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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
October 18, 2014

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Cancer Drugs: The Irrational Rationale for their Incomprehensible Prices
Menopausal Symptoms Are Common in Breast Cancer Survivors
High Red Meat Intake During Early Adulthood Is Associated with Elevated Risk
   for Breast Cancer
Long-Term Survival Not Improved with ADT for Localized Prostate Cancer
Influence of the Treating Physician in Low-Risk Prostate Cancer
Surveillance for Stage I Testicular Cancer: How Effective
Diabetes Linked to Increased Risk for Head and Neck Cancers

MM: It is maddening that drugs that treat catastrophic conditions are so incredibly expensive. This is typically not the case with maintenance drugs. Could this be solely due to the limited duration that it is anticipated that a patient will be using these medications? An example of this disproportionate drugs type pricing is the new drug that may be used orally and can CURE Hepatitis C. The course of treatment is approximately $85,000 and this drug is not alone in its price tag. The question arises, is it appropriate for drug companies to seek extremely rapid returns on their investments when it is the general public, through our taxes that are footing the lion's share of the bill for Medicare and other publicly financed insurance programs? This seems like gouging to me.
Cancer Drugs: The Irrational Rationale for their Incomprehensible Prices
Cancer drug prices keep rising. The industry blames the rising costs of drug development and the business risks they must take. Some think they charge what they can get away with, and the prices go up every year.
Look at Zykadia! The drug was approved by the FDA in April of this year, and the company charges $13,200 per month for it. Its competitor is the older drug Xalkori approved in 2011, costing $11,500 per month. In other words, Zykadia (the newer drug) costs almost $2000 more per month.
Relating to the risk that a drug they develop may not work, Novartis took that risk with Zykadia, a me-too drug. However, Xalkori, the drug it imitates, was the first of its kind. So the risk with Xalkori was greater, but Zykadia costs more!
Regarding clinical research costs, Novartis had to run a trial of 163 patients to convince the FDA about Zykadia. But Pfizer had to run two studies with 255 patients in total. More studies with more patients means Pfizer spent more than Novartis on clinical research, but Novartis drug costs more!
So, the pricing of Zykadia has nothing to do with what it cost to bring it to market, it has to do with when it came on the market. We seem to be more tolerant to high drug prices than three years ago and much greater than a decade ago when the median price of cancer drugs was about $5,000 per month (in today's dollars).
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MM: Sudden changes of hormone levels will typically bring an adverse reaction to the patient irrespective of their age or gender. This is not a surprise. Hot flashes, night sweats and vaginal dryness are common responses to surgical or chemotherapy treatments. The appropriate question to the clinician is what may be done to improve the Quality of Life (QOL) of these patients? Although many clinicians are reluctant to prescribe estrogen in any form for these patients, estriol vaginal cream and suppositories have been used safely in Europe for several decades to relieve all of these symptoms. If a nonhormonal alternative is desired for urogenital issues, then NeuEve vagitories are a safe and effective non-prescription product that demonstrate no ill effects and are effective as much as 75% of the time for vaginal dryness and painful intercourse. Finally, a wonderful, nonhormonal, non-prescription oral tablet, Estrovera, made by Metagenics is an herbal formulation and has been shown to be effective for a variety of menopausal symptoms in as many as 70% of patients and has demonstrated no ill effects, nor is it contraindicated for breast cancer survivors.
Menopause 2014 Oct; 21:1075
Menopausal Symptoms Are Common in Breast Cancer Survivors
Prevalence of vasomotor and sexual symptoms emphasizes the need for effective nonhormonal therapies.
To determine the prevalence and severity of menopausal symptoms among survivors of invasive breast cancer who had no evidence of recurrent or new disease and were no longer receiving adjuvant endocrine therapy (i.e., tamoxifen or aromatase inhibitors), investigators conducted a prospective cohort study of data from 843 women enrolled in a prospective Australian cohort study. Participants completed questionnaires at enrollment and every 12 months for 5 years (mean follow-up, 6 years after diagnosis).
Self-reporting of any vasomotor, psychological, physical, and sexual symptoms was common. Past chemotherapy or adjuvant endocrine therapy had no independent effects on vasomotor and sexual domain scores. Regardless of menopausal status, almost 80% of all women younger than 60 reported psychosocial and physical symptoms. Among postmenopausal women, menopausal symptoms were most common and severe in those aged 50 to 59; still, more than half of women aged 60 to 69 reported vasomotor or sexual symptoms, as did more than one third of those aged ≥70. Compared with healthy community controls, women with breast cancer had significantly higher severity scores for both vasomotor and sexual domains (P≤0.004).
Comment: These findings echo prior observations that menopausal symptoms are common — and not adequately managed — in breast cancer survivors. Despite the study's weaknesses as noted by editorialists (possible suboptimal adherence to adjuvant endocrine therapy, inconsistent documentation of symptom management), the data reinforce the need to develop more effective treatments for the ever-growing numbers of breast cancer survivors. In the meantime, clinicians who care for these women should question them about menopausal symptoms and offer what nonhormonal treatments (e.g., selective serotonin reuptake inhibitors) are available. In general, clinicians should be mindful that paroxetine should not be prescribed to women using tamoxifen (NEJM JW Womens Health Mar 4 2010). 
Citation(s): Davis SR et al. Menopausal symptoms in breast cancer survivors nearly 6 years after diagnosis. Menopause 2014 Oct; 21:1075. (http://dx.doi.org/10.1097/gme.0000000000000219

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MM: There has been a lot written on the benefits of a plant based diet and the evils of red meat. In my opinion, the key words here are 'High Red Meat Intake." Moderation and variety seem to be keys to optimal health. Whether it is moderate food intake, moderate exercise, moderate sun exposure or any number of examples.
BMJ 2014 Jun 10; 348:g3437
High Red Meat Intake During Early Adulthood Is Associated with Elevated Risk for Breast Cancer
Substituting other sources of protein for red meat might lower risk.
In the Nurses' Health Study, red meat intake during early adulthood was associated with excess risk for breast cancer in premenopausal women after 12 years of follow-up. Now, the same investigators report on associations between dietary protein intake during early adulthood and risk for breast cancer after 20 years of follow-up; analysis involved 89,000 premenopausal nurses (mean age, 36) who completed dietary questionnaires at baseline.
More than 2800 cases of breast cancer were documented. Adjusted for multiple potential confounders, the highest median intake of red meat versus the lowest median intake (1.5 servings daily vs. about 1 serving weekly) was associated significantly with elevated risk for breast cancer overall (relative risk, 1.2). In contrast, higher intakes of poultry, fish, eggs, legumes, and nuts were not associated with elevated risk. When data were analyzed by menopausal status, higher poultry intake was associated with lower risk for breast cancer in postmenopausal women (RR, 0.7), but not in premenopausal women. The authors estimated that substituting one serving daily of legumes, poultry, or a combination of legumes, nuts, poultry, and fish for one serving daily of red meat was associated with significantly lower risks for breast cancer.
Comment: In this large prospective study, high red meat intake during early adulthood was associated significantly with excess risk for breast cancer, whereas high intakes of other protein sources were not. Although residual confounding is possible, recommending that young women get their protein from sources other than red meat is reasonable — potentially to lower both breast cancer and cardiovascular risks.
Citation(s): Farvid MS et al. Dietary protein sources in early adulthood and breast cancer incidence: Prospective cohort study. BMJ 2014 Jun 10; 348:g3437. (http://dx.doi.org/10.1136/bmj.g3437)

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MM: Androgen deprivation therapy (ADT), though a popular form of treatment does not show marked improvement or enhanced survival in prostate cancer patients.There is no question that prostate cancer should not be ignored but ADT is not the way to treat it. We need to look at better approaches such as decreasing estrogen load and providing immune boosting treatments such as Probiotics, Vitamin D3, C, Selenium and Zinc. Immune boosting agents such as Isagenix Product B is also a very good supplement that is at least as effective as ADT and certainly has both fewer adverse effect potentials and is a fraction of the cost.
JAMA Intern Med 2014 Jul 14
Long-Term Survival Not Improved with ADT for Localized Prostate Cancer
Androgen-deprivation therapy was not associated with improvement in 15-year overall or disease-specific survival.
Although recent changes in screening guidelines have been broadly promulgated, an estimated 233,000 men will be diagnosed with prostate cancer this year, and the vast majority will have clinically organ-confined disease. Many of these men will undergo curative-intent local therapy (surgery and radiotherapy), but substantial numbers will receive primary androgen-deprivation therapy (ADT), despite the absence of data to support its use in this setting.
To provide additional insight into the utility of ADT for patients with early-stage prostate cancer, investigators performed a population-based cohort study involving 66,717 Medicare patients (66 or older) in the Surveillance, Epidemiology, and End Results (SEER) program database who were diagnosed with prostate cancer between 1992 and 2009. Enrollment was restricted to patients with clinical localized disease (T1/T2) who did not undergo definitive local therapy within 180 days of diagnosis.
At a median follow-up of 110 months, total of 5275 deaths occurred from prostate cancer and 39,801 deaths occurred from all causes. Primary ADT was not associated with improved 15-year overall or disease-specific survival. Patients receiving primary ADT tended to be older with a higher Charlson comorbidity score and higher mean prostate-specific antigen (PSA) values.
Comment: These results, along with similar findings from other recent studies, should inform clinicians that ADT fails to improve both prostate-cancer and overall survival in patients with clinically localized prostate cancer deemed unfit or inappropriate for curative-intent local therapy. A more thoughtful screening paradigm might ultimately reduce the number of patients brought into this therapeutic setting.
Citation(s): Lu-Yao GL et al. Fifteen-year survival outcomes following primary androgen-deprivation therapy for localized prostate cancer. JAMA Intern Med 2014 Jul 14; [e-pub ahead of print].
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MM: It seems that there is a disconnect between the amount of treatment that is recommended by clinicians who have a great deal of experience with prostate cancer and those who do not. Urologists were FIVE times more likely than oncologists to treat patients who were aged, at low risk and who would intrinsically not typically outlive the statistical increase in lifespan seen with younger, higher risk patients.
JAMA Intern Med 2014 Jul 14
Influence of the Treating Physician in Low-Risk Prostate Cancer
Urologists who recently graduated from medical school were more likely to manage low-risk disease with observation.
Prospective randomized trials have demonstrated that curative-intent local therapy (surgery and radiotherapy) fails to improve survival for most older patients with favorable-risk prostate cancer (T1/T2a, prostate-specific antigen [PSA] <10 ng/mL, Gleason scores ≤6). Yet, many such patients undergo primary therapy.
Now, investigators at a major U.S. cancer center have conducted a population-based cohort study to determine the impact of urologists and radiation oncologists on the management of patients with low-risk disease selected from the Surveillance, Epidemiology, and End Results (SEER) database. The diagnosing urologists and consulting radiation oncologists were identified from Medicare claims data, and physician information was obtained from the American Medical Association Physician Masterfile.
Results were as follows: 12,068 men (median age, 72; 80% white) received a diagnosis of low-risk prostate cancer (73% cT1 disease) from 2145 urologists from 2006 through 2009; 68% had also been seen by a radiation oncologist. 80.1% of patients received treatment; 19.9% received observation. Observation rates varied widely among urologists (4.5%–64.2%) and radiation oncologists (2.2%–46.8%). Patients seen by a urologist only were more likely to undergo observation than those seen by a urologist and a radiation oncologist (43.8% vs. 8.6%). Urologists who treated non–low-risk prostate cancer and who graduated from medical school in recent versus earlier decades were more likely to manage low-risk disease with observation. Multilevel analyses suggested that the urologist was the most influential factor and was responsible for 16.1% of the variance in management choice.
Comment: The most remarkable finding of this analysis was that in this large cohort of men with low-risk disease, 70% of those aged 76 to 80 and 55% of those older than 80 underwent curative-intent therapy. The authors (and I) found this striking, given that the average life expectancy for men 77 years and older in the U.S. is less than 10 years.
Citation(s): Hoffman KE et al. Physician variation in management of low-risk prostate cancer: A population-based cohort study. JAMA Intern Med 2014 Jul 14; [e-pub ahead of print]. (http://dx.doi.org/10.1001/jamainternmed.2014.3021)
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J Clin Oncol 2014 Sep 29
Surveillance for Stage I Testicular Cancer: How Effective
Disease-specific survival at 15 years was 99%.
After undergoing orchiectomy, men with stage I nonseminoma germ cell tumors (NSGCT) can be managed with retroperitoneal lymph node dissection (RPLND), adjuvant chemotherapy (cisplatin, etoposide, and bleomycin), or surveillance. Regardless of how patients are managed, the cure rates of these patients are in the range of 98% to 99%.
To examine outcomes associated with surveillance, investigators reviewed the records of 1226 men in the Danish National Patient Register who were observed after orchiectomy for stage I NSGCT between 1984 and 2007. Most patients had tumor markers drawn monthly during year 1, every 3 months during year 2, and every 6 months during years 3 to 5. Computed tomography (CT) imaging was performed at 4, 8, 12, 36, and 60 months. Median follow-up was 180 months.
Early relapses were mainly detected by an increase in tumor markers, and late relapses were detected by CT scans. Fifty-nine percent of relapses occurred within the first 6 months after orchiectomy, and 80% occurred within the first year (median time to relapse, 5 months). Of all relapses, 89% were detected at routine examinations, and 7% were detected by patient report. Six patients died of germ cell tumor, including one who refused systemic therapy. Testicular-cancer–specific survival at 15 years was 99%. At 5 years, six patients had relapsed, one had died, and five were without evidence of disease. Adherence to the surveillance program was good; only 48 patients (3.9%) dropped out before the final control at 5 years.
Comment: For the small subset of patients at high risk for systemic failure (with vascular or lymphatic invasion, embryonal carcinoma, and absence of yolk sac tumor), the potential utility of adjuvant chemotherapy should be discussed. However, for the bulk of patients with stage I NSGCT, this large, well-documented study with long follow-up provides a substantial level of comfort that patients can be managed safely without the adverse effects of chemotherapy or RPLND.
Citation(s): Daugaard G et al. Surveillance for stage I nonseminoma testicular cancer: Outcomes and long-term follow-up in a population-based cohort. J Clin Oncol 2014 Sep 29; [e-pub ahead of print].
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MM: Type 2 diabetes is frequently associated with risk factors such as obesity and high glycemic index carbohydrate intake. This dietary predisposition may lead to increased intestinal inflammation and with that a compromised immune system that is normally tasked with fighting off aberrant cancer cell growth.
Diabetes Linked to Increased Risk for Head and Neck Cancers
By Amy Orciari Herman, Edited by William E. Chavey, MD, MS
Patients with diabetes might face nearly a 50% increased risk for head and neck cancers, according to a retrospective, case-control study in JAMA Otolaryngology—Head & Neck Surgery.
Using Taiwanese health databases, researchers studied nearly 90,000 patients diagnosed with diabetes in 2002 and 90,000 matched controls without diabetes. During follow-up through 2011, head and neck cancers were diagnosed in 0.71% of diabetes patients and 0.50% of controls. After multivariable adjustment, diabetes patients showed a significant increase in the risk for head and neck cancer (hazard ratio, 1.48), owed mainly to increases in cancers of the oral cavity, oropharynx, and nasopharynx.
The authors note that the mechanisms underlying the association "remain unclear" but may involve "shared genetic risk factors, [diabetes]-related metabolic morbidities (e.g., hypertension and dyslipidemia), obesity, aging, and sex." They conclude that their findings underscore the necessity of monitoring diabetic patients for head and neck cancer.

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