Big pharma and COVID-19: Balancing social commitments and profits
It is quite possible that the attempt to treat COVID-19 will bear out as the peak of pharmaceutical research and development in human history.
The race is on, replete with attempts at a vaccine and repurposing of drugs — many of them from rheumatology — to mitigate the infection at various stages. However, millions of potential patients and unprecedented demand presents big pharma with a singular choice: capitalism or social commitment?
“The right to make a profit is preserved in the Constitution,” Gregg J. Silverman, MD, director of the Laboratory of B Cell Immunobiology at the NYU Langone School of Medicine, told Healio Rheumatology in an interview. “It is good for the country for people to own ideas and make a profit from those ideas. But that is for a time of business as usual. Now is not a time for business as usual.”
Thus, a number of manufacturers in the rheumatology space are reckoning with a significantly altered financial and social landscape. Some, like Sandoz, have taken the lead on social commitment by donating 30 million doses of hydroxychloroquine to the national stockpile.
The manufacturers of anakinra (Kineret, Sobi), baricitinib (Olumiant, Eli Lilly), sarilumab (Kevzara, Regeneron/Sanofi) and tocilizumab (Actemra, Genentech), among others, have pledged ensured access to medications and conducting clinical trials of their drugs in COVID-19.
But how they will respond if their drug proves to be a transformative or curative agent and is suddenly in significant demand remains to be seen.
Andrew Powaleny, director of public affairs for the Pharmaceutical Research Manufacturers of America (PhRMA), told Healio Rheumatology that many players in big pharma are actively considering social commitments as they watch the daily shifts in COVID-19 unfold. “We are working with governments and insurers to make sure these potential treatments and vaccines are affordable and accessible to patients,” he said
Some of the corporations involved may end up turning a huge profit as a result of the pandemic. Others may ultimately be remembered for their generosity. Although many questions remain unanswered, one thing is for certain: the world is watching.
Questions to Consider
Surely, the company that nails down an effective vaccine or treatment stands to profit greatly, and rightfully so, as Silverman said. But the first critical question is how much. The line between profit and profiteering is not clearly defined, and each corporation will have to assess their role in the pandemic as it pertains to their bottom line and make decisions accordingly. At that point, judgment in the court of public opinion will come, or it will not.
Another question pertains to the likelihood that no single drug will ultimately cure COVID-19. Rather, an antiviral early in the course of the infection may work for one subset of patients, while an IL-1 inhibitor may quell a rising cytokine storm in another, an IL-6 inhibitor could manage other types of inflammation in yet another subset, and so on. As these various approaches undergo off-label use and clinical trials over the next 12 to 18 months, the drug manufacturers must decide whether to profit or make them available for free.
This raises questions of pricing and, consequently, insurance coverage. “Up to this point, pharmaceutical companies have set the prices of drugs, and the FDA does not allow different pricing of the same drug, even if it is used in a different disease,” Silverman said. “But some of these drugs cost tens or hundreds of thousands of dollars for a course or a year of treatment. Can you charge $200,000 for a 5-day course of this same drug to treat COVID-19? The ethics of that must be worked out.”
This “unknown territory,” as Silverman described it, must be sorted out either by self-regulation in the pharmaceutical industry or by the FDA and other players in the federal government stepping in.
Whether the FDA will change the rules to suit COVID treatments remains to be seen. If the rules do, in fact, change, Silverman believes Congressional oversight will be necessary to ensure that everyone with skin in the game is playing fairly. This, then, will add a political layer to the situation and introduce more potential complications.
While Powaleny was unable to address specific corporations or pricing structures directly, he did offer perspective on the finances of the federal response to the pandemic. “We need to avoid policies that would make it harder for companies to make investments into research and development, as well as collaborate with government agencies on new treatments and vaccines,” he said.
Restoring a Tarnished Reputation
If COVID-19 has had another impact on the world’s culture at large, it is that those research and development and drug pricing decisions that once were reported in the back pages of the newspaper or only in trade journals have suddenly become headlines. Big pharma is much more in the public eye.
This is an industry, of course, that has garnered a significant amount of negative attention in recent years. Price gouging from Martin Shkreli with Daraprim and Heather Bresch with EpiPen became flashpoints for a national conversation about that line between profit and profiteering.
But Silverman believes it would be unhelpful to vilify the entire industry without also acknowledging positive steps taken. “Gilead, the maker of remdesivir, has been seemingly the most magnanimous, committing early on to provide a million doses for people with COVID,” he said. “They have said that nobody has to pay for remdesivir through 2020.”
Powaleny expounded on some of this generosity. “Our companies are helping those on the frontlines with donations of PPE, existing medicines and monetary support,” he said. “Some companies have created programs empowering employees with medical or laboratory expertise to completely or partially pause their current roles and volunteer their medical skills to help their local health care organizations.”
Regarding patient access, Powaleny highlighted the Medicine Assistance Tool, or MAT. “This helps patients connect to financial assistance programs,” he said. “The biopharmaceutical industry has a responsibility to not just develop treatments and cures, but to also help patients access them.”
Generosity can take many forms, according to Powaleny. “For example, adaptive trial designs and digital health technologies such as wearables, real-time monitors and digital diaries have enabled virtual site visits, monitoring, data capture and increased communication and patient connectivity by phone or video chat,” he said. “Members are sharing the learnings from clinical trials in real time with governments and other companies to advance the development of additional therapies.”
Devil in the Details
All of these efforts will surely benefit patients at some point, but Silverman stressed that the generosity of Gilead with remdesivir should be interpreted carefully. “They said they would provide the drug for all trials in the U.S., but it is uncertain who, if anyone, would get the drug outside of the country,” he said. “When you look closely at this pledge they made, the devil is in the details.”
To that point, the company is partnering with the federal government and the National Institute of Allergy and Infectious Diseases to distribute the drug, which raises a number of questions about who will get remdesivir, and when, and for how much. For Silverman, this raises red flags, and is emblematic of the larger problems surrounding drug pricing and distribution in the U.S. “Everything about drug costs in this country is veiled,” he said.
The fact that people are talking about these issues and watching pharmaceutical companies closely is important, according to Silverman, but he has no illusions that the answers to the big questions will come easily. “It will be interesting to see what happens with regard to pricing in 2021 and beyond for all of these companies.”