Author Interviews, Cancer Research, Cost of Health Care, JAMA / 08.01.2019
WHO: Profits Outweigh R&D Costs of New Cancer Drugs
MedicalResearch.com Interview with:
[caption id="attachment_46845" align="alignleft" width="200"] Dr. Kiu Tay-Teo[/caption]
Kiu Tay-Teo, PhD
World Health Organization
Geneva, Switzerland
MedicalResearch.com: What are the main findings?
Response: High costs and high risks of R&D for drugs have been presented to justify high drug prices, especially for cancer drugs. However, it is unclear whether prices are in fact justifiable compared to the overall return on R&D investment.
In this paper, we systematically compared incomes from the sales of cancer drugs with the R&D costs. We quantified the incomes generated from the sales of 99 cancer drugs approved by FDA from 1989–2017. This was based on sales figures reported in the originator companies’ annual financial reports, and where necessary, estimates deduced from the reported figures. The sales incomes were net of rebates and discounts, but without accounting for expenses and taxes. For the R&D costs of bringing one new cancer drug to the market, the literature reported a typical costs of between $219 million and $2.9 billion, after accounting for the costs of failed products that were investigated but not marketed and the opportunity costs. For the main analysis, we used a median cost of $794 million, as reported in the literature. To be clear, this analysis did not estimate profit return because we do not have information about the costs and year-to-year variations in costs (i.e. expenses and taxes) specific to cancer drugs.
Dr. Kiu Tay-Teo[/caption]
Kiu Tay-Teo, PhD
World Health Organization
Geneva, Switzerland
MedicalResearch.com: What are the main findings?
Response: High costs and high risks of R&D for drugs have been presented to justify high drug prices, especially for cancer drugs. However, it is unclear whether prices are in fact justifiable compared to the overall return on R&D investment.
In this paper, we systematically compared incomes from the sales of cancer drugs with the R&D costs. We quantified the incomes generated from the sales of 99 cancer drugs approved by FDA from 1989–2017. This was based on sales figures reported in the originator companies’ annual financial reports, and where necessary, estimates deduced from the reported figures. The sales incomes were net of rebates and discounts, but without accounting for expenses and taxes. For the R&D costs of bringing one new cancer drug to the market, the literature reported a typical costs of between $219 million and $2.9 billion, after accounting for the costs of failed products that were investigated but not marketed and the opportunity costs. For the main analysis, we used a median cost of $794 million, as reported in the literature. To be clear, this analysis did not estimate profit return because we do not have information about the costs and year-to-year variations in costs (i.e. expenses and taxes) specific to cancer drugs.
Dr. Dai[/caption]
Dr. Hongying Dai, PhD
Associate Professor at the College of Public Health
University of Nebraska Medical Center.
MedicalResearch.com: What is the background for this study?
Response: The 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA) banned cigarettes with characterizing flavors (e.g., candy, fruit, clove) except menthol. However, there are no restrictions on the marketing and sales of flavored non-cigarette tobacco products. This has led to a proliferation of flavored tobacco products in the marketplace. Flavoring has become one of the leading reasons for current tobacco use among youth. It is reported that 81% of e-cigarette users, 79% of hookah users, 74% of cigar users, 69% of smokeless tobacco users, and 67% of snus users attributed the availability of appealing flavors for their tobacco use in 2013–2014 among teenagers aged 12 to 17 years. In November 2018, the FDA proposed new restrictions on flavored tobacco products.
Dr. Thompson[/caption]
Rebecca R. Thompson, Ph.D.
Postdoctoral Scholar
Department of Psychological Science
University of California, Irvine
MedicalResearch.com: What is the background for this study?
Response: Our research team has been interested in how people respond to the repeated threat of disaster exposure for many years. We recently published a review of the literature on evacuation from natural disasters, and one of our main findings was that there have been no studies that include assessments of individuals’ intentions, perceptions, and psychological states assessed prior to an approaching storm’s landfall – all prior research has been retrospective, and recall is undoubtedly biased and unreliable. Our goal in undertaking this study was to fill this hole in the literature. We sought to assess individuals' responses to Hurricane Irma in the days leading up to and immediately after its landfall in the State of Florida.
Dr. Miech[/caption]
Richard Miech Ph.D
Professor
Principal Investigator, Monitoring the Future
Institute for Social Research
University of Michigan
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Every year Monitoring the Future conducts a survey to examine trends in adolescent substance use. We draw a random sample of schools from a list of all schools in the United States and conduct our survey in ~400 schools. Our survey is representative of U.S. 8th, 10th, and 12th grade students. In other words, our results are what you would find if you surveyed every single 8th, 10th, and 12th graders in the United States, within the bounds of a small sampling error of a few percentage points.
An increase in vaping is the big news for 2018. In 10th and 12th grade the increase in nicotine vaping was the largest we've ever seen for any substance in the past 43 years. As a result of this increase in nicotine vaping, overall use of nicotine increased as well, which suggests that vaping is drawing youth into nicotine use. We also saw a significant increase in marijuana vaping.
The lateral aspect of the left hand depicted here, reveals the presence of papules due to an infestation of the human itch mite, Sarcoptes scabiei var. hominis, in a case of what is commonly referred to as scabies.CDC image[/caption]
MedicalResearch.com: What is the background for this study?
MM: Scabies is extremely common. Globally in the region of 100-200 million people are believed to be affected by scabies annually.
Recently the WHO has recognised Scabies as a ‘Neglected Tropical Disease’ in response to this burden of disease. There has been increasing interest in using Mass Drug Administration (treating whole communities) as a strategy to control scabies in communities. In order to make this practical countries need an easy mechanism for establishing if scabies is a significant problem in their communities. In general when treating an individual, clinicians would conduct a full body examination to diagnose scabies – however this may not be practical or necessary when making decisions about whether to treat whole communities.
DE: Despite the fact that Scabies is a very common condition that causes a great deal of health problems, it has been largely neglected by health, research and funding agencies – but pleasingly, the WHO has now started to take action on scabies control, starting with the recognition of scabies as a "Neglected Tropical Disease"
Dr. Nguyen[/caption]
Oanh Kieu Nguyen, MD, MA
Assistant Professor
Division of Hospital Medicine
Zuckerberg San Francisco General Hospital
UCSF
MedicalResearch.com: What is the background for this study?
Response: In U.S. citizens and permanent residents with kidney failure or end-stage renal disease (ESRD), having health insurance, Medicare, or Medicaid guarantees access to regularly scheduled hemodialysis 2-3 times per week, the evidence-based standard of care for ESRD. This treatment helps people live relatively normal lives. In 40 of 50 U.S. states, undocumented immigrants with ESRD have limited access to hemodialysis because they are not eligible for any form of federal assistance including Medicare or Medicaid, and must wait until they are life-threateningly ill to receive dialysis through a hospital emergency department, a situation called “emergency-only hemodialysis.” There are an estimated 6,500 undocumented individuals in the U.S. suffering from ESRD.
A unique opportunity made it feasible for uninsured undocumented immigrants with ESRD receiving emergency-only dialysis in Dallas, Texas, to enroll in private, commercial health insurance plans in 2015 and made it possible for researchers to compare scheduled vs. emergency-only dialysis among undocumented immigrants with ESRD. This natural experiment included 181 
Dr. Johnson[/caption]
Dayna A. Johnson PhD
Department of Epidemiology
Emory University
Atlanta, GA
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There are several studies that have determined that African Americans have the highest prevalence of hypertension and are the most likely to have uncontrolled hypertension compared to other racial/ethnic groups. We were interested in studying whether sleep apnea contributed to hypertension control among African Americans.
We found that participants with sleep apnea were more likely to have resistant hypertension than those without sleep apnea. In particular, individuals with severe sleep apnea had the highest risk of resistant hypertension. Most of the participants with measured sleep apnea were undiagnosed (96%). 
Josephine Funck Bilsteen, MSc
Department of Pediatrics, Hvidovre University Hospital, Hvidovre,
Section of Epidemiology, Department of Public Health
University of Copenhagen
Copenhagen, Denmark
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The background of this study is that there is increasing recognition of the longer-term health and social outcomes associated with preterm birth such as independent living, quality of life, self-perception and socioeconomic achievements. However, much less is known about differences in education and income among adults born at different gestational weeks in the term period.
In this study shorter gestational duration, even within the term range, was associated with lower chances of having a high personal income and having completed a secondary or tertiary education at age 28 years. This is the first study to show that adults born at 37 and 38 completed weeks of gestation had slightly lower chances of having a high income and educational level than adults born at 40 completed weeks of gestation. 
