Corrupted: Operation Warped Trust

In the months since the Trump administration launched Operation Warp Speed, the president promised that the initiative’s culminating achievement—a COVID-19 vaccine—would come by Election Day. Yet that very promise, and the efforts administration officials made to fulfill it, instead hindered the vaccine effort on the whole.

Americans are increasingly skeptical of the government’s vaccine development and approval guidelines, and, needless to say, there’s not a vaccine yet.

So as infection rates spike across the country, we felt compelled to take another close look at the government’s effort to develop and distribute coronavirus vaccines and treatments.

Back in August, we could see it going one of two ways: “an honest, well-managed effort based on sound scientific principles,” or one “hampered by corruption, cronyism, and the influence of Big Pharma.”

We’re increasingly seeing signs of the latter scenario. Multiple accounts of political meddling in the federal scientific decision-making process and government decision-makers with financial ties to the pharmaceutical industry, as well as the overall lack of transparency, are feeding the public’s distrust in the vaccine development process.

A survey conducted last month by the Pew Research Center found Americans’ willingness to get vaccinated for the coronavirus dropped significantly since May. Over three-quarters of the respondents were concerned a vaccine will be approved too quickly, “without fully establishing safety and effectiveness.” And it’s pretty easy to see why.

Making Science Political

The president’s push to approve a vaccine by Election Day has “drowned out months of careful scientific work, reducing perhaps the most ambitious vaccine hunt in history to yet another presidential litmus test,” as Politico put it.

The politicization of science by this administration has been near-constant, as has Trump’s insistence that a vaccine would be ready by right about now. So in an attempt to reassure Americans that science would guide the process, the Food and Drug Administration (FDA) in mid-September announced plans to implement stringent guidelines for emergency approval of a COVID-19 vaccine.

Trump quickly called the forthcoming guidelines “a political move,” and the White House attempted to block them. According to the New York Times, the White House stalled for about two weeks, and a main point of contention in the guidelines was a provision that would likely delay emergency authorization of a vaccine until after Election Day.

The White House eventually relented and approved the guidelines—after the FDA essentially forced its hand by posting them on the FDA website. But the weeks of overt political interfering to influence scientific guidelines were damaging nevertheless. And this was just one of several recent incidents that have inflicted serious harm to the reputation of the FDA and other health agencies.

The convalescent plasma debacle this summer landed a major blow. After pressure from Trump, FDA Commissioner Stephen Hahn fumbled the messaging on the newly authorized COVID-19 treatment and exaggerated its effectiveness, as documented by the Washington Post. Hahn’s mischaracterization of convalescent plasma prompted backlash from experts, and he soon issued an apology and a correction.

More recent were Trump’s claims about the effectiveness of the Regeneron treatment he received while hospitalized with COVID-19 and how he would make it more widely available. His comments likely fed the public’s perception that the drug approval process isn’t entirely free of political influence.

The political pressure on career government scientists has been extensive. The Government Accountability Office is now investigating whether White House officials meddled in the work done by the FDA and the Centers for Disease Control and Prevention (CDC) to respond to COVID-19.

Public trust in the vaccine approval process is crucial. In order for a vaccine to be effective, it must be administered to as many people as possible—which, of course, may be a struggle if the public doesn’t see the effort as trustworthy. It’s also important that drug companies recruit a diverse range of participants for vaccine trials, but, as the New York Times reported, that’s been difficult. Many Black Americans, for example, have a well-founded historical distrust of government scientists and clinical research of just this sort. News reports suggesting that the Department of Health and Human Services might be inclined to let political objectives skew public health policymaking certainly won’t help convince historically exploited communities to get onboard.

Concern about the lack of trust in the vaccine process motivated one of the top government scientists overseeing vaccine development to publish an op-ed explaining the trial and approval process and stating that the government would follow the science and ensure the safety of any vaccine brought to market. But regaining the public’s trust may well be a long, uphill battle.

The politicization of the pandemic response has greatly diminished the public’s trust in the federal health agencies and Operation Warp Speed, and has also undermined Health and Human Services employees’ ability to do their jobs.

“The house is not only on fire,” an unnamed CDC staffer told NBC News. “We’re standing in ashes.” Another CDC employee said, “I don't know if the damage to our reputation can be overcome with a new administration. I worry it's a permanent problem.”

Deeply Embedded Corruption

Even if you set aside the bureaucratic infighting and election-year political pressure, there’s still more to set the public ill at ease with those calling the shots in the effort to find a vaccine and treatments.

Several officials with influence over or direct involvement in the development and approval of vaccines and treatments have ties to the pharmaceutical industry that could pose a conflict of interest and influence their judgment, or could at least appear to. Even the appearance of corruption is damaging—and especially so when the public’s health and safety are at stake.

It starts at the top with Moncef Slaoui, the co-leader of Operation Warp Speed who, with the administration’s blessing, has refused to give up the $10 million in stock he owns in his former company, GlaxoSmithKline. This, all while GlaxoSmithKline and its partner Sanofi will receive up to $2.1 billion from the government for vaccine development. Even though Slaoui does have considerable expertise in vaccine development, his large financial stake in Glaxo has left a cloud hanging over Operation Warp Speed.

In the case of the panel that will advise the FDA on the approval of potential COVID-19 vaccines, the Project On Government Oversight (POGO) revealed that some of the panel’s members have a history of financial relationships with the companies developing the vaccines. Apparently, the FDA thinks it’s mostly fine that some members have received tens of thousands of dollars from drug companies in the form of consulting fees and compensation for travel and lodging. The agency has granted waivers allowing two committee members to participate despite having conflicts of interest.

It’s not uncommon for administrations to tap former lobbyists for key positions in the federal government, but POGO reported that the revolving door between the pharmaceutical industry and Health and Human Services has been swinging much more frequently under Trump.

Nearly 30 of Trump’s Health and Human Services political appointees previously worked as lobbyists (and some have already gone back to lobbying). That’s about as many in four years as Presidents Barack Obama and George W. Bush combined nominated over 16 years.

Although it’s often hard to determine when officials’ private sector ties influence their decisions, these conflicts can at least create the appearance of favoritism. Take the example of Alvogen. In August 2019, the drug company won its first contract with the Department of Health and Human Services—a deal worth up to $470 million to supply antiviral drugs for the Strategic National Stockpile. Alvogen happens to be a former lobbying client of Eric Hargan, the second-highest-ranking official at the department.

Limited Information

On top of all this, the public has limited visibility into Operation Warp Speed.

Through creative acquisition methods, the government has taken the typically public function of contracting and hidden it behind a locked door. Instead of awarding contracts directly to some companies, Operation Warp Speed awards them through a contract management intermediary firm called Advanced Technology International under an arrangement called an Other Transaction Agreement (OTA). This allows the government to bypass the regulatory oversight and transparency requirements of traditional federal contracts.

Transparency is particularly critical in a time of growing distrust of the vaccine process. That goes for the contracts and the vaccine-making process itself. As to the latter, scientists and public health experts have been calling for the vaccine developers to publicly and proactively disclose more information about their research and clinical trials.

Looking Ahead

There is a crisis of public confidence in the government’s handling of the pandemic. We must find a way to bolster confidence in our health agencies—and agency leaders must make sure they deserve it. Government scientists must continue to push back against any inappropriate political pressure or undue financial influence. Stronger whistleblower protections would help in this regard. Pharmaceutical companies should be more transparent about their research to help assure the public their vaccines and treatments are safe, and Operation Warp Speed should release more information on its contracts with these companies.

And federal agencies must vigorously enforce the revolving door rules that restrict the movement of officials to and from companies with business before the federal government.