When it comes to adverse-event reports (AERs), what constitutes too much public information?
When it comes to adverse-event reports (AERs), what constitutes too much public information? That’s the question now facing the U.S. Supreme Court. In a class-action lawsuit, plaintiffs are arguing that investors should be notified whenever any AER, serious or not, arises over a company’s product. Their reasoning: one AER could predict a larger problem to come that could subsequently devalue stocks.
The case, Matrixx Initiatives Inc. v. James Siracusano and NECA-IBEW Pension Fund, centers on Zicam, the zinc nasal spray that FDA ended up recalling after receiving numerous AERs. Shareholders blame Matrixx, the marketer of Zicam, for not alerting them from the time Matrixx received the first AER about the product so that they could in turn make investment decisions. The case has made its way to the Supreme Court after the U.S. Ninth Circuit Court of Appeals decided that all AERs should be disclosed to shareholders, negating previous rulings that only significant AERs should be reported.
Although this case involves reporting safety issues, it is primarily about money. Shareholders believe that if they receive information about every AER filed, they can make an informed decision on whether or not to keep investing in a company. But can shareholders really make sense of the vast number of AERs that flood the market each year?
This year alone, FDA expects to receive more than 600,000 AERs, serious or nonserious, from consumers. This fact was pointed out by the Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association, who together in August filed an amicus curiae to the Supreme Court on the matter. (The Natural Products Association has also submitted an amicus brief.)
Moreover, the associations point out, AERs are a tricky thing and do not alone determine whether there is a definitive causal relationship between a product and a negative health effect. Numerous other factors can come into play. Was the person following the recommended dosing instructions? Did the person have any preexisting conditions that could instead have caused the AER? Was the person taking any other types of medication or supplements that instead could have caused the AER? The variables are immense, and I don’t believe shareholders, let alone a small-time investor, could make sense of all these variables effectively enough. Without someone to exert some kind of judgment about whether an AER or a collection of AERs is significant or not, it will be information soup.
More importantly, however, consumers will bear the brunt of this confusion as AER reports make their way to the media. “And what you’re doing is inundating consumers with too much information,” says Steve Mister, president and CEO of CRN.
Consumers will likely be confused as to whether or not a product really does pose a health hazard. “We don’t want to create a consumer who is overly anxious about all of these products simply because there has been a single AER report,” says Mister. Worse, consumers could stop taking a medicine or supplement that may actually benefit them. Or, if overwhelmed by piecemeal information, consumers may start to tune out AER news and one day overlook an AER that should be heeded.
I side with the associations on this one. As a journalist and editor, my job is to weed through the flood of information our magazine receives and present only the pertinent data to readers in a way that is easy to understand. I think we can all agree that no one wants to wade through my e-mail in-box.
There’s good information, bad information, and just too much information. Obviously, we only want one kind of information-the kind we can truly use.
Jennifer Kwok, Editor