Get the Facts

August 7, 2020

In recent days, The Boston Globe has published a series of articles about Brigham Health President Dr. Betsy Nabel’s interactions with industry. These stories have been misleading, and in some cases inaccurate. Below are the facts.

  • Nabel’s involvement with Moderna was vetted, approved and managed by the Professional Institutional Conduct Committee, a subcommittee of the Mass General Brigham Board of Directors.
  • Nabel scrupulously followed the guidelines put in place to mitigate concerns about potential conflicts of interest.
  • To ensure the public trust in the phase 3 vaccine trial, Dr. Nabel resigned from the Moderna board when she realized that her involvement could be perceived as a conflict of interest and cast doubt on the validity of the process and outcome. When legally able to do so, she will fully divest from Moderna.
  • The Brigham is one of 89 sites across the country involved in the clinical trial that is evaluating the Moderna COVID-19 vaccine candidate.
  • The study is double-blinded, meaning that neither the researchers nor the participants know whether participants are receiving the active vaccine or a placebo. Researchers at the Brigham report data from the study directly to a Data Safety Monitoring Board, which is overseen by the National Institutes of Health.
  • There is no opportunity for anyone at the Brigham to influence the reporting of the data or manipulate the findings of this nation-wide clinical trial.
  • Any inference of wrong-doing by Dr. Nabel is inaccurate and irresponsible.

How does the Brigham Board of Trustees feel about Dr. Nabel’s participation on the Moderna board and her recent decision to step down?

They are very supportive. John Fish, chair of the Brigham Board of Trustees, shared the following statement with the media:

The Brigham Trustees believe maintaining the confidence of the public is critical as we work toward the common goal of eradicating COVID-19. While her position on the Moderna board was reviewed and approved in accordance with our policies, and she followed all requirements, we fully support Dr. Nabel’s decision to step down from the Moderna board and divest her financial interests.

Is it a common practice for hospital leaders to sit on boards of companies that conduct business with healthcare organizations?

Yes, in fact, a recent article reported that 12 of the 19 largest pharmaceutical and biotech companies have at least one director serving on their board who simultaneously serves in a leadership position at a healthcare system. These include leaders from other academic medical centers like Yale, Duke and Mayo.

Why do we allow our leaders to sit on boards of for-profit companies?

Having our leaders serve on relevant boards is valuable for our organization. These interactions allow for the exchange of cutting-edge scientific expertise, support the establishment of research collaborations and foster translation of scientific and clinical innovation into products and services for the benefit of patients and the public.

When did Dr. Nabel join the Moderna board?

In December 2015, when Moderna was a privately-held company.

Did Dr. Nabel disclose to Mass General Brigham and Brigham and Women’s Hospital that she intended to join the Moderna board?

Yes, Dr. Nabel followed our internal processes to ensure that her election to the Moderna board was vetted and approved, prior to her taking it on, by the Mass General Brigham Professional Institutional Conduct Committee (PICC) and the Brigham and Women’s Hospital Board of Trustees.

When she joined, an individual management plan was put in place in accordance with Mass General Brigham policy and that plan was implemented and followed precisely.

Do senior level employees need to disclose if they own shares in companies with whom the Brigham or Mass General Brigham do business?

Yes, this information is collected from all Brigham leaders and disclosed annually to the Office of Interactions with Industry at Mass General Brigham. Staff are required to disclose financial relationships with biotech, pharmaceutical companies and any of Brigham’s vendors. For Brigham leaders, this activity is overseen by the Mass General Brigham Professional Institutional Conduct Committee (PICC).

Why did Dr. Nabel have stock in Moderna?

As part of their compensation for service on their board, Moderna granted stock options on a yearly basis to Board members when they became a publicly traded company in Dec. 2018. For all board members, stock options vested after one year, and then they were able to exercise the option to buy the shares.

When did Dr. Nabel sell the Moderna shares and how much did she realize from the proceeds of the sale?

It is important to note that Dr. Nabel can only sell shares in limited circumstances, as dictated and overseen by Moderna and the U.S. Securities and Exchange Committee.

As is required for all Moderna Board members, she must file a 10b5 pre-programmed selling plan during a Moderna open trading window. That plan then sits for at least 30 days, and a sale is made on a certain date or at a pre-determined stock price at some point in the future.

On May 12, based on a plan Dr. Nabel had put in place in March, shares were sold at a value of $1.98 million, and on July 15, an additional amount of shares belonging to her were sold that were valued at $6.5 million; however, the amount she netted was about half of that because of what she paid to acquire the shares.

When she is legally able to, Dr. Nabel will sell the rest of her stock to eliminate any concern about her continuing to have a financial interest in the company.

What is Dr. Nabel intending to do with the money?

Dr. Nabel has said she intends to make a contribution to a non-profit charity.

Was the Covid-19 vaccine trial awarded to BWH because of Dr. Nabel’s role on the Moderna Board of Directors?

No. Sites for the vaccine studies were selected by the NIH.

For 20 years, the Brigham has been part of the HIV Vaccine Trials Network (HVTN), a National Institutes of Health (NIH)-funded global network of sites conducting clinical studies related to HIV vaccine development.

Earlier this year, the NIH determined that several NIH-funded clinical trials networks, including the HVTN, would come together to answer important infectious disease questions related to COVID-19 under the COVID-19 Prevention Network (CoVPN). The Brigham, along with clinical research study sites across the United States, became part of this network.

Was Dr. Lindsey Baden selected as a co-principal investigator of the Moderna trial because of Dr. Nabel’s role on the Moderna board?

No. Dr. Baden is an expert in the development of novel diagnostics and therapeutics for viral diseases that disproportionately affect high-risk patients. He is the director of the Center for Clinical Investigation at the Brigham and the director of Infectious Diseases at Dana-Farber Cancer Institute. In addition, he is the vaccine clinical research site leader at the Brigham of the NIAID-funded Harvard HIV Vaccine Clinical Trials Unit and the program director for the Hub and Network elements of Harvard Catalyst (CTSA Award) at Harvard Medical School.

Dr. Baden was chosen by the leadership of the CoVPN to be co-principal investigator of the upcoming mRNA phase 3 vaccine trial based upon his clinical research experience and his knowledge of COVID-19. The home institution of a multi-site trial’s co-principal investigator is typically a trial site.

Why didn’t Dr. Nabel step down from the board when the Brigham became one of the hospitals selected by the NIH to conduct the phase three trial of Moderna’s Covid-19 vaccine candidate?

When the Brigham was identified as a potential site for the Phase 3 study, Dr. Nabel’s participation on the Moderna board was reviewed again by the Mass General Brigham PICC Committee. An enhanced management plan was implemented, involving additional actions to be taken by Dr. Nabel and further actions to be taken by the institution to ensure the integrity of the trial and appropriately manage conflict. These actions included:

  • Nabel would recuse herself from any matter relating to the study at the Brigham
  • Nabel would recuse herself from any decision-making role in connection with the study at Moderna
  • Administrative oversight for the trial be transferred from the Brigham to the Chief Academic Officer of Mass General Brigham.
  • Her role on the Moderna board was disclosed to the NIH and to leaders at the Brigham.
  • The Brigham Board was confident that the management plans put into place were sufficient to effectively monitor and manage this matter; however, they supported Dr. Nabel’s decision to step down from the Moderna board, as they agree that maintaining the confidence of the public is essential as we all work toward the common goal of defeating COVID-19.