The story behind the problems with Riata electrophysiology leads made by St. Jude Medical has yet to be fully fleshed out, so it’s only natural that there is still a lot of uncertainty. Here are the top five questions I have.
Five: What is the role of the surgeon?
I have no idea what it takes to implant these things, but I haven’t seen data on lead fractures by center or implanting physician. We know doctors make mistakes, but how will the specialty societies respond if it turns out that skill and experience play a role? Leaving this question entirely to the specialty societies might be asking a bit much.
Four: What is the role of the patient?
I won’t argue it’s all on patient characteristics, but FDA’s Bill Maisel, MD, cites patient anatomy (along with surgeon skill and experience) in an editorial he co-authored in 2008. Maisel offers no details, but Ratika Parkash, MD, of Dalhousie University (Halifax, Canada) noted that “bony anatomy” may be associated with lead failure in a presentation to the 2012 Heart Rhythm Society annual meeting.
Parkash also observed at HRS 2012 that leads implanted in younger patients, more active patients, and patients with more robust ejection fractions may be more susceptible, which she said was the case with the Medtronic Sprint Fidelis.
What are a doctor’s options if the patient’s anatomy suggests a problem? Lead fracture versus sudden cardiac death? That’s a no-brainer, but it’s still not a great predicament.
Three: Which is better; single- or dual-coil leads?
According to Parkash’s data, single-coil leads are slightly less likely to require a revision than dual-coil leads, but Todd Cohen, MD, of Winthrop University Hospital (Mineola, New York), said at HRS 2012 that his data indicated no difference.
There may still be a debate among doctors whether a dual coil lead is necessary – an article in 2001 in EP Europace makes clear there was such a debate 11 years ago – but any such debate will find new life if dual-coil leads really are more susceptible.
Two: Does lead diameter really have anything to do with it?
The numbers I’ve seen are all over the place. Cohen’s presentation at HRS 2012 included the remark that his study indicated “larger diameter leads tended to have better survival,” while Parkash said her data suggest the opposite.
I’ll wait for some sort of consensus statement, but one wonders whether there is some sort of interaction between lead diameter and materials, and between diameter and the single/dual-coil issue. The only reason I omit materials as a separate point is that there seems to be a consensus on little more than that silicone is out.
One: What about the role of bench and animal testing?
This could be sub-titled “the question of predictive science.” Do anatomical issues ever force a surgeon to insert a lead in such a way as to leave the lead kinked? That might be tough to replicate in the testing lab (and surgeon skill may be a factor in this scenario). Perhaps real-world use subjects a lead to torque that is difficult to replicate.
Does pre-clinical testing need beefing up? It’s tough to say because nobody talks about it, including FDA. I’m trying to line up an interview with the agency on this subject, and readers of Medical Device Daily should soon have a clearer picture of how pre-clinical testing has changed over the past decade or so.
There’s more to this than can be covered here, but one or more of these five factors may prove decisive in the Riata saga. Which will prove most decisive? Only time will tell.
A patient lies tethered to a hospital bed with sensors and wires taking readings. Their mobility is severely limited and, on top of that, healthcare professionals have to be in a position where they can maneuver through these wires to treat the patient. This is a scenario that plays out in many hospitals throughout the country.
But that could change if the Federal Communications Commission (FCC) approves a measure that would expand the spectrum capacity for Medical Body Area Networks (MBAN), or wireless patient monitoring systems that use low-cost wearable sensors and allow clinicians to remotely monitor vital signs of patients. If the spectrum is increased, then this would give companies like GE and Philips Healthcare the greenlight to work on a variety of MBAN devices.
Some industry insiders have told Medical Device Daily that they expect the FCC will approve this measure, even Julius Genachowski FCC chairman indicated that he thought agency would vote in favor of expanding the MBAN frequency.
When this happens, the confusing ball of wires that we see patients trapped underneath probably won’t immediately go away, but in time we’ll start to see a transition. With that transition we will see more ease of use, less clutter in hospitals and better service.
As these changes occur, members of the med-tech industry said healthcare professionals will be able to identify patients earlier, whose conditions are deteriorating, and intervene in a more timely fashion. As these sensors become available they can become embedded in homes and long-term care facilities, which will give unprecedented monitoring for patients.
I consider myself an omnivore, but I never much cared for the taste of crow. All the same, it seems there’s some bird meat on the menu thanks to a blog I posted last year about the problems Medtronic was having with Infuse. On the other hand, I’m not alone. The U.S. Dept. of Justice has a heaping helping of the stuff on its hands.
As I wrote last August, Medtronic agreed to pay Yale University $2.5 million to review adverse events connected with Infuse, a bone morphogenic protein product that had become conspicuous for allegations that adverse events were not reliably reported by clinical trialists. Another problem was that a hefty percentage of consulting fees the firm paid in connection with the product were concentrated in what seemed a small number of doctors. That’s probably not unusual, but it looks bad under the modern med-tech microscope. A much bigger problem, however, was that a large majority of the sales volume was reported to be for off-label use.
The problem hurt Medtronic somewhat financially, including that it lost an $85 million shareholder lawsuit, but its market cap of roughly $39 billion meant the lawsuit was a bigger problem as a distraction than as a subtraction. How much the combination of lawsuit and DoJ investigation affected share prices is tough to say because the story played out over four years, but it couldn’t have come at a lousier time for anyone with a 401(k) invested in MDT.
In all fairness to my posting in 2011, I didn’t say this would kill the company or the product, and I didn’t say Medtronic was guilty of anything pernicious. What I said was the predicament suggested the need for more caution where off-label use is concerned. And I’d maintain that if more than half your sales are for off-label use … well, to use a simile the lead-footed among us can appreciate, that’s like driving a red sports car in a town where the budget is also in the red and the police are bored. You just know you’re going to get pulled over.
Now, let’s talk about Johnny Law (a.k.a. DoJ). After four years of this, that and the other thing, DoJ now says it has closed the investigation. What does the department have to show for all this? Nothing. Zip. Squadoosh. No charges and no fines. Color me cynical, but I doubt we’ll hear attorney general Eric Holder say “oops!” or “hey, real sorry about that! Still buddies, right?”
Government never makes amends when it botches things horribly, which it does with the kind of reliability that makes Old Faithful seem like just another geyser. Still, one assumes shareholders might be hacked off at DoJ’s attorneys, whose fishing expedition could not have helped anyone’s retirement plan.
I’m not arguing in favor of being able to sue government, but sometimes it seems immunity gives government attorneys too long a leash. At any rate, score one for Medtronic, and here’s to playing blogger and legal beagle. These jobs actually do put food on the table, although there’s no accounting for how appetizing that food might be.
When my Great-Grandfather became too elderly to care for himself I watched my grandmother take him in and care for him. When that same grandmother became elderly herself, I watched my aunt take her in and care for her. And someday it will be my turn to care for one of my elderly parents (please God, just don’t let it be my mother-in-law).
But what if we had robots to take care of our elderly parents for us, or at least fill in during the day while we’re at work? An emerging robotics company in Houston is actually exploring that possibility. Quantum International says advanced personal assistance robots could someday help elderly and chronically ill patients lead more independent and productive lives.
The company reported this week that robotics developers in the U.S. are already testing new home-care robots designed to reduce stress on families and other caregivers with assisting seniors and others requiring day-to-day care.
The robots, according to Quantum, can carry third-party sensors for monitoring blood pressure, pulse, oxygen and more, allowing human nurses and other care providers to devote more time to more demanding tasks. Apparently, these bots have been well received by both caregivers and receivers.
But why stop at assisting the elderly and chronically ill? I’m sure plenty of new parents would love to have a robot nanny to help with diaper changes and midnight bottle feedings. And while we’re at it, I’d love to have one that could help me around the house - laundry, dishes, window cleaning, and if it’s not too much to ask can it make dinner too?
As a member of the media, I’m not exactly unaware of the pitfalls of my profession but it might be time to take a look at some of the coverage of proton beam therapy in recent months.
Frankly, most of the mainstream media coverage failed to paint a complete picture and in the process trampled on vital details. On the other hand, some hospitals perhaps could use a lesson in basic economics because you don’t have to install a $300 million cyclotron facility to get protons in your hospital or clinic.
Click here for an example of mainstream media coverage that utterly fails to note the availability of systems that ring in at less than $100 million. Harold Brubaker’s April 29 piece mentions systems coming in for more than $300 million. He’s not alone in that omission, however.
So what’s the problem?
Hospitals in a hurry to spend more?
The problem for hospitals is that they’re dashing off to find the nearest provider of proton beam capability, for one thing. The other problem is that Brubaker doesn’t bother to put enough work into his trade to discuss the availability of much less expensive hardware that requires a much smaller footprint than the traditional cyclotron set-up.
For instance, as I wrote in the April 11 edition of Medical Device Daily, the Radiance 330, made by Protom, can be installed for roughly $50 million. Hospital administrators who feel that’s too much might consider waiting a couple of years to see if the dielectric wall accelerator under development by Compact Particle Accelerator gets through development and an FDA scrub-down. This approach might require a generator of about 15 feet in its longest dimension, and the firm projects a total cost – infrastructure included – of something in the neighborhood of $30 million.
Nearly fired for misbehaving, Levy mouths off
Here’s an example of the worst possible coverage. One article quoted Paul Levy, formerly the president of Beth Israel Deaconess Medical Center, as saying the success of proton beam therapy was simple. “The easiest group to market to in the country is a group of men worrying about the functioning of their penis,” Levy said, according to a March 26 Bloomberg story.
I dare Levy to make a similarly cavalier remark about any part of a woman’s anatomy, especially since he nearly lost his job at Deaconess in 2010 because of an inappropriate relationship with a woman who worked for him. Massachusetts’ attorney general Martha Coakley is quoted as having said that Levy’s relationship with the woman “clearly endangered the reputation of the institution and its management.” He resigned a year later.
Leave it to the mainstream press to quote someone with that much irony-laden baggage.
I know I’m horribly geeky about some things, and I’m especially geeky about things I don’t understand at all, such as protons. But I do understand two things. One is that $30 million is a lot less loot than $300 million – even the kid who throws cereal at Jimmy Fallon knows that – and the other is that if you’re too lazy to tell more than half the story, you really are not very good at what you’re paid to do.
The demise of the Global Harmonization Task Force as a regulator-plus-industry forum for harmonization – or “convergence,” as the cautiously optimistic like to say – was met with little more than silence from the trade associations, but one can be sure the off-the-record discussions were intense. Now with the International Medical Device Regulators Forum coming together, the time has come to ask what the future of international medical device regulation holds.
First let’s examine the obvious. The chatter about demonstrations of efficacy as a requirement for a CE mark has been going on for some time, and the flap over breast implants made by Poly Implant Prosthèse has generated quite a bit of support for tighter scrutiny of devices in Europe. The problems with metal-on-metal hip implants and electrophysiology leads have pushed this agenda, too.
One should bear in mind that elected officials have large patella tendons where such things are concerned, especially when the mainstream media coverage prompts calls from constituents. That has been true in the U.S. for decades and one suspects it is becoming more the case in Europe as well.
European Parliament getting nervous
Don’t believe me? Take a look at the recent vote by a committee of the European Parliament asking the European Commission to perform a more drastic recast of the Medical Device Directives than might have been planned. The Parliament’s April 26 statement includes the request that the Commission impose a system featuring “more stringent checks and product traceability” as well as “a pre-market authorization system” more robust than that in place now.
The statement also notes that the PIP predicament “has shown a malfunctioning at European and national levels, notably a lack of cooperation . . . and a lack of traceability of raw material used for medical devices.” The statement asserts further that the widely reported problems with metal-on-metal hip implants has demonstrated “a failure of the current system of certification of compliance . . . as well as of the controls of the notified bodies and their surveillance by national competent authorities.”
One might also bear in mind the lack of reaction to something said by FDA’s Bram Zuckerman, MD, at CRT 2012. He claimed FDA drives most of the literature on cardiovascular devices, explaining that trials for devices “usually are done frankly because there is an FDA” demanding those trials. He also remarked, “I have a hard time finding CE-mark trials in publications of the first order.” Nobody dissented, and there were quite a few people in the room who were in a position to argue if they disagreed.
Gravitas is great; gravity is better
My working hypothesis on this is ably reflected by the notion of a binary star. If you picture FDA’s and the EU’s regulatory paradigms as two stars orbiting each other – one heavier and more stationary, the other lighter and anything but dominant – it’s difficult to avoid the conclusion that FDA is the more massive of the two, with the obvious implications. Prefer a more complex model that incorporates non-EU initiatives? Perhaps you’d find a depiction of a solar system more to your liking, but I’d point out that the most massive object is always at the center.
Of course the details matter, but let’s not be confused about the overall direction. FDA still outweighs everyone else, and will almost always have its way in a close call. If anyone is going to move anyone else out of their spot in the firmament, it’s not the European Commission, Health Canada, China’s State Food and Drug Administration or anyone else. It’s FDA.
An Army wife friend of mine is diabetic and has been taking insulin for eight years. Last fall she and her husband were moved to a new duty station where she was assigned a new primary care manager at a military hospital that shall remain shameless – oops, I mean nameless.
When she tried to order her diabetic supplies, including insulin, a representative of the hospital told her she couldn’t possibly be diabetic because they didn’t have any record of her diabetes. I have experienced similar frustrations with the same military hospital because of my own unusual medical history.
It all comes down to the fact that military families move A LOT. When we move, we change doctors. Not only do we move, but our military doctors get transferred around a lot as well, so we end up seeing a dozen different doctors within a span of six months – no exaggeration. On top of that, we may have a chronic condition that requires us to see one or more specialists outside the military healthcare system. The result is inconsistent and very fragmented healthcare.
Fortunately, Humana Military Healthcare Services has recognized this problem and is trying to create a solution – in the form of a website for Tricare Prime beneficiaries (such as myself) to help manage our chronic care health information, even when we see a civilian doctor. When I learned about this website idea I nearly jumped up and did a jig.
While I don’t expect the MyActiveHealth website to end all of my military healthcare frustrations, I do think this is a huge step in the right direction. The idea is for the website to offer a secure way to store our health information and medical history so that we (hopefully) won’t have to deal with anyone telling us we don’t have a chronic disease simply because it’s not in their records.
Years ago at another publication, one of my former colleagues made one of the greatest rookie mistakes a person could make during their career. He triumphantly displayed how much money he was being paid to several reporters in the newsroom.
The pandemonium was classic. Many marched up to management and demanded salary adjustments, using this poor naïve writer's pay as a "negotiating" ground.
I wonder if something similar to this scenario will play out when the Physican Payment Sunshine Act will go into effect. I realize that med-tech said that it doesn't mind the transparency, but are companies considering the kind of backlash this will have from paid consultants, who now have a sense of what their competitors are getting paid?
I really didn't start thinking about this point until after I had a conversation with Michaeline Daboul president/CEO MMIS, a company that designs systems that enable organizations to manage and exchange data, earlier this month.
"When all this information gets published in a public online database and everybody from pro-publica to individuals start combing through this data, companies are going to have big PR nightmares," Daboul said in an April 15th interview with Medical Device Daily. "They're going to have customers who're going to be upset with them. You're going to have situations where you have customers that say, you didn't tell me you were going to tell the world that you bring us lunch every week."
While it might seem a bit simplistic, these kinds of issues can create a rift between med-tech firms and their clients, Daboul pointed out.
And I agree, whole-heartedly. It's going to be interesting when this hits the fan. But I wonder, med-tech, are you truly ready for total transparency?