Metro Health’s role in vaccine trials prompts internal conflict

Among the Nashville institutions assuming a role in upcoming clinical trials for a potential COVID-19 vaccine is the Metro Public Health Department, a decision receiving pushback from some members of its oversight board.

The decision for the already overstretched department to partner with a private for-profit company in a vaccine trial has not received the full backing of its board of directors.

Two of the six-member board voted against the plan, concerned, in part, that the speed with which Metro Public Health Director Dr. Michael Caldwell urged approval left little time to examine protocols or evaluate the wisdom of the public health department’s participation.

“I understand and appreciate and want to act rapidly when something like this could potentially be a benefit to the community but I didn’t get the answers I would have liked to have had in why the swiftness had to be there to the degree it was,” said Carole Etherington, member of the health board member and associate professor for nursing, emeritus at Vanderbilt University. 

The clinical trial would require the involvement of Dr. Caldwell and two of the agency’s top doctors in patient evaluation.

Tene Hamilton Franklin, vice chair of the board and vice president for diversity equity and inclusion at Health Leads, said she was concerned about the time staff would be spending away from other pressing duties.

“I think the best thing right now for the health department is to educate the community about the benefits of a vaccine and leave it to our academic research institutions that have the resources to do this work,” Franklin said, who co-chairs the health board said late last week. “We don’t.  We are already stretched thin.”

Franklin said she was also concerned about community trust. It will ultimately be the role of the department to promote vaccination when a final candidate or candidates are found to be safe and effective. 

“Moving forward there might be several political layers involved in clinical trials,” she said. “I wonder why the health department is getting tangled up in something that could be pretty precarious.”

The plan calls for the agency to partner with Clinical Research Associates, a Nashville-based medical research firm that contracts with pharmaceutical corporations to test drugs and vaccines. 

Meharry Medical College and Vanderbilt University Medical Center are engaged in their own trials for vaccine candidates through the federally coordinated “Operation Warp Speed” effort. 

In order to test the vaccines as widely as possible, pharmaceutical companies are independently conducting separate trials. Clinical Research Associates is partnering with companies AstraZeneca and Pfizer to conduct trials for those pharmaceutical companies in Nashville. It’s not yet been determined which candidate the health department will be testing.

Dr. Caldwell, who formerly served as field medical director for AstraZeneca, said the urgency lies in the public health crisis caused by the COVID-19 pandemic. 

“While Meharry and Vanderbilt do have some capacity the Department of Public Health has the ability to amplify those efforts in partnership,” Dr. Caldwell said, noting he has participated in 18 clinical trials over his career. 

“This is something that I have great experience with as well and can help provide oversight as well as experience and knowledge to the community and to help our community learn about what clinical research is, how these vaccines work and overall amplifying these efforts will help connect and educate the community.”

Asked whether he foresaw any conflict of interest if the health department participating in the AstraZeneca vaccine trial — or if he holds a financial stake in the company, Dr. Caldwell said:

“No, I do not see this as a conflict of interest.  As a physician and an investigator my focus is on patient safety, education, and assuring that all of the highest ethical standards are met at all times.  I will review and divest myself from any company where I will be participating as an investigator.”

“I continuously review my work for any potential conflicts so that they can be identified and mitigated.  My previous work as an employee of a vaccine company does not represent a current conflict of interest.  On the contrary, it gives me more experience and insight to assure that all standards are being appropriately followed to benefit our community.”

As a city employee, Dr. Caldwell must submit conflict of interest disclosures. Since he began his position in March, his disclosures are not due until next year. 

Dr. Thomas Campbell, a board member and practicing psychiatrist, supports the trial. 

“We’ve got to have the trials if we’re going to have the vaccine,” he said. “We all have a lot of concerns about how it’s going to be set up, how it will involve staff and who will make decisions but I hope our participation might increase the numbers and diversity of people participating in Phase III clinical trials.”

The trial will not involve recruiting existing patients of the health department, Caldwell said. Individuals who call the health department’s health line would be informed about the opportunity to participate.

Clinical Research Associates will provide compensation to the city that covers the cost of the portion of time Dr. Caldwell and other department staff spend with participants. The company will also provide compensation to participants.

Metro Council approved the plan last week.