Five years after an Ebola epidemic killed more than 11,000 people across West Africa, the U.S. Food and Drug Administration announced at the end of December 2019 that Merck, the behemoth, for-profit pharmaceutical company based in New Jersey, had received approval for an Ebola vaccine.
But this is hardly a success story. In fact, the saga behind the vaccine’s development sheds light on how involving private pharmaceutical companies may have obstructed the vaccine’s progress, profiting from publicly funded research only once the vaccine’s development proved to be lucrative business.
A new report, published in the Journal of Law and the Biosciences, details how the Ebola vaccine, Ervebo, was almost entirely researched and developed using public money, challenging the common assumption that only private, profit-driven companies are able to bring drugs to market.
Matthew Herder, one of the authors of the report, noted parallels between the Ebola response and the current coronavirus outbreak. “It seems fairly clear that the same approach — of patenting and licensing out to the private sector — is being relied upon by the public sector to advance vaccine development,” he told Truthout via email.
Herder emphasizes that their case study on Ebola cannot be generalized. Nonetheless, the authors raise a particularly urgent question as the U.S. struggles to marshal a response to a spreading coronavirus outbreak: Could the Ebola vaccine have been produced earlier, potentially saving thousands of lives, if researchers could have avoided the profit-driven trappings of private pharmaceutical companies?
The story begins at Canada’s National Microbiology Laboratory in Winnipeg, Manitoba. The impetus for the publicly funded research came from fears over bioterrorism that had been planted in the 1990s and blossomed after 9/11. By 2005 — a full decade before the Ebola outbreak — the Manitoba lab had discovered, researched, developed and produced a vaccine for Ebola that was highly effective in animals, making it ripe for further clinical trials.
Interest in biosecurity research nominally ensured government funding, yet the process of securing those funds could be frustratingly slow, and ultimately subject to changing federal government support for civil servant scientists. The report authors argue that despite these constraints, the Manitoba lab conducted sophisticated experimental trials and worked through various technical hurdles, far exceeding the “basic research” churlishly attributed to public-sector science.
In 2007, a private company based in Iowa — BioProtection Systems Corporation, now a subsidiary of NewLink Genetics Corporation — bought rights to the vaccine, promising to run further experimental tests, obtain U.S. regulatory approval and ultimately manufacture the vaccine in large quantities. The agreement granted the Iowa lab sole rights to license the vaccine, but contained a carveout that allowed the Public Health Agency of Canada — of which the Manitoba lab was a member — to use the patent under certain conditions, such as during a humanitarian crisis.
However, once BioProtection Systems had secured the rights to the drug, nothing happened. The research just sat on the shelf, as The New York Times reported. BioProtection Systems failed to meet the most basic terms of its licensing agreement, such as experimental research, amounting to what the authors of the Ebola vaccine study cite as a “fundamental breach” of contract.
But this should not have come as a surprise. Neither BioProtection Systems nor NewLink Genetics had ever developed a product through to regulatory approval. The future of a clinical-grade, potentially life-saving therapeutic intervention was essentially dependent on a company that had no proven track record of being able to deliver.
By 2014 — four years after the patent agreement was officially signed, a time during which no further research or development was conducted by the private lab in possession of the vaccine — Ebola was erupting across West Africa. The humanitarian crisis had arrived. While the epidemic raged from 2014 to 2016, the public Manitoba lab, working in tandem with the World Health Organization, nongovernmental organizations and governments of the most severely affected countries, could finally run clinical trials.
Not only was the private lab unnecessary to the vaccine’s development, the Journal report authors write, the involvement of the private lab “likely slowed it down.” The vaccine, “from sponsoring early stage research through to carrying out clinical trials during the epidemic, was instead the result of the combined efforts of the Canadian government, its researchers, and other publicly funded institutions.”
Public Funding, Private Profit
In 2014, while the Ebola epidemic unfolded, BioProtection Systems sublicensed the vaccine patent to Merck for a handsome $50 million.
The real issue with the case of the Ebola vaccine, the authors of the report point out, is not just that money flowed into private coffers. Instead, they focus on the more systemic problem: the dominating assumption that only the private sector can advance drug and vaccine development.
The Journal report cautions that the reason the publicly funded Manitoba lab didn’t develop the vaccine on its own had nothing to do with it being some lumbering public-sector institution allergic to innovation, as the trope would have it. Rather, the lab faced not only tight budgets, but, perhaps more pervasively, the “conventional wisdom” that assumes that private companies will be better positioned to bring new drugs to the market. As this case amply demonstrates, these companies bring new drugs to market only when they anticipate cashing in on an inhumane bounty.
The fact that the Ebola vaccine wasn’t approved until 2019 is a perfect example of disaster capitalism, with private companies raking in huge profits by privatizing the means of addressing widespread crises. Pumping funding into vaccine research is antithetical to market incentives — unless there’s a market.
Even worse, these companies made their profit by privatizing the innovative research that was paid for and made wholly possible by public money. Public-sector science “designed, paid for, and carried out the clinical trials” that ensured the approval of Ervebo, the authors urgently remind us.
We can avert these problems in the future, the report tells us, by avoiding the “conventional logic of commercialization.” But what does this alternative actually look like?
The Alternative: Public Pharmaceuticals
As The Democracy Collaborative’s Dana Brown recently demonstrated in her 2019 report, “Medicine for All,” publicly owned pharmaceutical companies would better respond to public health needs and deliver better health outcomes — and at lower costs.
Some money-chasing drug makers — such as Purdue Pharma, which knowingly profited from the opioid crisis — are such bad actors, so flagrantly hostile to the public interest, that they’ve been impossible to ignore.
But there aren’t just a few bad actors. The whole system of privatized pharmaceutical production, as Brown’s report demonstrates, is broken. Brown’s work builds on a growing groundswell of recognition that we need to wholly recreate the pharmaceutical industry.
In 2004, Ohio Rep. Dennis Kucinich proposed legislation that would establish a national biomedical research and development institute. In 2018, Physicians for a National Health Program, an organization with more than 20,000 members across the U.S., called for fundamental reforms to the current, for-profit system. And in just the last few weeks, the nonprofit Public Citizen has forcefully demonstrated how the coronavirus outbreak is just the most recent example of how private interests have corrupted vaccine development.
In Stat News, the authors of the Ebola report noted that “important interventions like life-saving vaccines may be neglected, delayed in development, or priced beyond reach unless and until we entertain alternative ways of bringing innovations to market.” Indeed, Health and Human Services Secretary Alex Azar told Congress on February 26 that the federal government could not assure that a coronavirus vaccine would be affordable for everyone: “We can’t control that price because we need the private sector to invest,” he said.
We can do better. Public pharmaceutical companies operate for the public good in Sweden, Brazil and Thailand, among many other countries. Democratic presidential candidates Senators Bernie Sanders and Elizabeth Warren have taken small steps in the right direction by putting public drug manufacturing into their health care proposals. Overhauling our broken pharmaceutical industry will take a whole lot more than that. But a good place to start is with political will — and, of course, by not being in the pockets of private drug manufacturers.
Could the coronavirus outbreak have been mitigated if the profit-motive were eliminated from vaccine development? It’s not quite that simple, Herder urges. Yet, he adds, the “risks of ceding total control over the resulting product to industry” — a risk made clear by both his report and Public Citizen’s — “underscores the need for a more innovative approach to infectious diseases.”
One thing is certain: excising for-profit pharmaceutical companies would mean our lawmakers and public health officials could focus on taking action, rather than debating whether they could ensure that the life-saving vaccine would be “affordable.”