Peter Selley and I have many friends in and a soft spot for The BMJ – the journal for members of the British Medical Association. One of us has read every issue since 1970. We thought there might be some response to our post Are Journalists the Answer to Clinical Medicine’s Cause and Effect Problem, which, in the nicest possible way, accused The BMJ of cooking up the equivalent of a pandemic virus in one of their laboratories – something that has badly affected all of medicine, maybe even fatally. Despite making sure the post appeared somewhere it might be noted, there has not been a hint of a response.
So perhaps another approach is needed. Peter and I can’t expect to have the stellar success the actors here in Not the 9 O’Clock News had. It ran on BBC 2 at the same time as The Nine O’Clock News on BBC 1. It was slow to take off but ultimately won lots of awards and spread to HBO in the US as Not Necessarily the News.
Pregnant and Reading The BMJ
If you were or are pregnant, reading The BMJ may have put pressure on you to have a Covid Vaccine. The BMJ has run several articles about vaccines for and clinical trials of vaccines in pregnant women. (They use the word people rather than women).
- Facilitating participation in clinical trials during pregnancy.
- Covid-19 vaccination in pregnancy.
- Protecting infants through covid-19 vaccination during pregnancy.
This is a tremendously tricky area that needs sensitive handling. There is no doubt that, just like other viruses, Covid can infect the placenta and harm or kill a foetus terminate a pregnancy. It also looks like vaccines given in pregnancy might do the same. Current trials of a Pfizer vaccine (RSVPref) given in pregnancy to prevent RSV infections suggest it can also cause a placentitis, prematurity and neonatal death. The BMJ avoided grappling with this in its recent coverage of these trials – See Are Journalists the Answer to Clinical Medicine’s Problem.
More to the point, Pfizer also have a randomised controlled trial C4591015 of its SARS CoV-2 RNA Vaccine (BNT162b2) administered in pregnancy. Why is it that The BMJ won’t discuss this trial. Not discussing it seems like a male – ‘let’s not bother the pretty little heads of these girlies’ – with this tricky stuff. We men can be politically mature about it – they, especially now, are likely to be a bit emotional.
Peter and I come at this from the point of view of figuring women who are, or who are thinking about getting pregnant, are the most assiduous and responsible researchers on earth.
Vaccine mandates have faced lots of women with a truly agonising choice – get the vaccine or lose your job in healthcare, or universities or elsewhere. Shouldn’t people in this position have access to all the information there is rather than just a set of Nudges from The BMJ and others to conform?
Pfizer’s Covid Vaccine in Pregnancy Trial
To date the only preclinical safety trial of BNT162b2 in pregnancy was performed in 44 Wistar rats, which have a gestation period of about 22 days.
A multinational clinical trial set out in February 2021 to recruit 4,000 pregnant participants. Initially there were 16 trial sites in the USA. By October 2021 an additional 68 sites, in Brazil, South Africa, Spain and the UK were set up.
Yet recruiting stopped on 25 October 2021 with only 348 pregnant women on board. That is on average four participants per site but maybe up to 20 in each of the US sites.
The trial ended formally on July 15, 2022. By convention the results should be published within 12 months of the end of the trial. In this case Pfizer supplied some irrelevant ‘sore-arm’ data on July 14, 2023.
The National Library of Medicine, which runs ClinicalTrials.gov, lamented the lack of data on the primary endpoints of antibody measurements and secondary endpoints of incidences of Covid-19 illness.
Pfizer say they have been terribly busy, and that the remaining results will not be made available until July 2024.
By contrast, in the Polack and Thomas NEJM paper on the pivotal trial of the same vaccine in more than 40,000 subjects, ghostwriters had analysed the data, written, and submitted the paper, which was published online within two months of the last patient being recruited.
At the start of the pregnancy trial Pfizer agreed to “provide access to individual de-identified participant data … upon request….” But in February 2022, this arrangement was rescinded. Pfizer state they will no longer share the data. So there.
But there is one extraordinary feature of this trial which has leaked into the public domain. The very small number of participants – 348 – is embarrassing. What could be done about this?
- Perhaps recruit family members of those who ran the clinical trial centres (e.g. Ventavia) as described by Brook Jackson; but that would be possibly illegal.
- Or, in a first ever (that we know of) maneuver of its type, in July 2023 Pfizer recruited all the babies born into the trial as participants.
“A total of 726 participants were enrolled in this study. 391 were maternal participants who signed informed consent form and were enrolled out of which 41 were screen failures and 2 participants were not randomized. Eventually 348 maternal participants were randomized to receive treatment. 335 were infants born to maternal participants.”
This is an extraordinary situation. The failure of any medical outlet, periodical, magazine to cover it is equally extraordinary. The difficulties here are ones that journalists cannot readily handle by inviting experts to say anodyne things like ‘we don’t have the full picture yet’ or ‘we don’t have the data so it’s difficult to say if there is an issue’.
Peter and I have been faced with a version of this when dealing with The BMJ. The official Consent Form for the Pfizer RSV maternal vaccine trial told pregnant women, remember your baby cannot be harmed by this vaccine it is you not your baby who is getting it.
How do you get anyone to say this is Okay. When this form was drawn to the attention of some of the centres who had been using it, they freaked out and said of course this is not acceptable. Given there is no clear way to put this in mitigating journalistic context The BMJ’s lawyers blocked coverage of the issue entirely.
We drew this Consent Form, and the injuries to babies known about from a prior GSK trial of an almost identical vaccine, to the attention of colleagues in New Zealand, who have a no fault compensation scheme for medical injuries.
Now here is where things get murky. One way to read the paper trail is New Zealand IRBs – ethics committees – were told that their no-fault compensation was not acceptable to Pfizer. Any injuries would have to be covered by Pfizer. But there is also some understanding that NZ’s no fault compensation scheme doesn’t cover injuries that happen in trials from which the sponsor stands to benefit – See Boland NZ Medical Journal.
To treat something doctors have to decide what has caused the problem. In Augusto Roux’s case, his doctors decided it was the vaccine. This was not acceptable to Pfizer who had to make Augusto vanish – Disappeared in Argentina. Astra-Zeneca made Brianne Dressen vanish in the same way. If they don’t disappear, companies have to let FDA know about the problem.
In the Boland case, the NZ no fault scheme did not cover the man’s injuries because the doctors were clear the vaccine had caused it and the result was years of disruption, litigation and legal bills for the injured man and his family.
The New Zealand ethics committees agreed to Pfizer’s terms, but alerted women that they would not be covered by the usual no-fault compensation scheme and would have to take their chances with Pfizer.
As outlined in this Healy, Roux and Dressen article, and as the Boland case shows, Pfizer and other companies have sown even more dense beds of dragons’ teeth and mines in the way of anyone seeking compensation after an injury in any of their clinical trials than the Russians have sown in Ukraine. See Women Clinical Trials and Pregnancy for more on this.
The BMJ not only do journalism these days, they have opinion pieces by ethicists and lawyers like Daniel Sokol, as well as clinicians, saying mandates are wonderful, who refuse to answer emails pointing out that mandates might well be fine where we have access to the data and can assess how reasonable they are but what about when, contrary to the basic norms of science, we don’t have access to the data and the articles that governments appeal to in justifying mandates are ghostwritten?
In the case of the issues being handled here, its all too easy to imagine The BMJ lawyers not just blanching but having a stroke.
Journals are only interested in letters that are “responses” to their articles, and even those letters are vetted and rejected if the lawyers get anxious. Which leaves posts like this, with links to the evidence backed up by correspondence to the appropriate bodies. Readers are left to interpret what the absence of an answer might mean – we always post answers.
Other Ethical Issues 1
Anyone becoming pregnant now faces an increasingly strange situation. In the last 15 years it has become normal for to be “offered” several vaccines by “healthcare providers”. These include Tdap – tetanus, diphtheria and pertussis. You have to get all three even though only pertussis is claimed to be beneficial. And a Covid vaccine, which is strongly recommended in many countries. And an influenza vaccine, which is vigorously recommended. Hepatitis B will be offered but may not be pushed. Pfizer’s maternal RSV is likely to be scheduled also.
Extraordinarily, a week ago, CDC voted to reclassify Nirsevimab, Astra-Zeneca’s monoclonal antibody, a treatment to mitigate the severity of RSV infections, as a vaccine and recommend that every healthy infant get it during the first year of life. Monoclonal antibodies can be highly toxic. They have a welcome place in clinical practice and an earlier version of nirsevimab was used sparingly and likely to good effect but giving this to every infant looks like a recipe for problems – perhaps a widespread loss of confidence in the authorities.
Women these days go out of their way to avoid alcohol, tobacco, processed meats and soft cheeses while pregnant. Following thalidomide they stopped taking drugs above all – for a while. But in recent decades while avoiding meat and cheese etc, they have been prescribed and are taking drugs in ever increasing amounts. Why? Uniquely compared to Foods etc, Drugs come with a ‘This Works’ label.
Few appreciate that things that have a ‘This Works’ label, like antidepressants can kill more people than they save. Antidepressants are now the second most commonly taken group of drugs in pregnancy.
Into this mix we now have vaccines. Vaccine recommendations have crept in individually. We have reached a point where, whatever about the potential harms of each vaccine, there is also evidence that RSV vaccinations reduce the effectiveness of Tdap and influenza vaccines if given at the same time. There are a lot more vaccines in the pipeline.
This is a compelling demonstration of the risks of polypharmacy and the need to reduce medication burdens. Effectiveness has limits and will require choices. Who should make these choices?
Other Ethical Issues 2
4. Vaccine trials in pregnancy have been obsessed with measuring antibody levels in the babies and the protocols call for an extraordinary number of blood tests on infants – leading one NHS ethics committee to reject a GSK trial for exactly this reason. It is more important to monitor clinically significant infection as well as placental function and intrauterine development of the fetus.
5. Should we encourage women to get involved in trials in pregnancy where there is no extra monitoring of their pregnancy? Where inducements of over $1,000 are provided? Where they do not appear to be informed for instance that breast-feeding offers the best protection against RSV and other infections and where Pfizer subsequently provide no data on the benefits of breast feeding.