AJPH ON THE PRESIDENTIAL CAMPAIGN TRAIL When Will Presidential Candidates Ask, “What Do Women Want in Health Care?” In 1916, Margaret Sanger opened the first birth control clinic in the United States. She was arrested for this shocking act, but her work changed women’s lives. On the presidential campaign trail a century later, our political leaders are still debating women’s reproductive health and rights. Unfortunately for the approximately 120 million adult women in America, women’s reproductive organs continue to be the only women’s health issue that is getting much attention in presidential politics. While access to health care in terms of saving, killing, or replacing the Affordable Care Act is a popular topic on the campaign trail, candidates’ medical focus is still on our reproductive organs. Even when politicians talk about cancer, the focus is usually breast cancer. To paraphrase Ronald Reagan in one of his better movie roles, what about the rest of me?
THE POST–FAMILY PLANNING GENERATIONS While reproductive health is a very important issue for many women, there are 63 million women in the United States for whom family planning is a distant memory—for themselves and often for their daughters. For those
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Editorial
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women, Medicare and affordable insurance are very important, but so is an array of other health issues that have been too nuanced or complicated to make it into the presidential candidates’ talking points. Even the candidates that know we have the most expensive health care system in the world but rate 33rd in quality of care1 tend to focus on high prices and lack of access to care, ignoring the equally essential policy issues of lack of evidence-based prevention and treatment strategies and comparative effectiveness data. While those latter phrases do not make great sound bites, they have one issue in common that candidates know that women care about: the skyrocketing costs of prescription drugs. The assumption by the candidates has been that although the prices are too high, all screening and medications are essential and patients deserve to have them. However, the candidates never question the risks compared with the benefits.
AFFORDABILITY AND EFFICACY
Women want to know, “Can I afford medical care and will it help me live longer—and better?” Outrageous medical costs have become an angry topic for all Americans, not just
low-income ones. It is a particularly important issue for women, who live six years longer than men on average and annually spend 26% more for health care per person.2 In addition to their own health care costs, women are usually the caregivers for family members with medical problems, thereby bearing even more of the burden of unaffordable medical treatments. Pharmaceutical spokespeople claim that regardless of the costs, screening tests and medications save money by reducing the need for hospitalization and other expensive care. However, research indicates that is often not true. In fact, some types of screening do more harm than good, and many highly priced drugs are not safer or more effective compared with other, less expensive treatments.3 Even those that have modest benefits may not be worth risking serious side effects or sending one’s family into debt. For example, scientists from the National Cancer Institute and the Oregon Health and Sciences University recently coauthored an article about the newest cancer
drugs.4 These researchers studied all the cancer drugs that were approved by the US Food and Drug Administration (FDA) from 2008 through 2012, choosing those years so that they could review the research used as the basis of FDA approval and all required studies that were completed after approval. Of the 54 cancer drugs approved, 36 were approved based on a type of fast-track review system that enabled companies to get approval for their drug based on preliminary data, using surrogate endpoints such as tumor shrinkage rather than clinically meaningful outcomes such as survival or quality of life. Although the short-term results were considered promising, postmarket studies were required as a condition of approval, to make sure these drugs were truly effective. When they examined the research literature for the required postmarket studies, the authors found that only five (14%) of the 36 drugs had been found to improve overall survival (compared with placebo or an older drug), whereas published studies for half of the 36 drugs (all of which are prescribed to women) found no evidence of such benefit. There were no postmarket studies of survival published for the remaining 13 drugs. The published studies also failed to show any other benefits for most of the other 18 drugs. But despite published evidence of the lack of
ABOUT THE AUTHOR Diana Zuckerman is the President of the National Center for Health Research, Washington DC. Correspondence should be sent to Diana Zuckerman, National Center for Health Research, 1001 Connecticut Ave, NW, Suite 1100, Washington, DC 20036 (e-mail: [email protected]). Reprints can be ordered at http://www.ajph.org by clicking the “Reprints” link. This editorial was accepted March 3, 2016. doi: 10.2105/AJPH.2016.303174
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AJPH ON THE PRESIDENTIAL CAMPAIGN TRAIL
benefit for these drugs, they are still on the market. And, our research center found that many cost more than $100 000 per year. Cancer is the leading cause of death5 for women between the ages of 35 to 84 years. Surely, paying more than one’s annual salary for cancer drugs that are not better, and sometimes worse, than either placebo or older, less expensive treatments is an important women’s health issue. If our politicians promised that comparative effectiveness research would be required for all new drugs and the results would be easily available to all physicians and patients, that would be a great benefit to all patients, and especially women.
PRECISION MEDICINE One example of current policy efforts that could improve women’s health is President Obama’s Precision Medicine Initiative. Should presidential candidates jump on that bandwagon? The goal of precision medicine is to tailor treatments to small groups of patients, rather than the one-size-fits all approach of traditional drug development and medical guidelines. Ironically, however, President Obama’s FDA, like the FDA of every president before him, has continued to focus on one-size-fits-all analysis, usually ignoring even the best established, basic physiological differences that often affect the safety and effectiveness of screening tests, diagnostics, and treatments. For example, experts of all
May 2016, Vol 106, No. 5
AJPH
political persuasions agree that women, people older than 65 years, and some racial/ethnic groups tend to metabolize drugs differently or react differently to certain treatments. As a result of the FDA’s failure to take even those first steps toward a more precise approach, cardiac implants are approved based on their safety and effectiveness in clinical trials constituted disproportionately of White men,6 diabetes drugs are tested primarily on relatively young White men and women,7 and it took more than 20 years for the FDA to issue warnings8 that the typical dosages for many popular prescription sleeping pills were unsafe for most women. Rather than just waiting for a new government-funded Precision Medicine Initiative to be designed and implemented, wouldn’t it be politically popular for presidential candidates to demand that the FDA immediately require subgroup analyses of more diverse samples? Candidates could explain that this is the quickest, simplest way to start determining which tests and treatments are best for women (as well as all voters older than 65 years and people of color). Since women are more than half the US population and constitute 57% of people older than 65 years, that would be an easy way to improve the health of most Americans and make immediate progress toward the goals of precision medicine. And, it would not cost taxpayers a dime, because it would merely require companies to analyze their data differently. Meanwhile, the more
complex aspects of the Precision Medicine Initiative should also be developed, but they will take years to become reality.
women, who are the majority of US patients and their family caregivers. Diana Zuckerman, PHD REFERENCES
WHAT ABOUT THE REST OF ME? THE REST OF US? It is difficult to imagine “subgroup analysis” and other technical research terms coming out of the mouths of presidential candidates. But, if the GlassSteagall provisions of the US Banking Act of 1933 (which protected consumers by regulating bank activities) are worthy of discussion at Democratic presidential primary debates, perhaps evidence-based prevention and treatment, comparative effectiveness research, or even ineffective surrogate endpoints could be the next big topic. All voters deserve to have presidential candidates focus on health policy issues that could improve our health—even if they aren’t easily translated to sound bites. If women are asked what we want from our health care system, we will tell the candidates that our health concerns extend beyond our reproductive organs, and even beyond our own personal health needs. We want a health care system that works for us and for the people we care about, and that enables us to choose prevention and treatment strategies that are proven to work and that we can afford. With the right messaging, these public health issues could resonate with all voters—and especially
1. Health outcomes and cost: a 166-country comparison. The Economist. Available at: http://stateofreform.com/ wp-content/uploads/2015/11/ Healthcare-outcomes-index-2014.pdf. Accessed March 7, 2016. 2. Health Care Cost Institute. 2013 Health Care Cost and Utilization Report. Available at: http://www. healthcostinstitute.org/files/2013% 20HCCUR%2012-17-14.pdf. Accessed March 7, 2016. 3. Olfson M, Marcus SC. Decline in placebo-controlled trial results suggests new directions for comparative effectiveness research. Health Aff (Millwood). 2013;32(6):1116–1125. 4. Kim C, Prasad V. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals. JAMA Intern Med. 2015;175(12):1992–1994. 5. Centers for Disease Control and Prevention. Leading Causes of Death by Age Group, All Females—United States, 2013. Available at: http://www.cdc.gov/ women/lcod/2013/womenall_2013.pdf. Accessed March 7, 2016. 6. Dhruva SS, Bero LA, Redberg RF. Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices. Circ Cardiovasc Qual Outcomes. 2011;4(2):165–171. 7. US Food and Drug Administration. Drug Trials Snapshot: Tresiba. Available at: http://www.fda.gov/Drugs/ InformationOnDrugs/ucm478924.htm. Accessed March 7, 2016. 8. US Food and Drug Administration. FDA Drug Safety Communication: risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist). Available at: http://www.fda.gov/Drugs/ DrugSafety/ucm334033.htm. Accessed March 7, 2016.
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Editorial
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THE POST–FAMILY PLANNING GENERATIONS While reproductive health is a very important issue for many women, there are 63 million women in the United States for whom family planning is a distant memory—for themselves and often for their daughters. For those
790
Editorial
Zuckerman
women, Medicare and affordable insurance are very important, but so is an array of other health issues that have been too nuanced or complicated to make it into the presidential candidates’ talking points. Even the candidates that know we have the most expensive health care system in the world but rate 33rd in quality of care1 tend to focus on high prices and lack of access to care, ignoring the equally essential policy issues of lack of evidence-based prevention and treatment strategies and comparative effectiveness data. While those latter phrases do not make great sound bites, they have one issue in common that candidates know that women care about: the skyrocketing costs of prescription drugs. The assumption by the candidates has been that although the prices are too high, all screening and medications are essential and patients deserve to have them. However, the candidates never question the risks compared with the benefits.
AFFORDABILITY AND EFFICACY
Women want to know, “Can I afford medical care and will it help me live longer—and better?” Outrageous medical costs have become an angry topic for all Americans, not just
low-income ones. It is a particularly important issue for women, who live six years longer than men on average and annually spend 26% more for health care per person.2 In addition to their own health care costs, women are usually the caregivers for family members with medical problems, thereby bearing even more of the burden of unaffordable medical treatments. Pharmaceutical spokespeople claim that regardless of the costs, screening tests and medications save money by reducing the need for hospitalization and other expensive care. However, research indicates that is often not true. In fact, some types of screening do more harm than good, and many highly priced drugs are not safer or more effective compared with other, less expensive treatments.3 Even those that have modest benefits may not be worth risking serious side effects or sending one’s family into debt. For example, scientists from the National Cancer Institute and the Oregon Health and Sciences University recently coauthored an article about the newest cancer
drugs.4 These researchers studied all the cancer drugs that were approved by the US Food and Drug Administration (FDA) from 2008 through 2012, choosing those years so that they could review the research used as the basis of FDA approval and all required studies that were completed after approval. Of the 54 cancer drugs approved, 36 were approved based on a type of fast-track review system that enabled companies to get approval for their drug based on preliminary data, using surrogate endpoints such as tumor shrinkage rather than clinically meaningful outcomes such as survival or quality of life. Although the short-term results were considered promising, postmarket studies were required as a condition of approval, to make sure these drugs were truly effective. When they examined the research literature for the required postmarket studies, the authors found that only five (14%) of the 36 drugs had been found to improve overall survival (compared with placebo or an older drug), whereas published studies for half of the 36 drugs (all of which are prescribed to women) found no evidence of such benefit. There were no postmarket studies of survival published for the remaining 13 drugs. The published studies also failed to show any other benefits for most of the other 18 drugs. But despite published evidence of the lack of
ABOUT THE AUTHOR Diana Zuckerman is the President of the National Center for Health Research, Washington DC. Correspondence should be sent to Diana Zuckerman, National Center for Health Research, 1001 Connecticut Ave, NW, Suite 1100, Washington, DC 20036 (e-mail: [email protected]). Reprints can be ordered at http://www.ajph.org by clicking the “Reprints” link. This editorial was accepted March 3, 2016. doi: 10.2105/AJPH.2016.303174
AJPH
May 2016, Vol 106, No. 5
AJPH ON THE PRESIDENTIAL CAMPAIGN TRAIL
benefit for these drugs, they are still on the market. And, our research center found that many cost more than $100 000 per year. Cancer is the leading cause of death5 for women between the ages of 35 to 84 years. Surely, paying more than one’s annual salary for cancer drugs that are not better, and sometimes worse, than either placebo or older, less expensive treatments is an important women’s health issue. If our politicians promised that comparative effectiveness research would be required for all new drugs and the results would be easily available to all physicians and patients, that would be a great benefit to all patients, and especially women.
PRECISION MEDICINE One example of current policy efforts that could improve women’s health is President Obama’s Precision Medicine Initiative. Should presidential candidates jump on that bandwagon? The goal of precision medicine is to tailor treatments to small groups of patients, rather than the one-size-fits all approach of traditional drug development and medical guidelines. Ironically, however, President Obama’s FDA, like the FDA of every president before him, has continued to focus on one-size-fits-all analysis, usually ignoring even the best established, basic physiological differences that often affect the safety and effectiveness of screening tests, diagnostics, and treatments. For example, experts of all
May 2016, Vol 106, No. 5
AJPH
political persuasions agree that women, people older than 65 years, and some racial/ethnic groups tend to metabolize drugs differently or react differently to certain treatments. As a result of the FDA’s failure to take even those first steps toward a more precise approach, cardiac implants are approved based on their safety and effectiveness in clinical trials constituted disproportionately of White men,6 diabetes drugs are tested primarily on relatively young White men and women,7 and it took more than 20 years for the FDA to issue warnings8 that the typical dosages for many popular prescription sleeping pills were unsafe for most women. Rather than just waiting for a new government-funded Precision Medicine Initiative to be designed and implemented, wouldn’t it be politically popular for presidential candidates to demand that the FDA immediately require subgroup analyses of more diverse samples? Candidates could explain that this is the quickest, simplest way to start determining which tests and treatments are best for women (as well as all voters older than 65 years and people of color). Since women are more than half the US population and constitute 57% of people older than 65 years, that would be an easy way to improve the health of most Americans and make immediate progress toward the goals of precision medicine. And, it would not cost taxpayers a dime, because it would merely require companies to analyze their data differently. Meanwhile, the more
complex aspects of the Precision Medicine Initiative should also be developed, but they will take years to become reality.
women, who are the majority of US patients and their family caregivers. Diana Zuckerman, PHD REFERENCES
WHAT ABOUT THE REST OF ME? THE REST OF US? It is difficult to imagine “subgroup analysis” and other technical research terms coming out of the mouths of presidential candidates. But, if the GlassSteagall provisions of the US Banking Act of 1933 (which protected consumers by regulating bank activities) are worthy of discussion at Democratic presidential primary debates, perhaps evidence-based prevention and treatment, comparative effectiveness research, or even ineffective surrogate endpoints could be the next big topic. All voters deserve to have presidential candidates focus on health policy issues that could improve our health—even if they aren’t easily translated to sound bites. If women are asked what we want from our health care system, we will tell the candidates that our health concerns extend beyond our reproductive organs, and even beyond our own personal health needs. We want a health care system that works for us and for the people we care about, and that enables us to choose prevention and treatment strategies that are proven to work and that we can afford. With the right messaging, these public health issues could resonate with all voters—and especially
1. Health outcomes and cost: a 166-country comparison. The Economist. Available at: http://stateofreform.com/ wp-content/uploads/2015/11/ Healthcare-outcomes-index-2014.pdf. Accessed March 7, 2016. 2. Health Care Cost Institute. 2013 Health Care Cost and Utilization Report. Available at: http://www. healthcostinstitute.org/files/2013% 20HCCUR%2012-17-14.pdf. Accessed March 7, 2016. 3. Olfson M, Marcus SC. Decline in placebo-controlled trial results suggests new directions for comparative effectiveness research. Health Aff (Millwood). 2013;32(6):1116–1125. 4. Kim C, Prasad V. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals. JAMA Intern Med. 2015;175(12):1992–1994. 5. Centers for Disease Control and Prevention. Leading Causes of Death by Age Group, All Females—United States, 2013. Available at: http://www.cdc.gov/ women/lcod/2013/womenall_2013.pdf. Accessed March 7, 2016. 6. Dhruva SS, Bero LA, Redberg RF. Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices. Circ Cardiovasc Qual Outcomes. 2011;4(2):165–171. 7. US Food and Drug Administration. Drug Trials Snapshot: Tresiba. Available at: http://www.fda.gov/Drugs/ InformationOnDrugs/ucm478924.htm. Accessed March 7, 2016. 8. US Food and Drug Administration. FDA Drug Safety Communication: risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist). Available at: http://www.fda.gov/Drugs/ DrugSafety/ucm334033.htm. Accessed March 7, 2016.
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