Taxpayer-funded Opioid Research in Australia is Rife with Conflicts of Interest and Corruption

But even worse - So are the journals publishing these conflicted studies

Today I have confirmed something I already suspected, but wanted to verify before making any noise about it…

Introduction

Over the last almost twelve months I have been working on a review of academic literature and related public policy and reports from Australia concerning the use, misuse, harms and deaths allegedly related to opioid medications. I began this work after reading several works discussing the up-scheduling of over-the-counter codeine medications (panadeine, nurofen plus and their generics) and the escalating claims that were used first to put them behind the pharmacist counter, then to make them prescription-only, and more recently how this has further escalated into a situation where one or two much stronger and still under-patent opioid medications are enjoying year on year increases in prescribing while most others drugs in the same class have rapidly declined.

Academic research from the authors whose works promoting the idea of an ever-burgeoning opioid crisis I reviewed, was heavily cited in government reports and public policy documents. This evidenced that their research was instrumental in achieving the public policy and regulatory changes that have occured for opioid and analgesia medications over the last fifteen or so years in Australia. The names of the authors whose works I reviewed came up time and time again - not just on their academic papers, but also as governmental advisors on matters of addiction, chairpersons or members of regulatory committees making recommendations on funding and public policy decisions based on the findings of their academic work, as recipients of pharmaceutical company funding, as consultants to those same pharmaceutical firms educating doctors about which particular opioid medication to prescribe, and as people who were concurrently in seemingly innocent academic posts while also occupying senior board and research roles for a non-government organisation (NGO) that was heavily promoting the need for opioid research and public policy to find results, creating alarm when that research always managed to return the findings they sought, creating the sometimes incredible curated datasets used in the academic research, and profiting from the public and political reaction they could manufacture by promoting those results.

The diagram below is an anonymised example that arose from my initial investigation of just one of those academic authors, and for which I have collected, as the saying goes, all of the receipts. That academic author appears for several years to have been collecting two or more incomes simultaneously, including one as the leader of an organisation promoting the needs of and providing counselling and services for opioid addiction that used the alarming results of ostensibly independant academic research, and the other as the leader of an academic research group at a university both creating those alarming reseach results, and overseeing the training of other doctoral students and postdoctoral academics who appear to have gone on to do the same.

My Issue

There are two parts to my main issue with their opioid crisis promoting work (leaving aside the conflicts of interest, poor quality datasets and the potential biases these issues can and sometimes do create in their results).

The first part is that each time their work has resulted in exactly the public policy and regulatory change they have sought - such as proclaiming over-the-counter low-strength codeine preparations as the gateway drug to stronger prescription and illicit drugs and thus demanding these medications were first placed on restricted sale and later made prescription-only, they have immediately and without pause moved to promote a new issue as the cause of the percieved opioid crisis - such as proclaiming all prescription opioids are the cause, or that the taxpayer should fund tens of millions of dollars of Naloxone supply to any person getting an opioid prescription, or presenting research claiming one of their research-funders still patented and expensive opioid drugs is safer and less abused than others whose patents are expired (and as you will see in our larger review, framing results that speak poorly to that funders drug in a favourable light or completely removing negative results about that funders drug to supplemental materials that few bother to download and fewer still actually read). In this way they actually support the suggestion that the public policy changes they have effected with their research were failures - because there is immediately ‘evidence’ suggesting the problem that change was enacted to address persists and that yet another boogey-man needs to be regulated away.

The second part is that we are now starting to see patients: (i) with pain who should (and previously would) legitimately receive opioid medications who are not - unresolved pain has escalated in Australia and some sufferers are resorting to suicide and unsafe illicit drugs to fill the gap that clean, regulated, pharmaceutical opioids would have filled¹; and (ii) patients with pain who would have taken low-dose, less harmful and less-addictive analgesic medicines like over-the-counter codeine preparations are now forced to go to their GP who, it seems on the PBS data alone, is more likely to provide a prescription for a much stronger opioid that the data suggests is going to be a more expensive and in-patent one like the one made by the pharmaceutical company that funded these academics and that I mention in the paragraph above². There is also suggestion that some with unresolved pain are resorting to illicit street opioids for relief. Both aspects of this second part have potential to increase the number of people addicted to strong opioids, which is entirely contradictory to the claims for potential benefits made by these researchers in their results and when promoting their recomendations become regulation.

And now, This…

In reviewing the studies behind Australia’s opioid policy and regulation by these academics I noted that several journals were consistently involved in publishing their works, yet many, even the most glaring, of the issues I (and now the group of other researchers working with me on this) identified had seemingly never been picked up during editorial or peer review. And worse, in some cases the journals had allowed unfavourable findings regarding the funders drug to be removed from the manuscript and placed in supplemental materials after acceptance and before publication!

I wanted to understand whether the journals were an honest and fair science venue and editors and peer reviewers had simply missed these things, or whether the journals were possibly part of the problem. To achieve this I prepared a draft of my first manuscript from the larger 100+ page dissertation monograph from my review that included a couple of minor ‘issues’ (such as some intentional spelling mistakes introduced to the authors and titles of three articles in the reference manager software’s database, that would be replicated into the reference list of the paper - one I expected to be noticed and two that I was less certain would be identified, a missing ‘unknown’ value in an early table, and inappropriate use of a personification apostrophe in a couple of places³). All of the actual research findings and reporting was faithfully presented, and none of these minor alterations were or could have been construed as affecting the honest reporting or results presented.

The response I received from the Editor in Chief (EiC) of that journal, also annexing what she stated were the comments of the Managing Editor (ME), who is a frequent collaborator with several of the authors whose works I review but especially with the academic I introduced the mis-spelling into⁴, was certainly telling.

The focus of both EiC and ME focused on two things: (1) pedant nitpicking; and (ii) veiled threats and claims that honest reporting with references was defamatory. For reference, in Australian law public interest dissemination (which this would certainly be), honest opinion (the detail of my work is most certainly my honest opinion of the evidence I reviewed), truth (based on the material I sourced and the references I provide, I believe what I produce is factual and therefore honest truth), fair reporting and several other defences to defamation would apply in this case. It is not defamation when you have created a work that falls well within the public interest that fairly reports your honest opinion about the truth contained in an extensive collection of referenced evidence and materials.

The first was expected, except that the nitpicking focused on only two things: (i) the fact that the title of the paper correctly reports the original methodology name as The Triple Helix and the fact that the version of this method that I apply in the paper uses a fourth (or quad) actor approach (the original name of the method is valid and, as I stated to them in my response, represents what good science should do - as new knowledge about a thing arrives, rather than dismissing it because it doesn’t fit with current narratives, the new knowledge has resulted in an update to the methodology model); and (ii) They fail to pick up any mis-spelling or even the intentional grammatical issues with the personification apostrophe in the main body of the paper but yes… you guessed it… the intentional mis-spelling of the academic author’s name buried within the reference list was found and used as justification to say there were multiple spelling mistakes.

The second was unexpected but it probably should have been. what we see here is the reason why so much of academia has become corrupted during the last several decades. Here we have academics who are not only involved, as I assert based on my honest opinion after review of public documents, in every aspect of creating, funding, regulating and promoting a supposed opioid crisis, but they are also involved at senior level in controlling positions in the journals publishing their tortured research. This last finding will lead to an update of my own work - in that it now needs to reflect their embedding and involvement in getting what I believe in my honest opinion to be unreliable research into the public record.

You can read the manuscript (without the deliberately introduced mis-spellings) here: http://dx.doi.org/10.13140/RG.2.2.29943.12961

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My response to the EiC and ME is provided here:

Hi [EiC],

Thank you for your email.

Speaking first as a legal scholar it is not ‘defamatory’ to identify and point out that there are conflicts of interest that are easily evidenced (and that they have at times sought to avoid mentioning, and in these instances it can only be because of something in the content of a particular paper or the funder of the work - especially where the undeclared prior conflict IS with the admitted funder of the study) and that should have been considered by journals such as your own prior to publication of papers - to claim that is defamatory to point out that researchers not only have a huge glaring conflict of interest, but that they have done a lot of hard lifting to avoid true disclosure of that conflict AND reframed results to protect that conflict speaks more towards suggestion your journal and yourselves prefer ‘protecting the racket’ than providing honest, reliable science reporting?

It is only by identifying these biases and conflicts and trying to understand the impact they have on the results returned, and how those results have come to affect science and public policy and public understanding of the issue that we can begin to right the ship and return to producing credible science with honest results that all parties can have faith in. It is also only by questioning that we can verify, validate and update the dogma that egos and politics in many domains has seen become accepted as ‘settled’ science (science should never be ‘settled’ - it should always be willing to question itself and update its beliefs based on new knowledge).

The work I, and more recently the group I am working with to complete the manuscript of the larger review, have undertaken has not only identified and verified the existence of the issues outlined, but has further identified issues and biases with the datasets the reviewed authors use - issues they were clearly aware of but sought to simply pretend were not present in their earlier works, only to go on later, after the results of those biased works had affected public policy in potentially harmful ways, and publish more recent works identifying only one side of the issue spectrum - those that understate the item of interest - while avoiding the other - those that overstate the item of interest. I initially, and later the group I brought this to the attention of who are now working with me, found this odd - until we noticed that they essentially (and while pointing at others uses of the datasets and not their own) were discrediting even their own use of almost all of those datasets in order to claim that one particular one (that also had issues and biases) was somehow magically ‘better’ and wholly ‘accurate’ - because they were seeking millions of dollars in additional taxpayer funds to do yet another study with that dataset.

Because the full dissertation monograph of this review was over 100 pages, it became necessary to break the review down into relevant sub-units. The Triple Helix Analysis, the dataset analysis and other units therefore became separate entities - hence why the Triple Helix manuscript cites forward to the main review paper that is soon to be submitted.

The applied methodology is and has been long known as The Triple Helix, even though through that process I mention above of science being reflective and updating itself in the presence of new knowledge, it has come to have, in some applications such as the one I apply it for, a fourth member. Just as with the ‘defamation’ statement, it seems improper and wholly pedant to point that out at the outset without having noted that I do explain this discrepancy of updated science with the method within the manuscript, with suitable references - and without actually noting that this ‘three’ or ‘four’ issue is inherent and established in that methodological domain (a point my cited references bear out).

Your editor points to a mis-spelling of the first name of Suzanne Nielsen. This would seem to be another example of pedant thinking - given that it is in the Burnet reference (whose spelling you also make note of) and not something that was done in the main body of the work. This is hardly a justification for rejection of the manuscript on the whole, and is something that journals who are not avoiding publishing work that presents new findings that might argue against the current mainstream narrative would simply have dealt with during production. We all accept that a manuscript may need edits and tweaks to become its best, and this is in part what an honest peer review process will highlight. So rejecting it for a few spelling mistakes in a citation from my citation manager app is hardly credible.

I must say that to receive such nonsense from a journal was not unexpected - especially when several of the reviewed authors also have a conflict in being on the editorial board of that journal. As with the failure to disclose many of their conflicts of interest in their works, I notice you carry on this “failure to disclose” in your response. Well done you!

This too will make for an interesting publication. It’s like confirmation of the confirmation of something we already established: that the domain is a protection racket and publicly funded money-go-around.

Regards

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1. E.g. see: https://www.painaustralia.org.au/mediaold/news/botched-government-rollout-leaves-people-in-pain-with-no-support

2. E.g. see: https://www.abc.net.au/news/2021-03-09/pain-sufferers-say-limiting-their-access-to-opioids-in-cruel/13219230

3. These minor annoying changes were the sort of thing that might get picked up during review or preparation for publication. The changes to an author’s name was intentional to see whether the manuscript would be given to that author (who is a member of the editorial team at the journal) or a member of her research group for review. Anyone not connected with that author might have entirely missed the single letter change in her first name lost within the three pages of references… however, if that author or a member of her research group were reviewing the manuscript they would be almost certain to be searching for her name and hence more likely to bring their attention to that one deliberate error.

4. E.g. see: https://doi.org/10.1016/j.eclinm.2024.102489 and https://doi.org/10.1111/jvh.70001 and https://doi.org/10.1111/dar.12308 and https://doi.org/10.5694/mja2.50659. I was able to locate more than 20 papers where Suzanne Nielsen, the academic researcher, and Peter Higgs, the Managing Editor of the journal, had published together.