AAPS PharmSciTech, a journal of the American Association of Pharmaceutical Scientists, has retracted a 2013 paper by a group from India. The reason appears to be manipulated data, although the wording of the notice leaves that open to interpretation.
The article, “Design and Formulation Technique of a Novel Drug Delivery System for Azithromycin and Its Anti-Bacterial Activity Against Staphylococcus aureus,” was written by a trio of researchers at the Center for Nanobiotechnology at VIT University in Vellore.
The article, published online in June, purported to find that:
Azithromycin, an important member of the azalide subclass is effective against both Gram-positive and Gram-negative organisms. Certain physicochemical properties of the drug like poor water solubility and relatively low bioavailability of 37% due to incomplete absorption after ingestion, aroused the need for the development of a novel drug delivery system to enhance the solubilization potential and antibacterial activity against Staphylococcus aureus at a very low concentration. Cinnamon oil (Cinnamonum zeylanicum)-based microemulsion system formulated using non-ionic surfactant, Tween 20, and water was characterized. The drug-incorporated system F4 (oil to surfactant ratio of 1:4 (v/v)) showed enhanced solubilization of the drug, droplet diameter of 5-8 nm, and a good thermodynamic stability. The effect of surfactant concentration exhibited a negative correlation with droplet size diameter and turbidity and a positive correlation with stability and viscosity. The system was investigated for its antibacterial activity that demonstrated a significantly higher activity at a minimum concentration (4 μg/ml) of the novel drug-loaded system in comparison with the conventional formulation (128 μg/ml). Examination through scanning electron microscopy analysis further confirmed a considerable morphologic variation due to alteration in the membrane permeability of the microemulsion-treated system. The small droplet size of the microemulsion system and the antibacterial property of cinnamon oil, together, accounts clearly for the enhanced efficacy of the new formulated system F4 and not just azithromycin alone. Staining with acridine orange/ethidium bromide dyes as examined through fluorescence microscopy also substantiated with the results of membrane permeability of bacteria. Thus, our study discloses a potential oral drug delivery system of azithromycin with improved biocompatibility.
But as the retraction notice states, that disclosure was premature:
“Design and Formulation Technique of a Novel Drug Delivery System for Azithromycin and Its Anti-Bacterial Activity Against Staphylococcus aureus,” AAPS PharmSciTech. 2013; 14(03): 1045–1054, has been retracted due to inability to verify the original data.
Of course, one way to read that sentence is that the authors were unable to replicate their findings in follow-up experiments. But it could also be a fair reading that the data were corrupt. We tried to find out, but when we asked journal editor Lee Kirsch for more details, he forwarded our query to AAPS director of publications Todd Reitzel, who responded, unhelpfully:
Per the AAPS Electronic Journal Ethics Policy, which is publically available at http://www.aaps.org/PharmSciTech/#Submit, the paper was retracted due to inability to verify the original data. We do not provide specific reasons separate from this response.
Reitzel, we should note, blogged about the 2012 study in PNAS that, as he writes:
revealed an unexpected result on the state of biomedical publishing: Most retractions stem from scientific misconduct.
Reitzel seems to have picked up on the fact that the reason the authors of that study found a different result than previous studies had was that they went beyond retraction notices to sources such as the Office of Research Integrity findings. (They also relied heavily on Retraction Watch.)
He apparently missed this part:
Although some retraction announcements are specific and detailed, many are uninformative or opaque. In 119 instances, no information regarding the reason for retraction was provided by the journal. Announcements are often written by the authors of the retracted article themselves (27), who may be understandably reluctant to implicate themselves in misconduct.
probably there is something serious with the data here…otherwise, is it a practice to verify the original data by the journals these days!!