The most transformative drugs of the past 25 years: a survey of physicians

Kesselheim, Aaron S.; Avorn, Jerry

doi:10.1038/nrd3977

Cited by 40 publications

(32 citation statements)

References 22 publications

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“…During the study period, several targeted cancer therapies that appear to extend life became available to patients, and the use of statins for prevention and coronary revascularization markedly expanded, likely easing the morbidity and mortality associated with cardiovascular disease. 20 In addition to drug and device innovation, the proliferation of other technologies may be contributory; for example, advances in telecommunications have helped many patients, especially those in rural areas, to receive medical attention more rapidly.…”

Section: Discussionmentioning

confidence: 99%

Mortality, Hospitalizations, and Expenditures for the Medicare Population Aged 65 Years or Older, 1999-2013

Krumholz

Nuti

Downing

et al. 2015

JAMA

131

102

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In a period of dynamic change in health care technology, delivery, and behaviors, tracking trends in health and health care can provide a perspective on what is being achieved.OBJECTIVE To comprehensively describe national trends in mortality, hospitalizations, and expenditures in the Medicare fee-for-service population between 1999 and 2013. DESIGN, SETTING, AND PARTICIPANTS Serial cross-sectional analysis of Medicare beneficiaries aged 65 years or older between 1999 and 2013 using Medicare denominator and inpatient files. MAIN OUTCOMES AND MEASURESFor all Medicare beneficiaries, trends in all-cause mortality; for fee-for-service beneficiaries, trends in all-cause hospitalization and hospitalizationassociated outcomes and expenditures. Geographic variation, stratified by key demographic groups, and changes in the intensity of care for fee-for-service beneficiaries in the last 1, 3, and 6 months of life were also assessed. RESULTSThe sample consisted of 68 374 904 unique Medicare beneficiaries (fee-for-service and Medicare Advantage). All-cause mortality for all Medicare beneficiaries declined from 5.30% in 1999 to 4.45% in 2013 (difference, 0.85 percentage points; 95% CI, 0.83-0.87).

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Section: Discussionmentioning

confidence: 99%

Mortality, Hospitalizations, and Expenditures for the Medicare Population Aged 65 Years or Older, 1999-2013

Krumholz

Nuti

Downing

et al. 2015

JAMA

131

102

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“…4 Drug innovation can be defined in many ways. 5 For the purposes of our study, a transformative drug was defined as one that both was innovative and had a groundbreaking effect on patient care.…”

Section: Study Data and Methodsmentioning

confidence: 99%

The Roles Of Academia, Rare Diseases, And Repurposing In The Development Of The Most Transformative Drugs

2015

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Transformative drugs, defined as pharmaceuticals that are both innovative and have groundbreaking effects on patient care, are the "holy grail" of drug research and development. The sources of drug innovation are often debated, with pharmaceutical manufacturers arguing that high drug prices support innovative output from their sector. We studied the developmental histories of twenty-six drugs or drug classes approved by the Food and Drug Administration between 1984 and 2009 that were judged by expert physicians to be transformative (in two cases, the first drug in a transformative class was approved before 1984). Most of the twenty-six were first approved early in the study period; only four were approved in 2000 or later. Many were based on discoveries made by academic researchers who were supported by federal government funding. Others were jointly developed in both publicly funded and commercial institutions; the fewest number of drugs had originated solely within pharmaceutical industry research programs. Nine of the twenty-six (35 percent) were repurposed from products developed for other indications, and ten (38 percent) were developed for rare diseases before much broader applicability was found. The insights from these case studies provide an experience-based foundation for policies to encourage the development of future transformative drugs.

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“…15 participants received a list of new molecular entities approved between 1985 and 2009 and instructions to identify the 5 "most transformative" products in their fields. 15 participants received a list of new molecular entities approved between 1985 and 2009 and instructions to identify the 5 "most transformative" products in their fields.…”

Section: Methodsmentioning

confidence: 99%

Medical Innovation Then and Now: Perspectives of Innovators Responsible for Transformative Drugs

Xu¹,

Kesselheim²

2014

J. Law. Med. Ethics

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Effective medical innovation is a common goal of policymakers, physicians, researchers, and patients both in the private and public sectors. With the recent slowdown in approval of new transformative prescription drugs, many have looked back to the "golden years" of the 1980s and 1990s when numerous breakthrough products emerged. We conducted a qualitative study of innovators (n=127) directly involved in creation of groundbreaking drugs during that era to determine what made their work successful and how the process of conducting medical innovation has changed over the past 3 decades. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis to identify the positive features of and challenges posed by the past and present therapeutic innovation environments (70 of the 127 interviewees explicitly addressed these issues). Interviewees emphasized the continued central role played by individuals and the institutions they were a part of in driving innovation. In addition, respondents discussed the importance of collaboration between individuals and institutions to share resources and expertise. Strong underlying basic science was also cited to be a major contributing factor to the success of an innovation. The climate for modern-day medical innovation involves a greater emphasis on patenting in academia, difficulty negotiating the technology transfer process, and funding constraints. Regulatory demands or reimbursement concerns were not commonly cited as factors that influenced transformative innovation. This study suggests that generating future transformative innovation will require a simplification of the current technology transfer process, continued commitment to basic science research, and policy changes that promote meaningful collaboration between individuals from disparate institutions.

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The most transformative drugs of the past 25 years: a survey of physicians

Cited by 40 publications

References 22 publications

Mortality, Hospitalizations, and Expenditures for the Medicare Population Aged 65 Years or Older, 1999-2013

Mortality, Hospitalizations, and Expenditures for the Medicare Population Aged 65 Years or Older, 1999-2013

The Roles Of Academia, Rare Diseases, And Repurposing In The Development Of The Most Transformative Drugs

Medical Innovation Then and Now: Perspectives of Innovators Responsible for Transformative Drugs

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