Ask the CLL Expert – Dr. Jeff Sharman

Ask the CLL Expert – Dr. Sharman

 

“Ask the Expert” session with CLL specialist Dr. Jeff Sharman from Willamette Valley Cancer Institute and Research Center.


Transcript:

Recorded on: September 27, 2018

Andrew Schorr:
Greetings to this live Ask the Expert program for those of us dealing with CLL. I’m Andrew Schorr from Patient Power. Welcome to this Patient Empowerment Network program with financial support from AbbVie and Pharmacyclics. Thank you so much for being with us.

We have a wonderful expert with us today who is so knowledgeable about this, and that is Dr. Jeff Sharman. Dr. Sharman is the medical oncologist, of course, one of them at the Willamette Valley Cancer Institute and Research Center in Oregon. He’s also the medical director for hematology research at the US Oncology Network with oncologists all across the country. Jeff, welcome back to our program.

Dr. Sharman:
Thank you so much. It’s nice to be here today.

Andrew Schorr:
Okay. Let’s get started. We have a lot of questions coming in, and if you, our viewer, have an additional question send it to cll@patientpower.info and we’ll cover as much as we can in the next half hour.

Here’s a question that came in based on news events that people follow related to CLL, and this is from William. He says, I heard there’s a new drug approved for CLL, duvelisib. Can you tell more about this? Where does it fit in in the CLL landscape?

Dr. Sharman:
Absolutely. Duvelisib is another PI3 inhibitor. It has considerable molecular similarity to idelalisib, which was the first in class medication approved amongst the PI3 inhibitors a few years ago. This molecule has considerable both biochemical similarity, structural similarity but also quite a bit of clinical similarity. So when you look at the patient population in which it’s approved, similar clinical trial designs led to approval, and so as a result it’s sort of in the third‑line setting that you could use it.

It is a‑‑the drug class is a sort of the whole PI3 family of which there’s a growing number. There’s idelalisib, umbralisib is in late‑stage clinical trials. Copanlisib is approved in follicular lymphoma but not CLL. And as a family they tend to be utilized less frequently than the BTK inhibitors such as ibrutinib and to some degree less frequently than venetoclax, as well, the Bcl‑2 family, and that has to do with some of the side effects, that there is, a frequency of diarrhea, LFT abnormalities and so forth. So it follows on the heels of idelalisib, and I would say has more similarities than differences.

Andrew Schorr:
Okay. Let’s go on. You mention about side effects. People ask about that all the time, so here’s a question from Judy. She says, I’m not able to get an answer from my husband’s oncologist regarding ibrutinib and severe body cramping. Have there been any reports showing this is a possible side effect from ibrutinib?

Dr. Sharman:
Absolutely, it is. It is‑‑well, absolutely possible, let’s say that. It actually is what I would say one of the most common side effects that I encounter as a limitation for ibrutinib. The medical term for it is arthralgias, which is sort of translates into joint pains. Sometimes you’ll also see actual cramps or spasms. I’ve had patients’ hands lock up when they’re driving sometimes, which can be a little bit concerning.

There is I think considerable question in the field. There are differences amongst thought leaders on this as to whether‑‑how to best manage it.

There’s some studies that suggest that lower dosages may‑‑after a patient has been on ibrutinib for a length of time you may be able to get away with lower dosages. Those pieces of clinical trial data are not as large and not as well validated, so I think it’s still in the hypothesis‑generating mode, but there’s some data that suggest you could do it. And if the choice was lower dose of ibrutinib or no dose of ibrutinib, I would probably go with a lower dose.

The other potential solution now is acalabrutinib, which is a second BTK inhibitor approved. It is approved by the FDA for mantle cell lymphoma. However, a lot of the clinical trials are in chronic lymphocytic leukemia, and there have been studies that looked at patients who have limited tolerance of ibrutinib, and in many cases they were able to go on acalabrutinib without a recurrence of the same side effects.

So that’s another possibility. It is in the NCCN guidelines that for those patients who have intolerance of ibrutinib consider acalabrutinib. So whether it’s dose reduction or drug substitution, those are sometimes two ways that I use to get around that scenario.

Andrew Schorr:
Okay. Now, we should be clear that acalabrutinib is not yet approved for CLL. Does it seem like that’s forthcoming? I mean, nobody can guess the FDA, but.

Dr. Sharman:
Yeah. So the clinical trial that will lead to approval, presumptive approval, was a head‑to‑head comparison against investigators’ choice of bendamustine rituximab or idelalisib rituximab, and that study is fully accrued and waiting for end points.

And I think that the feeling would be that should be a positive test and that it would eventually get CLL approval. Most of the studies have been done in CLL. It’s just the mantle cell indication came along more quickly.

Andrew Schorr:
Okay. All right. A lot of people worry about other side effects like fatigue, of course, in CLL. So here’s a question from Patty. She says, I’ve been taking 60 milligrams of Vyvanse, which is often used for ADHD, for extreme fatigue that she struggles with. And she says her blood pressure is elevated, and she’s read that that can be a side effect of Vyvanse. Are there any new or additional medications that can be used to treat fatigue without the worry of high blood pressure?

Dr. Sharman:
The way I would approach that situation, fatigue‑‑what I don’t know about this particular patient, is this fatigue that is attributable to the CLL or fatigue that’s attributable to medications?

CLL fatigue is probably one of the most bothersome sort of clinical realities, and for some patients even though they may not meet other treatment criteria such as rapid rise in white blood cell counts, systematic (?) inaudible adenopathy, marrow dysfunction. Sometimes fatigue is so debilitating that you need to do treatment for it. In the 2008 guidelines, fatigue was one of the‑‑it was like the sixth indication for when you treat CLL.

And I’ve seen some patients, you know, one immediately jumps to my mind. He’s clinician himself, very busy individual, likes to surf and so on and so forth, but his CLL left him so fatigued that he had to cut back on clinical work and so forth. And getting his CLL under control really made a huge difference for him. So in the setting of CLL I think that you may wish to consider talking to your doctor about going ahead and treating.

I find those are difficult, difficult discussions because if you don’t have the more classic indications for therapy it’s hard to know. Because fatigue can be a number of things. It can be thyroid dysfunction. It can be hormone imbalance with other hormones. It can be nutrient deficiencies and so forth.

Andrew Schorr:
It could be having three kids.

Dr. Sharman:
Absolutely.

Andrew Schorr:
Yeah, I know. Lots of things.

Here’s another question from Bob. Bob wants to know, will approaches likely change for first‑line treatment, for instance venetoclax, or Venclexta, within the next two years? You have ibrutinib first line.

Dr. Sharman:
Yeah.

Andrew Schorr:
You have FCR that’s been around. You have idelalisib I think could be used first line.

Dr. Sharman:
Actually, idelalisib is specifically contraindicated for first‑line therapy because of side effects.

Andrew Schorr:
Okay. So what about first‑line therapies, Jeff? Where are we there and what’s coming?

Dr. Sharman:
Yeah, so you’re kind of in this bind currently where your choices are chemoimmunotherapy or targeted therapy, and both of them have strengths and weaknesses. The strength of chemoimmun0therapy is that you give treatment for a fixed duration of time, and then you get treatment‑free interval that in properly selected patients should be measured in multiple years.

Andrew Schorr:
I went 17 years.

Dr. Sharman:
Yeah, absolutely. So effective therapy in appropriately selected patients. Now, when I say appropriately selected patients, that does get into some of the nuance about FISH changes and IGHV mutation, and I will tell you even amongst thought leaders in the field there’s some debate as to where you draw the line. Some patients are more suitable for ibrutinib either because of co‑morbidities or wish to avoid chemotherapy, but at least as of today ibrutinib is something you start and then stay on indefinitely.

And per the prior question, some patients have difficulties with that, whether it’s arthralgias or bruising bleeding and so forth. The medication you made mention of I think is the frontline therapy that may have the most profound impact on treatment selection in the next two years.

Andrew Schorr:
Venetoclax.

Dr. Sharman:
So the German Research Group, which is really just absolutely one of the best out there, have fully enrolled a clinical trial of obinutuzumab venetoclax versus chlorambucil and obinutuzumab, and I have to believe that that is going to result in a superior outcome for the venetoclax arm and that we will have the combination of obinutuzumab venetoclax for front‑line setting.

And what’s really appealing about that is that is one year of treatment and then treatment is suspended and stopped. And though we haven’t compared that to more traditional BR or FCR, I think it would be a highly effective regimen. We are currently conducting a study in the United States in our research network looking at the combination of obinutuzumab and venetoclax, and what I like about our study is we give‑‑for the listeners who might not be familiar with venetoclax, starting venetoclax is a little bit clunky because it works so quickly we have to be careful about a condition called tumor lysis syndrome, which is if you kill too much cancer cells too quickly that can cause some dangerous conditions, and venetoclax does do that.

And so what we’re doing is we’re giving two months of obinutuzumab and sort of getting rid of the bulk of the CLL and then starting the venetoclax hopefully under much safer conditions because, you know, in the Pacific Northwest we would say you can’t have forest fires if you don’t have any trees. So if we get rid of all the CLL or a substantial fraction of it somebody is less likely to have tumor lysis. So I think that’s the approach that is probably the next up in frontline.

The one other thing that could potentially change is acalabrutinib has conducted a three‑arm study‑‑excuse me, Acerta with acalabrutinib, where they give‑‑it’s a three‑arm study with either chlorambucil Gazyva, acalabrutinib or acalabrutinib with Gazyva. And so does the addition of a C‑20 antibody make BTK work better, remains the question outstanding.

Andrew Schorr:
All right. Let me just explain things to people. I’ve been around this for a long time and Jeff deals with these acronyms all the time. So, first of all, Gazyva is the same as obinutuzumab.

Dr. Sharman:
Thank you, yes.

Andrew Schorr:
It’s an infused CD20 that’s targeting the CD protein on the B‑cell, the bad guy, and it is sort of I don’t know if you’d describe it as a more powerful version but it followed from Rituxan or rituximab that many of us had. So the idea is you have an infused therapy for some length of time, and then you may have an acalabrutinib with it or you may have a venetoclax or Venclexta with it. Get I get it right, Jeff?

Dr. Sharman:
Yes. And if I just had one other comment. I think there are a lost questions and certainly some very compelling data about the combination of a BTK inhibitor such as ibrutinib with a Bcl‑2 inhibitor such as venetoclax.

Andrew Schorr:
Two pills.

Dr. Sharman:
Two pills, yes. And I think the preliminary data really looks extremely encouraging.

The challenge with that approach is it’s not approved in that combination and probably not going to be approved in the next two years unless the FDA does something that maybe I’m not anticipating at this point. That clinical trial that compares that to an existing standard is really only just getting off the ground now.

Andrew Schorr:
Okay. All right. Let’s buzz through some others. So John writes in, please compare purpose and benefit differences for FISH testing versus next generation sequencing. So maybe you could explain them too.

Dr. Sharman:
Absolutely. Thank you for the question. It’s one that I think is often very difficult to comprehend.

So a little bit of history here is that we’ve known for a long time with that patients with chronic lymphocytic leukemia have a pattern of common chromosome gains or losses, and we generally pay attention mostly to five separate categories.

There are some others that people sometimes look at, but ranging from sort of worst to best, worst is having a loss of chromosome 17p and P stands for petite arm, so part of the short arm of chromosome 17 is lost. 11q, Q stands for the long arm of chromosome 11. And then you have normal chromosomes or the addition of an extra chromosome 12 or the loss of a portion of chromosome 13 that kind of goes from worst to best. And that is very different than actual mutations in genes. So these are wholesale losses of large clunks of chromosomes.

And if you look at 17p the reason that 17p is bad is because there’s a particular gene there that’s very important called TP53, and you can actually have a mutation in TP53 without the presence of a chromosome loss. And so next generation sequencing looks at a host of additional genes that really until the last three to four years we didn’t know have the significance that they have. So TP53 is probably the most important, but you’re also seeing things such as SF3B1, NOTCH1, FA1. There are a variety of them that are out there. Some are better understood than others, and I think to some degree we’re still as a field even trying to figure out how best to integrate these into our clinical practice.

Andrew Schorr:
Okay. So would you recommend for the typical CLL patient that they have FISH testing, which tells you about the chromosomes, right?

Dr. Sharman:
Yeah.

Andrew Schorr:
And when do we need to do genomic testing to see with whether if any of those genes you just rattled off?

Dr. Sharman:
Yeah. So I can tell you about my own personal practice on that. I do think that the field, as I indicated before, is still trying to digest this, and a number of those specific mutations there isn’t necessarily super robust consensus as to when is the best time to draw those. So I’ll explain how I’ve thought through it, and if that resonates with you.

So my question in the previously untreated patient is whether or not this patient is suitable for chemoimmunotherapy. Previously I said appropriately selected patients get very long duration responses. I don’t want to give chemoimmunotherapy to a patient who is not going to get a sustained benefit.

If I anticipate that I’m only going to get 18 months benefit or two years of benefit, it is not worthwhile in my mind going through the chemotherapy to get that. I would rather put those patients on a tyrosine kinase inhibitor.

So my first stratification is the IGHV mutation status, and I would say in general if somebody’s mutated, which is the more favorable form, I would tend to err more on the side of chemoimmunotherapy for those patients. For those who are unmutated, which is the bad one, I would tend more towards targeted therapy. These aren’t totally black and white.

But my next level of stratification is FISH. So if you’ve got a bad FISH finding even if you’re in that favorable category I strip you out from the chemotherapy group.

Andrew Schorr:
So like if you had a 17p deletion, those chromosome deletions?

Dr. Sharman:
Yes. So if you’re mutated, which you think is good, but you also have a 17p, then I wouldn’t give that individual chemoimmunotherapy.

So if you have good IGHV, good FISH, good functional status and I’m thinking about give you FCR, that’s my final check is let’s make sure there’s not something lingering underneath the surface here that I don’t know about. So that’s where I check it.

Now, in the relapsed/refractory setting it is more the norm that those patients are almost all going on novel agents where those mutations are sort of a little bit less salient, so I don’t necessarily check that. However, I do recheck FISH with successive lines of therapy because that certainly can evolve. And to make things even a little bit worse now for somebody who has been on BTK, we need to think about BTK mutations and whether or not that patient might be suitable for a second‑ or third‑generation BTK inhibitor that can get around that.

Andrew Schorr:
Okay. And the genomic testing, when do you do that?

Dr. Sharman:
Well, so genomic testing is looking for those smaller mutations that don’t show up on FISH.

Andrew Schorr:
Okay.

Dr. Sharman:
So that’s my final break point before I would give somebody chemoimmunotherapy. But I will tell you, there are opinion leaders out there who will argue that chemoimmunotherapy is dead and shouldn’t do it.

Andrew Schorr:
Right. There are.

Dr. Sharman:
I’m in the camp that thinks there’s still purpose and value in doing that in appropriately selected patients.

Andrew Schorr:
Okay. Let’s get to some others. So Grant said he was diagnosed with a double diagnosis of diabetes and then, as he had additional testing, voila, he also had CLL. So he’s currently able to control his diabetes, and he’s in watch and wait for CLL. Is there any advice for me going forward with these two conditions? Diabetes and CLL.

Dr. Sharman:
It‑‑so I guess my question in such a circumstance is how is that CLL behaving. If he has a molecularly favorable CLL and he’s on watch and wait and things are simmering along, it may very well be that his diabetes poses a greater threat to his overall health than the CLL.

In contrast, somebody with an unmutated 17p deleted CLL, it’s the CLL that’s going to be more dangerous. Fortunately, the treatment interactions don’t overlap all that much. Sometimes with chemoimmunotherapy we give steroids, and that can be problematic for patients with diabetes, but I would manage them by and large independently.

Andrew Schorr:
Okay. We’ve gotten several other questions. Sharon, we got yours and Jason. They were asking about first line with ibrutinib, and I think we spoke about that and other choices that may have a different side effect profile if ibrutinib has a problem. And also Sharon had written in about she’s in this watch and wait and she wonders about FCR, and I think we can hear from you that FCR and maybe BR in some cases, which is this chemoimmunotherapy approach, still has a place in your mind. So, Sharon, stay tuned.

Lucy wrote in. She says, given the 17 (?) (p53) deletion what role does that play in determining the beginning of treatment for the CLL naive patient, and you were just saying probably not FCR or BR.

Dr. Sharman:
Yeah. Boy if somebody had a 17p deletion I would strongly advise against traditional chemoimmunotherapy. I think it can actually be more harm than good in some cases.

There is a more subtle point though that I would jump onto, which is what factor does it play in first‑line therapy. It’s not so much the agent. Some people feel like because they’ve got a 17p they need to jump into treatment sooner rather than later.

I will tell you I have several patients with 17p deleted CLL that I’ve been able to watch for years and years and years without treatment. The indications for starting therapy really remain the same. If I see somebody clearly heading towards treatment with a 17p I may start them a little bit earlier, but again some of these folks can be watched and wait quite well.

Andrew Schorr:
Okay. You’re a director of research, and we’re starting to hear about CRISPR or gene editing.

Dr. Sharman:
Yeah.

Andrew Schorr:
So do you think this gene editing will play a role in CLL?

Dr. Sharman:
Hoo, boy. You know, I think that probably dovetails with the question you didn’t ask, which is about CAR‑T cells. I think CRISPR, for members of the audience who may not be familiar with it, is a highly efficient, highly directed way of making genetic manipulation within cells,

and with a lot of the gene therapy that’s been done over the years we sort of randomly insert genetic material into cells to sort of reprogram them. That’s sort of the classic way of doing gene therapy. The problem with that is there are parts inside the genome that don’t like to be broken, and so the field really was set back a number of years when there were some early cases of leukemia caused by gene therapy.

And so what CRISPR does is it does allow you to make very targeted genetic modifications so that you can precisely put in new genetic material sort of wherever you want it. And I think that in the context of CAR‑T therapy there’s now goals to make it much more off the shelf than this sort of highly manufactured thing, and that’s where I would see CRISPR having the most likely early role.

Andrew Schorr:
Okay. So CAR‑T, chimeric antigen receptor T‑cell therapy, taking a virus, I think, and combining it with stuff for your T‑cells, targeting your CLL. So Lynne just asked, she’s 71, would somebody older like that‑‑tomorrow is my 68th birthday, folks‑‑would we be candidates for CAR‑T should we need it?

Dr. Sharman:
Well, I need to articulate some of my limitations as a community practice oncologist, thus far the CAR‑T research has been sort of in the exclusive purview of academic centers, so I haven’t had the chance to do it yet. That having been said, we are working with a variety of sponsors to get such a program up and running.

However, I will say there’s a lot of enthusiasm in CLL because the original New England Journal of Medicine paper that described CAR‑T was done in both pediatric acute leukemia and adult chronic lymphocytic leukemia, and it is now approved by the FDA for the pediatric ALL, acute lymphoblastic leukemia. It is not approved for CLL. And part of that‑‑there’s a lot of reasons why it doesn’t work as well in CLL as it does in other diseases, and I think that the‑‑it’s okay that this is moving a little bit more slowly in the CLL field because I think we’re getting a lot of benefit of accumulating knowledge in how to make it work best in CLL. I think it will become an important therapy in CLL.

Keep in mind that the toxicity of chimeric T‑cell is significant, and the possibility of neurotoxicity or this syndrome that looks a little bit like sepsis that’s not sepsis but it looks like it in a lot of ways, what we call cytokine release syndrome make this a therapy where caution is advised.

And so if it’s something you’re thinking about I would say go get yourself seen in your very specific circumstances with somebody doing this in research studies and decide if it’s right for you.

Andrew Schorr:
Okay. And we’ll have‑‑in other programs we’ll talk about CAR NK research that’s going on. Lot to talk about, maybe at ASH, folks. Dr. Sharman will be at the American Society of Hematology meeting, the ASH meeting here in San Diego in a couple of months. We’ll have coverage from that as these new areas come out.

Now let’s go back to the basics before the end, Jeff, and this that is flu season coming up.

Dr. Sharman:
Yes.

Andrew Schorr:
And there’s also a shingles vaccine. And also some people related to hepatitis B.

What are you telling your patients about vaccines? My friend Jeff Folloder said somebody at MD Anderson had them maybe getting two flu shots.

Dr. Sharman:
Yeah.

Andrew Schorr:
So first of all, flu shots, and do we need more than one? And what about these other shots?

Dr. Sharman:
Yeah, so starting with flu I would encourage all my patients CLL patients to get flu shots. The response is nearly universal. Everybody always says, well, I got a flu shot and I still got sick. A flu shot does not prevent all illness. Flu prevents flu. And patients with CLL get more complications from flu because their immune system has a cancer in it. So CLL is a cancer of the immune system, so to whatever extent you can give yourself a head start to fight off flu I would encourage patients to do so.

Andrew Schorr:
More than one shot?

Dr. Sharman:
Well, so I will say that patients with CLL generally have less of a response to a flu vaccine than somebody without CLL.

So you don’t get as much protective benefit if you have CLL as somebody without it. I don’t think, at least, I’m not familiar with data that says two flu shots are better than one. It may be out there and I’m not aware of it, but I mean I could understand why you might. It at least biologically makes sense.

Andrew Schorr:
And the shingles vaccine?

Dr. Sharman:
Yeah, so very few clinic days go by where I don’t curse shingles at least once. For anybody who has had shingles you know it can hurt really badly, and there is this condition called post herpetic neuralgia, which is a sort of a lingering pain syndrome that can go on for years for patients who have had shingles and can be a life altering pain. And so, again, I think whatever head start you can give your immune system it’s worth doing.

And I guess the reason why I curse shingles so frequently is because it does seem to go part and parcel with lymphomas and CLL. Again, you have a cancer of the immune system. The immune system doesn’t work as well, and, boy, I can’t count the number of times where somebody gets shingles just as their CLL is acting up and then it delays treatment, or somebody is going through treatment with a lot of pain as a result.

Andrew Schorr:
So you’re not worried about the vaccine?

Dr. Sharman:
No. Not only am I not worried I highly encourage it. But I would point out that the old vaccine was a live virus, and there were problems giving that to patients with CLL. There is a new dead virus, Shingrix, that’s in short supply.

Andrew Schorr:
Okay. Well, we’re going to wrap up. I want to just help everybody understand what I alluded to a minute ago, the world series of blood cancer‑related discussions where a lot of data, and, Jeff, you may have data presented there, is the American Society of Hematology meeting which is near me in San Diego in December and about 30‑, 40,000 people come and discuss all this.

So stay tuned. We’ll be doing programs from there, and we’ll bring you updates. Dr. Jeff Sharman, thank you so much for being with us once again.

Dr. Sharman:
My pleasure, Andrew. Thank you for your time.

Andrew Schorr:
All right. And this is what we do. Thanks to the Patient Empowerment Network so devoted to this. We’re happy to help from Patient Power, and thanks to the supporters for this program. They had no editorial control, but they believe in education. That’s AbbVie Incorporated and also Pharmacyclics.

I’m Andrew Schorr. Remember, knowledge can be the best medicine of all.


Please remember the opinions expressed on Patient Empowerment Network are not necessarily the views of our sponsors, contributors, partners or PEN. 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.

Clinical Trial MythBusters: Actionable Advice for Knocking Down Obstacles to Trial Participation

Actionable Advice for Knocking Down Obstacles to Trial Participation

Downloadable Program Guide

Clinical trials offer tomorrow’s medicine today, but more often than not, only a small fraction of patients ultimately enroll in a trial due to barriers posed by financial logistics, distrust and travel, to name a few. In this MythBusters program, we will examine the barriers to enrollment, evaluate patient needs and discuss resources to help guide people through the clinical trial process with the help from two experts, Dana Dornsife of Lazarex Foundation and Myeloma Survivor Reina Weiner.


Transcript:

Andrew: Hello from Carlsbad, California, near San Diego. I’m Andrew Schorr from Patient Power. Welcome to today’s Patient Empowerment Network program, clinical trials myth busters and actionable advice, resources for knocking down obstacles to trial participation. I wanna thank the companies that have provided financial support for this program. They have no editorial control, but we definitely thank them for their support. Those supporters are AbbVie Incorporated, Astellas, Celgene Corporation, and Novartis.

Okay. We have a lot to talk about. First of all, I’ll just say I’ve been in two clinical trials; one Phase 2 many years ago at MD Anderson for the leukemia I have, chronic lymphocytic leukemia. And that gave me tomorrow’s medicine today. It worked, but I had travel far to do it and there were costs involved.

And then I was in a second Phase 3 trial close to home, and that was good too, and discovered another cancer that I have, myelofibrosis, through the monitoring in the trial. So, I’m a believer, but there are obstacles, and let’s talk about some of these. And we’re gonna give you some very specific resources to overcome these obstacles, so that hopefully, if a clinical trial is right for you, you can participate, you can feel good about it, and you can move medical science along to help everyone who is dealing with that condition.

So, what are some of the issues? Financial, of course; logistical issues, of course; distrust, are they really gonna take care of you or are they gonna protect your safety? Is it really right? And are you being given the straight scoop? What about travel costs? I went from Seattle to Houston, Texas a few times. Costly, okay? Stay in a hotel. It’s costly. Get a babysitter, leave work; costly.

The guinea pig syndrome; you’ve heard about it so many times. Are they gonna experiment on you, and are they really protecting you, and are you a number, or you are a person with cancer, or your loved one? And then is your medical team that you’re talking to about your treatment, are they informed about clinical trials? Or are they pooh-poohing clinical trials because they don’t wanna do the paperwork, or it’s happening down the road and not at their clinic. Lots of issues; we’ll talk about that.

Okay, I got some great helpers. So, first let’s go to Asheville, North Carolina, and you are used to live in Charlotte. Reina Weiner joins us. Reina, welcome to our program today. There we go. Say that again, Reina, you were muted.

Reina: Thank you.

Andrew: Okay. Now we should tell you that last June, well, June of 2017, Reina had a autologous transplant for multiple myeloma. And along the way, leading up to that, over many years she was in four trials. So, first of all, Reina, let’s start with what’s most important. Post-transplant, how are you feeling today?

Reina: I’m feeling very well. Thank you, Andrew.

Andrew: Okay, and what’s coming up at the beginning of September?

Reina: What is coming up at the – oh, a big party is coming up. Our children are throwing us our 50th wedding anniversary party, so that’s been cool.

Andrew: Yeah. Well, congratulations. And you’ve been dealing with what became multiple myeloma since 1999. We’re gonna come back and track that in a minute, as far as the steps along the way, the concerns you had or not at different times about being in four clinical trials.

And now let’s go up near San Francisco in the East Bay of San Francisco Bay, Danville, California. Dana Dornsife. And Dana is the Chairman of the Lazarex Cancer Foundation. Dana, thank you so much for being with us.

Dana: Thank you, Andrew.

Andrew: Okay. Now ladies and gentlemen, I want you to know Dana and her husband and her family, overall, they’re incredibly philanthropic across a number of issues that are faced globally, and also in the US. But one of them is helping people with the financial issues that prevent them from being a clinical trial. So, Dana, this is a personal story for you, so maybe you could just tell us why did you start the foundation? It was a family issue.

Dana: It was a family issue, and that family issue really revealed to me a gap that exists in cancer care for advanced-stage patients who want to remain in their battle with cancer through clinical trial participation. My youngest sister’s husband, Mike, was diagnosed with pancreatic cancer in his early 40s. He was given one half of one percent chance to live, and at the time 35,000 people a year were diagnosed, and 35,000 people a year were dying from pancreatic cancer.

So, we decided as a family that if Mike wanted different results that we would need to do something different. And Mike and Erin went ahead and pursued standard of care, and I was tasked with identifying clinical trial opportunities for Mike. And, of course, that sounds very linear, but in fact, for a layperson it was a very difficult task to undertake. I did identify some trial opportunities for Mike. He did participate in a trial and responded well for a period of time, he had good quality of life.

And during that period of time he was meeting people who were asking him, “Hey, what are you doing? I wanna do what you’re doing.” And he would say to them, “Oh, just call my sister-in-law, Dana. She’ll help you.” And that’s literally how this organization began. Through those phone calls that I was receiving from other pancreatic cancer patients, I began to understand that Mike was able to take advantage of medical breakthroughs in clinical trials because he had a family who could afford to support him through the process. And all of these other families that I was talking to, they just didn’t have the financial wherewithal.

So, we started Lazarex in order to fill that gap and help people identify clinical trial opportunities, and then provide financial assistance to them to help cover the out-of-pocket expenses that create huge barriers for patients who are already experiencing financial toxicity due to their disease.

Andrew: Well, thank you for what you do. And we’re gonna talk a lot along the way about resources. There’s a downloadable guide that you’ll be provided with, along with a link to the replay of this program. And that’s gonna have specific resources that you can access, whether it’s financial issues, other issues you may be facing. So, look for that.

Today we’re really focused on actionable resources. So, let’s go to Reina for second. So, Reina, you had been in the pharmaceutical industry.

Reina: Yes, I had.

Andrew: So, you knew about drug development, and you understood about clinical trials. So, I’m willing to bet you were pretty proactive. People who weren’t in the field, they don’t know from clinical trials, and maybe they’d been worried about it. They’ve worried would they be experimented on, would they be a number and not name, would they get quality care. But you were probably, I have a feeling, pretty proactive. And you write about that. I know you have a book as well. So, is that Step 1 for people to speak up for themselves?

Reina: It is Step 1; absolutely, Step 1. And what I found is, first of all, people don’t know about trials. And if you go to a small community practice where they’re very busy, they don’t have the time, they don’t have the staff to really educate patients about trials, the best, best step for patients to take is to ask, “Is there a clinical trial that might be appropriate for me?” That’s huge.

Even when I went to a very well respected hospital and there was a researcher who was following me as I had smoldering myeloma and the numbers kept going up and up and up. I said is there – because I was living close to the NCI – is there a trial that would be appropriate to me at the NCI. And he said just a minute, turned around, went to his computer, found the trial and that’s how I got in.

Andrew: But it wasn’t at where you were receiving care or being monitored at that time. It was somewhere else.

Reina: It was not. It was at somewhere else.

Andrew: Okay. Dana, is one of the obstacles, not just financial, or maybe it’s even the business of cancer where if an oncology practice that you’re going to that’s maybe close to home is not doing the trial, maybe it’s not even in their financial interests to tell you. I mean, is there an awareness issue, do you feel?

Dana: There’s a huge awareness issue there, Andrew. And it all starts with knowledge is power, right, so I completely agreement with Reina’s comment about one of the first questions you need to ask is, is there a clinical trial out there for me because many doctors who are in community environments don’t offer that information. It’s not what they do every day. They’re there to administer standard of care. Only 6 percent of doctors actually engage in conversation with their patients about clinical trials, and that’s usually the 6 percent who are associated with research universities, right?

So, knowledge is power. If the patient doesn’t know about a clinical trial, they’re never going to participate. But once you find out and once you’ve identified an opportunity, the second biggest hurdle is that out-of-pocket expenses associated because most patients have been dealing with their disease for a longer period of time, and they’re basically broken in every way: physically, emotionally, spiritually, and, sadly, financially.

So, patients start to make decisions about the outcome of their care based on the size of their checkbook, and not focused on what’s best for them. And so, Lazarex eliminates that financial barrier as well to help patients say, “Yes, I can participate,” and we can get them where they need to be when they need to be there.

And that’s just the tip of the iceberg, Andrew, because there are many other barriers that exist; socioeconomic barriers, language, culture, historical barriers. And we are tackling all of those barriers one at a time. But really, the biggest two barriers are knowledge and financial.

Andrew: Right. And you mentioned about the historical barriers. Some people know about the Tuskegee experiments with African-American people, so in the African-American community, there still is a distrust among some people. Yet if you think about it from the FDA’s point of view where a company that’s developing a drug, or the NIH, they say okay, how does it work on broader populations or different ethnic groups or different ages or genders, et cetera?

They want to understand that data, and so not just having a number of people participating in the trial, but having it reach people who are in different situations, if you will. And so –

Reina: And if I may – ooh, I’m sorry.

Andrew: Reina, please, go ahead.

Reina: Well, if I may say that because people don’t know about it and the trials, the best trials, are trials with a variety of patients, but they do try to accrue populations who are certain ages, certain genders, ethnic groups, whatever they can get. And only 3 to 5 percent of patients participate, cancer patients, participate in clinical trials, and so much is lost if people don’t participate.

Andrew: Here in San Diego it’s sort of a pocket of a lot of medical research. There’s a lot up in your area, Dana, in the Bay Area, San Francisco Bay Area. I mean, it’s in North Carolina in the research triangle where that’s home state for Reina. And not to disclude others, and then certainly up around Boston. There are like companies all over the place and many of them are in earlier drug developments.

So, when you talk about immuno-oncology now, can we harness our immune system with the help of some medicine to fight the cancer, and I know some people who’ve received it; lung cancer patients who are living, et cetera, melanoma patients who are living for an extended time. These companies can’t move forward unless there’re people who are in the trials. So, the FDA says where’s your data? And they’re saying well, we’re trying, but we haven’t been able to complete this trial. Right, Dana? So, we can’t move towards cures unless we all come together.

Dana: That’s exactly right. So, let me just throw a few statistics out at you that I found astounding when I learned of them. So, we have a 48 percent failure rate of clinical trials, and it’s not because the drug didn’t work. We will never know, quite frankly, if the drug would have worked or not. And we will never know because there weren’t enough patients enrolled in the trials to find out.

So, 11 percent of trials never enroll a single patient, if you can believe that. So, here we are with an almost 50 percent failure rate, and yet we have 600,000 patients a year in this country who are dying from cancer. So, there’s this incredible disconnect between the thousands of patients who would participate in clinical trials if they could, and the thousands of clinical trials that need patients to participate in order to succeed. And without successfully completing those trials, those drugs are never going to get market to help the cancer patients that they are intended to serve and help.

That’s why Lazarex Cancer Foundation exists, and that’s why removing the barriers to clinical trials is so important. Our process does not lend itself well to that. And I just want to take a step back, Andrew, to address the minority participation in clinical trials. We all understand because of epigenetics and, yeah, advances in medical science that we need to have the full spectrum of our population participating in clinical trials. But that doesn’t happen. When you look at the 5 percent of patients who actually participate and you break it down ethnically and racially, less than 5 percent are from minority communities combined.

So, in theory, though we say we understand the importance of that, we’re actually not in practice doing what needs to be done. And so a lot of our work is also focused on reaching out to those socioeconomically challenged and racial and ethnic minority communities to raise awareness and help people like you’re doing on this program dispel the myths around clinical trials, so that they’re more inclined to ask better questions.

Andrew: Right. So, so important, and I applaud for that work. We’re gonna talk about the financial process in a second. Reina, so you were involved in a National Institutes of Health or National Cancer Institute trial.

Reina: Yes.

Andrew: A couple of them, I think, and one at Memorial Sloan Kettering in New York’s premier resources. So, we talked about your tip was you gotta speak up and ask about trials, where they’re at that center, wherever you are, by XYZ oncology in a suburban area, whatever it is or not. So, what’s Step 2? So, for instance, now I understand there are people – and Dana, I’d like your comment on it too.

At some clinics now where there are clinical trial – there are nurse navigators, but often sometimes there are clinical trial navigators too, but often you gotta ask about that too, right, Reina? I mean, it’s speaking up and looking for the resources that are available to you there or wherever you choose to go, right?

Dana: Yes, and there are organizations like Dana’s who help people do clinical trial searches because that’s a bit overwhelming when you are already frightened, you already have the financial issues coming up. And like you mentioned, logistical issues. So, there is Dana’s organization; therefore, myeloma, the SparkCures. There’s the MMRF. There’s the International Myeloma Foundation. There is something called Cis Crypt. And so, they will help you find a trial.

And there are lots of regional trials groups, so you may not need to go to the big, big research center. They might be able to do it locally for you. But I always want to bring up the fact that there’s so much misinformation about trials and what it entails. There’s a tremendous amount of fear. And when I went on the first trial, as I wrote about a little blog recently, everybody said to my husband – well, not everybody, but an awful lot of people said why would you let your wife going in a clinical trial? She’s definitely gonna be a guinea pig.

And I can tell you very, very, very clearly that you get so much care. There’s so much documentation. And the patient’s health is never sacrificed for the research ever. And so, and you sign a consent form, so you’re very clear about what is going to happen. And yes, there’s more there’s more bloodwork. Yes, there are more biopsies. And it’s part of research. And when you sign up, you sign up. And I had more than I’d like to even talk about, but I feel very grateful and very humbled for the care that I received.

And I can tell you, too, that I talked to other people on the trial. And yes, they hope to gain better control of their cancer. But, in addition, they really hope to help the next group of patients who are coming up, so that these new treatments actually happen.

Andrew: I feel the same way. I was in a trial at MD Anderson in 2000, and the three-drug combination I got was not approved till ten years later, but they learned a lot. And you were on a three-drug combination, which I think still has not been approved for first line, but it’s is widely used, I think.

Dana: Right.

Andrew: So, in multiple myeloma. I wanted to mention some other resources, the Leukemia & Lymphoma Society also has a resource center. You can call them. So, there’re these different groups that help you identify a trial, and doctors who specialize, so let’s say pancreatic cancer, you mentioned earlier Dana. I got a call from a friend in Miami, “How do I find a pancreatic cancer specialist?” And I connected them with PanCAN, Pancreatic Cancer Action Network in Los Angeles, who knows who are the doctors who have the most experience with that.

Now, Dana, so then the next thing comes up is alright, I’ve identified the trial, but it’s not where I am. So, now we talk about logistics and finance. So, let’s say somebody calls your foundation. Tell us how it works. So, I don’t have the resources. Maybe they live in Northern California and the trial is in Southern California or in Salt Lake City. What happens next?

Dana: So, Andrew, in some cases it’s not even that distance. In some cases it’s getting from Sacramento to San Francisco, which is literally a one hour, one-and-a-half hours without traffic, in your car. And sometimes it’s a tank of gas, a bridge toll, and parking. I mean, we’re not talking about thousands of dollars in some cases, but it’s still the difference between life and death.

When someone calls Lazarex Cancer Foundation, they can contact us directly. We have a financial application that we use to determine the degree of eligibility for patients to get their out-of-pocket expenses reimbursed. Or they can be referred to us by their social worker at the institution where they are receiving, or thinking about participating in a clinical trial.

We take a look at the household income of the patient, and I believe our guidelines are very generous. We go up to seven times the federal poverty guidelines for patients. And we arrived at that number through trial and error. Our goal is to help as many patients as possible participate in clinical trials, and turn away as few as possible. And then we reimburse on a sliding scale from 100 percent to 75 percent to 50 percent depending upon your household income.

And it’s a pretty easy process to go through in order to be enrolled and receive the reimbursement. And then we reimburse our patients monthly, on a monthly basis. And in some cases, we’ve been working with patients, we follow them, like Reina, through two, three, four clinical trials. And we’ve been supporting them in trials for years. And without doing what we do, they may not be here with us today.

Andrew: Well, I’m sure you’ve saved some lives and lengthened some lives. Reina, so you were in the pharmaceutical industry and in oncology, I believe, before all of this started happening to you. And you’ve continued teaching nurses and devoting yourself to education and your book and your blogs. Thank you for all that. Maybe that’s what life’s about.

But knowing on the inside there are pharmaceutical programs, in some cases, I think, particularly for rare cancers where they may provide assistance. They can’t pay you to be in the trial, but there are at times assistance and travel logistics, particularly for rare cancers where maybe the trial is not, not one hour away. Am I right, Reina? Are you familiar?

Reina: Oh, there are. And sometimes when I was working, there would be a patient who had a cancer that really was not aligned with a particular treatment that would be effective for them. And so, the doctor wanted to try an off-label use of a product, and so then they would come to me and asked me if I could get the pharmaceutical company to provide the drug for free.

And sometimes it takes a little doing, but I was concerned about the patient and hoping to get them a better quality of life, if not an extended period of life. And so, yeah, the company would do that. Not every day, not all the time, but if the company had evidence that this was a patient who would benefit from the off-label use of a product then they would help them out.

Andrew: Okay. So, Dana, related to other organizations providing assistance, and I recently interviewed someone from the Family Reach Foundation where they help with rent or things, groceries, things like that. So, somebody says, “Oh my God, I’m afraid of a trial, I can’t go there,” or if they hear about it and they say, “Hmm, well, maybe I could, but I’d have to leave work, or maybe my spouse would have to leave work, we’d have to find somebody to pick up the kids from school, oh my God.” There are organizations that can help with some of these family processes, aren’t there?

Dana: Absolutely. And I think we’ve provided the Patient Empowerment Network with a list of those. 21st Century C.A.R.E. is an organization that provides patients with immediate financial assistance for expenses related to active cancer treatments. Cancer Care provides assistance for cancer-related costs. There’s a Cancer Care Co-Payment Assistance Foundation. We get that question a lot.

We’ll help with the out-of-pocket travel expenses, and in fact, some of the medical and diagnostic expenses that aren’t covered by insurance. When you’re participating in a trial, sometimes you have to get more stems than insurance will cover or whatever. But co-pays are a big deal for people to be able to afford those, and so, that is another organization that can help. Patient Advocate Foundation, which is an underinsured resource directory.

So, there are a lot of you nonprofits out there who exist to support patients through the fifth process. It’s just a matter of helping patients really understand and put together all of those resources in a way that they can access them.

Andrew: Okay. So, Reina, you’ve been through it four times, and you’re a pretty savvy person. Not all of us know as much, so help us now. So, one of the questions in a trial is, and in cancer, am I gonna get what I describe as the good stuff, knowing that the good stuff that’s being tried may not be good. I mean, it may not work out. There are trials that go bust. Not just for not getting people, but they got people, but it wasn’t as effective as they hoped it would be.

But let’s say we’ve done our homework and we go to a certain clinic, but it’s some sorta controlled trial. We don’t know whether we’ll be in the arm. So, was a concern for you? Were you gonna get the good stuff, and why do it?

Reina: Well, no, really, Andrew, because I know that like if it’s a Phase 3 trial, so you’re comparing standard of care versus the newest and hopefully the latest and greatest. If it turns out that one arm of the trial really shows a significant improvement, patients are always switched to the more effective arm of the trial. They don’t leave you on this arm of the trial thinking well, what the heck, we’ll just leave you there and see how the research pans out. So, they are always switched over to the most effective.

So, I wasn’t really concerned about that. And in the Phase 2 trial, it’s just seeing if the product was effective. And so, that was obviously not a concern for me. So, it worked out, and I do think, though, like what Dana does is absolutely wonderful at totally, totally, totally past wonderful.

But I always try to let people know who have friends and family who are facing some chronic significant illness that don’t just call and say let me know, let me know if I can help you because that’s so ambiguous. And most people will not call because they have pride or they think they can do it all by themselves.

So, I always try to suggest to people that if you’re calling somebody who you think might need some help, be specific. Call and say, “Can I walk the dog? I’m going to the grocery store in an hour. Is there something I can pick up for you? Can I mow the grass?” Anything that will help, but make sure that you are specific in your offering.

Andrew: I want to talk about a related issue. You use the word pride. Some people, maybe in some cases it’s even shame. They developed a certain cancer. Where these are maybe middle-class people who’ve had some resources. They’ve been paying their mortgage. They’ve been paying their expenses, making do. But now they get hit with a cancer diagnosis, which is catastrophic, and there is help available, Dana, but they’re too proud to ask for it when this could happen to anybody. And maybe you’ve even countered that along the way or know there’re people out there. What would you say to people, to not be shamed and to speak up?

Dana: Yeah. Well, sadly, one in three women will be diagnosed with cancer, and one in two men. And so, this is not an uncommon scenario, right? The likelihood of knowing someone who will receive a cancer diagnosis is very likely. So, I think that patients have to understand that pride doesn’t help you in your process with battling this disease. You have to take advantage of every opportunity that’s out there in order to come out on the positive side of this experience. And if you don’t take advantage of every opportunity, you may not.

And so, it’s one of those things that we just have to deal with right from the beginning, and just say okay, again, knowledge is power. I’m going to surround myself or engage with the people that are around me who want to help me. And you have to put that team together because you will need your team with this disease.

Andrew: Okay, so great advice. Reina, part of your team maybe could be the first doctor you saw who gave you the diagnosis, but they might not be the one where a trial was offered. So, first step is you talked about speaking up, but it takes a lot of courage to say to the doctor in the white coat with all the letters after their name, you know, thank you so much, Doctor, and I’ve either found out about a trial, or your turned and typed it in somewhere else. I hope you don’t mind, but I am going to go over there. Maybe you can advise me along the way.

But that takes courage because people are terrified, and they may be bold in principal in that situation with the person in the white coat. What advice would you give?

Reina: Ooh, well, that’s a big one for a lot of people. And, really, you know what, I imagined that it would be people who are older, who come from a generation where the doctor has the final word. But what I found out when I was writing my third book is that there were younger people who also feel very uncomfortable speaking up, asking a doctor, and so forth. But really, what to really put in your little mind and in your heart is this your life.

This is not just kind of a trip to the mall. This is really important for you to either improve the quality of your life or extend the quality of life, so take a deep breath, be very polite, and I think most doctors who are professional and open-minded will hear what you have to say if you present it in a way that they can hear. And if they really don’t hear you then it might be time to have a look around to see who will.

And, really, the bottom line is you need to trust yourself. And if you feel that this is really right, that there is a clinical trial that you would be eligible for and you can participate in with Dana’s help, with the financial, with the logistics, and so forth. Like I said, you just take a deep breath. And most doctors, like I said, really want the best for you.

Andrew: Okay, let’s talk about something that comes up. One of the things for people is the criteria of different trials. Dana, I don’t know if this is in your area, too, related to financial, but people let’s say okay, I wanna be in a trial, but the criteria are so narrow that I really wanna be in the trial, but they say I can’t.

Dana: Yeah, so that is a sad reality in many cases. And I refer to this as Clinical Trial Nirvana Syndrome where as a drug sponsor for trial, you want to attract the healthiest patients you can to participate in your trial, so that you have the greatest chance of success. But, unfortunately, in many instances, in most instances, a cancer diagnosis is accompanied by other comorbidities like heart disease or diabetes or other maladies that would preclude a patient from being able to participate in a trial.

So, that is an area that we are looking into and trying to – we have several proposals out there with various aspects of our government to try and really take a closer look at that, to try and make the trial makeup in relation to patient participants better mirror the realities of our situation because the likelihood of someone, if the drug gets approved, taking that drug and having a comorbidity is pretty likely.

And yet we won’t know what will happen there, right. So, we have to drill down on these issues and it’s a great, great issue to bring up. So, we’ve got a lot of work to do ahead of us.

Andrew: Right. And another thing that comes up too, and Kevin sent in a question. Kevin, thank you for this, matching what’s available in clinical trials to where you are in your journey with an illness. So, on Day 1 you’re diagnosed. I know Esther and I, we were crying and almost on the floor. And I thought I would be dead the next day. And it really took a while to overcome the terror of the diagnosis. And so, we were not even – well, the doctor wasn’t talking about trials; we wouldn’t have been hearing it anyway.

And some of us, thank God, with some trials, with some cancers now, are blessed with living longer and we start to learn. And then we want to know, in our situation, what applies to us. So, I know there are a lot of efforts being made to match trial offerings to where you are and what you might need to know now, what might need to be offering.

And some of you have heard this term, artificial intelligence, where we in the Internet business are all trying to fine tune what we’re suggesting or putting in front of you based on who you are and where you are, recognizing privacy and all those kinda things to make it more manageable.

We still have a long way to go. I mean, we have clinicaltrials.gov, but it’s not tied to where I am, who I am, where I am in my journey. It’s just what’s being done in a certain illness, right, Reina?

Reina: Yes.

Andrew: So, we have to refine our tools.

Reina: Absolutely.

Andrew: We have to refine our tools. Well, we’ve been getting in a number of questions. So, here’s one. So, David; so, he says as the excessive use of CT scans in clinical practice moves away from being the norm, have they lessened their use in clinical trials? In other words, this is about testing, and maybe it’s about the requirements.

Dana, I don’t know if you have feelings about it, but the scientists who are doing these trials, they wanna know everything. They would like to test us. So, the CT scan, and I mean I’m gonna have one next week, but it has radiation, right?

Dana: Right.

Andrew: So, let’s do a bunch of CT scans. No, let’s do a bunch of bone marrow biopsies. No. So, I’m saying I’m sorry. Not just do I have to pay something for these tests, or is there a co-pay or whatever, but also am I gonna be radiated? Am I gonna be poked? So, what about those issues? Is there dialogue going on, not just to help us financially, but also make it less onerous, I guess?

Dana: Yes, in fact there is dialogue going on about that, and it’s good, heartfelt dialogue. And it’s coming from a myriad of stakeholders, right, not just from patient advocacy organizations, but also from within industry insurers. And the whole goal is to okay, let’s stop looking at patients as a chart or a number on a piece of paper, and let’s understand that these are living, breathing human beings who are voluntarily participating in this clinical trial process for the benefit of not only themselves, but future patients to come and our industry.

And let’s start treating patients as humans who are participating, and let’s see what we can do to lessen the number of visits or minimize the number of scans and blood work, et cetera. So, there is active dialogue around that, and I think there’s a much higher degree of sensitivity on behalf of the teams who are actually putting the protocols together now.

Andrew: All right, I think so. And I know in some cases they’re doing what’s called trial simulations with a panel of patients and saying okay, we’re trying to answer these scientific questions and see if this drug that’s in development can do better for patients and would require so many office visits. Or so many, you come to the site, but so many could be done, maybe with your local doctor if that’s closer to home. So many blood tests, so many CT scans, so many biopsies. Imagine lung cancer patients with another lung biopsy. Not fun, and often not available.

So, there are all these kind of questions. And I think that’s going on although it needs to happen more. Now Dana, do you talk to the pharmaceutical industry? We had a question from Vi Life wanting to know related to trial awareness. Beyond the financial, do you work with pharmaceutical companies at all, as you are now, today? I mean, what we’re doing here is just to raise awareness about trials or other programs that you may do.

Dana: So, we are engaging with pharma right now. We were very fortunate to work with the FDA earlier this year in securing language around reimbursement of patients’ out-of-pocket expenses associated with clinical trials. There was some very nebulous language out there that was really preventing pharma from being able to support programs like ours.

And what we’re doing now is, in addition to we’re bridging this gap for patients that exist every day by reimbursing patients, but that is not a sustainable business model. It’s noble, but we have to have our tin cup out every day. And the number of patients we can help is directly related to the amount of money that we have in our account, right?

So, in addition to that program, our Lazarex Care Program, what we are also doing is trying to fix this problem and do it in a sustainable way. And in order to do that, we actually have to shift the burden from the patient back into industry, right, and help industry understand why they should include these out-of-pocket expenses as part of the clinical trial protocol every time, right, so they can enroll trials on time, on budget, save R&D dollars, preserve patent years, right?

I mean, there are a lot of reasons why pharma would want to participate in a program like that, in addition to the fact that it’s the right thing to do, right? And then we get more drugs to market faster, and we provide a platform of equitable access for everyone. So, we are engaging pharma in discussions right now about funding this program, we call Lazarex our IMPACT Program, that’s being rolled out at comprehensive cancer centers across the country. And it stands for Improving Patient Access to Cancer Clinical Trials.

It has been received very well and I’m happy to say that Amgen actually stepped up and funded this, so we are rolling it out here in California, and we are hoping that we’ll have similar opportunities in a couple of other areas in the United States. So, they are interested, and they want to improve clinical trial enrollment retention, and especially minority participation.

Andrew: Right. Boy, that you. Again, I keep saying thank you for what you’re doing, but you’re a real leader in the field. I’m going back next month to the Biden Cancer Initiative Summit continued by Vice President, Biden, former Vice President Biden, and his wife who continue to do leadership in this. And there’ll be a lot of senior people there and I’m hoping we can talk. And I know this issue of how can we advance cancer care through research in partnership with patients is a big one. So, Dana, thank you for helping lead the way in getting this going. And thanks to Amgen just as an example.

Reina, so, we talked about the cultural differences of people being in trials. We talked about the pride people may have in asking for assistance, the fear people have maybe participating in trials. You still have a – not now. I mean, you’re doing so well and you’ve been through trials and it’s worked out well. But there must have been some bumps along the way. Were there any misgivings at different times? And if so, how did you overcome it?

Reina: Oh, yeah. Well, there were definitely misgivings, I am sure. The first trial was when I asked the doctor if there’s something going on at the NCI. And there was no misgivings about that because that was a very observational trial. The second trial was much more progressive and I felt kind of a little uncertain about it, and so I asked the researcher at this well-known institution if I should participate because the trial, I should back up a little bit, that was for either smoldering myeloma patients or active disease patients.

At the time I was smoldering, and most physicians didn’t believe that that was a good idea to treat smoldering and wait until it became active. So, I asked this one researcher and he said absolutely, not, do not participate in the trial. And then I called someone else also from a very respected institution where I had been, and he said well, if you join that trial you’ll be crossing the Rubicon, which I didn’t even know what the Rubicon was at the time. I had to go look it up.

But, basically, once you start treatment, you kind of go on that journey and there’s no way to step off. But then I thought about it, I thought about it, thought about it, and finally I decided to trust myself because I had been to the NCI. I felt very safe there. And I decided to move ahead with it.

So, yes, I had plenty of misgivings about that. The other trials, not really because that trial changed my life and it gave me a very reasonable complete response. And the other ones, like I said, they just kinda fell in with the collecting a good amount of stem cells for a transplant and so forth.

Andrew: I wanna talk about family issues. So, the decision to be in a trial affects the family, whether it’s somebody’s driving you to the doctor, somebody’s taking off work, their worry, how they feel about trials, their own view of it, family logistics, costs, et cetera. We’ve talked about that. So, you wrote this blog about people questioning your husband, I guess, was your wife gonna be in a trial? So, how did you overcome that, whether if not with your husband, just with your community that you weren’t like crazy?

Reina: Well, they already know I’m crazy, so that’s a total aside. But, really, trying to educate people about the misinformation about trials; say, look, I will never be a guinea pig because that’s not what trials are about. And it’s very well controlled and there’s a lot of data that follows you. The care that I got was excellent.

And I try to dispel, like I said, a lot of the myths; that you signed consent form, which clearly explains what the trial is about, what your commitment to it is, and you can also drop out for any reason. There was hope that you don’t because they would like to have some results that then will lead into future treatments for patients. But you can drop out, so, really, taking that opportunity to educate people about what a clinical trial is like and that there are no guinea pigs.

Andrew: I wanna just – oh, yes, please, Dana.

Dana: Yeah, if I could just offer something in that regard. For people who haven’t gone down this path, the journey with cancer, having a cancer diagnosis is not like other chronic diseases, right, like diabetes, for instance, that you can typically control with insulin or whatever, right? For a cancer patient who has failed standard of care, who’s gone through maybe second- or third-line treatment options, but still has progressive disease, that patient will die if they don’t do something, right?

And so, clinical trials offer tomorrow cures today in some instances, right, and we don’t always have positive results in clinical trials. But for a patient who’s at that crossroad where their doctor has delivered those words, “You need to get your affairs in order,” right, it’s not a matter of am I crazy if I participate in a clinical trial. What it is a matter of is do I wanna live? And if so, what clinical trial can I participate in? It’s a very different decision tree.

Andrew: Right. And I certainly say that all the time. I got a call, as I mentioned, from a friend in Miami. The mother has a very serious cancer. And I said part of the initial discussion, even the initial discussion, Dana, can also be are there clinical trials that we should consider along with standard therapy? So, certainly, if you’ve failed or they’ve failed you, the treatments no longer work, what is the 360 degree view? And if you don’t do it here, so they do it down the road, or do they do it across the country? And what are the issues for you participating?

So, a lot of thinking, but it’s gotta be part of the discussion. So, so sadly now, what are we seeing; 3 percent, 4 percent, 5 percent of adults participating in cancer clinical trials in the US. Not good at all. And are we hurting ourselves with the chance of future therapies that can be more effective, or even cures because some of these companies sometimes are venture-backed. They don’t have money forever, you know, and they’re trying to get to the goal line to go the FDA.

Look, here is another question we got in. Tamara, our producer, just sent in. She says well, what happens when you join a clinical trial and it doesn’t have a beneficial impact? So, Reina, they didn’t know that the trials would necessarily work out for you. So, what happens then? Do you go on another trial? What do you do?

Reina: Well, if it doesn’t and you don’t seem to be responding to the therapy on the trial, or you find it intolerable yourself, then they will always return you to your oncologist who you had been seeing previously. But, on the other hand, they may offer you another trial that’s available that you would be eligible for as well. So, I mean, I really try to stress to people that the researchers are looking out for you. They want the best income, in addition to accruing the data that they hope.

And I can tell you that when I was on a trial at the National Cancer Institute, when I had questions, especially about the trial with smoldering versus active disease for myeloma, they would spend a couple of hours for me, explained with me, can I say that, right? Yes, spent a couple hours with me explaining all of the aspects of the trial, so yeah.

Andrew: I wanna point up an example that some people have heard of a woman I’ve become friendly with in the myeloma community, Reina. Cherie Rineker. So, Cherie’s down in Houston, and she was dying of myeloma. And she’d been in trials and treatments. She was at MD Anderson. Bob Orlowski is one of the top doctors in the world, and her doctor. And she was in different trials and then things were not working.

And she was put in touch with another researcher doing this CAR T investigation for multiple myeloma, which is pretty new, pretty new. And they’re learning a lot. It’s not a slam dunk, but so far it’s worked for her. It saved her life. She went to Nashville, Tennessee from Houston where she lives, and maybe I’m not sure the financial issues, Dana, about going. But that’s where she’d been in successive trials. And some were not working or no longer were working. There was another approach.

I wanna ask about another concept I’ve heard called siteless trials. And I don’t know, Dana, you’re nodding your head. Maybe you are familiar with this. One is a siteless trial because we talked about these trials going on at these academic medical centers, but not much elsewhere.

Dana: So, I have tell you, I don’t have a lot of experience with siteless trials, but there is a lot of dialogue taking place around rather than having the patient go to the trial, bringing the trial to the patient, and I think that’s the impetus behind a siteless clinical trial.

I think cancer has some unique challenges, especially blood-based cancers in clinical trials, and the oversight of patients participating in those trials that make siteless trials a bit of a challenge. But I think the place to start is in other diseases, or perhaps where you have a cancer diagnosis that’s not a rare form of cancer, whatever that requires, a high degree of oversight.

But the whole goal in doing this is to understand how we can get more people into these trials and make it less obtrusive on their life, right, so that more patients would be inclined to participate, increase our enrollment retention, our minority participation, and, ultimately, reduce the burden on the patient to participate.

Andrew: Esther and I’ve given a lot of talks at different conferences, and we said you have to see patients who might be considering or are in a trial as investors. So, they’re gonna invest with their body, their time, sacrifices, and other things in their lives for the hope of being cured if they could, or doing better.

And there needs to be the communication, financial support, logistical support in really treating people with a lot of respect as a person. Reina, do you agree with that, that we have to get to that concept where we’re taken care of? And you felt that way, but we need to do it for more people and have more people feel confident that it’ll work out that way.

Reina: Oh, certainly. Certainly, I do. And the education is really essential. And after I was in the first trial, I talked to everybody who would listen to me. And even if they didn’t, I would talk anyway just to try to say this is a place where you can go where you will receive what is hopefully the newest and the best treatment that’s available. That you will be cared for as well as you can possibly be, and that everything is documented. You know all the options that you have staying on the trial, giving consent, making sure you have all the information that you need to feel comfortable.

And Dana’s organization, hopefully, helping people out financially and logistically. There are ways to get into trials that at times are very successful. For me personally, I don’t know that I would be alive now if I had been on that trial, and that’s really my claim to fame, what can I say?

Andrew: And, Reina, I would say the same thing. Had I not been in a Phase 2 trial for chronic lymphocytic leukemia in 2000, I wouldn’t be around to have had retreatment last year, which has work quite well; 17-year remission. And I wouldn’t have been able to do this, and really have a purpose in life. So, I’m very grateful for being in the trial.

Dana, I can’t tell you – we were talking about gratitude, for you; came up in your family. You saw the gap for, not so much your family, but so many other families. The issues, financial issues, and you’ve been very philanthropic and, obviously, trying to have leadership in getting at some of these – we have a very imperfect system right now, so we have a long way to go. But for our viewers, if you’re living with cancer now, if your loved one is living with cancer, there are resources, people like Lazarex, people have been through it, like Reina.

We’re gonna give you this downloadable guide. And you’re gonna connect with these resources. Don’t… Put your pride away. Dana said it so well. There’s a very high likelihood we’re gonna be affected by cancer in our families, and there is help to navigate what’s kinda complicated right now, but is doable and can offer you the chance of doing better. Dana, did I say it right?

Dana: You did. You did. You did a great job, Andrew. Thanks.

Andrew: Okay. Well, thank you. And thanks to the Lazarex Cancer Foundation and, really, all you’re doing. And let’s hope that we can improve this process, increase participation, and have so many of these companies and the government that are trying to get scientific answers. We participate as respected patient investors. And we do better well. Reina, any final words from you with your 50th wedding anniversary coming up?

Reina: I’m very grateful. I’m very grateful to be here. I’m grateful for all the clinical trials, all the physicians who have taken care of me and who listened to all my concerns and fears. And I am super-duper grateful to my husband who has supported me, helped me, been there, been my caregiver, and washed the food for me when I had the transplant, and really, all the people who have been on the journey with me. So, if you are considering a clinical trial, if there is one that you might be eligible for, give it some thought. It’s a really important choice for you to make.

Andrew: Reina, thank you so much, all the best. Happy anniversary, early. Dana, best to you. Dana Dornsife, joining us from the Lazarex Cancer Foundation in the San Francisco Bay area. Dana, good health to your family, and thank you for all you do. Thanks for being with us, Dana.

Dana: Thank you.

Andrew: And, Reina, all the best, and thank you for those great words of wisdom. And we’ll meet in person sometime and I’ll give you a big hug, okay?

Reina: I hope so. I hope so. You take care of yourself, Andrew. Thank you so much.

Andrew: Thank you for joining us for this Patient Empowerment Network program Clinical Trials Mythbusters. We hope to do more. I wanna thank the companies that have helped provide funding for it; Abbvie Incorporated, Astellas, Celgene, and Novartis, for their support.

Thank you for joining us. I’m Andrew Schorr from Patient Power down near San Diego. Remember, knowledge can be the best medicine of all.

Notable News – July 2018

There is some seriously risky business being reported in July. Meal times, diabetes, and bitter-taste sensitivity are all now being linked to a higher risk of cancer. Not to mention what researchers say the risks of complementary medicines might be.

There was another significant risk factor recently revealed, says dailymail.co.uk. A study of 20 million people conducted by Oxford University found that having diabetes increases your risk of cancer. Women with diabetes were 27 percent more likely to develop cancer and men were 19 percent more likely. The study, which included both type 1 and type 2 diabetes, showed that women with diabetes were more likely to develop leukemia and kidney, oral and stomach cancers. The men had a higher risk for developing liver cancer. Diabetes also puts people at risk for heart attacks, strokes, and dementia. You can read more about the findings and diabetes risks here.

Still another new cancer risk factor for women was reported by sciencedaily.com. It was discovered that women who have a high sensitivity to bitter taste also have a high cancer risk. The study tracked the diet, lifestyle, and health of 5,500 British women for 20 years. The women were divided into three categories of bitter sensitivity: super-tasters, tasters and non-tasters. The super-tasters had a 58 percent greater risk and the tasters had a 40 percent greater risk of developing cancer than the non-tasters. Researchers hypothesized that lower vegetable consumption would be a cause for the significant increase in cancer risk for the tasters and super-tasters, but their theory was not proved by the research. Researchers continue to suspect a relationship between diet and cancer risk and hope to further study the overall diet of the tasters and super-tasters to try to determine the connection. More details about the study can be found here.

Alternative medicine may not put you at risk for cancer, but it may increase your risk of dying from it, reports nbcnews.com. A study done by the Yale Cancer Center found that treatments commonly referred to as complementary medicine, including the use of herbs and homeopathy, aren’t harmful when used with standard, conventional cancer treatments, but if the complementary treatments are used instead of the conventional treatments, patients are twice as likely to die from their cancer. The patients who were most likely to use the alternative treatments were young, affluent women and the researchers noted that doctors should use the information from the study to make sure they are meeting the needs of their patients who may turn down standard treatment in favor of alternative treatments. Researchers also acknowledged that alternative treatments such as yoga, acupuncture, and meditation can help to improve a patients quality of life and if they make the patient feel better they should be encouraged to use complementary medicine in addition to conventional treatments. You can read more here.

Make sure you aren’t at risk of missing out on the latest and most compelling cancer-related information. You can find it all here at powerfulpatients.org.

Clinical Trial Mythbusters: Does the Clinical Trial Process Need an Extreme Makeover?

Does the Clinical Trial Process Need an Extreme Makeover?

Clinical Trial Mythbusters: Does the Clinical Trial Process Need an Extreme Makeover? from Patient Empowerment Network on Vimeo.

Downloadable Program Guide

Many cancer patients feel that the clinical trial process is in need of a serious makeover. One of them is Jim Omel. Jim, a retired oncologist living with multiple myeloma, turned patient advocate, makes it his business to understand myeloma from the inside out. He joins this program to share his experience in clinical trials and how he learned about his vulnerabilities as a cancer patient.

Also joining the discussion is, Dr. Michael Thompson, medical director for the Early Phase Cancer Research Program at the Aurora Research Institute and an active clinical researcher developing new treatments, particularly early phase (Phase I and II) molecular biomarker-driven clinical trials.

Join us for a meeting of the minds on debunking myths around clinical trials. How are patients protected within a trial? Will I as a patient be lost in the clinical trial system? Can I select my own arm in a trial? The questions are endless and, left unanswered, contribute to the barriers to trial enrollment.


Transcript:

Andrew Schorr:

Welcome to this Patient Empowerment Network program. I’m Andrew Schorr from Patient Power. I’m joining you from near San Diego, Carlsbad, California, and I’m so excited about this program, Does the Clinical Trial Process Need an Extreme Makeover? Having been in a clinical trial, and I’ll talk about my experience in a little while. I am a big fan, but I know that people have concerns, and I know that the percentage of cancer patients who are in clinical trials among adults is very low. How does that affect drug development and having the chance to get closer to cures for us?

I want to thank the financial sponsors for this program who provided assistance to the Patient Empowerment Network. They are Celgene Corporation, Astellas and Novartis. They have no editorial control, so what happens in the next hour is what we say, the questions you ask, what we hear from our experts who are joining us.

If you have a question, send it in to questions@patientpower.info. Again, if you have a question, send it in to questions@patientpower.info, and our wonderful producer Tamara will take a look at it, forward it to me, and as we can over the next hour we’ll be discussing questions you have already sent in. And we’ll have a very inspiring, I think, and provocative dialogue between our experts.

So let’s meet them. I want to take you to Grand Island, Nebraska, where my dear friend Jim Omel is there. He’s a retired now family practice physician. And, Jim, for years you’ve been a myeloma patient. When were you diagnosed with myeloma, and what’s happened along the way? You’re taking regular treatment now, I think, some treatment for the bone complications. How are you doing, and when were you diagnosed?

Jim Omel:

Andrew, I was diagnosed in 1997. It started off with a plasma cytoma at T10. I broke my back, I underwent a stem cell transplant in 2000 and had six years of remission. It came back in 2006, and I had radiation and lenalidomide (Revlimid), and it went away a while. Came back again in 2010, and I had radiation, bortezomib (Velcade), Revlimid, dex, and it went into remission. And since then, Andrew, I’ve been so fortunate that all I’ve been taking is bone-protective bisphosphonates.

Andrew Schorr:

Oh, good for you. Now, you were in a trial, but you decided not to continue, but yet you’re a believer in trials.

Jim Omel:

Oh, absolutely. Without trials our treatment wouldn’t change. When I had a full evaluation at Arkansas they suggested that I join their trial, and I did, and at the end of that trial was a tandem transplant. And I got to thinking and reading, and I didn’t really want to get that extent of treatment. I had a single transplant, and I dropped out of the trial. And that’s one of the things that I would certainly tell our listeners, that they can stop a trial at any time. They’re not bound to it. Ever since then, Andrew, I’ve had the good fortune of having fairly responsive myeloma, and when I had my treatments they responded to standard therapy. I certainly would have rejoined another trial if necessary, but I was fortunate that it responded the way it did.

Andrew Schorr:

Okay. And before we meet our next guest, I just wanted you to list some of the committees you’re on, because you’re very active locally and nationally on behalf of patients. So what are some of those activities you’re doing?

Jim Omel:

Well, I’ve been doing this since about 2000, so that involves a lot of activity. Peer review with the NCI was one of my main ways to get started.

Andrew Schorr:

National Cancer Institute.

Jim Omel:

Yes, and I progressed on to the Board of Scientific Advisors, which was a really good, important work with the director of the NCI. I’ve been an FDA patient representative for many years and was on the advisory board that brought Kyprolis or carfilzomib to us. I spend a lot of time each month for sure with the Alliance Cooperative Group working with Paul Richardson as we bring you new trials to patients. I’ve been with CINBR, Center for National Bone Marrow Transplant research for several years, several advisory boards. I’m on two pharma accompany advisory boards as they seek patient input.

Andrew Schorr:

Wow. All right. Well, the point of this, what I wanted our viewers to get, is that Jim is—trained as a physician, worked many years as a family physician, became a patient, eventually had to retire. He’s been through a lot of treatment and is very much an advocate for all of us, particularly in this process of trials. So we’re going to talk about the unvarnished truth about trials and see how we can make it better. Okay.

Let’s skip over to Milwaukee, Wisconsin, where we’re joined by Dr. Mike Thomson, who is very involved in research, and Mike has been very involved in all sorts of programs related to education. So, Mike, first of all, welcome to the program, and tell us a little bit about your involvement both locally in research and in education of other physicians nationwide and worldwide.

Dr. Thompson:

Sure. So not as impressive as Jim, but he’s one of my heroes who has really dedicated himself to improving the clinical trials process. I have an MD, PhD. My PhD is in pharmacology, and I was interested in pharmacogenetics and how individuals vary in their response to drugs, especially cancer drugs. I did my fellowship at MD Anderson and worked with a lot of myeloma doctors there and have worked in the community setting seven years in one place and about five years now where I’m located at and Aurora Healthcare in Milwaukee. I have been on the NCI Myeloma Steering Committee. I’m currently on the NCI lymphoma steering committee. I helped organize the ASCO 2016 meeting. I was the Chair of Education. As of June, I’m one of the editors for cancer.net around myeloma, so taking over from Paul Richardson who did that. So I’ll have about three years doing that and probably asking people like Jim for help to provide educational materials for people. And in the world of myeloma, I’ve created the MMSM or Multiple Myeloma Social Media hashtag to have Twitter chats, which I know some people don’t think are the optimal form of communication, but it is a way to get information out from experts and some opportunity for patients to ask questions. So I’ve been highly involved in social media, highly involved in the NCI and NCORP for increasing access to clinical trials in the community. And right now I am in the middle of an NCI designated clinical trial called EAA172 for multiple myeloma, which has gone through ECOG Executive Committee, the NCI Myeloma Steering Committee, and now we’re discussing with the companies and with Ctap how to bring that forward. And I think that’s—one of the things is how much effort it takes to bring some of these trials from concept to activation.

Andrew Schorr:

Okay. Now, we’ve mentioned this more rare cancer, multiple myeloma, not rare if you have it, but Jim has it, Mike specializes in it a lot. But what we’re talking about applies to the clinical trial process about broadly. So we may have people with us living with lung cancer and hoping to live longer and better, prostate cancer, chronic lymphocytic leukemia, like me, are also myelofibrosis. I’m a two-fer, if you will. There may be many different cancers among our audience, and the process applies to all. So we’re going to talk about that. So whatever it is, ask your questions, questions@patientpower.info. I’m just going to share a little personal story for a second, because I’m very passionate about it, and I wanted to mention it. And this is part of our Clinical Trials MythBusters series, and we have previous programs on Patient Power with lung cancer experts, experts in other conditions about the clinical trial process, so look that up on patientpower.info. There will be a replay of today’s program and also a downloadable guide with highlights that you can share, talk about it with your doctor, with other patients, with people you know and for your review. Okay.

So now my own story. I was diagnosed with chronic lymphocytic leukemia, the most common adult leukemia, in 1996—terrified, had no idea what it was. Didn’t know anything about what a trial was, didn’t know what the treatments were. Quite frankly, thought I’d be dead like within a week. I didn’t know. And so you start getting educated, and eventually that led to me connecting with academic medicine specialists and ultimately suggestion at the appropriate time of being in a Phase II clinical trial. I didn’t know what the phases were, we may talk about that along the way, and it was 2,000 miles from my house. So I traveled a number of times to be in that trial, and I had my local oncologist collaborating on that. And the end result was I had a 17-year remission. I had treatment again for chronic lymphocytic leukemia. It wasn’t until last year, 17 years. And I got the combination of medicines 10 years before that combination was approved. So I’m a believer.

The second thing I’d say about trials was I was in a second trial along the way, and I had deep vein thrombosis, blockages in the veins in my legs, for a blood thinner trial. And by being observed in that trial, that led to them discovering a second cancer which was at work related to those clots, myelofibrosis, and I was observed, so I liked the attention. It had nothing to do with what they were testing. It had to do with the observation you get. So, again, I love the attention of being in a trial. It may give you access to tomorrow’s medicine today, but there are things that may be broken. So, Jim, let’s start with that. Jim, what has been some of the frustration points for you the way the process has been today?

Jim Omel:

Well, I think one of the main things, Andrew, is that clinical trials tend to be designed to answer scientific questions. I think what they should do is be patient friendly. I think they should be designed to help patients. If you ask any researcher, what is the purpose of the scientific trial, clinical trial, they will say, to answer a question. If you ask a patient, they’ll think the purpose of the trial is to help patients. The—it may seem like a minor point, but it’s not. Patients need to be the center of them. We need to help patients understand what their contribution is to a trial. For instance, hardly ever does a patient hear how their outcome, what they did during a trial improved the final outcome of a trial. The patient needs to be centered. If we get the trial to a point where some of the questions are pretty obviously answered, rather than continuing to recruit patients just to be statistically valid, I think trials should close sooner. I think they should be more focused on getting patient care without necessarily the scientific question. I’m not a radical. I’m certainly a fan of trials. We wouldn’t be where we’re at without trials, but I think they should just become more patient-centered and patient-friendly.

Andrew Schorr:

Okay. Now, Mike, Dr. Thomson, so we know we can’t have new drugs approved by the FDA unless there are trials, Phase I, Phase II for sure, and often, typically, Phase III and sometimes even monitoring after a drug has been approved. I think you call those Phase IV trials. But from where you sit having been around this a long time what are some of your frustrations? What would you like to see be improved?

Dr. Thompson:

I agree a lot with Jim. I think another word to put on it is pragmatic trials. So I’ve been on a number of advisory committees, NCI investigator-initiated studies and pharma-directed studies. And when you have an advisory group with a bunch of academics they often think about the theories, and they think about what would be interesting to know. And increasingly both the NCI and others are getting not only patients but community physicians who will say I don’t really care about this question here. And we don’t think that it will fly and won’t accrue, and we know a lot of trials don’t complete accrual, so therefore patients are wasted, if you will, because we won’t have the information, we won’t be able to answer questions. So I agree. There are so many things get to involved it’s hard to break them all down, but part of the issue is answering a clinically meaningful question. I think the meaning should be patient-centered. Within those questions you can ask scientific questions that are imbedded in what are sometimes called secondary imports or co-relative studies. But I just last week was talking to some pharmaceutical leaders, and I said, you have to design a trial to answer a question people care about, and that’s patients and physicians. Because sometimes the trials are designed to get FDA approval, and they’re comparator arm if it’s a randomized study, is an arm that we don’t think is the current standard of care, and we have to do them in countries where they don’t have as many therapies and they don’t have as much access, so they’ll get them done. But then when they’re approved in the U.S. we don’t know what to do with the trial, because it’s not a question we’re asking. So that’s important. And I think if more studies are done not to get FDA approval but to go on pathways and to ask, what are the clinical branch points for decision-making, I think that’s when you’ll start getting good trials.

There are a number of other issues around the pragmatics. So there’s this NCI Match study, tons of people screened, very few people on the matched drugs, and they switched over to a strategy more like an ASCO TAPUR, where they waited for people that already had testing and then the people that had already kind of pre-screened couldn’t get evaluated for the study. And many, many more people went on study. The imaging and other things in the middle were not as rigorous as a usual clinical trial. It rolled quickly, and I think the point is you’re looking for big end points. Where you have to sort of go back to the classical, randomized, Phase III large study is when you’re trying to make incremental improvements, so, for instance, breast cancer where the cure rate or progression-free survival rate may be in the 90-something percentile rate, or even CML or other things where we’re doing so well you’d need a lot of patients and probably a standard design. But in many other areas you can do a variety of different techniques—Bayesian analysis, continuous reassessment models.

And one thing Jim mentioned was stopping for futility or if there’s an obvious benefit, and that is done but probably not as often as it should be. And the designs using what are called interim analyses or futility analysis with data safety monitoring boards or DSMBs, probably could be more robust. There could be more of them. I think people are afraid to do them, because they do slow the trial down, they slow accrual, and that has to do with stuff both within the trial as well as extrinsic to it. So there are a number of barriers and issues, but I think Jim’s pinpointed them as well.

Andrew Schorr:

Okay. Well, folks, you can tell that Dr. Thomson is a scientist. We’re going to unpack this and get down to the nitty-gritty. So, okay. So, Jim, so first of all, we mentioned this term “randomization.” So people wonder in cancer am I going to get the good stuff? I know that I’m sick, maybe like in your area, multiple myeloma, there have been lots of new medicines, but in some other areas not, like pancreatic cancer, for example.

So, say, I understand the standard therapy, and you’re testing it maybe against that, but I want to get the good stuff, because I’m really hopeful. I want to be a believer. So could you just describe where we are with randomization, because that’s a concern people have?

Dr. Thompson:

Absolutely, Andrew, and thanks for asking that question. That’s a real red, red hot button item for me. I maintain that if the patient has gone through the effort of studying their cancer, studying the possible treatments, and they’ve learned of a trial that’s opened that they would qualify for, they’re excited, they go talk to the principal investigator, and they say I want to be in this trial. And the PI turns to them and they say, well, we’ll flip a coin. You may get the medicine we’re going to be using, or you may get standard therapy. Just imagine how disappointing that would be. And when it comes to randomization, Andrew, there’s many, there are many trials that absolutely lack equipoise. And I’m afraid that scientists often use equipoise.

Andrew Schorr:

Now, tell us what that means. You’ve got to define that for us.

Jim Omel:

Equipoise basically means equal, equal balance within the arms. In other words, technically, officially the principal investigator doesn’t know which arm is best. And yet look at it from the patient’s standpoint. Let me give you an example. There was a trial in which patients had the choice of three oral drugs in one arm versus a stem cell transplant in another arm. Now, think about that. Think of the insurance ramifications. Think of the fact that it takes almost a year to really totally recover from a stem cell transplant, versus taking three oral drugs. How can anyone say that there’s equipoise in a trial like that? So how can you pattern your life with the flip of the coin or a computer randomizing you into one of those arms?

Andrew Schorr:

Wow. That’s, that’s an important issue. Another one is, Mike, you know, people are—one of the ladies wrote in on Facebook I posted about this program, and she said, well, the trials are not really accessible to me because I live in a rural area, and they’re only in the big cities. You’re in one, Milwaukee. But Jim’s in Grand Island, Nebraska, and some people if you set requirements for the trial, well, you’ve got to come see me, you’ve got to come to the clinic for a variety of tests with some frequency and somebody has to drive four or five hours and take off work and get babysitters and all that, it just makes it impractical. Where are we with more trials being available or having an aspect of it, like testing, closer to home?

Dr. Thompson:

So I work at a community setting. I’m at our kind of flagship hospital but we cover most of the population centers of Wisconsin, so I think we cover about 70 or 80 percent of the population. So that’s a huge issue for our site is that we—when I talk to sponsors including as recently as last week I say if we can’t do it at all our sites I’m not really interested in doing your trial.

There are exceptions of course. We’re doing a surgical trial or a radiation trial that has to be at one site or sometimes a Phase I trial with just a lot of blood monitoring, very intensive, they can only be done at a few sites. But in general I completely agree that we should try to have the drugs available to people in the community they live in, because that’s where their social networks are, right? So that’s where their family is. They can stay at home. They don’t have to just go into a hotel. They don’t have to pay for travel, and I think it’s better for everyone. And for companies, I’ve been trying to tell them that it’s more generalizable to the reality of where cancer patients are. So

85 percent of cancer patients are in the community setting and are treated there, and drugs should be accessible to them there. So, you know, both the using the CCOP mechanism or NCCCP, and now we have the NCI Community and College Research Program or NCORP. The whole idea is to increase that access to community sites. So this has been going on a long time. I think there were budget cuts, and so the U.S. and the way we’ve established our cancer budgets has been to decrease access at least NCI trials and usually need some of those NCI trials to support the research infrastructure to do other studies. So I think part of that, you know, a lot of these things you follow the money. And if there was more money for community research sites, you could hire more research staff to get these things done.

But I think we need to get them done in the community, because we know if you do early phase studies and they look promising in highly selective patients, then when you expand them and put them in the community you go from efficacy to effectiveness, and the effectiveness isn’t there because the patients are different. So there are all these things with real-world data and comparative effectiveness research at ASCO’s cancer link trying to get at some of that not on study to just try to get the data.

But we need to have access to people, and the way to make drugs cheaper, make them develop faster and answer more questions, both scientific and patient-oriented, is to get more people on trial. There’s a big example for immunotherapy drugs where there are so many immunotherapy drugs and trials there are not enough patients to get it done. So we’re going to enrolling in trials which don’t complete, or we’re not going to be able to answer these questions, so it’s going to stall and move it out the process of moving faster. In myeloma, we move very fast, but we need to do this in other areas too.

Andrew Schorr:

Right. So let’s talk about that. So, Jim, you know, the president had a big kick-off, HHS Secretary Azar I think just yesterday as we do this program, was before Congress and part of it was the discussion of can we lower the cost of drugs ultimately? And one aspect of it is can we speed drug development. So instead of all these trials languishing at the cost of millions of dollars, hundreds of millions of dollars, how do we speed it up?

So one is participation, certainly, but can the process be simplified as well, Jim? What work is going on there, so we can try to get these answers and get to the FDA and present the data quicker, and hopefully there’s been lower cost in getting to that point?

Jim Omel:

Well, as we’re learning more and more about each individual patient, personalized medicine and targeted therapy, we certainly should start relying more on biomarkers. Biomarkers can be a way to select patients that would particularly fit a given treatment.

We need to lower costs. We need to make trials slicker and faster. Single-arm trials are those in which a patient just get—all the patients get the therapy. They all get the same treatment. And FDA has actually approved drugs based on single-arm trials, a much faster and efficient way to get an answer.

The problem is that the costs are going to be there. When I think about Mike and all the work that he does in developing his venetoclax (Venclexta) trial that he mentioned, Mike has put in months or years, and it’s all above and beyond his normal time. I mean his day job is to take care of patients, so all of the work that he does to develop a trial is just remarkable in the extra hours it takes and the consistency that Mike gives to doing his work. We need to make the trials more efficient.

We need to use biomarkers. We need to make them shorter. We need biostatisticians to come up with ways to give us an answer without having to approve so many hundreds or thousands of patients to all these potential new treatments.

Andrew Schorr:

So, Mike, let’s talk about that. And, Mike, first of all, I want to thank you for your—well, both of you, but, Mike, certainly in the clinic, thanks for your devotion to this.

But continuing on that, so this was brought up by Jim, biomarkers, and I know in some of the blood cancers now we’re talking about more and more minimal residual disease testing, and we’re doing genomic testing to see what genes have gone awry, what’s our version of lung cancer or a breast cancer or a myelofibrosis or whatever it is.

And then do we qualify for a trial? What’s our specific situation? Do you feel that that sort of precision medicine testing and analysis can help refine this, so we know which trial is right for which person at which time and also some analysis along the way of how is it going?

Dr. Thompson:

Yeah, so at my site I’m the director for precision medicine, and I gave a talk at ASCO on precision medicine and barriers in the community setting, so I’m very passionate about that. And I think that is one of the ways you can try to get things done with smaller numbers of patients and things done faster. And part of this is alignment, right? So there’s different perspectives, a patient perspective, a payer perspective, a pharma sponsor perspective, the physician. There’s all these different perspectives, and I think it’s trying to get them all aligned and trying to get things done faster.

So, you know, there are some areas where we don’t know enough, and we can’t use biomarkers. But there are other areas where we have a biomarker, and there’s feasibility, and we can test that quickly. And if we are looking for a large effect size—here I am in jargon mode—but if you’re looking for a big, big hit, a home run, is to look for an alteration that is very specific and we think is—a drug can target. So-called targeted therapy—it’s a little bit of a misnomer.

So—and lung cancer has been one of the hottest places for this. So there’s ALK inhibitors, ROS1 inhibitors, EGFR inhibitors, and now BRAF inhibitors, HER2 targets. So lung cancer has exploded with precision medicine therapy, and the same with melanoma and BRAF. So, you know, I think even skeptics will say you don’t really need statistics if the prior therapies, nothing worked, and you give something, and 80 percent of people respond.

There are issues with precision medicines, but the main thing is not response rate but durability. And I think that’s going to be the next iteration of the NCI Match study, which is a large precision medicine study, is stop doing just these small groups of people who are showing activity, but then they relapse quickly. And I think it’s going to look at systems analysis, and how do we overcome resistance.

But one way to get at this and another different take on it is inclusion and exclusion criteria. So this has to do with access and individualizing and being patient-centric. Many of the inclusion and exclusion criteria, when somebody says, oh, I have lung cancer, oh, here’s a lung cancer trial, and they say, oh, you can’t go on the trial. And much of that is because there’s language that’s been cut and pasted from a previous trial which is not really pertinent.

So if the new drug is metabolized by the kidney, you don’t necessarily need to look at the liver studies. And we did a small study or I was aware of a small study done by Kaiser where if we improve the inclusion-exclusion criteria, accrual rate can go up 30 percent—so no cost to that.

Andrew Schorr:

Wow.

Dr. Thompson:

And Ed Kim led a publication about six journal articles in JCO about different aspects of inclusion-exclusion criteria including function, HIV status, age, etc.

Andrew Schorr:

Well, yeah. We had Ed Kim on the program just a week ago, as a matter of fact.

So, Jim, inclusion, exclusion, so first of all, we’re in this age where electronic medical records, it would seem that at your fingertips there could be some analysis of your record and some matching or offering of trials that could come out of an analysis of your results, genomic results. Do you have ALK or ROS or whatever, if it’s lung cancer, whatever it may be maybe JAK2 positive in myelofibrosis, what is various status for us?

And also broader inclusion criteria, and Mike was getting at that, saying some was just—excluding was just cut and pasted. And a lot of us patients would feel, well, that’s just unfair. So what’s your comment on all that, about inclusion and exclusion and analysis so we can be matched with trials more easily, can be offered to us?

Jim Omel:

Inclusion and exclusion criteria are really important parts of trials. They’re what get people into trials, they’re what keep people from being in trials. And, unfortunately, Andrew, many times the criteria are very defined, very narrowed, and drug companies especially want to do it this way to get the best effective appearance of their drug. They want to get approval. And yet in the real world, in fact most times, patients who would not even need inclusion criteria are the very patients that are going to be taking these drugs.

And Mike’s right. There’s too much cut and paste. If a trial takes a thousand patients to write a proposal or protocol, too many times researchers will just take the exclusion criteria that might have been from a previous trial and, like Mike said, cut and paste it when perhaps it’s not even necessary to have creatinine values or kidney values measured so precisely on this particular drug compared to the other one.

So those are the criteria that let people in or keep people out of trials, and they absolutely need to be widened. To make a drug more applicable to the general population we need to reflect the general population more in trials.

Andrew Schorr:

Right. Right. It’s sort of a Catch-22. So if somebody is at a drug company and they’re investing hundreds of millions of dollars maybe to develop a drug, and then that trial is languishing or taking longer to get there, somebody ought to go back and say, well, can I loosen up this criteria, get the big answer and do benefit to patients who may be very willing to be into a trial that doesn’t have all of these requirements that are not really necessary? And we get the answer and get it quicker, and help people along the way. I mean, it’s pretty obvious to me, and I hope they’re watching, folks.

So, Mike, here’s a question for you, though, and you work with people in the community setting. So we have patients who have written in and said, you know what, where I go to the cancer clinic they never mentioned trials to me, and Jim alluded to the extra time it may take for physicians and their teams is when there are trials. You have just treating people with current therapies, and then you’ve got research layered on top of that. It’s very time consuming.

But what about just awareness at the community level? What can we do about that so that wherever I go into a clinic they have a clear picture of what I’m dealing with, and if there is important research going on that relates to me I hear about it? Now, maybe they say, you’ve got to go to a university center, you’ve got to go to Milwaukee, wherever you have to go, but there’s that discussion.

Dr. Thompson:

Yeah, so with all of these, you know this has been analyzed in multiple different papers. We were on one looking at a trial log, trying to look at some of these issues, and what seems to be clear is when people are offered trials they tend to go on them at about the same rate, and that has to do—seems to be somewhat independent of socioeconomic status, race, etc., or geographic area.

So one of my colleagues, Dr. Verani, told us about—about this, about rural settings how do you get people on trial. So there are different barriers. So one is the trial, and like Jim said, if you can only do some therapy that you have to come in quite a bit for that limits the geographic area you can accrue to for most people.

There are site issues where if you don’t have enough research staff to be there enough the doctor doesn’t feel supported to spend time on it. There are physician issues where they may not care about trials, or they have too much people scheduled in clinic, they’re an hour behind, and they can’t stop to spend time on it.

Also in the community setting you may be seeing every type of cancer, and you can’t remember everything, versus at many academic settings you may only see one or a cluster of types of cancer. So if you’re seeing lung cancer all day and you have 10 trials open, you probably know those trials very well for lung cancer, because you don’t care about the CLL or myeloma trials, you only care about lung.

And then there are patient factors. So patients that are in rural Wisconsin may have different characteristics, and the reason they’re in rural areas, you know, the motivations is about, you know, going in for things and stuff like that may be different than people who have the capabilities to fly to Boston or Houston or New York, and they can do that. So all of those areas are important.

Now, one potential way to help mitigate some of those things is we have got a clinical decisions support tool, which is an IT product, which our physicians have to enter in what they’re going to do with the patient. So it could be observe, no treatment, hospice or various therapies. And when they put in the cancer and the stage it pops up with the clinical trials, the first thing that pops up. And so the physician doesn’t have to do the trial, but they have to say why they’re not doing it. And so we can track over time. It doesn’t necessarily help that individual patient, but that doctor has been aware of the trial, and we kind of get an idea of why people are not going on studies, and so that’s one way to do it.

Something we just did the last week is we had a different IT product where the NCI-matched precision study opened up five new arms with different targets for different drugs. So we looked back at the number of patients that had those targets identified within our entire system, and then we screened those to see how many people were still alive, and were their organ functions still good enough to go on these trials because of the inclusion-exclusion criteria, and we found several. So we’re now able to contact the physicians and the research staff to go back for these patients that had screened for molecular testing and now they have new options.

So I think there are IT issues that you can do systemically to try to take some of those barriers away, and then each of those points does have barriers which probably have different solutions and different ways of tackling. But one reason, you know, the accrual rate hasn’t gone up a lot is it’s not easy. It’s a complex problem, so there’s not going to be one single thing you do. There’s going to be many different ways to try to improve things, including patient education.

Andrew Schorr:

Yes, well, okay. To let’s flip that over. Jim, you and I are patients. So what do we want to say, and from your perspective?

So back at the clinic and from group has, so Mike is working on IT to identify trials and have it pop up on the screen for the doctor. Okay. Great. But we’re the ones living with the condition. What can we do so that promising research that we may learn about is available to us? We can see whether it matches up with us. Maybe we have to go down the road. Maybe we have to have a discussion with our doctor to even encourage them to have you us be in a trial. How do we make it happen, okay?

Jim Omel:

Well, of course, we all need to educate ourselves about our cancer. When I was in medicine school I had heard about myeloma, but I certainly wasn’t any expert in it. I had two patients in my practice that had myeloma. I knew sort of how to take care of them. But since I developed my myeloma, I have become my own expert. And as I lead my support group, Andrew, I make them experts. I teach this cancer to them so that they can make educated decisions.

Patients are very likely to go on the Internet, watching Patient Power. In my particular cancer, they’re going to go to the IMF and MMRF to look at myeloma trials and see what’s available. And they will take that information to their doctors, many times making their doctor aware of trials that perhaps they aren’t each advocating or aware of.

So, Mike’s right. There are many factors that keep patients from trials, but one of the things that patients really do themselves is educate themselves and perhaps even to the extent of bringing or educating their doctor about what can be available for their treatment.

Andrew Schorr:

Mike, I want to ask you about cost. So you mentioned different inclusion, exclusion, or what’s your liver function or this or that. So there is a problem where maybe certain drugs or certain aspects of a trial are covered, but then your insurance company, you know, that you have or Medicare or whatever, they say, oh, no, we don’t pay for that, but yet it’s part of the trial or it goes along.

So people have a concern about cost. I want to ask you about two aspects of cost related to testing sometimes. And then also are there programs that can assist with the logistical costs for patients as well?

Dr. Thompson:

So when I trained at Mayo Clinic and MD Anderson, and when I got—first went into practice I prided myself in not caring about cost. And then I realized you have to think about these things because you can bank—you know, we bankrupt, about 40 percent of people with cancer get bankrupted. So these are huge issues for people who want to keep their houses, that want to hand something down to their kids, and cost is huge, right? So that can either be throughout the whole course of standard treatment, or it can be trying to meet the cost of going places, trying to find clinical trials.

So the Affordable Care Act and various other national and state legislative initiatives have tried to make insurance companies pay for the standard costs in clinical trials. There are some carve-outs for smaller companies and things like that, and so this is, you know, not perfect, but in general insurance companies should pay for the standard cost of clinical trials. They should pay for standard imaging stuff too, and they try to get out of that. So it’s not a perfect world, but that should be covered. And any research-associated costs should be covered by the company. Even in some NCI trials some people disagree with what should be covered and isn’t, and it’s complicated. But in general, a patient, the research cost should be covered.

Now, that does not include travel, lodging and a lot of incidentals. So there are a variety of foundations, that could be The Leukemia & Lymphoma Society, that could be other organizations which could help with that. Individual hospitals or health systems might have ways of approaching that. And sometimes there are things you can do within the various companies. So there’s a new target called Entrek, and the company Loxo, I’ve heard will fly people who wherever there’s a site and pay for them to go on the study, which I think is amazing. That’s not true for every company and every drug being developed. But that’s one way to do it.

One of the issues that comes up with IRBs if you’re giving people money, are you coercing them? And, you know, if you’re just recovering the cost to travel, I don’t think you are, right? But those are one of the things that come up. But certainly there are lots of disparities. And just like in different countries, they don’t have access to the drugs we have as standard drugs here, and not all of these disparities are going to be fixed because we have—outside of cancer we have lots of disparities in the United States, but cost is a big issue.

And then value, which we’ve been increasingly talking about in the oncology community, which is utility over cost. And that’s more for once we’ve done the trial figuring out even if shows like it works, how do we figure out how to use it based on those characteristics?

Andrew Schorr:

Thanks. And also I wanted to mention that Mike Snyder is sending that question, answering why it cost so much. I hope that answers it.

We have—you know, some people wrote in as we were preparing for this program and they were bitter because they thought they had a spouse, let’s say, that had died in a clinical trial. And that relates to a couple of things. One is transparency. Is the data from a trial and any dangers that show up, is that reported and analyzed in public, Jim? And also what are the risks being in a trial, and what is the monitoring to try to have trials be at safe as possible. So, Jim, maybe you could talk about that from a patient perspective.

I want to make sure I know what I’m getting, I know what the risks are, and if any have come up along the way I want it to be reported, and I want to know that there’s a team looking out for me.

Jim Omel:

You have every right to expect that, Andrew. If you’re in a trial you have the right to get that knowledge if there’s new things that come up that we’ve learned about. And part of every trial as it’s being written, there has to be a data safety monitoring board. These are the experts who will do what you’ve asked be done. They will monitor the trial as it goes along. They will look for any safety issues. If there are patients who are developing liver toxicities, they will find this. They will point this out and perhaps see if the trial needs to continue or if something needs to be revised.

The presence of institutional review boards review whether trials should go forward or not. Patients who are in trials actually get very, very good medical care and medical coverage. In fact, I would maintain, Andrew, that they get better care than just standard care. They have experts that are watching them even more carefully than would be in a general routine care setting because they’re looking for these concerns and problems.

The person who mentioned the bad outcome, we can’t ever say that every trial is going to be perfect. There are going to be concerns. That’s why trials are done. But they’re relatively rare, and we do have boards and review organizations during the trial, not afterwards, but during the trial to be looking out for your benefit, Andrew, so that you’re not hurt by the trial.

Andrew Schorr:

All right. But let’s say this—and, Mike, for you. So, first of all, admittedly a lot of these trial start, and people are sick people, and they’re feeling maybe the trial is their last hope. We had a friend, Lisa Minkove, who died in the CAR-T trial for CLL not long ago. She had been very sick with CLL, so we’d hoped that it would work. It didn’t work for her, whether CLL won. And we know other people whereas the learning is going on about often powerful new medicines they didn’t benefit. Or in one case, there was a drug, venetoclax we know about, there were some deaths early on when the drug was far more powerful than was originally understood. So what do we do? I mean that’s the real world I guess of scientific study, but that’s a concern, you know, Mike, of people saying, oh, my God, I’m worried about being a guinea pig the unknowns on the subject of dangers.

Dr. Thompson:

So there are a couple of things. So whenever people say—it doesn’t come up as much recently about being a guinea pig, I say, well, guinea pigs don’t have choices, so. And so like Jim has said you can drop off a trial if you want to drop off it. But—so I think for adverse events and things that can happen, one reason to randomize people is that you do understand then if you treat someone with one thing and then another and the death rate the same in both, the drug is not causing it. That’s just the disease. And a couple years ago, there was a presentation from the group at Dana-Farber on the precision medicine program, and the issue was they were taking so long to get people evaluated that their performance status or how well they felt was good, and by the time they got through the evaluation many of them had died. Because the disease, you know, when you get to fifth, sixth, seventh-line therapy it can often progress very rapidly.

And so I think that’s one of the issues, that people can feel the drug did it, and it’s hard to know. And we get these—doctors get these things called adverse events reporting forms, and we have to try to come up with is this probably related, possibly related, and we also get these forms that say you have a patient on the study. The study is open in three countries, thousands of people on it. One person died of a heart attack, and you have no idea as the physician, well, is that the same rate as—you know they’re 70 years old. Is that the same rate as this other 70-year-old. So you need the enumerator and the denominator, and that’s what the DSMB or the Data Safety Monitoring Board is supposed to do, which is look at the data and say, is this beyond what we would expect? And they can stop the trial. They can do expanded cohorts. They can do things to try and figure that out. Now, we know from like even car companies lying about their exhaust systems that if the Data Safety Monitoring Board gets false data, well, you can’t fix that. But that’s pretty nefarious. Like that I think is not something that’s commonly happening and would be a very serious thing to happen.

Now, one thing for transparency is that almost all studies I’m aware of get registered on clinicaltrials.gov or maybe some other sites but usually that site, and they’re supposed to report out the outcomes. It’s not also a perfect process, but you should be able to see how long the study has been open, are there any complications related to it and those types of things. So this whole process is not perfect, but I would say in general the people at the companies are trying to develop something they think is going to work. They’re trying to do it safely, both to help develop their drug well as well as to avoid a bunch of regulatory issues, and the people on the Data Safety Monitoring Board are trying to do their best to answer these questions. But the smaller the number of patients which increasingly will take the trials we are doing and almost are aiming for, it’s harder to be definitive about when these things happen and what caused it.

Andrew Schorr:

Right. Right. It’s imperfect, as we said. So, Jim, Mike Thompson mentioned earlier, gave lung cancer as an example and, of course, across immunotherapy, there are so many companies endeavoring to move this research along. So let’s say you had lung cancer or one of these others where this is big, although it’s going on in the hematology area too, so a patient says, oh, my god, there are all these trials, and I might qualify for one, two, three, four. How do I prioritize? What do I bet on? And maybe my own doctor is doing more than one. So what do you say to patients if they become receptive to being in a trial and there’s more than one trial that they qualify for?

Jim Omel:

That’s a very good question, and it’s a nice kind of problem to have, to have choices of trials. I think, Andrew, the best answer is the patient needs to look at what they are looking for. Are they looking for longevity? Are they looking for something that’s going to expend their life? Are they looking for a trial that maybe will greatly improve their quality of life? Perhaps they’re looking for a trial that gives them one pill per week versus two injections a week. So there are certainly effectiveness end points. There are different things that patients find of value.

But to answer your question it really comes down to each patient needs to ask themselves, what is it I’m looking for in a trial? Do I want something that makes my burden lighter? Do I want something that’s going to extend my life? How much am I willing it accept as far as potential problems versus the standard of care that I know what the problems exist with if I don’t go on a trial?

Andrew Schorr:

Right. So that’s a question we got in, is they’re trying to assess that. One was about how do I prioritize? The other is, by being in a trial, Mike, is it going to make me sicker? Like, to do I have to go through the valley of the shadow of death to get, hopefully, to a better place, and how do you discuss that with your doctor when not everything is known?

Dr. Thompson:

Yeah, maybe I’ll kind of step back and say for phases of trials, Phase I, the intent—both ASCO and NCI say the intent of a Phase I trial is therapeutic. But the statistical design is to evaluate safety. A Phase II is to look at initial efficacy or how well it works, and Phase III is to compare versus standard of care the efficacy. So there’s other types of designs, phase 0, Phase IV and other things, but it used to be, I think, you know, I—we would say don’t go on a Phase I unless that’s the last option because you’ve already gone through the safety initial efficacy if it’s a Phase III trial. It costs a lot of money to do Phase III trials so fewer are being done now, and we’re kind of finding that in this era of precision medicine people are going on trials, and there’s no one rule, but I look at it as if it’s a study involving a lot of different groups of patients, a lot of—you know, it’s not individualized to you, I don’t know, but I think it will have less of a benefit probably than if it’s something like a study designed for BRAF melanoma back when that was a study and you have BRAF. Well, it’s targeted for you. It doesn’t mean it will work, but even if it’s an early phase, a Phase I or II trial, it’s really aimed at your disease.

And we’re finding this with venetoclax, with T1114, and there’s other markers, FLT3 in AML, all these things, and sometimes we find that the drug doesn’t work like we think it’s going to work. The ALK and ROS story in lung cancer, it may benefit other people that we didn’t recognize before, and that’s part of–we’re trying to find people besides T1114 that respond to venetoclax in myeloma because it looks like some people will. But I think as we’re getting more targeted therapy it doesn’t mean there’s no toxicity, but it at least has the suggestion that we’re targeted more at your specific cancer. And some of these pills can have as much toxicity as IV chemo s, but our aim is to decrease toxicity and increase efficacy. And I think, like Jim said, you’ve got to look at different trials and hopefully with a physician who has time to sit down and run through several scenarios. And some people will take the most aggressive therapy because that’s what they’re after, and some people will try something that’s easier and closer to home. So everyone’s values are a little bit different, and you have to try to individualize as a patients.

Andrew Schorr:

Right.

Dr. Thompson:

One thing about trial matching is besides clinicaltrials.gov, there’s myeloma and other groups that are doing these matching, so you can put in characteristics of your cancer and you can try to filter out and get a closer approximation, including at clinicaltrials.gov you can click on the states in the surrounding area or how many miles you’re willing to travel.

Andrew Schorr:

Right. I would mention, put in a plug for our advocacy group friends, whether it’s Lung Cancer Alliance, Bonnie Addaria Lung Cancer or the International Myeloma Foundation with The Leukemia & Lymphoma Society, you can be in contact with them directly and talk about your situation, and they will often be very aware of trials and how it’s starting to line up with these sub groups, subtypes of illness. Here’s a question we got it in with Jack. I just want to get in a couple more before we have to go. This relates to what you were talking about the National Cancer Institute’s Match trial, as I understand it, Mike. He said, regarding precision medicine I thought I heard that initial results have been disappointing for the NCI trial which treats patients with a specific mutation with a specific drug for that mutation. How does this impact precision medicine? You want to talk on that? Mike?

Dr. Thompson:

Yeah, so the people who are opponents of precision medicine would say that the SHIVA trial in Europe and the NCI Match trials were failures. I think you need to look at it a little more carefully. And if you do a huge screening and you don’t have many drugs you don’t have many matches and not many people are going to benefit. So there are some arms in match that match the accrued the number they wanted, and the drugs didn’t work well. So those were truly we think negative studies. But I think the things about Match are there is a huge interest in the community, and they had thousands or several hundred people screened when they only had a few arms opened, and those people weren’t matches, and it basically overwhelmed the system. And then they had to rejigger it to open up more arms. So I think we could—you know, pick holes in the design of the initial study, but I think it took everyone by surprise how much interest there was in trying to personalize these molecular therapies. And other iterations such as ASCO TAPUR, there’s company versions of it like Novartis Signature, and I think the new design of Match do allow for better match rates, and we’ll see how after they’ve adjusted how well they can hit their targets.

Andrew Schorr:

Okay. So that’s an example, where we’re going through a makeover there. Before we go, Jim, we have people watching from all over the world, and Mike alluded to sometimes trials done in other countries. Certainly they are. So we have somebody from New Zealand, we have people from other countries now. How do I access trials? Does it have to be in my country? Or what would you say to an international audience as far as finding out what’s available to them?

Jim Omel:

That’s a difficult question because every country has their own standards. Each country has their own boards that review. What is allowed in some countries are not even allowed. Observational trials can have more importance in some countries than others. Again, it’s a tough question. I think perhaps the person who asked it really needs to be again their own advocate and go online, go with their physician, go to their local support groups, go to their national groups, because they’re the ones that can give that local person their answer. There’s no one set answer for every country because there are some many variances.

Andrew Schorr:

Right. I do want to tell one of my favorite stories. I had a friend Jan Rin in Dublin, Ireland. She had a tremendous problem with more advanced chronic lymphocytic leukemia, one of the conditions I have, no trial for her there. She heard about Imbruvica being studied in Leeds, England, different health system, national health system. She was in Ireland, didn’t have it. She got permission from the Irish government to go over to Leeds and be in Dr. Hellmann’s trial there, and I think it saved her life. She would tell you that. So she had to be pushy. There were newspaper articles. She had to do lots of things to make it happen. It’s going to be varied by country but it starts with…

Jim Omel:

…drug like the one you mention, and it’s not available in the country, and there’s so much of that in myeloma. We have many, many drugs in the US that they don’t have in other parts of the world, and it would be so sad to be a patient in those countries, know that a treatment like that is available but not have access to it. So we all need to work to get these drugs available to patients wherever they’re at.

Andrew Schorr:

Right. Amen. I want to just get some final comments from you. We may just go a couple minutes over. So, Mike, the process is improving, I hope, you’re working on it. Can we feel confident that these gaps, if you will, improving it for prevision medicine, more awareness among the doctors wherever we may go, financial assistance, working with the insurance companies, are you working on it so that this process, we can have some improvement and hopefully have higher levels of enrollment and can get drugs approved quicker?

Dr. Thompson:

Yeah, I think we’re all very concerned about it. We should all be aligned in having more patients on trial, moving things faster and getting it done more cheaply. And I think we’re making progress. It’s not as fast as any of us want, but we’re all trying to move the ball forward.

Andrew Schorr:

Okay. So, Mike, it comes—excuse me. Jim, it comes down to us then as patients. We have to push, right? We have to see what’s within ourselves, what are we willing to do, understand our clinical situation and what’s going on for our cancer, and we’ve got to push, right?

Jim Omel:

And one of the things we need to push for are more interesting trials. We need to make pharma companies put up their drug against another pharma company’s drug. I think it’s so troubling when they’re afraid to take big steps. They just take little, incremental steps with their trials. If we can put drug A of one company versus drug A of another company—pharma companies are really reluctant to do those kinds went trials, and yet those are the kind that would be exciting to patients. I could give certain names of myeloma drugs, but we won’t get into that. It just needs—we need to get better, more interesting trials, and that will attract patients.

Andrew Schorr:

Okay. So I want to just put in a plug for something. We started something at Patient Power called the Patient Power Ambassador Program, and you can see it listed on our site, where you can share your voice. So we can all work with Jim, work with Dr. Thompson, and we cannot just be getting what’s right for us, but we can push on this process. So please consider doing that. Because I want to thank you, Jim Omel, for not just getting what’s right for you as a myeloma patient, but working on these government panels and with advocacy groups to try to advance it for all of us. Jim Omel, thank you for doing this.

Jim Omel:

Thank you, Andrew. It’s a pleasure to do this, and I’ll keep doing it.

Andrew Schorr:

Yes. And long life, Jim. Thank you.

Jim Omel:

Thank you.

Andrew Schorr:

And, Dr. Mike Thompson, thank you, Mike, for your leadership too and those extra hours put in, not just for programs like this but all the clinical research speaking to industry and the government to try to improve this process. Thanks for being with us, Dr. Mike Thompson.

Dr. Thompson:

Thanks for having me on, and I think this is the some of the most powerful patient educational material that people can get, this type of program.

Andrew Schorr:

All right. Thank you so much. So, folks, we’re all in this together. So you have your own issues about whether you know about trials, whether you want to be in a trial, that’s right for you or a loved one, whether it’s close to home, not close to home, so—but we have these discussions. So please look ongoing at the clinical trials mythbuster series. The let us know how we did today. You can always write to me, andrew@patientpower. Our producer, Tamara, T-A-M-A-R-A, at patientpower.info. And talk to your own doctor and your own healthcare team about clinical trials and where they line up, what are the obstacles, for you participating. And let’s see if we can improve this process and ultimately have more medicine that can lead to a cure for us be available sooner. Thank you for watching. We’ve done our best today, but this is an ongoing discussion. In Carlsbad, California, I’m Andrew Schorr. Jim joined us from Nebraska, Dr. Mike Thompson joined us from Wisconsin. Worldwide, we’re here for you. 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.


Please remember the opinions expressed on Patient Empowerment Network 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.

Get Moving: Exercising with Limited Mobility

Over 53 million American adults live with some type of disability. However, one in eight live with the most common form of disability which is limited mobility. This is where a person experiences severe difficulty with climbing stairs or walking. If your mobility is severely restricted, exercising may be something you have come to think of as impossible. But exercise can be performed by anyone, including individuals with limited mobility.

Anyone can benefit from exercise

People who experience problems with their joints, issues with their weight, or a serious injury or illness can enjoy the benefits of carrying out regular physical activity. In fact along with the physical benefits, exercise can also help depression, reduce stress and anxiety, boost energy, and improve your sex life and quality of sleep.

Exercise improves cognitive function

Research has shown that there is a significant link between the body and mind when it comes to preventing memory loss. People who get regular exercise reduce their risk of experiencing a drop in their mental function in their later life. This also includes a reduced risk of developing Alzheimer’s or dementia.

You need to get your body moving to help keep your body and brain healthy. But while the challenges caused by restricted mobility may be unavoidable, you should still be able to find an enjoyable and rewarding way to be physically active.

Flexibility exercises

Stretching exercises like yoga are an ideal way to help prevent injury, improve your range of motion and reduce pain and stiffness. Even with very limited mobility in your legs, you can still enjoy the benefits gained from stretches and flexibility exercises. These can significantly help delay or even prevent further muscle atrophy.

Cardiovascular exercises

These exercises will increase your strength and endurance while raising your heart rate. Cycling on an exercise bike, walking, playing tennis or even dancing are great cardiovascular exercises. If your mobility is severely limited then how about swimming and water aerobics? The water will support your body while reducing the risk of any joint or muscle discomfort. It can also feel wonderfully relaxing too.

Strength training exercises

Strength training exercises use resistance such as weights to help you build muscle while also increasing your bone mass. Strength training is also important in helping to improve your balance, crucial in helping to prevent falls. If you have restricted use of your legs, then instead focus on developing your upper body strength. However, if you have issues with your upper body, then focus more on strength training your abs and legs.

Regular exercise may not feel like a priority when your mobility is restricted. However, instead of focusing on your physical limitations, concentrate on finding rewarding fitness activities that you will enjoy. It may feel a challenge to start with, but it will get easier the more you do it and you will feel the physical and emotional benefits in no time.

ASCO 2018

It’s almost time for ASCO 2018, the biggest event in cancer medicine. The American Society of Clinical Oncology’s annual meeting brings together more than 32,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field. View the latest ground-breaking science that will be featured at this year’s Annual Meeting here. This year’s meeting will take place from June 1 – June 5, in Chicago, Illinois.

The meeting offers informative educational and scientific sessions that highlight the latest in cancer care treatments. Educational sessions feature world-renowned faculty discussing state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field. Science sessions present the latest ground-breaking research in oral and poster format. You can check out the 2018 Program here.

Follow Along

During the conference you can follow along on Twitter with the official meeting hashtag #ASCO18 or by following @ASCO to get the latest meeting news, research, and announcements.

We will also be tweeting the patients’ perspective during #ASCO18. Follow us on Twitter to experience it through the eyes of patients.

For expert perspectives on controversial topics as well as highlights from education and scientific sessions, check out the official news source, ASCO Daily News.

Join the Conversation

In honor of  the 2018 ASCO theme, Delivering Discoveries: Expanding the Reach of Precision Medicine, we will be hosting a special #patientchat on Friday, June 1st about what precision medicine means for the patient. Please join us on Twitter at 10am PT | 1pm ET.

If you are attending the conference, consider attending the #ASCO18 Tweetup. The official ASCO Tweetup is an informal gathering for attendees interested in the intersection of oncology and social media to meet and mingle. Join us on June 2, 5:45-6:45 PM in the Plate Room food court (North Hall Level 2.5).

Spotlight On: National Cancer Research Month

Cancer research. It has taught us about risk factors, environmental factors, health screenings, causes, treatment options, metastasis, recurrence, rates of survival, and even how healthy cells might be used to wipe out the cancerous cells. Cancer research is broad and reaches far beyond the study of the infected cells. The research helps us to understand cancer and the many aspects of it that will affect the estimated 1,735,350 people who will be diagnosed with cancer in 2018, not to mention the millions already living with the disease. The years upon years of research devoted to cancer has led to valuable insight and life-saving measures. To emphasize the importance of the contributions of cancer research, the month of May was established as National Cancer Research Month and is led by the American Association for Cancer Research (AACR). More information about National Cancer research month can be found here and here.

When it comes to cancer, the areas of research are vast. Many people may not know that there is more to cancer research than looking for treatments or a cure. To understand cancer, researchers spend years discovering how the disease forms, what environmental factors play a role, and what treatments might stop it. The types of research range from basic cancer research that studies the actual cancer cells to survivorship research that studies how cancer affects people after treatment. Database and population-based research are also critical to learning more about cancer. At cancer.ca the Canadian Cancer Society gives a thorough description of the various kinds of cancer research and the value they have which can be found here.

Once considered a hopeless disease, cancer plagued civilizations dating as far back as ancient Egypt, which you can read about here and here. However, it was in the early 1900s that worldwide cancer research began to offer a more clear understanding of the disease. Groups, like the AACR formed in 1910 and the Canadian Cancer Society formed in the 1930s, brought doctors and scientists together with the mission to search for ways to eradicate the disease and help improve the quality of life for those living with cancer. It was 1971 when President Nixon declared a war on cancer. The disease had become the second leading cause of death by 1970 and Nixon’s signing of the National Cancer Act of 1971 aimed to amplify the national efforts against cancer. The act established the National Cancer Institute (NCI) in its current form. Formerly created by the National Cancer Act of 1937 as the federal government’s agency for cancer research, the NCI was strengthened in 1971 with broader authority given to the director and more emphasis placed on research that included public and private partnerships, funding for additional cancer research facilities, and the creation of an international research data base. Today, the NCI is made up of about 3,500 people and 30 divisions, offices and centers all working to advance cancer research. The NCI, which calls itself the leader in the nation’s cancer research, reports that in the last few decades there have been declines in rates of new cancer and overall cancer deaths and that the number of cancer survivors in the United States more than doubled between 1992 and 2016 from 7 million to more than 15 million and the number is expected to rise to more than 26 million by 2040. More information about the NCI and it’s history can be found here and here and here.

For those affected by cancer, the research can be critical and today it is more accessible than ever. Research groups and advocacy organizations are available to patients and caregivers all day, every day through the internet. Data can be found, reviewed and discussed all from the comfort of your own home, favorite coffee shop, or wherever you have access to wifi thanks to programs such as the Patient Empowerment Network (PEN) Empowered Patient Chats , Patient Cafe , and Facebook groups. Not only are the patient resources increasing in number, they are increasing in value. “Online communities may be virtual, but they are no less real in terms of support and influence,” writes Marie Ennis-O’Connor in her September 2017 post for PEN’s Patients Helping Patients Blog. Ennis-O’Connor’s post, 12 Keys to Finding, Growing, and Nurturing Your Online Community, emphasizes the value of online communities to cancer patients when it comes to research, support, or any number of topics critical to ensure that patients stay informed, supported, and empowered.

Introducing Our New Facebook Community: Empowered Patient Chat

We are excited to announce that our new Facebook group is now live, and waiting for you to join! This new online community builds on the success of our Empowered Patient Chat (#patientchat) tweetchat and aims to extend the discussion beyond Twitter and engage a larger population of patients and caregivers on Facebook.

Living with a disease or other chronic condition is challenging for patients, their families and friends. The Empowered #patientchat strives to engage and empower patients and caregivers by connecting them with each other, sharing resources and inspiration across conditions, and exploring important topics of interest to those in healthcare who want to elevate the patient voice in all healthcare matters. The community is guided by a belief in keeping the patient perspective at the forefront of all healthcare interactions, the strength of peer support, and the power of shared decision making in healthcare. 

Empowered Patient Chat (#patientchat) is a community of patients, caregivers, and healthcare professionals, interested in achieving their best health possible by discussing topics of interest in healthcare from a patient’s perspective. 

Topics of interest have included:

  • Including Patients and Care Partners: Let’s Talk Healthcare Conferences
  • Overcoming Disparity in Clinical Trials
  • Are We Missing the Mark with Patient Involvement
  • Understanding Medical Research
  • How Does Technology Benefit Patients
  • How to Include Patients in Design
  • What to Do When No One Will Listen
  • Caring for the Whole Person
  • Self-Care Goals
  • Managing Stress of Being a Patient
  • and more…

Join our group today

Spotlight on National Minority Health Month

April is National Minority Health Month. Supported by Congress with a resolution in 2002, National Minority Health Month is meant to bring awareness to the disparities in health and healthcare among minorities. Led by the Health and Human Services Office of Minority Health, efforts are made to understand the disparities and the reasons they occur. The 2018 theme, Partnering for Health Equity, encourages organizations to come together to find solutions that will help equalize health for all races and ethnicities. More information and resources for National Minority Health Month can be found here.

Evidence of disparities in minority health exists in all major illnesses and diseases, including heart disease and diabetes. However, the disparities, compiled by aetna.com, related to cancers, clearly emphasize the impact on people’s lives. In the United States, African Americans have the highest death rate and shortest survival time of any other group of cancer patients. Cancer is the leading cause of death for Asian Americans and Pacific Islanders. Heart disease is the leading cause of death for all other groups. According to cancer.gov, African American women have a higher incidence of aggressive breast cancer. American Indian and Alaskan Natives have higher rates of kidney cancer. Hispanic and African American women have higher rates of cervical cancer and die from it more often. More disparities can be found here and here.

There are a number of reasons believed to be involved in causing the disparities in minority health. They range from socio-economic status and environment to lack of scientific data about minority groups which results in disparities even in some of the most common healthcare screenings. For example, consumer.healthday.com reports, the guidelines that determine when women of average risk should begin screenings for breast cancer come mainly from the data gathered on white women. However, researchers discovered that those guidelines could delay detection in minority women, who tend to develop the disease at earlier ages. More about the study, which emphasizes the importance of understanding how cancer occurs in people of all ethnicities, can be found here.

Another reason for the existence of disparities could be biological. Researchers are looking into the occurrence of prostate cancer in African American men, who not only have a higher risk of developing prostate cancer, but they develop it at a younger age and tend to develop a more aggressive form of the disease. According to the U.S. Department of Health and Human Services National Institute on Minority Health and Health Disparities website, nimhd.nih.gov, researchers are studying why African American men are more at risk for prostate cancer and what can be done about it. Genetic makeup, access to healthcare, and environment are all being considered as factors. One study discovered that African American men and white men have a difference in the biomarkers that predict the aggressiveness of a prostate tumor. The study results are being tested further and expanded to look at other more factors and other biomarkers. More about the study can be found here.

There is much more to be learned about the disparities in minority health, why they exist, and how to prevent them. Increased attention and the increasing awareness of National Minority Health Month spotlights the need to eliminate the inequities in health for all races and ethnicities, which will empower us all.


Related Reading:

US Health Care & Medical Debt Statistics

Uber Health and Five More Groundbreaking Ideas Changing Healthcare Delivery

Healthcare in the U.S. is an industry that’s ripe for innovation. From a convoluted insurance system to a complicated chain of care to a lack of price transparency, many factors combine to create a healthcare system that’s slow, expensive, inefficient, and difficult to navigate.

But some companies are fast at work addressing the many pain points of patient care. Whether they’re small startups or large companies we already know, there are plenty of businesses out there working to make a difference in the healthcare space. Below, we’ve rounded up six ideas that are changing how healthcare is delivered today.

Uber Health

Every year, 3.6 million Americans miss doctor appointments due to a lack of reliable transportation, contributing to a high rate of no-shows, reaching as much as 30 percent nationwide. At the beginning of March, troubled ride-share company Uber announced the launch of Uber Health, a new initiative that partners with healthcare organizations to provide reliable transportation to patients in need. Here’s how it works: a coordinator schedules the Uber ride on behalf of the patient, and the patient communicates with the driver via text or call to facilitate the logistics.

The HIPAA-compliant system helps reduce appointment cancellations and saves the healthcare organizations money (as compared to using taxis or other transportation options). “Uber has helped us drastically reduce appointment cancellations. It’s great to be able to quickly request a ride with so that in-need patients can make an appointment they’d otherwise miss,” said Pete Celano, Director of Consumer Health Initiatives at MedStar Health, in the release announcing the nationwide launch of Uber Health.

Zocdoc Insurance Checker

Insurance is notoriously cryptic and confusing, and health insurance is even more difficult to decipher than other kinds of policies. How do you know what your health insurance will cover and what it won’t? Can you be 100 percent certain that a new doctor is in your network? To answer these questions, the online medical scheduling platform Zocdoc launched their Insurance Checker at the very end of last year. Patients take a picture of their insurance card, then Zocdoc extracts the important data and determines whether or not a doctor is in-network under the patient’s plan. This makes it easier for the patient to schedule visits and cuts down on surprise out-of-network charges.

Nomad Health

Have you ever been sick, only to discover that the earliest available appointment at your primary care physician’s office is in two weeks? Instead of waiting, you can call up a doctor, speak to one within a few minutes, and get a diagnosis and even a prescription, all without leaving the comfort of your home. While telemedicine has been around in some form or fashion for years (early leader Teladoc was founded in 2002), startups have recently jumped into the telemedicine space, hoping to provide a new twist on the concept of a virtual doctor visit.

The startup Nomad Health seeks to combine this telemedicine idea with the gig economy, allowing doctors to contract for virtual freelance via videoconferencing appointments. The service also includes postings for full-time positions, as well as travel nurse positions. Like employees in other industries, medical professionals are seeking more flexible and remote work schedules, and Nomad Health hopes to seamlessly connect them with these very opportunities while providing convenient video appointments for patients.

Osso VR

For decades, cadaver dissections have been the primary way of training surgical residents. But a host of new companies are using virtual reality (VR) technology to train future healthcare providers in a variety of situations. Osso VR, a startup that closed $2 million in funding last year, uses realistic simulations to teach orthopedic surgeons new techniques. Unlike cadavers, which often can only be used once, surgeons can practice VR simulations over and over again until they achieve proficiency.

Not only does VR make it cheaper to train surgeons, it also means that patients are being operated on by more experienced residents who have performed dozens of simulations (rather than just a handful). “In med school, they say ‘see one [surgery], do one, teach one’…but the truth is you need to do 50 to 100 cases for proficiency,” Justin Barad, Osso VR CEO and Founder, told Forbes.

Google’s Launchpad Studios

Google’s new Launchpad Studios program matches machine learning startups with Silicon Valley experts — and the inaugural class of seven startups all focus on addressing healthcare and biotech problems using artificial intelligence. American and international startups Augmedix, Cytovale, Nanowear, Owkin, Portal Telemedicina, Byteflies, and BrainQ joined the effort.

Each startup seeks to use machine learning in a slightly different context; for example, BrainQ identifies brain wave patterns in patients after neurological disorders to help aid in treatment, while Nanowear uses nanosensors in smart textiles to gather patient data and improve diagnostics. Google plans to establish other tracks for Launchpad Studios, but the fact that the company chose healthcare and biotech to be the first one indicates that Google is prioritizing healthcare innovation.

Forward

The year is 2030. You check in at your doctor’s office, and before you enter an exam room, you get a full body scan, and its data is fed to an AI algorithm that can spot patterns that might indicate health problems. By the time you make it to the exam room, your doctor has your data queued up, ready to review it with you and compare it to your genetic testing results. Before you leave, you’re given a wearable that will continuously relay health data back to your provider.

Sound futuristic? This process is already happening at Forward, a new kind of doctor’s office that has locations in Los Angeles and San Francisco. Not every doctor’s appointment can be done virtually through telemedicine, and Forward wants to make sure that when you do go to visit your doctor in person, the experience is seamless and digitally integrated.

The Future of Health

These concepts are just a sampling of the many new startups and innovations in the healthcare space. The future of healthcare is bright, primarily because these thinkers are funneling their efforts into problem-solving solutions that make the healthcare system smarter, more user-friendly and more well-connected.

A Song for Raising Hope and Awareness for Pancreatic Cancer

The Voice Finalist Erin Willett Teams Up with Songwriters Elizabeth Russo and Tova Litvin To Write an Anthem of Hope and Raise One Million Dollars for Pancreatic Cancer Research

Pancreatic Cancer Action Network (PanCAN) Sets Goal to Double Survival by 2020

 Songwriters Elizabeth Russo, Erin Willett and Tova Litvin, whose lives have all been touched by pancreatic cancer in their families, have joined forces to write an original song “Hope’s Alive” and raise one million dollars this year for pancreatic cancer research.  “Hope’s Alive” is produced by Russo’s good friend Dan Whittemore. The songwriters have teamed up with the Pancreatic Cancer Action Network (PanCAN) to raise awareness, as early detection is the best way to improve outcomes for the disease.  The current five-year survival rate is 9%, but PanCAN’s goal is to double that by 2020.  100% of proceeds from sales of “Hope’s Alive” will go to PanCAN to fund cancer research.

Russo, who spearheaded the project, learned her father was diagnosed with pancreatic cancer in 2017 and is currently fighting the disease.  Russo recruited Willett (who was a finalist on the Voice and most recently transformed herself on the Biggest Loser) to co-write and sing “Hope’s Alive”.  The project was poignant for Willett, whose father sadly passed from pancreatic cancer in 2011.  “It’s all about putting my energy into something positive,” Willett said.  “I can’t control the fact that my father isn’t here, but I can control my activism and my actions via the story I tell.”  Willett, who has been advocating for pancreatic cancer research since her father passed, connected the songwriting team with PanCAN.  Russo also recruited Litvin, whose mother is a five-year survivor, and together the three women combined their efforts with PanCAN to combat the disease. 

To give “Hope’s Alive” an anthem quality, Russo knew she wanted to include a choir as part of the song.  With the help of PanCAN, Russo assembled a choir of pancreatic cancer survivors and caregivers.  The choir members are also the faces of the song’s accompanying music video.  “There are things everyone can do,” Russo said.  “Don’t feel helpless or hopeless.  We are all here, we are all going to stick together, and we are going to make a difference with this disease”. 

Watch Hope’s Alive


To learn about risk factors and early detection of pancreatic cancer, please visit www.pancan.org.

For inquiries, please contact Elizabeth Russo at Elizabeth@annearful.com

Hope’s Alive is now available for download on iTunes and all other platforms.


 

Living With Two Cancers

My story with cancer started in 2008 when I was diagnosed with Multiple Myeloma. I was fortunate to have a primary care physician who noted abnormalities in routine blood work and sent me to a hematologist oncologist. At the time of diagnosis I was at the MGUS stage, precursor to active Myeloma, and was monitored every 6 weeks. During that time I switched to a Myeloma specialist in the health system where I was employed as a PT. I also hit the internet to learn more about this cancer that I had never heard of. BIG MISTAKE! The published survival rates at the time were 2 years. I wasn’t ready to hear that so I stopped reading.

Over the next year I pretty much refused to own the fact that I had a cancer diagnosis. I wasn’t being treated, might never be treated and felt ok except for fatigue. That all came to a screeching halt one day when I had extreme pain in my left arm and suddenly couldn’t lift my arm. I went to the ER and was diagnosed with a pathological fracture of my left humerus, upper arm. I saw my specialist the next day and began treatment immediately since I now officially had active Myeloma.

I responded well to treatment and went on to have an autologous stem cell transplant (ASCT) 9 months later. This led to a complete response and almost 3 years with no treatment until I relapsed. I began treatment again with the same drugs that had worked so well before and again had a good response. I continued with this for almost 4 more years until one day in October 2016 all hell broke loose. I was in my oncologist’s office for a regular appointment waiting for him to come into the examining room when I crashed. I was rushed across the street to the ER where I was admitted. A few days later, after many tests, I was diagnosed with Acute Lymphoblastic Leukemia, ALL.

I spent the next month in the hospital receiving induction chemotherapy for the ALL and the next 6 months for consolidation therapy. During those months of treatment for the ALL I relapsed again for the Myeloma. After I completed my ALL treatment, that’s now in remission, and recovered from that chemo, I began treatment with one of the monoclonal antibodies for the Myeloma. Now, 8 months later, I feel about the best I have in years and my blood levels are all in the normal range.

Although I’ve gone through a lot, especially since being diagnosed with the ALL, I continue to enjoy and live my life. I worked 6 more years after my diagnosis with Myeloma. I specialized in treating people with cancer as a PT. My cancer diagnosis brought me closer to my patients since they knew that I understood what they were going through. I continued to travel to Europe to teach, attend conferences and for pleasure. After my retirement I  have also been volunteering for the American Cancer Society and been very active as a board member and program chair of my local Myeloma support group.

Encouraging others who have been diagnosed with cancer has been a mission of mine for many years. Now, as a person with two blood cancers, I find that that helps others, but also me. With the treatments that are now available to us, we often can live fairly normal and long lives. Who would have thought that I would still be here when I was diagnosed 10 years ago? I attribute that to the wonderful medical care I have received from my oncologist and his team, the research that has led to more effective treatments and to the support of my friends and family. But, most of all, is my own self education about my cancers and my relationship with my oncologist. I believe that being an active partner in my care has been extremely important. I look forward to continuing to enjoy those things in life that are important to me.

Nancy Stewart
Multiple Myeloma 2008
Acute Lymphoblastic Leukemia 2016

Health Tips To Support A Senior Through Cancer Recovery

Cancer can happen at any age, but it’s most common in the elderly. The American Cancer Society explains 87% of all cancer cases in the United States are diagnosed in people 50 years old and over. Cancer in older age brings with it many unique problems, including, pain, depression, loss of strength and fitness, cognitive decline, and dementia. If you’re caring for an elderly cancer patient, it’s important you coordinate with their cancer team. Recovery plans focus on physical, social, and emotional health to give senior cancer patients the best quality of life possible.

Prepare healthy food

It’s never too late for anyone to start eating healthy. It’s important you give the elderly person you’re caring for enough nutrients from a variety of fruits, vegetables, dairy, pulses, and grains. Red and processed meat should be limited, or preferably avoided altogether. You should also check with their doctor whether they have any special dietary requirements.

Cancer patients often have reduced appetite. The key is to give them calorie-dense food — soups, smoothies, and stews, for example. It’s also important to set routine family meal times. Socializing is an important part of recovery.

Protect their safety

An elderly cancer patient is in a vulnerable position. Do your best to make sure they’re safe around the home before they return from the hospital. Install night lights in the hallways and bedrooms. Ensure carpet is securely fixed in place and remove loose rugs to prevent falls. They may need help with everyday tasks, such as, bathing, dressing, moving around, and going to the toilet.

Encourage exercise

Unfortunately, cancer treatment takes its toll on the body and mind. It often leaves patients fatigued, which is a feeling that can often strike without warning. Nonetheless, a gentle yet regular amount of physical exercise is highly beneficial seniors. Not only does it boost their mood, but it also helps improve mobility, strength, flexibility, and balance.

Give emotional support

Cancer treatment is stressful, but talking about it can help. While it’s up to the senior you’re caring for how much they open up, let them know you’re there for them if they want to talk. They may also be interested in joining a support group for practical advice.

Ultimately, it’s important your senior has a social and emotional outlet to support them and make them feel less alone. If you ever have any problems or concerns, let their cancer team know. You’ll be given as much help and support as you need.


About the Author: Chrissy Rose is a Content Manager and is working to build one of the best senior resource sites.

How a Cancer Planner Helps Patient & Caregivers Keep Track of Progress

I know, it’s so scary. Making a plan to cure yourself and save your life. Literally, you have the weight of your world in your hands. But not to fear. Even though there is still no “cure” for cancer, many have successfully healed themselves from the deadly disease. Be assured there have been many countless cancer survivors before you who have paved the road to recovery with hope and encouragement. We’re just here to guide you on your way.

Being diagnosed with cancer is terrifying. So finding assistance and helpful information should be easy. In this blog entry, I will be guiding you through how to create the best appropriate cancer plan for your body and your condition. Within a cancer plan are three distinct segments – a treatment plan, a payment plan and a recovery plan. A treatment plan considers all of the patient’s therapy options, including conventional care and alternative methods, to make the best informed decision per condition. A payment plan accounts for the finances and how to outsource funds to pay the inevitably heft medical bills. And lastly, a recovery plan includes the supplementary actions that need to be taken, such as changing your diet and lifestyle goals. When all three parts function together, it is intrinsic to improving the chances of survival. Effectively enforcing and efficiently keeping track of a cancer plan will help a patient progress through healing swiftly and with a greater peace of mind.

To begin, you should assume it’s your responsibility to know everything about your body and your condition. But isn’t this my doctor’s job? You may askWell, sadly, most doctors won’t be able to provide personal quality care because of the largely disproportionate ratio of registered oncologist to new patients. With approximately 1.6 new cancer cases each year and only 21,200 registered oncologists, there’s a dire shortage of cancer specialists in our country (American Cancer Society, 2014). It’s best if you don’t become solely reliant on your doctor. He/She should really only be there to clarify esoteric information for you. Bring out the doctor in yourself by having a cancer planner to keep all of the information pertaining to your cancer organized & easily accessible. Be prepared for every appointment by doing your own research and coming up with questions beforehand. Make the most out of the time you have with your oncologist because it may be hard to get in touch with them during off hours. Take notes of every appointment so you can keep track of how you’re progressing after each. Accumulating all the data you can possibly find will only benefit you as a patient and caregiver. All you have to do is seek and you will find the answers. And the more you know, the more you have to fight with.

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The first thing to consider after your initial diagnosis is – What are the treatment options for my type of cancer? If your cancer is invasive, your doctor will strongly urge you to perform a very aggressive form of orthodox treatment as soon as possible. Be ready to be convinced to do surgery, radiation or chemotherapy. But just know that there are many alternatives on the spectrum of treatments. From surgery, chemotherapy, immunotherapy, gene targeted therapies and clinical trials, to some of the more obscure treatments such as plant extract therapies, there are just so many options available. It’s also common to integrate therapies of the conventional norm and of the alternative. For example, a patient with stage 2 lung cancer may opt to have surgery and also adopt Gerson Therapy as a supplemental treatment where they heavily regulate their diet. So how do you choose the best route? This is where the beauty of having a cancer plan comes in. Start by weighing out your different options in terms of cost, duration, side effects, convenience and the general pros and cons for each. This will help you to filter out the options that aren’t plausible for you and your family. Trust your gut feeling and narrow your list down to the top three options. Create a visual roadmap for each treatment option listing the action steps you’ll need to take in order to see this through and picture yourself after each milestone. How are you mentally, physically, emotionally and financially? Trust me when I say that you’ll have a greater peace of mind knowing that you’ve weighed out all of your options and have narrowed your focus down to the treatment plans you believe will work best for you. Trusting your treatment plan is absolutely vital to fighting your disease. Believe you can and you’re half way there.

Now how do you pay for all of this? There are ways to pay for all of your expenses when you get creative with it. Since crowdfunding has taken off in the last couple years, you’ll be surprised at how many people, whether it’s your friends or those who’ve just heard your story but have never met you, are more than willing to help your cause. You can check out platforms like GiveForwardGoFundMe or Indiegogo. For further financial assistance and direction, you can evaluate these helpful organizations from our resources list (www.familyreach.org, cancercarecopay.org, cancerfac.org, thechainfund.org). Having a cancer planner will help you to keep track of all your medical expenses in one place and stay on top of your payments. The last thing you want to worry about is all your expenses adding up and getting out of hand.

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Finally as part of your recovery plan, it’s important to ask yourself what vital changes to your lifestyle choices are necessary to help you heal and strength your immune system. A breakdown of the immune system is the primary reason humans develop cancer; we must work towards recovery by building back up the immune system with nourishing therapies. There’s a bunch of research you can do on cancer fighting foods you should incorporate into your diet. There is a cancer fighting food pyramid inside of CanPlan to help you get started. What you put into your body is one of the only elements you can control in your fight against cancer, so don’t ignore the importance of it. Now to create the best plan of action to guide you towards recovery, start by keeping track of your daily diet, exercise and medications. Then at the end of the day, rate how you feel overall on a scale of one to ten and what your general mood was for that day. Do this everyday as you start to make your lifestyle changes and notice what elements are and aren’t working for you. Perhaps you noticed that running for 30 mins greatly improved how you felt for that day. Take note of this and be consistent with it in your treatment plan. The more aware you become of your body and how it reacts to certain elements, the better you’ll be able to detect any new symptoms and find ways to combat against it. Keeping track of your progress will help put you in the driver’s seat with your fight against cancer. Don’t wait around for your doctor to tell you how you’re doing. This is your fight. You control how you want it to go.

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Remember, you know your body best so always honor your body and how it reacts to certain treatments. A one-size-fits-all approach, much like the plan your doctor will prescribe you, won’t work in this situation. Since there is no “cure” to cancer as of right now, you’ll have to discover the best recovery plan through experimental trial and error. We encourage you to ask for help and seek guidance as much as you can. We’re lucky enough to live in an era, and country, with unlimited access to infinite knowledge where we can freely acquire information to make a well-informed decision (just be sure to double check your sources). It’s as if we’re given all the tools we’d need to be our own doctor. Now isn’t that a progressive thought.


Meet the Author : Sharon Kim

Notable News: February 2018

Sometimes, even the most seemingly unrelated of symptoms can be a warning sign of cancer, says nytimes.com. While some might associate depression as a side effect of cancer, it can actually be a sign of cancer growth in the body. Some cancers actually trigger depressive symptoms. The phenomenon was first noted in 1931 with pancreatic cancer patients and more recent research supports the findings. The invasion of the cancer cells causes the body to release cytokines which are messenger chemicals that when released by certain cancers create an inflammatory immune response in the body along with the neurological response that causes depression. The theory is that when the cancer is removed from the body, the depression will gradually be reversed. This story emphasizes the importance of listening to your body and not ignoring symptoms that something more serious might be going on. Learn more here.

A new treatment for a common, but often not discussed side effect of breast cancer is showing positive results, says npr.org. Lymphedema, a condition that is common after cancer treatment, can cause painful swelling of the soft tissue of the arms and legs and can increase the risk of infection and can be life threatening. It is often the result of the removal of lymph nodes and radiation used to treat cancer. Some surgeons are experimenting with repairing or recreating a healthy lymph system for patients who develop lymphedema. The surgery, which has been around for about ten years, but has recently been perfected due to advances in body imaging, involves transferring lymph nodes from parts of the body that weren’t affected by the cancer treatment. Another type of surgery is designed to prevent lymphedema altogether. When the lymph nodes are removed, instead of cutting off the vessels they are reattached to a vein so that the drainage system has as little interruption as possible and the risk of lymphedema is reduced. You’ll find more about lymphedema, the surgeries to prevent it, and some patient stories here.

There’s new research from the National Cancer Institute, says dailymail.co.uk, that might make you stand up and take notice. It turns out that even just one hour of sitting increases your risk of getting nine types of cancer, including lung, and head or neck, in addition to breast and colon cancers. The information was reported at the American Association for the Advancement of Science conference in Austin, Texas earlier this month by Charles E. Matthews, an epidemiologist at the National Cancer Institute. Matthews says that eliminating health risks requires four to five times more exercise than previously thought. While exercising more is important, says Matthews, even more important is less sitting. Matthews recommends adding in light household chores or taking a walk instead of watching television. Get more information here and you can also watch a short video reporting the findings here.

Finally, February is Cancer Prevention Month. According to moffitt.org, research and studies continue to show that the majority of cancers are the result of lifestyle choices and environmental factors that could be changed or avoided to prevent between 70 to 90 percent of the gene mutations that cause cancer. Fortunately, some of the ways to prevent cancer are pretty easy and painless. You can find six strategies from Moffitt Cancer Centers here and seven tips from mayoclinic.org here. Of course, whether it comes to prevention, treatment, or support, you will find some of the best resources available right here with Patient Empowerment Network. Check out our programs here.