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In an article on the front of its business section, the New York Times (2/22, B1, Meier, Subscription Publication) reports that, in contrast to Johnson & Johnson’s statements prior to its recall of an all-metal artificial hip that “it was safe and maintained that its internal studies refuted complaints by surgeons and regulators abroad that the [...]
CQ (2/18, Bristol, Subscription Publication) reported, “While the Food and Drug Administration takes heat from members of Congress over slow approval for medical devices, Public Citizen argues the regulatory system is too weak and that new proposals could endanger patients. ” Public Citizen “objects in particular to bills introduced in Congress that it says ‘aim [...]
Modern Healthcare (2/12, Lee, Subscription Publication) reported, “The Food and Drug Administration issued draft guidance addressing the amounts and types of safety data that companies developing drug and biological products should collect in late-stage, pre-market and post-market clinical investigations.” The FDA “said in the draft guidance (pdf) that ‘more selective safety data collection’ could improve the safety database, [...]
Bloomberg News (2/15, Cortez) reports, “St. Jude Medical Inc. (STJ)’s Riata, a cable used in heart defibrillators, is the latest example of a defective medical device that wasn’t spotted quickly enough because US surveillance systems are lacking,” according to an article published in the New England Journal of Medicine. “St. Jude and US regulators aren’t [...]
Medscape (2/15, Hitt) reports, “Many US Food and Drug Administration (FDA) drug-risk communications have a delayed effect, or no effect on drug monitoring or prescribing behaviors, according to the findings of a new report“ published online Jan. 18 in the journal Medical Care. After analyzing data from 49 studies which “covered 16 drugs or therapeutic classes,” [...]
The Hill (2/14, Pecquet) “Healthwatch” blog reported that Reps. Henry Waxman (D-CA), Edward Markey (D-MA), and Rep. Diana DeGette (D-CO) “on Tuesday raised concerns with federal health agencies’ enforcement efforts after a British medical journal reported that drugmakers ‘routinely fail’ to publish the results of clinical trials within the timeframe required by law.” The lawmakers sent [...]
On its website and on the air, KPCC-FM (2/16, Varney) reported on “The Madeleine Brand Show” that California “electronically track(s) the prescriptions for powerful narcotics, (More Californians die from overdosing on prescription drugs than from illegal street drugs.) but it’s unrelenting budget cuts are threatening to close the system down.” Last year, “Governor Jerry Brown announced…that, for budget [...]
The Louisville Courier-Journal (2/17, Riley) reports that in Kentucky, the estate of Mary Moore, of Louisville, “has filed a wrongful-death lawsuit against the Walgreens drugstore in Jeffersontown and one of its pharmacists, (Anthony Bower is named as the pharmacist in charge that day at the store) claiming she died as the result of getting the wrong prescription.” [...]
The IEP (Individualized Education Program), is a source of angst for both schools and families of children with disabilities. Meetings can be difficult to coordinate, and schools and parents, as well as the students in question, may not agree on reachable goals and the services needed to reach those goals, as well as the setting in which [...]
Fluoxetine Decreases The Risk Of Suicidal Thoughts In Adults, While In Children No Change Was Noted The Los Angeles Times (2/7, Roan) “Booster Shots” blog reports that a review published online Feb. 6 in the Archives of General Psychiatry “suggests there is no reason to believe that antidepressants influence suicidal thinking in kids.” For the study, researchers [...]
