The CEO of Novartis on Developing Drugs During a Pandemic

[Karlston]

The CEO of Novartis on Developing Drugs During a Pandemic

Vas Narasimhan talks about drug prices, vaccine development, the rise and fall of hydroxychloroquine, and how Big Pharma might win back the trust of consumers.

Photograph: Simon Dawson/Bloomberg/Getty Images

 

 

As CEO of Novartis, the world’s second-largest drug company, Vas Narasimhan knows that Big Pharma is an object of love and hate. Pharmaceutical products save lives and help people manage difficult medical conditions. But the industry’s drug prices are often indefensible, and companies’ practices are sometimes questionable or worse. In the pandemic year of 2020, the stakes are even higher, as people look to Narasimhan’s industry to produce preventions or cures for the SARS-CoV-2 virus devastating the world’s health and economy.

 

The perils and promise are embodied in recent Novartis developments. As a manufacturer of hydroxychloroquine, the company was in the uncomfortable position of distributing a product that was overhyped for an unintended—and, as the FDA concluded, not likely to be effective—use as a Covid-19 treatment or preventative drug. And recently Novartis, which exited the vaccine business in 2014, dipped a toe back in by agreeing to manufacture vaccines gratis for a clinical trial of a genetic-based approach. If the trial is successful, Novartis has the option of producing it commercially.

 

Narasimhan, 42, grew up in Pittsburgh, went to Harvard Medical School, and had stints at the World Health Organization and the consulting firm McKinsey & Company before joining Novartis in 2015. He spoke to WIRED from his home in Basel, Switzerland, where the company is headquartered. The interview was edited for brevity and clarity.

 

Steven Levy: One year ago, you told The New York Times, “We are not at all prepared for a pandemic,” speaking generally. That sounds pretty prescient now. But was Novartis prepared for the pandemic?

 

Vas Narasimhan: We were better prepared than I expected. If you had asked me in January if we had taken 110,000 people and most of them turned virtual and our operations would still run, I wouldn’t have believed it. More important, our clinical trials were able to run largely seamlessly. Because of investments in data science and predictive machine learning, our manufacturing operations were aided significantly. Also, our relations with patients and physicians also were enabled by that transformation. All three of those digital investment areas previously seemed like nice-to-have experimental areas that may transform us in five years. Suddenly they became things that were fundamental.

 

Novartis makes hydroxychloroquine, which became the center of a fiasco. Are you satisfied with the way your company responded, as it supplied a medicine that was later shown unlikely to be effective for Covid-19, while reportedly the drug became scarce for patients who needed it for its intended use?

 

I follow the data. So I was agnostic as to whether or not hydroxychloroquine would work or not, until we had good clinical studies. In mid-March, though, we were in a moment in time where a lot of governments were in a very desperate situation. You had some very early indications from non-appropriately designed, but indicative, clinical studies in China and France that this might help. We didn’t believe we would be impacting patients with rheumatological illnesses that need hydroxychloroquine anyway, and I don’t think we did. So we said we’d be willing to donate to any government that wants to use the medicine under appropriate oversight. When the data came out that showed the drug may not be having the impact we had hoped, obviously we stopped our trials and now are winding back the program. I don’t think you could reasonably have done anything differently in that moment when you had a drug that might help and, if used appropriately, could be managed in terms of its risk. Unfortunately, it was used in many instances outside of the hospital, which was never the intention.

 

What is your responsibility when the leader of the most influential country in the world basically calls it a miracle cure and you know it’s not?

 

I tried to consistently say that we’ve got to do high-quality science. Right now, unfortunately, the words “study, results, scientific evidence” in the media are not actually reflecting what scientists know is high-quality evidence. A study is not a study is not a study. There are studies that are very poor quality, or conjecture. And then we have appropriately-powered randomized control blinded clinical studies, which is what regulators expect of us, and that is the only way to really know if a drug has an impact or not. So right now, we’re sponsoring well-designed studies over 30 clinical trials of our medicines [for Covid-19], and we’ll see what the data shows.

 

Is there a chance that an existing drug might prove better than what we have now in terms of either prevention or treatment?

 

We’re going to go through three phases of development of drugs and vaccines. Right now is the repurposing phase. We have the results from the UK Oxford group, which showed a steroid was able to have a positive impact on mortality. Assuming that that data is robust, that’s the first evidence now we have of a repurposed drug. Even the Gilead drug, remdesivir, is a failed Ebola drug that now has been repurposed. I think there will be other drugs that will show an effect. I don’t know how robust the effect will be, but you’re going to exit the summer with clinicians knowing they can better manage Covid. I think towards the end of this year we’ll get the results from antibodies and maybe some of the more novel drugs. And then over the course of next year we’ll see what happens with the vaccines.

 

Let’s talk about vaccines. You’re in a partnership with Massachusetts Eye and Ear and the Massachusetts General Hospital for a gene-based vaccine. What distinguishes that from some of the other candidates?

 

We’re only supporting the clinical trials on this vaccine—we’re not a major vaccine manufacturer. In general, there are a few different thrusts for the vaccines. The established technologies primarily take proteins of the virus and put them into people, or other components of the virus, or [work by] inactivating the virus then generating an immune response. Interestingly, those two technologies are a little further back. The ones that are further ahead are either putting the Covid genome into another virus, which is the Oxford approach with AstraZeneca, or injecting RNA or DNA [into human cells.]. This is uncharted territory—we have never successfully had a licensed RNA or DNA vaccine generate a safe and effective immune response. How much data do you need to understand that it is safe and effective enough to give it to billions of people?

 

A lot of people are concerned that the pressure to quickly produce a vaccine will lead us to prematurely push out a product that might be ineffective, or even dangerous. Is that a concern of yours?

 

I’m hopeful that the FDA and the European Medicines Agency keep to their remit, which is ultimately to be a data-driven, neutral, apolitical regulator. We are a highly-regulated industry. We all have to hope that these regulatory agencies hold the line, because their role ultimately is to demand very, very rigorous data in these instances.

 

When we do have effective medicines or vaccines, who will get them first and how will costs be controlled?

 

Again, we’re not a vaccine manufacturer, but I can comment as far as drugs are concerned. We don’t see this as a place to drive profit. I think most of the major vaccine manufacturers have also committed to providing broad access at either reasonable or minimal cost. Now, very quickly, the question would be: Who gets the vaccine first? If you go back to the H1N1 vaccine in 2009, that was a big question, and in the end the decision was taken to prioritize pregnant women and children. There were also geographic considerations, and Europe and the US ended up getting vaccine in that moment before Latin America, Africa, and Asia. So, I don’t know exactly how this is going to play out. There’s three main camps: a US-funded camp, a European-funded camp, and then there’s China. And how whoever wins the race will ultimately allocate doses has not at all been determined, as far as I know.

 

Anti-vaxxers are already telling people not to take whatever is developed. What’s the role of the drug industry in convincing people that a safe and effective vaccine should be taken by all?

 

We as an industry should want a very robust data package to back this up, because the worst thing that could happen is that vaccines go out and cause an adverse event we weren’t expecting. Then, people lose faith in vaccines more broadly. It’s easy to forget the only reason we live in such healthy times is because of the advances in vaccines and medicines. Unfortunately, the anti-vaccine lobby now has the power of social media. The only way we’re going to combat it is with data, and credible scientific leaders speaking out in the media as well.

 

Novartis released a study recently that indicated because of the current crisis, more talented people are considering going into healthcare and the medical sciences. Do you think that Novartis and others will be able to hire people who ordinarily would go to Google or Amazon?

 

We hope so. This crisis has led to a big shift in the overall view of the sector and the industry. I think if you look at most of the surveys that have been put out by the various firms, you’ll see a significant favorability shift overall on the pharmaceutical industry. We made a big investment in data science and digital two years ago, well over $500 million. We hired talent from Amazon, from IBM, from Google, to lead the various elements. I think the arms race now in our industry is going to be who can digitize many of these elements much more quickly than the competition.

 

One factor in drawing talent might be your industry’s problem with trust. A couple of weeks ago, attorneys general from 50 states and territories, plus DC, filed a complaint against Novartis’ Sandoz Division and other companies for allegedly colluding on prices. In general, people feel drug prices are way out of line. What are you doing to win back trust? Can we expect an end to some of these crazy price increases?

 

One of our top priorities as Novartis is to build trust with society. And one of the things we’re going to need to do as a company is put behind us many legacy matters. The Sandoz topic that you just discussed all happened pre-2015. We’ve already settled with the federal government and now of course the states’ attorneys have come back, and we will of course defend our position. If you go back to the history, in the 1960s, 70s, 80 and 90s, [pharma] was the most revered industry because of the incredible breakthroughs that were being brought to extend human life. In recent decades, the combination of not always appropriate business practices, and inappropriate pricing practices, has eroded all of that trust. So now we need to build it back. I can’t undo the past 20 years, but at least going forward we can try to do the right things. Our margin for error is very small. Nobody is going to cut us any slack. That’s what the challenge is to lead a company like this. How can you remind people we create medicines for 900 million people all around the world, even through a pandemic, and have that be the story and not all of the missteps?

 

Getting back to Covid-19, are you optimistic that we’re going to get a treatment that will allow us to return to normality in a reasonable timeframe?

 

I am optimistic that the world public health and medicine establishment is going to find a way to manage this pandemic to allow people to find a new normal that is sustainable. Whether that is a vaccine or not, I don’t know. What’s really growing exponentially is knowledge. We have had over 10,000 publications, over 1,000 clinical trials, in the last three months. As that knowledge unfolds, you’re going to see patients better managed, you’re going to see repurposing of existing drugs, maybe some new drugs in the mix, and hopefully we get to a vaccine. But I’m one of the people who believes we’ll be able to manage this pandemic, even without a vaccine, in a reasonable way. When the vaccine does come, I wouldn’t want to see us rush it before it’s been appropriately tested.

 

 

The CEO of Novartis on Developing Drugs During a Pandemic