How informed are doctors? The answer is not obvious. Doctors know enormous amounts of data and have years of clinical experience. Many have solid science backgrounds and some conduct research keeping them at the top of their field. Most rely on published studies to make their decisions on which products to use.
However, only a small percentage of all published studies are level 1 studies: the studies with data that is reliably true. Very few doctors actually conduct outcome studies on the techniques they use. Only a small number of doctors participate in wide clinical trials or device registries that track the outcomes of implants they use such as artificial joints, vessel stents, meshes for hernias, etc.
In fact, there are no national registries of any orthopedic surgical implant used in America. Shocking? That means that when a doctor implants a total knee or a hip prosthesis, there is no national registry tracking whether or not those implants fail. There isn’t a state or local registry either. There isn’t even a company registry. The only way most doctors know if a device fails is if the patient comes back to them. If the patient moves away or is angry about their outcome, the doctor may never know.
And it is not just implants. There is no registry or required post-market approval (meaning after the FDA gives its initial blessing) for drugs or braces or breathing devices or just about anything doctors place into or on patients. We rely solely on reports to the doctor and then, hopefully, the doctor reporting to the FDA.
Now, it might be argued that the rigorous initial FDA approval process makes all products highly likely to be safe and effective. It’s true that this process is arduous and expensive. So much so that few new products are actually being introduced, which is problematic. The process now is estimated to take an average of 4.5 years for a new device to complete pilot and pivotal clinical phases with average costs of $30 million for low-to-moderate risk devices and a whopping $91 million for higher risk devices. For new drugs, the costs are in the hundreds of millions of dollars.
So what is the solution? How can we get new and improved devices for our patients and find out whether they actually work? The answer lies in a non-intuitive combination of relaxing the rules for approving medical devices while strengthening the requirement to report any problems.
We could start with a new way of approving medical devices. It would go like this: A company completes all the safety testing required and then conducts a phase I clinical trial in a small number of patients required to prove safety, not efficacy. The company is then allowed to release (sell) the product to the public with a strict web reporting program in place so that any complication, no matter how small, is reported by the patient and or the doctor, and each report is public. By crowdsourcing the entire experience, experts from across the globe can comment on the efficacy of the device and problems can be immediately identified. With this system, companies are freed from the burden of decades of expensive studies to prove efficacy in a relatively small clinical trial, they can sell and create revenue immediately, and importantly, doctors and patients will actually know which devices work and which don’t.
By gradually extending this to a comprehensive Web-based national medical products reporting program for devices and treatments currently on the market, we can then collect real time actual information on whether or not they work.
Well-informed doctors could be at hand.
Kevin R. Stone is an orthopedic surgeon and chairman, Stone Research Foundation.