blog.bioethics.net
a Nature Top 50 science blog from The American Journal of Bioethics
Entries from blog.bioethics.net tagged with 'FDA'
Bioethicist Charo Accepts Key FDA Post
University of Wisconsin law professor R. Alta Charo has accepted the post of senior adviser in the Office of the Commissioner of the FDA. According to the Chicago Trib, as of August 30th, Charo will be part of an elite group of policy advisors asked the tough questions on food... (read the rest)
It's Not August! But The August Issue of AJOB is Already Online at Bioethics.net
Now available at bioethics.net is the August issue of The American Journal of Bioethics. This month's issue contains articles ranging in topics from organ conscription and whether the US ought to have an opt-out system for organ donation and a number of thought experiments supporting that position by Delaney and... (read the rest)
Pucker Up!
Ladies, how much risk of lead exposure would you be willing to undergo for ruby red lips? Is it even something to be concerned about? Well, it depends on who you ask. According to the NYT, a debate is ensuing at the FDA over lead suspected in tubes of women's... (read the rest)
Will Your Tweets Keep You Healthy Or Make You Sick?
Google has been tracking flu trends to monitor disease outbreaks for some time, but with the most recent outbreak of swine flu, social media has taken on a new role in the monitoring of health in our lives. Not only did we, here at bioethics.net, decide to create pandemic.bioethics.net on... (read the rest)
Dr. Hamburg, Divest Thyself
One of the wealthiest of the Obama administration appointees, Dr. Margaret Hamburg, has to offload her stock pretty quickly--apparently that's what comes from being married to a very successful hedge fund manager and holding a wide range of health and other medical related stock, says the Wall Street Journal. The... (read the rest)
President Obama Takes Food Ethics Seriously
In his Saturday morning radio address, President Obama took on the issue of food safety as a moral responsibility for our nation. The lack of food safety and a "demoralized" Food and Drug Administration was characterized as a "threat to public health" by the President, according to the Wall Street... (read the rest)
DBS for OCD? OMG!
As I read on the Triage health blog at the Chicago Tribune, deep brain stimulation (DBS) has been approved by the FDA as a treatment for obsessive-compulsive disorder (OCD). Medtronic was given "humanitarian device exemption" for its DBS device based on the data: 26 patients were shown to have a... (read the rest)
Goats: Not Just for Making Feta Cheese and For Petting Zoos Anymore
Researchers have finally done it. Engineered a goat to save lives. On Friday, the FDA approved a genetically engineered goat that is able to produce in its milk (not for feta cheese making, mind you) a drug that will save the lives of patients born with a rare hereditary deficiency... (read the rest)
A Well-Timed Step Forward
Today, the FDA announced its approval of the first stem cell clinical trial in human beings. Geron will perform the trial on 10 spinal cord injured patients. To call this trial, "medical treatment" is the biggest overstatement one could make--and fully illustrates one of the biggest ethical problems with stem... (read the rest)
Move Over CoverGirl and Revlon. Here Comes Latisse.
Here is one enhancement I think the world could have lived without. From the makers of Botox, Allergan, Inc, comes a drug that will make your lashes--longer, thicker, darker, Latisse. According to the Washington Post, the FDA has approved this drug for daily use on the upper (but only the... (read the rest)
When It Comes to Nano, Feds are Passing the Buckyball
According to an article from Scientific American, the National Research Council has weighed in on the regulatory efforts of the federal agencies responsible for monitoring the safety and use of nanoparticles and objects using nanotechnologies. For the more than 800 consumer products using nanotechnology, the NRC has said that no... (read the rest)
Medical Ads on YouTube Go Unregulated
According to the Wall Street Journal Health Blog, a consumer advocacy group is up in arms over unregulated pharma ads found on YouTube. The Prescription Project reports that medical device ads for prominent companies appear on YouTube, but without the disclaimers and warnings that pharmaceutical or medical device ads must... (read the rest)
deCODE demoted
I have something to tell you about deCODE--there's good news and there's bad news. First, for the good news: today deCODE announced that it has filed an IND with the FDA for a new drug on cognition designed to combat memory loss and the other effects of Alzheimer's disease. The... (read the rest)
Beware! Food Allergens WIthin!
The Washington Post reported on Tuesday that the FDA is considering changing food labeling for products that may contain allergens such as nuts, wheat, and others. Advocates say that there are just too many ways to say that your favorite candy bar was made in a factory containing nuts or... (read the rest)
Coming Soon: Robo-Pancreas
Thanks to the folks at Engaget we have learned that researchers have developed an artificial pancreas complete with a remote device that monitors your blood sugar, morning, noon and night. This device could be a lifesaver for those with diabetes, particularly juvenile diabetes, if it could be a permanent implant... (read the rest)
Zetia situation demonstrates need for a more open clinical trial process
By Alan C. Milstein The news about Zetia and Vytorin once again raises a major problem in the way the FDA allows drug companies to control the information about the clinical trials they conduct, often to the detriment to public health. Apparently, Merck and Schering-Plough had completed the trial which... (read the rest)
Art Caplan at MSNBC: Report paints grim picture of drug trial safety
Art writes that criticism of the FDA's weak oversight is on target, but Congress shares the blame: When a bridge collapses in an American city or a mine implodes, it does not take long before government gets in motion to figure out what to do about the problem. We see... (read the rest)
Regulating nanotechnology
The FDA's Nanotechnology Task Force recently released a report laying out its take on regulation of products containing nanoscale materials. Here's a clip: A general finding of the report is that nanoscale materials present regulatory challenges similar to those posed by products using other emerging technologies. However, these challenges may... (read the rest)
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