Robert A. Buckman, M.D., Ph.D.
Adjunct professor, Behavioral Science
The University of Texas M. D. Anderson Cancer Center
Dr. von Eschenbach:
Hello, I'm Andy von Eschenbach. I'm here to introduce this program about the importance of communicating with your patients. In addition to the conventional therapy that we prescribe, patients are also using complimentary and alternative medicines. It's our responsibility to learn what are patients are using and doing in addition to conventional therapies. This is our responsibility as healthcare providers and it is a matter of growing concern in today's healthcare.
Hello, I'm Rob Buckman and I'm speaking to you from M. D. Anderson Cancer Center. Now when we talk about CAM - C, A, M - we're referring to complimentary and alternative medicine: approaches to, prevention or treatment of disease or symptom control outside of the conventionally prescribed therapies. CAM therapies include activities like yoga, like meditation, massage or acupuncture many of which have very beneficial effects for cancer patients, and a low potential for harm if they are done under the supervision of qualified experts. Acupuncture for example has proven helpful for nausea from chemotherapy.
CAM may also include biological substances like herbs and vitamins. Some of which might have beneficial effects for patients, but... any substance that acts biologically has the potential for other effects. Ginger for example, may prove to be helpful for nausea from chemotherapy, but it may also increase bleeding tendencies. Still other substances might actually interfere with or even negate the effect of chemotherapy or radiation. So now, let's hear from Dr. Laura Michaud, an expert in the whole area of medication interactions.
Dr. Laura Michaud:
With ingestible CAM it's -- the most important thing is that patients are aware of the fact that they are potent pharmacologically. We look for things that have known drug interactions. Things that have been shown in the literature to be problematic such as St. John's Wort: a very common herb used for depression primarily and mood elevation. St. John's Wort actually affects multiple cytochrome P450 enzymes in the liver. And some examples of things that may have hormonal properties that would be problematic in breast cancer patients specifically would be things that are estrogenic. Black cohosh is a very common product that many women seek out for treatment of hot flashes, menopausal symptoms: may or may not have estrogenic properties so that particular product we really are cautious about. Things that affect blood coagulation, that may thin the blood and interfere with drugs like warfarin, or coumadin, or heparin like products would be things such as ginseng, ginkgo biloba.
Things that affect the immune system - adversely affect the immune system - we of course would want to avoid. Antioxidants for patients and for patients to understand that even though they may be good in terms of helping heart disease and they may be helpful in preventing cancer, more is not better and the fact that free radicals are not necessarily all bad. Many of our cancer chemotherapies will produce free radicals to attack the cancer cells as we all know. And those mechanisms are very important for certain drugs: certain chemotherapy drugs. So if patients understand that, and understand how those things interact, most of the people I talk with choose not to take it. They don't want to take that risk.
And when you consider biologic substances, don't forget food. Nicki Lowenstein can tell us more. She's a dietician who works with cancer patients.
There's a lot of data that supports patients that are not well nourished when they go through treatment, actually do not do as well in treatment. And patients that aren't adequately nourished are often fatigued and suffer a tremendous amount more side effects than patients that come in well nourished. So those are some of the things that patients need to think about, because often times nutrition's not really at the top of their agenda of things to do. The most common questions that patients ask during chemotherapy are about additional supplementation.
The most common questions are "Should I be taking extra vitamin C? Should I be taking extra vitamin E? Should I be taking extra vitamins at all? Should I take some herbals or things like that that my you know great-grandmother's hairdresser told me to take?" And what we will do is we'll look at the supplements that they're asking about and we'll look at them individually along with their chemotherapy and let them know just how much if any of those supplements may be beneficial, or whether or not those supplements that they're considering taking may in fact interfere with their treatment. So supplement questions are probably the number one question.
So we have growing interest in CAM among our patients. In fact, studies show that over 50 percent of our patients are using some form of CAM. And although the body of scientific knowledge about some of these therapies is growing, it can present a real challenge to our preference for delivering evidence based medicine. One of the big issues here of course is that of our legal responsibilities with regard to CAM. Let's here from an expert in that area. Michael H. Cohen is a legal scholar in complimentary and alternative medicine law, an attorney in private practice and an Assistant Professor of Medicine at Harvard Medical School.
I'd like to discuss 2 areas of malpractice law that can affect clinical practice involving complimentary and integrative medicine. The first is informed consent and the second is standard of care. Informed consent is both a legal and an ethical obligation. Failure to provide adequate informed consent can be a ground for malpractice liability. When people typically think about informed consent, they often think about a signed piece of paper, but that only documents that informed consent has occurred.
More importantly, informed consent is a conversation between clinician and patient. The clinician is required to discuss the diagnosis, the nature of the proposed treatment, the name of the procedure and a description in lay person's terms, the risks associated with that treatment, the risk of no treatment and alternative treatments and associated risks. Under this rule, do clinicians need to discuss complimentary and alternative medical treatments with their patients and the associated risks and benefits of such therapies? The answer is yes if the complimentary therapy would be material, meaning that it would make a difference to a treatment decision.
To sum up, if knowing about a particular complimentary therapy is likely to make a difference in the patient's decision to undergo or forego the recommended conventional treatment, then the clinician has an obligation to disclose and discuss the risks and benefits of that complimentary and alterative approach. This obligation of informed consent applies across the board, whether the treatment is considered CAM or conventional. Of course meeting the legal requirement of informed consent is just a start. Even more important when describing risks and benefits of all the material options is engaging the patient in a process of shared decision making.
Now let's turn to standard of care. Failure to provide the standard of care and thereby injuring the patient constitutes a second theory for malpractice liability. Does this mean oncologists could be liable for going beyond discussing complimentary therapies and actually recommending or providing such therapies? The law is evolving but the best answer we can give is to look to the evidence of safety and efficacy available for the given therapy. Think of a grid with safety along one axis and efficacy on the other. Where the evidence of safety and efficacy is strong, it makes clinical sense to recommend the therapy and liability is unlikely. On the other hand, where the evidence for safety and efficacy is weak it makes clinical sense to avoid and discourage the patient from using that therapy as liability would be likely. But many complimentary therapies fall in the region where there is mixed evidence regarding safety or efficacy. Here the stronger the evidence that if therapy may be dangerous or inefficacious, the more likely patient injury will result and that malpractice liability will follow.
On the other hand, the stronger the evidence of safety or efficacy, the stronger the argument that the therapy is, or at least should be considered within the standard of care. In this way, liability principles follow good clinical sense. And this same analysis should apply across the board, whether the therapy is considered conventional or CAM. When applying these principles, one area in particular to watch is the risk of adverse interactions between conventional treatments and complimentary therapies. We've already mentioned that drug-herb interactions can be a significance source of adverse events. Therefore, it's important to ask about the patient's use of herbs and other complimentary therapies. And consult relevant literature about possible interactions, in much the same way you would handle conventional medications that patients may be taking. More importantly, whether or not herbs are involved, conventional monitoring is always advisable when including complimentary therapies. If the patient wishes to try a therapy with mixed evidence for a time, it's important to stand ready to intervene conventionally should results from a time limited CAM approach prove unsatisfactory.
To wrap up, legal rules governing informed consent and standard of care suggest the importance of talking to patients openly about their existing and desired use of complimentary therapies. Liability principles often mirror sound clinical decision making. And evidence based recommendations can compliment a patient centered approach. Many other areas of law can apply to any given clinical situation. I encourage you to consult additional credible materials.
It's clear then that we need to discuss CAM use with our patients. In my own oncology practice, I spent a lot of time thinking about the best ways to communicate with the patients. And this can be quite a touchy subject. We know that only about half of the patients who use complimentary medicines actually tell their healthcare provider. The reasons for not telling, they say are they didn't realize it was important: that we might not understand. We might disapprove or discourage them, but more often they say that they were never asked. So it's important to know how to help your patient to feel free to discuss this with you.
Remember, this is something that patients have got surprisingly strong feelings about. So as with any emotion, it's very helpful to incorporate at least 1 of these 3 things into the interaction. If you don't know what the emotion is, explore. If you do know what the emotion is, validate or empathize. Explore, validate or empathize: EVE. Explore firstly, find out who they feel. Very simple. "How does that make you feel? What have you been thinking about that?" Then validate. "A lot of people have been thinking a lot about this kind of issue." And then empathize. Let them know that you understand their feelings. "This is obviously awful for you. You're obviously really worried about this" or "You've given this a great deal of thought and concern." Something like that. E-V-E
So since our last visit, have you changed your medications, changed supplements, modified your life any way?
Yes, I don't know if I mentioned it last time but I've been feeling a little depressed and I heard that St. John's Wort is good for that. So I started taking St. John's Wort. I also heard that garlic is good, just for general health and cholesterol so I've started taking garlic capsules. And I've been feeling a little tired during the days. I go for a while and I have to rest. Go for a little longer: rest. So I was reading about bee pollen, that it increases stamina. So I've started taking bee pollen.
And your stamina has been challenged so what are you doing exercise and diet wise to deal with that?
Well I started yoga. I've taken up yoga and I really like that. And in terms of diet, I have a very healthy diet.
What does healthy diet mean for you?
You know what they say, low fat, low carb.
Now once you've got your patient to share this information with you, what do you do with it? You should be able to let them know whether what they're taking is helpful or harmful. And if harmful, tell them why and suggest alternatives. For a very long time, this was a major stumbling block because so little credible information actually existed. Now however, we do have some good resources to look up the information that we don't necessarily have in our heads.
So it sounds to me as though you've taken charge of a lot of things in your life to kind of give a little more control and order and structure to things, so let me check on some of these supplements you're taking: the St. John's Wort, bee pollen and garlic capsules. And we have you on some treatment here. Let me check in the computer and see what kind of interactions there may be, whether there's anything we should consider modifying.
There are some really good resources online. I found very high quality information provided by independent review organizations such as The Natural Standard, Natural Medicine, Herb Med. The National Cancer Institute has got a CAM section. And major centers like M. D. Anderson and Memorial Sloan-Kettering also provide excellent evidence based reviews. M.D. Anderson's CIMER website - that's Complimentary and Integrative Medicine Education Resource - has got links to all of these. So it's a really good place to start. If you prefer, you can use your PDA to access this information. Now that you've got some of that information, there's the matter of communicating it to the patient.
So you're doing some really good things, and some things maybe we ought to talk about a little differently and maybe modify. So the good things okay. Exercise: exercise is excellent. There are good randomized studies that people who remain active and participate in exercise going through treatment do better than those who don't. So the yoga's a good thing. You might want to consider adding some aerobic activities like walking or swimming to that. The St. John's Wort is another issue though. Although there are some studies suggesting it can help mild depression, it also interferes with metabolism by revving up your liver.
So we prefer that you not do that and if you need something for depression, we'll get you in to see a person who's a specialist. We have folks here who can take care of that and help you with it. The other supplement - the garlic - I'd prefer you get your garlic in Italian food or cooking. Okay? If you eat too much garlic however, it can affect your coagulation parameters and may make it more likely for you to bleed, especially if you're taking coumadin or eprin like with a CVC which we use heparin all the time. So you might want to consider taking that as food instead of a supplement. Now the diet, you eat a healthy diet. And you kind of were sketchy about healthy diets, so do you want some help with the diet or...?
I think that might be useful.
One of the things that we do have here that can help you maybe is a nutrition service - Clinical Nutrition - and they can make up a diet plan for you, assess what needs, keep a food diary...
Now, there may be situations where there is no scientific evidence based information about a particular substance. In that case, I find it's best to simply share that and my concerns with the patient.
So bee pollen is really interesting. They're aren't any good studies especially in people who have cancer whether bee pollen is helpful, harmful or does anything. So we try to deal with evidence based medicine, provide best evidence for what we do. I don't know of anything that I can find that says it's harmful, but I don't of anything that we can find to say it's helpful.
So, having explored, validated and/or empathized with the patient's feelings about the subject, you will more than likely reach an agreement between the 2 of you about whether to continue or not. The other take home messages here are these. First, you must have the discussion. Ask your patients about CAM and about their diet. Two, use the resources. Many of these are listed on the M. D. Anderson's CIMER site. Third, communicate what you've found back to the patient in terms of your concerns and useful information. And finally, use your colleagues. Make referrals to pharmacologists, dieticians, other health care specialists and hospital based wellness centers. That way you will get an approach that is both patient centered and informed by evidence. And it just doesn't get better than that.
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