With a bill to license naturopaths (HB 4531) wending its way through the Michigan legislature supported by supplement manufacturers, its current status being in consideration by the full House of Representatives, periodically I feel the need to provide ammunition to the bill’s opponents, because we need to protect the patients in the state of Michigan from the naturopathic quackery that would be unleashed if this bill were to be passed into law.
If there is one area that naturopaths have been invading with a vengeance and even gaining enough seeming legitimacy to propose what they risibly refer to as “evidence-based guidelines,” it’s oncology. Many are the times I’ve written about how much naturopaths, who use the abbreviation “ND” (which from my perspective means “not a doctors”) and have formed their own specialty of “naturopathic oncology,” signified by FABNO (which I like to refer to as, “FAB? NO!”) subject patients to. Not surprisingly, one organization that’s really embraced naturopathic oncology is the Cancer Treatment Centers of America, a for-profit hospital chain that’s made its name advertising the “integration” of quackery with real medicine, known as “integrative medicine.” Depressingly, the Society for Integrative Oncology (SIO), an organization supporting the integration of “complementary and alternative medicine” (CAM) modalities (i.e., quackery) with real oncology, seems to accept naturopathy as a valid specialty, as two naturopaths were among the authors of the aforementioned SIO guidelines for the integrative treatment of breast cancer. As I found out, their naivete is profound, as evidenced by the SIO’s surprised and indignant reaction to my dwelling on homeopathy in my critique of integrative oncology. The SIO responded by accusing me of dwelling on the modalities with the “weakest evidence bases” (like homeopathy), apparently unaware that naturopathic training includes a lot of homeopathy and the naturopathic licensing examination (the NPLEX) has a whole section on homeopathy, and that one of the naturopaths who wrote the SIO guidelines for breast cancer was running a clinical trial of homeopathy at the time. Heck, an ex-naturopath has even revealed a scary practice question for the exam. That’s not even counting what naturopathic oncologists say when they think no one’s listening and the quackery to which they subject their patients.
Naturopathic oncologists even brag about it. They’re proud of it, so much so that they’re more than happy to publish what they do, as they did in this article for Integrative Cancer Therapies entitled Breast Cancer Integrative Oncology Care and Its Costs. But wait. I bet you’re thinking, “But, Orac, integrative oncology and naturopathic oncology are not the same things.” Right you are! Two of the authors of this paper are FABNOs, and they declare in the abstract, “Naturopathic oncology in conjunction with conventional treatment is commonly referred to as integrative oncology (IO),” and state specifically that the purpose of this study is to “To describe the types of IO therapies prescribed to breast cancer patients by ND FABNO physicians.” So, yes, this paper is about naturopathic oncology more than “integrative” oncology. Sure, there’s a fair amount of overlap, but not all integrative oncology is naturopathic oncology, although all naturopathic oncology is integrative oncology; that is, if you accept the nomenclature, which I do not.
Nor do I accept this premise of the study:
Because of their training and their licensed scope of practice, ND, FABNO are among those able to offer comprehensive whole-person integrative cancer care. For this reason, IO clinics directed by ND, FABNOs are a source of high-quality data for describing these therapies and their costs and measuring clinical outcomes. IO clinics are a rich source of data for cost-effectiveness research. Such care consists of a whole-person-oriented approach, including a variety of evidence-based complementary and integrative medicine practices that include a diversity of nutrient and botanical natural products, diet and exercise plans, acupuncture, hyperthermia, and mind-body medicine. Many of these therapies are based on clinical evi- dence. Although cost and cost-benefit analyses of CAM and integrated health care have been conducted5, and CAM use among breast cancer patients described, neither IO care nor its costs as it is practiced in community settings has been well described. Description of IO medical services is a required step toward evaluating its impact on disease-free and overall survival in breast cancer as well as measuring its cost-effectiveness.
Of course, to measure cost-effectivness, there has to be effectiveness to be begin with. With the vast majority of naturopathic treatments, the evidence of efficacy is sketchy at best, usually nonexistent, or at worst contradictory to any claims of efficacy. In any case, there were 324 patients with breast cancer treated at one of six naturopathic oncology clinics in the Seattle area, who agreed to be enrolled in a five year observational outcomes study. Of course, given that there’s no control group and any outcomes observed would have to be compared to historical controls, this trial design virtually guarantees that naturopathy won’t be embarrassed by poor outcomes, mainly because it’s likely that women attracted would be a select group. Indeed, I note that only 3.7% of the participants had stage IV disease when they sought out naturopathic treatment, and only 9.9% were stage III. Thus, the vast majority of the subjects had early stage disease. In fairness, though, I do note that only 6.2% of the patients had stage 0 disease (ductal carcinoma in situ, or DCIS, which is premalignant and noninvasive), a lower percentage than at most cancer centers.
Table 5 is the money table. It shows the types of treatments received by the subjects in the cohort who had at least two office visits. These included, predictably, a whole boatload of supplements, such as Coriolus, also known as Yun Zhi, Turkey tail, or Trametes versicolor, which an astonishing 62.7% of the patients received. I was unfamiliar with this particular herbal medicine. Basically, it’s a mushroom used in traditional Chinese medicine as a tonic. There are studies that suggest antitumor activity for some cancers, but the results in breast cancer have been unimpressive. The rest of the supplements included the usual suspects, such as melatonin, vitamin D3, digestive pancreatic enzymes, green tea, seaweed poultice, black cohosh, and many others. About 12.3% of patients received various injectables:
Of the 287 women described in Tables 4 to 6, 76 (26%) were prescribed some type of injectable therapy. Injectable IO therapies included subcutaneous injections of mistletoe (Viscum album) and a diversity of parenteral therapies that included vitamin B complex intramuscularly (12%), IV high-dose ascorbate (12%), IV artemisinin (7%), and IV nutrition and hydration (4%). Injectable therapies were used almost exclusively in stage 4 breast cancer patients (data not shown).
Other than hydration, the vast majority of these treatments range from quackery to unproven. Worse, they’re used for the patients who can’t be cured and would be expected to be most desperate. I’ve discussed high dose vitamin C/ascorbate on many occasions. It almost certainly doesn’t work for any cancer, and even if it does it requires incredibly high doses for incredibly underwhelming effects. As for nutrition, which is supposed to be the strong point of naturopaths, who castigate MDs every chance they get for supposedly not knowing much about nutrition and not emphasizing it enough in their treatments, this is what the naturopaths provided:
Whereas some patients (20%) were referred for nutritional counseling by a certified nutritionist, most received dietary advice from the IO physician within the visit. Dietary recommendations included increased green tea as a drink (24%), increased vegetables (17%), broth fast (16%), increased protein (13%), increased water (15%), reduced simple sugars (8%), increased fish (7%), and decreased mammalian fat (5%).
None of these are likely to be harmful, other than a broth fast, which is not a great idea for a cancer patient undergoing chemotherapy. Be that as it may, there were other recommendations that are less helpful, such as juice fasts, eliminating dairy, eliminating wheat, and the like. Of course, one can’t help but note that the 20% referred to nutritionists were almost certainly referred to woo nutritionists, as real nutritional counselors practicing evidence-based nutrition counseling are called dieticians.
In any case, the remainder of the modalities examined were of the “mind-body”variety, including massage, meditation, unspecified “mind-body” therapy, and qi gong, which aren’t likely to be harmful, but 6.8% were also referred for the quackery known as craniosacral therapy.
Now let’s look at the cost:
The direct costs of care include medical visits (naturopathic oncology consultation and mind-body medicine visits), procedures (acupuncture), and pharmacy. Pharmacy includes nutritional and botanical medicines administered orally, intravenously, subcutaneously, intramuscularly, or topically. Yearly cost for office visits ranged from $512/year to $1084/year. Stage 3 women had the most visits and the highest visit costs compared with women at other stages of breast cancer at diagnosis.
That doesn’t sound so bad. However, this does:
We asked the ND, FABNOs to describe an ideal core protocol for IO care for each stage and type of breast cancer. We then calculated the cost of IO pharmacy for 1 year of care for a stage 4 cancer patient. Table 8 presents an IO core therapy program for 1 year of treatment for a stage 4 breast cancer patient. Total cost of the medicines used in this treatment plan for 1 year is approximately $27137. Parenteral therapies were the most costly of IO treatments, and few stage 4 breast cancer patients completed such an idealized treatment. Total costs (visits and IO pharmacy and procedures) of 1 year of IO treatment for a women with progress- ing stage 4 breast cancer is approximately $31662/year. ND, FABNO visits cost approximately $4525/year (see Table 3). Office visits are reimbursed by medical insurance providers, including Medicaid but not Medicare.
Naturopaths will say that chemotherapy costs more, and that much is true. The difference, however, is that chemotherapy is an effective adjuvant therapy for early stage breast cancer and for stage III, while it can, when judiciously used, be a good palliative treatment for stage IV breast cancer. Nothing in the list of intravenous treatments for breast cancer listed in Table 8 is proven, either as an adjuvant therapy or palliative therapy. Certainly nothing in Table 8 is curative.
So how does one justify spending $30,000 a year on intravenous therapies that do nothing? The funny thing about this article is that it doesn’t even try. It is simply an observational study, which reported what treatments were received by this cohort of 324 breast cancer patients and how much it cost. The naturopathic oncologists and other authors of the paper seem to have simply assumed that these treatments are worthwhile and effective. They do not question them. From my perspective, doing studies like this is totally putting the cart before the horse. Efficacy should be established first, and then utilization and cost are worth studying. In the world of naturopathic oncology, it doesn’t matter if the treatments being studied work or not.
I’d just like to leave with a question and an answer. The question is: Who funded this study? The answer: The National Center for Complementary and Integrative Health. Yes, the NCCIH continues to waste taxpayer money on pointless studies like this.
from ScienceBlogs http://ift.tt/1t0MSxN
With a bill to license naturopaths (HB 4531) wending its way through the Michigan legislature supported by supplement manufacturers, its current status being in consideration by the full House of Representatives, periodically I feel the need to provide ammunition to the bill’s opponents, because we need to protect the patients in the state of Michigan from the naturopathic quackery that would be unleashed if this bill were to be passed into law.
If there is one area that naturopaths have been invading with a vengeance and even gaining enough seeming legitimacy to propose what they risibly refer to as “evidence-based guidelines,” it’s oncology. Many are the times I’ve written about how much naturopaths, who use the abbreviation “ND” (which from my perspective means “not a doctors”) and have formed their own specialty of “naturopathic oncology,” signified by FABNO (which I like to refer to as, “FAB? NO!”) subject patients to. Not surprisingly, one organization that’s really embraced naturopathic oncology is the Cancer Treatment Centers of America, a for-profit hospital chain that’s made its name advertising the “integration” of quackery with real medicine, known as “integrative medicine.” Depressingly, the Society for Integrative Oncology (SIO), an organization supporting the integration of “complementary and alternative medicine” (CAM) modalities (i.e., quackery) with real oncology, seems to accept naturopathy as a valid specialty, as two naturopaths were among the authors of the aforementioned SIO guidelines for the integrative treatment of breast cancer. As I found out, their naivete is profound, as evidenced by the SIO’s surprised and indignant reaction to my dwelling on homeopathy in my critique of integrative oncology. The SIO responded by accusing me of dwelling on the modalities with the “weakest evidence bases” (like homeopathy), apparently unaware that naturopathic training includes a lot of homeopathy and the naturopathic licensing examination (the NPLEX) has a whole section on homeopathy, and that one of the naturopaths who wrote the SIO guidelines for breast cancer was running a clinical trial of homeopathy at the time. Heck, an ex-naturopath has even revealed a scary practice question for the exam. That’s not even counting what naturopathic oncologists say when they think no one’s listening and the quackery to which they subject their patients.
Naturopathic oncologists even brag about it. They’re proud of it, so much so that they’re more than happy to publish what they do, as they did in this article for Integrative Cancer Therapies entitled Breast Cancer Integrative Oncology Care and Its Costs. But wait. I bet you’re thinking, “But, Orac, integrative oncology and naturopathic oncology are not the same things.” Right you are! Two of the authors of this paper are FABNOs, and they declare in the abstract, “Naturopathic oncology in conjunction with conventional treatment is commonly referred to as integrative oncology (IO),” and state specifically that the purpose of this study is to “To describe the types of IO therapies prescribed to breast cancer patients by ND FABNO physicians.” So, yes, this paper is about naturopathic oncology more than “integrative” oncology. Sure, there’s a fair amount of overlap, but not all integrative oncology is naturopathic oncology, although all naturopathic oncology is integrative oncology; that is, if you accept the nomenclature, which I do not.
Nor do I accept this premise of the study:
Because of their training and their licensed scope of practice, ND, FABNO are among those able to offer comprehensive whole-person integrative cancer care. For this reason, IO clinics directed by ND, FABNOs are a source of high-quality data for describing these therapies and their costs and measuring clinical outcomes. IO clinics are a rich source of data for cost-effectiveness research. Such care consists of a whole-person-oriented approach, including a variety of evidence-based complementary and integrative medicine practices that include a diversity of nutrient and botanical natural products, diet and exercise plans, acupuncture, hyperthermia, and mind-body medicine. Many of these therapies are based on clinical evi- dence. Although cost and cost-benefit analyses of CAM and integrated health care have been conducted5, and CAM use among breast cancer patients described, neither IO care nor its costs as it is practiced in community settings has been well described. Description of IO medical services is a required step toward evaluating its impact on disease-free and overall survival in breast cancer as well as measuring its cost-effectiveness.
Of course, to measure cost-effectivness, there has to be effectiveness to be begin with. With the vast majority of naturopathic treatments, the evidence of efficacy is sketchy at best, usually nonexistent, or at worst contradictory to any claims of efficacy. In any case, there were 324 patients with breast cancer treated at one of six naturopathic oncology clinics in the Seattle area, who agreed to be enrolled in a five year observational outcomes study. Of course, given that there’s no control group and any outcomes observed would have to be compared to historical controls, this trial design virtually guarantees that naturopathy won’t be embarrassed by poor outcomes, mainly because it’s likely that women attracted would be a select group. Indeed, I note that only 3.7% of the participants had stage IV disease when they sought out naturopathic treatment, and only 9.9% were stage III. Thus, the vast majority of the subjects had early stage disease. In fairness, though, I do note that only 6.2% of the patients had stage 0 disease (ductal carcinoma in situ, or DCIS, which is premalignant and noninvasive), a lower percentage than at most cancer centers.
Table 5 is the money table. It shows the types of treatments received by the subjects in the cohort who had at least two office visits. These included, predictably, a whole boatload of supplements, such as Coriolus, also known as Yun Zhi, Turkey tail, or Trametes versicolor, which an astonishing 62.7% of the patients received. I was unfamiliar with this particular herbal medicine. Basically, it’s a mushroom used in traditional Chinese medicine as a tonic. There are studies that suggest antitumor activity for some cancers, but the results in breast cancer have been unimpressive. The rest of the supplements included the usual suspects, such as melatonin, vitamin D3, digestive pancreatic enzymes, green tea, seaweed poultice, black cohosh, and many others. About 12.3% of patients received various injectables:
Of the 287 women described in Tables 4 to 6, 76 (26%) were prescribed some type of injectable therapy. Injectable IO therapies included subcutaneous injections of mistletoe (Viscum album) and a diversity of parenteral therapies that included vitamin B complex intramuscularly (12%), IV high-dose ascorbate (12%), IV artemisinin (7%), and IV nutrition and hydration (4%). Injectable therapies were used almost exclusively in stage 4 breast cancer patients (data not shown).
Other than hydration, the vast majority of these treatments range from quackery to unproven. Worse, they’re used for the patients who can’t be cured and would be expected to be most desperate. I’ve discussed high dose vitamin C/ascorbate on many occasions. It almost certainly doesn’t work for any cancer, and even if it does it requires incredibly high doses for incredibly underwhelming effects. As for nutrition, which is supposed to be the strong point of naturopaths, who castigate MDs every chance they get for supposedly not knowing much about nutrition and not emphasizing it enough in their treatments, this is what the naturopaths provided:
Whereas some patients (20%) were referred for nutritional counseling by a certified nutritionist, most received dietary advice from the IO physician within the visit. Dietary recommendations included increased green tea as a drink (24%), increased vegetables (17%), broth fast (16%), increased protein (13%), increased water (15%), reduced simple sugars (8%), increased fish (7%), and decreased mammalian fat (5%).
None of these are likely to be harmful, other than a broth fast, which is not a great idea for a cancer patient undergoing chemotherapy. Be that as it may, there were other recommendations that are less helpful, such as juice fasts, eliminating dairy, eliminating wheat, and the like. Of course, one can’t help but note that the 20% referred to nutritionists were almost certainly referred to woo nutritionists, as real nutritional counselors practicing evidence-based nutrition counseling are called dieticians.
In any case, the remainder of the modalities examined were of the “mind-body”variety, including massage, meditation, unspecified “mind-body” therapy, and qi gong, which aren’t likely to be harmful, but 6.8% were also referred for the quackery known as craniosacral therapy.
Now let’s look at the cost:
The direct costs of care include medical visits (naturopathic oncology consultation and mind-body medicine visits), procedures (acupuncture), and pharmacy. Pharmacy includes nutritional and botanical medicines administered orally, intravenously, subcutaneously, intramuscularly, or topically. Yearly cost for office visits ranged from $512/year to $1084/year. Stage 3 women had the most visits and the highest visit costs compared with women at other stages of breast cancer at diagnosis.
That doesn’t sound so bad. However, this does:
We asked the ND, FABNOs to describe an ideal core protocol for IO care for each stage and type of breast cancer. We then calculated the cost of IO pharmacy for 1 year of care for a stage 4 cancer patient. Table 8 presents an IO core therapy program for 1 year of treatment for a stage 4 breast cancer patient. Total cost of the medicines used in this treatment plan for 1 year is approximately $27137. Parenteral therapies were the most costly of IO treatments, and few stage 4 breast cancer patients completed such an idealized treatment. Total costs (visits and IO pharmacy and procedures) of 1 year of IO treatment for a women with progress- ing stage 4 breast cancer is approximately $31662/year. ND, FABNO visits cost approximately $4525/year (see Table 3). Office visits are reimbursed by medical insurance providers, including Medicaid but not Medicare.
Naturopaths will say that chemotherapy costs more, and that much is true. The difference, however, is that chemotherapy is an effective adjuvant therapy for early stage breast cancer and for stage III, while it can, when judiciously used, be a good palliative treatment for stage IV breast cancer. Nothing in the list of intravenous treatments for breast cancer listed in Table 8 is proven, either as an adjuvant therapy or palliative therapy. Certainly nothing in Table 8 is curative.
So how does one justify spending $30,000 a year on intravenous therapies that do nothing? The funny thing about this article is that it doesn’t even try. It is simply an observational study, which reported what treatments were received by this cohort of 324 breast cancer patients and how much it cost. The naturopathic oncologists and other authors of the paper seem to have simply assumed that these treatments are worthwhile and effective. They do not question them. From my perspective, doing studies like this is totally putting the cart before the horse. Efficacy should be established first, and then utilization and cost are worth studying. In the world of naturopathic oncology, it doesn’t matter if the treatments being studied work or not.
I’d just like to leave with a question and an answer. The question is: Who funded this study? The answer: The National Center for Complementary and Integrative Health. Yes, the NCCIH continues to waste taxpayer money on pointless studies like this.
from ScienceBlogs http://ift.tt/1t0MSxN
Aucun commentaire:
Enregistrer un commentaire