Clinical Trials Registries: A Reform That is Past Due.Jennifer L. Gold &David M. Studdert -2005 -Journal of Law, Medicine and Ethics 33 (4):811-820.detailsSeveral high-profile episodes have recently thrust drug safety and the pharmaceutical industry's practices into the spotlight. Merck's recall of the drug Vioxx, for instance, was a major news event. GlaxoSmithKline's suppression of data linking suicidal behavior among children to Paxil also galvanized tremendous public attention. What differentiates these events from the usual evolving process of scientific knowledge, and marks them with an aura of “scandal,” are questions about the propriety of corporate behavior. Who knew what, and when did they know (...) it? Concerns are growing about the potential for industry sponsors to suppress negative results from clinical trials research. Scientists, medical journal editors, legislators, and the public have called for greater transparency in the conduct of clinical trials and the drug approval process. (shrink)
Physician Responses to the Malpractice Crisis: From Defense to Offense.Allen Kachalia,Niteesh K. Choudhry &David M. Studdert -2005 -Journal of Law, Medicine and Ethics 33 (3):416-428.detailsMedical science brings innovations in patient care at an astounding pace today - new chemotherapeutic agents, coated stents, and minimally invasive surgery are just few recent examples. For physicians, though, the specter of malpractice liability can overshadow the marvel of practicing in this era. Many physicians are working in a volatile liability environment; they face spiraling costs for malpractice insurance, have difficulties purchasing liability coverage at any price, and see record payouts in a growing number of claims against their colleagues. (...) The American Medical Association has declared that at least 20 states are currently in a malpractice “crisis,” with another 24 states showing early signs of an impending crisis.There have been two comparable periods of instability in the last thirty years, but these predecessor crises differ from the current one in important ways. First, while physicians mainly experienced dwindling options for obtaining coverage in the mid-1970s and exorbitant prices in the mid-1980s, the current crisis appears to have elements of both availability and affordability. (shrink)
Making the Case for Health-Enhancing Laws after Bloomberg.Michelle M. Mello &David M. Studdert -2014 -Hastings Center Report 44 (1):8-8.detailsThe last of five commentaries on “Bloomberg's Health Legacy: Urban Innovator or Meddling Nanny?” from the September‐October 2013.