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Ex-Wayne State scientist, ORI square off in court

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WASHINGTON, D.C — Last week, former brain scientist Christian Kreipke stared down the third set of research misconduct allegations against him since 2011. Or, possibly, according to him, it was the third iteration of the same research misconduct allegations he’s faced for years, a piling on by the most powerful of the three institutions out to ruin him after he allegedly uncovered a grant fraud scheme at Wayne State University, his former employer.

All the same, over three days Kreipke faced off against the U.S. Office of Research Integrity in a virtual administrative law courtroom as he contested a finding of research misconduct and an accompanying 10-year ban on receiving federal funding. In Washington, prosecutor Patricia Mantoan, a U.S. Department of Health and Human Services (HHS) attorney representing the ORI, brought the government’s case against him, wrapping up well before the end of Monday, July 10. Onlookers at the public hearing watched on video monitors as Kriepke sweated, literally, through hours of testimony, much of it with him on the witness stand. Despite being confined to what his lawyer, Shereef Akeel, of Detroit-area firm Akeel & Valentine called an “85 degree” room at the U.S. District Court in Detroit, Kreipke’s defense team took their time laying out his side of the story.

Since the allegations were first raised, Kreipke’s defense has remained largely the same: the misconduct allegations from Wayne State, brought in 2011, are retaliation against him for raising doubts the year before about accounting practices related to federal grants. At trial, Akeel characterized Wayne State’s misconduct investigation as a “witch hunt” that was out to get Kreipke, no matter what.

Now, Kreipke — who has had five papers retracted — is saying that the ORI’s case simply parrots Wayne State’s investigation. Through a public records request, Retraction Watch has obtained Wayne State’s 36-page final investigation report, along with hundreds of pages of supporting documents. The report, issued Nov. 30, 2011, and its attending exhibits, paint a picture of a researcher who frequently falsified images, changing their labels to show whatever was expedient.

Readers may recall that in October 2012 — after he was ultimately fired by Wayne State on the basis of the misconduct report — Kreipke filed a False Claims Act lawsuit against the university on behalf of the US government, to reclaim $169 million in funding he says the school fraudulently obtained. In the suit, he alleged he had been wrongfully terminated earlier that year. Until 2012, he had held a joint appointment as a tenure-track professor at Wayne State, in Detroit, and as a researcher at the associated the associated John D. Dingell Veterans Affairs Medical Center. The VA also investigated him for misconduct and fired him in 2013. The following year, a federal judge dismissed Kreipke’s lawsuit against Wayne State, on procedural grounds.

But Kreipke hasn’t given up his legal battle, and earlier this year, a different judge ordered the Department of Veterans Affairs to reinstate Kreipke’s position, noting

The existence and motive to retaliate against the appellant was shown.

A precedent for future cases?

Last week’s trial was a first, of sorts. The last live hearing for scientific misconduct occurred nearly 20 years ago; this is the first to be conducted under federal regulations governing misconduct in research supported by the Public Health Service, enacted by Congress in 2005. Judge Keith W. Sickendick, an administrative law judge with the HHS Departmental Appeal Board, presided over the hearing via videoconference from his office in Kansas City, Kansas.

Richard Goldstein, an attorney at Meyer, Connolly, Simons & Keuthen, who has defended scientists accused of misconduct, told Retraction Watch the case is an important development in how the government enforces the current regulations:  

ORI has been successful up to this point in getting all of their sanctions affirmed by an administrative law judge without a hearing. The presumption is you don’t get a hearing unless you can establish a reason for it.

To debar a researcher, ORI has to present a so-called “charge letter” outlining the misconduct allegations and the proposed “administrative action” of a funding ban. To get a hearing, the accused, also known as the “respondent” must submit a “hearing request” within 30 days. Submitting this request is no small feat, Goldstein told us. It essentially requires the respondent to lay out his or her entire case against the allegations.

At this point, we don’t entirely know what ORI’s list of allegations against Kreipke looks like, but based on the trial it appears the case is at least strongly reliant upon Wayne State’s investigation. NIH HHS declined to share a copy of ORI’s charge letter and other important documents. An HHS spokesperson told us:

The case documents, including the charge letter and [a declaration from ORI scientist investigator Alex Runko], are Privacy Act-protected, and ORI doesn’t have authority to release these documents without the advance written consent of the Respondent.

In all, Wayne State addressed six “specific allegations” of misconduct against Kreipke. In addition to several instances of falsifying figures, the report shows that Wayne State investigated Kreipke for fabricating data and falsifying other written material submitted in NIH grant applications. Among the allegedly falsified materials were a letter of support from a pharmaceutical company he was collaborating with and an inflated biographical sketch stating that he was a “full member” of the UK’s Royal Society. Wayne State’s report suggests there’s evidence to support all six allegations. From what we could gather from the trial, ORI has added at least one more.

Though it won’t be resolved for months, Goldstein told us ORI’s case against Kreipke is already setting precedent:

The way they’re handling this case could be important for the way other cases are handled in the future.

“There’s been no attempt to hide this”

The allegation that triggered Wayne State’s investigation came from one of Kreipke’s former students, Christian Reynolds. In February 2011, Reynolds told Wayne State’s research integrity officer that a paper in that month’s Neurological Research, co-authored by himself, Kreipke, and Kreipke’s mentor Jose Rafols, contained a duplicated image, also found in an NIH grant application. Kreipke and Rafols had served as guest editors for that issue.

Kreipke, for his part, doesn’t deny that the paper contained a duplicated image. He told the Wayne State investigators that Reynolds was responsible for selecting all the images for that manuscript. Nevertheless, Kreipke characterized the image duplication as a “minor mistake;” Kreipke testified that he immediately contacted the journal to submit a corrected figure, which was included in a corrigendum.

At last week’s hearing, he said:

There’s been no attempt to hide this.

The image in question, a fluorescent stain of an injured rodent brain purporting to show decreased damage with administration of a particular drug, had been used elsewhere to show the same effect, but with a different drug in the same class (endothelin A antagonists). Kreipke said:

The correct images are almost indistinguishable. They do not change the interpretation.

However, the paper has been retracted at the request of Wayne State following its investigation, one of five papers the report suggested be removed from the scientific record.

Five manuscripts, 14 grants, and “numerous presentations”

From that first allegation sprang others, Wayne State’s report said:

During the course of our investigation, several additional instances of misrepresentation were discovered involving at least five published manuscripts, 14 NIH grant proposals and numerous public presentations that extended our investigation beyond the special edition of Neurological Research for which Dr. Kreipke and Dr. Rafols served as editors.

In the report, Wayne State’s investigation committee — led by Phillip Cunningham, a former biology professor and currently VP of Research at Wayne State — detailed its efforts to evaluate the six allegations. Some allegations were broken down into multiple parts. In all, the report presented conclusions on 11 allegations and sub-allegations. For each one it presented its analysis; including original documents like grant applications;  primary data, such as lab notebooks; evidence; and conclusions. Using the standard of a “preponderance of evidence,” meaning that the so-called weight of evidence in favor of misconduct was more than that against it, the investigators found Kreipke had committed misconduct in all but one instance: the committee determined there was “insufficient evidence” to support the allegation Kreipke had intentionally lied about being a member of the Royal Society, though it called the matter “worrisome.”

By way of example, Wayne State’s report detailed how it determined Kreipke had committed misconduct in the case of the 2011 Neurological Research paper, which Reynolds had brought to the university’s attention.

During Kreipke’s interview with the investigation committee, he told them the image — which implied that fewer neurons showed sign of damage following traumatic brain injury (TBI) if the animal had received an injection of the drug Clazosentan — actually showed the effects of a different molecule, albeit one with a similar mechanism of action. Kreipke told them he was “confident” it was an image showing the results with an “anti-calponin” antibody treatment, but the report suggested even that wasn’t true.

Based on computer files and filenames available to the investigators, they said the original image actually depicted cells in an entirely different part of the brain than had been reported in either the paper or the grant application, showing no treatment of any kind. The same image had also been found in numerous other documents with different labeling, all of which had simply changed the exposure, contrast, and rotation of the image. The committee said they found it “highly unlikely” that the original image, created Oct. 31, 2008, could have been merely “mislabelled” one thing for an NIH grant submitted in November 2008 and then re-used in a paper by mistake years later.

Even worse, the report’s concluding remarks suggest that an image Kreipke sent to Neurological Research to correct the 2011 paper was itself a duplicated, renamed file. In August 2011, the committee asked him to send along the materials he’d submitted as part of the corrigendum. He provided a single image file, one that the investigators said they couldn’t find anywhere on his computer. What they did find was an identical image with a different filename:

This suggests that [Kreipke] changed the title … and then submitted the file to the journal and to the Investigation Committee.

Evidence, planted and withheld?

In addition to several more papers and grant applications on which Kreipke was listed as primary investigator, that image found its way onto several posters where Kreipke is listed as a co-author — often as first author. Kreipke testified at the ORI hearing that in almost all the cases, he never actually presented those posters and had no idea how the falsified images found their way onto them, besides his suspicion that they were planted by Wayne State during the investigation:

[The posters containing questionable images] are manufactured from posters that did have my name on them … My guess is they were concocted or manufactured to add to the volume of misconduct here.

Judge Sickendick probed him on that matter:

You would go so far as to say Wayne State went to hang you with these posters?

Kreipke replied:

That is my assertion. These were not in the computers that were returned to me. When they took them, these files did not exist.

Among Kreipke’s many allegations is the particularly inflammatory charge that Wayne State planted evidence against him.  

Wayne State’s report repeatedly said its investigators couldn’t find evidence in Kreipke’s lab computer or notebooks to back up questionable figures. But Kreipke alleges that the institution deliberately ignored potentially exculpatory evidence held by Rafols:

Why didn’t they have the data? Because they didn’t take Dr. Rafol’s computer.

He’s suggested that Rafols might be an equally good target for a scientific misconduct investigation. Though Kreipke presented him as a potential witness in his defense, the Wayne State investigators never spoke with Rafols. Cunningham, the lead investigator, testified that this was because Rafols would only submit answers in writing, which Wayne State’s protocol does not allow.

Still, Wayne State did not sequester a computer belonging to Rafols until August 2012, months after Kreipke was ultimately fired by Wayne State.

And Wayne State wasn’t the only entity out to get him, Kreipke says: Reynolds, too, had motivation to torpedo his career. Wayne State documents suggest that over the course of his time in the lab, Reynolds developed an intense dislike for Kreipke, going as far as to muse out loud about cutting the brake lines of Kreipke’s car.

ORI says it needs only one

Kreipke testified to all these aspects of his defense, spread out over three days of the hearing. Throughout the trial, prosecutor Patricia Mantoan, of the NIH’s HHS Office of the General Counsel, objected that the surrounding issues were beside the point.

In ORI’s view, the judge only needs to find one instance of misconduct, supported by a preponderance of the evidence, in order to justify its findings and HHS’s decision to debar Kreipke. But justifying the decade-long ban might require more than just one. Judge Sickendick said:  

The number may impact my view of the sanction.

While the hearing is over, it will likely be at least four months, possibly six, until Sickendick issues his opinion. Mantoan and Akeel will have two months to submit post-hearing briefings, given in lieu of closing arguments, and another two months to file responses to each other’s briefings. After that, Judge Sickendick will have another two months to decide the case.

Despite the fact that a federal judge overseeing Kreipke’s VA case ordered the VA to restore his position in March, he remains out of science. He works at a tire factory for the Ford Motor Company.

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Written by Andrew P. Han

July 18th, 2017 at 8:00 am

Comments
  • science lawyer July 18, 2017 at 4:09 pm

    “Since the allegations were first raised, Kreipke’s defense has remained largely the same: the misconduct allegations from Wayne State, brought in 2011, are retaliation against him for raising doubts the year before about accounting practices related to federal grants.”

    We believe the EVIDENCE shows that Kreipke’s defense has changed frequently. This RW story itself shows this: “He told the Wayne State investigators that Reynolds was responsible for selecting all the images for that manuscript.” And “Reynolds, too, had motivation to torpedo his career.” This raises two questions: 1) Which is it–WSU or Reynolds? My associate was there when he claimed that WSU planted faked data. 2) Why would Reynolds want to torpedo Kreipke? Maybe for committing misconduct?
    Further, his claimed whistle blowing is KNOWN to have occurred only after Wayne State fired him in 2012.

  • Boyer July 18, 2017 at 4:18 pm

    Can anyone explain why three independent agencies would want to take this guy down? I know, I’ve seen the whistleblower talk. And the false claims act lawsuit. But why would ORI, an arm of the Department of Health and Human Services (HHS), team up with Wayne State, who Dr. Kripke claims stole $169 million from HHS? It makes no sense. It’s equivalent to a bank conspiring with the bank robber to disparage the police who caught the robber. How gullible are people?

  • Boyer July 18, 2017 at 5:52 pm

    Another thing: if he claims that Wayne State did bad stuff with grant funds, why would the Department of Veterans affairs care? Why are they involved in the conspiracy?

  • Mary Kuhner July 18, 2017 at 7:04 pm

    There’s also a very strange statement in the full report (linked from above) where Kreipke seems to be saying that some of the grants in which he is alleged to have used falsified figures did not exist. It staggers the imagination that ORI would miss this easily verifiable fact. But I suppose on the conspiracy theory, anything said by Wayne State is automatically discounted.

    The part that Kriepke does not try to deny is that he published quite a few papers with manipulated and duplicated images. It does not take Wayne State to corroborate this; it’s in the record in black and white for anyone to see. He resorts, according to the Wayne State report, to “I didn’t do it, it was an accident, and anyway it doesn’t matter as the results would have been the same.” I could possibly buy “I didn’t do it.” I could possibly buy “It was an accident,” although if so he has been very, very sloppy for a long time. But the third one is a huge red flag. If you are not in control of which images get published, are you in control of whether the research is validly reported? If you think you have a saboteur in your lab, should you feel 100% solid on all of your results??

    I don’t think so. If his defenses are accurately reported, he fits the profile of so many other data fraudsters we’ve seen: no concern for truth, only for appearances.

  • thomas July 18, 2017 at 7:50 pm

    I just skimmed the linked transcript of Kreipke’s interview with the Wayne investigators. Very interesting reading; so interesting, in fact, that when I have time, I’ll read it “cover-to-cover”. But it’s clear that, contrary to the story above (“Since the allegations were first raised, Kreipke’s defense has remained largely the same: the misconduct allegations from Wayne State, brought in 2011, are retaliation against him for raising doubts the year before about accounting practices related to federal grants.”) his defense HAS changed. In his transcript he never mentioned anything related to whistle blowing (at least from my quick read).

    Also, contrary to his assertion that Wayne planted the fake data, he acknowledges in the transcript that the data misuse is real and not fudged by the university. It certainly seems like his stories have changed pretty frequently!

  • LShields July 18, 2017 at 8:12 pm

    “There’s been no attempt to hide this”

    From all these stories, Kreipke claims it’s no big deal–he corrected the paper. I looked it up. He corrected one of the erroneous figures. But another figure in the paper appears in a different article, also published in Neurological Research, but it’s labeled to be something different than in the other paper. Why was this figure never corrected?

  • Brasko July 18, 2017 at 9:11 pm

    Thanks to RW for making the Wayne State files available! This offers a singular insight into the minds of those involved as it was happening. I can’t think of another opportunity like this in the past. Maybe we can learn something valuable about those who commit misconduct.

  • Alan R. Price July 19, 2017 at 5:03 pm

    Dr. Boyer, to your question of why 3 agencies — Wayne State University (WSU) in Michigan, federal Department of Veterans Affairs (VA), and federal Department of Health and Human Services’ Office of Research Integrity (ORI) — would all pursue such a misconduct case:

    It is because each agency has independent authority and obligations to purse misconduct under its own jurisdiction. ORI pursues research misconduct related to HHS / mostly National Institutes of Health (NIH) research grants and applications for support from HHS agencies. WSU as the recipient of NIH/HHS research grants is required to investigate and report to ORI on research misconduct investigations related to NIH/HHS grants. The federal VA is obligated to investigate misconduct related to VA grants at its VA medical centers or other institutions (and those related to NIH/HHS grants given to VA medical centers, and to report the latter to ORI). Agencies may act independently or act cooperatively in such investigations, as well as with the investigators and prosecutors in the federal Department of Justice; each agency may impose its own administrative actions in such cases.

  • Boyer July 19, 2017 at 5:35 pm

    Thank you Dr. Price. Actually, my comments/questions were of a more skeptical nature. What I should have written was why would the three agencies try to take him down in the absence of misconduct, since the whistle blowing doesn’t really seem to fit reality, by his own testimony. After all, he says he did his whistleblowing in 2012, but had bad data in a paper published in 2006.

    I wondered what people thought of the apparent conspiracy theorizing presented by this person and his attorney. They seem to try to portray the respondent in the case as an innocent who is being ganged up upon by the big government. And rhetorically, why would they do that in the absence of reasonable suspicion of misconduct. I have colleagues who have done investigations and I don’t envy them the effort, sacrifice and absolute misery of going through it, with no winners in the process.

  • Taylor Stenson July 19, 2017 at 9:39 pm

    Thanks to RW for providing links to previous testimony and other information in this case of scientific misconduct. Thanks also to the other commenters for their incisive thoughts. I read the testimony of Kreipke in the earlier Wayne State investigation into scientific fraud on his part and something is askance. Not once in his previous testimony did Kreipke claim that Wayne State was punishing him because he reported the University for grant fraud. He admitted that data had been misused. He also never mentioned previously that the University planted the fraudulent data and figures. Now he uses both arguments in an ever-shifting defense strategy. It strains credibility to the limit to charge that Wayne State stole $170 million of NIH grant dollars yet Kreipke’s current claim that the University planted the false data (or was it Reynolds, or Rafols, or little extra-terrestrials) goes beyond the grant fraud claim. Kreipke may be asserting self-defense positions (i.e., the Devil made me do it) based on attorney recommendations, but these are outlandish and seem to be akin to trying to close the barn door after the horses have bolted. It was interesting that Kreipke was perspiring profusely during his testimony as this is a tell-tail sign of lying. Was it a Freudian slip that his attorney used the term “confined” to make an excuse for the sweating by his client? Kreipke and his attorney should heed Healy’s first law of holes.

  • Tedtalks July 20, 2017 at 6:48 am

    Here’s a different question angle: I believe I’ve seen reports that kreipke’ FCA claim was dismissed. He appealed and that was also dismissed. Then they asked the US Supreme Court to hear the case. Even though all of these actions went Wayne Sate’s way, I would think the university spent big money for legal costs…even though the claims against them are illegitimate.

    1. How much would all this cost WSU?

    2. Are these costs recoverable from the person who initiated the legal actions?

    • Dr. Shelley July 20, 2017 at 9:46 am

      Not to mention–how much has all this cost Kreipke. Any legal experts out there: would Dr. Kreipke’s attorney do all this work on a collect-if-we-win basis? Otherwise, it seems like Kreipke’s costs would be HUGE!

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