This post runs hand in hand with Women and Children First by Peter Selley. Both posts link to a BMJ Consent Article and Vaccine contre la bronchiolite: Pfizer Essais en zone d’ombre by Ariane Denoyel for Blast, a French investigative journalism unit..
Peter Selley first contacted me in April 2020. As I now know Peter has an impeccable background in common sense. He and his practice partner in a rural English Family Doctor practice had run into trouble with the British powers-that-be for prescribing fewer medicines than the norm. Clare, his marital partner, has an even more extraordinary background in making the right kind of difference.
I was struck by the little things that caught his attention. A patient who was a former sportsman had put on huge amounts of weight and become seriously diabetic. Peter laid out the treatment options – pills or diet and lifestyle. The man went away, lost huge amounts of weight and changed his lifestyle, and, without taking a single pill, came back cured. Peter went into the practice computer to remove the diabetes diagnosis, but found the computer refused to allow this.
It looked to me from his early overtures that Peter figured something could be done to dig into clinical trial fraud. He bounced ideas off me and somehow pretty quickly his wondering about doing things slipped into doing them. The Covid pandemic and its vaccines gave lots of scope for engagement.
The New England Journal of Misinformation
Among his many balls in the air in April 2022, Peter mentioned data from a just published article in what we had begun to call the New England Journal of Misinformation paper on a phase 2 trial of Pfizer’s Maternal RSV vaccine.
What caught his attention seemed trivial to me. Pfizer had hidden a neonatal jaundice problem under 5 headings – neonatal jaundice, hyperbilirubinemia, jaundice of the newborn and others.
For anyone used to company trials, this is common – the SSRI induced agitation tht causes suicide can be coded under anxiety, hyperactivity, restlessness, tension, nervousness, emotional lability and other headings – leaving companies declaring there was no signal of a problem in their ‘clinical trials’.
Multiple codings for jaundice in infants is a pointer to preterm births – which, as it turns out, has also been hidden under multiple codings like premature birth, premature labor, premature rupture of membranes, pre-term birth etc.
When the issue came up first, as a man and doctor with nothing to do with reproduction, I wondered why the fuss. A shorter pregnancy and lighter baby would probable appeal to many women. I now know it creates lifelong problems – people born prematurely or with low birth weights are likely to die earlier.
The ghostwritten paper was blatantly disingenuous. The abstract stated:
“The incidences of adverse events in the women and infants were similar in the vaccine and placebo groups.”
But in the appendix Peter found there was 3.5 more pre-term births in the vaccinated mothers.
We raised our concerns in a polite letter which avoided telling the NEJM editors that teenagers in high school could have spotted this possibly deliberate attempt to misinform. NEJM editors have belle indifference (hysteria) when it comes to their reputation on matters like this. The dynamics of this state are shaped by the fact that how they are viewed is totally out of their control but very unlikely to change any time soon. See The New England Journal of Misinformation and Eric Rubin Boston Strangler.
Peter at this point was not in the business of attaching his name to his concerns and we persuaded a colleague to be the author of the letter.
NEJM of course didn’t publish – they never engage with adverse events. We had a beyond ridiculous response from Pfizer, including Eric, telling us that and half of children born have some evidence of jaundice and the trial findings were therefore not a matter of concern. See Women, Pregnancy and Clinical Trials.
Exchanges like this left us viewing the NEJM somewhat like an IKEA catalogue – a glossy brochure for healthcare products that are shiny on the surface, standardized and relatively shoddy – or should that be absolutely shoddy?
The British Medical Journalism Journal
On November 16 2023 THE British Medical Journalism Journal (BMJJ) published an article on Pfizer’s Maternal RSV vaccine trial.
Simultaneously Ariane Denoyel published an article on the same issues in Blast, a Parisian investigative journalism unit. The two articles could not be more different. This post is about that difference.
A year earlier in early Dec 2022, Peter had approached THE BMJJ investigative journalism unit with a story about RSV vaccine trials and GSK and Pfizer hiding the problems.
His original puzzlement about the multiple codings for jaundice led him to discover:
- Eric Simoes the lead ‘supposed author’ on this ghostwritten article had several years before been an advocate for breast-feeding as the best way to prevent neonatal infections
- There was no mention of the breast-feeding status of any of the women in either of the Pfizer trials or in the GSK trial.
- A proposed phase 2 GSK trial of an RSV vaccine for children had been refused ethics approval in the UK.
- There had been a phase 3 GSK trial that terminated early because of excess premature births and neonatal deaths.
- That GSK had informed investors in the company of this fact early in 2022, but likely did not inform regulators in detail and told doctors nothing.
- That Eric Simoes was on the Data Safety Monitoring Board for this GSK trial – so there appears to be no way Pfizer could not have been aware of the problem.
- A Pfizer/Advarra/Icon consent form for the trial that told mothers no harm could come to their babies because they, the mother, who was getting the vaccine, not their babies.
This was super-sleuthing of the type that Anne-Marie Kelly has done in respect of SSRIs and alcoholism – See A Medical Triumph – and so many others have done to draw our attention to the sexual, fertility and other effects of SSRIs.
While, single-handedly Peter had uncovered a treasure trove of material, in December 2022 we figured an investigative journalism unit could surely add to what he had found.
Despite expressing an interest, THE BMJJ were slow to engage. We went along with this because if you can’t trust THE BMJJ who can you trust? This delay was almost certainly to Pfizer’s advantage.
Finally BMJJ put us in touch with a healthcare journalist we liked. One of my earliest questions to him was whether he knew why THE BMJJ were using journalists to write accounts about medically important material that doctors, academics and others had discovered and were all too willing to write about – but The BMJJ were refusing to let them. He didn’t offer a view on this.
A THE BMJJ piece came out in late March 2023. It was a great disappointment.
- It contained nothing of any substance beyond what Peter had discovered.
- It omitted the Consent form and other details about the consent process.
- It exemplifies a new form of Ghostwriting, perhaps common to other major medical journals, but definitely the modus operandi for THE BMJJ.
As regards the Consent form story, we were told this had been omitted because of concerns THE BMJJ’s lawyers had. But it would appear. We’re not sure it would have appeared without regular harassment by us. It did on November 16, almost a year after Peter took his discoveries to THE BMJJ investigative journalism unit.
The Nov article contains nothing new. In fact like the previous article not only is there nothing new but the article is stillborn – there are details but little sign of life.
Ghosts in the Magazine
Twenty years ago medical ghostwriting was a matter of concern. Pretty well all the literature on on-patent drugs was written by ghostwriters and there was little awareness of this. Everybody saw distinguished authorship lines and the distinction of the apparent authors sold drugs and concepts.
The only problem many could see with this was the element of deception – the ghost authors were not getting credit. Not many knew that one point behind the exercise was to introduce important commercial messages into the text. Another point was to write articles about negative studies of unsafe drugs in a manner that would ‘take out the good bits and publish them’ as GSK said or would ‘overcome data with spin’ as Sally Laden, one of the most famous ghostwriters put it.
I was recently interviewed by a medical colleague who has solid skeptical credentials, and was interviewing me hoping for a skeptical point of view. When I suggested everything is ghostwritten, she seemed surprised, intimating that all that had been sorted out ages back.
I was surprised in turn and realized that for those focused on the minor element of deceit involved, the problem was easily solved. Acknowledge the ghost’s name in small print at the end of the article. S/he was then no longer a ghost. Problem solved.
Clearly this is far from the case.
We now know Sheena Hunt wrote most of the Pfizer Covid and RSV trials – and did so very persuasively. The problem is these article are not aimed at genuinely representing the results of these studies or informing clinical practice. They are aimed at capturing it. The apparent authors – Stephen Thomas and Fernando Polack and others – make clear they have not seen the data and depend on Sheena to get things right. But she hasn’t seen the data either. No ghostwriter ever does.
In the bad old pharma world, the minor ornamental movement – listing Sheena in small print – removed one concern about ghostly practices.
In both their earlier March article and now in the November follow-up THE BMJJ, however, reverted to old style twentieth century really ‘unethical’ ghostwriting – where there is no mention of the true authors of the piece. No footnote to hint at who generated the material that a journalist has tweaked for his audience.
We raised this first in Are Journalists in the answer to Medicine’s Cause and Effect Problem. This met with, as they say, a deafening silence. None of the many THE BMJJ colleagues we know and some of whom we had got on well with responded. Several researchers on medical ghostwriting expressed dismay at the situation – privately but not publicly. The general view, which we shared, was that having an article written by a journalist – on the issues we were mentioning which were not confined to vaccines, dilutes the cause and effect impact.
THE BMJJ Readers?
Who is THE BMJJ’s audience? From the THE BMJJ branding through to these ghostwritten articles, it is almost certainly not doctors. The new, ex British Medical Journal, enterprise lacks the engagement needed to reach doctors.
After Antidepressants, A Loss of Sexuality, an article on post-SSRI Sexual Dysfunction (PSSD) that appeared a few days earlier in the New York Times points up hazards the folk behind THE BMJJ are likely unaware of.
In 2009, I persuaded Philip Fine to ask NEJM about their policy on access to trial data. NEJM told Philip that they didn’t see establishing the integrity of clinical trial data as part of their business. At roughly the same time the NYT was engulfed in a controversy about a reported who had invented stories. NYT made clear that integrity of the data was critical for them – the reporter was fired.
For ages afterwards, I routinely suggested we’d all be a lot safer if our clinical trials were published in the NYJM rather than the NEJM.
A concern for data integrity, however, is one thing but journalistic maneuvering to avoid legal difficulties is quite another.
Some congratulations are owing to Azeen Ghorayshi and NYT for following the BBC earlier this year and mentioning PSSD, which we have known something about for over three decades.
But she, or her editors, felt forced to include an ‘on the one hand and on the other’ section to her article, just as THE BMJJ have felt forced to do for over decade and as they do with all articles written by journalists, but which a doctor would not do without good cause.
In this case, Azeen has Anita Clayton stating she thinks PSSD is just depression. This is shockingly misinformative. The only published diagnostic criteria for PSSD begins with listing genital numbing as the cardinal symptom – no genital numbing no PSSD. The genital numbing can be so clear cut that a patient can rub a hard bristled brush up and down her genitals and feel nothing. There is no disorder in medicine (except perhaps an extremely rare PIEZO2 protein deficiency) that can produce this.
Anita is being disingenuous in the extreme. But Azeen is being investigation averse in the extreme. A quick google reveals Anita is a consultant for Lundbeck who market vortioxetine, an on-patent antidepressant, which she is pushing as the treatment for people who think they have PSSD (but really have depression).
She has featured on a video hosted by the International Society of Sexual Medicine making these claims. There was an outcry when this video first surfaced and the ISSM took it down – See post about The Outcry. One of the extraordinary features of this debacle was that the ISSM has a conflict of interest division headed up by Anita Clayton, no less, who doesn’t mention anything about this in the video. But Anita seems as belle indifferente about these issues as Eric Rubin.
Five years earlier some of us submitted a petition to the European Medicines Agency (EMA) asking them to include PSSD in the label of serotonin reuptake inhibiting drugs. They did. But not for vortioxetine. Asked why not, EMA said they had received no reports of PSSD on this. They didn’t ask RxISK if we had received reports. We have. While the number of vortioxetine reports is only 5% of the number on Zoloft or the number on Citalopram, this is almost certainly because this drug is recent and far less used than others. Our petition perhaps gave Lundbeck time to build up key opinion leaders like Anita to spout the kinds of things Azeen is now reporting.
Vortioxetine’s lesser use is not for want of marketing. Lundbeck have been aggressively pushing it for children. The trials in children were done in the US, Russia and Eastern Europe, South and Central America – everywhere except Denmark (Lundbeck’s home turf). They are also pushing it for people concerned about sexual function but it has no advantages over other drugs – it causes suicidality, homicidality, sexual dysfunction and PSSD and likely will reduce fertility also.
In the wake of the NYT article, Ed Koehler from FabreKramer, a Texas based outfit who have been trying to get Gepirone on the market for years, got in touch sending me a link to the article, and telling me that they have got FDA approval to launch Gepirone in 2024. Unlike EMA, FDA have so far failed to include PSSD in drug labels – Ed tells me he thinks PSSD should be in the labels of all other antidepressants in the US. That I guess includes vortioxetine.
Gepirone is an old drug. It’s been around for 40 years. Is it worth having it on the market? Possible more useful than having an extra SSRI like vortioxetine. Will it cause PSSD? We don’t know. It is like mirtazapine (Remeron) in not causing the immediate genital numbing SSRIs cause but mirtazapine appears to cause an enduring sexual dysfunction and protracted withdrawal syndromes.
This story casts Lundbeck, EMA, NYT and BMJJ in a bad light. Journalists become superficial experts in an issue for a few weeks but risk being blind to the bigger picture. To the Snooker or Pool game in which they take part that can leave a marketing director for Prozac telling me at one point that I was doing more to sell Prozac than anyone else around the place.
A Bigger Picture
There are several bigger pictures here, one of which involves silencing doctors. All doctors and anyone who thinks having a independent medical profession is important might well download a recent article Silencing Journalists written by journalists about how concerns about strategic lawsuits against public participation (SLAPP) litigation is silencing journalists and consider how this might also apply to medicine.
Has an erstwhile medical journal, like THE BMJJ, developed a risk aversiveness to mentioning ghostwriting, lack of access to trial data or any mention of treatment linked adverse effects for fear of lawsuits, perhaps linked to trade deals. We have heard lots about trade deals that enable corporations, usually US corporations, to sue countries who attempt to limit company activities that may be polluting their country. Could something similar be playing a part in neutering a former medical journal?
We’ll only know if some serious investigative journalism tackles this issue – something closer to what we thought we might get by approaching THE BMJJ investigative journalism unit.
In the meantime, are we really saying that a doctor like Peter Selley, who is not telling anyone not to have an RSV vaccine but who draws attention to the mismatch between an absolute benefit that RSV trials point to, of the order of 0.5%, compared with the 84% efficacy the company claims, would not have an independent medical profession standing behind his right to draw tricks like this to attention of other healthcare colleagues?
Our lawyers and insurance companies are supposed to support medical practice, which necessarily involves supporting doctors to take justified risks, just as travel insurance is there to support us to take the risks of travelling. Insurance and legal input operating in this fashion helps make markets rather than inhibits them.
If pharmaceutical companies knew the BMA – a trade association – was almost certain to stand behind medical authors in their exploration of treatment related medical issues, some of which include medical hazards, there would be far less threat of SLAPPs. Perhaps BMA’s lawyers and insurers know that BMA is not likely to do this.
One of the clearest scandals out there is how medical defense union insurers work hard to tell doctors never to implicate a drug in a death of injury – to the point of telling doctors to shut up at inquests. Health ministers, Royal Colleges, Chief Coroners and the Defense Unions themselves show no signs of correcting this perversity. See Morgan v Morgan, Will Medical Insurers Stop Killing People, A Suicide Note and other linked posts. Why not?
Doctors have far more power than they realize. They could refuse to prescribe a newly released drug or vaccine without full access to the data. There are lots of older, cheaper and better drugs than those being foist on them.
These products are not being foist on the people who put pills in their own mouths – they are being foist on doctors. While these products are prescription only, doctors are the consumers and they consume these products by putting them in our mouth. They never suffer an adverse effect unless they take our side in agreeing a product has harmed us. This is a morally hazardous position to be in.
Vastly more marketing dollars are spent on each of these medical consumers than any other industry on earth spends marketing to any of its consumers – except perhaps armament industry spend on the Heads of Defense Forces. The spend leaves companies confident that few doctors have a thought in their head not put there by them or their competitors.
You’d imagine though that even a few doctors like Peter Selley would still be interested to explain that what we call company studies are really assays and doctors, politicians, and academics are making a category error in calling them trials and in calling them evidence rather than hearsay.
Would enjoy pointing out to doctors, politicians and academics that regulators like FDA and EMA are bureaucrats who have no expertise in working out if a drug causes a problem – that’s something doctors are supposed to do.
But companies have THE BMJJ to silence doctors.