The Ethical Dilemma Confronting ACIP

Commentary

In one his first post-confirmation actions as secretary of Health and Human Services, Robert F. Kennedy Jr. fired the whole of the Advisory Committee on Immunization Practices, or ACIP. In doing so, he cited the existing committee members’ stated and unstated conflicts of interest with the industry they were tasked with judging. He replaced them with known experts on the safety and efficacy profiles of vaccines.

Their first meeting in June addressed the monoclonal antibody shot for babies for RSV, a generally very mild illness. The CDC committee that serves up data and testing results to ACIP told the committee that the shot had passed all relevant tests with no significant safety signals.

The ACIP committee had precious little time to examine the studies but defaulted to approval. Two of the seven members had doubts, which they expressed during the meeting. They voted no. Later research by independent observers discovered grave faults in the data reporting and study design. One member wrote that he regretted going along with the CDC’s recommendations and would no longer trust by default in the future.

More committee members are now being added to ACIP in preparation for its next meeting in mid-September. There is already a hew and cry that the new members are not already in the pocket of industry.

Keep in mind that this committee does not approve or disapprove drugs. That is the role of the FDA. Nor does it impose shots on anyone. It votes either to approve or disapprove the inclusion of products on recommendations promulgated by the CDC. Whether and to what extent these products are imposed on children or adults is a matter of state law. The states have a huge variety of laws concerning immunization.

The Florida surgeon general just announced that the state plans to no longer force shots on anyone. In this decision, it joins many nations of the world that refuse to mandate any vaccines or injections. These include the UK, Sweden, Mexico, and another dozen or so nations. In the past, there has been no serious difference in vaccine uptake between countries with mandates and countries without. That may change following the COVID-19 experience but there is no sense in which Florida has departed from the consensus of nations in allowing medical freedom.

On the other hand, five states in the United States have disallowed even religious exemptions. A child whose parents have doubts about inoculations cannot attend public or even private schools in those states. They face barriers everywhere they turn, all the way through college and professional life. Very few people are willing to put up with this, and so they give in. Most other states permit various exemptions which have to be approved by the authorities.

The system by which the public accepts or rejects vaccines is hugely complicated, stretching over several agencies, many committees and study groups, and falling to states to accept or reject. ACIP is only one part of this system, but it is an important part. It provides the layer of independent scientific approval to the shot regime. It has no final power, but it has serious influence. If ACIP votes to reject a shot or study, the burden falls to the CDC to overrule the committee. It certainly can, but nothing like that has ever happened before.

Kennedy recently came into conflict with the head of the CDC, Susan Monarez, over a number of matters. Reportedly, one of them was whether she was willing to defer to ACIP’s judgment on matters of science. She apparently said no, she would go with what the industry and the CDC had to say and reject what ACIP had to say. He pressed the issue on her personal integrity and willingness to say what’s true, to follow the evidence regardless.

“Are you trustworthy?” Robert F. Kennedy Jr. asked of CDC director Susan Monarez.

“No,” he reported her as answering.

That’s when he fired her.

She might have a different story, I do not know, and we’ll all hear her version in time. That said, there is no question that the CDC is a deeply troubled agency. By making very small changes in the childhood schedule, Kennedy seems to have summoned the wrath of the pharmaceutical industry, arguably the world’s most powerful industrial lobby. It had reliably influenced the decisions of the CDC until Kennedy came along, and now its members are very upset.

ACIP is on the front lines of this battle because it is made up of the academics, medical doctors, and scientists who are there to ratify the scientific legitimacy of the entire vaccine project. In the past, there had never been a question that they would do so. They had a rubber stamp and used it in every meeting.

Now it is a different matter. Members are pushing back, asking questions, going over studies with a fine-toothed comb, and looking at all the data with fresh eyes.

ACIP faces the challenge of judging the science on its merits. That is no small task. This requires a critical eye and a high degree of specialization in quantitative specifics, including statistical modeling and drug-test protocols. Not everyone is up to the task, especially when the judgment contradicts the industry. The industry obviously knows this game far better than any outsider, so it usually wins the fights.

ACIP deals with two additional ethical considerations. Their decisions can result in approving shots against the wishes of parents and against the wishes of other adults. In effect, millions of people will have these shots forced on them. If there are safety signals in the data, even small ones, ACIP bears some degree of moral culpability for the results.

These committee members must be willing to look parents in the eye and say, “Your child’s sacrifice is worth it for the immunization status of the whole.” Can they do that? Should they?

That’s a difficult calculation to make and not one that we would usually say is consistent with the idea of human rights and freedom. The U.S. Bill of Rights and the U.S. Constitution do not have scientific utilitarianism as the foundation of their philosophical justification.

There is an additional problem. Since 1986, the industry has been indemnified against liability for harms imposed by its products. Pharma obtained this special liability shield when it argued that the costs of litigation were growing so high that vaccines might not be available because the companies will be sued out of existence.

As a result of this decision, an entire industry of shot makers faces no consequences for damage to lives that are brought about by the forced injection of healthy babies even if the results of doing so are injury and death. No one pays any sort of price for being wrong.

ACIP is a scientific committee. Members can console themselves that their only job is to judge the quality of the studies and the results obtained in the data. They can imagine that they are not preachers and moralists and therefore should not bear any approbation for merely making a scientific judgment as befits the task at hand.

That said, they are also human beings. They are aware that a vote of yes of any drug destined for the routine schedule will see that drug forced on people against their will. They must also be aware that for many of these products, the industry bears absolutely no financial risk for being wrong even when its products result in injury and death, as they certainly do.

Sizing all of this up—and I’m certainly not a moral philosopher and am not in a position to say this with certainty—it strikes me that ACIP cannot really do a purely scientific job until 1) all vaccine mandates through the entire country are repealed, and 2) the industry is stripped of its liability shield. Only then can its approvals be regarded as disconnected from the ethical concerns that come from forced injury with no accountability. In other words, under these conditions, I don’t see how any member of ACIP can morally vote to approve anything at all.

No drug and certainly no vaccine is 100 percent effective and 100 percent safe. Not even the industry can deny that statement. Given that reality and given the possibility that someone—and it could only be one person—could be injured by the shots made by an industry that bears zero accountability, they surely must vote no on every product that comes before them.

Even if the science is not always clear, under present conditions, the ethical obligations of these committee members do seem clear. The ethical calculation only changes when every individual and family obtains full choice to accept or reject and the industry bears the financial liability for damage to health and life resulting from these products.

Views expressed in this article are the opinions of the author and do not necessarily reflect the views of The Epoch Times.