Doctor used ill-informed assistants in study

Triers says she did work for some doctors and nurses involved in the study

A physician researcher who has been skeptical of the health benefits of immunotherapy shots in patients with newly diagnosed lung cancer relied on colleagues who received them for research and their knowledge to describe their findings, and then provided political support for her role in funding the study, two pages of a letter reviewed by The Washington Post show.

A letter written to the J.&J. Everlight Foundation, in which three co-authors behind the 2013 study defended themselves in a rare public acknowledgement of their role, shows that the lead researcher relied on people who provided other medical services to form their conclusions.

Triers says she did work for some doctors and nurses involved in the study, but that “it was later revealed that there were people who received Pfizer medicines” in the study who “helped me select subjects, and thus write the manuscript.” Pfizer Laboratories’s inhaled immunotherapy drug, Darzalex, is a drug used to treat patients with myeloma.

Another researcher who co-authored the 2013 study and who received funding from Triers and others directly supporting the research, Dr. Jonathan Gutmann, confirmed that her assertion was correct.

Triers declined to say how much she contributed to the work, but wrote in an email that “these documents provide the most complete picture” of what happened. She has been an oncologist at Georgetown University Health System’s Wistar Institute since 2012.

The findings add an uncomfortable new wrinkle to a multi-year scandal that has raised questions about ethical standards and conflicts of interest inside medical institutions throughout the United States. It took years for the foundation, the scientific arm of Johnson & Johnson’s subsidiary Janssen Pharmaceuticals, to publicly acknowledge the involvement of the drug’s manufacturers in the study’s results.

The 2013 study, published in The New England Journal of Medicine, said that drugs administered through intraperitoneal rather than intravenous infusions, or I.P.I., did not significantly improve survival or lung function in patients with newly diagnosed non-small cell lung cancer. After the finding was published, Triers was supportive of a letter written in defense of the study that was sent to The Washington Post by Dr. Susan P. Cohen, a longtime lung cancer researcher at Weill Cornell Medical College. The letter, which also criticized the study’s design, was signed by more than a dozen scientific leaders from well-known academic institutions and the New York City lung cancer support group, the LUNGevity Foundation.

At least one of those letters was forwarded to Triers by Cohen, who said they had written each other and had a “great respect” for each other’s work.

“Since that time, Dr. Triers and I have corresponded frequently, and she invited me to do research and other related work for J&J,” Cohen wrote.

Such business connections between researchers and those who funded them have created tension, with some researchers and administrators saying they were confused about whether it was legal for researchers to accept money from a pharmaceutical company to research a drug it made. Critics say those relationships threaten to erode the independence of researchers.

In her letter to the foundation, Triers said: “I was asked by Dr. Cohen to send her a letter in response to the recent New England Journal of Medicine article (‘The Effect of Intraperitoneal Immunotherapy on Oral Neuroendocrine Neoplasia in [non-small cell lung cancer]’) and I did so. Her signature was on the letter.” Triers said her signature had been forged by one of her colleagues.

Documents provided by the foundation and hospitals including Yale-New Haven Hospital, Harvard University and the University of Southern California — an institution that gave its support for the study — provide the broader background for the 2013 study.

“We are pleased that Dr. Cohen, and the authors who issued the recently published article, are now candid about their ties to the pharma companies that make the I.P.I. drugs,” said Sonya Lerner, a spokeswoman for Janssen. “The institute wishes to clarify that the institute and the authors at no time sought to solicit or accept compensation from companies to conduct I.P.I. trials. The institute obtained funding only from the New England Journal of Medicine and Janssen.”

The collaborations between the research subjects and Triers were eventually not revealed to the National Cancer Institute, which acts as the catalyst for grant applications and oversight of clinical trials. The Institute granted Triers and the drug company the

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