Censorship in Medical Journals Is Harmful, Also for Patients

It has become increasingly difficult to publish articles in medical journals that are critical of drugs or the drug industry, or that expose fraud and other wrongdoing committed by doctors. It is also difficult to publish articles documenting that the status quo in a medical specialty is harmful for the patients even though such articles should be warmly welcomed. Particularly in psychiatry, it has been amply documented that guild interests are far more important than the patients’ survival and well-being.1,2

For top general medical journals, e.g. Lancet and New England Journal of Medicine, the conflicts of interest are obvious, as the revenue from drugs ads and selling reprints of trial reports constitutes a substantial proportion of their income.3 Top specialty journals have similar conflicts. In addition, they usually have part-time editors who are keen to protect the specialty’s guild interests and prevailing dogmas.

Another problem is the threat of litigation. The BMJ has an insurance that mandates the editors to adhere to their lawyers’ advice; otherwise, the insurance won’t cover the costs of a libel lawsuit. Medical Freedom Journa... Medical Freedom, Citiz... Buy New $8.99 (as of 03:59 EDT - Details)

The corruption of our most prestigious medical journals has been exposed by current or previous editors-in-chief of the top journals, e.g. BMJ, Lancet and New England Journal of Medicine.4

Aggravating the situation is the fact that big publishers buy smaller enterprises all the time. This means that there are fewer players on the market, which are therefore easier to corrupt than if there had been many. The five big publishers are Reed-Elsevier, Springer, Wiley-Blackwell, Taylor & Francis and Sage. They published more than half of all academic papers in the peer-reviewed literature in 2013.5 In 1973, the five largest publishing houses controlled 20% of scientific papers published, but by 2006, that number had already risen to 50%.5

Not surprisingly, there has been increasing concern that journals may be censoring scientific research and stymieing debate, and there are many examples of gross violations of publication ethics and even of journals violating their own rules.2,4,6-8

The HPV vaccines

A particularly egregious recent example was when a Springer journal refused to publish two papers from my research group9,10 even though its editors had accepted them after peer review, and we had paid the fees for open access. Researcher and medical reporter Maryanne Demasi described these events in an article from 13 July 2020.4

By using clinical study reports we had obtained from the European Medicines Agency, we found evidence suggesting that the HPV vaccines in rare cases may cause serious harm.9 This finding contradicts the official reassurances that there is nothing to be worried about but agrees with other independent research, e.g. from the Uppsala Monitoring Centre,8,11 which is a WHO collaborating centre that accepts reports of suspected harms of vaccines and other drugs.

Our systematic review of the HPV vaccine trials9 is much more reliable than the 2018 Cochrane review as we based it on clinical study reports and not on journal publications. It was accepted for publication in Systematic Reviews on 6 March 2019.8 However, a year later, it had still not been published although the journal promises publication within 20 days of acceptance. Our email correspondence took up an astonishing 74 pages,4 and we had been given a total of 20 apologies and a variety of odd, contradictory and implausible reasons why our paper had not been published. One of the excuses was that the journal lacked staff to publish our papers, which was clearly not the case, as Systematic Reviews had published 309 papers during that year. Vaccines: truth, lies ... Gu00f8tzsche, Peter C. Buy New $15.69 (as of 03:59 EDT - Details)

On 16 February 2020, we wrote to Springer that it seemed they deliberately delayed the publication and highlighted that, “If this is the case, it is scientific censorship that borders on scientific misconduct and fraud. We have a big network with renowned scientists, many connections with the international media, and a strong social media presence. If Springer Nature, BMC and Systematic Reviews fail to publish our papers before 1 March 2020, we are obliged to alarm our fellow scientists and the international and social media about Springer Nature’s, BMC’s and Systemic Reviews’ editorial practices. We will also involve the Nordic Cochrane Centre’s and the Danish taxpayers’ legal teams if the 1 March 2020 deadline is not met.”

This caused Springer to publish our review with record speed, only 12 days later, on 28 February, during which time we checked the proofs and corresponded several times with a high-ranking person, William F Curtis, PhD, Executive Vice President Journals, Medicine & Life Sciences, Springer Nature. We had clearly made Springer nervous.

During the stalling of our papers, we sought an explanation from the journal’s editor-in-chief, David Moher, who put the blame on Springer: “The delay is a substantial embarrassment … We have experienced some internal issues at Springer Nature.”4

When Demasi asked whether it had any financial conflicts of interest, Springer Nature strenuously denied any external influence on its decision-making process, stating: “With a company the size of Springer Nature it is difficult to know for certain whether any of our advertisers, authors and subscribers are associated with the pharmaceutical industry, or manufacturers of the HPV vaccine or other HPV therapies.”4

This is a non-answer. Just like if a medical student had been asked whether he had ever cheated in a test and stated: “With a university this size it is difficult to know for certain whether any of our administrators, researchers and teachers have cheated.”

All three editors-in-chief of BMC Systematic Reviews have since announced they are stepping down, but none has responded to numerous requests for comment about reasons for their exit.4

I congratulate them with this decision, which is the only correct reaction to Springer’s abuse of power and inappropriate censorship of the worst kind. False Positive: A Year... Dalrymple, Theodore Best Price: $10.82 Buy New $15.65 (as of 04:35 EDT - Details)

My research group also experienced huge delays when we submitted a paper to the BMJ where we described what happened when we complained to the European Medicines Agency and subsequently to the European Ombudsman about the agency’s inappropriate handling of concerns about the safety of the HPV vaccines. The BMJ assured us repeatedly that they were keen to publish our paper and it was rewritten several times, once even by an editor, and subjected to legal review, which also led to changes. However, as with Springer, the process stalled.

On 14 April 2020, I had had enough and wrote to the editor-in-chief, Fiona Godlee: “I wrote the email just below more than a month ago, and more than three months after I was reassured that the BMJ wants to move forward with our paper, and 3 years after I submitted our first version. Absolutely nothing has happened in the last three months. This is not acceptable. I have said and written many times that BMJ is the best medical journal in the world, but if BMJ wants to be up there, you cannot treat your contributors like you have treated us in this case. Please read my email from 10 March just below and please respond now.”

Godlee responded two days later: … “we are not near being able to make a decision on your paper, and therefore not near to being in a position to publish it. Under these circumstances, you may decide that you would prefer to take the paper elsewhere … There are still multiple steps that would need to take place before we would be able to send an acceptance letter. The major ones are sorting the legal issues, further peer review (since it was last reviewed in November 2016 and the piece has changed substantially since then), and then further revision.”

I consider several of the legal issues absurd. We were not allowed to reiterate what had been documented elsewhere and were told that we could not quote certain documents I had uploaded on my website even though anyone can get access to them by sending a Freedom of Information request to the European Medicines Agency.

I have published our criticism of the European Medicines Agency in a book.8 I have come to the point where I much prefer to write books instead of battling with peer reviewers that are keen to protect their financial and guild interests and with editors that are afraid of litigation.

One of my colleagues had a similar negative experience with the BMJ. Their paper about the HPV vaccines had been under consideration for three years before it was finally rejected, in September 2019. It was a critical appraisal of the trials and their use of surrogate outcomes. Admirable Evasions: Ho... Dalrymple, Theodore Buy New $15.99 (as of 03:59 EDT - Details)

On this occasion, Godlee wrote to my colleague that “The fact that this is also a highly controversial topic makes it all the more important to ensure that the messaging is clear when speaking to a wide international general medical and health policy audience … Despite everyone’s best efforts, the paper does not succeed in striking the right balance between detail and bottom line.” Godlee said that when the paper had been published elsewhere, there might be scope for a clearly messaged summary paper in the BMJ; “You may however have had enough of us by now, which I would entirely understand.”

This is one of the main problems. Editors should not waste years of researchers’ time giving them hope that they will publish their paper and then ultimately reject it. It should not happen. Research should come out in the open, as quickly as possible, but medical journals are a serious impediment for this.

The paper was published elsewhere, in another prestigious general journal, just half a year after BMJ’s rejection.12

Mammography screening and the European Journal of Cancer

The Springer affair is not the only time a medical journal has refused to publish one of our accepted papers. I have even had an article withdrawn for no good reason which was already published in the articles-in- press section on the journal’s website,13 and other researchers have had similar experiences.8

The Swedish Two-County trial of mammography screening was instrumental for the introduction of screening. The researchers had used Swedish registries but when we combined data from the same registries with information on the study population, dates of randomisation, and length of follow-up, we found many more breast cancers and deaths than what the investigators had published.

Three weeks after we had published our concerns in the articles-in-press section on the European Journal of Cancer’s website, the editor-in-chief, John Smyth, informed us that his journal had received “comments from a number of sources regarding some of the claims made in the article” and that our article had been removed pending further discussion and clarification. He did not forward these comments to us but asked for very minor clarifications and changes. We submitted a slightly revised paper in which the most important change was that we had deleted a sentence that might have been interpreted (wrongly) as suggesting that the trial authors had deliberately changed the cause of death in favour of screening.

To our great surprise, as our paper had already been published, the revised manuscript was sent out for peer review, and two months later Smyth informed us that his decision to withdraw our paper was final. He referred to “the release of new information concerning the randomization process and the trials opening and closing dates” and forwarded selected “Comments from the peer review process.”

Some of this new information contradicted not only the published data but also the randomisation dates we had received in earlier peer reviews. This was totally bizarre but using any of the three different sets of randomisation dates in our analysis, we confirmed our original results.

However, despite two appeals, Smyth refused to publish our results. The abuse of power was extreme. The peer reviewers complained that we had not responded to “the letter from the paper’s critics”, and noted that the letter contained “details of the way the randomization was performed and the screening periods” that “have never been emphasised before.”

We have not seen this letter, and, like us, one of the peer reviewers also saw only selected comments from the other reviewers.

We found out that our paper was listed as withdrawn in PubMed. Smyth violated the rules. The European Journal of Cancer is a member of the International Committee of Medical Journal Editors which states: “In no instance should a journal remove an article from its website or archive. If an article needs to be corrected or retracted, the explanation must be labelled appropriately and communicated as soon as possible on a citable page in a subsequent issue of the journal.”

The Committee mentions that it is a serious step to retract a published paper and that this should only be done after due process and only if scientific fraud has been established. Smyth not only retracted our paper but removed it entirely from the journal’s website without leaving a trace of it, and without even notifying us. It is also clear from the Committee’s guidelines that “inadequacies exposed by the emergence of new scientific information in the normal course of research … require no corrections or withdrawals.”

Elsevier, the publisher of the journal, is a member of the International Association of Scientific, Technical & Medical Publishers which states that if an article is removed, “bibliographic information about the ‘removed’ article should be retained for the scientific record, and an explanation given, however brief, about the circumstances of its removal.” Smyth also violated this rule.

We published our results elsewhere.14 We wondered if the European Journal of Cancer had been threatened with litigation. The primary author of the Two-County trial, László Tabár, is very wealthy and has threatened litigation before to prevent publication of results that seriously question the reliability of his trial. I wrote about this in a book, with reference to an investigative journalist from Chicago Tribune:6

“Crewdson has the reasonable view that what people do with taxpayers’ money must be open to public scrutiny. He beleaguered Tabár for several days until he got away with data sheets that described causes of death, which he showed to me. These documents were very interesting and Crewdson worked on them for quite a while but never published anything. Several people have informed me that this was because the Tribune had been threatened with litigation, but Crewdson has not confirmed this. Crewdson published other articles. He noted various irregularities in the Two-County trial, e.g. that 750 women disappeared from published reports of the Kopparberg part of the trial after 1989.”

To say that Tabár’s cause of death assessments were very interesting is an understatement.

Conclusions

Scientific freedom is under pressure. What we see now is that, more and more, medical scientists are moving away from major for-profit publishing houses and publish their research elsewhere, e.g. for free on open access websites or in journals they establish themselves. This is a good and necessary development.

References

  1. Whitaker R, Cosgrove L. Psychiatry under the influence: institutional corruption, social injury, and prescriptions for reform. New York: Palgrave Macmillan;
  2. Gøtzsche PC. Mental health survival kit and withdrawal from psychiatric drugs. Copenhagen: Institute for Scientific Freedom;
  3. Lundh A, Barbateskovic M, Hrobjartsson A, Gøtzsche PC. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue – cohort study. PLoS Med 2010;7(10):e1000354.
  4. Demasi M. While their ads are prevalent, drug companies and medical journals will remain uneasy bedfellows. 2020 July
  5. Krisch JA. These five corporations control academic publishing. 2015 Jun
  6. Gøtzsche PC. Mammography screening: truth, lies and controversy. London: Radcliffe Publishing;
  7. Gøtzsche PC. Deadly medicines and organised crime: How big pharma has corrupted health care. London: Radcliffe Publishing;
  8. Gøtzsche PC. Vaccines: truth, lies and controversy. Copenhagen: People’s Press;
  9. Jørgensen L, Gøtzsche PC, Jefferson T. Benefits and harms of the human papillomavirus (HPV) vaccines: systematic review with meta-analyses of trial data from clinical study reports. Syst Rev 2020;9:43.
  10. Jørgensen L, Gøtzsche PC, Jefferson T. Benefits and harms of the human papillomavirus (HPV) vaccines: comparison of trial data from clinical study reports with corresponding trial register entries and journal publications. Syst Rev 2020;9:42.
  11. Chandler RE, Juhlin K, Fransson J, et al. Current safety concerns with human papillomavirus vaccine: a cluster analysis of reports in Vigibase (R). Drug Saf 2017;40:81-90.
  12. Rees CP, Brhlikova P, Pollock AM. Will HPV vaccination prevent cervical cancer? J R Soc Med 2020;113:64-78.
  13. Gøtzsche PC, Mæhlen J, Zahl P-H. What is publication? Lancet 2006;368:1854-5.
  14. Zahl P-H, Gøtzsche PC, Andersen JM, Mæhlen J. Results of the Two-County trial of mammography screening are not compatible with contemporaneous official Swedish breast cancer statistics. Dan Med Bull 2006;53:438-40.