The biggest scandal in cell therapy

by Alexey Bersenev on July 7, 2013 · 1 comment

in Uncategorized

In the last decade, we have been witnessing many scandals and lots of scam in stem cell research. The field is very hot and filled with a hype. Well, it seem like cell therapy field (which is all about translation of stem and cell research in the clinic) was not able to avoid the “same destiny”. This week, some very interesting data, compiled by UK’s cardiologist Darrel Francis were reported in Int J Cardiol. He scrutinized almost all papers, published by famous Strauer’s group. The story was (magically!) picked up by Larry Husten of Forbes and went public. It looks ugly, guys! Ugly for Strauer, ugly for the field!

A German Professor – Bodo-Eckehard Strauer, was the first well known clinician, whose group developed cardiac cell therapy with autologous bone marrow cells. They initiated clinical trials more than a decade ago and started to publish results in 2001. He became famous after publication results of the first trial in 2002 in Circulation. I clearly remember that time. It was only one group, which was conducting trials and publishing results that time. We followed all their reports and credited Strauer widely. However, what we didn’t know is that some cardiologists were scrutinizing and criticizing Strauer’s data for years. Most of action happened “locally” and was not highly publicized. In 2012 fraud allegations were reported against Strauer. Now, after Francis report, Forbes and Nature coverage, the scandal got so big!

So, what is in Francis report? A quote from Forbes:

According to Francis et al, the 48 papers from Strauer’s group contained reports on only 5 actual clinical studies, or “families” of reports, and that duplicate or overlapping reports were common. The paper contains details about more than 200 errors in the papers, including contradictory descriptions of the design, protocol and results of the trials.

Francis provided very precise and detailed analysis of all discrepancies and errors in Strauer’s papers. He also discussed how could it happened and why it was not picked up by peer-review process. The conclusion from his analysiswe can not trust any clinical data from Strauer’s group:

In our efforts to understand the work of the pioneering group in au- tologous bone marrow stem cell therapy for heart disease, we discovered many unexplained discrepancies in articles, sufficiently severe as to make articles’ conclusions doubtful. Citing papers and meta-analyses appear not to have recognised these problems. Findings may become incorporated into clinical practice. Current journal processes are not always able to make readers aware of discrepancies that come to light.

In agreement with Francis, the editor of journal wrote:

I can see no logical option but to suspend belief in any of the data reported in these publications until an appropriate investigation has been performed.

Another German cardiologist – Andreas Zeiher, who was watching Strauer’s work very tightly, told to Forbes:

“It is indeed more than scary and disappointing to learn that the extent of ‘imperfectness’ in reporting clinical data by the group of Strauer is so enormous. This will be another major blow against an emerging field (cell-based therapies), which did raise tremendous expectations, but appears to be crippled by irresponsible ‘clinical scientists’, who appear to be focused exclusively on their own agenda.”

According to Forbes, Francis report was also criticized by some cardiologists:

…Francis overstates the prominence of Strauer and the impact of his work. Although the paper describes Strauer’s group as the “foremost group in this field,” other researchers in the field strongly disagree with this opinion. Strauer appears to have been an active researcher with many publications, but he is not considered a thought leader or highly influential figure.

Another more serious critique of the Francis paper is that it fails to sort out minor or trivial errors from major flaws that raise the possibility of serious scientific misconduct or fraud. The overwhelming amount of detail contained in the paper makes it difficult to assess the situation without an enormous commitment of time and energy. But the experts I spoke with agreed that there were enough instances of serious flaws to warrant concern.

Unfortunately, Forbes neither reveals names of these critics nor cites original sources. Yes, Strauer’s errors, reported by Francis, could have different impact on conclusions. But what have been revealed, already enough to doubt any Strauer’s conclusions and start investigation. Indeed, such investigation was initiated by University of Düsseldorf in 2012, but no results were reported.

This scandal will add more reasons to mistrust efficacy of bone marrow cells in cardiology. This type of cells was already in a “bad shape” for future clinical development. Now, I’m sniffing some retractions and more negative conclusions on efficacy.

{ 1 comment… read it below or add one }

Charles Dawson July 14, 2013 at 1:57 am

We advise all readers to bear in mind that there has been no criticism of our own company’s work.

Zygotron Metadynamics provides ethical bone-marrow based stem cell therapy for heart disease and although based entirely on the work of Prof Strauer, is specifically not named by the current allegations which remain unproven.

While the bone-marrow stem cell therapy is our primary source of income, we are expecting royalties on the spinoffs we have developed including NatriChlor, a uniquely developed and commercially secret mixture of two ions in a precise electrical balance, that permit sterile water to be made isotonic to be in ideal harmony with the body’s natural fluids. We expect to licence this to other stem cell companies who need to find alternatives to injecting placebo-control patients with unlicensed ex-vivo cell culture medium.

We will soon reach profitability and secure the pipeline of groundbreaking paradigm-shifting innovation for which our company name is a watchword.


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