‘There is a lot of misinformation and disinformation out there’ about vaccines, says attorney in HHS lawsuit

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A federal court case is necessary to stem the anti-vaccine tide among the nation’s highest health leaders, said an attorney involved in the case.

In May, Department of Health and Human Services Secretary Robert F. Kennedy, Jr., announced the COVID-19 vaccine for healthy children and healthy pregnant women was removed from the immunization schedules of the U.S. Centers for Disease Control and Prevention. The American Academy of Pediatrics, the American College of Physicians, the American Public Health Association, the Infectious Diseases Society of America, the Massachusetts Public Health Association doing business as the Massachusetts Public Health Alliance, the Society for Maternal-Fetal Medicine, and an unnamed physician are plaintiffs in the complaint filed July 7 against Kennedy. His top advisers and department leaders also are named as defendants: Food and Drug Administration Commissioner Marty Makary, MD, MPH; National Institutes of Health Director Jay Bhattacharya, MD, PhD; and Matthew Buzzelli, acting director of the Centers for Disease Control and Prevention (CDC).

Richard H. Hughes IV, JD, MPH
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Richard H. Hughes IV, JD, MPH, is one of the plaintiff’s attorneys and is a voting director for Vaccinate Your Family, a nonprofit vaccine advocacy organization. He spoke to Medical Economics about the case, which remains pending in U.S. District Court for the District of Massachusetts, and about the Advisory Committee on Immunization Practices (ACIP), which reviews vaccine tests and makes recommendations to CDC about the preventive shots for children and adults.

In a statement sent to Medical Economics, HHS spokesman Andrew Nixon said: “The secretary stands by his CDC reforms.”

Medical Economics: You represent a group of health care organizations that have filed a lawsuit against the U.S. Department of Health and Human Services. Can you give an overview of that situation?

Richard H. Hughes IV, JD, MPH: We filed a lawsuit on behalf of the American Academy of Pediatrics, the American College of Physicians, the Society for Maternal-Fetal Medicine, and other groups, including a Jane Doe plaintiff who's a pregnant woman who believes that she will have difficulty accessing the COVID vaccine if she wants to protect herself and her unborn child. And we brought this suit to challenge the HHS secretary, in a broad sense, to stop him from a steady stream of actions that undermine vaccine access and vaccine confidence in the United States. And then in a specific sense, so that we could bring the legal claims that we need to bring focused, really, on the final agency action in the form of the video that he produced with Marty Makary and Jay Bhattacharya. And that was the video where they announced that they were rescinding the COVID vaccine recommendations. Basically, that prevents many people from having access to COVID vaccines, and that's the action that we're challenging specifically.

Medical Economics: Can you talk more about that whole notion of the recommendation and how it affects access?

Richard H. Hughes IV, JD, MPH: It's important for many reasons. First of all, it's used in clinical practice as a standard of care. Professional societies have their guidelines, but this is really a recommendation that has been considered by a whole body of experts across different disciplines and specialty areas of practice and really in consideration of the harmonization of various recommendations. And so clinical practice is one area, and then you actually have various policies and laws that do rely on ACIP recommendations, whether that's pharmacist scope of practice laws or the requirement under the ACA that coverage, be tied to ACIP recommendations and that patients receive vaccines with zero out-of-pocket costs. So there's a lot of access that's determined through these recommendations. ACIP recommendations are not mandatory, and I think that's something that is often confused, that they're mandatory, and that's simply not the case. They are recommendations. Many states will then use those recommendations to actually implement requirements for, say, school entry, or that certain health care professionals should be immunized.

Medical Economics: With your client organizations that have brought this case, how do they believe the directive, or perhaps the lack of a recommendation or directive, will affect public health, particularly for pregnant women and children?

Richard H. Hughes IV, JD, MPH: It really does complicate the ability of providers to practice according to the standard of care, because it creates, certainly, patient doubts. Patients have a lot of questions, and it makes it really difficult to counsel patients effectively, and it takes up a lot of time in clinic to have to spend counseling patients. And then given the issues around coverage and payment, the uncertainty that a vaccine will be covered can certainly discourage discourage providers from offering it. So there's a real concern that this is just all around something that makes practice really complicated.

Medical Economics: Regarding the secretary and his directive for the COVID-19 vaccine, do you believe the HHS leaders have been relying on established scientific evidence in making that directive or decision?

Richard H. Hughes IV, JD, MPH: No, I don't. I mean, I don't think that they gave a lot of thought at all to the actual evidence or gave it a hard look, as we say, under administrative procedure law. I think that what they did was engaged in a decision that reflects a lot of bias against vaccines, and in particular against COVID vaccines. And so I don't think they considered a lot of the access issues in the United States for vaccines. I think that by overturning the recommendation, they really did not consider the fact that a lot of people might not have access because of the issues that I just described, and they also really ran roughshod over a lot of processes and procedures that are normally undertaken. As the ACIP applies its evidence-to-recommendation framework, as it really goes through the process of discussing, considering the evidence in order to formulate its recommendations, which the director of the CDC, and ultimately, the secretary, have the authority to reject or approve. But none of that process happened in this case.

Medical Economics: The complaint describes some of the recent actions surrounding members of the ACIP. Can you talk about some of their deliberations? Are the members going to get a chance to advise the secretary on the directive?

Richard H. Hughes IV, JD, MPH: They will likely move on to other vaccines that I believe will become a target of the secretary and the new committee. Will they continue to revise COVID recommendations in the future? I could see that as a possibility, but I think they have their sights set on other specific vaccines at this time.

Medical Economics: Can you name names?

Richard H. Hughes IV, JD, MPH: Sure. I mean, obviously, at the last meeting, they voted to no longer recommend thimerosal-containing flu vaccines, which was a vaccine containing the preservative thimerosal so that multidose vials could remain shelf-stable. They looked at the measles-mumps-rubella and varicella combination vaccine, basically revisiting evidence that was looked at 15 years ago by the ACIP in considering the safety of those combination vaccines. I think that what we're going to see, and what's really been indicated, directly by the chair of the ACIP, but also by the secretary, is that they will wholesale evaluate, reevaluate, the childhood immunization schedule.

Medical Economics: At the courthouse door, so to speak, what has to happen next?

Richard H. Hughes IV, JD, MPH: We are requesting a preliminary hearing for a preliminary and consolidated with so what we hope for is a hearing within the next few weeks, and then potentially a decision by mid-September.

Medical Economics: Do you think that court action can take place quickly enough to make a difference in the upcoming respiratory illness and flu season?

Richard H. Hughes IV, JD, MPH: That remains to be seen. The season tends to run, you know, hit or miss, through early spring. And so I think that there certainly is some time.

Medical Economics: Our main audience is primary care physicians. What would you like to say to them? Or what would you like to them to know, either in general or about the case specifically?

Richard H. Hughes IV, JD, MPH: It's important more than ever that, because of the state of affairs that we're in, that we double down on professional society guidelines and talking with patients about what's in those guidelines, why vaccines are important, and, really clarifying that there is a lot of misinformation and disinformation out there, and that there's an effort that we're undertaking to really put a stop to this. That's what our lawsuit is about.