Talk about a brutal retraction notice.
The Journal of Translational Medicine has retracted a 2017 paper after multiple investigations into the work concluded that the data were fabricated. At least two of the authors hotly dispute that conclusion, as you’ll see. [Warning: Colorful language ahead.]
The study, “Stromal vascular fraction cells for the treatment of critical limb ischemia: a pilot study,” came from a group of researchers in Lithuania led by Adas Darinskas. At the time of publication, Darinskas listed his affiliation as the National Cancer Institute of Lithuania, in Vilnius. Now he works at Innovita Research, a company trying to develop:
novel extracorporeal immunotherapeutic technologies and modalities based on autologous and allogeneic human peripheral blood components for subsequent clinical introduction and application in health care delivery systems.
According to the abstract for the paper:
This study included 15 patients, from 35 to 77 years old, with rest pain and ulceration. [Stromal vascular fraction] cells were injected once or twice in the ischemic limb along the arteries. Digital subtraction angiography was performed before and after cell therapy. The clinical follow up was carried out for the subsequent 12 months after the beginning of the treatment. …
Results of this pilot study demonstrate that the multiple intramuscular SVF cell injections stimulate regeneration of injured tissue and are effective alternative to achieve therapeutic angiogenesis in CLI patients who are not eligible for conventional treatment. Trial registration number at ISRCTN registry, ISRCTN13001382. Retrospectively registered at 26/04/2017.
However, the retraction notice tells a different story:
The Editor-in-Chief and the publisher have retracted this article [1]. An investigation by the Lithuanian Bioethics Committee concluded that, contrary to the statements in the article, the study described was not conducted in the Vilnius City Clinical Hospital and the Commission of Medical Ethics did not issue any approval for such a study. Additionally, investigation by the State Health Care Accreditation Agency of the Ministry of Health revealed that the records of the patients described in this study could not be located and verified. The Lithuanian Bioethics Committee therefore concluded that the data are unreliable. The Ombudsperson for Academic Ethics and Procedures conducted a follow up investigation and affirmed that the information presented with respect to the location of the study, the ethical approval, and the period of data collection was fictional but was provided as if it was true, i.e. this information was fabricated.
Adas Darinskas and Thomas E. Ichim disagree with this retraction. The other authors did not respond to any correspondence about this retraction.
‘Insane’
Ichim, who is now the chief executive officer at Batu Biologics, in San Diego, told us:
I disagree with the retraction and I plan to sue the journal
The data was not fabricated
Some ill-intentioned people caused this scandal and they will be exposed
Ichim added that he had directed his lawyers to notify the journal of his intent to sue. He also told us that he’d seen the allegedly fabricated data:
How the hell does one invent angiograms !!! Like pre and post angiogenesis therapy??
Insane
Darinskas told us — a bit more colorfully — why he and Ichim dispute the journal’s move:
this is absolutely not true, this is lie, we never fraud the data, the data presented in the article is correct and genuine
So why did the Lithuania officials reach their conclusion?
Because they are arseholes and bitches, thats why, because when we conducted the study there was one law and now it is another law so they fucked us according to the new law…this is the story and investigation took 3 years, I am furious about decision….
Regarding that legal change, Darinskas told us:
cells were regulated as not a advanced cell therapy product and now it is regulated as ATMP this is big difference, we applied as non manipulated tissues and no permissions are required, but when it goes to ATMP it is drug so plenty of documentation is required then
We asked Asta Čekanauskaitė, the acting director of the Lithuanian bioethics committee, about the apparent legal change. The reply:
we could only refer to the findings and conclusions of the three competent reported in the retraction note. These findings and conclusions have been based on the existing law. Unfortunately, I‘m not sure what „change in a law“ is meant in the argument provided by the authors.
Darinskas was a co-author on this 2015 paper in Cell Transplantation that was withdrawn before it appeared in print — and which therefore doesn’t carry a formal statement of retraction. He did not respond when we asked him why the article was removed.
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Salty language indeed!
That exchange certainly perked up my Friday afternoon slump.
Thank you.
The authors’ reaction is very weird, actually. This is a strawman argument; the journal claims that “the location of the study, the ethical approval, and the period of data collection was fictional”, and the authors reply on the fact that the angiograms were not invented.
There should be a real discussion on such cases, where the conflict does not concern the scientific data, but rather the paper metadata (authorship, funding, affiliations, paperwork, ethical statements…). It is of course morally wrong to conduct research without authorization, but is it morally acceptable to trash valid scientific data afterwards because the paperwork was not done properly?
In any case, threats to scientific journals are not acceptable. Editorial decisions need not to be validated by lawyers and judges. What will be the next step? Suing reviewers because they disliked the paper? Suing the editor because the paper was rejected in spite of positive reviews? This is insane.
Do the data exist or don’t they? That seems to be at the heart of the issue, no?
I am puzzled. Why suing the journal when the key problems rest with the investigation and the decisions at home, specifically with the Lithuanian Bioethics Committee?
At this point the *threat* to sue appears to be the all they have done. Sometimes legal threats like this are made to scare critics into remaining silent and won’t be followed up with an actual suit; will be interesting to see how this plays out.
I am reminded of when Dr. Richard Fleming blustered that he had reported me and other critics to the authorities for libel/slander… which isn’t even a criminal matter. The police never showed up at my door.
It’s noteworthy that the investigation apparently found no sign that the study had been done at the hospital where it was said to have been done, nor of the patient records. Without those, there’s no particular reason to think the study was done at all.
Also, the argument that angiograms can’t be faked is silly. Pubpeer is currently reporting on dozens of papers all using the same photographs of cells. I am sure those are real photos of real cells, and that the angiograms are real angiograms; but are they angiograms that accurately represent the described research? The cell photos clearly are not–they represent different experiments in each paper in which they appear.
If it had been just ethics approval missing? I personally think you still retract the paper. Yes, it loses data that could be valuable; but allowing such papers to stand incentivizes researchers to do this, which endangers patients’ lives. And researchers shady enough to falsify ethics approval are often, it seems, shady in other regards.