Living Longer and the NIH Eli Lilly National Center for Advancing Translational Science (NCATS)

Over the past few years, health care reform has consistently made news headlines.  The significant costs and problems generated by the U.S. health care system, coupled with the landmark passage of the Patient Protection and Affordable Care Act (ACA), has kept journalists, bureaucrats, health officials and politicians busy. 

A sizeable portion of the attention surrounding the health care system and health care reform has involved the role of the healthcare industry: insurance companies, pharmaceutical and medical device manufacturers, managed care organizations, etc.  While much of the press coverage has focused on the problems that these stakeholders have allegedly created or failed to address, there has been little attention regarding the positive health outcomes and benefits our country has seen over the past few decades.  

Consequently, a recent article that looked at statistics “stretching from 1935 to 2010 found significant improvements in Americans’ expected lifespans, mainly due to factors such as better medical care and declines in smoking rates.”  Specifically, the average American’s overall risk of dying at a given point in time dropped 60 percent since 1935, the study found.  This increased American lifespan is directly attributable to the advances of medical device and pharmaceutical manufacturers who have pushed the envelope and invested billions of dollars to improve the quality and health of us all. 

A combination of lifestyle changes and medical advances fueled the dramatic drop in death rates, according to the U.S. Centers for Disease Control and Prevention (CDC) report published in the March NCHS Data Brief.  Highlights of the report include: 

• In each year, heart disease, cancer and stroke were among the five leading causes of death.
• The risk of dying dropped in all age groups but was strongest among children aged 1 to 4 years, where the rate dropped 94 percent.
• For those aged 85 and older, the risk of dying dropped 38 percent.
• Death rates were higher among men, although they decreased for both genders during the 75-year study period. From 1975 to 1981, the risk of dying was 65 percent higher for men than women, while it was only 40 percent higher for men than women in 2010.
• The decline in deaths was seen in all racial and ethnic groups. However, there are still disparities, with the biggest gap found between 1988 and 1996, when one white person died for every four blacks. 

“Overall, the improvement in mortality has been significant over the last 75 years,” said report author Donna Hoyert, a health scientist at CDC’s National Center for Health Statistics.  To compile the statistics for the report, Hoyert used data from the National Vital Statistics System for the 75 years covered, including preliminary data for 2010. 

The reasons for this trend are varied, Hoyert said.  “The way we live now is much different than in the [1930s]. In the medical field, there have been advances and changes in behavior over time,” she said.  Among the most significant changes have been the decrease in smoking rates and more aggressive treatment of heart disease, she noted. 

In addition, the introduction of antibiotics in the 1940s made a huge impact. “There were some easily treatable potentially fatal diseases, such as pneumonia, that all of a sudden we got antibiotics for,” said Dr. Laurence Gardner, executive dean for education and policy at the University of Miami Miller School of Medicine. 

A more aggressive approach to treating cardiovascular disease also evolved in the past 20 years, Gardner said.  “Even more important, the use of cholesterol-lowering drugs [statins] in such a large proportion of the population has contributed to decreased death rates,” he said. 

The advances in treatment were really only seen in one area — cardiovascular disease, Gardner said.  “The folks in the cancer world are still pulling their hair out, because while there may be increases in survival, the cure rates have not improved very much despite the enormous efforts,” he said, although he added that he believes there will be advances in cancer treatment in the future that will help lower mortality rates. 

Despite the positive benefits in cardiovascular disease, Garndner pointed to the obesity epidemic, which is fueling a diabetes epidemic.  “If we don’t effectively address the obesity/diabetes issue, we may lose some of the benefit we have gained,” he stressed.  “We haven’t seen the effect of the epidemic of obesity and diabetes reflected in the death rate [yet].” 

Another issue is the growing cost of expensive medical interventions.  The United States spends more on health care than any other nation, and there is a point of diminishing returns where the costs outweigh the benefits, Gardner said.  He noted how the U.S. does not “manage the end-of-life care very well and we do spend unnecessary funds and cause some unnecessary hardship.” 

Discussion 

While the statistics of this report offer hopeful insight into medical progress in America, there are some troubling trends that may create obstacles and hurdles for continued success in cardiovascular disease and other chronic illnesses such as cancer.  In particular, the current regulatory environment at the Food and Drug Administration (FDA) as well as the push for transparency (i.e. Physician Payment Sunshine Act) in the Obama Administration has the potential to cause a chilling effect on innovation and scientific progress in America.  

Transparency and accountability are certainly important goals, which we agree with.  However, the cost of increased regulations and economic burdens, as well as a misinformed public can stigmatize an already difficult and uncertain regulatory and research environment in the life sciences.  

Although we have seen advances in the last 75 years, the regulatory landscape has changed dramatically, as has science, medicine, and humans in general.  In order to continue the success we have seen in the past, the government, academia, and industry must continue working together, in a way that encourages collaboration, instead of attacking it.  

One example of the kind of collaboration that will lead to further scientific and medical advances is a new partnership announced between the National Institutes of Health (NIH) and Eli Lilly.  The partnership, announced earlier this month, “will generate a publicly available resource to profile the effects of thousands of approved and investigational medicines in a variety of sophisticated disease-relevant testing systems, NIH announced today.” 

NIH recognized that, “Comprehensive knowledge of the biological profiles of these medicines and molecules may enable biomedical researchers to better predict treatment outcomes, improve drug development, and lead to more specific and effective approaches.” 

Through the collaboration, the NIH’s newly established National Center for Advancing Translational Sciences (NCATS) and Lilly Research Laboratories have agreed that NCATS’ Pharmaceutical Collection of 3,800 approved and investigational medicines will be screened using Lilly’s state-of-the-art Phenotypic Drug Discovery (PD2) panel. This panel features assays (i.e. tests) that are designed to reveal novel mechanisms or pathways of potential medicines and, as part of this collaboration, approved medicines as well. As such, the panel may provide new insights for drug discovery. 

“This innovative collaboration with Lilly is exactly the type of partnership that NCATS is eager to foster with many other groups from industry, government and academia,” said NCATS Acting Director Thomas R. Insel, M.D.  “Working together, we can make drug development pipelines more productive.  The key is precompetitive collaboration to benefit all partners, ensuring broad access to the results.” 

The NCATS Pharmaceutical Collection (NPC) is a comprehensive publicly available database (http://tripod.nih.gov/npc) and is a physical sample collection.  The PD2 assay panel, part of Lilly’s Open Innovation Drug Discovery platform, consists of sophisticated human disease pathway-related assays relevant to cardiovascular diseases, cancer and endocrine disorders, among others.  These testing systems are designed to reveal novel mechanisms or pathway activities of drugs. 

“This profiling, broad in terms of the therapeutics tested and the range and complexity of the biological readouts, will leverage the NPC in just the way I envisioned when we assembled the pharmaceutical collection,” said Christopher P. Austin, M.D., director of the NCATS Division of Preclinical Innovation.  “The combination of the power of the PD2 component of Lilly’s Open Innovation Drug Discovery platform and the NPC will benefit of the entire scientific community.”

The screening will take place over the next 12 to 18 months, and results will be made freely available at http://tripod.nih.gov/npc/.  For example, if an approved medicine is found to be a possible treatment candidate for a new disease indication, a partnership with the organization that owns the chemical compound could be formed to pursue additional studies.  These might include clinical trials required for marketing approval by FDA.  Alternatively, medicines with activity in the PD2 assays might serve as starting points for additional chemistry research efforts to produce new medicines. 

“This initiative is a great example of how we can collectively leverage unique capabilities from the public and private sectors toward our shared goal of advancing science and improving patients’ lives,” said Alan D. Palkowitz, Ph.D., vice president of discovery chemistry research and technologies at Lilly.  “It also attests to the importance of collaborative research because, despite major advances in biomedical science, much work remains to be done.” 

Conclusion 

NIH and Lilly’s partnership should be applauded and encouraged to ensure that Americans continue to have the best health care treatments available.  Moreover, NIH, life science companies, and other research institutions should pursue similar partnerships and arrangements.  With continued collaboration such as this, Americans may live to see a cure for cancer.