NIH tells Congress it lacked authority to investigate whistleblower complaints about Axel Grothey’s sexual misconduct

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Axel Grothey, MD
Former co-chair of NCI’s National Clinical Trials Network GI Steering Committee
Rep. Cathy McMorris Rodgers (R-WA)
Republican leader of the House Committee on Energy & Commerce
Lawrence Tabak, DDS, PhD
Principal deputy director, NIH

Women who report sexual misconduct to NIH may find that their complaints have a limited shelf life—these complaints may become null, or at least ineligible for “even a cursory review” once perpetrators cut ties with NIH.

NIH may be “constrained” from investigating sexual misconduct at NIH-funded institutions once alleged perpetrators are no longer affiliated with grantee institutions, according to NIH Principal Deputy Director Lawrence Tabak, writing in a letter to members of Congress.

Tabak’s letter, dated Sept. 17, is NIH’s response to an Aug. 9 congressional letter asking NIH to describe the procedures employed for rooting out sexual misconduct committed by advisors (The Cancer Letter, Aug. 10, 2021). 

The congressional letter, addressed to NIH Director Francis Collins, also asks for an explanation of policies used in investigating sexual harassment complaints from whistleblowers.

NIH leadership is still not fully protecting women and other victims of sexual harassment from achieving their rightful place in science.

Rep. Cathy McMorris Rodgers (R-WA)

The initial letter was signed by Rep. Cathy McMorris Rodgers (R-WA), ranking member of the House Committee on Energy and Commerce, and Rep. H. Morgan Griffith (R-VA), ranking member of the House E&C Subcommittee on Oversight and Investigations. Their Democratic counterparts didn’t sign the letter. 

The congressional inquiry is based on The Cancer Letter’s investigative story of the case of Axel Grothey, an oncologist who was able to retain an influential advisory position at NCI even after being disciplined by three states for inappropriate sexual behavior that involved a mentee (The Cancer Letter, May 28, 2021).

In the Grothey case, two women reported Grothey’s misdeeds to NIH and NCI in April and May 2019, with no results. The NIH Office of Extramural Research sent an automated response to one of the women and never followed up.

Tabak said NIH was unable to conduct an inquiry into allegations of sexual misconduct because Grothey had left Mayo Clinic—an NIH-funded institution—in May 2018, a year before the complaints were filed with NIH, and was no longer “key personnel” on NIH grants.

“Dr. Grothey was not employed by an NIH grantee institution in 2019,” Tabak wrote in the Sept. 17 letter. “Dr. Grothey was not then and is not now key personnel on any NIH award. Nor was he at the time or is he at the present employed by an institution that receives NIH funding. This greatly constrained NIH’s authority to make inquiries or conduct even a cursory review of the allegations made.”

NIH didn’t respond to questions from The Cancer Letter for this story.

“NIH leadership is still not fully protecting women and other victims of sexual harassment from achieving their rightful place in science,” Rodgers, the Energy and Commerce Republican leader, said to The Cancer Letter. “There are still two critical questions Dr. Collins has yet to answer for Congress: 

“Where are NIH plans to foster a safer environment for junior faculty? Why isn’t NIH uniformly implementing across all institutes and centers the new policies to properly vet candidates for NIH leadership positions so a case like Dr. Grothey’s never happens again?”

Reportage by The Cancer Letter prompted NCI Director Ned Sharpless to remove Grothey from the NCI National Clinical Trials Network’s Gastrointestinal Steering Committee, which he co-chaired. More than 10 cancer organizations and institutions have censured or barred Grothey (The Cancer Letter, June 4, 2021).

In his letter, Tabak did not describe NIH’s rationale for allowing Grothey to remain on the NCI steering committee until May 27, 2021—two years after the two women filed complaints with NIH, and a year after medical boards in Minnesota, Tennessee and Arizona issued reprimands against Grothey.

“The NIH Office of the Director worked with and strongly supported Dr. Sharpless in his removal of Dr. Grothey from an NCI steering committee,” Tabak wrote.

Rep. Frank Pallone (D-NJ), chairman of the E&C Committee, and Rep. Diana DeGette (D-CO), chair of the E&C Subcommittee on Oversight and Investigations, are cc-ed in Tabak’s letter.

Karyn Goodman, the remaining co-chair of the GI Steering Committee following Grothey’s termination, said NIH could have initiated an investigation earlier.

“I believe that the response from Lawrence A. Tabak, D.D.S., Ph.D. did not fully address the NIH’s lack of any response to the email notifications in 2019 from two women who had filed complaints of sexual misconduct at Mayo Clinic, leading to an investigation and his departure from Mayo Clinic in 2018, and filed grievances to the Minnesota Board of Medical Practice, which ultimately led to a reprimand and fine for engaging in ‘unethical or improper conduct’ in March 2020,” Goodman said to The Cancer Letter

“The NIH could have investigated the womens’ complaints earlier given the leadership position Dr. Grothey held as the NCI GI Steering Committee co-chair where he played an influential role in the decision-making about study concepts that were proposed, oftentimes by junior faculty,” Goodman said. 

“Unfortunately, these situations have for too long been brushed under the rug, and it took media coverage by The Cancer Letter to initiate any action.”

Advocates: Poor excuses for multiple failures by NIH leadership

Does NIH’s authority to ask questions peter out the moment an alleged perpetrator leaves an NIH-funded institution? 

Do NIH leaders owe the women an explanation for why Grothey was allowed to remain on the NCI steering committee?

The Cancer Letter asked two experts on professional misconduct to review Tabak’s response:

Pringl Miller, founder and executive director of Physician Just Equity, a nonprofit that provides peer support for physicians who experience harassment, discrimination, and retaliation; and 

Shea Holman, director of law and policy at the Purple Campaign, a nonprofit focused on ending sexual harassment in the workplace.

Miller and Holman have no involvement in the Grothey case. Their full remarks appear here.

NIH’s apparent inaction on the Grothey case is unjustifiable, Miller said to The Cancer Letter

“In the interest of adhering to their no-tolerance policy and being a stakeholder in the scientific and academic community, I would think that ethically, [NIH] would be obligated to pursue the proper course of action,” Miller said. “They may not have legal standing if the perpetrator is not receiving NIH funds and/or working at an NIH-funded site. 

“I think the fact that Dr. Grothey had during the events, but not at the time of recognition, is a poor excuse for their inaction,” Miller said. “[NIH leadership] should have taken action when the complaints were brought to their attention.”

NIH is facing bipartisan pressure to formulate rules on sexual harassment for institutions receiving NIH funds through grants or cooperative agreements. A disclosure provision, contained in the FY2022 House appropriations committee bill, would give NIH the authority to “issue regulations” that would delineate reporting requirements for institutions (The Cancer Letter, July 23, 2021).

Many individuals who experience sexual harassment remain silent because they assume that their institutions will not take corrective action—and NIH exemplifies that problem in the Grothey case, Holman said to The Cancer Letter.

“We advocate for fair and thorough investigations and steps demonstrating accountability, neither of which have fully occurred here,” Holman said. “Although NIH has stated it is unable to legally require reporting of sexual misconduct by outside entities, NIH failed to conduct even the most basic follow-up that it promises to internal employees and employees at awardee institutions. 

“The organization did not follow up with these women, did not reach out to senior leadership to ask about a timeline to investigate or restrictions placed on Grothey, or inquire whether corrective action was being taken,” Holman said.

“Not only did NIH fail to reach out to the awardee institution, but it failed to maintain any transparency with the reporting parties on whether an investigation would occur or what corrective action would take place.”

NIH’s support for Sharpless’s decision to fire Grothey from the NCI steering committee is “only one element of accountability, ‘ Holman said.

“Grothey maintained his position at NCI as a co-chair of the National Clinical Trials Network GI Steering Committee and NIH has failed to explain why Grothey wasn’t removed from the committee at the time the complaints were made,” Holman said.

NIH should be held accountable for their inaction, particularly in light of their Feb. 28, 2019, update on Efforts to Address Sexual Harassment in Science, Miller said. 

“‘Demonstrate accountability and transparency’—how did they do that in Dr. Grothey’s case?” Miller said. “‘Provide clear channels of communication’—they didn’t do that, because the complaints went unaddressed as far as I can tell until The Cancer Letter contacted NCI in May 2021. Did the NIH ‘incorporate the survivors’ perspectives into future actions’?”

“A need-to-know basis”

In the Aug. 9 congressional letter, lawmakers sought clarification on NIH’s policies on confidentiality:

“It is unclear why the NIH cannot provide confidentiality to such whistleblowers but is able to maintain confidentiality of other personnel or intellectual property information,” the congressional letter states. “We … want to ensure that the NIH is holding its committee leaders to the highest standards of conduct and to promote a safe work environment for junior researchers, particularly those in mentor relationships that are vulnerable to abuse of authority.”

NIH doesn’t inform individuals who report sexual harassment of the outcome of investigations at NIH-funded institutions, said Holly Atkinson, a clinical professor at the City University of New York, a member of Physician Just Equity, and past president of Physicians for Human Rights, a nonprofit that investigates and documents human rights violations.

“The NIH says ‘it is on a need-to-know basis’ … they wouldn’t even provide us with a definition when asked for further clarification of what they mean by ‘need to know basis,’” Atkinson said to The Cancer Letter. “We, as survivors, of course, need to know.

“[It’s] so easy for an institution to say, ‘We investigated their complaint, there is no problem—doesn’t rise to level of sexual harassment.’ NIH then just goes away? Not enough transparency on the NIH investigation part. Reporters risk coming forward to NIH and get little in return.”

NIH perpetuates “ongoing trauma to survivors” through a system that places all risk on the individuals who report, said Anu Anandaraja, a pediatrician, a member of Physician Just Equity, a public health educator, and founding director of Women Together Global Inc.

“Reporters are not guaranteed confidentiality and are also told not to expect any information on progress or outcome of investigation, thereby placing the reporter at risk of further retaliation but with no means to prove it,” Anandaraja said to The Cancer Letter. “How is this a safe, effective or survivor-friendly system? We know that this process deters reporting and will grossly underestimate the incidence of sexual harassment among grantees and grantee institutions.”

In his letter, NIH’s Tabak noted that a “large proportion” of over 300 individuals who were being investigated for misconduct were “removed from peer review committees” while NIH investigated allegations.

“In June 2021, NIH provided the [Advisory Committee to the Director] with an update of its approaches to addressing sexual harassment, along with results to date,” Tabak wrote. “At that time, the Office of Extramural Research had handled extramural harassment (sexual and other) allegations involving over 300 individuals since 2018. A large proportion of these individuals were removed from peer review committees, at least temporarily, while allegations were being assessed. The update was well-received by the ACD.”

However, NIH has failed to follow its own procedures for enforcing accountability in the Grothey case, Holman points out.

“NIH has policies which state the organization will follow up with the relevant applicant/grantee institution to request information such as timeline to investigate and restrictions on persons designated on an award,” Holman said. “Yet, NIH allowed Grothey to maintain his position at NCI as a co-chair of the National Clinical Trials Network GI Steering Committee and allowed him to retire with his reputation intact. 

“As a result, NIH leadership should explain why it failed to follow its own policies in this case.”

Tabak’s Sept. 17 letter in response to the congressional inquiry follows:

September 17, 2021 

The Honorable Cathy McMorris Rodgers 
Ranking Member 
Committee on Energy and Commerce 
U.S. House of Representatives 
Washington, DC  20515 

Dear Representative McMorris Rodgers: 

Thank you for your August 9 letter to National Institutes of Health (NIH) Director Dr. Francis Collins. As the Principal Deputy Director of NIH, I am pleased to reply.

Sexual harassment is morally indefensible, it’s unacceptable, and it presents a major obstacle that is keeping women and other victims of sexual harassment from achieving their rightful place in science. NIH takes sexual harassment seriously and has made clear that it does not tolerate sexual harassment. In 2015, NIH issued Guide Notice NOT-OD-15-152 to make stakeholders aware that existing civil rights regulations apply to activities supported by NIH and protect individuals from unlawful sexual harassment, sexual violence, and sexual assault. From late 2018 through 2020, recognizing that more needed to be done, NIH developed a series of policies and approaches to address sexual harassment in both internal and external environments. 

  • In September 2018, NIH issued a Federal Register Notice on a new policy manual chapter on addressing and preventing harassment, inappropriate conduct, and inappropriate relationships in the NIH workplace. NIH used the opportunity to state that the agency “expects that organizations receiving NIH funds have in place similarly rigorous policies and related procedures for their employees, contractors, trainees, and fellows who engage in agency-funded activities.”
  • In February 2019, the NIH Director issued a detailed statement, which described steps the agency had already begun, at the suggestion of both an internal Anti-Harassment Steering Committee and the newly formed Advisory Committee to the Director (ACD) Working Group on Changing the Culture to End Sexual Harassment. These steps included clarifying expectations of organizations to ensure a safe workplace and inform the agency of investigator or key personnel changes and to provide clear channels of communication to NIH whereby anyone can report concerns. At that time, NIH established a dedicated mailbox granteeharassment@nih.gov to receive notifications of possible violations of NIH policy or rules.
  • In March 2019, the Director of the NIH Center for Scientific Review (CSR) issued a statement that, out of an abundance of caution, CSR would exclude some reviewers from committees until concerns had been resolved.
  • In December 2019, the NIH ACD endorsed recommendations issued by the Working Group, and the NIH Director accepted those recommendations. The recommendations included steps NIH should take to address sexual harassment as seriously as it takes other types of misconduct.
  • In June 2020, NIH issued a detailed description of its processes for handling sexual harassment allegations. The processes are centralized (mainly in the NIH Office of Extramural Research, which sits in the NIH Office of the Director) and include the ability to remove individuals from NIH committees (usually peer review committees that may be located in CSR or in Institutes or Centers). In addition, NIH issued a Guide Notice NOT-OD-20-124 which stated that organizations should inform the agency of concerns about safe working conditions (including concerns about sexual harassment) when they seek prior approval for changes in principal investigators or key personnel named in the Notice of Award.
  • In September 2020, NIH and the Department of Health and Human Services (HHS) Office for Civil Rights signed a memorandum of understanding whereby the two entities would share information and work with each other on addressing specific allegations.
  • In June 2021, NIH provided the ACD with an update of its approaches to addressing sexual harassment, along with results to date. At that time, the Office of Extramural Research had handled extramural harassment (sexual and other) allegations involving over 300 individuals since 2018. A large proportion of these individuals were removed from peer review committees, at least temporarily, while allegations were being assessed. The update was well-received by the ACD.

In the case of Dr. Grothey, NIH was concerned about the complaints when they were received and worked to determine how it might be able to address them. However, two factors affected NIH’s ability to respond more fully to the complaints we received in 2019. First, in many of the oversight processes that NIH conducts, it is the institution’s acceptance of federal funding that gives NIH the authority to gather information from the institution about employee conduct. When NIH received the complaints detailed in your letter, OER conducted a thorough search of Dr. Grothey’s involvement in NIH activities. Dr. Grothey was not then and is not now key personnel on any NIH award. Nor was he at the time or is he at the present employed by an institution that receives NIH funding. This greatly constrained NIH’s authority to make inquiries or conduct even a cursory review of the allegations made. 

[It’s] so easy for an institution to say, ‘We investigated their complaint, there is no problem—doesn’t rise to level of sexual harassment.’ NIH then just goes away? Not enough transparency on the NIH investigation part.

Holly Atkinson

Second, the complaints were made at a critical time in NIH’s deliberations about how to change our policies to address sexual harassment. As noted above, NIH established mechanisms for notifying NIH about concerns related to harassment at NIH-funded institutions in February 2019. When establishing those notification channels, NIH indicated that they would follow up with the relevant applicant/grantee institution on all concerns related to NIH-funded research. As previously stated, Dr. Grothey was not employed by an NIH grantee institution in 2019. Further, the NIH notice recommended that affected individuals could make formal reports to the HHS Office for Civil Rights, providing another avenue for someone to report sexual harassment at an institution that receives financial support from HHS, even if they are not NIH-funded. Since 2019, NIH has made great strides to address harassment in research. We deeply regret that these women endured harassment during their training. Harassment has no place in science, and NIH remains committed to developing an improved culture in which any type of harassment is not tolerated. 

NIH’s efforts in addressing harassment have led to substantive change, with certain individuals removed from NIH-funded activities, including from NIH committees. The NIH Office of the Director worked with and strongly supported Dr. Sharpless in his removal of Dr. Grothey from an NCI steering committee. 

This case exemplifies the need for other entities to play a role in reducing harassment in science. While NIH plays a very crucial role in reducing harassment in biomedical science, the biomedical research space is much larger than NIH-funded research alone. NIH needs partners from other organizations, including licensing boards, scientific societies, and research institutions, to successfully minimize harassment in science. 

We hope you find this information helpful and would be happy to offer a briefing on NIH’s anti-sexual harassment efforts. 

I have also provided this response to Representative H. Morgan Griffith who co-signed your letter.

Sincerely,
Lawrence A. Tabak, D.D.S., Ph.D. Principal Deputy Director

cc: 
The Honorable Frank Pallone, Jr. 
The Honorable Diana DeGette

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