„Wo woar mei Leistung?“
„Disclosure is not enough“ oder österreichisch: „Wo woar mei Leistung?*“
* Vor ein paar Jahren hatte sich dieser unrühmliche Satz „Wo woar mei Leistung?“ aus einem Abhörprotokoll der Polizei im Nu nach seiner Veröffentlichung in das kollektive österreichische Gedächtnis gebrannt.
Beim Durchblättern meiner alten Unterlagen fand ich einen kurzen Brief, einen letter to the editor. Den Brief schrieb ich in Fortsetzung meiner jahrelangen und beharrlichen Bemühungen um Transparenz und Konfliktfreiheit in der Wissenschaft, bereits bevor ich Mitglied bei Transparency International – Austrian Chapter wurde.
Eine Co-Autorin, ein Co-Autor und ich versuchten erfolglos einen kurzen Brief, der weniger als 500 Worte zählte, in einem großen internationalen high-ranked Wissenschaftsjournal zu veröffentlichen. In weiterer Folge hätte dieser kurze Brief noch in vielen anderen Wissenschaftsjournalen eingereicht werden sollen.
Die Antwort folgte prompt:
[…] Dear Dr. Aboulenein-Djamshidian:
I am sorry that we will not be able to publish your recent letter to the editor. The space available for correspondence is very limited, and we must use our judgment to present a representative selection of the material received. Many worthwhile communications must be declined for lack of space.
Sincerely, […] 03. Jänner 2019”
Ich frage mich bis heute, was wohl an diesem kurzen Brief – letter to the editor – so schlimm ist, als dass dieser einer breiten medizinischen Öffentlichkeit nicht zugemutet werden darf?
Urteilen Sie bitte selbst:
To Whom it May Concern,
It is undisputed that evidence based medicine (EBM) is a prerequisite for our scientific medical thinking and most importantly for our scientific discernment and medical judgment. Thus, it seems at least a little peculiar that up to two thirds of clinical trials are initiated, designed or financed by the pharmaceutical and medical device industry and that only the disclosure of potential conflicts of interests (COI) appear to suffice to prevent cognitive bias and undue influence on scientific judgment.
Yet, from a strictly scientific point of view it would be very easy to strengthen the EBM and in particular the credibility of medical data,
- If all scientific data, in particular negative results, are published.
- If strictly transparent peer-review processes are established.
This means that the reviews of all, even of rejected papers should be published on journals’ homepages after their peer-review processes and linked to the scientific databases. Also if papers are published elsewhere, the information about the reviewers and the disclosures of their COI should also be disclosed.
The publishing, open access and global visibility of these very important additional data has never been easier than today and this can ensure full data-transparency. COI of reviewers can, as a result, be recognized very easily, and therefore be well managed.
- If clinical trials sponsored by industry are excluded from journal metrics, i.e. rating of journal quality.
From a strictly scientific point of view it is incomprehensible what the actual scientific achievement of such studies is, since the study-design is almost always predefined (by the sponsor) and the data only have to be collected in a standardized way. If no impact factor or other ’scientific merits‘ are awarded for such clinical trials, bias can be prevented as it is never possible with a simple disclosure of COI.
- If all clinical trials and post-marketing observation studies were designed and conducted independently by the regulatory authorities but paid for by the industry at a fee.
Independent head-to-head trials would also make it possible to compare drugs and medical equipment directly with each other, and to reduce the meanwhile unmanageable numbers of published papers and meta-analyses which no one person can practically cope with.
- Finally, guidelines must be created by genuine independent experts, i.e. these experts must not have received honoraria or funding from industry without a considerable cooling-off period.
(395 words).
#transparency #coi #disclosures #bias
Ihr
Fahmy Aboulenein-Djamshidian
Foto: Was könnte einen Beitrag mit dem Titel „Wo woar mei Leistung?“ besser illustrieren als ein Buch mit dem Titel „Die Pharma Falle“?