An internationally renowned breast cancer expert has failed to disclose millions of dollars that he received in payments from the pharmaceutical industry and extensive corporate relationships, according to an analysis by the New York Times (NYT) and ProPublica.
José Baselga, MD, PhD, currently physician-in-chief and chief medical officer, Memorial Sloan Kettering Cancer Center (MSKCC) in New York City, has not disclosed financial ties in dozens of research articles published in prestigious journals, including The New England Journal of Medicine and The Lancet.
According to the analysis, Baselga has held board memberships or advisory roles with Roche and Bristol-Myers Squibb, among others; has had a stake in start-ups during early-phase trials; and has played a key role in the development of new therapies that have helped to change the paradigm of breast cancer treatment.
Baselga also failed to abide by the financial disclosure rules that were set by the American Association for Cancer Research (AACR) when he was president of the organization and omitted payment he had received from companies connected to the research in his articles published in the AACR’s journal, Cancer Discovery. At the same time, he has been one of the journal’s two editors-in-chief.
On top of that are consultation agreements made with industry.
Baselga received nearly $3.5 million from nine companies from August 2013 through 2017, according to the federal Open Payments database, which compiles disclosures filed by drug and device companies.
In addition, he has disclosed other investments and advisory roles in biotech start-up companies but has declined to provide detailed information about those interests, the report notes. If a product has not yet received regulatory approval, manufacturers do not have to disclose the payments that they made to physicians.
An analysis of Baselga’s publications in medical journals since 2013, the year he joined MSKCC, showed that he failed to declare his disclosures in over 100 publications, or about 60% of the time. In 2017, he failed to list any potential conflicts of interest in 87% of the articles that he wrote or coauthored, the report maintains.
The investigation also reported that he put a positive spin on two clinical trials that were sponsored by Roche, when he presented their results at the 2017 and 2018 annual meeting of the American Society of Clinical Oncology (ASCO). Since 2014, he has received more than $3 million from Roche in consulting fees and for his stake in a company that they acquired.
Baselga has not disputed his relationships with at least a dozen companies and stated that the disclosure lapses were unintentional. He has also said he would correct his lack of disclosures for 17 articles, including those published in The New England Journal of Medicine, The Lancet and Cancer Discovery, but that he did not believe disclosure was required for dozens of other articles reporting early research.
In response to the NYT/ProPublica article, an email was sent to all MSKCC staff by Craig B. Thompson, MD, president and chief executive officer, and Kathryn Martin, chief operating officer, saying that the institution and its faculty “need to do a better job” of disclosing relationships with industry.
“The matter of disclosure is serious,” they wrote, adding that the issues surrounding author disclosures are complex and guidelines for reporting industry relationships are “nebulous” as to how and when to make voluntary disclosures.
The email further noted that they have asked Baselga to review his disclosures and to work with the various journals and organizations to correct the record, and this process has already begun.
“We need to work with journal publishers and professional societies to standardize the reporting process,” they wrote. In addition, they noted, they have been in discussions with ASCO about the society’s model as well as the value of having a common standard for oncology disclosures in journals and presentations.
The issue of disclosing relationships with industry crosses all medical specialties.
It received wide attention and spurred congressional action about 10 years ago, when several notable psychiatrists, including Charles Nemeroff, MD, PhD, from Emory University, Atlanta, Georgia, allegedly failed to accurately disclose payments from drug companies.
In January 2009, Sen. Charles Grassley (R, IA), then ranking member of the Senate Finance Committee, and Sen. Herbert Kohl (D, WI) reintroduced the Physician Payments Sunshine Act. The bill requires drug and medical-device manufacturers to disclose all payments and gifts to physicians if the annual total to an individual is more than $100 per year, including funding given for continuing medical education and research grants.
That proposed legislation also required that the Department of Health and Human Services (HHS) establish procedures for drug companies to submit information and for HHS to make this information publicly available on a website no later than November 1, 2009. The federal government began requiring pharmaceutical manufacturers, as well as those making devices, to publicly disclose payments to doctors in 2013.
A native of Spain, Baselga received both his MD and PhD degrees from the Autonomous University of Barcelona in 1982, and completed a fellowship in medical oncology at MSKCC. From 1996 to 2010, he was the chairman of the Medical Oncology Service and founding director of the Vall d’Hebron Institute of Oncology at the Vall d’Hebron University Hospital in Barcelona.
Relocating to the United States, he then served as the chief of the Division of Hematology/Oncology and associate director of the Massachusetts General Hospital Cancer Center in Boston from 2010 to 2012, before his current appointment at MSKCC.
His current research at MSKCC focuses on identifying mechanisms that limit the sensitivity to targeted therapy in solid tumors, in particular to PI3K/Akt/mammalian target of rapamycin inhibitors and anti-human epidermal growth factor receptor 2 agents.