HHS Secretary Sebelius, proponent of clinical research, resigns
Health and Human Services Secretary Kathleen Sebelius—whose agenda included keeping clinical research a priority—has resigned on the heels of the Affordable Care Act (ACA) web site turmoil last October, even though more recently she had achieved the goal of 7.5 million registrations for coverage.
“For many patients, access to cutting edge medicine available through clinical trials can increase their likelihood of survival,” Sebelius told Medscape editor-in-chief Eric J. Topol, M.D., last year. “This is an important protection for patients that not only could have a life-altering impact, but it’s also one that serves to facilitate participation in research that is critical to expanding our knowledge base and finding cures and treatments for those illnesses that threaten the lives of Americans each day.”
Physicians, who have long lamented the lack of participation by patients in clinical trials, have viewed the ACA as an opportunity for patients to keep their health insurance while participating in clinical research.
The clinical trial provision (section 2709) of the ACA, which took effect in January, states that a health insurer may not deny a qualified individual’s participation in an approved clinical trial for the treatment of cancer or another life-threatening disease or condition nor deny coverage of routine patient costs for services during trial participation. The law also says insurers cannot discriminate against an individual for participating in a clinical trial.
“The clinical trial section is a very important piece of the Affordable Care Act and is an important piece of healthcare policy,” said Harry P. Selker, M.D., MSPH, professor at Tufts Clinical and Translational Science Institute and Tufts Medical Center for Classical Research and Health Policies. “Clinical research is part of the nation’s obligation to improve healthcare.”
Selker said he was surprised at Sebelius’ resignation, citing the timing and that she was able to dodge numerous problems, calling her a stalwart champion of the ACA.
“Her five-year leadership of Health and Human Services makes her one of the longest-serving secretaries of that department,” said Selker, co-editor of The Affordable Care Act as a National Experiment: Health Policy Innovations and Lessons, a book about the history and impact of healthcare reform from 16 authors involved since its inception.
Just over 18 months ago, Sebelius delegated to the FDA the task of determining whether CROs and pharmaceutical companies were accurately reporting clinical trial information. In a Federal Register notice she wrote that she wanted to make sure organizations running trials were not leaving out any data in their disclosures, giving them 30 days to rectify any omissions. Federal law requires that results of clinical trials become publicly available on the federally operated ClinicalTrials.gov.
Despite the spotlight on the troubled rollout of the healthcare law, she helped open up information about clinical trials, as well as public health and Medicare data, to the public. Data often was published in formats that were indecipherable and inaccessible. She acknowledged it was “lazy” data and that it contained potentially valuable information. Now, HHS has, through HealthData.gov, made the data “active.”
“What we’re finding is if we make data open and accessible, the private and nonprofit sectors use it to start innovation,” she told Modern Healthcare in February, citing the growing role of physicians and hospitals using electronic health records. “Nationally there has been tremendous progress in the last five years from quills and clipboards to computers and keyboards.”