The authors of a study in Urology that was at the center of two 2009 lawsuits brought by a company that funded the work have retracted the paper.
The idea behind the research — by Robert Getzenberg and colleagues at Johns Hopkins — was to find an alternative to the prostate specific antigen (PSA) test, which many urologists recommend, but which many groups — including the US Preventive Services Task Force — find wanting. The work gave rise to a company, Onconome, Science reported in a 2009 story about the lawsuits:
According to the Pitt complaint, in 2001 while at Pitt, Getzenberg told Onconome’s potential investors that nuclear proteins from prostate tumor cells could be detected in blood and offered an alternative to the prostate specific antigen test, which has well-known limitations. Onconome was founded in 2001 to develop antibody-based tests that detect one such protein, which Getzenberg discovered and called Early Prostate Cancer Antigen (EPCA). The company “depended entirely” on Getzenberg to conduct its scientific research through research agreements with Pitt and later JHU, the suit says.
Things seemed to go well, Science reports, until some of the data were peer-reviewed:
In more than 20 updates to Onconome’s board, the Pitt suit says, Getzenberg reported results for EPCA and biomarkers for other cancers that he described as “amazing”: sensitivities and specificities approaching 100%, which means that the tests identified nearly all cancerous samples and rarely resulted in false positives. Two top medical journals rejected a paper by Getzenberg on a second biomarker called EPCA-2, the suit says.
The paper — now retracted — was finally published in Urology:
It drew widespread media coverage, thanks to a press release from JHU, where Getzenberg had moved in 2005 to take over for [Hopkins cancer biologist Donald] Coffey as research director of the James Buchanan Brady Urological Institute.
A deeper look, however, failed to support that excitement, in phrasing that’s more harsh than that of the eventual retraction notice:
When Onconome hired its own scientists to develop and market the EPCA tests, they were unable to replicate Getzenberg’s experiments. The Pitt suit says that when Onconome compared lab records that were “only recently obtained,” it found that many statements from Getzenberg were “false.” The suit alleges that he exaggerated statistical associations, “cherry-picked the data” to report favorable results, that his technician broke the blind on samples, and that he falsely claimed to have determined the DNA sequence coding for EPCA. In the end, the suit claims, EPCA markers “were and are imaginary.”
The now-retracted study has been cited 67 times, according to Thomson Scientific’s Web of Knowledge. Here’s the retraction notice, which was posted on October 3 of last year and refers to serious problems with the data:
This article has been retracted at the request of the authors. They believe that the article contains findings that may be unreliable. As the authors re-reviewed the data points presented in the article, they identified differences between some of the plate reader values and those that were reported in the article. For some of the duplicates run, one of the values was indeed from the plate reader data, whereas the source of the counterpart value is not easily apparent. Therefore, because the authors could not replicate some of the counterpoint values, they cannot state if the data points represent the actual data generated in the experiments described. Furthermore, the duplicate values may not have been handled in the manner described within the Materials and Methods section of the paper and the values were not blanked. Taken together, the inconsistencies in validating the data collection and recordation warrant retraction of the article. The authors sincerely apologize for any inconvenience this might cause.
The suits were settled for an undisclosed amount, ScienceInsider reported in 2010. We asked Hopkins whether this retraction was a condition of the settlement, but the university said the terms were confidential. We’ve also tried contacting Getzenberg, and the journal, and will update with anything we learn.
Ouch!
Still, at least this is one case where the blame didn’t end up getting pinned on a junior lab member.
There are other papers about EPCA-2, e.g. http://onlinelibrary.wiley.com/doi/10.1002/pros.20963/abstract Wonder what will happen to them.
This situation resembles that with Mikovits and Whittemore regarding their blood test for XMRV-associated myalgic encephalitis, in that a researcher appeared to establish a scientific finding that supported a clinical assay useful in the diagnosis and/or treatment of a common disease. In the case of XMRV, the Whittemore Institute sold a blood test (not certified by FDA, since it was conducted solely in-house) for as much as $2400 a pop, to patients with myalgic encephalitis, patients who are uniquely anxious and fearful and thus open to exploitation. In this case, Onconome did some due diligence before marketing their test, and detected Getzenberg’s apparent fraud in time.
The development of new clinical assays–blood tests that can be used by doctors to help treat their patients–is a potentially highly lucrative undertaking. This is particularly so when the disease in question is common, feared, and currently in flux with regards to diagnostic/treatment options.
There are many others working in a similar way, hoping to make money by producing new clinical assays. This is because of the atmosphere surrounding medicine in this country. Huge and increasing expenditures for diagnosis and treatment are supported by patients who are well off, insurance companies that contract to pay for patients’ care, and Medicare/Medicaid (despite the forces within the insurance industry and the government who attempt to control the expense). There is a smell of money around anything having to do with medicine.
The lure of money has led to many fractures of the ethical framework on which good science depends. As consumers of scientific information, we are obliged to be especially skeptical of purported new developments that redound to the profit of the investigators and their venture capitalist supporters.
Based on the text of the lawsuit cited, and beyond the text of the retraction notice, we can be fairly certain that the research behind EPCA was conducted fraudulently. This casts doubts on Getzenberg’s EPCA-2 work as well.
How many other new clinical assays are based on fraudulent research?
Do these cases not support the argument that scientific research should be government funded and regulated to ensure objectivity? Scientists should be able to earn a decent living but not be tempted by venture capital to make extravagant claims. The government and the people should profit from licensing lucrative new scientific advances instead of allowing capitalists to distort the structure of science.
I was impressed to find this link in the NYT. My opinion, having trained in a surgical specialty at a major research university with formal research experience(with a PhD wife) is that fraud and plagiarism is rampant and too often excuses made and swept under the rug. This is a major reason why taxpayer medical research funding should be more carefully distributed if not cut drastically. So many articles in major clinical journals are shill pieces funded by drug companies. I have even heard of a surgeon-scientist I know personally in my specialty who was reportedly fabricating data–now he’s at another university. All these universities are addicted to the funding so they look the other way, not unlike the clinical side of things where sloppy and even dangerous doctors are permitted to continue their near-criminal pursuits.
These are serious allegations, and you are anonymous. What university looks the other way? Name one, and don’t give us this crap about “some big university”. Also, what is your name?
As of July 3rd, 2012, Dr. Getzenberg is no longer Director of Research for the Brady Urological Research Institute at Johns Hopkins. A search committee is seeking his replacement.
“I have even heard of a surgeon-scientist I know personally in my specialty who was reportedly fabricating data–now he’s at another university.”
I “doubt” your sincerity Thomas. If you are so concerned as to how tax payer dollars are being spent why did you not report this person. Even if this individual was not receiving Federal funding, as a physician scientist do you not care that the research record is accurately represented?