Author

Jonathan Darrow

  • Bioethics

    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…

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

    By

    Jonathan Darrow

  • Bioethics

    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…

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

    By

    Jonathan Darrow

  • Bioethics

    Pharmacy Compounding: Federal Law in Brief

    by Jonathan J. Darrow Until recently, most ordinary people had never heard of “pharmacy compounding.”  Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled…

    Pharmacy Compounding: Federal Law in Brief

    By

    Jonathan Darrow

  • Bioethics

    FDA Reprimands Genentech for “Drastically Overstat[ing] the Efficacy of Tarceva”

    by Jonathan J. Darrow On October 3, 2012, the FDA’s Division of Professional Drug Promotion issued an untitled letter to Genentech in connection with its cancer drug Tarceva.  Tarceva (erlotinib) was approved in 2004 for…

    FDA Reprimands Genentech for “Drastically Overstat[ing] the Efficacy of Tarceva”

    By

    Jonathan Darrow

  • Human Subjects Research

    Why Consent Is a Requirement for Ethical Research

    by Jonathan J. Darrow In a Petrie-Flom Center event last month, Dr. Alan Wertheimer raised the question of why consent is needed in ethical research.  Without commenting on his answer to the question (attendees were…

    Why Consent Is a Requirement for Ethical Research

    By

    Jonathan Darrow

  • Conflicts of Interest

    When Do Doctors Discount Clinical Trial Results?

    by Jonathan J. Darrow A research study reported today in the New England Journal of Medicine found that physicians are able to discriminate between clinical trials with high levels of rigor versus those with low…

    When Do Doctors Discount Clinical Trial Results?

    By

    Jonathan Darrow

  • FDA

    Generic Drugs: Grabbing a Bigger Slice

    by Jonathan J. Darrow The expiration of the patent on $11-billion-per-year Lipitor® (atorvastatin calcium) last November received wide media attention and was eagerly greeted by consumers, reflecting public excitement that seems to have not yet…

    Generic Drugs: Grabbing a Bigger Slice

    By

    Jonathan Darrow