The Sunshine Economy: The Business Of Testing COVID-19 Vaccine And Volunteers
The global search for COVID-19 vaccines has included South Florida as drug companies use clinical research firms to find, manage, and follow local volunteers.
Howard Schwartz may not have been involved in the search for a COVID-19 vaccine if it weren’t for Hurricane Andrew.
In 1992, Schwartz had a gastroenterology medical practice in Kendall, near Baptist Hospital. Then the storm hit.
"Nobody wanted to have a colonoscopy," he said.
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He was asked by a pharmaceutical company to take part in an antibiotic drug trial to treat a stomach bacteria that can lead to ulcers. He did. It was the start of a new direction in his medical career.
Twenty-eight years later, the company he co-founded — Research Centers of America, where he is also the chief medical officer — is one of the South Florida research firms responsible for finding, managing and following volunteers testing experimental COVID-19 vaccines.
"Our entire focus for the past eight or nine months has been working on any type of testing, the safety and efficacy of medications, testing procedures and vaccines for COVID-19," Schwartz said.
Research Centers of America was purchased by a Massachusetts-based private equity firm in 2019. The company has about 80 employees in South Florida to manage its research projects. It has conducted trials for the Pfizer and Moderna COVID-19 vaccines. Both of those have received emergency authorization use okay by the Food and Drug Administration. Schwartz said it is working with three other experimental vaccine candidates for the virus.
"We typically do about five to 10 vaccine clinical trials in a year. Some of those vaccines are for common things such as flu vaccines," he said. "We've worked with HPV vaccine, shingles vaccines, vaccines for bioterrorism. I think last year we did something for anthrax. So we've been working with vaccines for quite some time."
The Value Of Volunteers
"The cog of our existence is trial participants," said Headlands Research CEO Mark Blumling.
Headlands is the parent company of JEM Research Institute in Lake Worth. Headlands is majority owned by a New York-based private equity firm. JEM Research is managing volunteers for the experimental vaccines from Johnson and Johnson and AstraZeneca. Both remain in phase three clinical trials.
"A big focus on patient recruitment, particularly for the COVID-19 trial, is to ensure that you have diversity of patient populations," he said. "Diversity is both ethnic diversification as well as age diversification."
About 10% of the volunteers for Pfizer's vaccine are Black, a quarter are Hispanic. Volunteers at least 65 years old make up one in four of the participants according to FDA documents.
Headlands Research is expanding in Florida. Earlier this year, it opened facilities in Sarasota and Orlando, in addition to completing the purchase of JEM Research Institute in Palm Beach County. However, Blumling said the Florida-focused strategy has not been driven by COVID-19. The firm now has a dozen sites with a concentration in the southeastern U.S.
"The speed at which you can get the trial done is what the clinical trial sites do. They're essentially the nuts and bolts — the cogs that make the engine work," he said.
There is no financial risk to the clinical site companies if an experimental drug fails to produce the results necessary to get regulatory approval and bring it to market.
"The value proposition is, we need to make sure that whatever therapies are out there — vaccines or otherwise — are safe and effective. That is the mandate of the FDA," Blumling said. "The FDA cannot do that without data. And that data is from trial participants generously giving their time."
The federal government's Operation Warp Speed names the ambition about how fast vaccines are needed to help address the virus. The plan had the federal government prepaying for hundreds of millions of doses of an approved vaccine, even before one was deemed safe and effective. The money helped pay for the research.
While not every vaccine maker participated in the program, the strategy was rocket fuel for the usual research timeline for new drug treatments.
"I will tell you that one year ago from December 2019 all the way back to when I started in the industry in February of 1996, the industry moved at a slower pace," said Palm Beach Research Center CEO David Scott. The facility is conducting vaccine trials with Moderna, AstaZeneca, and Johnson and Johnson.
Nothing has been missed with the faster research, Scott said. Each vaccine still must undergo the usual trial phases and the data is reviewed by experts. All of that time has been compressed by the global demand, and infuse of billions of dollars.
"So can that happen across other indications and even apply to orphan indications where instead of the expense of years of research, you could condense it down to less than a year? Yeah, it could become more cost effective by shortening that time and by getting those clinical trials done faster," Scott said. "Faster doesn't mean poorly."
Palm Beach Research Center usually would be conducting twice the number of clinical trials that it is now, according to Scott. But it is managing at least twice the number of volunteers for COVID-19 studies ranging from preventative measures to post-exposure treatments and vaccines. Scott said the facility will participate in more coronavirus vaccine research to come, including with pregnant women, children and teens, and people with a history of allergies.
Suzanne Citere of Lighthouse Point is a dance studio owner, a Broadway lover and a previvor. She also a volunteer for a two-shot Johnson and Johnson COVID-19 experimental vaccine.
Twelve years ago she learned she carried the BRCA genetic mutation that can cause breast and ovarian cancer. Her mother died of breast cancer so Citere decided to have pre-emptive surgery.
"I'm a big fan of preventative medicine," she said.
As for the compensation to participate in the study? Citere said she is donating that to a charity that benefits actors and behind-the-scene workers in the performing arts.
"I'm not a millionaire. I own a dance studio. But it was my little contribution to the Broadway community," she said.
German Gobel's job in Miami Beach is to hunt down and stop computer viruses. So he thought it was a natural extension to volunteer for a COVID-19 vaccine. He received his first dose in the Moderna vaccine trial in October and the second four weeks later. He also has a family connection to vaccines that goes back to his native Cuba.
"My mother told me the stories of an uncle that was very young, that was playful, vibrant, the life of the party. And he developed [polio] symptoms and he became paralyzed and couldn't speak and eventually just could not respond to any treatment," he said.
That was in the 1940s in rural Cuba before there was a polio vaccine.
"That always stuck with me," he said. "He just happened to have that disease at the wrong period of time."
Ty Russell, of Miami, volunteered weeks before he was chosen to participate in the Moderna vaccine trial.
"I figured I needed to do it, since there's a lot of questions, especially in the Black community and among minority communities in general. So I needed to step up to show others that it's safe," he said.
Russell attributed that desire to his volunteer service-learning activity while he was a student at Florida State. Those experiences "really changed my life" he said.
"I also have a passion for helping the elderly. And during the COVID-19 pandemic, this is something that's really, really hurting that population. And whatever I can do to help out, I did," Russell said.
Ken Roberts of Coral Gables didn't know it at the time when he volunteered, but he now thinks the same company that made the experimental COVID-19 vaccine he received may have helped save his father in World War II.
Roberts received the Pfizer vaccine. In the spring of 1944, Pfizer was mass producing penicillin that would be shipped to Europe in anticipation of what would be D-Day and the Allied invasion of France. According to Roberts, one of the two Purple Hearts his father was awarded came when the Jeep he was in drive over a landmine. Three others in the Jeep died and Roberts' father was injured by shrapnel.
"I now have some sense that it's quite possible – though I don't know it – given the amount of shrapnel he had, that that penicillin may have helped save his life. The Pfizer company may have saved my father's life," Roberts said.
Gregory Rummo in Lake Worth was guided by his faith to volunteer and he trusted the science involved. He is a chemistry lecturer at Palm Beach Atlantic University and a volunteer in the Moderna vaccine trial.
"I guess my faith motivated me as well as the kind of thing where people were dying and I wanted to do something," he said.
Rummo thought he may have caught a mild case of the virus in the spring, but an antibody test later showed negative results. He was disappointed because he wanted to donate plasma to help others battling the virus.
He is not a "first adopter" by his own admission. Rummo said he had never volunteered before for a medical trial — "completely out of my comfort zone," he said. But he felt his faith and a civic duty to join.
"I understand a bit about biochemistry," he said. "So I wasn't afraid of the science and I knew I was going to be in good hands."
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