The following letter, from Primegen’s Fari Izadyar, responds to comments made about PrimeGen by former executive Francisco Silva in a recent article in Nature Reports Stem Cells.
We wish to comment on certain aspects of the interview with Francisco Silva published in Nature Reports Stem Cells (9 April 2009), which accompanied an analysis of his recent publication. First, we applaud Dr Phil Schwartz’s rigorous discussions on the sham surgery effect of untethering the spinal cord and removing scar tissue, and the acknowledgement of both the placebo and the potentially therapeutic physical effect of the manipulation, which is separate and distinct from the cell therapy component. In other words, with so much noise, how does one see a signal in such a small uncontrolled study?
In the article, Francisco Silva described our company as having “…a corporate strategy regarding publishing their work, which differed from my belief that peer review is required and needed process providing validation and transparency. As a result, I left [the company] in 2007.”
In the interview, PrimeGen Biotech was erroneously described by Silva as having a corporate strategy that did not believe in validation, transparency or the peer review publication process. Our company has a demanding corporate policy for a rigorous and careful validation process prior to publication of our results, and, contrary to Silva’s claim, our company has published research in respected peer-reviewed journals, such as Biochemical Biophysical Research Communication, Reproduction, Human Reproduction and Tissue Engineering and Regenerative Medicine (in press). Silva is one of the senior authors on two of these papers, which were submitted prior to his departure, and this clearly demonstrates that peer-review publication has always been an important part of our corporate policy and directly refutes Silva’s claims.
It should be pointed out that the R&D leaders of our company have always advised our nontechnical management and board as to what statements should be issued and released to the public. Mindful of past inaccurate portrayals of the state of our research, the company has comprehensively revamped its R&D management and has instituted a strictly enforced policy of publication prior to any press releases. For example, during his tenure as the former executive VP of R&D, Silva was one of the leaders who presided over such public relations events. It is interesting that Nature Reports Stem Cells pointed out the lack of disclosure in Silva’s Cell Transplantation paper that described his team’s animal model data, which he discussed in the interview — an apparent pattern of discussions about data in the media without prior peer-reviewed publication that Silva claims to denounce.
Lastly, we want to point out that the circumstances regarding Silva’s departure from PrimeGen were misstated.
1. Director of research and development, PrimeGen Biotech LLC, Irvine, California.
[Editor’s note: Francisco Silva has prepared a reply to this correspondence.]