Innovation Testing in U.S. Healthcare: Ethical Dilemmas

Introduction

According to Business Services Industry (2007), the medical technology industry is an ever-growing one, constantly fuelled by increasing demand from the medical community. Ground-breaking innovations such as drug-eluting stents, cardiac rhythm management devices, joint replacements, intravascular ultrasound, endoscopes, minimally invasive surgical devices, surgical staplers, and lasers have increased longevity and life expectancy. Business Services Industry (2007) further declares that these innovations have dramatically improved overall treatment options for doctors and other medical practitioners by reducing associated effort and delivery time.

Lechleiter (2009) declares that "innovation testing" is an emerging issue posing two new ethical dilemmas in U.S. healthcare. According to Lechleiter, the first dilemma is set in laboratories and clinics, and it is a hopeful story of how innovation may continue to improve human health; while the other dilemma is set in Washington conference rooms and corporate boardrooms, and it concerns the reform of healthcare access, financing, and regulation. As a scientist who leads what he calls "the last unmerged large pharmaceutical company," Lechleiter (2009) is a rare player who moves between these two arenas — though he does so with growing concern.

According to Lechleiter (2009), inventions such as biosynthetic human insulin, bone-forming agents for treating osteoporosis, new cancer therapies, and a first-ever treatment for severe sepsis have gone from glimmers of intuition to everyday medical tools. Lechleiter appreciates that these innovations — made possible through "innovation testing" — have transformed the most basic expectations of human life. Notably, the average life expectancy at birth in the U.S. is now 78, compared to 57 in 1928. To support the claim that rising life expectancy can be attributed to the availability of new medicines, Lechleiter cites a study by Columbia University economist Frank Lichtenberg, who found that new medicines accounted for 40% of the increase in life expectancy across more than 50 countries during the last two decades of the 20th century.

Christensen et al. (2007) and Nussbaum (2010) declare that the U.S. spends more money on healthcare innovation than any other nation. Mandel (2010) further asserts that when it comes to government spending on health Research and Development (R&D), the U.S. surpasses the rest of the world by a significant margin. However, Mandel notes that when it comes to government spending on non-health civilian R&D, the U.S. actually lags behind other major countries. Mandel ultimately concludes that, to some degree, the U.S. has staked its economy on the success of life sciences innovation.

United States vs. Europe on Innovation Testing

However, Christensen et al. (2007) claim that most of these social investments by the United States are used to maintain the status quo rather than addressing the needs of less affluent populations — populations that often outperform the U.S. on basic health indicators such as infant mortality. For instance, Christensen et al. (2007) point to hospitals, which typically use endowments to develop more sophisticated services for the limited number of patients they already serve, thereby excluding the far broader population that needs basic healthcare.

Consequently, Nussbaum (2010) declares that government healthcare R&D has gone into life sciences that have not paid off — such as genomics — or into advanced medical procedures that are extremely expensive and help very few people. Nussbaum notes that in terms of longevity, the U.S. lags behind Europe and Asia. He argues that U.S. healthcare needs platform innovation that uses social media to connect people to the medical system in new, cheaper, more personal, and more productive ways, as well as the kind of decentralization that design and innovation consultants can provide.

By contrast, Business Services Industry (2007) notes that in the past decade, home-based care has gained rapid importance in the United States, representing a segment with high potential for growth and innovation. Apart from being the largest market for medical technology, the U.S. is characterized by very high growth potential and has served as the cradle of innovation for many revolutionary technologies. Companies in the sector spent an average of 11.4 percent of their sales on research and development in 2002.

According to Atlas (2009), medical care in the United States is often derided as miserable compared to healthcare systems in the rest of the developed world. Economists, government officials, insurers, and academics alike call for a far larger government role in healthcare. Much of the public accepts these arguments because the calls for change are ubiquitous and the topic is complex. However, before turning to government as the solution, it is worth examining several underappreciated facts about America's healthcare system.

The Concord Working Group (2008) and Verdecchia et al. (2007) declare that Americans have better survival rates than Europeans for common cancers. Breast cancer mortality is 52 percent higher in Germany than in the United States and 88 percent higher in the United Kingdom. Prostate cancer mortality is 604 percent higher in the U.K. and 457 percent higher in Norway. The mortality rate for colorectal cancer among British men and women is about 40 percent higher than in the U.S.

Comparative Health Outcomes and Access

U.S. Cancer Statistics from the National Program of Cancer Registries, the U.S. Centers for Disease Control, and the Canadian Cancer Society/National Cancer Institute of Canada, as analyzed by O'Neill and O'Neill (2007), concur that Americans have lower cancer mortality rates than Canadians. Breast cancer mortality is 9 percent higher in Canada, prostate cancer mortality is 184 percent higher, and colon cancer mortality among men is about 10 percent higher than in the United States.

Schoffski (2002) and Tanner (2008) declare that Americans have better access to treatment for chronic diseases than patients in other developed countries. Some 56 percent of Americans who could benefit are taking statins, which reduce cholesterol and protect against heart disease. By comparison, only 36 percent of eligible Dutch patients, 29 percent of Swiss, 26 percent of Germans, 23 percent of Britons, and 17 percent of Italians receive these medications.

O'Neill and O'Neill (2007) proclaim that Americans also have better access to preventive cancer screening than Canadians. Among the appropriate age-population groups: 89 percent of middle-aged American women have had a mammogram, compared to 72 percent of Canadians; 96 percent of American women have had a Pap smear, compared to fewer than 90 percent of Canadians; 54 percent of American men have had a PSA test, compared to only 16 percent of Canadians; and 30 percent of Americans have had a colonoscopy, compared with just 5 percent of Canadians.

O'Neill and O'Neill (2007) further declare that lower-income Americans are in better health than comparable Canadians. Twice as many American seniors with below-median incomes self-report "excellent" health compared to Canadian seniors (11.7 percent versus 5.8 percent). Conversely, white Canadian young adults with below-median incomes are 20 percent more likely than lower-income Americans to describe their health as "fair or poor."

Esmail, Michael, and Bank (2007); Esmail and Wrona (2008); Willcox et al. (2007); O'Neill and O'Neill (2007); and Williams et al. (2007) all concur that Americans spend less time waiting for care than patients in Canada and the U.K. Canadian and British patients wait about twice as long — sometimes more than a year — to see a specialist, to have elective surgery such as hip replacements, or to receive radiation treatment for cancer. In total, 827,429 people are waiting for some type of procedure in Canada (Esmail, Michael, and Bank, 2007), while in England, nearly 1.8 million people are waiting for a hospital admission or outpatient treatment.

Conclusion and Recommendations

According to the Association of American Medical Colleges (2010), the United States continues to have difficulty bridging the gap between conceptualizing and creating a better-functioning healthcare delivery system. In such a situation, improving quality and reducing costs nationally will require a fundamental redesign of both the systems of care delivery and payment for healthcare in the U.S. today. Therefore, the Association of American Medical Colleges proposes the creation and testing of a concept called the "Healthcare Innovation Zone" (HIZ), which is designed to demonstrate that coordination of care — coupled with a multiple-payer reimbursement model — will support more effective planning and delivery of care, and enable resources to be allocated where they can add the greatest value. The Association claims that this demonstration will be large enough to show the efficacy of fundamental changes in healthcare delivery and financing models that are needed to increase quality and reduce costs throughout the U.S.