A cardiology researcher in Illinois coerced trainees to fake the results of a heart test so that patients would qualify to enter a clinical trial, according to a new finding by the Office of Research Integrity (ORI).
Here’s an excerpt from the ORI’s notice about Parag V. Patel, of Advocate Lutheran General Hospital, in Park Ridge, Illinois:
ORI and Advocate Health Care found that the Respondent engaged in research misconduct by directing or intimidating fellows and others to influence left ventricular ejection fraction (LVEF)scores of ≤ 35% and requesting attending physicians to reassess scores of LVEF to be reported as ≤ 35% for research subjects after being diagnosed with acute myocardial infarction, thereby causing and being responsible for falsification of research records. These falsifications made subjects eligible for enrollment into the “Vest Prevention of Early Sudden Death Trial” (VEST) when they otherwise may not have been eligible.
The LVEF is a measure of how efficiently the heart pumps blood, and a normal range is somewhere between 55% and 70%. The VEST trial “explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias,” according to its entry in ClinicalTrials.gov. It began recruiting 1,900 participants in 2008, and is expected to be complete in 2015.
Patel’s work was supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) grant U01 HL089458.
Patel agreed to having his research supervised for two years, and to not serve on any NIH peer review committees for the same length of time, but he did not confess to any wrongdoing. The ORI report continues:
The Respondent, Advocate Health Care, and the U.S. Department of Health and Human Services (HHS) want to conclude this matter without further expenditure of time or other resources and have entered into a Voluntary Settlement Agreement (Agreement) to resolve this matter. Respondent neither admits nor denies ORI’s and Advocate Health Care’s findings of research misconduct. This settlement does not constitute an admission of liability on the part of the Respondent.
Patel and one of his patients were the stars of a 2011 story in a local paper about an unrelated trial for the AngelMed Guardian cardiac monitoring implant. We found two papers by him in PubMed, neither of which has anything to do with the VEST trial.
Patel, who was born in Kenya, is also chairman and founder of the Foundation for International Cardiac & Children’s Services, which helps “promote sustainable healthcare for poor and needy women and children who are discriminated against and given less opportunities” in his birth country.
We’ve contacted Patel, his hospital, and the VEST trial organizers, and will update with anything we learn.
The ORI has been in the news recently, as its director, David Wright, stepped down in a scathing resignation letter.
Update, 10:20 a.m. Eastern, 3/18/14: Advocate Health, the parent organization for Advocate Lutheran General Hospital, sent us this comment:
Providing the safest and best place for our patients to heal and physicians to practice is our top priority. Because the terms of the settlement agreement prohibit public comment, we are unable to provide any specific details regarding the matter.
Please see an update on this story.
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Another harsh punishment from the notoriously Draconian ORI.
As has been repeated ad infinitum, the ORI lacks legal authority to do more. If you are not satisfied, you can write to the Justice Department to demand action, or you can write to Sen. Grassley to encourage him to change the law.
If these accusations are true, this offense is EXTREMELY dangerous. In addition to potentially killing the people he’s enrolling (remember the early gene therapy case at Penn), he is risking the lives of people who may in the future rely on his false research for their health care. This isn’t just faked Westerns. The ORI does have the legal authority to complete their investigation without a settlement that is utter garbage. They aren’t required to agree to terms that prohibit the hospital from comment or that allow this guy to not accept responsibility. Sure, they lack the legal authority to pursue criminal charges but they can complete their investigations.
It shocks me that people commenting here don’t seem to realize that of all the federal agencies that investigate misconduct and punish research/scientific misconduct, ORI is the only one that publishes the names and the misdeeds. NSF, for example, does not. And it does fund human subjects research. So does the Department of Defense.
You are correct, Theresa. Since I was at ORI in 1992, ORI has published the names, institution, specific findings and papers needing correction or retraction, for all the hundreds of ORI findings, in the Federal Register, the NIH Guide to Grants and Contracts, in the online ORI Newsletter, ORI website, and ORI Administrative Actions Bulletin Board (over 90% are for falsification and/or fabrication). NSF OIG’s Semi-Annual Reports to Congress describe the case but provide no names (over 90% are for plagiarism); NSF posts the names on the Government’s list of debarred persons, but it does not state the reason for the debarment (which could be for financial fraud, etc.)
More complete PubMed listing, with publications more relevant to the trial:
http://www.ncbi.nlm.nih.gov/pubmed?term=Patel%20PV%5BAuthor%5D&cauthor=true&cauthor_uid=20802269
Just trying to read the PubMed listing as per Boehinglab, but it is not available. Is this part of the “No public comments”? I find this issue to be extremely troubling, as I attempt to provide credible information for cancer patients with limited options. To think that the basis for any research study has been undermined, as alleged, and that the researcher is still funded by the public is frightening.
No wonder such a large percentage of the population has come to distrust the medical world, skeptical of the latest data, and turning to charlatans–whose messages are generally consistent, if nothing else!
According to the website for LifeVest, this device was approved based on clinical trials involving fewer than 300 people. The VEST study aims to enroll 1900. This device is already on the market and rental is covered by Medicare, Medicaid and insurance.
“…the settlement agreement prohibit public comment…”
Does the settlement agreement really prohibit comment?
If so, I suggest one reform of the ORI that everyone will agree with: the ORI should be prohibited from entering into agreements that have gag clauses.
I don’t expect the ORI to comment further beyond the official report. But the respondent, and in particular witnesses, should be free to discuss the case in detail.
I would argue the reverse as far as commenting. As a journalist covering this topic for 7 years ORI definitely USED to talk about cases. They aren’t legally prohibited in general. Thanks to OASH, the overseers, that has stopped. I highly recommended rereading David Wright’s resignation letter. The research community needs information about these cases so they know what went wrong and can learn from them.
On the face of it, the following three parts of the announcement seem to be fundamentally at odds with each other…
(1) “ORI and Advocate Health Care found that the Respondent engaged in research misconduct”
(2) “Respondent neither admits nor denies ORI’s and Advocate Health Care’s findings of research misconduct”
(3) “Dr. Patel has voluntarily agreed for a period of two years, beginning on February 21, 2014: To [blah blah]”
From an objective view, it would seem that if a respondent is indifferent to findings, then they should not be bound by an agreement based on such findings. Likewise if one enters into an agreement, this undeniably creates an impression that they agree with its foundations (i.e., the findings).
BUT… what’s being allowed here is for respondents to both have their cake and eat it. They can take the 5th regarding any accusations, then just do the punishment anyway, and the whole thing vanishes in 2 years. By refusing to comment now, this leaves open the opportunity for respondents to refute findings at a later date, and to truthfully state “I never admitted misconduct”. Clever!
It’s like pleading no contest in court. You can’t assume Patel had “no comment.” It just means ORI didn’t want to take the case through the administrative procedures, for whatever reason, to force the issue guilt.
I worked in research for a short time – probably less than 2 years – and the nurses who worked in the research department were routinely pressed to enroll patients in studies when they didn’t meet criteria. This should not be news. All these studies eventually boil down to life and death and the cavalier attitude of some physicians who enroll patients in their studies is reprehensible, but not new.
An earlier post from Dan Zabertakis expresses the common assumption that individuals who commit research misconduct cannot be prosecuted..It’s rarely happened but can be done. It requires that ORI refer the case to the Justice Dept.The Feb 2006 issue of The Scientist, quotes Alan Price, a senior ORI official at the time,who stated that such cases are not prosecuted because the AG does not believe its worth the cost considering the small amounts of money(grants) involved.That’s 7 years ago. It might help if Senator Grassley pointed out to the AG and ORI that there should be additional criteria for prosecution.
Regarding research misconduct by support staff, it might occur less often if they were required to take a customized “RCR” course which explained the impact their study could have on clinical care and the dire consequences should fraudulent data be reported.
DSK
Of course, an RCR course would make all the difference in the world. Being told to sign up more patients and the implication is or else find another job that is a corner some cannot find their way out of. I found another job. Maybe coming down hard on the study principals would be more effective, since it’s the money, honey, that drives this – not principles.
“An earlier post from Dan Zabertakis expresses the common assumption that individuals who commit research misconduct cannot be prosecuted”
In fact I didn’t say that.
“such cases are not prosecuted because the AG does not believe its worth the cost considering the small amounts of money(grants) involved.”
This and the fact that the likelyhood of success is very small.
ICH GCP training is requirement for site personell in study conduct. I am wondering wether FDA and responisble IRB took note of that case….
I have said that more recently than 2006, Don, in retirement from ORI, and I am sure that it remains the case. It may well cost the Department of Justice hundreds of thousands of dollars to try to prosecute criminally as case of research misconduct, so it wants to be able to recover a million(s), and the legal threshold for a criminal finding is way beyond the preponderance of the evidence (51%) for an administrative law finding like ORI’s findings. However, as I have noted several times in recent years in Retraction Watch, DoJ has criminally prosecuted some very serious ORI respondents, like Eric Poehlman and Paul Kornak, who got fines and jail time, as well as ORI debarment for life. See websites:.
http://www.nytimes.com/2006/10/22/magazine/22sciencefraud.html?_r=1&pagewanted=6 – and
http://web.archive.org/web/20060203101242/http://www.usdoj.gov/usao/nyn/NewsReleases/2005/2005-02/200502031553.htm
Seems to me this behavior also constitutes very serious violations of the Common Rule (human subjects regulations), but I see no sign that OHRP has been involved.
“Approved for use for more than a decade, the LifeVest can boast not a single shred of clinical-trial evidence that shackling humans to a beeping, vibrating, shocking vest is any better than standard medical therapy. (The VEST trial is actively recruiting patients, after a nudge from the Centers for Medicare & Medicaid Services in 2011, but 11 years after approval one would have expected at least one trial result.)”
The plot thickens.
http://www.medscape.com/viewarticle/808931