PPTA Statement: Proven Safety of Human Albumin

Statements in the international media have described the events resulting from the retraction by several leading medical journals of a large number of articles describing scientific studies by a German physician, Joachim Boldt. Boldt was dismissed from his position as head of anesthesia in the Klinikum Ludwigshafen in the state of Rheinland-Pfalz in Germany in November 2010, following initial findings by a leading anesthesia journal that a paper describing a clinical study which Boldt published in the journal had been fabricated.

Like the majority of Boldt’s considerable body of scientific publications over the past decade, this paper claimed a clinical benefit for a class of synthetic colloid plasma expander drugs known as hydroxyethyl starches (HES). In line with many of Boldt’s published studies, this fabricated study alleged that HES showed superior features compared to the natural plasma protein therapy human albumin.

New statements report on the ongoing developments in this affair, including the retraction of a further 89 studies by Boldt and his colleagues. These studies have been found to be unethical as they reported experiments done on human subjects without their approval. Further investigations, including investigation into other possible areas of fabrication are ongoing.

It is, however, regrettable that the recent statements are confusing in as much as they refer to “colloids” as being implicated in this affair, rather than the HES products for which Boldt has advocated over the past decade, and which formed the basis of his fabrications. The human plasma protein therapy albumin was the first colloid to be developed for clinical use, and has 70 years of clinical experience and safety backing up its status as the colloid treatment of choice. Albumin has saved countless lives since its introduction, and its safety and efficacy have been confirmed through recent clinical trials and meta-analyses. Boldt’s constant advocacy for HES, a class of products demonstrably associated with causing bleeding and kidney damage to patients, has been highly influential in getting HES a presence in fluid therapy guidelines which, as pointed out by these recent media statements, are now being withdrawn. PPTA has pointed out the dangers of HES to guideline forming bodies several times over the past years. In addition, PPTA has written to regulatory agencies in Europe and North America requesting an urgent revision of the regulatory status of HES products given the unequivocal demonstration of their risks for patients and the dubious basis of the medical literature on which their approval was founded. PPTA is gratified that the German Physician Association and the Association of Surgeons of Great Britain and Ireland have heeded these developments and retracted current guidelines advocating the use of HES. The Association will continue its efforts to ensure that regulators are made aware of these products’ risks and that patient welfare is protected.

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