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People from Vermont to South Carolina felt yesterday afternoon’s 5.8 magnitude earthquake. We look briefly at what caused the seismic event … then we turn to the ongoing problems with metal hip replacements. Since January, the Food and Drug Administration has received more than 5000 complaints about failed hips. For some patients, hips have broken down and released tiny metal particles into their bodies. Last year, the FDA recalled one type of metal hip and required manufacturers to study the effects on patients. A look at the growing number of complaints over hip replacements and what patients should know.
- Diana Zuckerman president of the National Research Center for Women and Families.
- David Applegate senior science adviser for earthquake and geologic hazards at the U.S. Geological Survey.
- Dr. Craig Thomas orthopaedic surgeon at Rankin Orthopaedic and Sport Medicine Center.
- Dr. Josh Jacobs second vice president of the American Academy of Orthopaedic Surgeons; professor and chair of the orthopaedic surgery department at Rush University Medical Center in Chicago.
- Barry Meier staff reporter for The New York Times and author of "Pain Killer: A 'Wonder' Drug's Trail of Addiction and Death."
MS. DIANE REHMThanks for joining us. I'm Diane Rehm. A magnitude-5.8 earthquake shook the East Coast yesterday. It disrupted life from Vermont to South Carolina. The epicenter was in Mineral, Va. Here in Washington, D.C., schools are closed. The National Cathedral suffered damage, and cracks spread across the top of the Washington Monument.
MS. DIANE REHMJoining me for the first portion of our program to discuss yesterday's seismic event is David Applegate. He's associate director for natural hazards at the U.S. Geological Survey. The lines are open now. If you'd like to ask a question or make a comment, join us on 800-433-8850. Good morning to you, sir. Thanks for being here.
MR. DAVID APPLEGATEGood morning. It's a pleasure.
REHMI know that, relatively speaking, this seems minor considering, certainly, what happened in Japan, considering what happened in California. But the -- how unusual is this for the East Coast?
APPLEGATEWell, I think the significance of this earthquake, fortunately, as you said, doesn't come from the fatalities associated with it as with so many damaging events that we have that make the news. But this is an event that was felt probably by more people than an earthquake's ever been felt in U.S. history simply because these earthquakes in the Central and Eastern U.S., they're in parts of the crust that were far away from where most earthquakes occur.
APPLEGATEAbout 90 percent of the earthquakes occur on the plate boundaries where Earth's tectonic plates are colliding, the -- of course, the San Andreas Fault, Alaska, even the Caribbean. But 10 percent do happen in these inter-plate areas, but the crust here is more stable. It's older. It's colder. It rings like a bell. And so even a -- what's a moderate earthquake will be felt by a -- truly an extraordinary number of people.
REHMSo why didn't we see lots of damage?
APPLEGATEWell, I think the key is that it was a moderate-sized earthquake. The magnitude 5.8, we are seeing damage in the area, in the epicentral area. But it was in a fairly rural zone. You know, compare that with the earthquake -- it was only a magnitude 6.1 that struck in Christchurch, New Zealand, last -- earlier this year. And that was right under an area with a lot of vulnerable housing. And we certainly have that in the East. This is the big concern.
APPLEGATEYes. They're less frequent, but we have all of those, you know, 19th century brick buildings, unreinforced. They're not designed to withstand earthquake shaking. Fortunately, what we saw in this one was a lot of bricks coming down. We were fortunate there were not more injuries than there were. But we weren't seeing the kind of collapses we would see in a bigger event.
REHMI must say I'm sure everybody is going to have a story of where they were or what they were doing. I happened to be in an elevator going up to the 14th floor of my building. The elevator began to shake and then stopped at the 10th floor. Thank goodness it did not stop between floors. And then my husband and I got off. In a few moments, the elevators began working again.
REHMMy question to you -- because we've talked a great deal on this program about hydraulic fracking wherein water is injected along with chemicals into shale in order to release gas. To what extent do you believe that hydraulic fracking could have played a role in this particular earthquake?
APPLEGATEWell, for this particular earthquake, we're not aware of any specific activity in that area that would likely have been a trigger. But we have seen association elsewhere.
APPLEGATEFor example, in Arkansas, we've had quite a swarm of earthquakes in this past year that folks at the Arkansas Geological Survey have been working on the linkage not to the fracking itself, where in a sense you're trying to find places where the rock is not broken up. And you're breaking it up, so you can generate lots of little earthquakes.
APPLEGATEBut you don't have the kind of big structures or faults that would normally be a conduit that you would have used normally. But you're doing wastewater injection then, very high-pressure injection back into the ground. And there has -- there have been -- well, there are a number of famous cases of linkage there.
APPLEGATEProbably the most famous was the Rocky Mountain Arsenal out near Denver, back in the '60s, where they were doing high-pressure injection and managed to generate over a magnitude 5 earthquakes. I think the key thing here is, as this becomes a more common practice, is recognizing that people will be feeling earthquakes in places they're not used to.
REHMBut should that be regarded as a natural event, an aftermath of this kind of fracking? Or should the industry itself take more care in terms of moving forward as quickly as it has, knowing that these earthquakes could, by virtue of being small to begin with, become something that erupts along the whole East Coast?
APPLEGATEWell, that's the big concern, for example, in Arkansas where they're seeing a magnitude 4 and, I think, up close to 5 events. What they're wondering is, yeah, how big can they get? And, of course, that links to -- the size of the earthquake links to the size of the faults. You want to know what is the structure there that's available. This is something that now, I think, EPA is paying a lot of attention to. We've had briefings with them and others.
APPLEGATEAnd one of the key points is that, before a lot of these operations get going, there's going to be a real need for baseline data. You know, there are not a lot seismic instruments in the Central and Eastern U.S. We can monitor the larger earthquakes, of course, but you want to really understand what's already going on in the earth.
APPLEGATEAnd because there are certainly lots of places where there have been injection wells, and, you know, nothing's happened because there isn't a structure available. They're not lubricating an existing fault. So it's not that they're really creating brand-new, giant faults. But one thing we found in research is that most of the earth's crust is stressed.
APPLEGATESo, in other words, it's already kind of under pressure and, therefore, doesn't take a lot necessarily to trigger additional earthquakes.
REHMAll right. We're going to open the phones and take a call from Jonathan in Fairfax, Va. Good morning, Jonathan. You're on the air.
JONATHANGood morning. Thank you for taking my call.
JONATHANI was just wondering if you and the guest could comment on how building structure and building codes differ between the East and the West Coast. I mean, the West Coast seems pretty used to these sort of things. And I didn't know if older buildings here would exacerbate potential problems and how these things differ, you know, regionally.
APPLEGATESure thing. I'm happy to address that. In fact, my agency, the U.S. Geological Survey, were part of a four-agency effort called the National Earthquake Hazard Reduction Program. And, really, the heart of that is taking what we know about earthquake hazards. And earthquakes really are a national hazard. We have 39 states with moderate or greater hazard.
APPLEGATETaking that and translating that into building codes, so that the model building codes that are largely adopted by state and local government have those seismic provisions, but it is a mixed bag. Particularly in areas where earthquakes are less frequent, there's a tendency to sort of downplay that hazard or not necessarily adopt those seismic provisions. So the bottom line with building codes, of course, is they're not retroactive.
APPLEGATESo our biggest concern in areas of, say, the Central U.S., the Eastern U.S., where we have historical earthquakes, you know, cities like New York, Boston and, of course, the Central U.S.
APPLEGATEWe're just coming up on the bicentennial of the magnitude-7, 1811-1812 earthquakes. There's a lot of older buildings that have never been designed to a code. They're old brick buildings. They're not designed, you know, -- out west, there's a lot of wood construction. It can ride out earthquakes better. That's the biggest concern.
REHMAll right. Thanks for your call, Jonathan. To Mike in Tulsa, Okla. Good morning to you.
MIKEGood morning. I guess you've already answered -- sort of answered my question by mentioning the earthquake in Arkansas. But here in Oklahoma, we've had many more than usual, although they've been small earthquakes in Central Oklahoma. And I just wondered if these earthquakes and the earthquake yesterday indicates something unusual happening. And should we expect more?
APPLEGATEWell, we've worked with folks at the Oklahoma Geological Survey to deploy additional instruments in the area where there has been, as you said, this sort of additional sort of earthquake -- small earthquake swarms to try to do the sleuthing that is needed, looking at, is this simply a natural phenomenon that's going on? Is it potentially linked to human activity that may be sort of tipping the scales over to these additional events?
APPLEGATESo that work is underway. And we're hoping to, both there and in Arkansas, to really be able to nail that down, cause and effect.
REHMAll right. And I hope that answers it, Mike. I guess he's gone. Do you, at this point, David Applegate, expect that the East Coast, the middle of the country and the West Coast are going to see more and more of these occurrences?
APPLEGATEWell, the earthquakes are absolutely inevitable. We know it, from the historical record, that we've had these events. There's no particular indication that we're seeing any acceleration, you know, in the frequency of them. But what we are seeing is more people and more stuff that are in harm's way, urban areas that are at risk to earthquakes.
APPLEGATEAnd one of the key issues for us is to be able to improve our monitoring, to improve our understanding of the hazards so that people can live in buildings that are going to be able to withstand those earthquakes.
REHMDavid Applegate of the U.S. Geologic Survey, thank you so much for joining us this morning.
APPLEGATEThank you for having me.
REHMAnd we'll take a short break.
REHMAnd thanks for joining us. I'm Diane Rehm. More than 250,000 hip replacement procedures are performed in the U.S. every single year. Up until recently, surgeons used metal-on-metal hips in about one-third of those procedures. But some of them have begun to fail.
REHMJoining me to talk about the growing safety concerns over hip replacements: Dr. Craig Thomas -- he's an orthopedic surgeon -- Diana Zuckerman, president of the National Research Center for Women & Families, and Dr. Josh Jacobs of the American Academy of Orthopaedic Surgeons. We seem to be having a little difficulty with our phones.
REHMWe hope that those will get back on track very shortly because we are looking forward as well to talking with New York Times reporter Barry Meier. 800-433-8850 is the number to call. You can also send us an email to firstname.lastname@example.org. Join us on Facebook or Twitter. Good morning to all of you.
DR. CRAIG THOMASGood morning.
MS. DIANA ZUCKERMANGood morning.
DR. JOSH JACOBSGood morning.
REHMThank you for being here. Dr. Jacobs, tell us about the metal hips that were taken off the market last year and why.
JACOBSSo it's important to emphasize the fact that metal-on-metal total hip replacements is only one option for total hip replacements. As you said, at the -- kind of the peak of its utilization, it was up to a third.
JACOBSBut that utilization has gone down. In a direct answer to your question, one particular device was recalled by the manufacturer last year because of high failure rates recorded largely from registry data, including data from the United Kingdom.
REHMWhen you talk about failure rates, what does that mean?
JACOBSOne of the best ways to determine the failure rate is the number of procedures that have to be redone or revised. So that's a hard number. And so we commonly talk about survivorships, that is, the percentage of implants that continue to function with time. The averse of that is -- would be considered the failure rate.
REHMCan you explain why the failures?
JACOBSTotal hip replacements of any type -- metal-on-metal or some of the other combinations, metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic -- can fail for a variety of reasons. Some of the most common reasons include loosening, where there's not a good bonding between the implant and the bone.
JACOBSAnother reason is infection, where a microorganism gets in the joint and causes swelling and pain and can cause loosening the implant as well. Other reasons for failure can include fracture, and then other soft tissue problems around the hip.
JACOBSIn the case of metal-on-metal, another mode of failure that has been described, which seems to be more common in metal-on-metal devices, has to do with a local tissue reaction, what we call an adverse local tissue reaction to some of the debris that is coming off of the implant.
REHMDebris coming off the implant. Explain that.
JACOBSSo it turns out that all total joint replacements -- whether they're metal-on-metal, metal-on-polyethylene, ceramic-on-ceramic -- do release a small amount or a finite amount of debris.
JACOBSAnd the debris can be in the form of very small particles. They're less than a millimeter. They can be half a millimeter in the case of polyethylene. In the case of metal debris, they can be 10 times smaller than that. So this is an inevitable consequence of having an implant. If the amount of debris released is excessive, however, it can cause a local tissue response that can lead to pain. It can lead to loosening, and it can actually lead to bone loss.
REHMDr. Josh Jacobs, he is the vice president of the American Academy of Orthopaedic Surgeons. He is professor and chair of the orthopedic surgery department at Rush University Medical Center in Chicago. Turning to you, Diana Zuckerman, you had a hip replacement a year ago. You decided not to have metal-on-metal replacement. Tell us why.
ZUCKERMANI should start by saying that I studied medical devices for the last 20 years. So, as part of my job, I've been looking at what are the standards that are used to decide whether a medical device is safe and effective, including hips and knees. So when I needed to get one a year ago, I was trying my best to find out everything I could about, you know, what does the research show about these different kinds of hip replacements.
ZUCKERMANAnd what was shocking to me was that there was almost no published research in the medical literatures. But when I looked around, I did see that there were concerns about metal-on-metal implants already, a year ago. And I had also looked at other studies, many years ago, 10 or more years ago, looking at what's called debris wear, metal debris, and other kinds of debris.
ZUCKERMANSo we already knew -- we've known for many years that when there's a joint replacement, there's friction. And so the little pieces are going to -- microscopic little pieces are going to wear off. And when that gets into the body, it can cause inflammation and irritation and even more serious problems. So I decided that was not something that I wanted to try.
REHMSo what did you do?
ZUCKERMANSo I ended up with the polyethylene and metal. And that's kind of the old traditional way, but the polyethylene has changed over the years. We hope it's stronger and better than it used to be. But we don't know for sure because, for all of these hip replacements, there's almost no research because research isn't required on human beings before it can be sold in this country.
REHMAnd you've heard Diana Zuckerman. She is president of the National Research Center for Women & Families. Joining us now is New York Times reporter Barry Meier. Good morning, Barry.
MR. BARRY MEIERGood morning, Diane.
REHMSince January, I know that the FDA has received more than 5,000 reports of problems with metal-on-metal hips. Tells us what's happening.
MEIERWell, I think, you know, sort of the big picture view here is that we've got a slowly or fastly (sic) evolving medical device disaster unfolding in front of us in real time. You've got hundreds of thousands of patients who received these devices in recent years.
MEIERNow, we're starting to see thousands and thousands of reports of problems with these devices, people who are being required to undergo second surgeries a year or two after going through a painful first surgery and rehabilitation, and most struggling because of the medical -- metal debris problem. Scientists really don't know where this is going to go. I mean, we do know that most people won't be affected.
MEIERBut a substantial percentage, you know, anywhere from 4 to 8 percent, may be affected by tissue damage caused by this metallic debris. And the sad consequence is is that, when folks like this who have been badly affected get their hips replaced or get their replacements replaced, they're no longer as good as they were the first or second time around.
MEIERThere is damage that takes place that surgeons really can't repair in putting in these additional replacements.
REHMWhen you talk about getting replacements for replacements, what you're referring to, I gather, is the fact that younger and younger people, especially athletes, perhaps -- but baby boomers are having these hips replaced at younger ages.
MEIERYes, both that, but also folks who are in their 50s and their 60s, whose longevity is going to require them to receive more than one replacement. Typically, an artificial hip, a good one will last 15 to 20 years.
MEIERSo if you get your first one at 55, you are going to need another one, hopefully, as you age. So this problem is spread out across both middle age people who are getting these hips and older people who are getting these hips.
MEIERAnd for someone who is 70 and is getting an artificial hip for the first time, then suddenly discovers that two or three years later they need another one, these are not -- these are somewhat traumatic operations in the sense that they do take long -- longer recovery time. And as you get older, you're not -- you don't rebound as easily from these operations.
REHMBarry Meier, he's a reporter for The New York Times. He has been writing about these metal-on-metal hip replacements. Turning to you, Dr. Craig Thomas, as an orthopedic surgeon at the Rankin Orthopedic and Sport Medicine Center here in Washington, D.C., tell us why you continue to use metal-on-metal replacements.
THOMASSure. First, I'd like to point out that it -- we have to be very cautious in lumping metal-on-metal hip surgery into one big category. There are many different manufacturers with metal-on-metal. And, particularly, my experience was one that -- a device that was approved in the United States in 2006. And the FDA actually looked at an enormous amount of data that was provided by the maker of that device from the United Kingdom.
THOMASAnd even that particular device, which is a metal-on-metal bearing, at 20 years, has a 95 percent survival rate, which is significant. So there are many different types of articular bearings for hip replacements. You have to make a shared decision with the patient as to which one is best for them. There are risks and benefits associated with every device that we use.
THOMASWe have than informed discussion with the patient. And then together, we make a decision on what would be the best bearing service for them, given all the data that we currently have.
REHMBut given the reporting that has been done to the FDA, for example, about metal debris lodging in tissues, or even metal being released into the bloodstream, why would anyone continue to use metal-on-metal hip replacements?
THOMASWell, there -- again, we are -- and Dr. Jacobs will speak more on this in reference to the academy's efforts to survey those problems. We are -- one, we are aware, it's safety first. But when you're talking about cobalt, cobalt is actually in vitamin B12. And so the -- we are not specifically knowledgeable of certain effects that would be caused by metal ions, in terms of -- on a large-scale basis.
THOMASFor example, more than 25 percent of my practice, in terms of hips, is metal-on-metal bearings. And I was one of the first surgeons in 2006 to put in a metal-on-metal bearing replacement. And I don't have any patients that have had any symptoms, signs of metal toxicity. And that's -- you know, it's so significant.
REHMI'm glad to hear that. Dr. Craig Thomas is an orthopedic surgeon here in Washington, D.C. And you're listening to "The Diane Rehm Show." Barry Meier, if you or a member of your family were going to have a hip replacement, would you choose metal-on-metal because of, say, security? Would you choose another material?
MEIERThere's no question. For myself, I would choose metal on -- the advanced plastics that are now available. With respect to what Dr. Thomas said, just to parse it a little bit, he is well aware, or at least I hope he is well aware, that is a -- there is only a very specific group of patients whom doctors are now recommending that these devices be put into, that is typically men, 55 years and under and who are of larger stature.
MEIERThat then seems to be the standard that's been adopted all over the world, in places where even the types of devices that Dr. Thomas is using are popular. So the unfortunate experience has been, while some of these devices do work better than others, doctors have and may, in fact, continually -- continue to be putting them into patient candidates who are not appropriate for these devices: women, shorter people, older people.
MEIERAnd I know of many doctors who still use these devices. But they've narrowed their practice to what is really a tiny cohort of patients in whom these devices seem to be working well.
REHMDiana Zuckerman, when you had the initial hip replacement, did you have the metal-on-metal?
REHMIt's all right. It's all right.
ZUCKERMANI'm sorry. No. I -- my one hip replacement was metal-on-polyethylene, which is plastic. And let me just say, it was a terrible surgery. A lot of people undergo it. And for those of us who were healthy before and never have had problems before, it's -- you know, you're in the hospital for a few days. You're in horrible pain. You're not allowed to drive for a month, so that means, for most of us, we can't go to work.
ZUCKERMANActually, I was pretty much unable to do much of anything for a couple of weeks because of all the painkiller. It made me really out of it. And so the thought of having to go through this again any time soon is extremely distressing. And if my hip were to be recalled and I would have to do that in a couple of years, you know, it would really be terrible.
ZUCKERMANSo my goal in choosing a hip replacement was to look for something that I thought would last at least 15 to 20 years in the hope I'd only need one more additional surgery for the rest of my life. But there really are not the data out there that allow anyone, whether a doctor or -- my training's in epidemiology -- an epidemiologist or, you know, any patient to figure out what is likely to be best for them.
ZUCKERMANYou would hope that there'd be -- you know, this hip lasts an average of 15 years, and this one lasts an average of 10 years, so I'll take the one that lasts 15 years. But there just isn't that kind of information.
REHMDr. Jacobs, I want to ask you about Barry Meier's statements that metal-on-metal has been used in men of large stature, 55 and under. Has it been used in women as well?
JACOBSAnd the one thing, for context, to understand is that, overwhelmingly, total hip replacement has been a very successful procedure. And prior to the availability of total hip replacement, which really has only been done since the 1960s, individuals with end-stage arthritis in their hip would live in crippling pain. And they'd be extremely disabled.
JACOBSAnd so the vast majority of the patients that myself and Dr. Thomas see that have had a hip replacement are extremely grateful because it tremendously improves the quality of their life. And, even to this day, the vast majority of patients that have total hip replacements have those kind of results.
JACOBSWhat Mr. Meier was referring to was the fact that there is a lot of registry data that shows that that is the optimal patient population, that is, young, large males seem to do best with that procedure.
REHMDr. Josh Jacobs of Rush University Medical Center in Chicago. When we come back, we'll open the phones.
REHMAnd we are back, talking about hip replacements. We have two orthopedic surgeons here in the studio: Dr. Craig Thomas and Dr. Josh Jacobs, Diana Zuckerman of the National Research Center for Women and Families, and by phone, Barry Meier, reporter for The New York Times. Barry, before we go to the phones, I want to ask you about the FDA, what it has done and how the FDA is regulating and approving medical devices.
MEIERWell, currently, they're still taking a somewhat laissez faire approach to the approval of devices, like orthopedic hips and knees. The manufacturers just have to show that their devices are similar in design to devices that are already on the market. A recent report by the Institute of Medicine, one of the nation's most prestigious scientific organizations, basically declared this system a catastrophe and urged the FDA to dismantle it, redo it.
MEIERThe big problem here, Diane, is that there are no testing of these devices in patients before they go on the market. And there's no follow-up surveillance to patients who receive these devices after they go on the market. And neither lawmakers, nor regulators, nor professional organizations, like those that Dr. Thomas and Dr. Jacobs belong to, have urged the FDA or have lobbied the FDA to quickly sort the systems in place.
REHMDr. Jacobs, wouldn't you think that it might make sense to have not only testing beforehand but follow-up afterwards?
JACOBSWell, yes. And contrary to what Mr. Meier said, the American Academy of Orthopaedic Surgeons and other organizations are extremely interested in so-called post-market surveillance and follow-up. In fact, there's a tremendous body of research on the outcomes of total joint replacement that hasn't been referred to before that helps surgeons and then their patients make decisions.
JACOBSThe American Academy of Orthopaedic Surgeons has been instrumental in founding the American Joint Replacement Registry, specifically for the purpose of tracking implants, which will allow us to identify performance of implants early on, give us real time data so that we can identify an underperforming implant.
JACOBSThis is -- can be based on models in countries that have extremely effective registries, such as Sweden, Australia and United Kingdom. So our organization is actively lobbying and working towards establishing an independent not-for-profit American Joint Replacement Registry to specifically address the outcomes of total joint replacements and to improve the patient outcomes and the survivorships.
REHMI want to take a caller in Williamsburg, Va. Good morning, Ricky. You're on the air.
RICKYThank you for taking my call. My concern about any discussion of knees and hips must include the revelation by doctors of how much they are getting from the manufacturers of the devices for using them. Around here, we just call it a kickback. And, to me, I'd like to know the relationship between failures of products and the amount of money that's going to doctors directly.
REHMDiana, you're particularly concerned about this as well?
ZUCKERMANYes, I am. And as part of the health care reform legislation that passed, now, companies need to -- at least in the future -- will need to disclose the financial relationships they have with physicians. At the time that I had my surgery, that was not an option for me. But now, I'm able to look back, and I'm happy to say my surgeon did not get any money from the company that made my hip implant.
ZUCKERMANBut I did see some of the other doctors who I -- other surgeons that I interviewed, who I considered using, one of whom had more than a million dollars from one of the manufacturers. So I'm not saying that these financial ties always are bad. But I am saying that, as a patient, I would prefer my physician not be taking money from the company whose product he's putting in my body.
ZUCKERMANIt would make me feel better to know that he's looking at peer-reviewed independent research, not research that's been funded by the company.
REHMAnd Dr. Jacobs, I know you're a consultant for Zimmer, Johnson & Johnson, Medtronics and Implant Protection. Does -- I know that you receive research funding from those organizations. Does that, in any way, affect your thinking as to what kind of instrument should be placed in an individual?
JACOBSSo, yes, I do have those relationships with companies. And what I would say, and to make your listeners aware, is that relationships between companies and orthopedic surgeons are absolutely essential in order to have the most effective and safest products and bring them to market. You cannot design a surgical implant and not have a surgeon at the table saying what works and what doesn't work.
JACOBSFurthermore, to -- for outcome studies, so that the manufacturers know how their implants are performing, they have to work with surgeons who are working with the patients and following the patients to get the clinical results. So the vast, vast majority of relationships between orthopedic surgeons and industry are legal and ethical -- they're not kickbacks as the caller has suggested -- and, right now, that we are ethically obligated as orthopedic surgeons to reveal and disclose to our patients any sort of relationship we may have.
JACOBSAnd we're free to discuss that with our patients if they have any concerns.
REHMBarry Meier, do you want to comment?
MEIERAll I'd like to say is that, you know, a -- there are many surgeons in this country, like Dr. Jacobs who I have spoken to over the years, who I would not be concerned that they're receiving money from companies because they are extremely ethical.
MEIERThey're interested in patient safety, and they make independent decisions. Unfortunately, there's still probably a cohort of doctors in this country who receive money from companies who tend to follow the leader. And until there is independent data about the performance of these products -- I know Dr. Jacobs said his group is trying to start that kind of process now. Unfortunately, it's about 20 years after they first started trying to do it.
MEIERBut until that type of information is available, neither doctors nor patients will be able to make independent, fact-based decisions about which devices work best.
REHMSo, Dr. Jacobs, are surgeons tracking what happens after patients have hip replacements on a large scale?
JACOBSThat -- there are many centers, clinical research centers, joint replacement centers that have registries. Also, there are regional registries that are tracking the outcomes of patients. It would be best, obviously, if we had a national registry, so we can capture all the patients. But even before the national registry is set up, there's a lot we can learn from these follow-up studies done by these centers.
JACOBSAnd it does help inform us, in terms of patient selection and also implant selection for patients. So there is a large body of research that we work with. The real challenge in our field is we're looking for 15-, 20-year results, as was mentioned. And it's simply not practical to carry out a 15- or 20-year research study. It can't be done.
JACOBSSo we have to do it in real time and do our clinical studies in three -- two years, three-year increments to try to predict what's going to happen long term. So it's a challenge when we're looking at a field like total joint replacement. We're trying to guarantee long-term results.
ZUCKERMANI'd like to go back to what Barry Meier said, which is that we have a system in place at the FDA, where they don't require clinical trials before a product is approved if it's a hip replacement.
ZUCKERMANAnd one of the problems is, by the time you might find research published, a lot of the times that research is on a type of hip implant that's no longer being used or no longer being used in this country. That's actually what I found, that there were some data, but it was not for hip replacements that my surgeons were even considering.
ZUCKERMANSo you have a whole system in place that doesn't require studies in humans prior to approval. And then you have a system, as Dr. Jacobs says, that makes it difficult to do the studies, long-term studies, afterwards. That's -- really shouldn't be acceptable, I think.
REHMAll right. To Richmond, Va., good morning, Johnny.
JOHNNYOh, yes. Thank you for taking my call.
JOHNNYI understand -- this question is for Dr. Thomas -- understand one of the concerns with metal-on-metal surfaces is they typically do not put them in women of childbearing age or younger female patients. And I'm just trying to understand the rationalizations with this. And if you're not going to do that, why would you put it in anyone else if you're kind of thinking there is an issue?
JOHNNYAnd then, secondly, to Dr. Thomas, if you are putting it in still, are you choosing to put it in patients of childbearing age? And what's your rationalization for that?
THOMASOkay. Good questions. Women of childbearing age, we know from studies that the metal ions can cross the placenta. We don't know if that causes any problems at all. But because we know that it can cross the placenta, the recommendation is for any woman of childbearing age not to use a metal-metal implant. Number one, so, no, I do not recommend nor do I perform metal-to-metal implants in women of childbearing age.
THOMASThe second question was in reference to -- was it women older than 50, 55 or -- repeat your second question.
JOHNNYNo. I guess my second question was, you know, if you're kind of addressing that there is ion release that can cross the placenta, you're essentially addressing that there is a potential issue with ion release. And why would you still put it in other patients not being -- I mean, even male patients, not knowing in the long term what those ions can really do?
THOMASSo when you go back to total hip replacements as a whole, there are different type of bearing surfaces, ceramic-on-ceramic, metal-on-poly, metal-to-metal. And each one of those bearing surfaces has some wear debris, some wear particles of their own, of their own nature. And there are potentials for, let's say, complications with any procedure that you do. They're very small.
THOMASAgain, this is an extremely successful surgery, and it changes people's lives. And so, again, you go to a shared decision-making. So you and I will sit down, and we would talk about what is best for you. And you make the decision. One of the good things about doing what I do...
REHMBut how can you make the decision? I -- as a patient, I don't know all the facts unless -- unlike Diana and have done this kind of research, it seems to me that Johnny's question is a very good one. And perhaps, Barry, you can address this. If we know that ion particles cross the placenta, does that not indicate that these ions could cross any boundary whatsoever, even in non-pregnant women or indeed men?
MEIERLet me just start with this simple statement and reiterate what Dr. Jacobs said and what Dr. Thomas said. Hip replacement is traditionally an extraordinary successful procedure.
MEIERThe tragedy is that an extraordinarily successful procedure was diminished by devices that weren't adequately tested. So now we have thousands of patients whose first hip should be functioning extraordinarily well who will be put through the agony of receiving another replacement. That's for starters. Secondly, in terms of the ion release, we don't know a lot about it.
MEIERAnd I would suspect, and I would hope that, Dr. Thomas sits down with his patients and explains to them whatever data he's aware of about ion releases in patients of differing ages, the potential health effects that might accrue from that, what's known about the long-term health effects of ion releases and then says to them, here's your choice.
MEIERYou know, this resurfacing hip that I use may make your performance as a runner, as a jogger, as a skier better than a traditional hip. Here's the downside, about what we don't know about ion release. That's the basis on which a patient should be given to make a decision.
ZUCKERMANYes. And I would just like to say that I'm glad I had my surgery. I'm -- I can run up and down stairs now. I couldn't do that just before my surgery. I just don't want to have to go through this again in two years or three years or five years. So I'm not saying -- I'm not putting down the surgery. I'm saying, isn't it important to get a hip implant that is as safe as possible and lasts as long as possible?
ZUCKERMANAnd why take a chance on something that can really harm you and need to be taken out sooner?
REHMSo, Dr. Jacobs, let's put you in the patient's chair. What questions do you ask your surgeon, your doctor before you undergo hip replacement surgery?
JACOBSThat's a good question. And I would add, as an orthopedic surgeon, I've been watching Diana walk, and you're walking very, very well. So we got a really good result. I'm very happy to see that. I agree with what Dr. Thomas said, is that the decision to have a joint replacement is a big one. It is a major surgery, and there has to be a shared decision-making process.
JACOBSAnd we understand that the patient doesn't have the level of education of the orthopedic surgeon who's aware of all of the nuances in the devices that are chosen. So I think the patient should ask the surgeon which bearing surface to use and why. Certainly, the patient should ask what their particular experiences with the devices that they've chosen.
JACOBSIt's a reasonable question to ask the surgeon how often he does the procedure, what's been his experience, and also to get a sense of what his post-operative rehabilitation protocol is. I think it's important, as Mr. Meier said, is that a very frank discussion is had about the risks and benefits of any hip replacement, and they exist, no matter what the pairing combination is.
REHMWell -- but it seems to me that with all the information that the FDA is now beginning to release about this metal-on-metal operations, that you have to, as a surgeon, talk about those and say, these are the downsides. There have been reports of serious problems. And you, as a potential patient, need to know the downsides of this kind of surgery, as well as what we can do to make you better.
REHMI want to thank you all so much for being with us, Barry Meier of The New York Times, Dr. Josh Jacobs, Dr. Craig Thomas, both orthopedic surgeons, Diana Zuckerman of the Research Center for Women and Families. Thanks for listening, all. I'm Diane Rehm.
ANNOUNCER"The Diane Rehm Show" is produced by Sandra Pinkard, Nancy Robertson, Susan Nabors, Denise Couture, Monique Nazareth, Sarah Ashworth, Lisa Dunn and Nikki Jecks. The engineer is Tobey Schreiner. A.C. Valdez answers the phones. Visit drshow.org for audio archives, transcripts, podcasts and CD sales. Call 202-885-1200 for more information.
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