Giving RFK Jr. control of HHS would be disastrous: an Editor’s Commentary

It is past time for biopharma CEOs to speak out and affirm basic truths, even if it puts them in harm’s way

The pharma CEOs, lobbyists and hedge fund managers who confidently reassured me and anyone who would listen that they had an inside track to Trumpland, and that he wouldn’t nominate Robert F. Kennedy Jr. for an influential position, were wrong. It turns out that people who said they had spoken with Trump personally, to his transition team, to his advisers or to his golf caddie were just hearing what they wanted to hear.

Apparently so was Howard Lutnick, CEO of Canter Fitzgerald and co-chair of Trump’s transition team, who said in an interview with CNN on Oct. 31 that Kennedy wasn’t in line for a position at HHS. More about that interview below.

Now that President-elect Donald Trump has selected RFK Jr. to lead HHS, insiders will point to Trump’s promise that the anti-vaxxer and promoter of fringe medical beliefs will restore HHS agencies to the “traditions of Gold Standard Scientific Research.” They’ll say Kennedy isn’t so bad, that they agree with some of his ideas, and anyway, he won’t be able to accomplish his most pernicious goals. The argument is that checks and balances and bureaucratic inertia will prevent a bomb-thrower from doing much damage.

The insiders will be wrong again. Kennedy would be an unmitigated disaster for companies that research, develop and manufacture medicines and for people around the world who rely on those companies.

One theory is that Trump is trolling his critics, that he won’t actually nominate Kennedy. I don’t know why anyone believes this. The only way he will step back is if he faces massive resistance from people he cares about, and the only way that will happen is if pharma industry leaders speak out.

It is possible that Senate Republicans will choke on Kennedy, but they are getting ready to swallow some bitter stuff, so he might slide through.

If the Senate balks, Trump might manage to pull off a recess appointment.

And there’s a good chance that Casey Means, a wellness entrepreneur who shares RFK Jr.’s ideas, will be nominated as FDA commissioner. The names that are floating around Washington for NIH director are worse.

Whatever happens, it is time for the industry leaders to speak up, even if it is uncomfortable. They must not be complicit or complacent.

Keeping quiet hasn’t done biopharma CEOs and investors much good. Any benefits from a Trump trifecta — an IRA fix, a tax deal, conventional antitrust enforcement — pale in comparison to the harm that will be done if FDA is severely damaged, NIH takes a body blow, and CDC is dismembered.

Start with the truth

The best place to start is by telling some basic truths.

Biopharma leaders should make it clear that FDA is not corrupt.

They should say that NIH, FDA and CDC officials who made controversial decisions during the COVID-19 pandemic are not criminals.

And no one should be afraid to say that vaccines have saved more lives than any other medical intervention devised by humans, they do not cause autism, and mandatory childhood vaccination is essential to protect society against deadly pathogens.

BioCentury’s readers know that these statements are true, but knowing isn’t enough.

Biopharma CEOs should say these things publicly. And loudly. So should Republican politicians, and the heads of patient advocacy organizations. It may be too late to prevent disastrous appointments, but it isn’t too late to try to mitigate the harm and save some self-respect.

Unfortunately, in the current political environment, making statements that should be uncontroversial presents risks, both to an individual and to organizations they are affiliated with.

Industry leaders have been counseled to remain quiet, to keep their heads down and hope that the “MAHA” madness burns itself out. The word in Washington is that wiser voices speaking softly behind the scenes have everything under control.

Trump’s selection of RFK Jr., like his picks for attorney general and director of national intelligence, show that in the fight for power in the Trump administration, at the outset, the most extremist factions have the upper hand.

Assertions that it doesn’t really matter who heads these agencies because political appointees can’t accomplish much without the consent of career staff aren’t credible in an environment where norm-busting is normal, the White House may revoke civil service protections from many officials, and public confidence in government is declining.

Trump and his HHS secretary, Alex Azar, tried and in some cases succeeded in forcing FDA to bend to their will during the COVID-19 pandemic. Remember hydroxychloroquine? Or convalescent plasma? Democratic presidents and HHS secretaries have also overruled FDA regulatory decisions. Obama did so over access to the Plan B emergency contraceptive.  

Is there any reason to think RFK Jr. would hesitate to intervene in decisions made by FDA or CDC?

One argument for avoiding the fray is the fear that speaking out paints a target on a CEO’s or elected official’s back, inviting political retribution that can end careers and damage the interests of shareholders and constituents. This is a valid concern.

Speaking up could put at risk some of industry’s priorities, such as modifying the Inflation Reduction Act’s drug pricing provisions and fixing the R&D tax credit.

An angered Trump could reinvigorate his “Most Favored Nation” international reference pricing proposal. There’s a good chance he’s going to do this in any case. People who know Trump say he really believes in MFN for drugs.

Those fears have to be weighed against the harms to the life sciences community and society from an FDA brain drain, reductions in scientific research funding, and populist antipathy toward the pharmaceutical industry.

Speak now, or forever hold your peace

It is one thing to advise business leaders to refrain from making public statements about controversies that are not directly related to their companies. Suggesting that they shouldn’t speak out about appointments and policies that are central to their businesses is entirely different.

Remaining silent cedes the ground to crackpots who have spent years honing arguments that seem sound to people who distrust experts, denigrate civil servants and are uninformed about science, medicine or public health.

A recent incident illustrates the problem.

On Halloween, Lutnick reported in an interview on CNN that he’d recently spent two-and-a half-hours with RFK Jr. Lutnick’s account of their conversation shows the power of pseudo-science coupled to insinuations of corruption to persuade an accomplished business executive to endorse policies that would have devastating consequences.

Lutnick repeated Kennedy’s contention that “when he was born we had three vaccines and autism was 1 in 10,000. Now a baby’s born with 76 vaccines because in 1986 they waived product liability for vaccines. And here’s the best one — they started paying the people at the NIH. They pay them a piece of the money for the vaccine companies. So all of these vaccines came out without product liability. So what happened? Autism is one in 34. Amazing!”

What is amazing is that Lutnick distilled so much nonsense into less than a minute of television.

Unfortunately, what isn’t surprising is that the CEOs of pharmaceutical companies didn’t publicly repudiate Kennedy’s lies about the association between vaccines and autism. They also didn’t defend the vaccine compensation program.

Lutnick and Kennedy are correct about one thing. By the mid-1980s, financial liability for extraordinarily rare but real adverse effects and the far larger number of imagined harms had made it impossible to develop vaccines. The National Vaccine Injury Compensation Program saved the vaccine industry and eliminating it would cause companies to pull vaccines off the market.

Kennedy is also right about the role NIH has played in developing vaccines. For example, technology licensed from NIH made possible the development of papillomavirus vaccines that prevent cervical cancer, one of the most remarkable medical advances in recent decades.

If industry doesn’t publicly explain the importance of the vaccine injury compensation program, who will? Neither Congress nor Trump will heed warnings from academic public health experts.

Not one Republican member of Congress defended NIH scientists from the accusation that they have been corrupted by royalties on patents — royalties that Congress mandated as a way of incentivizing innovation.

Defending science and scientists

I have disagreed with FDA decisions and haven’t hesitated to criticize agency leaders when I think they’ve made mistakes.

It doesn’t take much imagination to come up with ways the agency could be improved.

Criticizing regulatory decisions and envisioning organizational changes is quite different from attacking the personal integrity of agency officials or questioning their motives.

Publicly accusing FDA or NIH of systemic corruption, threatening to prosecute their leaders or calling for mass firings should disqualify any nominee for a public health position, whether it is a Senate-confirmed job or heading an advisory body in the White House.

These kinds of comments crush morale and make dedicated civil servants look for exits. Pharmaceutical company executives told me last week that they’re already getting unsolicited resumes from FDA staff.  And some senior FDA officials told colleagues that they didn’t have the stamina for another Trump administration. That was before Trump said he had picked RFK Jr. to head HHS.

Kennedy has already said he opposes FDA user fees. If he’s confirmed, he and his FDA commissioner will be in charge of negotiations over user fee reauthorizations. Eliminating user fees would be a nightmare. There’s no way Congress would step in to fund the agency properly.

I could add more to the list of terrible things that could happen in an RFK Jr.-led HHS.

The same people who confidently said there was no way RFK Jr. would be nominated for a cabinet position will accuse me of fearmongering, of being hysterical. I hope they are correct this time.

Signed commentaries do not necessarily reflect the views of BioCentury.