Thanks to Dr. David Schwartz for the pointer to a story, by a Bloomberg, Reuters health reporter, on a JAMA online-first article on drug “side effects.” See David Schwartz, “Lack of compliance on ADR Reporting: Some serious drug side effects not told to FDA within 15 days” (July 29, 2015).
The reporter, Lisa Rapaport, wrote about an in-press article in JAMA Internal Medicine, about delays in drug company mandatory reporting. Lisa Rapaport, “Some serious drug side effects not told to FDA within 15 days,” (July 27, 2015). The article that gave rise to this media coverage, however, was not about side effects, or direct effects, for that matter; it was about adverse events. See Paul Ma, Iván Marinovic, and Pinar Karaca-Mandic, “Drug Manufacturers’ Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food and Drug Administration,” JAMA Intern. Med. (published online July 27, 2015) (doi:10.1001/jamainternmed.2015.3565).
The word “effect[s]” occurs 10 times in Rapaport’s news item; and yet, that word does not appear at all in the JAMA article, except in a footnote that points to a popular media article. And Reuters is the source of the footnoted popular media article.[1] Apparently, Reuter’s reporters are unaware of the difference between an event and an effect. The companies’ delay in reporting apparently made up 10% of all adverse event reports, but spinning the story as though it were about adverse effects makes the story seem more important and the delays more nefarious.
Why would a reporter covering a medical journal article not be familiar with the basic terminology and concepts at issue? The FDA’s description of its adverse event system makes clear that adverse events have nothing to do with “effects.” The governing regulations for post-marketing reporting of adverse drug experiences are even more clear that adverse events or experiences are not admissions or conclusions of causality. 21 C.F.R. 314.80(a), (k). See also ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R1) (10 June 1996).
Perhaps this is an issue with which Sense about Science USA can help? Located in the brain basket of America – Brooklyn, NY – Sense about Science is:
“a non-profit, non-partisan American branch of the British charitable trust, Sense About Science, which was founded in 2003 and which grew to play a pivotal role in promoting scientific understanding and defending scientific integrity in the UK and Europe.”
One of the organization’s activities is offering media help in understanding scientific and statistical issues. Let’s hope that they take the help being offered.
[1] S. Heavey, “FDA warns Pfizer for not reporting side effects” (June 10, 2010).
