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An editorial focuses on evaluating the validity of using late-stage cancer diagnosis as an alternative endpoint to cancer-specific mortality in clinical trials for cancer screening. It examines the findings of a study, which analyzed the correlation between these endpoints across various cancer types and concluded that late-stage cancer diagnosis is not a reliable substitute for cancer-specific mortality.

The article presents information on the increase in lung cancer in the U.S. A focus is on the reviewing the benefits and harms of screening in lung cancer which uses low-dose computed tomography (LDCT). The self-funded study was conducted by multisociety initiatives which included American Cancer Society, American Society of Clinical Oncology and American College of Chest Physicians. The result of the study showed that LDCT is beneficial for patients at increased risk of lung cancer. The issues related to radiation exposure are also discussed. INSET: Box. Role of Computed Tomography Screening for Lung Cancer....

The article presents a medical research study that examined whether computed tomography screening increases the frequency of lung cancer diagnosis and resection and if it reduces the risk of a diagnosis of advanced lung cancer or death from lung cancer. Asymptomatic current and former smokers were screened annually for lung cancer via computed tomography. The authors found that low-dose computed tomography screening can increase the frequency of lung cancer diagnosis and treatment, but that a reduction in advanced lung cancer or death from cancer may not be a result of the screening. The authors conclude that asymptomatic individuals should not be screened outside of clinical research studies. [ABSTRACT FROM AUTHOR]

In this article we address whether studies of care rendered to patients prior to their death (“studies of decedents”) produce an accurate portrait of care provided to patients who are dying. Studies of decedents typically analyze the care provided to patients over a defined interval antecedent to death. Studies of dying patients analyze care provided to patients subsequent to the time that their terminal status is perceived. We address whether 2 fundamental differences between studies of decedents and studies of the dying—the ways that subjects are identified and the time periods that are examined—lead to differences in interpretation of study results. Using examples from population-based cohorts of individuals with cancer, we show that both the differences in subject selection and time period introduce very substantial biases into studies of decedents. We conclude that studying care received prior to death can lead to invalid conclusions about the quality or type of care provided to dying patients. [ABSTRACT FROM AUTHOR]

Lung cancer is the leading cause of cancer death in US women and is responsible for as many deaths as breast cancer and all gynecological cancers combined. Most lung cancer is caused by cigarette smoke. Despite all that is known about the devastating effects of cigarettes, one quarter of women in the United States continue to smoke. Women are targeted in tobacco advertising, and teenage girls are often drawn to cigarette smoking under a variety of social pressures. Following the increase in smoking, the death rate from lung cancer in US women rose 600% from 1930 to 1997. Women may be more susceptible than men to the carcinogenic properties of cigarette smoke. In addition, differences in the biology of lung cancer exist between the 2 sexes with higher levels of DNA adduct formation, increased CYP1A1 expression, decreased DNA repair capacity, and increased incidence of K-ras gene mutations in women. The novel estrogen receptor β has also been detected in lung tumors and suggests that estrogen signaling may have a biological role in tumorigenesis. Given these differences and given the enormous toll this disease has on US women, undertaking sex-specific research in lung cancer is crucial. Finally, disseminating information about this epidemic may prevent a similar epidemic in other parts of the world where women are just now becoming addicted to tobacco. [ABSTRACT FROM AUTHOR]

Context: In recent years a theory that cancer biology is different in blacks and whites has gained prominence in reaction to epidemiologic observations that blacks have poorer survival than whites, even when diagnosed with cancer of similar severity. Yet, few studies have evaluated whether lower-quality treatment and shorter overall life expectancy due to a greater burden of other illnesses may explain the survival discrepancy. Objective: To estimate the magnitude of overall and cancer-specific survival differences between blacks and whites who receive comparable treatment for similar-stage cancer. Data Sources: We searched MEDLINE for English-language articles published from 1966 to January 2002 that reported on overall survival for black and white patients treated similarly for cancer. Study Selection: The abstracts or titles for 891 citations were independently examined by 2 authors. The full text was retrieved if the abstract mentioned both black and white patients, made some comment regarding either similarity of treatment received or presented an analysis based on the treatment received, and commented on survival. Studies were included if they included data for at least 10 black and 10 white patients; specified the cohort ascertainment method and what measures were undertaken to minimize loss to follow-up; summarized survival of both blacks and whites using actuarial measures; presented outcomes within stage, adjusted for stage, or based on cohorts with balanced stage distributions; and specified that blacks and whites in the study received similar treatment. We identified 89 unique cohorts in 54 articles that met our inclusion criteria. Data Extraction: Overall survival rates and hazard ratios (HRs) for death for blacks relative to whites were calculated. These were subsequently adjusted for rates of death due to causes other than the cancer under study to determine cancer-specific survival and cancer-specific HRs. Data Synthesis: Results represent 189... [ABSTRACT FROM AUTHOR]

In this Viewpoint, Peter Bach and colleague Stacie Dusetzina question the assumption underlying a 2019 proposed federal rule change to eliminate drug manufacturer rebates to pharmacy benefit managers (PBMs) as a way to decrease prescription drug prices, and they propose more extensive restructuring, including a cap on out-of-pocket spending for Medicare Part D beneficiaries, to better control drug costs and save patients money. [ABSTRACT FROM AUTHOR]

In this Viewpoint, the authors review Medicare & Medicaid Services 340B Payment program and recent rules to curtail expansion of drug discounts beyond serving poor patients. [ABSTRACT FROM AUTHOR]

The article provides commentary on the article "Tobacco Smoking as a Possible Etiologic Factor in Bronchiogenic Carcinoma: A Study of Six Hundred and Eighty-Four Proved Cases," by Ernest L. Wynder and Evarts A. Graham published in a 1950 issue. The author explains that the study was published before the link between lung cancer and smoking was accepted as fact. He notes that Wynder and Graham laid a foundation for tobacco control policy for public health.

In this Viewpoint, Peter Bach and colleagues distinguish 5 pricing reform proposals implied by the concept of value-based drug pricing and discuss the potential of each to ensure value in response to unsustainable drug price increases. [ABSTRACT FROM AUTHOR]

In this article, the author reflects upon the FDA's approval of Tisagenlecleucel, a drug used to treat cancer. Topics discussed include how the drug has been approved to treat acute lymphoblastic leukemia, how a one-time infusion of the drug costs $475,000 and details relating to the drug's black box warning as its use can cause hypotension, multiorgan failure and even death. Details relating to revenue outlooks for pharmaceutical companies including Novartis and Gilead are also offered.

The authors discuss the steps that should be considered by insurers, payers and policy makers to support and achieve a value-based pricing system for drugs. Topics include Medicare, the U.S. Food and Drug Administration (FDA), and the Institute for Clinical and Economic Review (ICER) and policies preventing the ability of the Medicare to apply a value-based pricing system.

The author discussed the pricing for cancer drugs. Topics discussed include the spending on specialty drugs in 2013, Medicare price for eight cancer drugs approved by the U.S. Food and Drug Administration (FDA) in 2013, the author's claim that the price of the drug is not linked to its benefits and the formulary determinations used by the National Institute for Health and Care Excellence (NICE) of Great Britain to consider the effectiveness and cost of drugs.

The author reflects on the aspects of the reformation of the payment system for medical oncology. He mentions that the three cancer payment reform approaches have been proposed including episode-based payment, payment for pathway adherence and third-party buy-and-bill that address the link between cancer drug prices and physician profits.

The author reflects on the U.S. Federal Drug discount program called "340B" that allowed some hospitals to buy drugs at a low price to treat their patients. He informs that the program requires the drug manufacturers to extend substantial discounts on drugs administered in the outpatient setting, including oral drugs. He further informs that the typical discount ranges from 30 percent to 50 percent off the drug's list price.

The author discusses a report delivered by J.M. Caziano and his colleagues analyzing data from the Physicians' Health Study II (PHS II) randomized controlled trial. He mentions that their study involved 14 000 male physicians and they found a marginally statistically significant inverse relationship between taking a daily multivitamin and the occurrence of cancer. In their study, they failed to find the efficacy of supplement in preventing any particular cancer.

The author comments on the study "WHI Investigators. Estrogen plus progestin and breast cancer incidence and mortality in postmenopausal women," by R. T. Chlebowksi et al, published within the issue. He explains that the Women's Health Initiative (WHI) randomized trial of placebo against hormone therapy was suspended following the discovery that hormone therapy increased a woman's risk of breast cancer and myocardial infarction. The findings of the current study are discussed. In conclusion, the author contends the need for further investigation.

The authors reflect on the high and increasing medical costs of cancer in the U.S. They note that medical expenditures for cancer increased from about 27 million U.S. dollars in 1990 to 90 billion U.S. dollars in 2008. They explain that the increase is due to increases in both the price and the quantity of care. They explore the benefit gained by physicians in fee-for-service physician payment methods used by most private and public payers.

A reply from Drs. Peter B. Bach, James R. Jett and colleagues is presented in response to letters to the editor about their article "Computed tomography screening and lung cancer outcomes."

A response by Doctor Peter B. Bach to a letter to the editor about his article "Indication-specific Pricing for Cancer Drugs" in an early 2015 issue is presented.

This study describes health services offered by USNWR "best hospitals" in executive physical packages, daylong comprehensive evaluations offering testing and screening of wealthy individuals and corporate leaders. [ABSTRACT FROM AUTHOR]

This article presents a reply to a letter to the editor regarding women and their survival rates from lung cancer.

Presents a reply to readers' letters about the authors' study on end-of-life care.

Recounts doctor Peter Bach's journey to Goma, Rwanda on a medical mission. Physical conditions; Treatment of several patients suffering from severe malnutrition.

Presents a study to determine whether hospital procedure volume predicts survival following colon cancer surgery. Design, setting, and participants; Main outcome measures; Results; Conclusion that hospital procedure volume predicts clinical outcomes following surgery for colon cancer.

This Viewpoint discusses a "Netflix" subscription model of drug payment being investigated by Louisiana for hepatitis C (HCV) drugs, in which a statewide coalition of payers would pay subscription fees over a fixed number of years for HCV drugs to treat all state residents and for efforts by the manufacturers to enhance treatment rates through patient outreach. [ABSTRACT FROM AUTHOR]

Context: Lung cancer is the leading cause of cancer death. Most patients are diagnosed with advanced disease, resulting in a very low 5-year survival. Screening may reduce the risk of death from lung cancer.Objective: To conduct a systematic review of the evidence regarding the benefits and harms of lung cancer screening using low-dose computed tomography (LDCT). A multisociety collaborative initiative (involving the American Cancer Society, American College of Chest Physicians, American Society of Clinical Oncology, and National Comprehensive Cancer Network) was undertaken to create the foundation for development of an evidence-based clinical guideline.Data Sources: MEDLINE (Ovid: January 1996 to April 2012), EMBASE (Ovid: January 1996 to April 2012), and the Cochrane Library (April 2012).Study Selection: Of 591 citations identified and reviewed, 8 randomized trials and 13 cohort studies of LDCT screening met criteria for inclusion. Primary outcomes were lung cancer mortality and all-cause mortality, and secondary outcomes included nodule detection, invasive procedures, follow-up tests, and smoking cessation.Data Extraction: Critical appraisal using predefined criteria was conducted on individual studies and the overall body of evidence. Differences in data extracted by reviewers were adjudicated by consensus.Results: Three randomized studies provided evidence on the effect of LDCT screening on lung cancer mortality, of which the National Lung Screening Trial was the most informative, demonstrating that among 53,454 participants enrolled, screening resulted in significantly fewer lung cancer deaths (356 vs 443 deaths; lung cancer−specific mortality, 274 vs 309 events per 100,000 person-years for LDCT and control groups, respectively; relative risk, 0.80; 95% CI, 0.73-0.93; absolute risk reduction, 0.33%; P = .004). The other 2 smaller studies showed no such benefit. In terms of potential harms of LDCT screening, across all trials and cohorts, approximately 20% of individuals in each round of screening had positive results requiring some degree of follow-up, while approximately 1% had lung cancer. There was marked heterogeneity in this finding and in the frequency of follow-up investigations, biopsies, and percentage of surgical procedures performed in patients with benign lesions. Major complications in those with benign conditions were rare.Conclusion: Low-dose computed tomography screening may benefit individuals at an increased risk for lung cancer, but uncertainty exists about the potential harms of screening and the generalizability of results. [ABSTRACT FROM AUTHOR]

Context: Rates of preventive services remain below national goals. Objective: To identify characteristics of physicians and their practices that are associated with the quality of preventive care their patients receive. Design Cross-sectional analysis of data on US physician respondents to the 2000-2001 Community Tracking Study Physician Survey linked to claims data on Medicare beneficiaries they treated in 2001. Physician variables included training and qualifications and sex. Practice setting variables included practice type, size, sources of revenue, and access to information technology. Analyses were adjusted for patient demographics and comorbidity, as well as community characteristics. Setting and Participants: Primary care delivered by 3660 physicians providing usual care to 24 581 Medicare beneficiaries aged 65 years and older. Main Outcome Measures: Proportion of eligible beneficiaries receiving each of 6 preventive services: diabetic monitoring with hemoglobin A measurement or eye examinations, screening for colon or breast cancer, and vaccination for influenza or pneumococcus in 2001. Results Overall, the proportion of beneficiaries receiving services was below national goals. Physician and, more consistently, practice-level characteristics were both associated with differences in the delivery of services. The strongest associations were with practice type and the percentage of practice revenue derived from Medicaid. For instance, beneficiaries receiving usual care in practices with less than 6% of revenue from Medicaid were more likely than those with more than 15% of revenue derived from Medicaid to receive diabetic eye examinations, hemoglobin A, mammograms, colon cancer screening, and influenza and pneumococcal vaccinations. Other variables associated with delivery of preventive services after adjustment for patient and geographic factors included obtaining usual health care from a physician who worked in group practices of 3 or more, who was a graduate of a US or Canadian medical school, or who reported availability of information technology to generate preventive care reminders or access treatment guidelines. Conclusions: Delivery of routine preventive services is suboptimal for Medicare beneficiaries. However, patients treated within particular practice settings and by particular subgroups of physicians are at particular risk of low-quality care. Profiling these practices may help develop tailored interventions that can be directed to sites where the opportunities for quality improvement are greatest. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Benefits and harms of CT screening for lung cancer" by Peter B. Bach and colleagues in the 2012 issue and response from the author is also presented.