Okay. So could you just begin by saying your name and what your current title is?
And my name is Joe Sevilla. I am Professor Perinatal Medicine and the Naval Department, Obstetrics and Gynaecology, Women of Reproductive Health.
This call now, and there's the General Electric Hospital, the University for Women and Reproductive Health.
But yes, that's in. So first of all, can you just tell me a little bit about yourself?
So starting from your earliest interest in your subjects, just give me the the main stopping points on your career so far.
Well, I'm an obstetrician gynaecologist by training and being around in different places and conducting always
research on maternal factors and foetal factors affecting perinatal outcomes and long term development.
And then I they work in in rural areas in Central America.
I went back to clinical practice ob gyn,
Johns Hopkins for ten years in the U.S. and then went back to sort of a public health
largescale research as a coordinator of maternal but maternal medicine at W.H.O. in Geneva.
Then I was there was a program.
This is an interesting background for the for the second part.
The third time was a program called Human to Human Reproduction, A Human Reproduction Program.
That was this is 1980 in the middle of 1980s.
It was mostly development and testing and and evaluating, say, think of of contraceptives, different contraceptive methods.
And then at one point, they decided that was too narrow and that women really because it was why they're then then contraception.
Then they eventually went up to the maternal and being the component.
There was there was another component infertility just to why they why there the concept.
No, only on only contraception. Then I went there in 1989 and they built a large scale multinational multicenter training.
We should receive training and research component on different factors related you to pregnancy, maternal health and prenatal health.
And so just so sorry to interrupt, but just to give a little bit of background.
How much of a public health issue was the kind of additional risks that women faced during pregnancy and childbirth?
What was the question again?
So what's what was the kind of scale of the of the public health concern around women at the time of pregnancy and childbirth?
Well, this is a there was basic error.
It is the role of the radio. You're supposed to be there.
Although Joe Biden said this because there is the risk of maternal health changes to relatively high maternal death,
for example, relatively high as in rural areas of Africa or Southeast Asia,
or to very low in in developed countries or different diseases have different rates and or some diseases are similar range of complications.
Then the idea was to understand the risk factors.
The issue is the mandate of this program was to understand the risk factors and to understand the environmental conditions and environmental factors.
And try to introduce a. Interventions to ameliorate the risk.
And then there's the question,
because that ranges from sort of a specific risk factors on preterm birth or or foetal malnutrition or being undernourished at birth,
where they have obviously large differences in by vision with other programs that were provided provision of care,
they get the care that women get during pregnancy or the extra care that they get with.
There's increased rate of caesarean sections. Now, now there is an epidemic of caesarean section, everybody.
There is a higher rate of caesarean section than needed for the risk.
But in many places, the risk profile of the women then that was then.
Then within that is directly leads to the commitment of our our reaction to react to the
reaction to the global pandemic was that we learnt in large scale multi-country studies.
That was my responsibility during 17 years in Geneva.
And then one of them, for example, it was the issue of socialisation.
What is the risk of is maternal risk associated with having a male surgery vis a vis the the benefit of saving, saving foetal life?
Then obviously there is a balance between and now we are in the balance of saving fewer foetuses with a 30, 40% of caesarean section.
And then this got this guide of a type of a balance.
Then we did we did a similar large scale study in the whole in the whole world.
No we didn't, we sort of a randomised we, we select randomly selected countries, hospitals and cities in the whole world.
And then this was a is, it is a landmark study on the effect of maternal maternal factor.
But interestingly enough there was, there was a, there was a very good contribution of this research.
And so these contractions,
there was a thing where we were in the it wasn't in the headlines or the newspapers in the UK actually saying that women were to push the push.
I remember I was sort of in a tree with a Jemmy, which was not the case, but I think was it a good, good sense going around with these things?
But I promote the papers as such. That was basically that the the they issue.
No. And in 2008 and 2006, I moved to a firm with M&A to try to, you know, remain the main.
There are there are several there are many maternal conditions affecting pregnancy.
Fortunately, most in most countries where adequate care is provided and environmental factors are acceptable and or other group, these risk are low.
But they still they are there and they need the risk.
I mean, the risk during the labour and delivery, if conditions are adequate, they are very low.
But there are still there are there are risk involved in pregnancy and feeding growth and so on.
Maternal diseases, anxiety, postpartum depression.
There are many other factors. Then they they they mandate.
I got a good job for inches I think I was to conduct specific research large scale is to try to understand
in a relatively short period of time with a large number of big big what is called now a big data a.
What are the risk factors? Possible interventions and targeting subgroup subgroups to reduce the negative pregnancy outcomes.
That being in general terms, the most central of these was preterm birth babies born earlier than than it should.
And why is that? Why is that a bad thing for the the outcomes for those children who were born preterm?
There's a risk of morbidity and mortality, long term development that that increases every week or every day that you get younger or earlier.
Then that's basically the mandate. Then the problem.
Obviously, this is a reason, of course, that then it has a has its extraordinary capability to provide care to southern England, if you will.
But it still was traditionally in the age of the issue of pregnancy.
It was sort of a regional hospital then we but the university is a is why it has a wider scope and it has a long tradition of international work.
Then the task was to expand the gynaecological activities to a larger scale,
according to the tradition of the university that has been a training for many tropical diseases or other things globally,
then that's where we started doing it. But the bottleneck was not there wasn't a patient, it was not the university, although,
as you know, huge, slowly, but there wasn't it was not the the University of the Negev.
These large skills and a project was that the the the the clinical and scientific status of pregnancy,
pregnancy care and pregnancy research was rather uncontrollably and not standardised.
Then it was, was basically very difficult to conduct multicenter studies with, with people more or less doing whatever they feel better.
By the obvious, you can imagine the feeling better.
It changes dramatically with it, which was this person of each institution.
Then the they were task. And then we spent about the 40 or five years until early just ten or 11 a standardisation.
Care occurs globally across those people.
I want you to do it. Obviously, you don't want to do it, but there are those people that were willing to do it.
Standardised care according to the best practices.
So you have participating hospitals in different countries around the world who were agreeing to fund the right thing.
Yes. Then that was that was one issue.
But the other issue was that. And in many areas, the standard of care was unknown.
And in other areas it's done. That care was risky.
And that's you know, I don't know if you're expecting this but the amazing is harder to modify and and non effective treatment is harder than
what you find an effective treatment than effective treatment then there are no effective practices or risk there has been.
No, no, I mean historically amazing just being inside the product.
They're amazing. They're very very difficult to take it over. And then the.
And this was one of the main challenges.
Fortunately, all four had these been involved in these efforts,
a change of settling practices and collecting data based on best best practices
and more effective effective which was eventually became evidence based medicine.
And a colleague and friend and gentleman, it was the director of the National Perinatal Epidemiology Unit.
And then he introduced promoted the concept of evidence based medicine in obstetrics.
Then with me on background and the university background, we identified which things would be standardised right away.
And but there were other, many other practices that were not ready to be standardised and even there were people having a conflict, the thinking.
Then we spent all this time, particularly in pregnancy and preterm birth and FEDOROV Then we spent all this time and by.
By 2014 or 18.
Can we just get some names so that one of the projects that you set up was called into growth?
Is that correct? You went back and.
Yeah, and then the main the main project, because that was part of the mandate.
The main project was called in the that will be a project to study the potential of foetal growth as a as a the early as a component of human growth,
if you will, a that is known to affect early and long term medical conditions, development and so on.
Then the the the issue the issue was to study a larger scale and the many different conditions,
the consequences of different growth, foetal growth patterns and as a result of the project is gone that it was calling the road.
The problem is, I don't know if you want to go on this.
The only the only problem was that one of the bottlenecks on the standardisation and implementation of
of large scale research or medical intervention was that it was entrenches and it still no in many,
many areas the concept that the foetal growth.
Is not a universal process and is more more related to a.
Environmental, religious rights, a skin colour and so on.
So the idea that people in but babies in some countries are naturally smaller than babies in other countries.
Exactly. Then obviously, obviously like in other is if you are if you consider a feeding growth, this is abnormal foetal growth.
And this is all bread and butter and this is your backbone earlier.
And that that pathology is associated.
With environmental factors, disease conditions, socioeconomic location, immigration, all the things.
No, but it may. As you said, the main issue is that the.
Following that concept. It is entrenched in many places still that that is is is is my is environmental is this is it.
But at the end of the day, foetuses grow differently depending on the race, skin colour, ethnicity or even even more.
Certainly not a country of origin of the mother or a all.
And there is a sort of it genetic conditions associate with ethnicity.
Where what did the integral study find.
Well, obviously, obviously this concept where in some area in some in some of its manifestations were rather bizarre.
Oh, I'm sure. And particularly people living in living in the in the in the previous century in in Europe or in in many developing countries
where the borders were changed as there'd be women even now even no women arriving in the UK it you and get pregnant.
Maybe they were living in one country when they left and they know the country has changed.
Regions got changed. You know this is this is going suddenly well.
But we we then confront a much larger scale resistance to this.
Now, obviously in the road they originally conceived of, the road that was already there.
Even more extraordinary thing was that they paediatricians in early 2000 decided for the
attack the same concept because the concept was also extended to the to the children,
that the children were genetically a smaller they were Indians from the subcontinent.
They were smaller than or Chinese. The Chinese were smaller then, obviously by the changed by 200.
Obviously, people start realising that Chinese were not any longer sure that they got it all.
And in the subcontinent, there are many millions of people that are totally innocent.
Then it's just to do with the mother being better nutrition environment nourished and the children being baptised and development development.
Then there all these.
Then they be regions immediately and before, which is, I think by the end the gist of it jump to Judaism and starting confronting these issues.
Then us basically what we did is we made the approach to go to different regions,
extreme regions like extreme related to the Mississippi and geographic areas,
but no by the European adequate regions as we select the populations in which there were different ethnicity,
religious skin, colours and noses and all the things different, but they were living, living under adequate conditions.
Then there was the study saying that girls, girls, the world in which there were Chinese.
Sort of just to make the argument simpler middle classes or high or middle middle classes in China?
Me the middle classes in Nairobi. Blah, blah, blah.
No different in Brazil. You know, places where in the US and England and in Europe.
In continental Europe. Then there was. And then that's what they say.
So. And the. And the hypothesis was. And then people started claiming, you know, the negative reaction was start blaming.
No, we don't. We are not all identical.
This is absurd. We're not identical. We never said that people would be identical.
But the answer to that question, it was the variability.
The answer is that they. Among humans.
In in in the growth of the foetus, the growth of the brain of the foetus, the growth of any brain structures, oh,
the foetuses and the development postnatal development of these multiple,
multiple geographic areas where they studied a standardised and very rigorously.
And when the background were similar in terms of carbon duration care, socioeconomic status,
environmental fibre, the big, the foetal growth and up to two years in terms of any anything you name where.
Unbelievable. Closer. Even age.
Age of language, acquisitions, you know, even even all the things or things that were less and less tangible,
like obviously tie or length is something you can measure.
But then there are many other developmental issues in the one year or two years that they are not a obviously easily measured well,
but then all the things were remarkably similar. More than expected.
More than expected. And even yesterday.
Yesterday I have we have a a colleague that is a workshop on artificial machine learning artificial intelligence in the in the in Oxford in the it.
And then she was showing me yesterday that they have it they have a special way to
take in three 3D volumes with ultrasound of the foetuses with our our foetuses,
if you will. And then she got a fantastic technique in where they changed that sort of a very complicated
are the individual intelligent things they in their measuring their the the the
volume of the brain and the and different different structures within the brain as she
was showing me yesterday that they they they they grow of children they are identical.
But one if you if you're wrong in a growth language of the brain volumes.
Of the foetuses of the original foetuses.
We're using these most sophisticated things to measure, to quantify and describe the grey matter of the brain of the foetus.
They are absolutely identical, but one line on top of the other.
It's a thrilling because he's obviously, as you can imagine, that there is variability.
They are not all identical, but the distribution, the distribution is the same.
Well, yes, but their variability is a very small.
But there is very religious. Your imagination can be both.
You know, we cannot control these. These are free living individuals.
But by the way, the more you get to things that are very specific to human nature,
like the size of the brain, you know, the size of the brain or the or the structures of the brain.
These are things that you can't know much about because, you know, people were saying they were completely even these things.
I think they you can grow more grosser than all the other things.
Mm hmm. In order to answer your question overall, we can say that the anything you want to measure we got, if the conditions were adequate,
thereby the ability between sides is always in any measure that you make, there's always less than 10%.
There is the variability. There is a 90% variability, which in humans is either or environmental or errors in they measure.
But between the among sites, the comparison among ethnic geographic areas in the world today,
there is never about 10% eight and for, as I said, sort of things that are basic to humanity, like size of the brain or a.
Or even then they had the self-confidence of the head bones, bones that you obviously,
once you get the bone, the length of your femur, you have it there, you can get the shoulder.
Well, all the things there are never, ever more than more than five, 10% of the total body ability.
Well, then this is the answer to this is a long answer to this question.
Then let's park for a moment. I mean, that was a fantastic result.
But what was also fantastic was that you had, over a period of years,
set up a research network of committed individuals in hospitals all over the world
who were prepared to adopt common standards in order to pursue answers to questions.
So now I think you can come to say I just I've been asking everybody this question.
Can you remember when you first heard about the pandemic?
Yes. There was something going on in China. And that that that that might be something that your research network could become involved with.
And. Yes. Well, actually I but precisely everything because a.
And in during the summer.
Well, during the the winter of 2020.
In the winter junket agenda because you mean January, January two.
You mean right at the beginning, January 24? Yes.
And one of this is sort of one of the one of the one of the few advantages of getting old is is that I have more flexibility than the summer.
You say that you keep working electronically rather than spend three, three months in the in the beach in South America.
Well, in South America, basically. And in the beach, because this summer it was a summer there.
Then I was there. I was preparing to go back. You were prepared.
You go back to your junior jog for in my area at the end of March, early February, early March.
And then we have these cases in June. But obviously, I follow that.
But then at one point, because one of our Winter Warrior Centres,
one of the main developed country operation is in northern Italy, in Torino and in Milan,
and particularly in the city of Torino, AC Milan, as I said,
the well-organised is we restudy all the liberties in the city of Torino during basic training for the growth project.
No. Then when they beat me because I'm basically ignorant about infectious diseases.
But when they when they realised that it was it was an infection epidemic or infectious disease, it was a recipe for respiratory transmission.
And I started thinking in February just is other than trending,
that is if this kid in northern Italy because northern Italy is in the winter in general.
But most of the cities in northern Italy, they're well developed by.
But housing is sometimes they are very, very nice to look at.
But the they are all there are all all buildings and also because they obviously lot in
culture there is many in the family leave the mother and father the children there.
You know it sort of it it very clear that instead of thinking that if this is a respiratory disease, we hit our area.
I mean, Turin or Lombardia, then I think there were these are the easily disseminate around.
And particularly because, as you know, the fertility rate is very low among Europeans,
but is relatively high or maybe about above replacement among immigrants and the immigrants living
in the benefiting area of the European cities they live in rather than a chronic condition.
Then I started thinking that maybe where I would bring up population instead of experience is this this epidemic like it happened with the flu?
And if you had been me before, was it was a disaster then.
Then in March, I went back the last day before they closed.
We when we went back to Europe and then immediately in March,
I contacted my geographic clinicians and colleagues in, you know, for the remainder remain active with us.
And I said, what we should do, we should do it. We should ask you, as you were thinking, who who is a network to the names of those colleagues?
We should. Stephen Kennedy. Then he was the head of the department.
I think is papageorgiou. That is our main clinical active clinician in charge of all the clinical component of the study.
And I remember I had a. A phone conversation within one Sunday in March.
And I said, where we should we should go now immediately and do two things.
One, activate all our centres to look at this.
And you go to these people, you know,
before and in the pharmaceutical industry without any contact and tell them that
we should immediately incorporate a pregnant women to do the vaccine trials.
Because if we don't, because in the end we don't incorporate the breakdown, we make a.
Immediately in these vaccine trials. In a year from now, we will be in the same situation.
And now, without knowing with the effect of pregnant women and and it is obvious that these diseases will affect pregnant women.
Then I said, then Stephen Guinea, that has no more people in it for our own.
And then we send a message to John Bell, the visual professor of medicine, that always John helps us support us in many in any way that he can.
Is there where we should get involved with bringing on women immediately and obviously getting back women in the vaccine trust was almost impossible.
They didn't do it. But the idea of component there was to activate our network and and and start immediately
we started we were capable of doing start recruiting basically because in the centres were
already standardised and we know that we make only a small modification to our they outright
were a medical record because in the world has a system of electronic medical records.
Then all of these centres participating they have the medical records electronic the same basically.
They obviously these hospitals have their own specific things, but the core of the data collection is standardised.
Then we only had you made modifications on the.
On the specific issues related to the respiratory condition.
At that time, nobody knew much about the disease but about the gore or the outbreak,
and children were already there electronically, and then we basically started activating it.
Obviously, there was a problem of testing. There were not there was no testing at the time, universal testing.
And there were there were no vaccines then.
But in any case, we in April and May, we started we started collecting collecting data.
And I went to see what was the design of the study that use it and reason I was it
was a prospective design because all are all this is another beauty of having that
the system already in place there all these women and all of them but the most most
of the women in these regions were China through the local medical institutions,
but also were channelled through the world. I mean, they wrote a recruitment all women, you know, Netflix video thing.
But then we did we did a detailed follow up in a smaller sample because these are some of these are big.
And we all all these were geographic areas. There's no regions, cities or regions.
So there should be then there was a this is a large volume of pregnancy.
You can imagine we manage about 50,000 deliveries a year.
This is something completely out of any easy, easy, any possibility to do it.
If you don't have a good commitment from local authorities and colleagues worldwide,
that then basically then then there was a prospect that to say, we know that these women will enter.
And then through the channels of these institutions that we have standardised and we know that we are
going to collect the data that we want to collect because they are already in online or electronically.
Then they we even usually we didn't even we didn't physically contact us.
A woman in the first trimester. The hospitals did contact these women early in pregnancy because they were part of the system and part of the system.
Then we sort of answer your question. We reconstructed a cohort of women who started in April to South and during the
day that were either part of the study because they arrived or were recruited,
by the way, or by our by institutions collaborating with for two or three months earlier.
Then we reconstruct the image created a huge cohort of pregnant women.
The problem was there were not enough testing at that time.
They were not know all old places. Most of the places, even even in developing countries, they have testing.
But no, they didn't have enough test and they were expensive at this and they really didn't have enough test to test all these women then.
Did they actually go for that? We follow.
It was with this was smaller than the the the or the in the growth cohort because obviously these were the interviews with older women,
but we didn't we didn't have enough testing for that.
And then we use testing on symptoms at that time because no, they were the women that have already had these symptoms, blah, blah blah.
But they didn't cause it this. Then.
But these were the limitations in April, May and June of 2020.
Those that's what you were looking to do was very simply to compare women who but whether it was by testing or by looking at their symptoms,
you were pretty certain had COVID. I did not.
And look at the outcomes. Yes. And this is exactly the way we did it, because we didn't call women with COVID.
These were women diagnosed. Of having COVID because they were diagnosed, whatever, whatever method they have, they were they were they not.
Somebody at the end of the day said, this woman hasn't gone and we recreate it prospectively.
And the other thing that was unique was we compare these women with pregnant women that they know are going.
And this is interesting because you you know, people always say, oh, that's obvious.
We're building a enabling. It isn't.
And there was no because there were there were many, many publications of ten, five, nine, nine in cases.
Of course, within this place, another place and so on.
Compare with Norway man with no comparison or compare with a known pregnant women.
And then we said, this is not possible. This is this is a this is a this is a wrong comparison.
And then at that time, the issue was, don't worry, this is a flu.
And pregnant women are not at different risk of a flu than non-pregnant.
That's was what it was known. Therefore, this is an old flu.
Women, pregnant women should be taken. This is not a problem.
And so on. But then, then, then our study and we were lucky also that, as I said, following the teaching,
the young children, we had a system already in place also doing continuous, systematic reviews.
We continuously review the literature in in collaboration with a group being bringing in that we continue to collect the data
any paper published in 2002 and the own respiratory diseases where were collected and read and classify and and summarise.
Then we were saying, listen, we are here saying that this is a new flu.
No problem. There is you are a pregnancy is not a problem.
And. And but but they don't have control groups.
Even if they do, they have their own control because it's a no brainer.
Women are different from their women for many, many working condition reasons, whatever.
Then there should be a concomitant control group of pregnant women with some symbol.
But then there was the difficult to convince people was difficult to convince a donors.
But immediately.
But interesting that neither one of centre we have Junes in February and in April 2002 ended with like a 5050 hospitals around the world as it were,
willing to participate on this. And it wasn't really anything.
It was that many of them did not exist because, you know, the pyramid was moved from China to northern Italy,
then in Europe and then eventually disseminated many other places.
But they were just because we don't have any place, any for any guys.
We don't get guys who want to be part of the study, but we all have cases and we said,
Don't worry, you will get away with it because you will get these cases is moving it.
And then fortunately, which is the reality is always rather complicated.
You have this diverse diversity in the U.S. We we really have immediately because we have had an integral jump from the U.S. and other.
And then, of course, with us in Boston that they're participating in gigabit.
But we're always satellites, friend friendly to us.
They jump in immediately.
Then we have a very nice, very nice representation with a concomitant contrast, I think that makes it make the whole difference.
And then by October 2020, the study was over.
We finished we have the largest study with controls and.
They only want one thing before I tell you.
They find that it was the funding issue.
Yeah. And the we there was a completely these violence.
Logical, logical. These balance between the investment made on many other things,
including vaccines and the investment made in systematically analysing and documenting the risk associated with with COVID, with pregnant women.
We we we did it before. The other thing for which we were already prepared is because we did it the same the same process with a sick epidemic,
the virus infection in north in Brazil, we have we were participated and documented, I think, for the first time.
And this this is another benefit of the decision.
We documented for the first time the magnitude of the effect of Zika on brain development of the foetuses because that that's
where they made their main problem was and because we were standardised already with the same way to measure the head.
Oh, they feed us and then you work. We were able to document the exact magnitude of the effect.
Then with all these background and then the funding was appropriate,
we have in the reserves have been always grateful and lucky to have very good donors.
And then with with good donors, we in general was blessed, which we conducted otherwise would have been impossible.
And who are the who are the donors? Well, then the use of usual suspects by the church.
By the. By the. If the pandemic was moving in a different direction, obviously, logically on on or on vaccine vaccine development.
But. If we were not, we were not lucky.
We were limited to lucky funding.
Then we operated in a in a rather a rather not a or a budget for the question that we thought that was the obvious question.
Then what is the concept? Pregnant women, particularly many in Europe and many, many.
There were all the time working. They were working in conditions that were conditions that they were at high risk.
Nurses and doctors and and a services restaurants support care and general care of the elderly.
They were always were working on a risky front line of risk and many of young women what
was there would be a large number of them pregnant eventually one woman and one boy.
And then just to me, still, I mean, this is this is why there was a high risk population, a pregnant woman in direct contact with a basis.
And then we still I don't understand why there were not a support or B or jump being donors to.
And you you of these and the sort of money that you needed would have been very
small compared with the money needed for a big amount of the money that we
needed was very small compared with the growth and compare with the gigantic
amount of money that was invested that logically I'm not complaining wasn't the.
But then then the interesting thing is we didn't get from the university and we are grateful to the universities
where we some yeah we get support just a minimum to operate but they we did get it and we gave for that.
But the interesting thing is that most of the other the rest of the countries.
The funding was only for coordination and standardisation as a priority because we knew that there were no standardised credibility will not be it.
We would have concerns about it.
The standardisation and data management and local issues were ignored by the rest of the institutions that participated.
We didn't provide any cash to them, but they immediately jumped in, saying,
this is the opportunity to do good research in a dramatic situation and finish it.
Then, by by October, November 2020, we finished.
There was a five month, five months, six months study from the first the first day from April to October.
November. We we kept we kept a month more in the way we were writing the paper because we
wanted to have more complete cases and cover more cases in other places and so on.
Then that was a no. That was perhaps the easiest part.
Then the results were clear. This was a very bad thing for women, for pregnant women,
compared with women that the pregnant women that did not have COVID then completely a throw
away the issue that what this was is just a fluke and they didn't have to worry and that the.
Then the the concept and that this was the same risk that non-pregnant women
therefore therefore if pregnant women were in the when when the vaccine appeared,
pregnant women were in the in the priority list of a woman.
25 year old or 28 years old.
That means it was very low, very, very low priority.
Then our I think our research a map provided a scientific foundation.
The first solid thing difficult and danger with proper controls that the women pregnant women should be jumping to in the
in the due to a high risk because it was a dramatic increase of maternal mortality and preterm birth on preeclampsia.
Then there was a dramatic effect, all of it on on preterm birth.
Can you just put some some numbers on that? What what was the risk, double or no double?
You can get there. We can get the exact numbers on the papers.
But the basically overall was double the risk.
On any major outcomes, plus a maternal severe maternal mortality.
The mortality was like 15 to 16 times higher than the norm, not known to pregnant women without COVID.
Then there was a massive effect. And perhaps because of that, is that the second?
The second process was that we got problems, even if it is a struggling me.
And it goes back to what I said before about that the medicine is worse,
it's more difficult to change but a habit that good habit and and is a we send it we I think in the growth yes and I think we
we personally also we have a very good track record of publication we publish in the best job and I think that's what it is.
Then we thought here with the first study, the most important study on COVID in pregnancy with concomitant controls,
not a sample, you know, road for the subject.
We go, we go and publish the paper from November, November, 2008.
You, April, Justin and Judy, when we send it to paper this,
this exactly the same to normal journals that we always getting with no problem during a war.
The paper was rejected in the New England Journal of Medicine.
It was rejected without even without even sending to reviewers.
We gave up a five month delay in the publication.
And there was no delay. Five months through the process of publishing and then the literature was still being evaluated because we had as I said,
we got these a whole life systematic review that everything their papers published was updated.
We're still seeing these things that were probably five cases in the rural provinces, whatever.
And then we got there. We have about 3000 women.
These are the women that are monitoring all their like.
And we publish the the most the most bizarre out of all of this, of the peer review,
all the reviewers we got and things that were or things that were obvious.
As I said at the beginning, no women have tested.
But because there were people to tend to be tested.
I mean really long queues and you got two weeks.
I think things are obvious, but they were. That's where they lived it.
And it was. Then a.
We have we spent about five months where it was rejected in the three main.
Maybe you got to make a journalist got to sit lance it in the in the in the unilateral
amazing a and they and and they and they they basically the comments were.
And then finally, like in in April or March, April something changing.
Once JAMA Paediatrics was in the JAMA, we sent it to JAMA and JAMA.
It was rejected in the in the main JAMA.
Just for the benefit of those who don't know. It's the Journal of the American Medical Association.
But the paediatric specialists? No, the journal.
JAMA mother is a Journal of American Medical Association.
My daughters are. Yes, a.
The then a. But at the same time, most of these are published in other papers.
The most bizarre things in one case of a blessing that we find out by year.
I'm not saying they were not relevant, but they definitely the implications for pregnant women at this point there,
where it will happen with you, I want you die and die.
What is your risk? Well, there is a preterm birth. Sure, we get a sensation.
And the other thing is, should we stop breastfeeding? He was the most dramatic thing.
Because there was, I believe, the time that they chose to grow the placenta, which is none of these babies placenta.
But anyway, there was a believer that that will be contaminating the milk and then the foetus in the newborn will get then the the a because.
Every day. People were scared of that. Then women were separated from the newborn.
Then not only they beat the virus, it was bad for the mother, and mother was there with the respiratory condition.
Then the baby was separated. Maybe it was breeding.
And another issue was stopping breastfeeding, which is maybe, you know, for you it's not such a big deal.
But in many rural areas around the world, if you stop breastfeeding, there was there was a death sentence for for these prisoners.
If you are 15, 34 weeks of gestation, no breastfeeding, no water.
It was a disaster. It was a how people and our babies.
Sure, there was no risk of breastfeeding. There was a double risk of preterm delivery.
So preeclampsia, high mortality and we couldn't prep.
I probably. Finally, Gemma, for whatever reason.
Decided that was no good enough for for Mother JAMA, but was good for JAMA Paediatrics.
So it's sort of a where we want to keep these guys going.
We're going to publish. And they and they were extraordinary because they publish they publish elegies over 21 April, May.
I can't remember exactly. And a front from from early May.
Major Jonathan and Judy went to the end in six months.
They have 600 citations. The then top citation of a better unit of time that we can help in any of our papers and obviously the journals.
This is a massive citation for it, for the paediatric or for the obstetric.
And you had quite a lot of press coverage as well, didn't do this service.
And we we published it after that because we were reanalysing more and more details and the effect on different pregnant women that were
overweight and diabetic and preeclampsia and the newborn I on with with a obsession on on reassuring people that never stop breastfeeding.
Because in these videos you have to get at content.
But they all their measures are cleaning the place cleaned enabled it put in the baby and the mother
with it with a cover the face and so on a demonstrate it with all these normal basic measures.
They were not risk. They were no risk.
And if there was any potential risk was minor compared with the stoppage.
But as we know then they were desperate there, frankly.
But I think they got another cover press covered.
The the newspapers I have a very good interview with a journalist that they promoted all over that and.
And they have citations. I think we have them by now.
All the papers together, about 750 citations, them for for a less than a year for their for their specialised topic.
It's a massive thing. And there was a.
There was a whole process. And then exactly at that time when when a vaccine was available.
Then. Then at that point, then the issue was, one, you didn't pay attention to us.
We honestly put the finger and now we had to vaccinate these women and nobody knows the risk.
But we do at least know that the risk of no vaccinated is very high.
Then at least you get just that vaccinated women. And there was.
And I think things to be honest with our papers, there was a clear evidence.
This is this is a bad thing. This is really bad.
If you have an instrument that can prevent this, you should vaccinated.
Obviously, as you can imagine, there were many, many negative reaction about vaccinating pregnant women.
And I know even the anti-vaccine groups, but the general public know that it was going to happen,
this and that and the virus is going to cross the placenta where most of the vaccines don't have virus.
But then that's basically what it is.
And and to what extent did the results that you were finally able to publish affect public policy around the world on on public health?
Large, large effect. Because, as I said, the citation is one measure, but immediately the CDC.
It is interesting because in.
Thus the Centres for Disease Control, the Centre for Disease Control in the in the U.S. have adopted a lot and say that our our
paper because I think the key issue is that they have concomitant controls does age does it.
That was a make a big difference they have a concomitant controls and a standardised condition.
No, don't do that. And then they they start promoting that.
But is throwing anything is that the people you got to believe always and people are not much in the scientific
community is that the is interesting because a the the most of the provision on the incision took longer.
They were dragging their feet to recommend a vaccination of pregnant women.
Bigger. I didn't have any.
We really didn't have any contact with the vaccine. There were no vaccine policies in any way.
But it was clear that these vaccines, they were they didn't have the virus divide us.
And then there was not that much of a risk,
but it was a massive risk you have to have if you are pregnant then we were pretty much by the provision organisation.
Was they the companies, you know, the subcommittee, the subcommittee was going to decide, well, maybe only high risk women that you'll be selected.
You know, this is sort of combining the political background to go in there.
But you know interesting is because I went but then in the US where the epidemic hit very hard, then nurses,
midwives and residents, the large proportion of women, nurses and midwife all and then residents are going after the and ecology.
That's what we call them. Junior doctors. Yeah.
Junior doctors. Yes. And in training there is a large proportion and then the these these women.
Many of them would bring them because they're just young women.
And many of them they said, well, I don't care the recommendation of the professor as it is or I'm going to get it,
you know, because I've seen all these people dying here and then the first the first massive baby.
But promoting or contributing the the the the promotion of actually nation
building as it was a paper in the US in which about three I think they started it
with a population account resulting but the public is about 30 something
pregnant women that were health professionals though they were there they said,
well I don't get the recommendation, I get the vaccine immediately.
And then there was the massive cohort that was the first published, about 30,000 and then was expanded to countries.
I think we've been there was virtually zero.
The risk of the foetus imbalance along with the vaccine is no, no risk associated with the vaccine itself.
Then we strongly recommended vaccination, but it was based in a study of women that basically refused to follow the recommendation.
But because they were there, the nurses and they saw well, they saw the people dying,
they said, well, I better get get the get the vaccine for myself then.
That's interesting how people are not generally provided a cohort of them.
Well, that's that's what it is. The last commercial for you is the second study.
Focusing only on Omega. Aye aye.
Aye. Started in January 2002. Did you. I would.
We repeated the next round. Of the original study in the in the in the same network.
Maybe a little bit more expanded,
but the same network repeated a senior study to evaluate the risk of Omicron because a new variant is said that is another flu.
Don't worry, The A.V. Club. Nothing's going to happen that we said we did.
The ones we're going to do again. A What?
What is the risk associated with Omega in pregnant women?
This time we were even worse. We didn't get any any money at all.
They said this topic is over or migraine is nothing, and so on.
And then we study 50 something women.
It started in January 2000 to do, and it started in preparation.
And we we started the study in April and finished in September.
And paper is ready. It has been submitted for publication and got got a favourable response the first time and we are waiting now
for the reviewers to have a set or come back with Gone with our responses to the reviewers in The Lancet.
Therefore, we are willing to move it up after the first round, and I don't know if we're going to be accepted or not, but the first paper.
A to go to Mosul in five months. The whole process, which we did in October and started then in February, was.
March. June. April-June. May.
June. Six month. Therefore Brussels. Then and then they just for you to listen to anything for so long.
And I think it is it is a mercy.
I think I have seen corroborating the it myself.
I gather MAXINE corroborates that a a and that the only current is less aggressive the previous variant.
But still, if you are not vaccinated and you have been not in a risk, you have been not exposed to COVID before.
If your building if you were for COVID, this variant is not as aggressive the previous,
but during pregnancy it does increase the risk of morbidity and mortality and should should be an incentive for a vaccination for pregnant women
actively because still we are with a with a complete said and and the and and the three with three doses is still in in most of the country.
We are not above 50% of vaccination. Then this then is it is a sort of a choo choo times all the same study and I would experience wonderful story.
Well let's just to the for the last few minutes talk about how the pandemic impacted you personally and and how you were able to work.
So you say you move back to the UK just as the first lockdown was beginning.
So what what circumstances where you personally working in during that time.
Well is it the is. Yeah.
Well we move completely we we were affected but not I personally but they were it was not much affected because we were already electronic.
The we already have one.
All the hospitals were connected already electronically. Then our our we're a statistical unit.
We very collaboratively unit in organisation.
Then our in our statistical and data analysis unit is a collaboration that we have with University of California, Berkeley.
Then our unit is in summer in the Bay Area in Berkeley.
Then we, we already we were already electronically then that didn't affect much.
And that is that these point that we are analysing a large amount of data and the knowledge is that
these networks and maybe these and this network works very well but require a lot of physical presence.
And you you look at you go and teach physically A and B, if we're truly a full colleague of all the colleagues that people you know,
the expression of vampire research, the research in which people go go take your blood and disappear and go back to joining Sofia's.
You get a lot then that can create a lot of us is that we don't do much of that but in any way by the I think does it I want to say that the
these people that the college in many places that live in a working condition that are not like the one that we work in in Europe in the UK,
then that, then they go in, they are teaching and being there and say, well we, we are here with you.
You know, the, that thing is a fantastic reward,
more than sometimes more than money then the issues that we did a lot of travelling then I was, I was travelling a lot of time then I didn't.
How did you time to say that the pandemic did not affect much our day to day
activities in the air because we are already moving a lot busier than that.
And then. And I benefit because I took the opportunity to write a lot and then the jail remained closed for a while.
And now I still say my career is not closed,
but people people remain working at home and the university got extended a policy then it did not affect much.
They knew they were. But colleagues that because I'm retired like several times, then I don't do any legal work.
But people that were cleaning the front line, they were a scare and they've been tested all the time because, you know,
I was going to ask you whether you personally, I mean, AdSense or if I may put it politely as an older person.
But were you at any time, did you feel personally threatened by the possibility of being infected before the vaccine was available?
Well. Yes.
But you know, the bigger the pandemic and just trendy the A there were still ignorance at least.
And then I spent time in Switzerland, daughter in Switzerland.
Then there was I ended up passing the pandemic personally in Nomad in a small village it was small communities or sort of say my rural areas.
Then it didn't have much of a social activity before.
And there was a I personally about people that live in the main in London, for example, the Irish population, like I say,
including St George, and he was being tested all the time and in the in the country there with patients and cases and so on.
Then that did affect to me personally I think the more.
And this is how I got my oldest son, those intensive care units in the Bay Area in San Francisco, and then in the intensive care unit,
they were very much affected these people, because normally the death rate of intensive care units, Kyra.
But with Kobe, they kind of 70% or minimum of death.
And then they were they were devastated by these.
And thus, I think the more the closer, the closer I get to myself as I really remain.
And I got immediately a vaccine. As soon as I get it, I got I got the vaccine.
And then the. And that's it.
I think that's. But people that were reluctant to vaccinate and they were more exposed and they were really scared.
And I think everybody. But I remain at home and I'm writing.
Then that was it. There was a way to do it.
And I'm publishing all this. All the all the first verse.
The first thing they wrote in the first Kobe started every day.
Then there's a. Well, it was a good opportunity to do that.
Yes, yes, yes. And must have given you a tremendous sense that however difficult living through the pandemic was,
you had done you and your colleagues had done a really good thing.
And that was something you could feel good about. Well, thank you.
So finally, has your experience of the pandemic changed your attitude or your approach to your work?
Um. Well, no, actually, it was reinforces.
In the force that we were we were on the right track and then one, we will remain that, he said.
Is it true that with globalisation is a global activity and there is nothing better to have it,
it's nothing better to have a large sample size in any area in India accommodating,
having a large sample size and is the best thing that can happen because you can do what you're going to explore.
QUESTION The results are solid and you don't need much statisticians.
There is, there is, is. And also importantly, is that immediately a contribution dissemination?
Because immediate reorg for within the rule book for forecasting it has a no limit.
The cost has a network of maybe a hundred institutions that follow immediately.
Where we recommend because they were part of is that they were somehow one way or the other.
There were policies then then is it is a massive army of people, committed people and they disseminated results.
This is it. This is a fantastic experience. And I think we reinforces our effort.
Yes. Thank you very much.
No, my pleasure.