April 2020 StatNews; On Wednesday Gilead Sciences, best known as a maker of HIV medicines, sent out a 177-word press release that led to a sigh of relief around the world: A study had shown that its experimental drug, remdesivir, had reduced the time it took for patients with Covid-19 to get better.
The data were only preliminary, and many questions still remain, including the nature of the treatment effect in patients. But for Gilead’s chief executive, Daniel O’Day, it was a big moment. O’Day was named as Gilead’s CEO in December 2018, and says he is “humbled” by what the company has accomplished.
But the journey has come with its share of criticism: of the studies Gilead chose to run, of the potential price of a desperately needed medicine, and of the way the news about the drug has been released, particularly the piecemeal way that data were made available about this trial.
O’Day, dressed in a white shirt and tie, joined STAT on a Zoom call to answer his critics and to offer assurance. “We’re going to make sure that access is not an issue with this medicine,” he said, promising again and again that Gilead takes its responsibility seriously.
A transcript of the conversation, edited for length and clarity, is below.
How are you?
Excited! It’s a good day for patients. I’m just kind of humbled by what this company has done. It’s really cool. It just reminds me of like the perseverance of this, just the science in this company and the two decades of experience in antivirals, or longer, and the 10-year journey for remdesivir. This is an important day for those people and for all of us. We’re excited for patients.
So tell me, when did you find out about these NIH data?
Oh, you know, it was over the past day or so. We’re part of the joint study team, obviously Gilead with NIH, so as the study team became informed by the data safety and monitoring board about their look at the data. NIH has been a great partner here. Obviously, NIH has the lead with this trial and Tony Fauci, he felt, upon seeing the results, that it was important to move quickly. And that’s why he moved to inform investigators yesterday evening. It all happened very quickly.
Why issue your own news release, followed by a more detailed NIH news release? Why not a joint press release between the NIH and Gilead or two releases timed similarly?
I think it’s just that we both have slightly different procedures. We wanted Tony to make sure that the NIH would communicate the data. That’s appropriate. They took the lead in this trial, even though we jointly worked together on it. And so it was up to Tony and NIH to decide when to do that, and he decided to do it during the day today. And we needed to alert people prior to the open of the market because of the investigator call last night. So we wanted to make sure there was uniformity of information.Related:
So, obviously, this is great news. But many people have expressed concerns about issues of corporate trust, particularly regarding the potential price of this new drug. What is your stance on pricing? Is this a medicine you plan to make a profit on? How will this be handled?
Look, I think we understand the responsibility that we have as a company. That’s exactly why, as we thought through the best approach to making this drug available in the early days, we thought it was very important to move with a donation of our entire existing supply. First of all, it’s just the right thing to do. And secondly, it was going to facilitate access in recognition of the public health emergency and the fact that data was still developing on the medicine and regulatory processes were still underway. We didn’t want access to be encumbered at all in the beginning, which is why we just went for a donation right up front of 1.5 million doses.
Bottom line is now as we approach supply, from July on, we’re going to work very closely with the government and with health care systems to make sure that it’s accessible, that it’s affordable to governments. We’re going to make sure that access is not an issue with this medicine.
This is a global pandemic. There should be no question about our ability to get medicine in the hands of patients, and that’s how we’re going to approach the period of time after the donation.
How much are you going to be able to manufacture? How much are you to be able to ramp up supply?
I’m very proud of what the team has done since we became aware of this virus in January, both from a clinical perspective, but equally from a manufacturing perspective. So you know, we had around 5,000 treatment courses in January. Today we have more than 50,000 treatment courses, and that number is going to go up, as I said, 140,000 treatment courses plus between now and July. And then we could ramp up, to the end of the year to multiple millions of treatment courses.
Now, the reason that I’m proud of the team is because this is a complicated chemical process. It’s many, many steps. Initially, in January, it took around 12 months from end-to-end to produce this product. Now, based upon the efforts of the team, really fine-tuning all the manufacturing processes, we have that down to now around six months. And immediately in January, when we knew there was even a possibility this medicine could be effective, long before we had any idea, even before the in vitro data came through, we made the commitment as a company to say, this is too important. We have to make every investment that we can in the event that this works given the human need and the societal need here. So we started ordering new raw materials immediately in January.
What gets us to the 1.5 million donation of vials is that we had a certain amount of raw materials in the supply chain and we were able to order some immediately to get us to the first half of this year. But what allows us to go to an exponential growth in the second half of the year is the actions we took in January to make sure we ordered those long lead-time raw materials, which are just coming in now and six months from now we’ll have end products. So that’s why when you get into the October timeframe, the November timeframe to the December timeframe, you get this very large increase in supply.
There have been criticisms about, in particular, the design of the SIMPLE trial, which lacked a control arm of untreated patients. And also the fact that both of your studies are open-label, meaning that doctors and patients know who got what treatment, though obviously, the NIAID study, the one we saw today, is not. Is there anything you would do differently and do you have any responses to those critics?
It’s really important that we put this into the context of what the clinical trial program was, what the strategy was behind it. I think it was a very thoughtful clinical trial program.
There were a variety of questions that had to be answered. Some have read out, we saw this morning, some are still to come. But this is a comprehensive clinical trial program that included immediately getting to China with a placebo-controlled study when that was the only place the virus was circulating. I mean the speed in which we got there to set that up as an investigator-initiated trial, combined with working with government organizations like NIH, CDC, FDA, obviously others and teeing up the second placebo-controlled trial with NIH…we knew that we needed those gold standard trials to be able to determine whether the drug was truly effective.
And so we had basically two shots on goal in the placebo-controlled trial. And then we decided to answer some other questions purposely with non placebo-controlled trials. In other words, not everything had to be a placebo-controlled trial because not everything was answering the same questions.
The SIMPLE open label trial was never designed to answer the question about comparison to a placebo. It was designed to answer the question … is five days as good as 10 days? We knew in a global pandemic like this, that that was a really important question to answer for patients first and foremost. You never want patients to take more medicine than they need to get better.
I wanted to come back to the question you get a lot in the industry, about trust and whether people can trust you not to profiteer on the release of this drug. Since we’re running out of time, I’d love to have you think a little more about what you’d say to those people who feel they can’t trust Gilead, because of things that have gone on in the past related to HIV, or other issues of access. What would you say to those people?
Well, look. I had a decision to make a little over a year ago, you know, about coming to Gilead and I was delighted that they wanted me to come. I couldn’t be more proud than I’ve been here this past year, learning more about what Gilead does every day to make sure that all of our medicines get the patients. I really mean that. I know that may sound like it’s an easy thing to say. The HIV PrEP donation program, the work we do every day with communities, disadvantaged communities in the United States and Eastern Europe and elsewhere to make sure that price isn’t a barrier to our medicines in countries around the globe. The work we’ve done recently with hepatitis C and working with states like Louisiana to come up with creative programs to make sure that everybody can have access to HCV medicines.
So I see the picture very differently. Let me just say that I’m fully committed and the company is fully committed and the board’s really committed to our responsibility, again, with this pandemic medicine.
It’s walking the talk, right? So, you know, the decision we took to say let’s donate the entirety of everything in our supply. Let’s make sure that if this medicine is effective, that there are no obstacles, particularly given the urgency and the plight of this pandemic around the world.
I can assure you, Matt, and the general public, that Gilead will continue to take its responsibility very seriously here and make sure that whatever model we come up with will ensure access around the globe, and that patients are put first, and that we work with governments around the globe to make sure we have a sustainable way of supplying this medicine. But we understand our responsibility in this kind of pandemic.