Rick Kingston PharmD, clinical professor of pharmacy at the University of Minnesota, is helping to organize the town hall. The present era is one of looming threats for the dietary supplement industry, said Kingston, who is also the president of regulatory and scientific affairs for the firm SafetyCall International. The activities of the New York Attorney General and other negative press fallout is putting pressure on the industry from a safety and quality perspective, he said. There is no data to conclusively show that these pressures have shown up in the marketplace in the form of depressed sales. But they have energized other law enforcement officials, legislators and have even stoked the fires of plaintiffs’ law firms, he said.
The town hall will be held as part of the annual International Conference on the Science of Botanicals put on by the National Center for Natural Products Research connected with Ole Miss, which is located in Oxford, MS.
Having a town hall type discussion is not one of the normal sessions at the annual conference, Kingston said. The decision to hold such a gathering was motivated by the perception that a team effort was needed to best address the challenges the industry faces in a timely fashion.
“Ole Miss is one of the few academic centers around the world dedicated to natural products research,” Kingston said. “It is therefore well positioned to bring together experts to talk about the issues of the day in the field. We decided to hold a town hall meeting to get the view from manufacturers about what we can do to promote a more encompassing view of product stewardship efforts.”
Kingston said that the well-publicized challenges of the supplement industry over the past couple of years “validates in the minds of some critics the concerns they’ve had about supplement quality and safety in the past. This fuels the perception that all supplements are essentially suspect. One thing I have seen is that there are cases in which the activities of some attorneys general and some of the information about that in the press has been prominently cited in litigation, so a lot of this certainly isn’t lost on the plaintiffs bar,”he said.
Adverse events reports
Another issue that will be addressed in Oxford will be the way in which the Food and Drug Administration has decided to open up the files on adverse event reports. While this was done with the laudable goal of increased transparency in mind, Kingston said it might only serve to muddy the waters. Adverse events, by their nature, are not intended in their raw form to present a coherent picture or to establish causal relationships. Kingston is familiar with the statistical conundrums presented by these sorts of data sets, as he helps companies manage their recall risk among other things. He said the way FDA is pursuing this initiative will serve to send the wrong message, one that could be potentially damaging to the industry.
Kingston said only 1% to 2% of all adverse events reports collected by companies and reported to FDA are associated with actual safety events connected to a supplement. The others represent statistical ‘noise,’ he said. The current situation, opening up all of the files without any statistical qualification–the spurious along with the significant–could be likened to the publication of a roster of all of the men in a given municipality who fit the demographic profile of a sex offender, with one or two actual sex offenders included in that list.
“The average person would not be able to distinguish who is a real person of interest from that list,”Kingston said. “In the same way, with the publication of the adverse events, without any evaluation from FDA, there is a misconception that these reports will send a signal on safety. In this form the data not amenable to that kind of evaluation.”
One aspect of the situation that is of particular concern, Kingston said, is the incentive it could give companies to not report their AERs as they should. Companies might be motivated to just clam up rather than have their name splashed on a wall, figuratively speaking.
“It is making companies a lot more leery about being proactive in providing case reports of suspected adverse events. Our concern is we don’t want to have this transparency piece impact a company’s willingness to share that information,” he said.
For more information on the conference or to register, click here.