Why some of us no longer want to publish in prestigious medical journals
By Peter C Gøtzsche
Institute for Scientific Freedom
Copenhagen
14 November 2023
Being one of the few people in the world who have published over 100 papers in “the big five,” BMJ, Lancet, JAMA, Annals of Internal Medicine and New England Journal of Medicine, I know how to get my work into the most prestigious medical journals. But I rarely knock on the door now. We discussed some of the reasons for preferring to publish elsewhere during a two-day meeting in Copenhagen in October 2022, Lack of scientific freedom: causes, consequences and cures, arranged by the Centre for Evidence-Based Medicine in Oxford and my Institute for Scientific Freedom. The most important reasons are:
1: Widespread censorship. Peer reviewers often abuse their anonymous position to protect their guild and financial interests by inventing all sorts of foolish and invalid criticisms of your paper. Editors are busy and may reject your paper without reading it, based on hostile self-serving peer reviews.
2: Most major journals and virtually all specialist journals are very beholden to the drug industry. The “big five” journals earn a lot of money by selling reprints of industry-sponsored trials and publishing drug ads, and many editors have a private income from their collaboration with the drug industry or have shares. This makes it very difficult to publish critical articles about drugs or the organised crime in the drug industry.
3: Lawyers. For insurance reasons, the BMJ is obliged to follow the advice of their lawyers, and lawyers are often worried that someone might sue even though everything that is being said has been documented before. Lawyers have rendered BMJ – which I once considered the best medical journal in the world – pretty toothless.
4: It often takes years before a submitted paper gets published. Even worse, it might be rejected after years of rewrites and editorial input and rewritings, which understandably make authors angry and feel betrayed.
5: Administrative screw ups.
In my long career, I have been exposed to many variations of these themes, and I shall give a recent example.
My Personal Opinion in BMJ, an Odyssey
in August 2021, I submitted a short Personal Opinion to the BMJ, “Efficacy and safety” and “benefits and risks” of drugs are misnomers.
Seven months later, I checked BMJ’s manuscript submission website, as I had not heard from the journal. According to it, editor Juliet Dobson had replied to me at tortoise speed, five months after my submission, but I could not find her email anywhere, my spam folder included. I wrote to her that, earlier, another BMJ editor had admitted that she had made an error and that her email to me was never sent.
Dobson responded the same day that she was interested and suggested some revisions. I sent a new version the next day and asked her to use email, as I might never get a message from BMJ’s editorial system.
Six weeks later, I asked if she had looked at my resubmission. Nine days later, I asked again and noted that, “In the research networks to which I belong we have had many discussions about BMJ’s slowness, which is something new. It is also new that BMJ sometimes rejects papers after having worked actively with them for 2-3 years, which was something the NEJM was known for. In the past, BMJ was much, much faster. I tell you this because we are many who treasure BMJ. We do not want it to become a sort of NEJM.”
Dobson acknowledged she had been slow and aimed to send an edited version to me “by next week.”
Next week became a month, and I asked Dobson if she had tried to reach me. A week later, she sent me an edited version, and I sent a third version of the paper the next day.
Seven weeks later, I asked if she had seen the new version and noted that “The changes I did to your edits and proposals were very minor.”
Three weeks later, I sent a reminder. Dobson replied the same day, a Saturday, that she thought some of my mails had gone to her spam folder, and that they had had this trouble before. She promised to check this and get back to me in the “start of the week.”
The start of the week became yet another month. I wrote that I realised she was busy, but also that there seemed to be nothing more to be done with my personal opinion of 506 words, “So why not accept my paper and publish it?”
Dobson never told me if she had checked her spam folder. I thought that – after having been patient for 15 months – I was close to the finishing line, but Dobson bombed me back to start: “I think some emails have gone astray (other colleagues have had similar experiences) … I understand that you don’t want to expand further on the points raised in the piece, but I think it does need some more detailed exploration or explanation to the reader as to why you are raising this now, and what this piece adds. Is there a topical peg to draw the readers in? I think you would need to draw out your ideas so that you give readers a more developed opinion on what needs to change and how. Another option would be to submit the piece as a rapid response. These are free to access and very well read and would be quicker. It is also a format more suited to this shorter piece. I am conscious that it has taken a while to work on the piece. I am sorry that I haven’t been quicker to get back to you about this. Happy to discuss further.”
Two days later, I sent the fourth version along: “I have benefited from your comments and editorial changes and now submit a very short piece, only 400 words, which I think is much clearer than earlier versions. I hope you agree so I can have this published.”
Three weeks later, I had lost my patience: “I submitted my humble personal opinion on 6 August 2021, which is now 16 months ago. Don’t you think it is about time that it gets published? I have published more in BMJ than in any other journal, much, much more, more than 50 papers, and I have published more with Doug Altman than with any other researcher, and Doug was statistical adviser to the BMJ. I have also been a member of the editorial board when Richard was the editor. But alas, not only I but some of my very sharp colleagues whom you would not like to lose have experienced that it has become virtually impossible to publish anything in BMJ. Some have even said: I regard the journal as dead now. You should take this seriously. Please act now!”
After another week, where I had not heard from Dobson, I asked Kamran Abbasi, the Editor-in-Chief, copying Dobson, what was going on, or rather, not going on, at the BMJ. I noted that “We are very many supporters of the BMJ that are deeply worried about that it has become close to impossible to publish anything of interest in BMJ, and some regard the journal as dead for this reason. And if you are lucky to get through the needle hole and BMJs lawyers, it may take years before it gets published (or it may even be rejected, after several years, which happened to my criticism of EMA’s handling of the suspected serious neurological harms of the HPV vaccines, which we then published in Carl Heneghan’s journal, BMJ EBM without any ado!).”
Abbasi replied that, “If you mean we’re asking you to do more to get your piece ready for publication then we plead guilty and I fully accept responsibility – but I’ve been doing that at The BMJ ever since I returned in 2013. So, nothing has changed on that front. In terms of this piece, you raise some interesting points and I agree that they would be of general interest. The piece, however, does not explore the issues fully enough as it stands to publish in our Opinion pages. Most readers will not be where you or I are at on these issues so you need to be a little more expansive in your discussion of each point. These are important points and they deserve to draw in a wider audience. Juliet is very experienced at developing opinion pieces. As it stands, this contribution works only as a rapid response, which you are free to post it as immediately, but I suggest you work on it more for Opinion. You have 600-800 words. Juliet will help. You’re always welcome to contact me if you grow frustrated.”
Dobson offered her help. I replied that a couple of examples of a drug called safe and effective being later withdrawn because it killed people in large numbers might be of interest, e.g., Vioxx. And a mention of the benefit/risk ratio, which drug regulators may use even though benefits and risk are not measured on the same scale and a ratio is therefore meaningless. And a note on the constant reassurance that the benefits outweigh the harms, which is almost a kind of mantra drug agencies use when they come in trouble before the bodies have piled up too much on the autopsy table.
Dobson agreed, and I sent the fifth version of my paper the next day. She responded that some additional details were needed to explore the issues more fully and sent an edited version with queries in the margins on 30 December. “However, there are still a few areas where I think it would benefit from further explanation, especially the example about Vioxx, which to readers who don’t know the details of that case, is not very clear.”
On 4 January, I sent the sixth version. “I feel very strongly that we should think about all the time that our drugs are the third leading cause of death – and therefore use less drugs – but I can see that it is a little off the track and therefore accepted you deleted also this.”
Three weeks later, Dobson replied that she would be in touch “at the start of next week.”
Two and a half weeks later, Dobson apologised for the delay and spoke again about “the start of next week.” Two weeks later, I noted that “It is now another two months.”
Dobson replied the same day that it all looked good but that she had one final query regarding Vioxx.
I sent the seventh version the next day: “The only change I made is that I inserted some verbatim text in reply to your question about Vioxx.”
On Friday, 3 February, Dobson wrote, “I will send you the final proofs on Monday.” Ten days later, I wrote: “Monday was last Monday, not today. Just writing to enquire if anything went wrong, as I have missed important emails before.” Dobson sent the proofs the same day; I returned them the next day, and three days later, my paper was published online, with the title, “The terminology we use about medical drugs can be misleading” (open access).
BMJ’s editorial input was biased
The editor’s interventions improved my paper, but the harms exceeded the benefits. The process took one and a half years, and the delays on my part constituted only two weeks of this. If I had known this in advance, I would never have embarked on this Odyssey.
What is worse is that I needed to accept editorial changes I disagreed with, which distorted the message substantially that I wanted to convey to the readers. Dobson downplayed drug harms, just as the drug industry would have done. This is inappropriate for any medical journal and particularly so for something called “Personal Opinion.” It is not my opinion, I write about, but BMJ’s opinion, which is that our drugs are pretty harmless.
I wrote in my manuscript: “No drug is safe,” which Dobson changed into: “No drug is completely safe or without side effects.”
I wrote: “Drugs always harm some people, otherwise they wouldn’t work,” which Dobson changed into: “Drugs always have an effect, otherwise they wouldn’t work, so there is always a risk of harm to some people, even if minimal.”
Dobson allowed me to write that “All drugs have harms,” but she added: “even if small or infrequent.”
I joined the CONSORT group for good reporting of trials when it started in 1993 and I co-founded the Cochrane Collaboration the same year. In these organisations, I advocated for a change in terminology, stopping using the terms “safe and effective” and “benefits and risks.” We agreed in both organisations that we would talk about the benefits and harms of interventions, and not about “side effects” of drugs, which are sometimes pleasant. We made this clear when we published CONSORT for harms in 2004.
Dobson’s editorial changes are seriously misleading, as they disregard the evidence. A random check of package inserts will reveal that most drugs have frequent and serious harms. Moreover, nine different studies have told us that our prescription drugs are the third leading cause of death, after heart disease and cancer. Thus, the harms of drugs are not “small or infrequent;” the “risk” of harm is not just a risk, it is very real; and it is not “minimal.”
I explained in my paper that instead of speaking about a benefit-risk ratio, which is only meaningful if benefits and harms are measured on the same scale, we should discuss the balance between benefits and harms even though it is subjective what people think about this according to the values they attach to various outcomes and how common they are. Given the same data, people might disagree about whether they think the benefits of a treatment outweigh the harms.
There can be a degree of self-interest or conflicts of interest when people make these decisions on behalf of others. When unexpected serious harms emerge after a drug has come on the market, drug regulators will usually tell us that that the benefit-risk balance continues to be favourable or that the benefits exceed the risks. They always talk about risk, which is a euphemism for harm.
It is prudent to be sceptical of such reassurances. Drug regulators are highly reluctant to admit their mistakes and take dangerous drugs off the market. Deaths associated with drug use reported to the US Food and Drug Administration trebled in just eight years, between 2006 and 2014.
Where is the BMJ at today?
Unfortunately, the drug industry’s influence on medical publishing is increasing, also for the BMJ. In this journal, the industry revenues as a percentage of all revenues increased from 12.6% in 2017 to 17.5% in 2020. There are no data for more recent years. This information appears on a website that at the top has an advertisement for Biktarvy, a drug from Gilead against HIV, which costs $4,000 per month!
Annals of Internal Medicine lost an estimated $1-1.5 million in advertising revenue after it published a study that was critical of industry advertisements.
Since advertisements for drugs are harmful for patients and our national economies, the only respectable thing to do is to drop them, and let those journals die that cannot survive without them.
We studied all 158 medical advertisements published in the Journal of the Danish Medical Association in 2015. The most advertised drugs were not better than older treatments but were substantially more expensive, and 11 safety announcements for five advertised drugs were issued compared to only one for a comparator drug.
The managing editor, a businessman, was very unhappy with our results and refused to publish them. We protested and after much negotiation, he accepted a short report but required we deleted the calculation that showed that it would not cost much for the subscribers if all ads were dropped. We had also suggested that the journal should not be printed but only published on the web, in which case the subscription fees could be reduced even if the ads disappeared. We fought hard, and from January 2021, the journal no longer published medical advertisements. We were of course not credited for this progress for the patients and taxpayers.
Inappropriate editorial interference in New England Journal of Medicine
In 2005, the editors of the Norwegian and Danish medical association journals and I published an article in NEJM where we called for registration of all clinical trials in a register, demanding the addition of all results after a certain amount of time had elapsed, to allow the researchers to publish in a journal first.
Letters came in and we responded to them. We thought. The Editor-in-Chief, Jeffrey M Drazen, interfered most inappropriately with our letter. We wrote that sanctions against researchers or companies that failed to report their data should be introduced, but Drazen deleted “companies” from our manuscript. He also changed our call for all data to be reported, which became “an agreed-on synopsis of the data.”
I wrote to my two co-authors that I found it completely unacceptable that an editor interfered to this extent with what the authors think and wish to say. I had never experienced anything like this before, and I had published well over 100 letters, many of them in journals like NEJM. A synopsis is a summary, which would give the companies free hands to continue presenting manipulated analyses and hiding serious drug harms. We had seen more than enough of this in industry-sponsored trials.
We protested but Drazen refused to remove his bit about only demanding a synopsis. He gave a helping hand to the drug industry, which is an enormous source of income for his journal. When we tried to find out how much this is, NEJM refused to give us the data, even when we modified our request and only asked for a percentage of the total income. But the journal’s owner, Massachusetts Medical Society, listed $88 million in total publishing revenue for the year ending 31 May 2005, an astronomical sum.
It is not surprising that this journal, which many – but certainly not me – regard as the most prestigious medical journal in the world is colloquially known under the name, The New England Journal of Medicalisation.
Conclusion
We need to find new publishing models and publishing on websites seems to be one of the best options we currently have. It’s easy and quick. My deputy director, PhD Maryanne Demasi, and I have published over 100 articles on websites in 2023 alone.