In early 2020, media reports indicated that an antiviral drug produced by Johnson & Johnson that was used to treat people with HIV might be effective against COVID-19. Orders for the medicine surged beyond what the pharmaceutical company could produce. Instead of ramping up production, though, the company paused and followed a specific playbook for responding to crisis. The company worked with internal and external independent experts, transparently laid out and shared the scientific data, and established and globally applied an ethical framework, all to ensure their decision-making process was rational, ethical and equitable. The benefits of this review process were born out months later when clinical studies on HIV antivirals in patients with COVID-19 showed that the drugs were not effective against COVID-19 in people. Acting hastily to fill the influx of orders early in the pandemic would not have helped patients with COVID-19. In addition, diverting the supply would have harmed those who needed the medicines for HIV.
In early 2020, we at Johnson & Johnson found ourselves with an unusual problem: There were too many orders for an antiviral drug used to treat people with HIV. The demand was coming not from HIV patients but from doctors on the front lines of the Covid-19 pandemic. Early media reports indicated that the drug might be effective against that disease, and orders for the medicine surged.
Excess demand might be a positive in some industries, but for J&J it created an ethical question: How to allocate supply to save the most lives? With thousands of new orders coming in from around the world, we knew that if we shifted to serving Covid-19 patients, we would very quickly run out of medicine for people with HIV. What’s more, as much as we wanted to identify treatments for Covid-19, our scientists had reviewed the data and didn’t believe the medicine could work against that disease. And even if they were mistaken, they did not think it was feasible to safely reach the concentrations quoted in the laboratory research reports as being effective in achieving an antiviral effect against SARS-CoV-2 (the official name of the novel coronavirus). Importantly, there had been no randomized controlled clinical-trial data on the safety and efficacy of the medicine in Covid-19 patients.
As requests poured in, we faced tremendous pressure to respond immediately. But my team and I recognized that we needed to take a deep breath, step back, and think critically. Our experience holds lessons for leaders in any industry about the importance of grounding an organization in foundational values and leveraging those guideposts in times of pressure to balance competing priorities and drive principles-based decision-making. It also illustrates how to map a strategy before you act, think creatively about solutions, tap expertise beyond your team, and apply an ethical lens for decision-making clarity. For those in health care, it reinforce the importance of gathering critical data and trusting science.
How we managed the problem of excessive demand
First, we reviewed the scientific data with experts in our company, looking at in-vitro (lab-based) data on tests of structure and inhibition of various viruses related to SARS-CoV-2. On the basis of what we learned, we did not think our medicine capable of meaningfully inhibiting the virus in concentrations that were safe for human beings. We also evaluated the in-vitro data reported in the media, focusing on the concentration at which our medicine was reported to inhibit the SARS-CoV-2 virus and extrapolating to calculate what dose would be needed to achieve those levels in people. The results would have to be tested in a robust human clinical trial. Even if we were to assume that the data reported in the media was correct, we calculated that the dose we would probably have to give would exceed accepted safety criteria.
We then reviewed the volume of product that was available, drawing on information from our supply chain colleagues. Although many people are affected by HIV, the Covid-19 pandemic was poised to affect millions more — meaning we would have insufficient supply. It would take many months to manufacture more, and there was uncertainty around whether there was enough raw material available to begin such large-scale manufacturing. It was clear that filling orders for Covid-19 could deplete the global supply of our HIV medicine.
We recognized that we needed to be transparent about our views on the state of the science, and we needed to establish an ethical framework — one that could guide decisions on the allocation of medicines that, like our HIV antiviral, were approved and marketed for other uses but lacked evidence or approval for use in treating Covid-19.
We sought objective input from internal and external experts. In my role as an affiliate faculty member of the Division of Medical Ethics at New York University Langone Health, I collaborate with the team at NYU to address moral and bioethical issues. In 2015, J&J partnered with the bioethics group at NYU Langone to create the Compassionate Use Advisory Committee, or CompAC, an independent external body of ethicists, physicians, and patient representatives. CompAC provides objective guidance to J&J on the ethical allocation of unapproved drugs in development in the context of Pre-Approval Access requests (sometimes referred to as Compassionate Use). Earlier in the pandemic, we had worked on an ethical framework for the distribution of personal protective equipment to health care workers. That gave us a running start on a framework for a Covid-19 response. Given its independent, objective input and experience, we called on CompAC, along with J&J’s own experts, to advise on our approach.
Finally, we worked to establish the ethical framework. Our working group was led by the Chief Medical Officer of J&J’s pharmaceuticals sector and included an internal expert in bioethics. Our CompAC partners contributed advice, and we talked through the situation, challenging one another until we had a preliminary framework. We gathered J&J’s senior leaders and others on the front lines — those working with hospitals treating Covid-19 patients who were, understandably, insisting that we immediately send a large supply of our drug. It was such an important issue, and it cut across many groups in our company. It was hard to feel totally comfortable, given the uncertainty around whether the medicine would be effective in treating Covid-19 patients — and in the unlikely event that it would, how many lives could it be expected to save under these unprecedented pandemic conditions? We all agreed that creating and using the framework to guide our decisions would be the most ethical approach, and it could help align our colleagues, many of whom worked in different countries and settings. As hard as it was, we felt a great urgency to reach consensus. As the requests for our medicine continued coming in, they grew more strident, putting the associates fielding them in an increasingly difficult position.
As we worked through the draft framework, we first agreed on our highest priority. In the absence of rigorous clinical trial data — and in the presence of conflicting in-vitro data — we resolved not to lessen the medicine’s availability to people with HIV, who were receiving it for an approved and proven life-saving use. We used pre-pandemic order levels as a proxy for our presumed HIV supply and then focused our discussion on the second priority: allocating the relatively small excess we would have after serving HIV patients. After some discussion, we decided to allocate the excess only to physicians and researchers undertaking a rigorous clinical trial to assess the drug’s efficacy and safety in Covid-19 patients. Although some argued that we should supply the medicine and gather experience-based data, we believed that rigorous clinical trials were the only way to accumulate unambiguous information that could be submitted to regulatory health authorities, inform evidence-based guidelines for clinical practice, and ultimately save the most lives — if the medicine proved efficacious and safe. If there was any excess supply remaining after those trials had been supplied, it could be allocated to physicians — but only to those who would agree to rigorously collect information on the patients they treated. Only if any excess remained after that allocation would we supply other physicians and hospitals.
We shared the framework with our supply chain colleagues who are responsible for filling orders and helped prepare them for difficult discussions with customers. We gave them a summary of the scientific assessment of the in-vitro data (and its extrapolation to efficacy and safety) that they could share, and we provided clear guidelines from our framework to help them communicate effectively. We all had to agree, globally, to stick to the framework, especially as the pandemic swept through Asia, Europe, and the United States. Because each new request for the medicine meant a new decision to be made, we returned to the framework many times.
The value of our pause
It can be hard to pause during a crisis. There is a natural predisposition to act — to jump in and do everything one can. But it’s important to remember that in science and medicine, we may end do more harm than good if we act too quickly, without pausing to consider the objective rigor of the data underpinning decision-making and the broader impact of any decisions.
The benefits of our review process became clear months later, when clinical studies done on HIV antiviral medicines with same mechanism of action showed that the drugs were not effective against Covid-19 in people outside the laboratory setting. We now know that acting hastily to fill the influx of orders early in the pandemic would not have helped patients with Covid-19. And diverting the drug to them would have harmed those who need it for HIV. This realization brought relief and satisfaction to our team; we had followed the science, and it had led us to the best course of action.
Working with internal and external independent experts, transparently laying out and sharing scientific data, establishing and globally applying an ethical framework, challenging ourselves and gaining alignment: All helped ensure that our decision-making was rational, ethical, and equitable.
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