TOO CLOSE FOR COMFORT: WHO SHOULD DECIDE?

BY STEVEN CHAN

From the sounds emanating from the federal government, market analysis, and the White House, you might believe that the public will have the first round of vaccines coming out somewhere between October and the end of the year.

The scramble is on, with one political party driven to get the preventative treatment to pharmacies before election day; the other, throwing shade on its effectiveness without knowledge of the final test results.

What matters is that Boston’s health care community is working in the trenches to deliver an effective vaccine as soon as possible—albeit with a caveat.

In late July, Brigham and Women’s Hospital (BWH) announced their leadership roll in the testing of COVID-19 vaccine trials. Through communication sent to media sources, the hospital indicated they advanced their effort to conduct a 30,000 subject phase 3 trial, including a phase 3 COVE study evaluating mRNA-1273.

The vaccine, manufactured by Moderna, located in Cambridge— and now practically a household name, may become the shining star in the battle against COVID-19.

The study will include participants from around the country, with the hospital acting as a clinical partner, in conjunction with the COVID-19 Prevention Network (CoVPN). From a press release, we learned that Lindsey Baden, MD, an infectious disease specialist and vaccine expert, will serve as a co-principal in the study.

“This is the first phase 3 trial that will test the effectiveness of the vaccine against COVID-19, and we have been working diligently across [the] industry, academia, and government to pave a path for launching this trial rapidly and safely,” said Baden. “Our goal has been to not only launch this important trial but also to develop a rapid, high-quality process for vaccine trials that are to come.”

The COVE study is under the umbrella of Operation Warp Speed (OWS), having a goal of delivering 300 million doses of a tested and proven vaccine for COVID-19 as early as 2021. OWS is part of a partnership under the Department of Health and Human Services, the Centers for Disease Control and Prevention, the FDA, the NIH, BARDA, and the Department of Defense.

Not only will trials take place leading up to disseminating the vaccine, but some subjects from the study will also be tracked for up to two years after the second of two doses are administered. The purpose of continuing to monitor participants is to look at long-term immune responses to SARS-CoV-2.

With all this good news, it has not been easy sailing for the hospital and its leader.

Officials recently disclosed that the president of BWH, Dr. Betsy Nabel, was a member of Moderna’s Therapeutics Board of Directors since 2015 and had a financial interest in the drug company.

In a statement issued by the hospital, they explained the relationship between Nobel and Moderna was reviewed, and satisfactorily meets all standards, policies, and procedures following the Mass General Brigham conflict of interest guidelines.

BWH went further to shine light between Nabel, the hospital, and the drug company. They pointed out that the CEO was not—at any time—acting as an agent for the hospital and her function at Moderna was personal. Additionally, the healthcare organization had a plan in place, outlining how Nabel would recuse herself from any matter relating to the joint study.

Further distancing included the disclosure that BWH is “to be one of 89 sites involved,” and that “all…key aspects of the trial,” as well as, “Dr. Nabel’s relationship with Moderna was fully disclosed to the National Institutes of Health.”

It should be noted that Nabel is compensated for her service on the Moderna Board.

With all of this, the pressure continued to mount. According to BWH, articles published by The Boston Globe were said to be “inaccurate” and “misleading,” as to Nabel’s relationships with the pharmaceutical industry and research conducted by hospitals. The newspaper addressed others in the upper echelons of medicine and pointed out other hospital administrators with questionable affiliations with high profile research conglomerates.

The series focused on the inappropriateness of the many cozy relationships between CEOs of medical non-profits and profit earning drug and biotech companies.

According to Erin McDonough, senior vice president, and chief communications officer for BWH, the hospital’s board was satisfied with safeguards set up to monitor and evaluate the ongoing relationship between the hospital’s president and Moderna. Yet, the damage had been done, with public opinion turning negative. The view that there was a conflict of interest was hefty enough to cause Nabel to resign from Moderna’s board on July 30, 2020.

In the final days, Dr. Nabel issued a statement explaining her position and reason for stepping down from the company in question.

“As a physician and scientist, I have dedicated my life to the health and well-being of others. Despite the management plans that have been put in place to ensure the COVID-19 vaccine study is not compromised due to my connection with Moderna, I have come to realize that those who do not know me, or how such trials are conducted, may perceive a conflict of interest. It is critically important that the pubic trust the conduct and outcome of the vaccine trials, so in the best interest of the greater good, I have made the difficult decision to resign from the Moderna Board.”

As we wait to see the results of this study, the debate will continue over public and private interactions. During this pause, all involved could benefit from a conversation focusing on who’s responsible for navigating these troubled waters; the media, or should these concerns be handled from within healthcare organizations?

Quite noticeably, even when the rules of conduct are spelled out and supervised, conflict over personal rights and responsibility remains a hot issue in Bean Town.

Perhaps, we need to ask ourselves whether hospital leaders should be prevented from serving on boards because a conflict of interest might result, or consider whether a claim of wrongdoing is being manufactured outside the laboratories and boardrooms for other reasons.