PolitiFact says Robert Kennedy is purveyor of 'Lie of the Year'

Robert F. Kennedy Jr.

From Kaiser Family Foundation Health News

As pundits and politicos spar over whether Robert F. Kennedy Jr.’s presidential campaign will factor into the outcome of the 2024 election, one thing is clear: Kennedy’s political following is built on a movement that seeks to legitimize conspiracy theories.

His claims decrying vaccines have roiled scientists and medical experts and stoked anger over whether his work harms children. He has made suggestions about the cause of covid-19 that he acknowledges sound racist and antisemitic.

Bolstered by his famous name and family’s legacy, his campaign of conspiracy theories has gained an electoral and financial foothold. He is running as an independent — having abandoned his pursuit of the Democratic Party nomination — and raised more than $15 million. A political action committee pledged to spend between $10 million and $15 million to get his name on the ballot in 10 states.

Even though he spent the past two decades as a prominent leader of the anti-vaccine movement, Kennedy rejects a blanket “anti-vax” label that he told Fox News in July makes him “look crazy, like a conspiracy theorist.”

But Kennedy draws bogus conclusions from scientific work. He employs “circumstantial evidence” as if it is proof. In TV, podcast, and political appearances for his campaign in 2023, Kennedy steadfastly maintained:

• Vaccines cause autism.

• No childhood vaccines “have ever been tested in a safety study pre-licensing.”

• There is “tremendous circumstantial evidence” that psychiatric drugs cause mass shootings, and the National Institutes of Health refuses to research the link out of deference to pharmaceutical companies.

• Ivermectin and hydroxychloroquine were discredited as covid-19 treatments so covid vaccines could be granted emergency use authorization, a win for Big Pharma.

• Exposure to the pesticide atrazine contributes to gender dysphoria in children.

• Covid-19 is “targeted to attack Caucasians and Black people. The people who are most immune are Ashkenazi Jews and Chinese.”

For Kennedy, the conspiracies aren’t limited to public health. He claims “members of the CIA” were involved in the assassination of his uncle, John F. Kennedy. He doesn’t “believe that (Sirhan) Sirhan’s bullets ever hit my father,” former Attorney General Robert F. Kennedy. He insists the 2004 presidential election was stolen from Democratic candidate John Kerry.

News organizations, including PolitiFact, have documented why those claims, and many others, are false, speculative, or conspiracy-minded.

Kennedy has sat for numerous interviews and dismissed the critics, not with the grievance and bluster of former President Donald Trump, but with a calm demeanor. He amplifies the alleged plot and repeats dubious scientific evidence and historical detail.

Will his approach translate to votes? In polls since November of a three-way matchup between President Joe Biden, Trump, and Kennedy, Kennedy pulled 16% to 22% of respondents.

Kennedy’s movement exemplifies the resonance of conspiratorial views. Misinformers with organized efforts are rewarded with money and loyalty. But that doesn’t make the claims true.

Robert F. Kennedy Jr.’s campaign based on false theories is PolitiFact’s 2023 Lie of the Year.

How an Environmental Fighter Took Up Vaccines

Kennedy, the third of 11 children, was 9 when he was picked up on Nov. 22, 1963, from Sidwell Friends School in Washington, D.C., because Lee Harvey Oswald had shot and killed Uncle Jack. He was 14 when he learned that his father had been shot by Sirhan Sirhan following a victory speech after the California Democratic presidential primary.

RFK Jr., who turns 70 in January and who lives in New York’s Hudson River Valley and on Cape Cod, wouldn’t begin to publicly doubt the government’s findings about the assassinations until later in his adulthood.

As a teenager, he used drugs. He was expelled from two boarding schools and arrested at 16 for marijuana possession. None of that slowed an elite path through higher education, including Harvard University, for his bachelor’s degree, and the University of Virginia for his law degree.

He was hired as an assistant district attorney in Manhattan in 1982 but failed the bar exam and resigned the next year. Two months later, he was arrested for heroin possession after falling ill on a flight. His guilty plea involved a drug-treatment program, a year of probation, and volunteer work with a local anglers’ association that patrolled the Hudson River for evidence of pollution that could lead to lawsuits.

Kennedy’s involvement with Hudson Riverkeeper and the Natural Resources Defense Council ushered in a long chapter of environmental litigation and advocacy.

An outdoorsman and falconer, Kennedy sued companies and government agencies over pollution in the Hudson River and its watershed. (He joined the New York bar in 1985.) He earned a master’s degree in environmental law at Pace University, where he started a law clinic to primarily assist Riverkeeper’s legal work. He helped negotiate a 1997 agreement that protected upstate New York reservoirs supplying New York City’s drinking water.

In 1999, Kennedy founded the Waterkeeper Alliance, an international group of local river and bay-keeper organizations that act as their “community’s coast guard,” he told Vanity Fair in 2016. He stayed with the group until 2020, when he left “to devote himself, full-time, to other issues.”

On Joe Rogan’s podcast in June, Kennedy said that virtually all of his litigation involved “some scientific controversy. And so, I’m comfortable with reading science and I know how to read it critically.”

PolitiFact did not receive a response from Kennedy’s campaign for this story.

He became concerned about mercury pollution from coal-burning power plants; methylmercury can build up in fish, posing a risk to humans and wildlife. As he traveled around the country, he said, women started appearing in the front rows of his mercury lectures.

“They would say to me in kind of a respectful but vaguely scolding way, ‘If you’re really interested in mercury contamination exposure to children, you need to look at the vaccines,’” Kennedy told Rogan, whose show averages 11 million listeners an episode.

Kennedy said the women sounded “rational” as they explained a link between their children’s autism and vaccines. “They weren’t excitable,” he said. “And they had done their research, and I was like, ‘I should be listening to these people, even if they’re wrong.’”

He did more than listen. In June 2005, Rolling Stone and Salon co-published Kennedy’s article “Deadly Immunity.” Kennedy told an alarming story about a study that revealed a mercury-based additive once used in vaccines, thimerosal, “may have caused autism in thousands of kids.” Kennedy alleged that preeminent health agencies — the Centers for Disease Control and Prevention, the Food and Drug Administration, the World Health Organization — had colluded with vaccine manufacturers “to conceal the data.”

Kennedy’s premise was decried as inaccurate and missing context. He left out the ultimate conclusion of the 2003 study, by Thomas Verstraeten, which said “no consistent significant associations were found between [thimerosal-containing vaccines] and neurodevelopmental outcomes.”

Kennedy didn’t clearly state that, as a precaution, thimerosal was not being used in childhood vaccines when his article was published. He also misrepresented the comments of health agency leaders at a June 2000 meeting, pulling certain portions of a 286-page transcript that appeared to support Kennedy’s collusion narrative.

Scientists who have studied thimerosal have found no evidence that the additive, used to prevent germ growth, causes harm, according to a CDC FAQ about thimerosal. Unlike the mercury in some fish, the CDC says, thimerosal “doesn’t stay in the body, and is unlikely to make us sick.” Continued research has not established a link between thimerosal and autism.

By the end of July 2005, Kennedy’s Salon article had been appended with five correction notes. In 2011, Salon retracted the article. It disappeared from Rolling Stone.

Salon’s retraction was part of a broader conspiracy of caving “under pressure from the pharmaceutical industry,” Kennedy told Rogan. The then-Salon editor rejected this, saying they “caved to pressure from the incontrovertible truth and our journalistic consciences.”

Kennedy has not wavered in his belief: “Well, I do believe that autism does come from vaccines,” he told Fox News’ Jesse Watters in July.

David Remnick, editor of The New Yorker, interviewed Kennedy for a July story. Noting that Kennedy was focusing more on vaccine testing rather than outright opposition, Remnick asked him whether he was having second thoughts.

“I’ve read the science on autism and I can tell you, if you want to know,” Kennedy said. “David, you’ve got to answer this question: If it didn’t come from the vaccines, then where is it coming from?”

How Covid-19 Helped RFK Jr.’s Vaccine-Skeptical Crusade

In 2016, Kennedy launched the World Mercury Project to address mercury in fish, medicines, and vaccines. In 2018, he created Children’s Health Defense, a legal advocacy group that works “aggressively to eliminate harmful exposures,” its website says.

Since at least 2019, Children’s Health Defense has supported and filed lawsuits challenging vaccination requirements, mask mandates, and social media companies’ misinformation policies (including a related lawsuit against Facebook and The Poynter Institute, which owns PolitiFact).

From the beginning, the group has solicited stories about children “injured” by environmental toxins or vaccines. This year, it launched a national bus tour to collect testimonials. The organization also produces documentary-style films and books, including Kennedy’s “The Wuhan Cover-Up and the Terrifying Bioweapons Arms Race” and “The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health.”

In 2020, Children’s Health Defense and the anti-vaccine movement turned attention to the emerging public health crisis.

Kolina Koltai, a senior researcher at Bellingcat, an investigative journalism group, had seen anti-vaccine groups try to seize on Zika and Ebola outbreaks, with little success. But the covid-19 pandemic provided “the exact scenario” needed to create mass dissent: widespread fear and an information vacuum.

Children’s Health Defense published articles in March and April 2020 claiming the “viral terror” was an attempt to enact the “global immunization agenda” and a “dream come true” for dictators. The group echoed these points in ads and social media posts and grew its audience, including in Europe.

On X, then known as Twitter, Children’s Health Defense outperformed news outlets that met NewsGuard’s criteria for trustworthiness from the third quarter of 2020 to the fourth quarter of 2021, according to a report by the German Marshall Fund think tank, even as Children’s Health Defense published debunked information about covid-19 and vaccines.

In 2019, Children’s Health Defense reported it had $2.94 million in revenue, and paid Kennedy a $255,000 salary. Its revenue grew 440% through 2021, according to IRS filings, hitting $15.99 million. Kennedy’s salary increased to $497,013. (Its 2022 form 990 for tax disclosure is not yet public. Kennedy has been on leave from the organization since he entered the presidential race in April.)

On social media, the message had limits. Meta removed Kennedy’s personal Instagram account in February 2021 for spreading false claims about covid-19 and vaccines, the company said, but left his Facebook account active. A year and a half later, Meta banned Children’s Health Defense’s main Facebook and Instagram accounts for “repeatedly” violating its medical misinformation policies. Several state chapters still have accounts.

As the group’s face, Kennedy became a leader of a movement opposed to masks and stay-at-home orders, said David H. Gorski, managing editor of Science-Based Medicine and a professor of surgery and oncology at the Wayne State University School of Medicine.

“The pandemic produced a new generation of anti-vaxxers who had either not been prominent before or who were not really anti-vax before,” Gorski said. “But none of them had the same cultural cachet that comes with being a Kennedy that RFK Jr. has.”

Demonstrators listen as Robert F. Kennedy Jr. is shown on screen speaking at an anti-vaccine mandate rally on Jan. 23, 2022, in Washington.(ERIC LEE/BLOOMBERG VIA GETTY IMAGES)

Rallying a crowd before the Lincoln Memorial on Jan. 23, 2022, Kennedy protested covid-19 countermeasures alongside commentator Lara Logan and anti-vaccine activist Robert Malone. The crowd held signs reading “Nuremberg Trials 2.0” and “free choice, no masks, no tests, no vax.” When Kennedy took the stage, mention of his role with Children’s Health Defense prompted an exuberant cheer.

In his speech, Kennedy invoked the Holocaust to denounce the “turnkey totalitarianism” of a society that requires vaccinations to travel, uses digital currency and 5G, and is monitored by Microsoft Corp. co-founder Bill Gates’ satellites: “Even in Hitler’s Germany, you could cross the Alps into Switzerland. You could hide in an attic like Anne Frank did.”

Days later, facing criticism from his wife, the actor Cheryl Hines, Jewish advocacy groups, and Holocaust memorial organizations, Kennedy issued a rare apology for his comments.

Asked about his wife’s comment on Dec. 15 on CNN, he said his remarks were taken out of context but that he had to apologize because of his family.

Recycle. Repeat. Repeat.

When he’s asked about his views, Kennedy calmly searches his rhetorical laboratory for recycled talking points, selective research findings, the impression of voluminous valid studies, speculation, and inarguable authority from his experience. He refers to institutions, researchers, and reports, by name, in quick succession, shifting points before interviewers can note what was misleading or cherry-picked.

There is power in repetition. Take his persistent claim that vaccines are not safety-tested.

• In July, he told “Fox & Friends,” “Vaccines are the only medical product that is not safety-tested prior to licensure.”

• On Nov. 7 on PBS NewsHour, Kennedy said vaccines are “the only medical product or medical device that is allowed to get a license without engaging in safety tests.”

• On Dec. 15, he told CNN’s Kasie Hunt that no childhood vaccines have “ever been tested in a safety study pre-licensing.”

This is false. Vaccines, including the covid-19 vaccines, are tested for safety and effectiveness before they are licensed. Researchers gather initial safety data and information about side effects during phase 1 clinical trials on groups of 20 to 100 people. If no safety concerns are identified, subsequent phases rely on studies of larger numbers of volunteers to evaluate a vaccine’s effectiveness and monitor side effects.

Kennedy sometimes says that some vaccines weren’t tested against inactive injections or placebos. That has an element of truth: If using a placebo would disadvantage or potentially endanger a patient, researchers might test new vaccines against older versions with known side effects.

But vaccines are among “the most tested and vetted” pharmaceutical products given to children, said Patricia Stinchfield, a pediatric nurse practitioner and the president of the National Foundation for Infectious Diseases.

Kennedy encourages parents to research questions on their own, saying doctors and other experts are invariably compromised.

“They are taking as gospel what the CDC tells them,” Kennedy said on Bari Weiss’ “Honestly” podcast in June.

Public health agencies have been “serving the mercantile interests of the pharmaceutical companies, and you cannot believe anything that they say,” Kennedy said.

Experts fret that the Kennedy name carries weight.

“When he steps forward and he says the government’s lying to you, the FDA is lying to you, the CDC is lying to you, he has credence, because he’s seen as someone who is a product of the government,” said Paul Offit, a pediatrics professor in the Children’s Hospital of Philadelphia’s infectious diseases division and the director of the hospital’s Vaccine Education Center. “He’s like a whistleblower in that sense. He’s been behind the scenes, so he knows what it looks like, and he’s telling you that you’re being lied to.”

Kennedy name-drops studies that don’t support his commentary. When speaking with Rogan, Kennedy encouraged the podcaster’s staff to show a particular 2010 study that found that exposure to the herbicide atrazine caused some male frogs to develop female sex organs and become infertile.

Kennedy has repeatedly invoked that frog study to support his position that “we should all be looking at” atrazine and its impact on human beings. The researcher behind the study told PolitiFact in June that Kennedy’s atrazine claims were “speculation” given the vast differences between humans and amphibians. No scientific studies in humans link atrazine exposure to gender dysphoria.

In July, Kennedy floated the idea that covid-19 could have been “ethnically targeted” to “attack Caucasians and Black people. The people who are most immune are Ashkenazi Jews and Chinese.” The claim was ridiculously wrong, but Kennedy insisted that it was backed by a July 2020 study by Chinese researchers. That study didn’t find that Chinese people were less affected by the virus. It said one of the virus’s receptors seemed to be absent in the Amish and in Ashkenazi Jews and theorized that genetic factors might increase covid-19 severity.

Five months later, Kennedy invoked the study and insisted he was right: “I can understand why people were disturbed by those remarks. They certainly weren’t antisemitic. … I was talking about a true study, an NIH-funded study.”

“I wish I hadn’t said them, but, you know, what I said was true.”

Kennedy answered using scientific terms (“furin cleave,” “ACE2 receptor”), but he ignored explanations found in the study. He didn’t account for how the original virus has evolved since 2020, or how the study emphasized these potential mutations were rare and would have little to no public health impact.

Public health experts say that racial disparities in covid-19 infection and mortality — in the U.S., Black and Hispanic people often faced more severe covid-19 outcomes — resulted from social and economic inequities, not genetics.

Kennedy says “circumstantial evidence” is enough.

Antidepressants are linked to school shootings, he told listeners on a livestream hosted by Elon Musk. The government should have begun studying the issue years ago, he said, because “there’s tremendous circumstantial evidence that those, like SSRIs and benzos and other drugs, are doing this.”

Experts in psychiatry have told PolitiFact and other fact-checkers that there is no causal relationship between antidepressants and shootings. With 13% of the adult population using antidepressants, experts say that if the link were true they would expect higher rates of violence. Also, the available data on U.S. school shootings shows most shooters were not using psychiatric medicines, which have an anti-violence effect.

Conspiracy Theories, Consequences, and a Presidential Campaign

The anti-censorship candidate frames his first bid for public office as a response to “18 years” of being shunned for his views — partly by the government, but also by private companies.

“You’re protected so much from censorship if you’re running for president,” Kennedy told conservative Canadian podcaster and psychologist Jordan Peterson in June.

In June, Kennedy’s Instagram account was reinstated — with a verified badge noting he is a public figure. Meta’s rules on misinformation do not apply to active political candidates. (PolitiFact is a partner of Meta’s Third Party Fact-Checking Program, which seeks to reduce false content on the platform.)

In July, he was invited to testify before the Republican-led House Select Subcommittee on the Weaponization of the Federal Government. He repeated that he had “never been anti-vax,” and railed against the Biden White House for asking Twitter to remove his January 2021 tweet that said Baseball Hall of Famer Hank Aaron’s death was “part of a wave of suspicious deaths among elderly,” weeks after Aaron, 86, received a covid-19 vaccine. The medical examiner’s office said Aaron died from unrelated natural causes.

Robert F. Kennedy Jr. arrives to testify during a House Judiciary subcommittee hearing on what Republicans say is politicization of the FBI and Justice Department on July 20 in Washington.(JABIN BOTSFORD/THE WASHINGTON POST VIA GETTY IMAGES)

Throughout 2023, alternative media has embraced Kennedy. He has regularly appeared on podcasts such as Peterson’s, and has also participated in profiles by mainstream TV, online, and print sources.

“You’re like, ‘But you’re talking right now. I’m listening to you. I hear your words. You’re not being censored,’” said Whitney Phillips, an assistant professor in the School of Journalism and Communication at the University of Oregon who researches how news media covers conspiracy theories and their proponents. “But a person can believe they’re being censored because they’ve internalized that they’re going to be,” or they know making the claim will land with their audience.

Time will tell whether his message resonates with voters.

Kyle Kondik, managing editor of Sabato’s Crystal Ball at the University of Virginia Center for Politics, said Kennedy may be a “placeholder” for voters who are dissatisfied with Trump and Biden and will take a third option when offered by pollsters.

The only 2024 candidate whose favorability ratings are more positive than negative? It’s Kennedy, according to FiveThirtyEight. However, a much higher percentage of voters are unfamiliar with him than they are with Trump or Biden — about a quarter — and Kennedy’s favorability edge has decreased as his campaign has gone on.

Nevertheless, third-party candidates historically finish with a fraction of their polling, Kondik said, and voters will likely have more names and parties on their fall ballots, including philosopher Cornel West, physician Jill Stein, and a potential slate from the No Labels movement.

Kennedy was popular with conservative commentators before he became an independent, and he has avoided pointedly criticizing Trump, except on covid-19 lockdowns. When NBC News asked Kennedy in August what he thought of Trump’s 2020 election lies, Kennedy said he believed Trump lost, but that, in general, people who believe elections were stolen “should be listened to.” Kennedy is one of them. He still says that the 2004 presidential election was “stolen” from Kerry in favor of Republican George W. Bush, though it wasn’t.

American Values 2024 will spend up to $15 million to get Kennedy’s name on the ballot in 10 states including Arizona, California, Indiana, New York, and Texas. Those are five of the toughest states for ballot access, said Richard Winger, co-editor of Ballot Access News.

Four of Kennedy’s siblings called Kennedy’s decision to run as an independent “dangerous” and “perilous” to the nation. “Bobby might share the same name as our father, but he does not share the same values, vision or judgment,” the group wrote in a joint statement.

Kennedy brushes it off when asked, saying he has a large family and some members support him.

On her podcast, Weiss asked whether Kennedy worried his position on autism and vaccines would cloud his other positions and cost him votes. His answer ignored his history.

“Show me where I got it wrong,” he said, “and I’ll change.”

In a campaign constructed by lies, that might be the biggest one.

PolitiFact researcher Caryn Baird contributed to this report.​

PolitiFact’s source list can be found here.

Mixed messaging of vaccine skeptics sows seeds of doubt

An early 19th-Century satire of antivaxxers by Isaac Cruikshank

Headquarters, in Cambridge, Mass., of Moderna, one of the major COVID-19 vaccine makers

From Kaiser Family Foundation Health News

“It seems to me to be implying the government knows the vaccine to be unsafe” and that it’s “covering it up.’’

— Matt Motta, a political scientist at Boston University specializing in public health and vaccine politics

It was a late-spring House of Representatives hearing, where members of Congress and attendees hoped to learn lessons from the pandemic. Witness Marty Makary made a plea.

“I want to thank you for your attempts at civility,” Makary, a Johns Hopkins Medicine researcher and surgeon, said softly. Then his tone changed. His voice started to rise, blasting the “intellectual dishonesty” and “very bizarre” decisions of public health officials. Much later, he criticized the “cult” of his critics, some of whom “clap like seals” when certain studies are published. Some critics are “public health oligarchs,” he said.

Makary was a marquee witness for this meeting of the Select Subcommittee on the Coronavirus Pandemic. His testimony had the rhythm of a two-step — alternating between an extended hand and a harsh rhetorical slap. It’s a characteristic move of this panel, a Republican-led effort to review the response to the pandemic. Both sides of the aisle join in the dance, as members claim to seek cooperation and productive discussions before attacking their preferred coronavirus villains.

One target of the subcommittee’s Republican members has drawn concern from public health experts: COVID-19 vaccines. Because the attacks range from subtle to overt, there’s a fear all vaccines could end up as collateral damage.

During that May 11 hearing, Republican members repeatedly raised questions about coronavirus vaccines. Right-wing star Rep. Marjorie Taylor Greene (R.-Ga.) emphasized the vaccines were “experimental” and fellow Georgia Republican Rep. Rich McCormick, an emergency room physician, argued the government was “pushing” Federal Drug Administration-approved boosters “with no evidence and possible real harm.”

Some Republican members, who have been investigating for months various pandemic-related matters, are keen to say they’re supportive of vaccines — just not many of the policies surrounding COVID vaccines. Rep. Brad Wenstrup (R.-Ohio), who chairs the subcommittee, has said he supports vaccines and claimed he’s worried about declining vaccination rates.

During the May hearing, he also two-stepped, arguing the COVID shots were “safe as we know it, to a certain point.” He questioned the government’s safety apparatus, including VAERS, the Vaccine Adverse Event Reporting System, a database that receives reports potentially connected to vaccines. He said the committee would be “looking” at it “to make sure it’s honest and to be trusted.”

It’s this two-step — at once proclaiming oneself in favor of vaccines, while validating concerns of vaccine-skeptical audiences — that has sparked worries of deeper vaccine hesitancy taking root.

“It seems to me to be implying the government knows the vaccine to be unsafe” and that it’s “covering it up,” said Matt Motta, a political scientist at Boston University specializing in public health and vaccine politics. The implication validates some long-held fringe theories about vaccinations, without completely embracing “conspiracism,” he said.

Vaccine skeptics run the gamut from individuals with scientific credentials who nevertheless oppose public health policies from a libertarian perspective to individuals endorsing theories about widespread adverse events, or arguing against the need for multiple shots. VAERS is a favorite topic among the latter group. When one witness testifying during the May 11 hearing attempted to defend covid vaccination policies, Taylor Greene cited the number of reports to VAERS as evidence of the vaccines’ lack of safety.

That muddles the purpose of the database, Motta said, which gathers unverified and verified reports alike. It’s a signal, not a diagnosis. “It’s more like a smoke alarm,” he said. “It goes off when there’s a fire. But it also goes off when you’ve left an omelet on the stove too long.”

In a March hearing focusing on school reopening policies, Democratic members of the panel and a witness from a school nurses association frequently touted the important role covid vaccines played in enabling schools to reopen. Wenstrup offered generalized skepticism. “I heard we were able to get more vaccines for the children,” he said. “We didn’t know fully if they needed it. A lot of data would show they don’t need to vaccinate.”

Witnesses can eagerly play into vaccine-skeptical narratives. After a question from Taylor Greene premised on the idea that the covid vaccines “are not vaccines at all,” and alleging the government is spreading misinformation about their effectiveness, Makary suggested that while he was not anti-vaccine, it was understandable others were. “I understand why they are angry,” he said, in response. “They’ve been lied to,” he said, before criticizing evidence standards for the newest covid boosters, tailored to combat emerging variants.

The signals aren’t lost on audiences. The subcommittee has, like most congressional panels, posted important moments from its hearings to Twitter. Anti-vaccine activists and other public health skeptics reply frequently.

“It’s hard for me to think of a historical analogue for this — it’s not often that we have a Congressional committee producing content that has its fingers on the pulse of the anti-vaccine community,” Motta wrote in an e-mail, after reviewing many of the subcommittee’s tweets. “The committee isn’t expressly endorsing anti-vaccine positions, beyond opposition to vaccine mandates; but I think it’s quite possible that anti-vaccine activists take this information and run with it.”

Motta’s concern is echoed by the panel’s Democratic members. “I pray this hearing does not add to vaccine hesitancy,” said Rep. Kweisi Mfume (D.-Md.), who represents Baltimore.

One witness reiterated that point. Many members “have a lot of skepticism about vaccines and were not afraid to express that,” Tina Tan, a specialist in pediatric infectious diseases at Northwestern University, told KFF Health News. She testified at the hearing on behalf of the minority.

Polling is showing a substantial — and politically driven — level of vaccine skepticism that reaches beyond covid. A slim minority of the country is up to date on vaccinations against the coronavirus, including the bivalent booster. And the share of kindergartners receiving the usual round of required vaccines — the measles, mumps, and rubella, or MMR, inoculation; tetanus; and chickenpox among them — dropped in the 2021-22 school year, according to the Centers for Disease Control and Prevention. Support for leaving vaccination choices to parents, not as school requirements, has risen by 12 percentage points since just before the pandemic, mostly due to a drop among Republicans, according to a recent poll by the Pew Research Center.

And vaccine skepticism is resonating beyond the halls of Congress. Some state governments are considering measures to roll back vaccine mandates for children. As part of a May 18 procedural opinion, Supreme Court Justice Neil Gorsuch cited two vaccination mandates — one in the workplace, and one for service members — and wrote that Americans “may have experienced the greatest intrusions on civil liberties in the peacetime history of this country.” He made this assertion even though American military personnel have routinely been required to get shots for a host of diseases.

“We can’t get to a spot where we’re implicitly or explicitly sowing distrust of vaccines,” cautioned California Rep. Raul Ruiz, the Democratic ranking member of the coronavirus subcommittee.

Darius Tahir is a Kaiser Family Foundation Health News reporter.
DariusT@kff.org, @dariustahir

Omicron boosters: Is salesmanship trumping science?

Moderna headquarters in Cambridge, Mass.

From Kaiser Health News

Last month, the Food and Drug Administration authorized Omicron-specific vaccines (with Moderna’s the best known), accompanied by breathless science-by-press release and a media blitz. Just days after the FDA’s move, the Centers for Disease Control and Prevention followed, recommending updated boosters for anyone age 12 and up who had received at least two doses of the original COVID-19 vaccines. The message to a nation still struggling with the COVID pandemic: The cavalry — in the form of a shot — is coming over the hill.

But for those familiar with the business tactics of the pharmaceutical industry, that exuberant messaging — combined with the lack of completed studies — has caused considerable heartburn and raised an array of unanswered concerns.

The updated shots easily clear the “safe and effective” bar for government authorization. But in the real world, are the Omicron-specific vaccines significantly more protective — and in what ways — than the original COVID vaccines so many have already taken? If so, who would benefit most from the new shots? Since the federal government is purchasing these new vaccines — and many of the original, already purchased vaccines may never find their way into taxpayers’ arms — is the $3.2 billion price tag worth the unclear benefit? Especially when these funds had to be pulled from other covid response efforts, like testing and treatment.

Several members of the CDC advisory committee that voted 13-1 for the recommendation voiced similar questions and concerns, one saying she only “reluctantly” voted in the affirmative.

Some said they set aside their desire for more information and better data and voted yes out of fear of a potential winter COVID surge. They expressed hope that the new vaccines — or at least the vaccination campaign that would accompany their rollout — would put a dent in the number of future cases, hospitalizations, and deaths.

That calculus is, perhaps, understandable at a time when an average of more than 300 Americans are dying of COVID each day.

But it leaves front-line health care providers in the impossible position of trying to advise individual patients whether and when to take the hot new vaccines without complete data and in the face of marketing hype.

Don’t get us wrong. We’re grateful and amazed that Pfizer-BioNTech and Moderna (with assists from the National Institutes of Health and Operation Warp Speed) developed an effective vaccine in record time, freeing the nation from the deadliest phase of the covid pandemic, when thousands were dying each day. The pandemic isn’t over, but the vaccines are largely credited for enabling most of America to return to a semblance of normalcy. We’re both up-to-date with our covid vaccinations and don’t understand why anyone would choose not to be, playing Russian roulette with their health.

But as society moves into the next phase of the pandemic, the pharmaceutical industry may be moving into more familiar territory: developing products that may be a smidgen better than what came before, selling — sometimes overselling — their increased effectiveness in the absence of adequate controlled studies or published data, advertising them as desirable for all when only some stand to benefit significantly, and in all likelihood raising the price later.

This last point is concerning because the government no longer has funds to purchase COVID vaccines after this autumn. Funding to cover the provider fees for vaccinations and community outreach to those who would most benefit from vaccination has already run out. So updated boosters now and in the future will likely go to the “worried well” who have good insurance rather than to those at highest risk for infection and progression to severe disease.

The FDA’s mandated task is merely to determine whether a new drug is safe and effective. However, the FDA could have requested more clinical vaccine effectiveness data from Pfizer and Moderna before authorizing their updated omicron BA.5 boosters.

Yet the FDA cannot weigh in on important follow-up questions: How much more effective are the updated boosters than vaccines already on the market? In which populations? And what increase in effectiveness is enough to merit an increase in price (a so-called cost-benefit analysis)? Other countries, such as the United Kingdom, perform such an analysis before allowing new medicines onto the market, to negotiate a fair national price.

The updated booster vaccine formulations are identical to the original covid vaccines except for a tweak in the mRNA code to match the omicron BA.5 virus. Studies by Pfizer showed that its updated Omicron BA.1 booster provides a 1.56 times higher increase in neutralizing antibody titers against the BA.1 virus as compared with a booster using its original vaccine. Moderna’s studies of its updated Omicron BA.1 booster demonstrated very similar results. However, others predict that a 1.5 times higher antibody titer would yield only slight improvement in vaccine effectiveness against symptomatic illness and severe disease, with a bump of about 5 percent and 1 percent, respectively. Pfizer and Moderna are just starting to study their updated Omicron BA.5 boosters in human trials.

Though the studies of the updated Omicron BA.5 boosters were conducted only in mice, the agency’s authorization is in line with precedent: The FDA clears updated flu shots for new strains each year without demanding human testing. But with flu vaccines, scientists have decades of experience and a better understanding of how increases in neutralizing antibody titers correlate with improvements in vaccine effectiveness. That’s not the case with COVID vaccines. And if mouse data were a good predictor of clinical effectiveness, we’d have an HIV vaccine by now.

As population immunity builds up through vaccination and infection, it’s unclear whether additional vaccine boosters, updated or not, would benefit all ages equally. In 2022, the U.S. has seen COVID-hospitalization rates among people 65 and older increase relative to younger age groups. And while COVID vaccine boosters seem to be cost-effective in the elderly, they may not be in younger populations. The CDC’s Advisory Committee on Immunization Practices considered limiting the updated boosters to people 50 and up, but eventually decided that doing so would be too complicated.

Unfortunately, history shows that — as with other pharmaceutical products — once a vaccine arrives and is accompanied by marketing, salesmanship trumps science: Many people with money and insurance will demand it whether data ultimately proves it is necessary for them individually or not.

We are all likely to encounter the SARS-CoV-2 virus again and again, and the virus will continue to mutate, giving rise to new variants year after year. In a country where significant portions of at-risk populations remain unvaccinated and unboosted, the fear of a winter surge is legitimate.

But will the widespread adoption of a vaccine — in this case yearly updated COVID boosters — end up enhancing protection for those who really need it or just enhance drugmakers’ profits? And will it be money well spent?

The federal government has been paying a negotiated price of $15 to $19.50 a dose of mRNA vaccine under a purchasing agreement signed during the height of the pandemic. When those government agreements lapse, analysts expect the price to triple or quadruple, and perhaps even more for updated yearly COVID boosters, which Moderna’s CEO said would evolve “like an iPhone.” To deploy these shots and these dollars wisely, a lot less hype and a lot more information might help.

Elisabeth Rosenthal (erosenthal@kff.org, @rosenthalhealth) and Céline Gounder (cgounder@kff.org) are Kaiser Health News journalists.

Brian Mullin/Sherelle Wu: Can colleges mandate that their employees get COVID-19 shots?

Via The New England Journal of Higher Education, a service of The New England Board of Higher Education (nebhe.org)

BOSTON

As COVID-19 cases continue to surge nationwide, the newly approved COVID-19 vaccines cannot come soon enough. Although higher- education institutions (HEIs) are not at the top of the priority list to receive scarce early doses of the vaccine, colleges and universities should prepare for how they will handle vaccination on their campuses.

In general, both public and private HEIs may mandate that their staff receive the COVID-19 vaccine once it becomes available to the general public and may discipline an employee who refuses to receive the vaccine without cause. The U.S. Supreme Court has upheld the constitutionality of a state vaccine mandate that was “necessary for the public health or the public safety” (Jacobson v. Massachusetts, 197 U.S. 11 (1905)) as well as the exclusion of students from both public and private schools due to refusal to receive a mandatory vaccine (Zucht v. King, 260 U.S. 174 (1922)).

Under the federal Occupational Safety and Health Act (OSHA), employers have an obligation to provide a safe workplace free from serious recognized hazards and should do their part to encourage compliance with governmental health and safety guidelines.

In practice, however, HEIs should be aware that staff may be entitled to medical exemptions under the Americans with Disabilities Act (ADA) and religious exemptions under Title VII. Institutions should have a uniform policy for staff to apply for such exemptions.

When an employee requests an exemption, both Title VII and the ADA require that the institution engage in an interactive process to determine effective accommodations or alternatives to vaccination specific to that employee. Such accommodations may include permitting the employee to work remotely; temporarily reassigning the employee to a different, less public-facing position or workstation; or allowing the employee to take a temporary leave of absence.

In certain circumstances, if the exemption poses an “undue hardship” to the employer, the HEI may deny the exemption and require that the employee receive the vaccination. An undue hardship under Title VII is defined as a minimal cost or burden to the employer’s operations. This will vary depending on the size and nature of the HEI, but can be any economic or noneconomic expense that would create a burden on its operation such as, for example, changes to schedules that increase payroll expenses or result in other employees working less desirable shifts. In comparison, an undue hardship under the ADA requires an HEI to show a “significant difficulty or expense,” a much higher standard to meet.

Under both statutes, consideration of an undue hardship includes both financial costs as well as cultural or operational costs such as whether the accommodation would compromise the integrity of a seniority system—for example, an HEI that has a collective-bargaining agreement which provides for seniority for bidding for positions. Relevant factors in considering an undue hardship in the vaccination context would include, the risk to the public due to noncompliance; the availability of an alternate means of infection control such as personal protective equipment (PPE); and the number of employees who actually request an accommodation.

While an employee’s refusal or inability to receive the vaccination may cause jealousy or friction between coworkers, such a conflict would not constitute an undue hardship unless the accommodation would infringe on the coworkers’ rights or ability to perform their duties in a safe way.

In deciding whether to mandate (rather than strongly encourage) staff COVID-19 vaccination, each college or university should carefully consider its own community needs and circumstances. For example, a medical or nursing school that employs certain staff in health-care facilities may have a much more compelling need to mandate vaccinations than an institution whose employees continue to operate on a mostly remote or hybrid basis. As the vaccination rollout varies widely from state to state, institutions should consult their own state’s laws and narrowly tailor their own vaccine policy to match their local public-health agency’s guidance.

HEIs considering mandatory vaccines should maintain an objective written policy based on business necessity (i.e. actual job requirements) and apply the policy consistently. The institution can narrowly tailor the mandate to apply only to specific departments or positions. For example, an institution could mandate vaccination only for public-facing staff positions which are required to perform work on-campus rather than positions that may be performed remotely. The HEI should educate their employees on the benefits of vaccination and the process to request an accommodation.

An institution that has decided to require compulsory COVID-19 vaccination should provide free and convenient vaccine administration to its employees and should ensure that staff can take the necessary time off from work to receive the vaccine and recover from any side effects if necessary.

Importantly, given the need to carefully track vaccine administration to ensure individuals receive both doses at the appropriate time, colleges and universities must be careful to safeguard the privacy of employees’ medical information, including keeping it separate from personnel files.

Since the currently available COVID-19 vaccines are approved on an emergency-use basis, HEIs should carefully watch any changes in approval, efficacy and best practices. For example, pregnant women were not included in the clinical trials and may be excluded from initial vaccine administration. Institutions should also look out for additional guidance from the Centers for Disease Control, Equal Employment Opportunity Commission, or  OSHA.

Brian Mullin and Sherelle Wu are lawyers practicing in the Employment & Higher Education Groups in the Boston law firm of Bowditch & Dewey LLP. 

David Warsh: A great victory in vaccine making and marketing

U.S. Government Accountability Office diagram comparing a traditional vaccine-development timeline to an expedited one

SOMERVILLE, Mass.

I often struggle to explain why I consider the Financial Times the best newspaper that I read. But my conviction begins with the consideration that the FT shows for my time and attention, as if it expects I have other things to do (in my case also reading The New York Times, The Washington Post and The Wall Street Journal). There are no “jumps,” all stories in the daily report end on the page where they begin. The front page displays just two stories (along with many teases of stories elsewhere in the paper); then come three pages of general news from around the world, followed by several pages of company and markets news; two pages of market data set in small type; a page of arts criticism, a full-page story (“The Big Read”); an editorial and letters page with four columns opposite, and, of course,  the second most widely read page of the section, the “Lex” column of edgy newsy tidbits on the back. It is a thrifty package.

My deeper admiration, however, has to do to with the news values that the paper displays throughout. Last week presented a prime example. It takes a good deal of self-confidence to run out a story under the headline, “Trump vaccine chief proves critics wrong on Warp Speed: Industry veteran navigated political hurdles to boost drug companies’ fight against virus.”

But reporters Hannah Kuchler and Kiran Stacey had delivered a persuasive story. Since the article itself remains behind the FT paywall, I quote more extensively than I might otherwise to convey the gist. They began:

 Sitting in the shadow of the brutalist health department building in Washington, with only a leather jacket for protection against an autumnal breeze, Moncef Slaoui cuts a defiant figure. Six months after the former GlaxoSmithKline executive left the private sector to become President Donald Trump’s coronavirus vaccine tsar, Mr Slaoui feels his decision has been vindicated, and critics of the ability of Operation Warp Speed to develop a vaccine in record time have been proved wrong.

“The easy answer for experts was to say it was impossible and find reasons why the operation would never work,” he told the Financial Times. But the vaccine push is now hailed as the bright spot in the Trump administration’s Covid-19 response, as products from Pfizer and BioNTech, Moderna, and AstraZeneca and Oxford university move closer to approval.

The next day, Karen Weintraub, of USA Today, produced an in-depth profile of Slaoui, a Moroccan-born Belgian-American vaccine developer and retired drug company executive. It is fascinating reading.  But the authority of the FT account derived from the three experts the reporters quoted zeroing in on the management tool that Slaoui used to achieve his results, known as advance market commitments. or AMCs (and from a little Reuters sidebar that listed some of the spending on pre-approved doses by the U.S.  government’s Biomedical Advanced Research and Development Authority (BARDA):

 The central achievement of Operation Warp Speed had been accelerating investment in manufacturing, said Angela Rasmussen, a virologist at the Columbia University School of Public Health. “Normally, that would be a huge investment for a vaccine manufacturer to make, and potentially be a huge loss for them if they developed a vaccine that never went on to the market,” she said.

Even Pfizer, which did not take direct investment from Operation Warp Speed, benefited from having a $2bn pre-order for when its vaccine gets approved, said Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering. “Even if J&J or someone else beat them to the punch, they were going to get paid,” he said.

Stéphane Bancel, chief executive of Moderna, the lossmaking biotech which took about $2.5bn in government funding from different bodies, said the money was “very helpful”, covering the costs of trials and helping it to buy raw materials. “The entire planet is going to benefit from it,” he told the FT. “We are going to file [for approval] in the UK based on the US data paid for by the US government. We’re going to file in Europe and hopefully have a vaccine available in France and Spain and Italy, all paid for by the US government.”

Part of the charm of the story turns on its rarity; it hadn’t been easy for mainstream media to find nice things to say about the Trump administration. The road to Slaoui’s hiring probably leads back to Vice President Mike’s Pence’s appointment in February as head of the White House Coronavirus Task Force.  As former governor of Indiana, Pence’s connections with the pharmaceutical industry are tight; Indianapolis is home to major firms, including Eli Lilly and Purdue Pharma. Much remains to be learned.

But the mechanism known as advanced market commitment is of comparatively recent origin. It is the discovery, if that is the word, of University of Chicago economist Michael Kremer, in a series of papers he wrote while teaching at the Massachusetts Institute of Technology and Harvard University some 20 years ago, culminating in the publication, in 2004,  of Strong Medicine: Creating Incentives for Pharmaceutical Research on Neglected Diseases, with his wife, Rachel Glennerster, in 2004.

The new mechanisms they advocated were similar to those that in the 18th Century gave rise to the development of the naval chronometer, necessary to determining longitude at sea. Governmental “pull” methods could complement the inherently risky “push” of private research and development.  AMCs – legally binding commitments to buy specified quantities of as yet unavailable vaccines at specified prices – were the most promising of the lot for bringing into existence medicines that otherwise might not pay.  I  wrote in 2004 that the general line of argument of the book was “one more example of why, more than ever, governments today need talented and sophisticated regulators. Technology policy has become as important as monetary policy – in some respects, maybe more so.” (I am told that governmentally guaranteed long-term purchase contracts were the backbone of creating the Indonesia-Japan LNG trade, and developing so-called private power generation in the U.S.)

I asked Kremer last week if he had been involved in the Warp Speed journey, The answer was no.  He and co-authors had spoken to staff at the Council of Economic Advisers in the run-up to the creation of Operation Warp Speed. They had co-authored an op-ed article in The New York Times last May. But they had not met with Slaoui. He seems to have imbibed the basic idea as long ago as 2013, when he organized a session on the industry’s stock of common knowledge for the Aspen Ideas festival

Kremer was recognized with a Nobel Prize in economics, with two others, in 2018, for work on policy evaluation, including the work on vaccines. But I was struck when Wall Street Journal editorial-page columnist Daniel Henninger suggested last week that the scientists at the pharmaceutical companies who developed vaccines against COVID-19 were “the obvious recipient for 2021’s Nobel Peace Prize.”

There’s no doubt that we owe a considerable debt of gratitude to the scientists. But it was the administration’s Operation Warp Speed that organized their successful quests. A Peace Prize for the swift development of vaccines is a very good idea, not for President Trump or for Vice President Pence, nor even, to make a needed point, for Moncef Slaoui. It is a pretty thought, but remember that Russian and Chinese scientists also produced vaccines. Let the Norwegian parliament figure it out!

David Warsh, an economic historian and a veteran columnist, is proprietor of Somerville-based economicprincipals.com, where this column first appeared.

Llewellyn King: COVID-19 points way to faster medicines

In a Food and Drug Administration lab in Silver Spring, Md.

WEST WARWICK, R.I.

This is the month when the national spirit should start to lift: COVID-19 vaccines could be administered by mid-December. While we won’t reach the summit of a mighty mountain this month, nor well into next year, the ascent will have begun.

It is unlikely to be a smooth journey. There will be contention, accusation, litigation and frustration. Nothing so big as setting out to administer two-dose vaccines to the whole country could be otherwise.

But the pall that hangs so heavily over us with rising deaths, exhausted first responders and overstretched hospitals, will begin to lift very slightly.

For the rest of foreseeable history, there will be accusations leveled at the Trump administration for its handling of the pandemic — or its failure to handle it.

But one thing is certain: Our faith in our ability to make superhuman scientific efforts in the face of crisis will be restored. Developing a COVID-19 vaccine will be compared to putting a man on the Moon.

The large pharmaceutical companies, known collectively as Big Pharma, have shown their muscle. The lesson: Throw enough research and unlimited money at a problem, accelerate the regulatory process, and a solution can result.

Even globalization gets a good grade.

The first-to-market vaccine comes from American pharmaceutical giant Pfizer. But the vaccine was developed at its small German subsidiary, BioNTech, by a husband-and-wife team of first-generation Turkish immigrants. (Beware of whom you exclude.)

Biopharmaceutical research often takes place this way, akin to how it happens in Silicon Valley: Small companies innovate and invent, and larger ones gobble them up and provide the all-important resources for absurdly complicated and expensive clinical trials. These contribute mightily to the cost of new drugs. A new “compound” -- as a drug is called in the trade -- can cost up to $2 billion to bring to market; and financial reserves are needed, should there be costly lawsuits.

The development of new drugs looks like an inverted pyramid. Linda Marban, a researcher and CEO of Capricor Therapeutics Inc., a clinical-stage biotechnology company based in Los Angeles, explained it to me: “The last 20 years have shown a seismic change in how drugs and therapies are developed. Due to the speed at which science is advancing, and the difficulty of early-stage development, most of the early-stage work is done by small companies or the occasional academic. Big Pharma has moved into the role of late-stage clinical, sometimes Phase 2, but mostly Phase 3 and commercial development.”

In the upheaval occasioned by the pandemic, overhaul of the Food and Drug Administration looms large as a national priority. It must be able -- maybe with a greater use of artificial intelligence and data management -- to assess the safety and efficiency of desperately needed drugs without the current painful and often fatal delays.

Marban said of the FDA clinical-trials process: “It is the most laborious and frustrating process which delays important scientific and medical discoveries from patients. There are many situations where patients are desperate for therapy, but we have to climb the long and ridiculous ladder of doing clinical trials due to inefficiencies at the site which include nearly endless layers of contracting, budget negotiations, IRB [Institutional Review Board] approvals and, finally, interest and attention from overworked clinical trial staff.”

This situation, according to Marban, is compounded by the FDA’s requirement for clinical trials conducted and presented in a certain way, which often precludes getting an effective therapy to market. “If we simplify this process alone, we could move rapidly towards treatments and even cures for many horrific diseases,” she added.

War is a time of upheaval, and we are at war against the COVID-19. But war also involves innovation. We have proved that speed is possible when bureaucracy is energized and streamlined.

When COVID-19 is finally vanquished, it should leave a legacy of better medical research and sped-up approval procedures, benefiting all going forward.

Llewellyn King is executive producer and host of White House Chronicle, on PBS. His email is llewellynking1@gmail.com and he’s based in Rhode Island and Washington, D.C.

Linda Gasparello

Co-host and Producer

"White House Chronicle" on PBS

Mobile: (202) 441-2703

Websi

Rachana Pradhan: How big pharma money colors Operation Warp Speed

Via Kaiser Health News

April 16 was a big day for Moderna, the Cambridge, Mass., Massachusetts biotech company on the verge of becoming a front-runner in the U.S. government’s race for a coronavirus vaccine. It had received roughly half a billion dollars in federal funding to develop a COVID shot that might be used on millions of Americans.

Thirteen days after the massive infusion of federal cash — which triggered a jump in the company’s stock price — Moncef Slaoui, a Moderna board member and longtime drug-industry executive, was awarded options to buy 18,270 shares in the company, according to Securities and Exchange Commission filings. The award added to 137,168 options he’d accumulated since 2018, the filings show.

It wouldn’t be long before President Trump announced Slaoui as the top scientific adviser for the government’s $12 billion Operation Warp Speed program to rush COVID vaccines to market. In his Rose Garden speech on May 15, Trump lauded Slaoui as “one of the most respected men in the world” on vaccines.

The Trump administration relied on an unusual maneuver that allowed executives to keep investments in drug companies that would benefit from the government’s pandemic efforts: They were brought on as contractors, doing an end run around federal conflict-of-interest regulations in place for employees. That has led to huge potential payouts — some already realized, according to a KHN analysis of SEC filings and other government documents.

• Slaoui owned 137,168 Moderna stock options worth roughly $7 million on May 14, one day before Trump announced his senior role to help shepherd COVID vaccines. The day of his appointment, May 15, he resigned from Moderna’s board. Three days later, on May 18, following the company’s announcement of positive results from early-stage clinical trials, the options’ value shot up to $9.1 million, the analysis found. The Department of Health and Human Services said that Slaoui sold his holdings May 20, when they would have been worth about $8 million, and will donate certain profits to cancer research. Separately, Slaoui held nearly 500,000 shares in GlaxoSmithKline, where he worked for three decades, upon retiring in 2017, according to corporate filings.

• Carlo de Notaristefani, an Operation Warp Speed adviser and former senior executive at Teva Pharmaceuticals, owned 665,799 shares of the drug company’s stock as of March 10. While Teva is not a recipient of Warp Speed funding, Trump promoted its antimalarial drug hydroxychloroquine as a COVID treatment, even with scant evidence that it worked. The company donated millions of tablets to U.S. hospitals and the drug received emergency use authorization from the Food and Drug Administration in March. In the following weeks, its share price nearly doubled.

• Two other Operation Warp Speed advisers working on therapeutics, Drs. William Erhardt and Rachel Harrigan, own financial stakes of unknown value in Pfizer, which in July announced a $1.95 billion contract with HHS for 100 million doses of its vaccine. Erhardt and Harrigan were previously Pfizer employees.

“With those kinds of conflicts of interest, we don’t know if these vaccines are being developed based on merit,” said Craig Holman, a lobbyist for Public Citizen, a liberal consumer advocacy group.

An HHS spokesperson said the advisers are in compliance with the relevant federal ethical standards for contractors.

These investments in the pharmaceutical industry are emblematic of a broader trend in which a small group with the specialized expertise needed to inform an effective government response to the pandemic have financial stakes in companies that stand to benefit from the government response.

Slaoui maintained he was not in discussions with the federal government about a role when his latest batch of Moderna stock options was awarded, telling KHN he met with HHS Secretary Alex Azar and was offered the position for the first time May 6. The stock options awarded in late April were canceled as a result of his departure from the Moderna board in May, he said. According to the KHN analysis of his holdings, the options would have been worth more than $330,000 on May 14.

HHS declined to confirm that timeline.

The fate of Operation Warp Speed after President-elect Biden takes office is an open question. While Democrats in Congress have pursued investigations into Warp Speed advisers and the contracting process under which they were hired, Biden hasn’t publicly spoken about the program or its senior leaders. Spokespeople for the transition didn’t respond to a request for comment.

The four HHS advisers were brought on through a National Institutes of Health contract with consulting firm Advanced Decision Vectors, so far worth $1.4 million, to provide expertise on the development and production of vaccines, therapies and other COVID products, according to the federal government’s contracts database.

Slaoui’s appointment in particular has rankled Democrats and organizations such as Public Citizen. They say he has too much authority to be classified as a consultant. “It is inevitable that the position he is put in as co-chair of Operation Warp Speed makes him a government employee,” Holman said.

The incoming administration may have a window to change the terms under which Slaoui was hired before his contract ends, in March. Yet making big changes to Operation Warp Speed could disrupt one of the largest vaccination efforts in history while the American public anxiously awaits deliverance from the pandemic, which is breaking daily records for new infections. Warp Speed has set out to buy and distribute 300 million doses of a COVID vaccine, the first ones by year’s end.

“By the end of December we expect to have about 40 million doses of these two vaccines available for distribution,” Azar said Nov. 18, referring to front-runner vaccines from Pfizer and Moderna.

Azar maintained that Warp Speed would continue seamlessly even with a “change in leadership.” “In the event of a transition, there’s really just total continuity that would occur,” the secretary said.

Pfizer, which didn’t receive federal funds for research but secured the multibillion-dollar contract under Warp Speed, on Nov. 20 sought emergency authorization from the FDA; Moderna just announced that it would do so. In total, Moderna received nearly $1 billion in federal funds for development and a $1.5 billion contract with HHS for 100 million doses.

While it’s impossible to peg the precise value of Slaoui’s Moderna holdings without records of the sale transactions, KHN estimated their worth by evaluating the company’s share prices on the dates he received the options and the stock’s price on several key dates — including May 14, the day before his Warp Speed position was announced, and May 20.

However, the timing of Slaoui’s divestment of his Moderna shares — five days after he resigned from the company’s board — meant that he did not have to file disclosures with the SEC confirming the sale, even though he was privy to insider information when he received the stock options, experts in securities law said. That weakness in securities law, according to good-governance experts, deprives the public of an independent source of information about the sale of Slaoui’s stake in the company.

“You would think there would be kind of a one-year continuing obligation [to disclose the sale] or something like that,” said Douglas Chia, president of Soundboard Governance and an expert on corporate governance issues. “But there’s not.”

HHS declined to provide documentation confirming that Slaoui sold his Moderna holdings. His investments in London-based GlaxoSmithKline — which is developing a vaccine with French drugmaker Sanofi and received $2.1 billion from the U.S. government — will be used for his retirement, Slaoui has said.

“I have always held myself to the highest ethical standards, and that has not changed upon my assumption of this role,” Slaoui said in a statement released by HHS. “HHS career ethics officers have determined my contractor status, divestures and resignations have put me in compliance with the department’s robust ethical standards.”

Moderna, in an earlier statement to CNBC, said Slaoui divested “all of his equity interest in Moderna so that there is no conflict of interest” in his new role. However, the conflict-of-interest standards for Slaoui and other Warp Speed advisers are less stringent than those for federal employees, who are required to give up investments that would pose a conflict of interest. For instance, if Slaoui had been brought on as an employee, his stake from a long career at GlaxoSmithKline would be targeted for divestment.

Instead, Slaoui has committed to donating certain GlaxoSmithKline financial gains to the National Institutes of Health.

Offering Warp Speed advisers contracts might have been the most expedient course in a crisis.

“As the universe of potential qualified candidates to advise the federal government’s efforts to produce a COVID-19 vaccine is very small, it is virtually impossible to find experienced and qualified individuals who have no financial interests in corporations that produce vaccines, therapeutics, and other lifesaving goods and services,” Sarah Arbes, HHS’s assistant secretary for legislation and a Trump appointee, wrote in September to Rep. James Clyburn (D.-S.C.), who leads a House oversight panel on the coronavirus response.

That includes multiple drug-industry veterans working as HHS advisers, an academic who’s overseeing the safety of multiple COVID vaccines in clinical trials and sits on the board of Gilead Sciences, and even former government officials who divested stocks while they were federal employees but have since joined drug company boards.

Dr. Scott Gottlieb and Dr. Mark McClellan, former FDA commissioners, have been visible figures informally advising the federal response. Each sits on the board of a COVID vaccine developer.

After leaving the FDA in 2019, Gottlieb joined Pfizer’s board and has bought 4,000 of its shares, at the time worth more than $141,000, according to SEC filings. As of April, he had additional stock units worth nearly $352,000 that will be cashed out should he leave the board, according to corporate filings. As a board member, Gottlieb is required to own a certain number of Pfizer shares.

McClellan has been on Johnson & Johnson’s board since 2013 and earned $1.2 million in shares under a deferred-compensation arrangement, corporate filings show.

The two also receive thousands of dollars in cash fees annually as board members. Gottlieb and McClellan frequently disclose their corporate affiliations, but not always. Their Sept. 13 Wall Street Journal op-ed on how the FDA could grant emergency authorization of a vaccine identified their FDA roles and said they were on the boards of companies developing COVID vaccines but failed to name Pfizer and Johnson & Johnson. Both companies would benefit financially from such a move by the FDA.

“It isn’t a lower standard for FDA approval,” they wrote in the piece. “It’s a more tailored, flexible standard that helps protect those who need it most while developing the evidence needed to make the public confident about getting a Covid-19 vaccine.”

About the inconsistency, Gottlieb wrote in an email to KHN: “My affiliation to Pfizer is widely, prominently, and specifically disclosed in dozens of articles and television appearances, on my Twitter profile, and in many other places. I mention it routinely when I discuss Covid vaccines and I am proud of my affiliation to the company.”

A spokesperson for the Duke-Margolis Center for Health Policy, which McClellan founded, noted that other Wall Street Journal op-eds cited his Johnson & Johnson role and that his affiliations are mentioned elsewhere. “Mark has consistently informed the WSJ about his board service with Johnson & Johnson, as well as other organizations,” Patricia Shea Green said.

Johnson & Johnson’s vaccine is in phase 3 clinical trials and could be available in early 2021.

Still, while they worked for the FDA, Gottlieb and McClellan were subject to federal restrictions on investments and protections against conflicts of interest that aren’t in place for Warp Speed advisers.

According to the financial disclosure statements they signed with HHS, the advisers are required to donate certain stock profits to the NIH — but can do so after the stockholder dies. They can keep investments in drug companies, and the restrictions don’t apply to stock options, which give executives the right to buy company shares in the future.

“This is a poorly drafted agreement,” said Jacob Frenkel, an attorney at Dickinson Wright and former SEC lawyer, referring to the conflict-of-interest statement included in the NIH contract with Advanced Decision Vectors, the Warp Speed advisers’ employing consulting firm. He said documents could have been “tighter and clearer in many respects,” including prohibiting the advisers from exercising their options to buy shares while they are contractors.

De Notaristefani stepped down as Teva’s executive vice president for global operations in October 2019, but according to corporate filings he would remain with the company until the end of June 2020 in order to “ensure an orderly transition.” He’s been working with Warp Speed since at least May overseeing manufacturing, according to an HHS spokesperson.

When Erhardt left Pfizer in May, U.S. COVID infections were climbing and the company was beginning vaccine clinical trials. Erhardt and Harrigan, whose LinkedIn profile says she left Pfizer in 2010, have worked as drug industry consultants.

“Ultimately, conflicts of interest in ethics turn on the mindset behavior of the responsible persons,” said Frenkel, the former SEC attorney. “The public wants to know that it can rely on the effectiveness of the therapeutic or diagnostic product without wondering if a recommendation or decision was motivated for even the slightest reason other than product effectiveness and public interest.”

Rachana Pradhan is a Kaiser Health News correspondent.

rpradhan@kff.org, @rachanadixit

Looking across the Charles River toward Kendall Square, Cambridge, headquarters of Moderna and other tech companies.

Chris Powell: Deconstructing COVID-19 hysteria

“Hysteria Patient,’’ by Andre Brouillet (1857-1914)

MANCHESTER, Conn.

Amid the growing panic fanned by news organizations about the rebound in the virus epidemic, last week's telling details were largely overlooked.

First, most of the recent "virus-associated" deaths in Connecticut again have been those of frail elderly people in nursing homes.

Second, while dozens of students at the University of Connecticut at Storrs recently were been found infected, most showed no symptoms and none died or was even hospitalized. Instead all were waiting it out or recovering in their rooms or apartments.

And third, the serious-case rate -- new virus deaths and hospitalizations as a percentage of new cases -- was running at about 2 percent, a mere third of the recent typical "positivity" rate of new virus tests, the almost meaningless detail that still gets most publicity.

Recognizing that deaths, hospitalizations, and hospital capacity should be the greatest concerns, Connecticut Gov. Ned Lamont last week recalled that at the outset of the epidemic he had the Connecticut National Guard erect field hospitals around the state and that 1,700 additional beds quickly became available but were never used. This option remains available.

The governor's insight should compel reflection about state government's policy on hospitals -- policy that for nearly 50 years has been, like the policy of most other states, to prevent their increase and expansion.

The premise has been the fear that, as was said in the old movie, "if you build it, they will come" -- more patients, that is. The demand for medical services, the policy presumes, is infinite, and since government pays most medical costs directly or indirectly, services must be discreetly rationed -- that is, without public understanding -- even if this prevents economic competition among medical providers.

So in Connecticut and most other states you can't just build and open a hospital; state government must approve and confer a "certificate of need." Who determines need? State government, not people seeking care.

Of course, this policy was not adopted with epidemics in mind. Indeed, in adopting this policy government seems to have thought that epidemics were vanquished forever by the polio vaccines in the 1960s.

Now it may be realized that, while epidemics can be exaggerated, as the current one is, they have not been vanquished and the current epidemic -- or, rather, government's response to it -- has crippled the economy, probably in the amount of billions of dollars in Connecticut alone.

That cost should be weighed against the cost of hospitals that were never built. Maybe they could have been built and maintained only for emergency use, and an auxiliary medical staff maintained too, just as the National Guard is an all-purpose auxiliary.

Also worth questioning is the growing clamor for virus testing. The heightened desire for testing in advance of holiday travel is natural, but testing is not so reliable, full of false positives and negatives. Someone can test negative on Monday and on Tuesday can start manifesting the virus or contract it and be without symptoms.

Testing may be of limited use for alerting people that they might well isolate themselves for a time even if they are without symptoms. But people without symptoms are far less likely to spread the virus than infected people who don't feel well.

Only daily testing of everyone might be reliable enough to be very effective, but government and medicine are not equipped for that and it would be impractical anyway. Weekly testing of all students and teachers in school might be practical and worthwhile but terribly expensive, and only a few wealthy private schools are attempting it.

Contact tracing policy needs revision. Nothing has been more damaging and ridiculous than the closing of whole schools for a week or more because one student or teacher got sick or tested positive. As the governor notes, because of their low susceptibility to the virus, children may be safer in school than anywhere else.

Risk for teachers is higher but they also are more likely to become infected outside of school. They might accept the risk in school out of duty to their students, whose interrupted education is the catastrophe of the epidemic.

Meanwhile the country needs two vaccines -- one against the virus itself and one against virus hysteria.=

Chris Powell is a columnist for the Journal Inquirer, in Manchester, Conn.