Consumer stories: Maryann Napoli - Informing Consumers, Negotiating Change

Thanks to a consumer stipend, I had the good fortune to attend my first Colloquium in 2001 in Lyons, France.  There was so much new information to absorb, not the least of which was how the Collaboration worked and how to understand Cochranespeak.  I happened into an ongoing workshop in time to hear something shocking and entirely new to me.  The speaker was reporting his review of drug trials and how common it is for the serious adverse events (SAE) data to be withheld. 

Why hadn’t I heard this before?  I have been a consumer advocate and a medical writer since the mid-1970s. Our mission at the Center for Medical Consumers (my day job) was --- and still is --- informed decision-making.   At the time of that 2001 Colloquium, consumer advocates and medical reporters in the U.S. had begun to expose the conflicts of interest among experts who set drug treatment guidelines, but SAE were barely given any advocacy attention.  After I returned from the Colloquium, I asked all the consumer advocates I knew whether they had ever heard that SAE were either not reported or selectively reported in most randomized, controlled drug trials.  No one had, including the doctors I mentioned it to.

Ever since that first colloquium, I have made a point of looking for the SAE whenever I served as a consumer peer reviewer for a Cochrane drug review.  I was disappointed to find that often they were not even mentioned, or selectively reported without further explanation.  In one review, the authors wrote (in the Discussion) that they had asked for the SAE data from the included trials and had been refused.  I couldn’t understand why such important information was not in the abstract or the plain language summary, which are the only two sections of a Cochrane review that most people will ever read. 

I joined the collaboration to have a larger impact on the public’s understanding of the need for high-quality, evidence-based medical information---that is, a larger impact than I was having as part of a low-budget consumer advocacy organization. It took me nearly two years to figure out how to join the collaboration.

Most consumers in Cochrane are caregivers or they have personal experience with a specific disease, thus they offer their skills to the relevant review groups. But I wanted to peer review on topics consistent with my long-time advocacy which is focused on medical interventions aimed at healthy people, e.g., screening tests, flu vaccines, and drugs to treat risk factors (drugs for bone loss, high cholesterol, etc).  Healthy people have the most to lose when a medical intervention becomes widely accepted before the full story on SAE becomes clear. What review groups should I volunteer for when my central concerns are overdiagnosis and overtreatment?  

Someone like me can now find her way within Cochrane more easily, thanks to the E-discussion list started around 2003 by Janet Wale, then the coordinator of the Cochrane Consumer Network.  Review groups with a final draft of a review but no consumer peer reviewers can send a request to the E-list and interested consumers can respond directly.  At this writing,I am about to start work with a newly formed Cochrane committee that will set new standards for authors of plain language summaries. I'm pretty sure that disclosure of withheld harms data will be on the agenda --- I know it will be on mine.

Maryann Napoli, Associate Director of the Center for Medical Consumers (New York City), is a member of CCNet’s Geographic Advisory Group as well as the US Cochrane Center’s consumer coalition, Consumers United for Evidence-Based Healthcare. A regular Cochrane contributor, she reflects on an opportunity for growth within The Collaboration’s plain language summaries.

Posted as part of the Consumer Network’s focus on Wise Consumer Month.

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