Behind ‘the apology’: Wayne Pines, who counseled FDA Commissioner Hahn to clarify plasma remarks, addresses the controversy

The comms veteran, who found himself at the center of a feud between the commissioner and HHS, also discusses concerns about the agency’s independence.

Photo credit: Getty Images
Photo credit: Getty Images

Wayne Pines, the public relations counselor who urged the commissioner of the Food and Drug Administration to correct statements he made about a COVID-19 treatment, has practiced in the D.C. corridor long enough to know how Washington works.

At the same time, when Pines’ contract was terminated by the Department of Health and Human Services a few days later – for what seemed like reasons related to the optics of the situation – even longstanding Beltway operators were surprised. 

Pines met FDA Commissioner Stephen Hahn last year, according to sources familiar with their relationship, and the veteran communications hand helped Hahn prep for his confirmation hearing. After COVID-19 struck, the commissioner asked Pines in March to assist him in message development. 

In order to be able to sit in on meetings at FDA – something he would not be able to do as an outsider – Pines was given a contract. Per sources familiar with it, the contract was a practical matter – a way of ensuring he had access to information – and merely spelled out Pines’ advisory role.

After an Aug. 23 press conference Hahn held with President Donald Trump about a COVID-19 treatment called convalescent plasma, Pines realized the commissioner had misspoken with regard to the benefits of that treatment. He recommended that Hahn issue a clarification, which he did the following day on Twitter

According to interviews Pines did with the Washington Post and The New York Times, he felt it was extremely important for Hahn to correct the record – which revolved around a claimed 35% reduction in mortality – in order to preserve the FDA’s integrity and reputation with the American public. Later that week, HHS decided to sever the contract with Pines, who’s also a longtime executive at the firm APCO Worldwide.

HHS told the Times and the Post that this was a “routine” matter spurred by the agency’s review of thousands of contracts. A senior official, however, disagreed with the notion that Pines’ removal was coincidental, telling Politico, “Wayne was scapegoated by certain FDA officials for Hahn’s apology tour.”

Subsequently, Hahn parted ways with Emily Miller, the FDA spokesperson who may have had a role in wording the official announcement of plasma’s emergency use authorization in political terms. It was characterized as an “achievement” for the Trump administration.

John Wagner, FDA’s external affairs chief and, like Miller, a White House appointee, was also removed. They were replaced by civil servants with actual experience in medical and scientific communications, which neither Miller nor Wagner possessed.

Pines, who served as the agency’s chief media spokesman for seven years and is a published author on FDA and crisis communications, spoke with MM+M about the messaging machinations of the last two weeks and their consequences for the fight against coronavirus. He also discussed a recent drug industry pledge to uphold safety and efficacy in any COVID-19 vaccine approvals.

The following interview has been edited for clarity and brevity.

MM+M: Those in public health hold you in extremely high regard as a healthcare PR counselor. How many FDA commissioners have you advised?
During the 10 years I was at FDA, there were five I served under. Since then, I have been asked by four or five other commissioners to give occasional advice.

Talk about your advisory role to the current commissioner and take us through the events of the last two weeks.
I had been serving as an advisor to commissioner Hahn for several months, dating to before he became commissioner. I did advise him on the messaging associated with COVID-19 and I did recommend that he clarify the record with regard to the efficacy of convalescent plasma. And I was notified that my small contract was being terminated.

Why did you feel it was necessary for him to correct the record?
I recommended the record be clarified because the FDA, especially in these times, must be transparent, must have the public’s confidence. The FDA will have to decide which COVID-19 vaccines are approved and when they’re approved, and it’s essential the public have confidence in those judgments. I’ve been involved in public affairs for many decades and I’ve always advocated transparency in government. 

Some questioned the extent of commissioner Hahn’s apology. Others even called for him to resign. Do you think his mea culpa went far enough?
I think it did. I think he retains a strong reputation for integrity, and that’s what’s necessary as we move forward.

Commissioner Hahn is in a tough position. Public-health experts and scientists were livid after he exaggerated the effectiveness of blood plasma as a COVID-19 treatment. Then, after he apologized, HHS engineered the replacement of his personal communications aide.
FDA in these circumstances will always be under pressure. Pressure from an unprecedented pandemic is totally expected.

Was the way the FDA rolled out this coronavirus treatment a sign of deeper problems at the agency, especially considering its prior EUAs for hydroxychloroquine and chloroquine have since been revoked?
No, I think it was just an error and that was quickly corrected by the commissioner.

The agency’s media strategy has clearly undergone a shake-up, with its associate commissioner for external affairs and spokesperson both asked to move on. Both were political allies of the president. Can these changes solidify FDA’s communications strategy?
I can’t comment on that.

The FDA has been front and center in the presidential campaign. A lot of people are uncomfortable with the political spotlight shining on this traditionally science-focused agency. What will it take for the public to believe in the FDA’s independence again?
The FDA has to be transparent about the process moving forward. It has to make sure that the public understands the data and that it’s been adequately reviewed by experts at the FDA as well as from the advisory committee. And I feel confident that when this process of review is over, the public will indeed have confidence that FDA has indeed gone through an appropriate process and will have confidence in whatever decisions the FDA makes.

This week nine vaccine makers pledged not to seek a vaccine approval or EUA until they’ve demonstrated safety and efficacy through Phase 3 clinical trials. Some saw this as an attempt by the drug industry to protect the FDA from the president. Do you agree? 
I don’t interpret it that way at all. I interpret that as these are challenging times and the public doesn’t understand how vaccines are tested and developed and so that’s designed to clarify that. The pledge provides an extra measure of assurance that any vaccine will be adequately tested, in addition to FDA’s oversight. 

In terms of FDA’s communications strategy moving forward, Hahn has said repeatedly that he will ensure that science drives any approval decisions, a message reinforced by both Peter Marks, who heads the FDA’s vaccine division, and Moncef Slaoui, who leads the U.S. vaccine push. But, polls show that nearly a fifth of adults would refuse a coronavirus vaccine if available, for fear that its approval would be politically motivated. 
What FDA needs to do is to show that that is not the case and indeed that the process is being driven by science. And that has to come through very clearly, because that will be the case.

Last month the HHS issued an RFP for a $250 million, multi-channel marketing campaign focused on public health and reopening America. Do you think this has a real chance to motivate people to get a possible COVID-19 vaccine and/or flu vaccine, despite widely held concerns that a rushed shot may not be safe? How else can officials bridge the trust gap?
All I know about the campaign is that it’s in the proposal stage… As we move forward with the review process, the public will continue to gain confidence in the FDA and that process.

This article first appeared on mmm-online.com.

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