This post continues the Silencing Safety, Lonesome Heroines, and Uterine Roulette theme of Consent. It is a twin birth with In Secula Seculorum. The original Xmas was not a peaceful event, nor is this Xmas, and this is not a peaceful post. It hinges on the work of Peter Selley – who is not responsible for any irreverence or edginess in tone.
The Very Dead of Winter
It is a time of year for pregnancies and babies and a tricky time for accommodation. This year it’s also time for empowering women. Pregnant women need the best information about what they can safely take. Can they accommodate a growing number of Vax Inns?
The appearance of a recent Bright Star caught the attention of far more than 3 wise women, bioethicists among them. Some of them, following the Star, advocate with the Zeal of a Convert, that all women when pregnant should participate in pharmaceutical company commercial exercises involving drugs and vaccines. Consider scheduling your pregnancy to coincide with one. Pregnancy must be brought in from the cold.
Whether drugs or vaccines, company commercial exercises are designed to find an effect from which companies can benefit, while systematically neglecting other effects that might be important to those who take the company product.
The Protestant Ethic form of capitalism is about doing well by doing good. Recent vaccines are the epitome of this, with capital doing well beyond the dreams of avarice by producing sacraments – something that can only benefit and cannot harm. Endorsing sacraments is not a Protestant thing, but they are not protesting these developments.
For pregnant women traveling around this time of the year – in the Global North – a vaccine, like a census 2 millennia ago, might be mandatory. It is Respiratory Syncytial Virus (RSV) season. We have better technologies than Herod ever had to track every newborn and ensure they are taken care of, along with dashboards to generate fear in the population by showing mounting RSV infections and a threat to our health systems from hospitalized infants.
To the Sounds of a Drum © Nina Otulakowski November 2022
We can:
Tell the Rabble to start Ranting, Stimulate a Riot,
Get the Common Crowd to Shout much too Loud
Telling your Mother who sings your song that She’s a Fool and She is Wrong
[Jesus Christ Superstar – adapted]
We can ensure that even grandparents are forced to get RSV vaccines to ensure the little fella remains safe. See Oh Granny.
An Iconic Moment
Two years ago, if you were pregnant, the Covid vaccine was mandatory in both Global North and South. Refuse it and you lost your job. In the absence of evidence that it was safe in pregnancy, there was pressure on Pfizer to join the Lets Empower Women Drive (LEWD) and set up a Comirnaty commercial exercise. It was set up but ground to a halt with only 348 of 4000 women empowered.
Wise women around the world believed recruitment was difficult because pretty well everyone had already been vaccinated. This message appeared to come from Pfizer. In fact the company running the exercise, Icon, on behalf of BioNTech, had been told – but didn’t mention – to change protocols and warn about a myocarditis and pericarditis risk. No hint of a barking Pfizo anywhere.
Even prior to this warning, the Comirnaty exercise protocol states: ‘clinical safety laboratory assessments will not be collected for this study’.
An -itis indicates inflammation. Vaccines produce injection site inflammation. Arm aches that might extend to headaches, all over aches, and potentially fever. Myocarditis affects the heart and can be lethal, especially for younger people. Not something to worry about, doctors at the vaccine sites told healthy young men with chest pains. That reaction shows the vaccine is working well. Having to warn about a lethal -itis doesn’t have the same empowering allure.
If those likely to engage in strenuous physical activity after their shot had been warned about this risk and told to take things easy for a week or two, many lives might have been saved – especially among athletes. Telling athletes to take time off from making money for so many vested interests, though, would have been a problem.
A possibly even trickier problem to manage in pregnancy when, even at rest, the body is working overtime and cannot just take a break. Think of it like a confinement – like all women used to do after birth – might not do it.
If you are tempted to take paracetamol or acetaminophen for any inflammatory symptoms, there is another problem. There has been evidence for several decades that this Vioxx-like Cox-2 inhibitor can cause premature closure of the ductus arteriosus and lead to pulmonary hypertension in the new born – Uterine roulette.
Little Boxes
While Pfizer were being nudged into exercising their commercial rights with Comirnaty, both they and GlaxoSmithKline (GSK) had set up commercial programs for their maternal RSV products in a much more gung-ho spirit. Gung-ho?
LEWD had grown so fast, FDA and EMA hadn’t even begun to think about what tickable boxes might be needed for them to say precautions were in place. There are first trimester boxes but these cover teratogenicity; the third trimester is virgin territory. Having boxes in place is more important to regulators than company adherence to them. It was only after maternal vaccines came along that our let’s-guard-ourselves-first (LGOF) guardians realized they need third trimester boxes. They now have a rolling program of meetings to remedy this.
RSV is a pretty harmless virus. Sixty years ago, the first RSV vaccine made by Pfizer spooked everyone by making post vaccine RSV infections more lethal than the natural version. A dead and buried virus, mummified in an antibody cocoon, could now return. Vaccine Enhanced Respiratory Disease happens with most respiratory virus vaccines.
Just as Chemie-Gruenenthal, the marketers of thalidomide, spent sixty years seeking something it might cure – to exonerate themselves – Pfizer and other companies have been trying ever since to get an RSV vaccine that works. Raiders of the Lost Teratogen and To The Death and Beyond.
GSK’s RSV commercial exercise terminated prematurely. Something amiss on pregnancy’s hallowed ground? GSK weren’t telling anyone – except their investors. There were a lot more pre-term births on the vaccine, especially among Africans and an excess of neonatal deaths.
GSK hinted there might be problems when women took other vaccines – Covid or perhaps influenza, tetanus, diphtheria or pertussis (TDAP). The women were not allowed to get any of the standard vaccines within 15 days either side of the RSV product, perhaps leaving GSK unable to work out what was going on because their data was patchy.
Pfizer, with an almost identical vaccine, allowed the flu vaccine a week after the RSV product and TDAP two weeks after. They also recorded an excess of pre-term births and pre-eclampsia in the mothers.
Both GSK and Pfizer had run exercises in which RSV and Flu/TDAP vaccines were given separately or combined to women – who were not pregnant. Pfizer’s ghosted report of the results of their exercise appeared in the Journal of Infectious Diseases with Major Article in a Big Red Box at the top.
Both RSV vaccines caused the Pertussis antibody count to plummet.
The protocols for these commercial exercises focused on getting blood samples from infants to test for antibodies rather than bloods from their mothers to test for inflammatory markers.
A prior study by Van Rijn et al had found, as the Christian et al study had found, that the influenza vaccine caused an inflammatory response. Van Rijn went further and showed a link to inflammatory markers and to pre-eclampsia and an enduring increase in inflammatory responses post-pregnancy.
Establishing the extent of inflammatory reactions, interactions between these and the vaccines, and any linkage with premature births or eclampsia would have been easy. A basic and cheap blood test would have done it. Any findings could have helped shape LEWD debates, but no wise women interested in these issues, except Hana El Sahly, has raised a peep.
Although their product failed, GSK might not be out of the woods. Their RSV vaccine is licensed for parents. This sets up more Oh Granny adverts insisting mothers get their parents to have both Pertussis and RSV vaccines before Little Red can come to visit. We don’t appear to have data on the effects of this. This is not quite the same as Pfizer’s conundrum who also have an RSV product for mature and responsible people, but not a Pertussis product.
Illustration: The Heart of Medicine, © 2013 created by Billiam James
The figure on the right is Andrew Witty – former CEO of GSK.
Stable Conundrum
LGOF brigades like to keep in lockstep, but with the RSV vaccines they don’t seem to be cribbing from each other. FDA nudge women to get the vaccine between weeks 32 and 36 eliminating the possibility of seriously preterm births and reducing the likelihood of any preterm births. But EMA have opened the door to women getting the vaccine as early as 24 weeks with a 24 to 36 week window.
No-one is fronting up on the issue of when, vis-à-vis the RSV vaccine, to give all the other vaccines, especially Pertussis, which in general most virologists seem to think are more important than an RSV vaccine. And what about Covid vaccines should a new virulent variant turn up?
The American College of Obstetricians and Gynecologists (ACOG) encourage doctors to ensure women get all vaccines, including any pandemic ones. ACOG don’t tell doctors how best to go about doing this but strangely do say:
- Maternal RSV vaccine can be administered at the same time as other vaccines routinely recommended during pregnancy.
The Centers for Disease Control say:
- ‘Data are lacking on the safety of coadministration with other vaccines recommended for pregnant women, such as COVID-19 vaccines and Tdap vaccine’.
[You thought there was data – look again, it was in non-pregnant women. We don’t know what the lower immune responses for pertussis mean and we don’t know what pregnancy might do to these or other responses or what these might do to pregnancy.]
‘When deciding whether to coadminister other vaccines with an RSV vaccine, providers should consider whether the patient is up to date with currently recommended vaccines, the likelihood of the patient returning for additional vaccine doses, risk for acquiring vaccine-preventable disease, vaccine reactogenicity profiles, and patient preferences’.
There’s that word ‘providers’ again. Joe Toerner used it at the FDA Advisory Committee meeting where Hana El Sahly raised these issues first. It means doctors or rather it means the technicians doctors have become, along with an increasing number of non-medical prescribers who are perhaps even less likely to tell women they can skip a product or two.
But how are these providers, who do not have access to the data, supposed to know how to advise someone when ACOG and CDC don’t seem to know what to say? If, as doctors like ACOG once did, ACOG had organized a proper trial designed to inform clinical practice and public health, with doctors able to access the data, rather than leaving us to the mercies of commercial exercises, women might have been empowered and it might be possible for a provider to give a woman a ‘steer’ – something better than holding a wet finger up to check the direction of the breeze. As things stand – well its anyone’s guess – thank God we have provider fall-guys.
This is a crisis. No-one wants to say out loud that we have a mess on our hands. No-one wants to point out that at some point if multiple customers are attempting to muscle their way into the same accommodation someone is going to lose out.
Nearest available accommodation Joe? Not sure you’ll get anything on the West Bank
If todays Wise Women discover wherever the infant ends up now but found s/he or her mother was not vaccinated – what would they do?
There was a Birth, certainly,
We had evidence and no doubt. I had seen birth and death,
But had thought they were different; this Birth was
Hard and bitter agony for us, like Death, our death.
We returned to our places, these Kingdoms,
But no longer at ease here, in the old dispensation,
With an alien people clutching their goods.
From TS Elliott Journey of the Magi. Here’s a challenge – spot the adaptation.
Written by Dr David Healy MD
Reviewed by Dr Peter Selley MB
RxISK has resurrected its Zones, adding in a new Vision Zone. In line with this post, early in the New Year, there will be a new Fertility Zone.
For anyone interested in the development of the pregnancy outlined in this post see:
annie says
@GSK
Dec 22
We’re committed to help raise awareness among those who are most at risk of RSV, especially older adults and those with health conditions. Safeguard yourself and your loved ones this holiday season by consulting your healthcare professional and learning how to reduce risk.
@AlbertBourla
RSV doesn’t discriminate on the basis of age. According to the CDC, each year, an estimated 60K-160K older adults in the US are hospitalized, and 6K-10K die due to RSV infection. The CDC also recognizes that RSV is the leading cause of hospitalization in infants. Talk to your healthcare provider about whether #RSV vaccination is recommended.
https://endpts.com/marketingrx-roundup-pfizer-boosts-rsv-vaccine-abrysvo-campaign-jj-videos-spotlight-renamed-janssen-unit/
Pfizer’s RSV vaccine brand campaign for Abrysvo continues to roll out with Meta social media ads debuted last week. The “Every Breath Matters” ad debuted on TV in October with a 60-second spot that is still running. It focuses on a trumpet player and the 579 breaths she has to show her stuff, the voiceover says, and advises viewers to not let RSV take their breath away.
The newer Meta ads running on Facebook and Instagram feature the same jazz trumpet player and include a link to the Abrysvo website along with the advice to ask a pharmacist or doctor about the vaccine.
The brand campaign follows an RSV disease awareness campaign begun in August, and still running on TV, digital and social media, with the theme “Not all dangers come with warning labels.” Pfizer’s Abrysvo vaccine was first approved in May to prevent RSV in older adults, and then again in August for pregnant women to help protect newborns against the respiratory infection.
Pfizer reported Q3 US sales of $375 million for Abrysvo in its most recent earnings call.
https://endpts.com/pfizer-and-gsk-marketing-battle-shaping-up-with-rsv-vaccine-advertising-debuts/
a bocce ball, the top of a woman’s hat, on a menu and even on a towel at the gym as a voiceover warns that RSV is highly contagious and can be dangerous for people 60 and older.
Dr Pedro says
Silent Night?
or so it seems
Dr. David Healy says
A deafeningly Silent Night.
Just so readers know, we haven’t just put up posts and hope for a response – we have reached out to friends who are obstetricians half expecting to be told – either there’s nothing new here or this is clearly wrong for this or that or the other reason.
You don’t have to be an obstetrician to have a view and we’ve reached out to hundreds of people beyond obstetricians – people who are into the adverse events of medicines – and again no response. We’ve also asked them to check it out with obstetricians they might know.
We’ve reached out to those promoting the vaccines in a relatively friendly and constructive way – tell us what we’re getting wrong here. No response. The responses from ACOG, regulators and others have been dissembling and non-engaged.
In line with this posts twin – In Secula Seculorum on davidhealy.org, these days the carol, anthem, would be Silent Night Healthy Night. But this seems to be exactly what we don’t have here.
It would be good to have Good News streaming from Heaven afar with Heavenly Hosts backing Leonard Cohen singing Hallelujah – showing normal CRP tests, or evidence that some angel is thinking about what do to manage elevations in CRP levels – is it safe to give acetaminophen – paracetamol – perhaps avoid it after week 32 or 36 and give X instead.
One of the other mysteries here is the
Radiant beams from bioethicists faces
At the dawn of redeeming Grace.
The GSK RSV commercial exercise was given the name – acronym GRACE. We have been reaching out to bioethicists, friends of ours among them who support vaccination trials in pregnancy – as do we in principle. Even these bioethical friends seem to have drunk the Cool-Aid of RCTs – that a mystery happens when an RCT is born that even if the father is a pharmaceutical company that the outcome will be glorious. Somehow the pharmaceutical company will be transformed into a scientific enterprise. And that if not, Regulators know what’s going on and will have all the right procedures in place.
Just to be clear, in terms of moving all these issues forward we have had more help from people within pharma than from bioethicists or all others who profess to be engaged in counteracting what is often described as the malign influence of pharma. Perhaps we should be looking at what we are getting wrong before casting stones. Its in that kind of spirit we have been asking people to respond – what are we doing wrong that is leading to increasingly problematic outcomes.
D
annie says
How deep does ‘the malign influence of pharma’ Go
RSV Vaccines are Finally Here after Decades of False Starts
Decades of failed attempts have given way to several successful vaccines and treatments for the respiratory disease RSV
https://www.scientificamerican.com/article/rsv-vaccines-are-finally-here-after-decades-of-false-starts/
Before RSV vaccine research could lead anywhere fruitful, researchers needed to know what had gone so wrong in the 1960s trials to cause antibody-enhanced disease. The mystery wasn’t solved until 2008, when Fernando P. Polack, founder of the Infant Foundation in Argentina, and his team at Johns Hopkins University published a study in Nature Medicine describing experiments with mice that demonstrated how the antibodies produced by the vaccinated children’s immune systems bound to RSV but did not neutralize it.
https://academic.oup.com/ofid/article/9/Supplement_2/ofac492.1871/6903998
Fernando Polack has written many articles on RSV and the quest he had been on https://pubmed.ncbi.nlm.nih.gov/33524290/ Before he was recruited to run trials in Argentina on Pfizer’s Covid Vaccine, which is, of course, anther story…
annie says
Is the pressure on
It only takes a moment to realise, on the Web, that doctors are falling over themselves with enthusiasm, for the new breakthrough RSV jabs from Pfizer for pregnant people and infants, and GSK for the older generation
Women’s Hour, R4, talks RSV
11.24
https://www.bbc.co.uk/sounds/play/m001trv6
St. Louis
Doctors suggest pregnant mothers get RSV vaccine
https://www.msn.com/en-us/health/other/doctors-suggest-pregnant-mothers-get-rsv-vaccine/ar-AA1m3TMC
FDA NEWS RELEASE
FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants
https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants
Getting back to Women’s Hour, when is an advert, not an advert?
When this RSV vaccine was first open to discussion, Peter Selley was right on it with his submissions and warnings.
Peter, with a lot of hype now openly open, is there any way back from the enthusiasm generated publicly on offer, or is this now cast in stone, with Pfizer. Perhaps on the back foot with the Covid Vaccine, but on the front foot, with the RSV Vaccine
mary H says
Hi Annie. have you noticed how the UK BBC news are falling over each other this morning to explain that the RSV vaccine IS NOT A VACCINE? Making a big thing of the ‘antibodies’ explanations!
Let’s look out for their next step shall we!
Dr. David Healy says
This is talking about Beyfortus – nirsevimab – which is a monoclonal antibody not a vaccine. Although there is every chance it will be widely called a vaccine soon.
It had a predecessor – palivizumab – also a monoclonal antibody which was used in children whose health was compromised by birth defects etc – why restrict it in this way – well the general sense was you do not want to give a monoclonal antibody to someone who does not need one. But nirsevimab is being pushed for all children. It feels a bit like giving an opioid for a minor ache.
D
mary H says
Yes, it was nirsevimab that they mentioned, to be used in really young babies. A gentle mention also about the research for its use pre-birth. The usual -“better to have this, which gives almost instant protection, rather than risk having a sick infant” said the doctor that was being interviewed.
annie says
Hi Mary
This is the study everyone is jumping up and down about today, from NEJM
The Harmonie study
https://www.nejm.org/doi/full/10.1056/NEJMoa2309189?query=featured_home
Almost every media outlet is carrying the New Study story.
Nirsevimab, developed by AstraZeneca and Sanofi, was licensed for use in the UK last year.
The Joint Committee on Vaccination and Immunisation (JCVI), which advises the government, has said a cost-effective RSV immunisation programme should be developed for both infants and older adults.
It says there are two options, either the antibody jab or an RSV vaccine given to pregnant women. The committee says either would make a major impact on hospital admissions in young children.
Sir Andrew Pollard, director of the Oxford Vaccine Group at the University of Oxford, said the jab could help combat a virus that places “huge pressure” on Britain’s health system.
Sir Andrew said the jab could help “protect the youngest in society and dramatically alleviate winter strain in the NHS”.
That went well…
https://www.stx.ox.ac.uk/article/andrew-pollard-announces-vaccine-breakthrough
Speaking about the vaccine, Prof Pollard said: “We have a vaccine for the world, because we’ve got a vaccine which is highly effective – it prevents severe disease and hospitalisation”.
Peter Selley says
Annie
My impression is that Pfizer’s Abrysvo given during pregnancy is losing the battle with nirsevimab for the babies..
The indecent haste with which both were introduced in USA in time for this “season” has highlighted the problems. Apart from confusion as to which vaccine can be given to which age group, there is an enormous problem with the “window” of just 4 weeks (32-36) when the vaccine can be given to mothers, who have also got to cram in the cocktail of Tdap, covid, flu and soon Pfizer’s GBS (streptococcus) vaccines
JCVI in UK say that it will come down to cost-effectiveness i.e. pricing.
But no one will debate the harms issue.
But the preterm births and preeclampsia worries unique to Pfizer’s vaccine and described in their US Label will not go away.
annie says
Thanks, Peter. Pfizer’s shot, not shot down…
Why is it unclear?
Preterm birth and high blood pressure during pregnancy, including pre-eclampsia, have been reported among pregnant people who received RSV vaccine during clinical trials. It is unclear whether these events were caused by the vaccine.
https://www.cdc.gov/vaccines/hcp/vis/vis-statements/rsv.html
Dr. Helen Keipp Talbot, the lone CDC advisory group member who voted against Abrysvo, expressed concern that the recommendation was too complicated.
“I think it’s going to make providing care more difficult,” said Talbot, an associate professor of medicine at Vanderbilt University in Nashville, Tennessee.
“If we just say the child should get the monoclonal [antibody drug], we have a very simple recommendation. It’s a cost effective and very effective mechanism of protecting the child.”
But other members said it was important to have more than one protective tool.
“I could not have imagined better options for our infants and children. This is what we’ve been striving for. As a neonatologist with high-risk babies, this is just fantastic,” said Dr. Pablo Sánchez, a pediatrics professor at The Ohio State University College of Medicine.
The most common side effects reported among pregnant women in Pfizer’s trial were fatigue, headache, injection site pain, muscle pain, nausea, joint pain and diarrhea.
There was also a slightly higher rate of preterm births (defined as before 37 weeks’ gestation) among women who got the vaccine than those who got a placebo. The difference wasn’t statistically significant, but the prescribing label for Abrysvo comes with a warning not to administer it before 32 weeks’ gestation nonetheless.
Last year, the pharmaceutical company GSK halted its trial of an RSV vaccine after it showed a higher preterm birth rate among some recipients. The CDC advisers said Friday that those results were relevant to the evaluation of Pfizer’s shot.
Pfizer’s trial also found a slightly higher number of hypertensive disorders like pre-eclampsia among the vaccine group. Pfizer has said it will monitor the risk of preterm birth and hypertensive disorders among vaccine recipients.
https://www.nbcnews.com/health/health-news/cdc-rsv-vaccine-pregnant-people-protect-babies-rcna116908
‘Last year, the pharmaceutical company GSK halted its trial of an RSV vaccine after it showed a higher preterm birth rate among some recipients. The CDC advisers said Friday that those results were relevant to the evaluation of Pfizer’s shot.’
The logic in their head, seems manifestly scrambled. Using the failed GSK, to prop up the Pfizer…
annie says
Dame Emma Walmsley guest edits Today, on New Year’s Day
She replaced Sir Andrew Witty, as CEO, of GlaxoSmithKline
https://www.bbc.co.uk/programmes/m001ts41
Jean-Pierre Garnier, GSK CEO, previous to CEO Andrew Witty
The same problems, the same answers
https://www.theguardian.com/media/audio/2008/may/19/james.naughty.interview
“Whaddya Want” —–
One trial investigator, speaking anonymously because they had signed a confidentiality agreement with the company, said they questioned Pfizer early in 2022 about the potential risk of preterm birth given the similarity between Pfizer and GSK’s products, but was told their data hadn’t shown any increase in risk.
Other trial investigators disagreed with the notion that participants should have been informed. Beate Kampmann, director of the Centre for Global Health at Charite University Hospital Berlin, one of the lead authors of Pfizer’s phase 3 trial paper, and who was responsible for a trial site in the Gambia, said that GSK’s results weren’t relevant to her trial participants “as most participants were already in follow up.”
Some Pfizer trial consent forms seen by The BMJ contain contradictory statements, both warning of possible “life-threatening” effects of the vaccine on the baby while simultaneously carrying a passage that said only the expectant mother is at risk from adverse effects.
“Knowing what we know now, the statement in question is irresponsible and, given the benefit of hindsight, is actually factually incorrect,” said Rose Bernabe, professor of research ethics and research integrity at the University of Oslo. “Considering the gravity of the risk that this irresponsible statement veils, this misleading statement should be a ground for questioning the validity of the consent process.”
The Guardian wrote that James Naughtie had ‘met his Waterloo’, and it was a lesson in politeness from J-P Garnier, who resented the seven times he was questioned about Seroxat.
Totally missing the point that this was the only time in GSK’s history, that a journalist had got his hook and was trying to fix it on the worm.
In Andrew Witty’s Reign, did he curse J-P. Study 329 did go through the millions of ‘data’, as the lack of RSV data is similar in vein, and missing.
Emma Walmsley’s stint, will likely be a celebration, not an interrogation…
Dr. David Healy says
It will be interesting to hear what you make of Emma’s stint
D
annie says
How very different J-P Garnier, Andrew Witty and now, Emma Walmsley are.
The Gallic firebrand, the industry-trainee brought up, who dazed his audience by not stopping talking, the extremely attractive ex L’Oréal executive.
Emma chose her vignettes carefully, putting a positive spin on pharmaceuticals without too much thrust, giving her a chance to be ‘Emma’ without too much ‘GSK’. I enjoyed her jaunt around Kew Gardens, where her glasses steamed up, in the leaf dense humidity where plants can aid in curing.
She got ‘a bit of god’ and some ‘nanoparticles’.
RSV was mentioned in one sentence when she obligingly listed HIV, Cancer, Diabetes, etc.
She spoke about IP and how once drugs went generic, no more money was to made.
How so many drugs did fail to make it. Poor little pharma.
I couldn’t imagine J-P or Andrew, or Albert, doing a stint as a Guest Editor, as I was quite surprised to see Emma, as CEO of GlaxoSmithKline, having this role. An unusual choice, a controversial choice, a fascinating woman at the peak of her career?
Emma is extremely well-educated, has lived and worked all over the world in high pressure environments, comes from a well-heeled background, is quite feisty and empowered.
In her last moments, was the pep talk and her choice of song Nina Simone’s Feeling Good
https://www.youtube.com/watch?v=D5Y11hwjMNs
What’s not to like, as Today thought so.
Dr. David Healy says
Thanks for the update. You are probably not looking at a difference between Emma and Andy but more at marketing updates. In the last few years the advice to CEOs of pharma or EMA (Emer) is we need to humanize you – listeners, readers want to know you’re reading lists etc, where you go on holidays – forget whether EMA has recently approved a bunch of generic drugs based on fraudulent data from India or GSK has authorized fraud in their clinical trial publications – trust in the industry depends on people feeling they know and like you not on your track record
I guess the question is are we more inclined to trust Emmas and Emers than Emmetts and Emmanuels and is this why Emma and Emer are in these roles now and in those roles do they have power or are they velvet gloves.
David
annie says
Or a velvet glove?
Extensively covered, a symbol of HOPE; the comment below, by a trainee, seems appropriate to Gloves Off https://www.bmj.com/content/346/bmj.f1458/rapid-responses
Emma Walmsley: the acceptable face of big pharma?
Andrew Witty: the acceptable face of big pharma?
https://www.bmj.com/content/346/bmj.f1458
It is difficult not to find the timing of your profile on Andrew Witty somewhat bemusing.1
Certainly, the moves made by GSK in recent weeks have been exciting. Simply signing up to the alltrials.net campaign is a huge step for such a large pharmaceutical company, and one can only hope that this is a watershed moment that will shame other companies into taking similar action.
But your article misses two very important points. Firstly, we have seen this all before. Time and again, drug companies have promised to reveal data, only to drag their feet. This is true of Roche, and it has been true of GSK in the Rosiglitazone scandal, which has overlapped with Witty’s tenure as CEO.2,3
Secondly, we should not be looking to a member of industry to correct the transgressions of the past. Stopping Big Pharma from partaking in fraudulent activities, hiding trial data, or promoting drugs inappropriately has to be the role of the regulators and the legal system, not the whims of whichever person happens to be in charge at a given time.
Even so, if we ever see real action – that is, all of GSK’s clinical trial data being available in an accessible, analysable format – it may, then, be appropriate to run an image of an industry leader on the front cover of a serious academic journal, portraying them as a symbol of hope for our profession.
Until that day, we should withhold our praise.