In a rather typically under-informed and over-reactive chase for a cheap headline, the media, in this case CBS news, has uncovered something of a tired scoop with its headline position which is that “A new Consumer Reports investigation shows artificial hips and some other medical devices are rarely rigorously tested to make sure they’re safe.”
In what looks like a deliberately naive stance the US news channel appears to have picked up a single clinician, a single victim and a consumer rights campaigning group, joined the dots and come up with a scathing report on the medical devices industry and its regulators. The theme for the piece is that devices apparently do not undergo rigorous testing prior to being cleared for sale. Indeed this is put forward as the reason why so many devices fail, not least the metal-on-metal hip debacle reported so feverishly, including on our own pages, over the last weeks and months.
“There is a consistent pattern of failure in medical devices,” said Dr. Steven Nissen, of the Cleveland Clinic. He co-authored a separate report that found more than 2,800 people died in 2006 because of faulty devices.
“I think people make the assumption that when their doctor implants a device, whether it be an artificial joint or a pacemaker, that it’s undergone very rigorous testing,” Nissen said. “That assumption isn’t always true.”
Well, actually it is true. The issue is this. Unlike a car, which can be occupied by a dummy and driven into a wall under highly controlled conditions, medical device testing can only go so far down this route, for several reasons. Firstly the car is designed to do one thing and the test designed to establish its safety when encountering one of a small set of eventualities which might be encountered when doing that thing.
Contrastingly, medical devices are incredibly varied and often incredibly complex. It’s virtually impossible to simulate every bad thing that might happen, which leaves us relying on benchtop testing to define physical parameters such as strength, resilience or a thousand other things. Beyond that we rely on experience of other devices and draw conclusions, which have to be supported.
So if a device is to be marketed even under the predicacy rules, it has automatically gone through two phases of what we could call “testing”… firstly the bench to ensure it’s strong enough and lasts long enough, then the risk analysis bit based on how well it can be shown it will perform compared with a device that’s already out there. Remember this only pertains to lower risk devices which are approved through the 510(k) route. Even then many such devices, where equivalence is not proven to FDA’s satisfaction using the tests described, will require a clinical study to support them. Devices considered higher risk will go through the higher level of premarket approval (PMA) which will definitely require a clinical study.
What’s gone on here, very unfortunately for the victims of failing hips, is that a device considered low risk has been deemed to be of benefit for American patients so has got to market without clinical testing. Subsequent problems have appeared, which have made us all wonder whether the regulatory regime should have been more rigorous. One might argue that clinical studies would have given the products a green light long before any problems were evident, but the fact remains that this horrendous situation might have been avoided with more stringent testing.
So is medtech staffed by greedy idiots chasing a quick buck?
The all-metal hip disaster shouldn’t tar the entire medtech industry and its regulators with the brush that the CBS article appears to be applying. Adopting a sensationalist stance is not very helpful, because it drives regulators into their most defensive postures and may well end up stifling technological innovation in the quest for 100% perfect devices, which is a pot of gold we’ll likely never find.
What’s far more interesting a debate is not the device per se, but the bloke on the end of it. That has to be part of the issue here. When Dr Nissen’s report identifies 2800 people who died because of “faulty devices” in 2006, does his report really mean devices that failed or clinicians who failed to use them correctly or other factors. All-metal hips are not all failing. Remember the design objective, which was to provide a hip that lasted longer, not shorter, than those currently available? Well, guess what, many such hips are doing just that with often outstanding performance. Not to suggest that they only go wrong when put in incorrectly, but surgical technique is almost certainly a factor in a proportion of cases, yet the clinician is never the target of media ire. Companies and regulators are much softer targets.
So let’s look at a few more excerpts from the piece
Quotes from the piece are in inverted commas.
“The artificial hips, all metal, have a high failure rate, and metals from the implants can seep into the bloodstream. That’s linked to an increased cancer risk, problems with eyesight and hearing, and other complications.”
More media misinformation? These risks are far from proven, to the extent that peddling this stuff is doing nobody any favours.
“And it’s not just hips that are failing. According to the investigation by Consumer Reports, “most medical implants have never been tested for safety.”
It’s a question of reasonableness rather than exhaustiveness isn’t it? Taking the EU’s less rigorous requirements as a stake-in-the-ground, we could provide a list of devices from which EU patients are benefitting, yet which remain unapproved in USA. Can it honestly be said that the risk of allowing products onto the market too easily is worse than the risk to patients of not having access to new technologies? Even adopting our most balanced and even-handed posture we cannot believe that companies put products out there (and FDA lets them) that are knowingly risky. Yet nothing’s perfect, which all points to closer post-marketing surveillance as the key to the ideal scenario. It would get products out there with the most appropriate regulatory control we can currently think of, yet address the problem of the “things we hadn’t anticipated” as soon as practically and pragmatically possible.
“So why would the FDA not want this testing done? Metcalf (from Consumer Reports) said it goes back to a loophole. “If you are a medical device manufacturer and you can prove that your device is sorta, kinda similar to a device that was sold earlier you can get it grandfathered in without any clinical testing and device companies have very smart lawyers and regulatory people who help them do that.”
No, not sorta, kinda similar, but similar enough in key performance parameters that proof of equivalence to another approved device is deemed adequate.
“In a statement to CBS News, DePuy says, “Dozens of tests and studies relating to the design, materials, and performance of components” of their recalled hips “were conducted” and point out the hips were “cleared for marketing by the FDA.”
Hmm. Probably not a good strategy to hide behind FDA approval. Sounds a bit like you slid something you knew was not quite right under the door while they weren’t paying attention. That said, FDA is known the world over for being among the toughest regulatory nuts to crack, so the fact that they allowed the DePuy ASR hip onto the market must again point to the fact that even they considered it safe.
“But that’s little comfort to Sagalow. She’s one of hundreds of patients suing the manufacturer. “I’m finding out now that these things that they put into me weren’t even tested,” Sagalow said. “And they’re in my body. It’s really quite upsetting.”
For heaven’s sake, will somebody take Ms Sagalow into a medical device company for a week and show her the hoops these people have to go through?
The Food and Drug Administration did not respond to a CBS News request for comment, and we don’t really blame them, because any opinion they proferred would end up as a damning soundbite.
It (FDA) told Consumer Reports that the current regulations have “served American patients well” and that “as a responsible guardian of public health, the FDA believes it’s a challenge to eliminate a program without having a better alternative.”
Source: CBS News, here. Medlatest staff