The corporate imprint on cancer research
Dr. Baselga, 59, supervises clinical operations at Memorial Sloan Kettering, one of the nation’s top cancer centers and wields influence over the lives of patients and companies wishing to conduct trials there. He was paid more than $1.5 million in compensation by the cancer center in 2016, according to the hospital’s latest available tax disclosures, but that does not include his consulting or board fees from outside companies.
Many top medical researchers have ties to the for-profit health care industry, and some overlap is seen as a good thing – after all, these are the companies charged with developing the drugs, medical devices and diagnostic tests of the future.
Dr. Baselga’s relationship to industry is extensive. In addition to sitting on the board of Bristol-Myers Squibb, he is a director of Varian Medical Systems, which sells radiation equipment and for whom Memorial Sloan Kettering is a client.
In all, Dr. Baselga has served on the boards of at least six companies since 2013, positions that have required him to assume a fiduciary responsibility to protect the interests of those companies, even as he oversees the cancer center’s medical operations.
The hospital and Dr. Baselga said steps had been taken to prevent him from having a say in any business between the cancer center and the companies on whose boards he sits.
The chief executive of Memorial Sloan Kettering, Craig B. Thompson, MD, settled lawsuits several years ago that were filed by the University of Pennsylvania, Philadelphia, and an affiliated research center. They contended that he hid research conducted while he was at Penn to start a new company, Agios Pharmaceuticals, and did not share the earnings. Dr. Thompson disputed the allegations. He now sits on the board of Merck, which manufactures Keytruda, a blockbuster cancer therapy.
Ms. Hickey said the cancer center cannot fulfill its charitable mission without working with industry. “We encourage collaboration and are proud that our work has led to the approval of novel, lifesaving cancer treatments for patients around the world,” she said.
Some disclosures are required; others aren’t
After the scandals a decade ago over lack of disclosure, the federal government began requiring drug and device manufacturers to publicly disclose payments to doctors in 2013.
From August 2013 through 2017, Dr. Baselga received nearly $3.5 million from nine companies, according to the federal Open Payments database, which compiles disclosures filed by drug and device companies.
Dr. Baselga has disclosed in other forums investments and advisory roles in biotech start-ups, but he declined to provide a tally of financial interests in those firms. Companies that have not received approval from the Food and Drug Administration for their products – projects still in the testing phases – do not have to report payments they make to doctors.
Serving on boards can be lucrative. In 2017, Dr. Baselga received $260,000 in cash and stock awards to sit on Varian’s board of directors, according to the company’s corporate filings.
ProPublica and the Times analyzed Dr. Baselga’s publications in medical journals since 2013, the year he joined Memorial Sloan Kettering. He failed to disclose any industry relationships in more than 100, or about 60% of the time, a figure that has increased with each passing year. Last year, he did not list any potential conflicts in 87% of the articles that he wrote or cowrote.
Dr. Baselga compiled a color-coded list of his articles and offered a different interpretation. Sixty-two of the papers for which he did not disclose any potential conflict represented “conceptual, basic laboratory or translational work,” and did not require one, he said. Questions could be raised about others, he said, but he added that most “had no clinical nor financial implications.” That left the 17 papers he plans to correct.
Early-stage research often carries financial weight because it helps companies decide whether to move ahead with a product. In about two-thirds of Dr. Baselga’s articles that lacked details of his industry ties, one or more of his coauthors listed theirs.
In 2015, Dr. Baselga published an article in the New England Journal about a Roche-sponsored trial of one of the company’s drugs, Zelboraf. Despite his financial ties to Roche, he declared that he had “nothing to disclose.” Fourteen of his coauthors reported ties to Roche.
Dr. Baselga defended the articles, saying that “these are high-quality manuscripts reporting on important clinical trials that led to a better understanding of cancer treatments.”
The guidelines enacted by most major medical journals and professional societies ask authors and presenters to list recent financial relationships that could pose a conflict.
But much of this reporting still relies on the honor system. A study in August in the journal JAMA Oncology found that one-third of authors in a sample of cancer trials did not report all payments from the studies’ sponsors.
“We don’t routinely check because we don’t have those kind of resources,” said Rita F. Redberg, MD, the editor of JAMA Internal Medicine, who has been critical of the influence of industry on medical practice. “We rely on trust and integrity. It’s kind of an assumed part of the professional relationship.”
Jennifer Zeis, a spokeswoman for the New England Journal of Medicine, said in an email that it had now asked Dr. Baselga to amend his disclosures. She said the journal planned to overhaul its tracking of industry relationships.
The AACR said it had begun an “extensive review” of the disclosure forms submitted by Dr. Baselga.
It said that it had never barred an author from publishing, and that “such an action would be necessary only in cases of egregious, consistent violations of the rules.”
Among the most prominent relationships that Dr. Baselga has often failed to disclose is with the Swiss pharmaceutical giant Roche and its United States subsidiary Genentech.
In June 2017, at the annual meeting of the ASCO in Chicago, Dr. Baselga spoke at a Roche-sponsored investor event about study results that the company had been counting on to persuade oncologists to move patients from Herceptin – which was facing competition from cheaper alternatives – to a combination treatment involving Herceptin and a newer, more expensive drug, Perjeta.
The results were so underwhelming that Roche’s stock fell 5 % on the news. One analyst described the results as a “lead balloon,” and an editorial in the New England Journal called it a “disappointment.”
Dr. Baselga, however, told analysts that critiques were “weird” and “strange.”
This June, at the same cancer conference, Dr. Baselga struck an upbeat note about the results of a Roche trial of the drug taselisib, saying in a blog post published on the cancer center website that the results were “incredibly exciting” while conceding the side effects from the drug were high.
That same day, Roche announced it was scrapping plans to develop the drug. The news was another disappointment involving the class of drugs called PI3K inhibitors, which is a major focus of Dr. Baselga’s current research.
In neither case did Dr. Baselga reveal that his ties to Roche and Genentech went beyond serving as a trial investigator. In 2014, Roche acquired Seragon, a cancer research company in which Dr. Baselga had an ownership stake, for $725 million. Dr. Baselga received more than $3 million in 2014 and 2015 for his stake in the company, according to the federal Open Payments database.
From 2013 to 2017, Roche also paid Dr. Baselga more than $50,000 in consulting fees, according to the database.
These details were not included in the conflict-of-interest statements that are required of all presenters at the ASCO conference, although he did disclose ownership interests and consulting relationships with several other companies in the prior two years.
ASCO said it would conduct an internal review of Dr. Baselga’s disclosures and would refer the findings to a panel.
Dr. Baselga said that he played no role in the Seragon acquisition and that he had cut ties with Roche since joining the board of a competitor, Bristol-Myers, in March. As for his presentations at the ASCO meetings in the last 2 years, he said he had also noted shortcomings in the studies.
The combination of Perjeta with Herceptin was later approved by the FDA for certain high-risk patients. As for taselisib, Dr. Baselga stands by his belief that the PI3K class of drugs will be an important target for fighting cancer.
Katie Thomas covers the pharmaceutical industry for the New York Times.