FDA Booster Decision Disappoints all Sides

The FDA ruling regarding the Pfizer booster shot may have not been completely in-line with the Health Ministry's recommendation, but the open and transparent decision-making processes employed by the American agency holds important lessons for Israel

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The recent discussion at the US Food and Drug Administration (FDA) of the proposal to provide a third booster vaccination in the United States was fraught with drama and tension. Pfizer wanted an approval; the US government wanted to begin a vaccination drive; and of course here in Israel, there was a desire for retroactive confirmation of the decision to launch an extensive booster vaccination campaign. In this sense, the decision eventually taken—to recommend giving the booster only to groups at high risk of severe illness and to people over the age of 65—was a disappointment for all three parties. But the enviable transparency of the decision-making process in the U. S. focuses our attention not only on the decision itself, but also on the discussion that led up to it. Welcome to the age of decision-making via videoconferencing.

The first thing that stood out was that even in this age of machine learning, when it comes to making important decisions, there is no substitute for a group of people coming together to review the data, consider alternatives, and choose one of them. There is still no magical technological machine that can do this for us, and having a single leader making decisions on his or her own has been tried on both sides of the Atlantic in recent years, without much success. That said, simply gathering a group of intelligent people in a room does not guarantee that the decisions taken will be good ones. For this to happen, what is needed is a discussion that is open, creative, evidence-based, and relevant to the problem at hand, and that leads to a decision that is understood both by the participants and by those outside the room.

Discussions of the type held by the FDA reflect three main challenges. The first relates to the familiar problems inherent in discussions: Unsuitable people being invited to take part, such as “public representatives” chosen by lottery rather than on the basis of their value to the discussion; and of course, faulty management of the discussion itself, including an inappropriate sequence of speakers, and failure to adhere to schedule. The FDA discussion was ostensibly being managed, but its format did not encourage active engagement of the participants. Most of them recited pre-written speeches, and each addressed a different topic: Does the drop in the level of antibodies necessarily require providing a third vaccination? Is the decline in protection common across all age groups? Does it represent reduced effectiveness against hospitalization and serious illness, or against infection? When the speakers were asked questions, there was no active moderator to say to them: please relate to the question that was asked.

The second challenge stems from the special nature of decision-making discussions. This relates to the ability to define the available alternatives, the parameters to be considered in choosing among them, and the relative weight of each. At the FDA, however, over the eight hours of discussion, no brainstorming took place. . The two questions finally presented for the participants to decide on were prepared in advance, included only a small segment of the relevant possible alternatives, and did not reflect any new knowledge that might have emerged during the discussion itself.

The third challenge, that of conducting discussions remotely, is one that has become common since the outbreak of the pandemic. The FDA meeting demonstrates that it is possible to hold highly significant discussions with global implications, via videoconferencing. This might seem less natural, but under the current circumstances there would have been no way to hold a discussion among participants from different places in the same room in such a timeframe. From a technical standpoint, however, the result was embarrassing: a messy screen, poor video and audio quality, internet glitches, and presentations that looked like they came from the 1990s.

Thus, the FDA discussion surfaces the need to create a new field of knowledge in which technology will play a central role-decision-making via video conference. This does not refer simply to the “technical” tools designed to facilitate convenient, reliable, and secure communication, but rather to a fundamental revolution in how discussions are conducted and decisions made, in ways that are not possible in physical meeting rooms. Some of the necessary technological tools already exist, while others will need to be developed, but together, they will upgrade the ability of individuals and groups to understand real-world circumstances and make decisions: They will enhance creativity, promote a "cocktail " of ideas, remove interfering factors, identify alternatives, define the considerations behind these alternatives, and use data in an informed way, making it possible to confirm or refute them. Such tools will help forge better public policy while also contributing to better decision-making in the business sector. Whether discussions are transparent to the public or not, the combination of people and technology should be used to overhaul this arena.

Dr. Tehilla Shwartz Altshuler is a senior fellow at the Israel Democracy Institute.

Brigadier General (res.) Itai Brun is the deputy director for research and analysis at the Institute for National Security Studies (INSS).

The article was published in the Jerusalem Post.