Medtronic is being scrutinized by the FDA for failing to report serious adverse events found during clinical studies of their Infuse bone graft product. Papers written by physicians and researchers based on the clinical work are alleged to have downplayed the seriousness of certain problems such as painful bone overgrowth or didn't attribute the problems to the Infuse product. This is an important issue for many reasons but mostly (IMHO) because surgeons and patients base their decisions on the procedures to use based on these research papers.
These are situations where we believe that studying patient experience data can help identify problems with products that are missed, misreported or even just unexpected.
As far as the Infuse bone graft, patient experiences would have identified problems sooner. In fact, the are patient reports of pain, overgrowth, throat swelling, difficulty breathing, and repeat surgeries that patients attribute to Infuse as far back as 2003. And their stories continue through today.
The type of technology we use to study patients experiences surrounding product safety and efficacy did not exist until 2008. However now we believe that there is no reason for companies not to study real-world and large-scale patient experiences to see how their products are performing. Not only is this the responsible thing to do for patients, it really is a way for the industry to protect its business. Medtronic has been embroiled in lawsuits over Infuse since 2008. It looks like the lawsuits will continue and will cost them millions. It's a shame because perhaps if Medtronic knew more about what patients knew, they might have been able to avoid lawsuits as well as what could result in the FDA rescinding of approval of Infuse. In March 2011, the FDA failed to approve Amplify, their latest bone graft product, without more data. So the stakes are high.
As I post this, the CEO of Medtronic is trying to diffuse the problem in the media. If Medtronic had been more in tune with patient experiences, maybe he wouldn't have to be doing that right now.
In the long run, not knowing what problems exist, how widespread they are, and how patients feel about them doesn't seem a wise business move. And it isn't good patient care.
Wool Labs is working to develop Phase IV/V programs to look at safety and efficacy of products through the lens of how patients report performance and experience. We already work with clients as well as publish our own research on how patients discuss their diseases and conditions, medication, and safety and efficacy measures. So the point to this blog is to explore this concept further.
The public may not know exactly how the data has been massaged, but I think there is growing public distrust that scientific research is tainted. AE reports are suppressed by excluding certain trial results and other acts of data shaping. The backlash can be an effective (but risky) device or drug being pulled from the market because of bad reporting. Open source data aggregation of the sort that Wool Labs does is a win/win. It fuels a more realistic risk benefit discussion with one's physician and better decision making.
ReplyDeleteUnfortunately, I would agree about the distrust that the public is feeling. We see it in our data. The distrust seems to stem, at least in part, from stories like this that highlight where a company is not on top of their own data.
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