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Making Sense of New Myeloma Treatments During Coronavirus

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Published on May 28, 2020

Key Takeaways

  • Isatuximab has been approved in combination with pomalidomide and dexamethasone for treating relapsed/refractory myeloma.
  • A new delivery system for daratumumab has been approved. It can now be given as a subcutaneous injection, reducing treatment times and healthcare costs.
  • The risk of getting COVID-19 as a viral infection is higher for myeloma patients than the general public. Wear a mask, wash your hands and stay home when possible.

New myeloma medicines are still being approved despite the coronavirus pandemic. How can patients and their doctors safely incorporate new therapies during a time of telemedicine and adjusted treatment schedules?
 
In this episode from our Myeloma Answers Now series, Dr. Saad Usmani from Levine Cancer Institute and leading patient advocate Jack Aiello join host Andrew Schorr to discuss myeloma treatments during the coronavirus. They cover new FDA approvals, COVID-19 safety measures, the reliability of antibody tests and more.

This program is sponsored by Sanofi Genzyme. This organization has no editorial control. Patient Power is solely responsible for program content.

 [Due to extreme load on our website and Zoom platform, viewers may experience a time delay between the audio and video of the interview - please note the transcript can be read below.]

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Transcript | Making Sense of New Myeloma Treatments During Coronavirus

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Recorded on May 14, 2020

Andrew Schorr:
Greetings, and thank you for joining us on this Patient Power Myeloma Answers Now program. I'm Andrew Schorr. Thank you for being with us. It's a kickoff to the whole Myeloma Answers Now series. I want to think our kickoff sponsor, Sanofi Genzyme, for their commitment to the myeloma community.

Let me introduce our guests. First, joining us from San Jose, California, a dear friend who's dealt with myeloma more than two decades, is really leading patient advocate, Jack Aiello. Jack, thanks for joining us once again on Patient Power.

Jack Aiello:
I'm looking forward to it, Andrew.

Andrew Schorr:
Okay. And also joining us now, clear across the country in Charlotte, North Carolina, at the Levine Cancer Institute, is a noted myeloma specialist, that's Dr. Saad Usmani. Dr. Usmani, thank you so much for being with us today.

Dr. Usmani:
Thanks for having me here, Andrew.

Andrew Schorr:
So Dr. Usmani, we've been blessed over the years with an expanding range of treatments for myeloma, so you can personalize care for somebody and where they are in their myeloma journey. And we have injectable therapies, and we have infused therapies, and we have oral therapies. Even with the coronavirus on top of that, and maybe what you're doing at the Levine Cancer Institute, can somebody get perhaps the right combination therapy, or even transplant, whatever is right for them now, and that it's safe?

Dr. Usmani:
I think that's a question that has been asked by patients across the country. And I think that the response that I would give is it's going to be based on geography. In our area, in the Greater Charlotte Area, and the state of North Carolina, we were anticipating a surge of COVID-19 cases in mid-April. And we started to prepare in advance for that. For patients who were receiving an infusion of chemotherapy, we try to modify the protocols to see if we can go from twice a week to once weekly dosing, or every other week dosing. And try to see if we can avoid their coming into the healthcare setting during those two or three weeks where we have expected a higher number of cases. Where possible, we do have an oral proteasome inhibitor ixazomib (Ninlaro).

If someone was on a proteasome inhibitor-based therapy, we start to switch over to an oral medicine in that case. I think we did what we could to make sure that the patients are safe. they stay in a good response, they're getting optimal therapy, and we can control their disease.

When it comes to cellular therapy or transplants, or even CAR T-cell therapies on clinical trials, for the most part, for myeloma and plasma cell disorders, it's probably the stem cell transplants that we give. And we do this for prolonged disease control, since myeloma is still considered a non-curable disease at this point. So, we try to delay the stem cell transplant for the majority of patients during that time. We did go ahead and collect their stem cells, where possible. We did proceed with stem cell transplants for patients who had high-risk disease, and still had considerable residual disease, despite getting adequate infection treatment.

So for those two or three weeks we were more careful. And we had to do that because, you've heard a lot about bending the curve, but the idea of bending the curve is not to avoid all possible new COVID-19 infections, but to ensure that the healthcare system does not get overwhelmed like it did in Italy. Where COVID-19 cases are not just showing up in masses, and you're rationing care, you are unable to care for patients who are super sick in the ICUs. You're unable to provide them with the respirators and adequate ICU care. So I think that that was the idea, that the healthcare system doesn't get overwhelmed. The doors are still open, and we can take care of the COVID-19 patients. Now that we have good PCR testing available in adequate quantities, and all the SOPs in place. Our state, our healthcare system and Levine Cancer Institute, is opening up the new norm. So we are in the re-entry process. We are going to be doing stem cell transplants the way that we were before. We obviously have all the COVID-19-related precautions in place, testing in place, before each of these procedures. So I've given you a very long answer, and tried to cover comprehensively, pick on each of those points. Please feel free to ask me questions and we can take a deeper dive into this.

Andrew Schorr:
Sure, just one follow-up. I was telling Jack before the program, I've been going on some of the Facebook groups, and there are people having transplants. I get immunoglobulin myself. I think, Jack, you were at the clinic at Stanford the other day. And so, in most places, there's a policy that you the cancer patient cannot have a visitor with you, and that's tough, right? But that's the way it is, right?

Dr. Usmani:
Absolutely. I think that was a tough decision to make, but a necessary one to keep everyone safe. There are always workarounds. There's always FaceTime, there are ways in which you can engage family, and I will share a personal experience with you. The first time I was consulting with a young, newly diagnosed myeloma patient, because the virtual platforms were not in place, were over the phone. And it was a very difficult conversation for me, because I like to have a one-on-one with patients. I'm a hugger, I shake hands, I hug my patients. And it was very difficult for me, especially having a conversation with a young patient who's got young kids. You need a very different kind of a connection. And I shared this with the patient over the phone: this is not the ideal situation, but it's necessary to keep you safe. We're trying to minimize your exposure to the healthcare setting. And the same holds true for the visitor issue. I don't see the visitor policy changing as businesses and states open up. Until we start seeing a consistent decrease in the COVID-19 cases, I think we will probably have to take this necessary precaution.

Andrew Schorr:
One last question, then I want to bring Jack into it. So, even after the FDA started having to really focus on improving tests and trials for drugs that might help with COVID-19, there were two approvals in myeloma. One for a new CD38 therapy, and also for a new delivery system of another therapy, daratumumab (Darzalex). So it seems like that's great that the FDA is still thinking about myeloma in the mix. So you have more tools than ever before, right?

Dr. Usmani:
Yes, absolutely. So, the subcutaneous formulation of daratumumab, or Darzalex, has been kind of a baby of mine. So, I started that study as a Phase I, right around the time when the IV daratumumab was approved, back in November of 2015. And that led to the COLUMBA trial that was reported last year, that compared the IV versus the subcutaneous formulation. And the data were actually submitted to FDA last year. But the timing couldn't be better, because as efficacious as the IV formulation of daratumumab is, there are always concerns about the duration of infusion, and the low grade infusion-related reactions that patients do experience. Three out of 10 patients would have that reaction the first time patients are getting it. Even when you employ rapid infusion of daratumumab protocols that some of the larger centers like ours do, it still takes about two, two-and-a-half hours of time of patient's day during that time.

And here you have this subcutaneous formulation that you can give in five minutes. It's safe, infusion related reactions are down to like 12.5 percent. You're saving on time, and kudos to Janssen for pricing the drug similar to the IV formulation as well. So, it's a win-win for patients, healthcare systems, oncology clinics, improves the workflow, and we're really excited about the availability of subcutaneous formulation. And the way that the FDA approved it, approved it for any prior formulations or regimens that IV daratumumab was approved with, except for maybe one or two. And that was just the FDA submission timing issue. But, we're really excited about it. We've been trying to move the subcutaneous formulation through our P&T committee, so that we can get this option for our patients as soon as possible.

Jack Aiello:
I just wanted to follow up on the subcutaenous daratumumab, because you said it also, that it's a five minute shot, and patients are hearing that, and they're thinking that, oh good, I have to go into the clinic, but only for five minutes. I assume there are still, like the infused daratumumab, some premeds and some post evaluations, and lab draws initially, and things like that. So what is practically the time from a patient walking in to get a subcutaneous daratumumab shot, until he's able to walk out?

Dr. Usmani:
So, I would say it's akin to you getting a bortezomib (Velcade) shot as well, as you're starting treatment. So, Velcade shots are supposed to be given between two to three minutes. But mostly, it's a fairly quick infusion, because the volume is about 3 to 5 milliliters. Here, the volume is about 15 milliliters. So, you can certainly give it quickly, but you're probably going to give it somewhere under five minutes. But the rest of the visit would be similar to any other subcutaneous shot—even if you're coming in for denosumab (Xgeva) shots, for example.

So, patients are getting labs—I would suspect the first-time patients are getting the subcutaneous daratumumab, they may be watched for an hour, hour-and-a-half, just to make sure that they are not developing any infusion-related reactions, even though the label may come out with even a broader timeframe, saying watch for three or four hours, whatever. But in our personal experience, we've been giving subcutaneous daratumumab, we haven't seen any grade two or higher IRRs, or any patient requiring hospitalization for any FDA-approved use of the subcutaneous daratumumab.

Jack Aiello:
Do you figure that you're going to switch over the daratumuamb IV folks to the subcuataenous daratumumab when subcutaneous becomes readily available?

Dr. Usmani:
Yes, that's the hope. The big decision, again, this is not my decision, but the decision for any healthcare system is, what's the benefit for going to the subcutaneous formulation. And if it's going to cost a lot, then it's not a healthcare saving in the grand scheme of things. But here I think Janssen has made a good decision. All in all, I think the subcutaneous formulation actually reduces the healthcare cost, because there's less infusion chair time, less nursing care time, and all of that. So all in all, I think it's a win-win.

Andrew Schorr:
Okay. Dr. Usmani, I just alluded to the other approval of, I think the brand name is isatuximab (Sarclisa), but a CD38 antibody, and antibodies have been really basic now to myeloma therapy. So I would imagine that's a welcome addition as well.Dr. Usmani:Yes. So, isatuximab is another anti-CD38 monoclonal antibody currently approved in combination with pomalidomide (Pomalyst) and dexamethasone (Decadron), for relapsed/refractory myeloma. And within that space, within the pomalidomide antibody space, that's the only phase III data that we have right now. And, we do have Phase II data with say daratumumab and pomalidomide/dexamethasone, elotuzumab (Empliciti)/pomalidomide/dexamethasone, but this is the Phase III data that we have. And, it's an effective treatment. And we're excited about having that in our armamentarium as well.Andrew Schorr:People wonder, as a myeloma patient, are they necessarily more at risk of getting the virus? And if they do, are they going to have a rough go of it, and really, will their life be at risk? So what are you telling your patients? I'm sure they ask you every day of the week.

Dr. Usmani:
So, my general answer, I start off by saying that our cumulative global knowledge about this new virus is only seven months or eight months old. This virus surfaced in October of 2019, and we were only getting patchy glimpses of what's going on in Asia. It wasn't until the European colleagues started to report cases, where some of the released data started to come in.

So I reassure patients that, we get you the information as quickly as we can, but myeloma patients in general are at a higher risk of infections, because of being immunocompromised by virtue of having this disease. And then, the treatments that we give for myeloma can also increase that risk as well. So, the risk of getting COVID-19 as a viral infection is higher than the general public for myeloma patients.

And we are seeing conflicting data, with the degree of severity of COVID-19 illness that patients with myeloma and other hematologic malignancies get. And the reason for that is the denominator. The number of people tested compared to the number of people being positive. So we don't have a true measure of—the ideal situation would be test all the myeloma patients, and then take a look at the incidents of infection, see who has got mild symptoms, who's got severe symptoms. But we're seeing small datasets, where some institutions in the New York City area are reporting what they're seeing. It's like a bunch of people with blinds on, and feeling the elephant, and describing the elephant based on what they're feeling. What we need is to remove that blindfold, and take a look at the whole elephant.

And that effort is underway. There are several large registries at the national level, as well as the international level, that are trying to collect this data so that we can provide more comprehensive information to our patients. In the meanwhile, why are we doing all those efforts, knowing that we've only known this virus for about six or seven months only. My advice is, myeloma patients are already geared towards taking care of themselves, and taking a set of precautions to prevent from getting infections. Keep on doing that.

I actually encourage wearing surgical masks. If you have an N95, that's great, use it. But stay indoors, do the social distancing, and do the necessary precautions. Even as things open up, we expect different parts of the country—West Coast, outside of Seattle, has not been hit hard with the virus, but it's coming. I think things are going to move in different parts of the country at a different pace. And we are going to see a rise in cases over the next two or three months.

Andrew Schorr:
Jack, what are burning questions for you?

Jack Aiello:
Well, let's follow up on that area. I've talked to my Stanford doctor, and I've gotten information from UCSF doctors, and asking them how many myeloma patients are they seeing that have gotten COVID, and they're saying zero. And so, I kind of wonder, are you seeing patients at your facility? I've talked with other doctors, and I think you're right. I think it's kind of different in different centers. But it also makes me concerned with the reliability of the testing. One of your peers, Dr. Noopur Raje, and her husband, both got COVID virus, and she took subsequent antibody tests, as did he. And he showed that he's got antibodies, and hers showed that it didn't show any antibodies. So, that's kind of a broad question, but are you seeing myeloma patients with COVID virus, and how do you feel about the reliability of the testing?

Dr. Usmani:
All right. So, when we talk about testing, we have to distinguish what kind of testing. So the PCR testing that we're doing right now to detect the virus is pretty reliable. And that's the test that we're using to diagnose patients. The immunoglobulin testing, the testing that tells us whether someone has had an infection, have recovered from it or not, we do not have reliable testing for those immunoglobulin or antibody testing. So the IgG levels against COVID-19, and IgM levels against COVID-19, both the qualitative and the quantitative. So qualitative meaning just a positive/negative, and quantitative meaning the actual milligrams of immunoglobulin detected for that specific antibody against the virus. Those assays are in development. I myself was tested for one of those antibody tests as a pilot study, so I'm actually a clinical trial participant right now for that assay.

But we will probably have more reliable testing later in the year for that. PCR testing, we can trust that. The tests that Noopur and Jag had, that tells you the non-sensitivity or non-reliability of some of the immunoglobulin qualitative testing that's out there. And there are a lot of companies that are trying to test and validate their assays. So, I take those results with a grain of salt. Even if they told me that I have positive results from an immunoglobulin test in this clinical trial, I don't trust it.

Jack Aiello:
Those companies developing those tests, are they taking patients like myeloma, who have skewed immunoglobulin results anyway, into account?

Dr. Usmani:
They have to. I mean, they have to. They simply have to.

Jack Aiello:
Okay.

Dr. Usmani:
That's another question.

Andrew Schorr:
Oh, go ahead.

Dr. Usmani:
I have to ask them—no, go ahead. Go ahead, Andrew.

Andrew Schorr:
Well, here's what I'm wondering. So, if my IgGs are not great to begin with, and for me as a leukemia patient, they're not, or a myeloma patient. First of all, if a vaccine comes along, is it going to do it for us?

Dr. Usmani:
So, just like the flu vaccine, or the other vaccines that you all receive, the pneumococcal vaccine polyvalent (Pneumovax), the zoster vaccine (Shingrix) vaccine, the other important thing to ask us, is how much of an immune response do you need as a myeloma patient to keep you safe from a flu, or a pneumonia, with pneumococcal bacteria? We don't know the answer to that question with COVID-19. And to address that question, the Multiple Myeloma Research Foundation is trying to develop a prospective protocol, in conjunction with other organizations, to prospectively study this, because we have not done that.

And we are right now in a period where a majority of myeloma patients, thankfully, have not been exposed to COVID-19, because of their careful nature. And in our region, because we had that lead-time bias, we were able to start social distancing, and medical distancing, and getting our virtual platforms up and running by the end of March. So, three weeks ahead of the potential surge, we had already disseminated the information within our hematologic malignancy and cancer patients in general, that guys, stay at home, we're going to figure out how to give you infusions less frequently, keep your disease under check. So, we have not seen a COVID-19 positive myeloma patient in our practice in the past six weeks, since we instituted that. And I think it simply goes to show the benefit of social distancing and medical distancing.

But we are seeing a lot of COVID-19 patients within our community. And ICU admission with COVID-19 cases has consistently remained over 20 patients for the past seven weeks. So, these are patients who are in the ICU on ventilators. But luckily none of the myeloma patients have been admitted to the hospital. We have had some other hematologic malignancy patients, who have been admitted. But, none of the myeloma patients.

Andrew Schorr:
Yeah. So, Jack, you are a support group leader, you hear this, what do you want to say to the myeloma community, your perspective as a patient advocate?

Jack Aiello:
Well, I still think it's important to do what Dr. Usmani said, and that is make sure you're doing physical distancing, without maybe trying to do social distancing, which is so important to folks. So I'm on a lot of video conferences. Instead of having our support group in-person, we've done it via video conference the last two months, and we'll do one this Saturday.

And it's interesting. To me, it's not as effective as being in the meeting. But yet, I'm having a lot of folks tell me, "We really enjoyed it." And I'm sure it just has to do with that social part of it, of seeing each other, and knowing that you're doing okay, and confirming that with each other.

But I'm still, like everyone—we've got a lot of questions in terms of how long will this go on? What's going to happen with the school systems? I mean, there are so many unanswered questions that I think we just have to play it really careful. And the good thing for myeloma patients who have had transplants, they're a little bit used to this. Because after a transplant, we're told to kind of keep ourselves away from grandkids who might have infections, and it's tough to keep your distance from them. So, maybe the physical distancing has been a little bit easier on myeloma patients than others.

Andrew Schorr:
Dr. Usmani, one of the things I wanted to ask you, and people have been sending in questions, and we'll just go maybe five minutes longer, is, is the risk, or the risk of complications, different if you have MGUS, smoldering myeloma, where you are in your myeloma journey theoretical? Or, do you have data on that?

Dr. Usmani:
It's all theoretical, right? And it's extrapolated, again, from experience with other viral entities that the general population is exposed to. But, my main concern is, when we don't know much about this virus and this disease in plasma cell disorders in general, it's still important to exercise caution.

So MGUS, and a subset of smoldering myeloma patients, have robust immune systems. We are not expecting them to not mount a good response, they're not immunocompromised. But there are subsets of patients who have other co-morbidities, who are older, that makes them immune-compromised. So even though they may have MGUS, they're 69. And we know that people who are over the age of 60 have a higher likelihood of getting severe symptoms with any viral infection.

So, given all these factors, myeloma just being one of them, or MGUS or smoldering myeloma being one of them, it's better to just err on the side of caution, and practice, as Jack said, physical distancing, and do the usual necessary precautions. Just be smart.

Andrew Schorr:
Okay. I want to see if I can summarize two things you're talking about. You gave that wonderful analogy of having blinders on, trying to feel the elephant, understand this virus. And it sounds like you and your peers, who are myeloma specialists around the world, around the country, are sharing the experience now, registries, and trying to get hard data on the virus in myeloma patients, right?

Dr. Usmani:
Yes.

Andrew Schorr:
Okay. The other thing is, you feel, and what you're doing in Charlotte, and I know you're in touch with many other major centers, patient safety is being protected, so they can get the right intervention. Might be partly oral, might be partly infused, might be transplant, right?

Dr. Usmani:
Yes.

Andrew Schorr:
That's all good news. Jack, I think we've seen this experience mature from kind of panic, to where our providers are getting their sea legs, if you will, and where we still need to do all the things you said, both of you said, about physical distancing, et cetera. And then we'll fill in with the data you're getting, right,

Dr. Usmani?

Dr. Usmani:
Yes. I think that's going to be very helpful in generating the hypotheses that will drive future research with COVID-19 disease. I think there is some early data that's coming from China about the immune responses to COVID-19 virus. We are waiting for Italian and other European data. I think the UK will be another hotbed of that research, and this will pave the way for us, to help manage our patients in an effective manner.

The vaccine trials are going to be coming sometime later this year. The first in human clinical trials with vaccines will probably begin by September or October. And there's no reason why myeloma patients, or cancer patients in general, won't be able to participate in those trials. And that would be the opportunity to look at the vaccine responses prospectively.

Andrew Schorr:
Okay. One last thing just hit me, and I want to add. Jack, you've probably been hearing about it too, convalescent plasma, is it? So, antibodies from somebody who's had the virus given to somebody who's super sick with the disease. I know there are trials going on in that too. In other words, could there be a safety net for us? Not just some of the other drugs, but even some injection of somebody's antibodies?

Dr. Usmani:
So, the concept is very similar to IVIG, right? IVIG is a pooled immunoglobulin taken from several donors. And the idea is that one or more of the donors, where that IVIG bag is coming from, have mounted a response to the flu, or the cold, and that immunoglobulin is going to keep our patients with low immunoglobulin levels safe. The concept is the same, but we still need to prove that point. And you're going to need a pretty large national effort, that's likely undergoing right now in the U.S., and our center is participating in that trial as well.

But, it still remains to be seen whether it will help or not. Right now, the other important thing is, since you don't have reliable IgG and IgM qualitative and quantitative testing available, how do you really know that a patient has cleared an infection and mounted a response? So, for the patients who are recovered, they are donating their serum, but what are the true metrics of measuring success? So, I can go into a lot of these hypothetical discussions here, but there's still so much unknown about this, and the convalescent serum plasma studies are just another way in which we are trying to see if we can help patients.

Andrew Schorr:
Wow. Well, it's still that elephant, and trying to take the blinders off and feel. Jack, are you hopeful for myeloma patients?Jack Aiello:Oh, I'm always hopeful for myeloma patients, even during this COVID situation. But I do have one follow-up question Dr. Usmani, and that is, patients still have to get lab draws, as you indicated, some patients still need to get infusions. What can patients do to minimize their risk of getting lab draws, and such? Should they be contacting the clinic where they go and asking questions? Should they do anything in advance of going? What do your patients do?

Dr. Usmani:
So, we have reduced the blood draws for the majority of our patients. And the way that we are reducing the likelihood of staying in the infusion center longer is having patients make their way to one of our labs around the city, and just go ahead and get their blood drawn a day ahead of time, so they don't have to wait in the infusion center. That's one way in which we are trying to reduce the time that they have in the infusion center.

Jack Aiello:
And then you get those reports from that lab?

Dr. Usmani:
Yeah. These are our own labs.

Jack Aiello:
Oh, okay.

Dr. Usmani:
So they just show up in our EMRs the same day. 

Andrew Schorr:
Right. I did that. I had an IVIG infusion at a sort of remote clinic. They did the blood tests there the day before a telemedicine appointment, and we'll talk about that in another edition of Answers Now. And it actually was pretty good. My doctor had all the results, she was on screen on my little cell phone, and away we went. And I think that's a great improvement. She couldn't feel around my body, and all that, but she had very sophisticated blood test results. I want to thank both of you for being with us. Jack, your commitment as a patient advocate, support group leader, social media leader and a patient yourself, Jack Aiello, in San Jose, thanks for being our friend, and being committed to the myeloma community, and being with us today.

Jack Aiello:
Thank you, and thank you, Dr. Saad Usmani.

Andrew Schorr:
Dr. Usmani, thank you from Charlotte, North Carolina, my former hometown. Say hi to everybody back there. I was a TV news reporter there for about eight years, so I have a love of the place, and I know Morehead Street where you are. Thank you for the work you're doing at the Levine Cancer Institute, and those trials. And thanks for communicating with myeloma specialists worldwide for all of us to understand the elephant, and then give all of us patients a better understanding of how we go forward, working with you. Thanks for doing this today.

Dr. Usmani:
Thank you, it's been a pleasure, Andrew. And take care, Jack.

Andrew Schorr:
Okay. Well, we'll let you go, Dr. Usmani. And I just wanted to mention about this Answers Now series, we're going to be continuing to do this, ideally every two weeks. I want to thank Sanofi Genzyme for being a supporter of our kickoff edition today. And also, as we go forward with more programs, send in your questions. And as we know, this is a moving target. This is a moving target. So, taking the blinders off, seeing the elephant, how does it apply to all of us living with a chronic cancer. And how do we get the full range of treatments, and also understanding now that safety is being protected?

Okay. Send in your questions anytime to myeloma@patientpower.info. In Southern California, asking you to be safe. Join us anytime, look for more Answers Now programs. I'm Andrew Schorr. Remember, knowledge can be the best medicine of all.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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