“Everyone involved was risking jail time”
Behind the scenes at the decision on the first human use of an unapproved experimental vaccine
By Dale Dauten, Syndicated Columnist
Let’s start with a quick bit of time travel — back to 2014, when the world was just learning of a new deadly virus spreading in Africa: no cure, readily transmitted, mortality rates thought to be anywhere from 50 to 90 percent. Whole nations were terrorized — the BBC brought home that fear by showing footage of a man lying motionless in the middle of a dirt road in an African village, possibly dead, but no one was sure because none of the passersby would dare check on someone who might have Ebola.
One Ebola victim was a young American doctor, Kent Brantly, in Liberia on a medical mission. He’d been bedridden for nine days with the disease and was failing fast. Brantly’s doctor, Lance Pryler, recalled that time for Brenda Goodman of WebMD:
“I’ve been doing internal medicine for 25 years, so I’m not an alarmist, but I was certain he had a couple of hours to live, at best.”
So there’s the scene: A terrifying outbreak, and a handsome young hero of a doctor, dying.
We pick up the story with Dr. Gary Kobinger, one of the creators of the Ebola vaccine, ZMapp. He recently spoke at the 2030 Summit at STC headquarters in Phoenix and we asked him about the emotions of at time.
Kobinger smiled as he recalled the joy he and his colleagues at the Public Health Agency of Canada microbiology lab felt upon discovering that their new drug cocktail (eventually called ZMapp) had worked with monkeys, reversing Ebola within hours. “The first time we rescued infected macaque primates from Ebola, 99.5% lethal, there was jumping and clapping, all in Level 4 suits.”
Then, just months later, came the call that Dr. Pryler wanted to administer the new drug on Kent Brantly and a second American aid worker who’d become infected, Nancy Writebol. There happened to be three doses of ZMapp in a freezer in Sierra Leone, awaiting testing on how it would hold up in the climate there. Did Pryler have permission to use it, starting with Brantly?
“It’s hard to manage those emotions,” Kobinger recalled. “Agreeing to use an experimental treatment that was not made for treating human beings who are sick — it’s a huge risk.
“We weren’t just risking our jobs, everyone involved was risking jail time. The FDA has warned that if somebody used an exploratory drug vaccine without regulatory processes, we will put them in jail. This was a warning shot in one of the meetings.” [Later, Kobinger and his colleagues learned that the threat of prison was overblown, but in the moment they had no time to investigate legalities.)
“People don’t realize how intense this was. I didn’t know where this was going to go. I knew I was putting my job on the line, but that I can deal with. Going to jail? That was not part of my ambition. I took the risk because we had international workers responding to an outbreak, putting their lives at risk. If these two were going to die, or even one was going to die, the impact would have been massive at a time when [the battle against Ebola] was not going well. International workers are going in to help and they’re warned that they have to be careful, but seeing other workers dying? So it was really important that we do everything we could to save those people from the community of first responders.
“My question at the time to myself was, ‘Do I really stand in front of the freezer and prevent them from accessing it?’ I cannot stand in front of that freezer. I’m not going to be the one pushing for injection or pushing for treatment, but if it’s requested I need to be moving aside and letting them access it.”
So Kobinger signed off on the first human use. Then he waited: “I started asking, ‘Did he get it?’ I was sweating. I started losing what little sleep I was getting. It was intense.”
Dr. Kent Brantly, believed to be within hours of dying, made his turn for the better almost instantly: he said later he felt the fever break within fifteen minutes, and an hour or so later stood and walked for the first time in days.
Last year, four years after his recovery, Brantly visited Gary Kobinger and his colleagues at the National Lab in Winnipeg to offer thanks, saying of those who cured him, they choose “..to do the right thing for your fellow human being rather than reacting out of fear and self-preservation.”
OTHER OBSERVATIONS FROM DR. KOBINGER’S TALK AT STC:
The “Lab-In-A-Box” evolved over the years. To cross rivers, small planes and helicopters, it has to be very light. We can repack and move and be operational in three hours. We are using two bags, seventy pounds, so one person can carry a lab.
Universal flu vaccine: It’s only a matter of time when we’ll start seeing a good flu vaccine that won’t be needed every year.
At a conference somebody said to me that we don’t have an HIV vaccine. I was disappointed. I said ‘No, we have a lot of vaccines — they just don’t work.’ You learn a lot more from failure than from success. Going from zero to 90 (percentage effectiveness) is hard, but going from 30 to 80 is not as hard.
A lot of projects that we work on are very low interest to most companies because they don’t make money, you have to spend money. You’d be surprised how much help we’re getting from big pharma, how much help we get from government, how much help we get from everybody.
NEW VIDEO SERIES FROM PHARMACY TIMES
The folks at Pharmacy Times have a video series called “Peer Exchange,” and it recently featured a discussion that included vaccines and registries. (That’s STC CEO Mike Popovich on the left.)
Vax Stats of the Month
Mothers: The Future’s Greatest Immunization Influencers
by Bill Davenhall, Geomedicine Analyst, STC Health Analytics (Bill_Davenhall@stchome.com)
Undeniably, mothers are the “headwaters” for protecting children from infectious diseases and most likely an instrumental factor in a person’s life-long immunization practices. In 2024, there will be a pool of about 23 million females between 25-34 years of age from which about 600,000 children will be born to first-time mothers – about 16% of all births in that year! And while birth mothers will originate from rural, metro, and urban communities, be at slightly different ages and levels of educational attainment, the decisions these new mothers ultimately make about their child’s immunizations will influence the next generations ability to avoid preventable infectious diseases. It also sets the stage for future acceptance or rejection of life-protecting immunizations for their lifetimes, about eight decades.
By 2024, the nineteen states (37%) depicted in the map below will account for about 75% of all females in this specific age group (25-34). In the foreseeable future, helping about a half million new mothers each year learn how to “stay in touch” with the importance of lifelong immunization practices will go a long way to protecting an entire nation for a century. Undoubtedly, a significant contribution by a small number of first-time mothers!
Source: STC Health Analytics, William Davenhall, Geomedicine Analyst and the NCHS, National Vital Statistical Center, 2017 Natality Data.