Earlier this week, the D.C. Circuit upheld the FDA’s authority to regulate stem cells (for a good news report see here). The company in question, Regenerative Sciences, had received a warning letter from FDA, which the company challenged claiming that its use of stem cells as therapy was not prohibited by existing federal law and that the FDA lacked authority to regulate it. They lost before the district court and appealed to the D.C. Circuit.
The growing burden of managing chronic illness has long been a critical issue for policy makers and clinicians seeking to improve the quality, cost and efficiency of healthcare systems in the United States. According to the Institute of Medicine, the costs of treating and managing the segment of the population living with chronic illnesses currently represents nearly $1.5 trillion of the over $2 trillion in annual healthcare spending in the U.S. Over 90% of Medicare costs are allocated to beneficiaries living with two or more chronic conditions, with close to 50% of spending on individuals living with 6 or more chronic conditions (approximately 14% of beneficiaries). The immense share of healthcare spending attributable to chronic illness is expected to climb as the population ages.
Earlier this month, a bipartisan bill entitled the Better Care, Lower Cost Act was introduced in Congress which aims to address the complex issues involved in chronic care management. The legislation outlines three key innovations toward this end.
On December 12, a bipartisan bill entitled the Excellence in Diagnostic Imaging Utilization Act of 2013 (HR 3705) was introduced in the House of Representatives which would require clinicians to use electronic clinical decision support tools (CDS) before ordering advanced diagnostic imaging tests for Medicare patients. Structured around appropriate use criteria developed by professional medical societies, the tools would aim to increase the value of advanced imaging studies by informing and guiding practitioners’ decisions across a variety of clinical settings.
Such tools would provide active feedback on the appropriateness and evidence base of various imaging modalities, and would require physicians to furnish rationales for ordering tests that are inconsistent with appropriate use criteria. The bill also envisions the creation of registries that document how diagnostic tests are used in order to facilitate research and to enable feedback to clinicians on metrics related to appropriate use criteria. In a press release, the American College of Radiology lauded the proposed legislation, stating that it would “revolutionize the specialty of radiology.”
Mandating the use of electronic clinical decision support tools portends at least three key improvements in clinical workflows and healthcare quality more broadly.
The Petrie-Flom Center is pleased to announce the launch of its new initiative in Ethics and Law. The initiative will be part of the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center. For more information, check out the full press release.
In 1972, biochemist Paul Berg and his student Janet Mertz published groundbreaking details of their first successful attempt at devising a procedure to cleave separate pieces of DNA and recombine them into a single novel molecule. These innovations, dubbed recombinant DNA (rDNA) technology, spurred a flurry of concerns from members of the scientific community who worried about the safety, risks and potential drawbacks of creating recombinant DNA molecules. Motivated by these concerns, the NIH established the Recombinant DNA Molecule Program Advisory Committee (RAC) in 1974. The RAC was charged with the mission of overseeing research and implementation of rDNA technologies, with a particular focus on proposals involving the transfer of recombinant or synthetic DNA into humans (i.e., human gene transfer).
Last week, after nearly 40 years of providing an additional layer of oversight to this class of research, the RAC received recommendations from an independent Institute of Medicine (IOM) committee that was convened to assess “whether the current oversight of individual gene transfer protocols by the Recombinant DNA Advisory Committee (RAC) continues to be necessary.”
The committee’s report calls for significant changes to the prevailing structures of rDNA research regulation and oversight, and represents a victory for many gene transfer researchers who have challenged RAC regulations. Read More
By Art Caplan
Are we ever capable of laying a stupid idea to rest in America? Apparently not. The latest tempest in the ever-resurrecting world of solutions to the shortage of organs is donation by executed prisoners. The Governor of Ohio held up a plan to execute a man on death row when he requested that his organs be donated to his mother and sister each of whom have serious health problems.
According to the AP,
“Ohio Governor John Kasich on Wednesday stayed the execution of convicted killer Ronald Phillips to assess whether Phillips’s non-vital organs or tissues can be donated to his mother or possibly others. Phillips, 40, was scheduled to be executed Thursday for the 1993 murder of 3-year-old Sheila Marie Evans.
“I realize this is a bit of uncharted territory for Ohio, but if another life can be saved by his willingness to donate his organs and tissues, then we should allow for that to happen,” Kasich said in a statement.”
The Governor need not have bothered. What child rapist and murderer Ron Phillips had in mind was donating his heart and kidneys to his family. He has shown no interest in helping anyone else nor did he ever mention tissue donation.
Moreover, getting organs from an executed prisoner is both impractical and immoral.
So You Want to be a Technology Developer…
The roots of Skype go back to one email. If that email hadn’t been sent, the world today might be different. In general, technology development is not something that “just happens” — instead, it’s a result of particular actions by individual people. Moreover, the responsibility of technology developers must increase proportionally to the power of their creations. The talk sketches out a vision of what it means to be a responsible technology developer, using behind the scenes stories and videos from the early days of Skype development.
Jaan Tallinn, co-founder of Skype
Wednesday, October 30th
5:30 – 6:30 PM
Science Center A
RSVP to this event
The event is organized by Harvard HIP (High Impact Philanthropy).
Loyola University Chicago’s Stritch School of Medicine recently announced that it is accepting applications from DREAMers – undocumented immigrants who are eligible for the Deferred Action for Childhood Arrivals (DACA) program, which grants qualified applicants a two-year, renewable authorization to remain and work within the United States. This news was met with predictable responses on both sides of the immigration debate – DREAMers applauded the decision, while critics of immigration reform derided the program as a “campaign by that elites who run higher education” who are insensitive to the program’s effects on American citizens.
Media reporting on Loyola’s new policy, however, has been unclear with respect to one issue – whether DREAMer graduates will ultimately be able to obtain medical licenses in the states in which they intend to practice. According to Geoffrey Young, senior director of student affairs and programs at the Association of American Medical Colleges in Washington, who was quoted in an article in Crain’s Chicago Business, “They’ll all be M.D.s, but whether or not they can practice legally in states is to be determined.”
Under the best interpretation of current law, however, DREAMers who successfully graduate medical school cannot be barred from obtaining a medical license on account of their citizenship status. While some states’ licensing requirements still include a citizenship requirement (New Jersey, for example, requires that applicants for a medical license be U.S. citizens or declare their intention to be a citizen; those who fail to gain citizenship within a set period of time will have their temporary licenses revoked), Supreme Court precedent indicates that withholding medical licensure based on citizenship status would likely violate the Equal Protection clause of the Fourteenth Amendment.