32 Standard of Care Q and A.mp3: Audio automatically transcribed by Sonix
32 Standard of Care Q and A.mp3: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Speaker1:
Hi and welcome to the Cancer Secrets podcast. I am your host and guide, Dr. Jonathan Stegall. Cancer is like a thief who has come to steal, kill and destroy. I have personally seen it wreak havoc on patients, friends and even my own family. But I am on a mission to change the cancer paradigm. Who? The practice of integrative oncology cancer treatment that integrates the best of conventional medicine with the best of alternative therapies backed by science and personalized to each patient. You need a positive voice you can trust. This podcast will share valuable information to give you practical hope for a better outcome. So I invite you to join me on this journey as we seek to change the cancer paradigm together. Hello and welcome back to the Cancer Secrets Podcast. I'm your host, Dr. Jonathan Stegall. This is season three and episode number 32. In today's episode, we'll be discussing the standard of care, what it is and how it can be both helpful and harmful. We will also be tackling some listener questions which were recently submitted. As always, we encourage you to listen with a loved one or friend. Learning and enjoying the show with a community will be more impactful than doing so alone. Today's show is going to be a great one as we discuss the importance of why the current model of cancer treatment exists. Today's topic was inspired by a listener to the show. Ken from Pennsylvania. Ken recently asked about the standard of care and how treatments become part of the standard of care. This is an excellent question, and we're going to dive into that today.
Speaker2:
Yes. This message is for Jonathan Stegall. This is Ken Matthew calling from Pennsylvania. Information about how the current health care goes off of standard of care and doesn't allow people to use your services and the time it takes to for services to become a standard of care and the history of standard of care and why people are just not avail themselves of of of your services. Thank you.
Speaker1:
The standard of care is defined as the treatment approach used by mainstream oncology. These treatments typically include, but are not limited to surgery, chemotherapy, radiation therapy, immunotherapy and hormonal therapy. These treatments have the most scientific evidence for their use to become part of the standard of care. A treatment or therapy typically has to undergo years of research. These treatments were shown in research to have a known level of effectiveness and safety, and thus they become the standard of care. The main way we obtain evidence for a given therapy is by a clinical trial. Clinical trials are research studies which evaluate potential new treatments. They typically compare new treatments to existing treatments. In other words, they compare the new treatment to treatments that are part of the current standard of care. Human clinical trials require several things. First, they require evidence in lab testing that a treatment shows promise. Now, these lab tests are either cell line studies which are performed on cancer cells in a petri dish, or more commonly, animal studies performed in a lab, typically on lab mice. Human clinical trials also have to go through an approval process by what is known as an institutional review board or IRB. For short, institutional review boards are usually affiliated with or at least work closely with major academic medical centers. And finally, human clinical trials also require funding. This funding typically comes from a drug company or a device manufacturer, and they're willing to put up this money because they believe that their therapy will prove to be successful and as a result, that therapy can be patented and then sold for a profit.
Speaker1:
So when we look at any treatment which qualifies for a clinical trial, we know that it must do a few things. First, it must solve a problem, or at least solve an existing problem better than the current solutions. It must be safe, or at least tolerable, although there is no way to know this for sure until the trial is underway, or in some cases, until the trial is completed. And finally, the treatment must be patentable. Otherwise, those funding the study have no incentive to provide the cash necessary to fund the study. So clinical trials are broken up into phases. Phase one is when the drug is tested to determine the optimal safe dose. This is typically a small study. Now, if the study goes well during phase one, it progresses to phase two. Phase two is a larger study to better define optimal dosing, while also seeing if the treatment actually works. If phase two testing goes well, it progresses into phase three. Phase three studies are large studies, often involving hundreds or even thousands of patients. These studies are often on specific patient populations with a certain type of cancer. These often occur simultaneously at multiple treatment sites, for example, at a handful of different cancer clinics throughout the country.
Speaker1:
In phase three trials, patients are randomized, so some test subjects get the treatment being studied while other patients get the standard of care or even a placebo. And in many cases, these phase three studies also have researchers who are blinded. And by that we mean that the researchers don't know which therapy they're giving to that patient. And this is done basically to create as fair and objective a situation as we can. Now, any phase of a trial can be stopped at any time. For example, if concerning findings occur in the drug is thought to be unsafe or not work as expected, the trial would be stopped immediately. However, if the trial progresses well through phase one, two and three, and thus the drug is shown to be successful, FDA approval will be given, and by the time phase three testing is completed, the drug has typically been under study for many years, many times for 8 to 10 years, costing the manufacturer and study sponsor millions of dollars in the process. And then once a treatment has been out for a while, we will we will do phase four testing and phase four studies take place after FDA approval and are designed to evaluate for any safety concerns that might have arisen. This phase typically lasts for a number of years as well, and you've probably heard of some of these therapies. Let's say a certain drug that has been out for a while and it comes out later that they found that the drug has some adverse side effect or or causes problems in some way.
Speaker1:
And in some cases, that drug will even be removed from the market. And that was the result of the phase four testing that was conducted. So as you can see, the standard of care therapies have plenty of research supporting their use. We know that this is why they've been adopted as part of the standard of care because they have years of research supporting their use. We typically know what dose to use. We typically know what side effects to expect, and that's why the medical community at large utilizes these treatments. And of course, that's also why these treatments tend to be covered by insurance. Of course, that's not an absolute, but in many cases, insurance companies are only going to pay for therapies which have undergone the level of research needed to become part of the standard of care. So that's really how this all comes about in terms of the treatments that patients are recommended to have in conventional oncology. So as we all know, the standard of care certainly has some things in its favor, namely the research that supports its use. But we know that the standard of care is not perfect. We know that surgery, chemotherapy, radiation, immunotherapy and hormonal therapy all have the potential to cause side effects, ranging from mild and temporary to permanent and severe.
Speaker1:
So due to concerns over side effects and or potential lack of efficacy, some patients refuse the standard of care completely. Instead, they seek alternative and natural treatments, such as nutrition, supplementation and others. Many proponents of natural therapies feel that these alternative treatments can be quite effective as well as being safer. Nonetheless, these therapies do not have nearly the level of scientific evidence for their use, and some have none at all. And the reason for this is quite obvious who's going to pay for a study, a long term study lasting many years and costing millions of dollars to study a natural therapy, which is not patentable? If we're talking about a nutritional approach or a supplement or any sort of lifestyle intervention which doesn't stand to be profitable for the company paying for the study, well, that research isn't going to happen. And so that's really the rock and the hard place that we're in when it comes to evaluating some of these alternative approaches. The fact that there isn't evidence for their use, or at least the fact that there isn't significant evidence supporting their use does not mean that they don't work. However, we also. Can't just be irresponsible and assume that they do work just because we want them to or just because we saw an anecdote on the Internet which seemed to suggest that that treatment worked. So this is where we get into the open minded skepticism.
Speaker1:
I talk about so much where we have to be open minded about any given therapy, but we also have to have a healthy level of skepticism as well and really require a certain level of scientific backing to, uh, to incorporate that therapy. And that's not always easy to do. I mean, I'll be honest with you. I mean, there are a lot of therapies out there that people ask me about, and I'm familiar with with pretty much all of them. But but there really is an art to saying, okay, do we think this therapy is going to work? Why do we think that? And then in addition to whether it works or not, we have to also think about safety and tolerability. And do we think this therapy is going to work in conjunction with the other parts of the protocol? And so that's not always an easy decision to make. And to be honest, in integrative oncology, our threshold for considering a therapy is much lower because, number one, we're just we're more open minded than our peers in conventional oncology tend to be. And second, because we're not sort of locked into the insurance mentality, we can take some risks and use some therapies which aren't part of the standard of care and are not going to be covered by insurance if we think they're going to work. But with that said, we certainly do still have standards for what we are going to consider using in our protocols.
Speaker1:
We just have a little bit lower threshold for being open to considering that treatment. So as we consider some of these alternative treatments, we do need to be aware that research studies have shown us that patients who use only alternative therapies to treat their cancer have much worse outcomes. This means that their cancer progresses faster and they die sooner and more often compared to patients who receive the standard of care. And this makes sense because these are therapies which, to be quite honest, are not proven. They may have some scientific evidence for their use. They may seem to work in some cases, but we don't fully understand how they work and we don't fully understand how they work within a larger protocol. So patients are taking a big risk using these therapies in isolation. But with that said, most patients come to what I call the fork in the road, and for most patients they feel that they have two options. Option one is a conventional standard of care with almost guaranteed side effects, some of which can be quite severe, leading to hospitalization and even death with no guarantee of benefit, but with the most scientific rationale for their use and a real confidence that this must give me some chance of success, or else it wouldn't be part of the standard of care.
Speaker1:
That's option one, or option two is to reject the standard of care and use alternative medicine, which typically contains far fewer side effects, but also much less evidence for potential benefit. And most patients come to me and they say, Dr. Stegall, I met this fork in the road. I don't know what to do. I need you to help me. So let's talk about choosing wisely. So many people assume that there are only these two choices the standard of care or alternative care. And as you know, by listening to my podcast, there is a much better approach which involves choosing both of these approaches. And that's, of course, what we know as integrative oncology. It's a personalized, evidence based approach to treating cancer, using a combination of conventional medicine and alternative medicine. This approach provides therapies with the most scientific evidence, such as surgery and chemotherapy, but also natural therapies which make sense good nutrition supplementation, stress reduction. These are things that we have a lot of evidence for their use. We're incorporating them because we would be foolish not to, but we're not doing that. Instead of the standard of care, we're doing it in addition to that's a true integrative approach. Integrative oncology makes sense because using conventional treatment alone leaves much to be desired. However, using alternative medicine by itself means relying on treatments with much less evidence supporting their use. Our next listener question comes from Lauren, who asks about integrative oncology testing.
Speaker1:
We covered lab testing in episodes five and six of this podcast. So if you haven't listened to those episodes, please check them out. My approach to testing is similar to my overall cancer treatment philosophy, which is to combine conventional testing with other innovative tests. This approach balances the science of readily available diagnostic testing with advanced testing, which has not yet become the standard of care. My advice for patients is to have the following lab tests to establish a baseline. First, a complete blood count. This looks at your immune system, your iron levels, and your platelet counts, giving a good look at the major cells in the body. Second, a comprehensive metabolic panel. This looks at your blood sugar, your kidney function, your liver function, and your electrolytes like sodium, potassium and calcium. Next, a lipid panel is important to evaluate your cholesterol levels. This looks at total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides. Next, a hemoglobin, a1c gives us valuable information about your blood sugar control over the last three months. I also recommend a thorough hormone panel, including a thyroid panel which commonly includes a T, H and thyroid hormones. Rt four and RT three. I choose to test free RT four and free RT three because these recommend the bioavailable portions of those hormones. Also included in a good hormone panel are FSH and LH, which are a good measurement of the amount of hormone the body senses and then how much the body is trying to stimulate production of more hormones as well as the main hormones such as estradiol testosterone and another one called DHEA sulfate.
Speaker1:
For women, I also would include a progesterone level. Now these hormone levels are most important in cancers, which are fueled by hormones such as most breast cancers, as well as some ovarian cancers and prostate cancers. But I choose to look at hormones for all patients because hormone levels are important regardless for overall health. I also look at some vitamin levels. Vitamin B 12 is important to look at because it's it's important for a lot of cellular processes. But it's also important because some cancers have actually been shown to be fueled by vitamin B 12. So I like to make sure vitamin B 12 is neither too low nor too high. A vitamin D level is extremely important. The level you want to check in the blood is vitamin D 25 zero. That's a vitamin D, 25 hydroxy. That's the best form of vitamin D to measure in the blood. And we like to make sure that's optimized because we know that an optimal vitamin D level not only protects the bones, but also is extremely important for immune system health as well. I also recommend checking some other markers. Inflammation is a big deal, not only because inflammation, which I really describe as an irritation on a cellular level.
Speaker1:
Inflammation not only contributes to cancer formation, but also is a big driver of cancer progression. And so getting a baseline C-reactive protein, which is also abbreviated CRP, is very important and also like to check a lab called the Lactate Dehydrogenase, abbreviated LDH. Finally, there's a couple of other inflammatory markers to look at. One, it's called ferritin. Ferritin is actually the storage form of iron in the body, so it can give a good look at the iron stores in the body. But also ferritin can be increased when there's a lot of inflammation present. So ferritin gives us some important information on both of those aspects. And then also fibrinogen is related to blood clotting, but it can also be elevated when there's some inflammation present. So that represents a good baseline of lab tests to get. Now these are all available through conventional lab testing companies. I would encourage you if if you don't have an integrative oncologist to ask your regular oncologist to order these things for you, hopefully he or she be willing to do that. And then there's certainly other things that you could get we could get into some more testing in terms of some different immune markers and other things we could get. But I found that these I just mentioned are really the extent of what you need to get for a baseline panel in terms of the regular labs. And then I also highly recommend a way to measure systemic cancer in the body, in the bloodstream.
Speaker1:
And so I utilize the IV gene test to do that. That's IVI, G and E, they are an independent lab here in the United States. And it's a blood test which can be drawn in the office with with their specialized kits. And then what they do is they test the blood for what's known as methylated circulating tumor cell DNA. And so this looks at what's known as methylation patterns, which methylation is a normal process in the body. But because it's so heavily related to cell growth and genetic material growth, that cancer cells undergo the methylation process much more frequently and more readily than normal cells do. So if we see a higher level of this methylation pattern in the bloodstream, then we know that that there is some cancer involvement in the bloodstream. And so this is very important, I think, for all cancer patients to get, whether you're a stage one or two or you're a stage three or four, because even if the cancer itself is only seen in certain areas of the body, if we're finding a lot of this methylated, circulating tumor cell DNA in the blood, then we know that the conditions are right for the cancer to ultimately spread somewhere else. So this is a good test to get at baseline. And then it's something that we like to follow during treatment and then after treatment as well.
Speaker1:
I found this to be superior to circulating tumor cell or CTC testing because circulating tumor cell testing requires the visualization of whole. Tumor cells, which is important to look at. But what you find in many cases is that these are difficult to detect in the blood, and they're certainly much larger entities than these little fragments of cancer cell DNA that the IV gene test is able to detect. So if you imagine a circulating cancer cell as the size of the room, you're sitting in a piece of circulating cancer. Dna is the size of a pen or pencil you're holding in your hand. So the I.V. gene test is a very sensitive test. It is not diagnostic. It is not part of the standard of care. But I do feel that it's a very good test, a very high quality test, and I definitely get that on all of my patients at baseline as well as at regular intervals, moving forward to monitor treatment and ideally monitor remission as well. So the other thing I recommend for some patients is some sort of what we call molecular profiling or tumor profiling. I recently had a question from a podcast listener about Dr. Negaunee. He's a doctor out in California who does some of this testing. There are other companies that do it as well. The one I typically use is the Caris molecular intelligence test.
Speaker1:
There are others. Neo genomics is another one. There's another one called Garden 360. There's another one called the Wiesenthal Test. Dr. Wiesenthal does some of this testing. They're all a little bit different in their methodology, but the concept is the same that we're taking some sort of cancer material. Typically, it's going to be a piece of tissue obtained via biopsy or surgery, but occasionally some blood testing can be done as well to obtain the information. But testing is done to basically look at different genetic mutations. And this is important because in the era of personalized medicine, the more information we can get about each specific patient, the better. And so getting some of these genetic mutations is important because it allows us to better customize treatments. So that can sometimes help us decide which chemotherapy agents are best to use. Or for some people who are doing immunotherapy, it can be helpful for that as well. So if possible, typically like to include one of these tests. It's not essential. We certainly treat many patients who don't have any of this testing. You know, the decision on whether or not to do this testing is going to be based on a few factors, including the diagnosis, the type of cancer when the last biopsy or surgery was performed, and other factors as well. So so I don't make this an absolute requirement, but if the conditions are right and if the patient meets the criteria in terms of diagnosis and all that, then it's something to consider.
Speaker1:
And they vary in terms of whether insurance will reimburse for them as well. So again, it depends on the patient's insurance. Some of these tests are going to be out of pocket and then some are going to be covered by insurance on occasion. So a lot of factors to consider. But all of these tests I've mentioned to you, including the baseline blood work and the IV gene test, represent a really robust look at lab testing. So, Lauren, I hope that answers your question. You know, every integrative oncologist is going to have their own preferences, but I would say that that the ones I just mentioned to you will give a lot of information that you and your doctor can use to best come up with your treatment protocol. Lauren also asked another great question about integrative oncology data and if treatment results and outcomes are being tracked and pooled amongst various integrative oncologists and integrative oncology centers, the answer to this is no. Not yet anyway. While I'm all for tracking treatment outcomes, the problem with this approach as it relates to integrative oncology is that integrative oncology doesn't have an established standard of care. This is both a blessing and a curse. One integrative oncologist is going to use different treatments than another integrative oncologist. The freedom we exercise to treat each patient as a unique individual rather than as a diagnosis code hampers us when it comes to measuring outcomes across hundreds or thousands of patients, with each patient being unique and each patient receiving different therapies.
Speaker1:
There is no way to standardize our results and compare those results to the current standard of care. For this reason, I'm very honest with my patients. Rather than give each patient a percentage chance of cure or remission, since that wouldn't be ethical or fair, I discussed goals with each patient. We discussed what I feel to be realistic goals in both the short term and the long term. I also tell patients honestly if I feel that my approach will help them reach these goals, if I don't feel that I can help them reach their goals, or if another approach might be better, I'm very honest about that. I only accept patients into my practice. I feel that I can help achieve their treatment goals while working within a mutually agreed upon treatment philosophy for integrative oncology to continue to gain traction in the cancer world. I believe that we must hold ourselves to a very high standard when it comes to our ethics and the way we practice medicine. Ultimately, we are held to a higher standard as a result of our departure from purely conventional approaches, and I'm okay with that. I welcome that. Based on what I've seen in my practice, I believe that integrative oncology can succeed, even when the standard of care can't.
Speaker1:
However, I understand that many people often want a way to know if a treatment is likely to work for them. While it would be nice to have data like we have in conventional oncology. We must remember that there is no way a treatment outcome can be guaranteed. That goes for whether we use conventional treatments alone or in combination with alternative therapies, as we do in integrative oncology. Studies are nice to have, but as I tell patients, we haven't done a study on you. In fact, your cancer journey can be thought of as a study of one. In essence, you are conducting your own study. This is why using good science and a wide variety of targeted treatment modalities is so important when dealing with a serious diagnosis like cancer. Please subscribe to the Cancer Secrets podcast to be notified when new episodes are released. If you're enjoying these podcasts, please take a minute and provide a review on iTunes or wherever you listen to podcasts. Finally, please share this podcast with your family and friends. All previous episodes are available for free on our website. Cancer Secrets. Our next episode will be a great one as we sit down with Dr. Eric Zielinski to discuss essential oils and how they can fit into your cancer treatment protocol. You're going to love the helpful, science based information we cover. I look forward to next time.
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