Exclusive-Medical journals broaden inquiry into potential heart research misconduct

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By Marisa Taylor and Brad Heath

WASHINGTON (Reuters) - Three medical journals recently launched independent investigations of possible data manipulation in heart studies led by Temple University researchers, Reuters has learned, adding new scrutiny to a misconduct inquiry by the university and the U.S. government.

The Journal of Molecular and Cellular Cardiology and the Journal of Biological Chemistry are investigating five papers authored by Temple scientists, the journals told Reuters.

A third journal owned by the Journal of American College of Cardiology (JACC), last month retracted https://www.jacc.org/doi/10.1016/j.jacbts.2019.10.006 a paper by Temple researchers on its website after determining that there was evidence of data manipulation. The retracted paper had originally concluded that the widely-used blood thinner, Xarelto, could have a healing effect on hearts.

"We are committed to preserving the integrity of the scholarly record," Elsevier, which owns the Journal of Molecular and Cellular Cardiology and publishes the two other journals on behalf of medical societies, said in a statement to Reuters.

Philadelphia-based Temple began its own inquiry in September 2020 at the request of the U.S. Office of Research Integrity (ORI), which oversees misconduct investigations into federally funded research, according to a lawsuit filed by one of the researchers.

The Temple investigation involves 15 papers published between 2008 and 2020 and supported by grants from the U.S. National Institutes of Health, according to the court records. Nine of the studies were supervised by Abdel Karim Sabri, a professor at Temple's Cardiovascular Research Center.

His colleague Steven Houser, senior associate dean of research at Temple and former president of the American Heart Association, is listed as an author on five studies supervised by Sabri. Houser was also involved in four additional papers under scrutiny.

Houser sued in federal court last year to stop the university's inquiry, saying Temple sought to discredit him and steal his discoveries.

Houser "has not engaged in scientific or other misconduct, has not falsified data, and has not participated in any bad acts with any other scientist or academic,” Houser’s lawyer, Christopher Ezold, said in a statement to Reuters. Houser helped review and edit the text portions of the Sabri-supervised studies and did not provide or analyze the data, Ezold said.

A Temple spokesperson said the university is "aware of the allegations and is reviewing them." He would not comment further or discuss interactions with medical journals. ORI also declined comment. Sabri and Houser did not respond to questions.

Several research experts said that Houser, as one of multiple co-authors, cannot be assumed to be involved in potential misconduct. The ultimate responsibility for a study usually lies with the supervising scientist and any researcher who contributed the specific data under scrutiny.

EXPRESSION OF CONCERN

The probes highlight concerns over potential fabrication in medical research and the federal funds supporting it. A Reuters investigation https://www.reuters.com/investigates/special-report/health-hearts-stem-cells/ published in June found that the NIH spent hundreds of millions of dollars on heart stem cell research despite fraud allegations against several leading scientists in the field.

The Temple inquiry also reveals a lack of consensus within the scientific community over how such concerns should be communicated, to prevent potentially bad science from informing future work and funding, according to half a dozen research experts interviewed by Reuters.

Temple did not notify the medical journals that it was conducting an inquiry at the request of the U.S. government agency, the journals told Reuters. They said that they began their inquiries independently.

Xarelto's manufacturer, the Janssen Pharmaceuticals division of Johnson & Johnson (NYSE:JNJ), also told Reuters the supervising researchers at Temple did not notify the company about the investigation or the retraction by the JACC journal, though two of its employees were listed as co-authors on the paper. Janssen said their contribution to the paper was not questioned in the retraction.

In some misconduct inquiries, universities have notified scientific journals that an investigation is underway. That has allowed journals to issue an "expression of concern" about specific studies, telling readers that there may be reason to question the results. If there is a finding of data manipulation, the journals would be expected to retract the paper.

None of the journals that published the papers under scrutiny by Temple have issued expressions of concern. They would not comment to Reuters as to why they decided not to.

"It's murky because of a lack of resources for these investigations, there's no standardization worldwide," said Arthur Caplan, head of medical ethics at New York University's Grossman School of Medicine.

Other journals are not scrutinizing the Temple researchers' work. Five papers flagged by ORI were published in the AHA journals Circulation, Circulation: Heart Failure, and Circulation Research, where Houser is a senior advisory editor.

The AHA said it had not been notified by the U.S. agency or by Temple about their inquiry, and that it does not view itself as responsible for investigating further. The AHA said it had issued a correction of data on one paper at the authors' request. The paper was the sole study under scrutiny that listed Houser as supervising researcher.

"The American Heart Association is not a regulatory body or agency," the AHA said in a statement to Reuters.

FEDERAL FUNDING

Researchers and their institutions can be forced to return federal funding that supported work tainted by data manipulation.

Houser has received nearly $40 million in NIH funding and Sabri has received nearly $10 million since 2000, according to a Reuters analysis of NIH grants. Houser's lawyer said that none of his NIH funding supported the papers supervised by Sabri.

The JACC journal said in its retraction of the Xarelto research that it launched its investigation after receiving a complaint from a reader. In response, the researchers issued a correction of some image data in the paper, which was supervised by Sabri and which listed Houser as an author.

However, the journal said that the correction raised further concerns, prompting it to hire an unidentified outside expert to review them.

According to the retraction notice, the expert evaluation found evidence of manipulation in seven images using a technique known as Western blot, which determines concentrations of a specific protein in cells or tissues under different experimental conditions. As a result, the journal said its ethics board voted to retract the paper.

NIH, ORI and Temple declined to comment on whether Temple would be required to return any federal funding of the work retracted by the JACC publication.