News & Media / Opinions & Features

How Mental Health is Shortchanged by Lack of Reimbursement for Vagus Nerve Stimulation

December 30, 2015

With a continuing weekly newsfeed on the destructive conse- quences of inadequate mental healthcare and with growing data on how depression negatively impacts the ability to perform daily tasks and engage in social interactions, why does a proven therapeutic intervention for chronic depression still remain far out of reach for so many patients?

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A 21st Century Nosocomial Issue with Endoscopes

March 19, 2014

On 3 January 2014 the results of a year long investigation by the US Centers for Disease Control (CDC) into an outbreak of New Delhi metallo-β-lactamase (NDM)-producing carbapenem resistant Enterobacteriaceae (CRE) were released. Of 69 patients with confirmed CRE infections, 29 went to Advocate Lutheran General Hospital (ALGH) for the same procedure—an endoscopy. The endoscopy itself is not dangerous, but the current cleaning process used between procedures leaves patients susceptible to infection and troubles many healthcare practitioners.

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Seeking Innovation: Incentive Funding for Biodefense Biotechs

December 1, 2010

In the current venture capital climate, it is easier to secure funding for late-stage, next-in-class therapeutic agents than for early-stage opportunities that have the potential to advance basic science and translational medicine. This funding paradigm is particularly problematic for the development of “dual-use” biothreat countermeasures such as antibiotics, vaccines, and antitoxins that target pathogens in novel ways and that have broad public health and biodefense applications. To address this issue, we propose the creation of the Drug Development Incentive Fund (DDIF), a novel funding mechanism that can stimulate the development of first-in-class agents that also possess the capability to guard against potential biothreats. This program would also support greater synergies between public funding and private venture investment. In a single act, this organization would secure science of national importance from disappearing, invest in projects that yield significant public health returns, advance the promises of preclinical and early phase research, revitalize biopharmaceutical investment, and create valuable innovation-economy jobs.

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The Long Shadow of the Stem-Cell Ruling: US Firms Could Get Left Behind

October 28, 2010

The recent litigation in the District of Columbia Circuit attempting to suspend the public funding of human embryonic stem cell (hESC) research in the United States also threatens privately funded research. It has created an atmosphere of grave uncertainty among Wall Street investors who now shy away from hESC products, alarmed by the increased risk that stems from protean federal policy and the ambiguous regulatory requirements.

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Caution – FDA Could Be Hazardous to Your Health

January 19, 2009

FDA is a troubled agency in need of fundamental reorganization. It has been criticized by Congressional watchdogs for years and recently, staff members sent a letter to Congress highlighting some of the problems they see within the agency. On October 14, a group of scientists and physicians in the FDA’s Center for Devices and Radiological Health (CDRH) wrote to Representative John Dingell (D-MI) saying “managers at CDRH with no scientific or medical expertise in devices, or any clinical experience in the practice of medicine have ignored serious safety and effectiveness concerns of FDA experts and have ignored scientific regulatory requirements.” The letter further accused FDA management of knowingly “allowing a continuation of management reprisals” against those who raised these and other concerns.

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