medicine.

    Anyway, since I typed it my wife has been invited to take part in a study to determine who has already been infected with the blasted virus. She inclines to accept it, on the principle that if she has already been infected there would be no point in taking the vaccine. Of course, whether their tests are any use is unknown to us. I think I’d better study the letter.

  7. dr-no Reply

    Tish – the key thing is informed consent. The information that there are known and unknown unknowns is central to informing the patient, so they can make an informed (they know there are unknowns) decision. Dr No rather suspects that carrying out fully informed consent might prove tricky in drive by style vaccination, in which case the vaccinators recruited by the likes of Total Assist’s covid team* are likely to need all the government indemnity they can get if and when things start to go pear shaped.

    The Pfizer phase 3 trial had previous covid infection (clinical diagnosis plus test or just clinical if not test) as an exclusion, and possible current infection as a deferment (presumably pending exclusion if the diagnosis was confirmed, or inclusion if it was ruled out), so here yet again is another unknown: the effect of the vaccine on those with previous covid +/- subsequent immunity. That said, it is highly likely that some of the participants had had previous asymptomatic covid, so the waters are muddied even further!

    We still know nothing about enduring immunity, apart from the short term anecdotal evidence that very few people appear to get covid twice, but it seems entirely possible that previous infection should produce similar, if not better, immunity than a vaccine (even if in both cases it is weak and short-lived) such that the person with previous, and let’s say PCR ‘confirmed’ infection, is just as ‘entitled’ to an immunity passport as someone who has been vaccinated, but they are not going to get one if the passport is based not on immune status, but on the vaccination status. Yet another reason why this whole passport idea is a VERY bad idea.

    Dr No doesn’t think he is being too extreme when he suggests that the emergence of a superior vaccinated class and so by definition an inferior unvaccinated subclass – the ‘refuseniks’ – is a very dangerous step on the path to an authoritarian state. It is but a short step to segregation, us and them, the superior class deciding ifs fine (actually a jolly good idea) to bash the underclass about a bit, kristallnacht, ghettos, camps and gulags.

    dearieme – fine, quite understand, just needed to air the ground rules for any GMC snoopers. Presumably, any test for past infection will be antibody based, and certainly some of these are dodgy, see the tables on page 6 of this Cochrane Review (second part of the table shows the effects of various underlying prevalences on true/false negatives/positives).

    Anyone who tests positive in the study your wife has been invited to participate in is going to find themselves in precisely the predicament Tish raised: if they quite reasonably decline vaccination, they won’t get a bit of paper saying they have been vaccinated. Perhaps they will get a letter from the people conducting the study, confirming their immune (or more accurately antibody) status? Will that letter magically open doors? And of course that still leaves all the people who haven’t got any bit of paper, and haven’t been vaccinated.

    Might be worth having a look at some of the stuff by Allyson Pollock and Margaret McCartney on screening harms (because a study looking for evidence of past infection is in effect a screening study; although the study may be population research, it will operate on individuals as a screening test).

    * From an email from Total Assist received by Dr No on 20th Nov:

    We have a number of contracts where we need your assistance, whether you are available or know of anyone who would be interested in the following:

    Covid swab testers – No experience necessary, as training is provided.

    Phlebotomists – to work on various Covid testing projects

    Vaccinators – to participate in the mass immunisation projects.

    Please pass these positions onto any friends and family who may be looking for additional work.

  8. Tom Welsh Reply

    “Tom – Dr No thinks SARS-CoV-2 and covid-19 are real, but they amount to just another seasonal flu like illness, and, though there was a spike in the Spring, the ‘pandemic’ is now a testdemic”.

    Thanks for your as-usual helpful reply, Dr No. I certainly agree with what you say.

    My reason for questioning the existence of a new virus is that it seems odd for such a virus to claim a lot of lives while flu seems to have vanished entirely. (And, according to Dr Genevieve Briand at Johns Hopkins, the “missing” deaths in the USA more or less equal the claimed “Covid” deaths).

    Of course the whole thing has now become so political that it will be very hard to get at the truth.

    As an unqualified layman, I very much appreciate your expert knowledge and opinion.

  9. Tom Welsh Reply

    The “informed consent” issue certainly is absolutely central. And it’s not just in medicine, either.

    One of the axioms of what is laughingly known as classical economics is that everyone in the economy has perfect knowledge of all events, prices, etc. – and all at the same time.

    Of course that is about as far from the truth as it’s possible to get, as one of business corporations’ main concerns is muddying the water, and especially making sure the many don’t get vital information until it’s too late. Companies pay stock exchanges huge sums to get their server moved a few feet closer to the exchange’s computers, so that their information will be a few microseconds more current than the competition’s.

    And in general an immense amount of deliberate disinformation is pumped out. Without it, the vaccine industry might hardly exist at all.

  10. John B Reply

    I am reminded of the phrase, ‘All dressed up with nowhere to go.’

    Isn’t the generally understood primary function of a vaccine to provide widespread community immunisation in order to prevent an epidemic? Giving a vaccine after an epidemic is long gone is like sending the fire brigade to a house fire when the fire burned out months ago.

    A vaccine to prevent or lessen effects of disease in elderly vulnerable individuals, most having reached life expectancy, does not protect them from other diseases particularly the ones they already have, nor make them immortal, so at best maybe delays death a short while.

    If SARS-CoV-2 does not mutate won’t we as a society be naturally immunised against it by now, or soon? Isn’t it why people die of new ‘flu strains in the Winter season, not old ones? ‘Flu vaccines produced each year anticipate the new strains in order to protect against these, not old ones.

    European Countries are not joining in the haste to use the Pfizer product… why would they when that buffoon in Downing Street is providing the lab rats?

  11. dr-no Reply

    Tom – the John Hopkins News-Letter (Published by the Students of Johns Hopkins since 1896 – it’s the student rag (and as a former joint editor of just such a rag, Dr No has a lot of time for these rags), not John Hopkins itself) retracted and then made available elsewhere the report – it wasn’t a paper per se – of Dr Genevieve Briand’s webinar. Her “findings” to indeed look highly questionable (and all credit to the News-Letter for not removing the report entirely, so we can still see it). A useful starting point is here, with links to other relevant pages.

    What about ONS data? This does not show influenza and pneumonia have disappeared. This chart is from the latest (8th Dec) weekly deaths report:

    As you can see, influenza and pneumonia deaths are very much present, but there is something rather interesting: most of the covid deaths are deaths from, whereas most of the influenza/pneumonia deaths are deaths with. This is almost certainly an artefact of the way covid deaths are defined and recorded. From the same ONS page:

    Glossary: Coronavirus (COVID-19) deaths: Coronavirus (COVID-19) deaths are those deaths registered in England and Wales in the stated week where COVID-19 was mentioned on the death certificate. A doctor can certify the involvement of COVID-19 based on symptoms and clinical findings – a positive test result is not required.

    That is, a ‘mention‘ is enough to make the death a death from covid. Given the importance of co-morbidities in covid related deaths, and the ages of those covid deaths (roughly 75% 75 and over, almost half (42%) 85 and over), quite whether covid was the true underlying cause of death remains a very moot point. In contrast, the influenza and pneumonia deaths were no doubt coded normally eg lung cancer > pneumonia > death gets coded as lung cancer (and influenza gets relegated to a contributing factor). Unfortunately, influenza and pneumonia deaths have not be broken down into influenza deaths and pneumonia deaths, so we can’t see the actual number of influenza deaths.

    One of the main reasons for saying covid is now (it wasn’t in the spring, that was a dry tinder conflagration after a previous season with lower than expected mortality in a population with no previous exposure to SARS-CoV-2) just another seasonal flu like illness is this chart of quarterly (so you get to see the seasonal variations) total deaths over the last 50 or so years:

    Link to a (correct, added 16:22) larger version here.

    The problem (or advantage if you want to inflate covid’s importance) with ONS’s weekly data is that it only goes back ten years, and as you can see from that chart, the last decade is notable for its lower than normal mortality, so covid, compared to the last ten years (or just the last five years, as ONS often do), looks rather bad. But stand back a bit and get a better historical perspective…

    The above chart is the raw data, not corrected for changes in population size and age structure. Here is the same data, adjusted for these factors, using standardised mortality ratios based on Q2 2020, ie actual numbers of deaths observed as a ratio of the number you would expect if each quarter had had the same age specific mortality as that which happened in Q2 2020. As you can see, it tells the same story:

    Link to a larger version here.

  12. dr-no Reply

    Having corrected the first large version image above, here is another version with a short Mark 1 Eyeball trend line added for the last few years. Not recommended viewing for those in full sway of the government/MSM pandemic horror narrative.

  13. Rick Reply

    Excellent article again thanks.

    What would you expect the reaction to be if a patient seriously considering getting the vaccine was to specifically ask the person administering for an explanation of risks and to highlight the possibility of legal action if anything is withheld? Basically being proactive in your discussion rather than passive Dr Knows best behaviour.

  14. dearieme Reply

    Happily we’ve found data for the prevalence of the virus among a large sample of asymptomatic people living near us. It’s 0%. Hurray!

    I note too that all their initial positive results were later determined to be false positives. Hurray again!

    I think I’ll try to persuade my wife not to be tested (especially as it seems to be a PCR test on offer, not an antibody test). I suspect that a false positive could turn one’s life upside down.

  15. dr-no Reply

    Rich – thanks. Any doctor these days should answer to the best of their ability if asked directly about risks; Montgomery means they should volunteer the information, even if not asked, if the doctor has reason to believe the patient will consider the risk significant (and for most patients, that will be the case). Highlighting the possibility of legal action tends to spook doctors, so maybe not a good idea! In any event, they have, if Dr No has got things right, been given indemnity by the government, which seems to mean they can’t be sued. But, yes, being proactive is in general always a good idea.

    Whether non-medical vaccinators (eg Total Assist’s ‘have a stab at it’ volunteers) will have a full knowledge of all the risks, and the skills needed to discuss them with people considering being vaccinated is another matter. They will however presumably also be covered by the government’s indemnity.

    dearieme – an interesting find (have redone the link, by adding it to ‘found data’ to stop the overflow)! As you can see from that report, low prevalence and high false positives go hand in hand, and yes, bit of a bummer to get a false positive in the run up to Christmas!

  16. dr-no Reply

    Rick – it seems anyone doing anything covid related on behalf of the NHS gets indemnity. I think I first saw it in the Independent. It’s confirmed here (and numerous other places), and this is the relevant part of the Coronavirus Act 2020, with more details here.

  17. Oldcontrary Reply

    Hello and thanks for your considered post.

    Not sure if this okay, but another website has some useful documents. One of which discusses informed consent and Bolam/Montgomery.

    The pdf is a printable form and checklist which may help the patients and Doctors to reach informed consent.


    The website is called and a number of health and legal people support it including Dr Malcolm Kendrick UK Med Freedom

    Many thanks

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