How Meaningful Will Changes Be to Ethical Guidelines Following Jose Baselga’s Fall?

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Jose Baselga, MD, PhD, FASCO, presenting Abstract 1006, Phase III study of taselisib (GDC-0032) + fulvestrant (FULV) v FULV in patients (pts) with estrogen receptor (ER)-positive, PIK3CA-mutant (MUT), locally advanced or metastatic breast cancer (MBC): Primary analysis from SANDPIPER, during the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2018 by © ASCO/Brian Powers 2018 Technical

In the aftermath of the fall of renowned breast cancer researcher Jose Baselga, MD, PhD, following revelations last month of his failure to disclose millions of dollars in payments from industry, I reached out to learn a little bit more about current institutional conflict of interest policies, especially in light of the current trend promoting academic-governmental-industry collaborations in research.

Although most peer-reviewed scientific journals have clearly stated guidelines requiring authors to disclose conflicts of interest, what conflict of interest policies did institutions have in place to govern the behavior of their researchers?

Series of Investigative Articles
Baselga’s case was reported in a series of articles written by reporters from the New York Times and ProPublica, a nonprofit investigative journalism organization.

The articles detailed a culture of self-serving standards that personally benefited a privileged few at Memorial Sloan Kettering Cancer Center, where Baselga served as physician-in-chief, until he resigned a week following publication of the first article in September.

Written by ProPublica senior editor Charles Ornstein, and Times staffer Katie Thomas, the articles reported on Baselga’s practice of not disclosing his financial interests in numerous peer-reviewed journals such as the New England Journal of Medicine, The Lancet, and Cancer Discovery, where Baselga still serves as one of two editors-in-chief.

Cancer Discovery is published by the American Association for Cancer Research, and
Baselga had served as AACR president from 2015-2016.

According to the Times, Baselga appeared to have violated societal conflict of interest rules during his tenure, and at research conferences, including AACR, had touted drugs that he had undisclosed financial interests in, despite less-than-glowing results reported at those same meetings.

The series reported that in addition to his $1.5 million annual salary from Sloan Kettering, Baselga had also received about $3.5 million in compensation from industry since 2013 including serving as a board member or advisor with Bristol-Myers Squibb, Roche, and Varian Medical Systems.

Subsequent articles noted claims of other ethical lapses at the New York cancer center including a questionable financial arrangement between Sloan Kettering and an artificial intelligence start-up company, Paige.AI.

Following the public exposure, Baselga stepped down from his corporate boards, and MSKCC president Craig B. Thompson, MD, resigned from his board positions with Merck and Charles River Laboratories.

Responses to the matter also appeared in two Times’s Opinion pieces by former New England Journal of Medicine editor Marcia Angell, MD, on September 14 2018, on “Transparency Hasn’t Stopped Drug Companies From Corrupting Medical Research,” and by the Times’s editorial board about “Medicine’s Financial Contamination” on September 24, 2018

On October 5 2018, an opinion piece by a MSKCC patient and active volunteer Steven Petrow appeared in STAT. Its title: “Memorial Sloan Kettering, You’ve Betrayed My Trust.”

AACR Still Deliberating Baselga’s Editorial Status
Although reports made it clear that Baselga no longer had any affiliation with Sloan Kettering, I contacted AACR about scheduling an interview with an AACR official to discuss the association’s actions regarding Baselga’s papers as well as his status as co-editor-in-chief of Cancer Discovery.

AACR replied that it would issue a statement, and after undergoing internal review over several days, the association emailed the following:

“We have been working with Dr. Baselga to issue updates of his disclosures as they relate to articles published in AACR scientific journals.  Dr. Baselga has identified and submitted the information required to update the published record for two articles in Cancer Discovery and three articles in Clinical Cancer Research.  These corrections will publish in the next month’s issues of these two journals.

The AACR is convening a panel of experts, including physicians, basic scientists, a patient advocate, and other relevant individuals, to evaluate Dr. Baselga’s case with the goal of making a fact-based decision regarding the status of his leadership role as one of the Editors-in-Chief of Cancer Discovery.

Also, the AACR is currently reviewing its Conflict of Interest Guidelines and will make any necessary updates or revisions at the conclusion of the panel’s comprehensive evaluation.”

Role Model for Avoiding Conflicts of Interest
For additional insight into institutional conflict of interest policies, I called a colleague, Thomas Tachovsky, PhD, who had served as a technology licensing officer at the Massachusetts Institute of Technology.

Tachovsky did not comment specifically about the MSKCC situation, but reflected about his experience at MIT, noting that the predominantly engineering school had a culture of finding solutions to problems.

He said that MIT was very serious about doing things the right way, protective of its image, and scrupulous in evaluating relationships between the institution and outside organizations or companies.

In general, he added, much of society seems to have lost its moral compass today, making it especially important to handle mistakes head on rather than by applying implemental band-aids.

Tachovsky referred me to his colleague, Rupinder Grewal, MIT’s conflict of interest officer, who was hired to lead the newly formed CoI-dedicated office in 2012 in response to revised federal policy on conflicts of interest related to grant recipients.

Grewal explained that the U.S. Department of Health and Human Services revised its Public Health Service regulations on financial conflicts of interests in research in 2011.

The changes went into effect in August 2012 and shifted responsibility for determining relatedness of outside activities to MIT research from the individual to the institution.

“Until the new regulation, it was left up to individual researchers to determine if an outside relationship posed a potential conflict to their funded research.

“After 2012,” she continued, “the most profound change was that now the institution was responsible for making the determination of relatedness of a discloser’s significant financial interests [SFI] to their research and the process involved asking researchers for relationship details at the point that an SFI was disclosed.”

She noted that at MIT it was the responsibility of the researcher to disclose details about whether outside consulting did or did not impact his or her MIT research.

“MIT also has two parallel systems.  Conflict of interest is a measure of money that’s triggered by established financial thresholds stated in MIT’s financial conflict-of-interest policy, and is reported on an ongoing basis. OPA, or outside professional activities, is a measure of time that is spent away from institutional activities that is reported annually.”

There is a two-step COI disclosure process at MIT, Grewal said.   At proposal stage, individuals are asked three COI questions in every proposal that is submitted through MIT’s system:

  • Do they have a financial interest in the sponsor?
  • Will they be purchasing goods or services from the sponsor?
  • Could the results of the project have an impact on any entity in which they have a significant financial interest?

At the award stage, she said that a more extensive disclosure process is triggered, and that funds are not expended until disclosure requirements are met.

“However, it’s still largely an honor system. Institutions can only go by what individuals disclose to them. At the end of the day, institutions can have the clearest guidelines and financial thresholds and sophisticated disclosure systems, but decisions are still made by the individual on what is disclosed.  At MIT, education on COI policy and process is a continually evolving and consistent effort, a strong partnership with faculty and research administrators. It’s important for faculty to know that they are not alone in this process, that there are resources available to help them make informed decisions about outside engagements.”

Fallout
When a researcher’s ethical lapses lead to resignation and abandoning administrative, research, and clinical responsibilities, there is often extensive fallout that extends beyond reputation and finances.

What happens with the researcher’s ongoing research and his or her laboratory personnel whose careers are dependent on the researcher? How do abandoned patients feel? How much retrospective review is needed for past research and publications? What becomes of the researcher’s legacy? And so on.

Over the years I’ve written a number of articles about the aftermath of fallen icons, including one related to AACR’s renaming one of its annual awards when it was revealed that the award’s namesake had made derogatory racial comments.

I pointed out then, and repeat now the importance of not always throwing the baby out with the bathwater, and providing sufficient context to distinguish the disgraced from that individual’s contributions.

Scientific Sacred Cows
I’ve also found that many individuals considered as “untouchable” or “sacred cows” are often treated as if they were beyond reproach and too important to be criticized, thereby receiving many passes on behavior that might not be tolerated in others.

And I’ve been warned away from pursuing certain stories because potential sources have either been too afraid to come forward on-the-record or claim that exposure—regardless of how truthful—of an individual or institution may do more harm than good.

It’s Not All About Sex
I contacted the National Institutes of Health regarding what policy was in place to continue research activities when a funded principal investigator was no longer able to continue functioning in that capacity.

NIH press officers responded via email with a the following statement:

“Typically, in an instance where the principal investigator or co-principal investigator named on the notice of award is placed on administrative leave because of the need to investigate an allegation of sexual harassment, the awardee organization would request a change of senior/key personnel supporting the NIH grant. When this occurs, NIH can take several actions, including approving a new lead principal investigator (PI) recommended by the grantee if scientifically appropriate, or suspending or terminating the grant.  Generally, NIH views a replacement PI as the best course of action, when possible, to allow scientific progress of a peer-reviewed project and allow other personnel working on the grant, including in some cases the victim of harassment, to continue their research.   Importantly, if NIH indirectly learns of an allegation of sexual harassment, we will contact the grantee institution to learn more, and among the range of possible actions, we may withdraw our approval of the PI if there is a reasonable basis to conclude the PI is no longer qualified or competent to perform the research objectives.”

When I replied that I was interested in a more extensive policy covering other areas of malfeasance, misconduct, or circumstances leading to inability to continue as a principal investigator, I received an email that said,” We appreciate your patience as we work on a response.”

However, despite stating my pending deadline, the response had still not been received by the time this story was posted. When it is made available, Onco’Zine will update the story.

This is the first in a periodic series exploring ethical issues in research.


Last Editorial Review: October 9, 2018

Featured Image: Jose Baselga, MD, PhD, FASCO, presenting the results of a Phase III study of taselisib (GDC-0032) + fulvestrant (FULV) v FULV in patients (pts) with estrogen receptor (ER)-positive, PIK3CA-mutant (MUT), locally advanced or metastatic breast cancer (MBC): Primary analysis from SANDPIPER, during the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2018. Courtesy: 2018 © ASCO/Brian Powers. Used with permission.

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Eric T. Rosenthal is an independent medical journalist specializing in providing insight, perspective, and transparency into various issues, trends, and controversies in oncology, and other areas concerning the politics of health care. He is currently editor-at-large with ADC Review | Journal of Antibody-drug Conjugates and Onco’Zine, special correspondent for MedPage Today, and a contributor to The Hill. Rosenthal was formerly special correspondent for Oncology Times, and senior correspondent and news director for Vital Option International‘s nationally syndicated The Group Room cancer talk-radio show. Rosenthal’s reporting is known for its balance providing perspective and context, and taking readers behind the scenes by exploring the “how” and “why.”  This is evidenced in his series ‘Eric Rosenthal Reports,’ which, in June 2017, returned to Onco’Zine. He also co-authors Op-Eds and develops forums for health care-related issues with Nancy G. Brinker, founder of Susan G. Komen, former U.S. State Department Chief of Protocol, Ambassador to Hungary and former U.N. World Health Organization’s Goodwill Ambassador for Cancer Control. Rosenthal’s work has also appeared in the Journal of the National Cancer Institute, Courage magazine, and elsewhere, and he wrote a series of guest posts for PBS/WETA-TV’s cancerfilms.org “Producers’ Blog” in 2015. He founded EvocaTalk® Research & Reports in 2002 as a service that identifies, explores, and helps resolve issues, and enhances insights through interactive interviews and analysis in both individual and group settings. After beginning his journalism career at the Trenton Times in 1972, where he received a state journalism award for a magazine cover story on schizophrenia research, Rosenthal served in a number of academic public affairs positions before returning to full-time journalism in 1998. These included: editor of publications and public affairs at the Franklin Institute; public relations director at Drexel University; news bureau manager for the American College of Physicians and its Annals of Internal Medicine; and public affairs director at Fox Chase Cancer Center, during which time he founded the National Cancer Institute (NCI)-Designated Cancer Centers Public Affairs Network in 1990. He was named press officer for the American Society of Clinical Oncology’s annual meeting in 1990, and has served on numerous national committees, including the NCI Director’s Consumer Liaison Group, the NCI External Work Group for the Cancer Progress Report, the Oncology Nursing Society’s Consumer Advocacy Panel, and as journalist member of Ken Burns’ Cancer: Emperor of All Maladies PBS Documentary Educational Subcommittee. He helped organize two national conferences focusing on the medical-news dissemination process at Cold Spring Harbor Laboratory and the Mayo Clinic; is an global health adviser for Concordia and served as co-chair its Concordia Summit global cancer research collaboration session in 2016 and its cancer burden in Latin America conference in 2017; and practices “3-D journalism” by organizing and moderating panels and conferences to further develop issues he has covered as a journalist. orcid.org/0000-0001-6778-0791

1 COMMENT

  1. On Thursday, October 11, 2018, the NIH Office of Extramural Research responded:

    NIH generally makes grant awards to institutions, not people. The institution designates individuals, including the program director/principal investigator (PD/PI), to intellectually and logistically direct the project. If an institution is concerned (or has determined) that an individual can no longer serve as PI, it must notify NIH and secure approval from NIH (what we call “prior approval”) before formally appointing a new PI.

    Prior approval is required any time there is a change in status of the PD/PI or other senior/key personnel designated on the award, where that change will impact his/her ability to carry out the approved research at the location of, and on behalf of, the recipient institution on the terms specified in the application and award. This requirement is detailed in the NIH Grants Policy Statement, 8.1.2.6, and NIH issued a Guide Notice (NOT-OD-18-172) to remind the community about the NIH’s prior approval policy requirements when an institution seeks to change the status of a PI or other senior key personnel as designated in the Notice of Award (Nexus Post). This Notice also helps clarify the situations in which NIH’s prior approval is required. This includes, but is not limited to, scenarios where a grantee institution takes administrative or disciplinary action against its employee(s) that impacts the ability of the employee(s) to continue as “senior/key personnel” on an NIH award.

    NIH reserves the discretion to withhold or withdraw approval of the PD/PI or other senior/key personnel if NIH concludes that the PD/PI or other named senior/key personnel are not qualified or competent to perform the research objectives.

    Additionally, the NIH GPS Section 8.5.1 states that the NIH awarding Institute or center “may withdraw approval of the program director/principal investigator (PD/PI) or other senior/key personnel specifically referenced in the Notice of Award (NoA) if there is a reasonable basis to conclude that the PD/PI and other such named senior/key personnel are no longer qualified or competent to perform the research objectives. In that case, the awarding NIH Institute or Center (IC) may request that the recipient designate a new PD/PI or other named senior/key personnel.”

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