President Donald Trump’s habit of touting potential coronavirus cures during daily White House briefings has changed the game for drugmakers, who are dropping their usually secretive ways to aggressively court public opinion.
From Gilead releasing anecdotal results on the drug remdesivir to Johnson & Johnson’s new reality series on the making of its experimental vaccine, pharmaceutical companies are seeking to shape the narrative like never before. The PR push could raise false hope about therapies that don’t end up working, or even put pressure on the Food and Drug Administration to approve drugs and vaccines whose effectiveness isn’t clear.
Gilead’s unusual move last week to publish data from compassionate use of remdesivir raised eyebrows among researchers. To a trained eye, the information revealed little about the experimental drug’s safety or effectiveness — and Gilead has multiple clinical trials underway that are set to produce more definitive results in just a few weeks.
This Wild West approach to promoting drugs and vaccines this early in the development process is a dramatic reversal for the pharmaceutical industry, which is normally guarded about the information it releases about ongoing clinical trials and the FDA approval process.
But the gambit appears to be paying off for drugmakers like Gilead. Trump mentioned remdesivir at his very next press briefing, on April 14, saying that the experimental treatment has shown “very promising” results. Trump’s repeated backing of another potential coronavirus drug, hydroxychloroquine, has already sent demand for it soaring across the country.
“Everyone wants drugs approved fast. Patients, the president, drug companies — they’re all pressuring the FDA to approve, approve, approve on the bare minimum of evidence,” said Christopher Morten, an NYU law professor who has wrangled with Gilead over the price of HIV prevention drugs.
The early release of Gilead data, along with the quick adoption of hydroxychloroquine, have fueled those concerns. “I fear it’s a way to build a kind of fever pitch of public anticipation and pressure from Trump on the FDA to get products approved," Morten said.
Veteran GOP strategist Doug Heye agreed. “When the president talks about something, that sucks all the oxygen out of not only other conversations but other things that would fall normally into that conversation,” said Heye, a former Republican National Committee chairman. It’s raised concerns, he said, that any good news “is then potentially hailed as the next miracle cure by the president, before anybody else is ready to definitively say that.”
Gilead would not comment on its interactions with the White House, and said initial data from clinical trials would be released in the coming weeks.
“We recognize there is a high level of interest in data on remdesivir, given the lack of approved treatments for Covid-19,” a Gilead spokesperson said. “While the results were encouraging, it would be inappropriate to interpret too much from these data, given the small number of patients in the cohort and the lack of a controlled trial design.”
Meanwhile, Johnson & Johnson posted the first episode of its eight-part online miniseries on Tuesday. Called "The Road to a Vaccine," it’s hosted by journalist Lisa Ling.
The PR game concerns policy experts who say pressure on FDA could fuel decisions made on thin ground. Several, like Harvard University health policy researcher Benjamin Rome, have already criticized the agency’s decision to authorize emergency use of hydroxychloroquine on sparse and mixed evidence — and worry that it signals more quick decisions in the future.
“Everyone is hoping that one of the many candidate drugs being studied proves effective against Covid-19,” said Rome. “However, the release of so much preliminary and anecdotal evidence … can actually be problematic, since it makes the public believe that drugs are effective, when we actually do not yet know the answer.”
It’s bred concern among lawmakers as well. Sen. Patty Murray (D-Wash.) sent a letter Friday to FDA Commissioner Stephen Hahn, pointing to the hydroxychloroquine authorization and urging him to make science-based decisions. An FDA spokesperson said the agency will respond directly to the senator.
On the broader question of coronavirus products in the pipeline, the FDA said that "there’s tremendous interest among all parties to identify and implement potential short- and long-term solutions" to the pandemic but that the agency will make independent, science-based decisions.
The industry moves also come amid a backdrop of renewed drug pricing talks in Congress, where lawmakers are readying their wish lists for a fourth coronavirus relief package. Democrats and Republicans alike have said that the possibility of coronavirus cures and vaccines within the year necessitates new drug pricing measures.
Pharmaceutical companies developing coronavirus cures and vaccines are looking to change that conversation and emphasize the life-changing products they could bring to the table. The industry has been on the defensive for years on drug pricing, generic competition and market exclusivity; the president himself said days before assuming office that the companies were “getting away with murder.”
“This allows them to remind customers, or potential customers, and elected officials why they exist and the benefits they can bring,” Heye said. “It’s not just a different conversation in topic, it’s a different conversation in tone. It moved from an almost universally negative conversation to a positive one.”
Johnson & Johnson, which is aiming for an emergency authorization for its potential vaccine in early 2021, said this week that it plans to offer the booster on a “not-for-profit” basis. The company’s web series aims to demystify the vaccine development for consumers, said Seema Kumar, J&J’s global leader for innovation, health and scientific communications, who has spearheaded the J&J show.
“People are so hungry for information. One of the things that science, and progress in science, provides is hope,” said Kumar. “Whenever our chief science officer talks about the vaccine, people go away feeling like somebody is working on something that is going to be helping everybody.”
The company’s second episode will answer viewer questions and there are talks to expand with partnerships for the show in countries like India. More than 50,000 people worldwide tuned into the first livestream and it later racked up 80,000 views on LinkedIn.
Others are more cynical about the effort. NYU’s Morten argued that the first J&J episode focuses on the company effort without acknowledging hundreds of millions of dollars poured in from the government at this point.
“A TV show that takes the American public around the sparkling, shiny, fancy-looking science labs at J&J is the perfect foundation for a fight six months from now over the prices that J&J is targeting,” said Morten.