Some of our readers may be familiar with Jose Baselga, MD, PhD, the former Physician-in-Chief at the Memorial Sloan Kettering Cancer Center, and the current controversy surrounding a mistake he made in not disclosing financial ties in some of his research articles.
The story broke over the weekend of September 8, 2018, when Charles Ornstein and Katie Thomas at the New York Times wrote an article in collaboration with ProPublica, entitled, “Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals.” The article outlines who Baselga is and the role he played in developing “breakthrough drugs that have revolutionized treatments for breast cancer.” The praise stops there, however, and the article turns to stating that “Dr. Baselga did not follow financial disclosure rules set by the American Association for Cancer Research when he was president of the group. He also left out payments he received from companies connected to cancer research in his articles published in the group’s journal, Cancer Discovery. At the same time, he has been one of the journal’s two editors in chief.”
Some believe that the 178 papers Baselga authored between 2013 and present could be “tainted,” even in situations where Baselga made a disclosure. In an attempt to explain his rationale to the New York Times and ProPublica, Baselga compiled a list of publications that cited him as an author from 2013 to present, and then divided the 178 publications into four categories: publications where disclosure happened, publications that represented basic laboratory or translational work, publications where disclosures are debatable (i.e., had no clinical nor financial implications), and publications where he needs to disclose. According to Baselga, 72 of the 178 papers he authored during the relevant time period had disclosures included; 62 of the papers were basic laboratory or translation work; 26 of the papers were debatable as to required disclosures; and 17 of the papers do need updated disclosures. In developing the story ProPublica used the Federal Open Payments Database and reviewed what companies disclosed versus with Dr. Baselga disclosed to medical journal publications.
Because of the disclosure controversy, on Thursday, September 13, 2018, Baselga resigned from his position at Memorial Sloan Kettering, saying that he was concerned that his “continued role leading clinical care and research will become too much of a distraction to the hospital and its remarkable team of physicians, researchers and staff.” Baselga also took “full responsibility for failing to make appropriate disclosures in scientific and medical journals and at professional meetings.” He noted that he has “already updated disclosures in medical journals and will continue to do so until the record is complete.” He also stated that his involvement in pharmaceutical and biotech companies – as well as consulting activities – have been public and were reported to and reviewed by Memorial Sloan Kettering.
In response to the resignation letter, Craig Thompson, President and CEO of Memorial Sloan Kettering, referenced the “numerous contributions” Dr. Baselga made to “our organization, our patients, and the field of cancer treatment and research.” Thompson then named Lisa DeAngelis, MD, as the acting Physician in Chief while a search for Dr. Baselga’s successor is conducted.
On September 14, 2018, Bristol-Myers Squibb responded to the resignation of Dr. Baselga, simply stating Dr. Baselga resigned from the Board of Directors of BMS and that the Board of Directors was the decreased in size “to eleven, effective immediately, in connection with Dr. Baselga’s resignation.” The release concluded with a brief paragraph about the Company’s commitments, “Bristol-Myers Squibb is committed to the highest standards of ethics, compliance and integrity. These principles are central to the Company’s mission and our ability to deliver innovative medicines to patients with serious disease.”
Then, this Sunday, September 16, 2018, an editorial in The New York Times piles on, opining that the “kinds of conflicts” that were present in Baselga’s case are “virtually universal in the upper levels of academic medicine” and that while there has been some reform and regulation surrounding required disclosures, it isn’t enough.
Interestingly, in all of the back and forth, no one is saying anyone – including any patients – were harmed from this failure to disclose. All that seems to have happened is America lost a gifted cancer researcher to carelessness in completing paperwork. It is possible that some cases could come forward but to date it has not been even mentioned in the media coverage.
Thomas Stossel , MD former Harvard professor and author of the book Pharmaphobia points to the fact that the Times/ProPublica article “produced no smoking gun pointing to the researcher’s compromising his integrity for money” and only included an “innuendo about his reported interpretation of the results of a clinical trial where there was disagreement among experts — which is the rule.”
Stossel also mentioned that the article “alluded to the researcher sporting ‘millions of undisclosed dollars.’ Companies complying with the Sunshine Act differentiate payments as being for research, for education or consulting. Usually when large amounts get reported, the sums are research grants for clinical trials that go to the physician’s institution, not into the named individuals’ pockets. The Times article made no such distinctions.”
Unfortunately, this experience has shown that the sin of omission will be treated as a mortal sin which could end a career, as opposed to a mistake or on omission. This story should act as a cautionary tale to all faculty and the importance of verifying all disclosures and ensuring they are properly made. Had Dr. Baselga simply reported those relationships including serving on corporate boards (Genentech and BMS,), the story would not have been written and he would still be focused on finding cures to cancer. The readers of these journal articles and presentations deserve to know what commercial interests he had and come to their own conclusions. The saddest part of this story is the patients at Memorial Sloan Kettering who will have to find a new oncologist. From personal experience as a care giver to a cancer patient, that alone can be devastating.
On the bright side for Dr. Baselga, another major institution will hire him in less than one year. One example is the University of Miami hired Charles B. Nemeroff, M.D., Ph.D. who left Emory almost 10 years ago under similar circumstances. From now on you can be assured he won’t be filing missing disclosures.
Unfortunately, there will likely be more stories following this one.