Seward Challenges Transcript

Title

Seward Challenges Transcript

Transcription

Q: Let's dig into that. What were some of those challenges that happened at launch?

SEWARD: We were hoping to launch before the end of March, and so March 31st we were hoping to actually get started, and that's what we'd planned for. We had a meeting with the minister of health right before we launched, and I attended that meeting. I think Oliver attended, Dr. Samai attended from the College of Medicine. At that meeting, some new concerns were raised that we hadn't heard about and that we had to then scramble to try to figure out how to address them, The minister had concerns about liability insurance and wanted a guarantee of fifteen to twenty years of liability insurance for the trial, which is unheard of. Nobody does that kind of liability insurance. We had a policy in place, and Merck did as well. There were a lot of phone calls with CDC and with Merck to see if we could increase our insurance, at least commit to the five-year tail of insurance period after the trial finished. We had insurance in place for the trial, both global liability insurance and local liability insurance, and then CDC ended up committing to an extra five years, which you purchase at the end of the study period, generally, and you generally only purchase that if there's anticipated to be a problem, or if there's been a problem. You don't usually go ahead and purchase that if you don't anticipate a problem. We committed up front to purchasing that for an extra five years, and that was quite a financial commitment, for an extra ten million dollars of insurance for five more years, and so that took some time to get that worked out.

The minister also had questions about vaccine availability after licensure. Assuming this vaccine were to be proved safe and effective, what would be the availability of the vaccine to the population of Sierra Leone? That was a very valid question, but in fact, people from his ministry had attended meetings at WHO on that very issue. There had been a commitment by GAVI, the Global Alliance for Vaccines and Immunization, to purchase vaccine for some of these countries if and when a vaccine were licensed.

The third issue that came up suddenly was about a renal dialysis unit. This was quite unexpected. We had been asked previously to help get an intensive care unit up to basic international standards at the main city hospital in Freetown, a hospital called Connaught Hospital, and CDC doesn't work in clinical care, so we had to work through partners to help get that done. We worked with King's College and DFID [Department for International Development], the UK [United Kingdom] aid organization, offered to help with that. DFID helped get some equipment and some training for staff in the intensive care unit, but that all hadn't been completed when we were ready to launch. It was all in progress but hadn't quite finished. The renal dialysis unit had never come up, so that was a completely new thing. "As well as the intensive care unit, we want the renal dialysis unit functioning and at international standards." Well, the renal dialysis unit was not being used. They in fact had one, but it was not functional, and you don't want to use it during an Ebola epidemic. They were doing hemodialysis, which involves blood going through tubes and is quite a dangerous procedure in any country. It has to be done under very, very good infection control. We then had to have a lot of discussions about what to do about that demand, because the minister made it a condition of launching the trial. I spent a lot of time on the telephone, I spent a lot of time summarizing meetings in-country, sending them here to Atlanta to Dr. Schuchat and Marc-Alain and leaders for STRIVE, Dr. Schuchat being the overall senior leader for STRIVE since the very beginning. That's been very useful to have that continuity and institutional knowledge at a high level. I mean, I knew which decisions needed to be made here. I was not in a position to make them, and so would have conference calls with Anne and Marc-Alain and people and say, "What do we do know?" Talk with Oliver at that end, and had further discussions with the vice minister of health.

I was thinking recently, actually, because it was Easter recently. Easter there is a four-day holiday, and that was early April last year, so it was while we were in this limbo period of trying to get the intensive care unit ready. She--the vice minister--was helping with that, and I spent time sitting under a tree at Connaught Hospital in the heat talking to her during the Easter break, when there was nobody to work there. She wanted the walls painted. She wanted the place to look better. She thought that would help with this final review by the minister, and so she was trying to get those things done, and I was just down there. I couldn't do it, but I thought I would try to see what I could do to help. So spent some time sitting there with the vice minister, getting to know her, as she tried to push to get the intensive care unit ready. Meeting with King's College, talking to them, could they accelerate getting the--the equipment had been delivered, but hadn't been put into the intensive care unit yet. Had to go through all sorts of regulatory review at the hospital, to be sure that it was all documented which equipment had come in, so that it doesn't go missing and things like that. Then they had to do the training. Turns out they didn't have, what's it called--equipment that you use to start the heart.

Q: A defibrillator?

SEWARD: Yes. Didn't have a defibrillator, and they wanted a new one, and so we borrowed one from the embassy. We borrowed an extra one that the US embassy had and delivered that to the intensive care unit. We patched together what we could for that. We came up with an acceptable compromise on the renal dialysis unit of offering some funding to help support purchasing equipment, although in the end we couldn't purchase equipment. We couldn't do it through CDC, and through appropriated dollars the CDC Foundation couldn't do it either, and so we committed to helping with consultancies if they had need for technical assistance to try to get the unit together. Then we would try to find partners to help with that, if needed. We had that letter signed and submitted to the minister. With that letter that Oliver signed and Anne signed from here, and the intensive care unit painted and the equipment in there and the training done, an extra ten million dollars from CDC for the liability insurance tail, and extra insurance also from Merck. We started with thirty-two million dollars of insurance, liability insurance, during the trial itself, and then $12 million will continue in the five years afterwards. With all those in place, we sat down again with the minister. In the interim there'd been a meeting with the president, so the minister requested a meeting with the president, so I went to that with Oliver. The ambassador's--the deputy, DCM [deputy chief of mission], the deputy person in country. The ambassador was out of the country. She attended, and was very experienced in negotiations, actually. She was great.

We attended that meeting with the president himself, and he essentially said, "You need to pick a date to start and work back from there to get these things done." He essentially gave a marching order that we should start, and I don't remember whether it was an exact date, but he did sort of say, "Thursday next week."

Easter came. It was right in that period, and so not a lot happened over that, and then Tuesday, Wednesday, the vice minister came back to Connaught Hospital. Things weren't quite ready. We were thinking, who's going to give us the green light here? We didn't have a green light, so each day we were sort of like, do we call the staff in? Do we not? Do we have to give them some warning to show up for the first vaccination site? They were being delayed. Finally, I think I was told to be down at Connaught Hospital for a final walkthrough by the minister, and then got a request that no, he wasn't coming there, we needed to go to his office. So, Oliver, the ambassador, who was back, and me attended a meeting with the minister, and actually the ambassador was extremely helpful in that meeting, in getting the trial started. The meeting went for an hour and a half, and in the end the ambassador suggested, he said, "What about if we start tomorrow? These other things are in progress, and let's just start and we'll keep meeting for following up on these issues." The minister said yes to that. We knew at like eight o'clock the night before we launched that we had a green light to launch the next day.

It was a challenging time. [laughs] It was really challenging. When I think back, I think at this end it was probably harder. It was probably easier to be there and experiencing it. But it was, yes, it was a very big deal. Exactly a year ago. It was April 9th that we launched, and we started the next day. Once we got started, it was very hard to stop. It was a very good suggestion of John Hoover's. We were waiting for the minister to say okay, but he didn't say it in this meeting. John, having more experience at a high level with negotiating, I think it was a very good suggestion on his part. "Why don't we just go ahead and start? Everything looks like it's okay, and then we'll just continue."

There was overwhelming demand and interest in the vaccine, and so I think there was a fair amount of media coverage and interest. I think it would have been challenging for the minister to stop things, once they started, provided there was no reason to stop, which there wasn't, fortunately. Once we started, that was it.

Citation

“Seward Challenges Transcript,” CDC Museum Digital Exhibits, accessed June 14, 2024, http://cdcmuseum.org/items/show/778.