In a brief to the court, PhRMA (the US pharmaceutical trade association) said "A collection of adverse event reports that is not statistically significant does not permit a reasonable inference that a particular medicine actually caused the reported adverse event" (the brief is attached to the post cited above).
But what is "statistically significant?" According to PhRMA, "The statistical significance standard requires disclosure only once a correlation between an adverse event and the subject product can be reasonably inferred to be causal. It is only at that point that a manufacturer or regulatory body might react to adverse events, that a medicine’s sales would be threatened, and that a rational investor might consider this information in making investment decisions."
"Writing for the unanimous court," NPR reports, "Justice Sonia Sotomayor said that medical researchers and the FDA often reach initial conclusions based on evidence that is not statistically significant."
"The decision will make compliance with the securities laws more difficult" for corporations, said James Martin, who filed a brief in the case on behalf of lawyers who represent corporations.
The decision will also make it more difficult for pharma marketers to engage in the social media realm, where the adverse event boogey man has often been cited as an excuse for not engaging consumers about product issues.
When the adverse event reporting issue comes up during industry conferences such as this week's CBI's iPharmaConnect, there are always pharma people in the audience who wish their companies would embrace adverse event communication with consumers/patients as a way of supporting the users of their products. During my panel discussion -- "Utilization of Social Media -- How Far Is Too Far" -- one pharma employee in the audience had this to say:
"I think as an industry that we should really turn this [social media] adverse reporting [issue] on its head and look on it as an INCREDIBLE opportunity to really engage with the ultimate end user who is really the most important person [my emphasis, I think] and use it as an opportunity to find out WAY more than we ever do about how [our products] really affect their lives. ...I think this [pharma aversion to dealing head-on with AER in social media] is EXACTLY why people don't like the pharma industry -- because we're always doing things that are SO secret -- 'Oh, we can't talk about that.' -- it's ridiculous! We save people's lives and we should be ENCOURAGING [patients] to tell us what's going on and how these medicines are affecting their lives. I just think it's a missed opportunity."Her statements were followed by immediate, spontaneous applause!
We have been told by our pharma marketing colleagues that the fear of lawsuits initiated by patients have prevented them from discussing adverse events in open forums. But it appears that the lawsuits pharma fears the most are NOT from disgruntled patients, but from disgruntled INVESTORS! That fear runs all the way up to the top of the organization; ie, the CEO, who is rewarded based upon stock price performance, not how well the company services patients.
Long gone are the days when a pharma CEO can truthfully say:
"We try to remember that medicine is for the patient. We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they will never fail to appear. The better we have remembered that, the larger they have been." -- George Merck - Founder of Merck & Co Inc.