Medical journals and professional societies require study authors and presenters to disclose conflicts of interest, but this didn’t stop José Baselga, M.D., who heads up research at Memorial Sloan Kettering Cancer Center, from fudging his disclosures. An analysis by The New York Times and ProPublica found that Baselga, one of the world’s foremost breast cancer researchers, failed to disclose his financial ties to industry in academic papers about 60% of the time since he joined the cancer center in 2013.
These include his relationship with Roche—he has received more than $50,000 in consulting fees from the Swiss pharma, as well as more than $3 million in his stake of Seragon after Roche acquired it for $725 million in 2014, the analysis found.
Baselga, the CMO at Memorial Sloan Kettering, disclosed neither conflict when he presented data on Roche’s PI3K med taselisib as a trial investigator at this year’s ASCO meeting.
While he did say the drug’s benefit to patients was “more modest than we had hoped for, and there is a risk of considerable side effects,” he also called the data “incredibly exciting.”
“This is proof that targeting the PI3K pathway has an effect in breast cancer and that there are patients who will benefit. To me that is incredibly exciting,” Baselga said in a Memorial Sloan Kettering blog post. “About 25% of all patients with advanced breast cancer have a PI3K mutation, which means they could benefit from taselisib or similar drugs that target this pathway.”
Despite the positive review, Roche decided to dump taselisib, part of a class of drugs that have been dogged with safety issues.
The Times/ProPublica analysis found Baselga had “extensive corporate relationships”—with companies including Bristol-Myers Squibb, Eli Lilly and Novartis, as well as several early-stage biotechs— and a “frequent failure” to disclose them. In fact, it found that as the years passed, he would disclose fewer and fewer of them. In 2017, he failed to disclose potential conflicts 87% of the time, compared to the 60% figure for his academic publications since 2013. These include studies published in The New England Journal of Medicine and The Lancet.
Baselga said in a statement that he would fix the disclosures in 17 papers. But that leaves 62 other papers in which he did not disclose any potential conflict; he argues that they do not need one.
While the medical community strengthened conflict-of-interest reporting requirements a decade ago, it still relies on the honor system. Case in point: In about two-thirds of Baselga’s articles from which he omitted potential conflicts, one or more of his co-authors disclosed theirs.
And it’s hard to check up on everyone: “We don’t routinely check because we don’t have those kind of resources,” Rita Redberg, M.D., editor of JAMA Internal Medicine, told the Times/ProPublica. “We rely on trust and integrity. It’s kind of an assumed part of the professional relationship.”
In response to the article, Memorial Sloan Kettering CEO Craig Thompson, M.D., told staff via email that they “need to do a better job” of disclosing conflicts of interest.
As for the journals Baselga has published in, the responses are mixed. The NEJM has asked Baselga to correct his disclosures and plans to improve the way it tracks industry relationships. The American Association of Cancer Research—where Baselga has served as president and editor in chief of its journal, Cancer Discovery—is doing an “extensive review” of his disclosure forms. And “The Lancet declined to say whether it would look into the matter,” according to the Times/ProPublica.