Safety Problems

SPOTLIGHT: Revised study still finds that FDA approval rush may cause harm

Anne Zieger — Thu, 03 Jul 2008 01:26:37 -0400

Harvard University professor Daniel Carpenter has come out with a revised version of a study concluding that drugs moving too quickly through the FDA approval process are more likely to be linked to safety problems later. Though admitting to data mistakes in his original study, he stands behind his original conclusion, Carpenter says. According to his new numbers, between 1993 and 2005, 88 drugs approved near agency deadlines had a 15 percent chance of being identified as having severe safety problems, as compared with 5 percent of 226 other drugs. Article

CA lawmakers push for tougher plastic surgery rules

Tue, 27 May 2008 06:59:54 -0400

Driven in part by the death of the mother of hip-hop star Kanye West, who was getting liposuction and breast implant surgery, California physicians and lawmakers are pushing to tighten up regulation of the cosmetic surgery industry in the state. Right now, such surgeries are increasingly being done in outpatient clinics, where doctors don't face rigorous reviews. However, as with doctors in other states (such as Florida), California legislators would like to see tougher oversight of doctors performing such procedures.

Legislators are being forced to take such steps despite their already being rules on the books designed to prevent safety problems during outpatient cosmetic surgery. More than 10 years ago, the state passed a law requiring cosmetic surgery centers to be recognized by the state, have resuscitation equipment and have procedures to transfer patients to a hospital. However, critics say the law hasn't been effective.

To learn more about this initiative:
- read this Los Angeles Times piece

ALSO NOTED: Nurse practitioners play big role in TN; CT hospital construction project creates collapse danger; and much more...

Mon, 31 Mar 2008 07:59:50 -0400

> Nurse practitioners are playing an increasingly important role in Tennessee, which is considering expanding the roles NPs can fill. Article

> A Hartford, CT hospital has been forced to stop its construction process after learning that the work threatened the structural integrity of a nearby building. Article

> A new study suggesting that on-deadline drug approvals lead to more safety problems has ignited controversy, with some critics arguing that they can't duplicate the study's results. FiercePharma

> Federal officials have decided that they're going to funnel more funds to basic AIDS vaccine research. FierceVaccines

And Finally... Talk about a rude awakening. Article