A return to normal life after the pandemic, which we can only hope will be better and more equitable than the one that preceded it, depends on the creation of a safe and effective coronavirus vaccine. Aware of this reality, the Trump administration has made incredible declarations about when a vaccine will be ready; Trump claimed yesterday that a vaccine would be available “right around” Election Day. The prospect that Trump will push for a vaccine to begin distribution, potentially before we know whether it’s safe or effective, in order to save his flagging election chances is real, and it forces us to consider a slew of potential dangers.
There is another complication: the profit motive of pharmaceutical companies. The unstated assumption throughout the stories that game out the future of vaccine distribution is that pharmaceutical companies would be happy to produce and ship products that aren’t proven to be safe or effective. It barely needs to be said, apparently, that these firms would willingly sign on to a project to push out a vaccine before it’s ready—not necessarily out of a desire to help Trump win but because the incentive to cash in on being the winning company to ship a vaccine to every American is so vast. There is a gold rush happening in the coronavirus vaccine race—but unlike the scant rewards available to nineteenth-century prospectors, there are hundreds of millions of dollars in participation trophies for the companies that don’t succeed.
Over the last 20 years, a number of high-profile cases has revealed how Big Pharma hides data that wouldn’t support the approval of their drugs or even data that would reveal the drugs were dangerous. One of the most deadly cases in recent memory involved the painkiller Vioxx. Merck, the company that made the drug, dragged its feet after research–conducted after the drug was approved and brought to market–showed patients who took the drug were at higher risk of heart attacks. In 2004, five years after it was introduced, Vioxx was withdrawn from the market; Merck eventually paid a fine of $950 million. This was a small price to pay: In the year 2003 alone, the company sold $2.5 billion worth of its deadly snake oil. A Lancet study would later estimate that 38,000 people died from taking Vioxx. No one went to jail.
There may be no more famous or deadly example of pharma malfeasance than the opioid epidemic. It’s now well-known that Purdue Pharma pushed aggressively to sell its drug OxyContin despite knowing that it was addictive and dangerous. Hundreds of thousands of people have died from opioid overdoses. As Eric Levitz noted in a 2016 New York piece, the ability to sell drugs at such massively inflated costs gives companies a “multibillion-dollar motivation to ignore—or suppress—evidence that your drug does more harm than good.”
These are extreme examples, but they are the inevitable result of a system that gives drug companies immense control over what evidence about their drugs reaches the public. The proportion of drug trials funded by pharmaceutical companies has grown dramatically: A Washington Post report from 2012 found that 60 of 73 original studies of new drugs in The New England Journal of Medicine were funded by drug companies, and 37 had lead authors who had been paid by the companies in the past. A 2014 report by the Public Accounts of Committee in Britain’s House of Commons found that trials showing drugs to be effective were about twice as likely to be published as those showing they weren’t and that half of all clinical trials were not publicly available. In 2019, The Washington Post reported that Pfizer had chosen not to share data that may have shown one of its drugs, Enbrel, had benefits in treating Alzheimer’s—possibly because the drug was near the end of its patent, and therefore they “they won’t be making any money off of it,” as one former pharmaceutical executive told the paper.
Combine these realities with an administration hell-bent on getting a coronavirus vaccine approved before the election and the legal authority to bypass usual clinical trial requirements, and you have a recipe for disaster. It would be a nightmare scenario for a vaccine that was actively dangerous to be rushed to market; tens of millions of doses could be administered before the health risks became clear.
But a vaccine doesn’t need to cause damage to the human body to be dangerous overall. As Dr. Natalie Dean, an assistant professor of biostatistics at the University of Florida, noted in a recent New York Times op-ed, “a weak vaccine might be worse than no vaccine at all.” If a vaccine that turns out to protect only a minority of the population is approved—the World Health Organization says a vaccine needs to be effective in at least 50 percent of the population to be effective—it may cause “people who are only slightly protected to behave as if they are invulnerable,” Dean wrote. Imagine if those who received a vaccine stopped wearing masks or started going back to crowded bars or swimming pools yet only had a 30 or 40 percent chance of being protected from catching and spreading the virus.
But the financial incentives push the other direction, away from safety and caution. Drug company executives have already reaped huge rewards from coronavirus vaccine candidates that are not even close to market. The New York Times reported recently that executives at some of the companies developing potential vaccines have seen huge payouts from stock price increases. Moderna, which has received nearly a billion dollars in government funding to develop a vaccine, has seen its stock price triple, according to the Times; company insiders have sold almost $248 million in stock since it announced it was working on the vaccine in January, “most of it after the company was selected in April to receive federal funding to support its vaccine efforts.”
The chief executive of Vaxart, another company working on a vaccine that employs just 15 people, received stock options valued at $4.3 million when he took the job in mid-June. Those options are now worth more than $28 million. On a call with investors, he claimed that “it’s OK to make a profit from Covid vaccines, as long as you’re not profiteering.” (Meanwhile, tens of millions of Americans are at risk of eviction and homelessness.)
At Novavax, executives are set to collect huge rewards even if their vaccine never makes it to market because of stock options that are set to be awarded if the vaccine makes it to a Phase 2 clinical trial. Novavax stock is worth 31 times what it was worth in January, according to The Washington Post. A recent New York Times story on the vaccine push noted that there are financial risks for drug companies in pushing an unproven vaccine, too, since a failed vaccine could “jeopardize their broader business.” That the free market might serve as the referee in this instance seems dramatically too optimistic—Merck still exists, after all.
Moderna recently announced that it has been charging the highest price yet per dose of the vaccine, between $32 and $37 per dose. If patients require two doses, administering the vaccine to every American at $37 per dose would net $24 billion in sales. The company claimed it would be “responsible on price, well below value, during the pandemic.” (“Value” means almost nothing here—can you put a value on ending a global pandemic?) As the advocacy group Public Citizen noted, this means we may end up paying twice for the vaccine: Once in almost $1 billion worth of government funding for its development and again to actually receive the vaccine.
It is vanishingly unlikely that all the vaccine candidates the government has now funded to the tune of billions of dollars will end up being effective. We can’t even be sure that any of them will work. This doesn’t mean that we should never fund drugs that we aren’t sure will work; for a start, that’s impossible. The government should actually be funding more drugs, including drugs that pharmaceutical companies don’t want to pursue because they believe they wouldn’t profit sufficiently from them. The government should be funding the development and manufacture of all drugs.
The invention of new drugs isn’t that different from other forms of scientific discovery. At its heart, drug development is still just a process of unlocking the secrets of the inexplicable universe we find ourselves in; these molecules do this thing to the human body, preventing or treating this illness, and so on. The results of this process don’t need to be trapped behind a wall of profit, funded by inscrutable Wall Street firms, or guided by prospective revenue.
Yet across America and the world, drug companies hold patients hostage. Companies that hold the legal right to manufacture drugs leverage this into charging hundreds or thousands of dollars for drugs that cost almost nothing to make or that cost far less in other countries because they can–because we let them. This situation is not an unchangeable fact of medical science: According to Elisabeth Rosenthal’s book, An American Sickness, drugs were not expensive and vaccines cost “pennies” into the 1980s. It wasn’t until the introduction of promising HIV/AIDS drugs, she writes, that things changed with the new and vital drugs commanding high prices—and even changing the Food and Drug Administration approval process to encourage getting the drugs patients needed to market.
The fear that the Trump administration will rush an unproven vaccine through the approval process is legitimate. But the bigger problem is that we allow these hugely profitable private companies to run the process of drug development and sales in the first place. We do not need Pfizer or GlaxoSmithKline to exist in order for humanity to discover and manufacture drugs, and we certainly don’t need to let them make billions of dollars or game the legal system in the process. Scientific progress can happen without venture capital. We will be immensely lucky if the coronavirus vaccine gold rush doesn’t conclude with billions of dollars getting raked into the pockets of wealthy drug executives even as their cut-rate products dispense unnecessary death and harm to ordinary Americans.