KEY TAKEAWAY: Right now, medical devices are less rigorously regulated than drugs: Only 1 percent of medical devices get FDA approval with high-quality clinical trials behind them. Even in these cases, devices typically reach the market based on data from a single small, short-term trial, Redberg wrote in a 2014 editorial in the New England Journal of Medicine, where she called for a sham control study of stents. So what do you do if you’re a stent patient or candidate?
One in 50 stent patients will experience serious complications — such as a heart attack, stroke, bleeding, or even death. So these devices don’t come without risks, and a Lancet paper again suggests they may not be helping patients.
The new Lancet study demonstrates why this kind of investigation is so critical in medicine. “The results of the study clearly show why regulatory agencies, the medical profession, and the public must demand high-quality studies before the approval and adoption of new therapies,” Redberg and Brown wrote in their recent editorial. Right now this isn’t happening. And stents surely aren’t the only device patients may be getting that are more placebo than proven, and have potentially deadly side effects.
Now if you’re a stent patient where do you turn for information to help clarify this information? Should you make an appointment with your cardiologist just to discuss this study? If your doctor has recommended a stent do you follow his advice or ask for a second opinion? This is where online health information has failed most patients.
There is a huge opportunity for doctors and health sites to help clarify the misleading world of online health information, but it has to be done quickly and with transparency, something which pharma and medical device companies usually can’t do.
One of the reasons for the success of social media is that it’s about “now” and instant responses. Patients who want answers to these stories are pretty much left on their own at a time when the debate around fake news is at its peak. Will doctors take the time to help patients understand these stories or will the pubic be left to its own to determine if these stories require a more in depth look?