Clinical Research

  • Read more: Are You Ready for Some . . . Research? Uncertain Diagnoses, Research Data Privacy, & Preference Heterogeneity
    Article

    Are You Ready for Some . . . Research? Uncertain Diagnoses, Research Data Privacy, & Preference Heterogeneity

    By Michelle Meyer As most readers are probably aware, the past few years have seen considerable media and clinical interest in chronic traumatic encephalopathy (CTE), a progressive, neurodegenerative condition linked to, and thought to result from, concussions, blasts, and other forms of brain injury (including, importantly, repeated but milder sub-concussion-level injuries) that can lead to…

  • Read more: Finasteride as an FDA-Approved Baldness Remedy: Is It Effective?
    Article

    Finasteride as an FDA-Approved Baldness Remedy: Is It Effective?

    By Jonathan J. Darrow Questionable baldness remedies have been peddled since the beginning of medicine. According to Pliny (23-79 A.D.), ashes of seahorse could cure baldness.  Almost 2000 years later, the British Medical Association warned the public of the increasing “number of preparations put forward for the cure of baldness,” particularly those which “are not…

  • Read more: Save the Date – May 17th “Issues and Case Studies in Clinical Trial Data Sharing – What Have We Learned?”
    Article

    Save the Date – May 17th “Issues and Case Studies in Clinical Trial Data Sharing – What Have We Learned?”

    By The Petrie-Flom Center Please save the date for this upcoming conference at Harvard Law School on May 17, 2013: Issues and Case Studies in Clinical Trial Data Sharing: What Have We Learned? Co-sponsored by the Multi-Regional Clinical Trial Center at Harvard University, and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at…

  • Read more: No Access to Medicines without Access to Research
    Article

    No Access to Medicines without Access to Research

    By Adriana Benedict In December, I wrote a blog post noting that access to biomedical research is critical not only for informed patient care, but also for the sustainable development of pharmaceutical R&D responsive to local needs, especially in developing countries.  In recent years, open access issues have taken on an increasingly important role in…

  • Read more: Accentuate the Negative
    Article

    Accentuate the Negative

    By Suzanne M. Rivera, Ph.D. While attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R) last month in San Diego, I had the opportunity to hear a talk by Dr. John Ioannidis, in which he debunked commonly accepted scientific “truths.”  Calling upon his own work, which is focused on…

  • Read more: Outsourcing the Up Goering of My Job Talk Paper to Forbes: Personalized Medicine, Personalized Regulation
    Article

    Outsourcing the Up Goering of My Job Talk Paper to Forbes: Personalized Medicine, Personalized Regulation

    By Michelle Meyer So, one thing they say about being on the law teaching market is that you likely will never before have enjoyed — and, less happily, will likely never again enjoy — so much attention to your work and so many opportunities to discuss it. That’s totally true, and it’s totally fabulous. But there’s…

  • Read more: Guest Post on Animal Research: Inadequate laws don’t – but research alternatives will – protect animals in labs
    Article

    Guest Post on Animal Research: Inadequate laws don’t – but research alternatives will – protect animals in labs

    By Theodora Capaldo [Ed. Note: A few weeks ago, we had a post comparing the protections offered to humans and animals used in research, and it prompted quite a stir. We thought the issues merited more discussion from both sides, and therefore solicited blog posts from two divergent perspectives: Theodora Capaldo, President of the New…

  • Read more: At $28,000 a Dose, How Effective Is Acthar?
    Article

    At $28,000 a Dose, How Effective Is Acthar?

    By Jonathan J. Darrow In a well-researched, recent post, Patrick O’Leary addresses the FDA’s efficacy requirements as applied to an old drug, Acthar (corticotropin), that was first approved in 1952 and granted an orphan designation in 2010 for the treatment of infantile spasms. The initial approval therefore occurred before the Drug Amendments of 1962, which…

  • Read more: Bad to the Bone
    Article

    Bad to the Bone

    By Christopher Robertson I just came across this excellent story by Mina Kimes, which gives a detailed chronicle of how the lines between physician discretion, off-label promotion, and human subjects research can be blurred by an aggressive manufacturer, in a context where life or death is on the line (bone cement used in spine surgery).…

  • Read more: The Risk of Revictimization and the Ethics of Covering School Shootings: What Journalists Can Learn from IRBs
    Article

    The Risk of Revictimization and the Ethics of Covering School Shootings: What Journalists Can Learn from IRBs

    By Michelle Meyer Updated below Like most parents, after learning about the latest mass school shooting this morning, my thoughts immediately went to my own kindergartener. And of course, like most reading this blog, I thought about how poorly we handle guns and mental illness. Before too long, though, I couldn’t help but make a…