September 21st, 2011 by GarySchwitzer in News, Opinion
No Comments »
MedPage Today reports:
Mehmet Oz, MD, the Columbia University thoracic surgeon who gained fame first in books and more recently with his syndicated television show, has run afoul of the Food and Drug Administration with his report about levels of arsenic in popular brands of apple juice.
The FDA called the report “irresponsible and misleading” and another TV doc, ABC’s Richard Besser, MD, accused Oz of fear-mongering.
Fox News’ Dr. Manny Alvarez rushes to Oz’s defense, though:
“I’m very proud of Dr. Oz for his report today on potentially dangerous levels of arsenic found in certain brands of apple juice, which may classify some of them as unsuitable for consumption. He’s sounding the alarm for an issue that I believe needs to be brought to attention.
…
Don’t get me wrong, I don’t want to Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
September 15th, 2011 by AndrewSchorr in News, Opinion
No Comments »
I speak to people in the pharmaceutical industry much more than folks who develop medical devices. I know how pharma researchers spend years and hundreds of millions of dollars trying to develop a useful, safe new drug that the FDA will approve for marketing. Certainly there are big payoffs, but the road is filled with potholes and trapdoors and the analysis by the FDA is rigorous.
But for years we’ve been hearing that it is much less rigorous when it comes to medical devices. Artificial hip joints and stents to open blocked arteries fall into this category. And recently, the less stringent review process has been highlighted in the news. Metal-on-metal hip joints are being removed from patients who had them implanted. They thought Read more »
*This blog post was originally published at Andrew's Blog*
September 2nd, 2011 by RyanDuBosar in Research
No Comments »
Severe shortages for life-saving medications have driven a “gray market” in the wholesale drug supply industry, a watchdog group reports.
And the mark-up on gray market drugs is a budget-buster, reports the Institute for Safe Medication Practices, a Philadelphia-based nonprofit organization devoted entirely to medication error prevention and safe medication use. Purchasing agents and pharmacists at 549 hospitals responded to a survey on gray market activities associated with drug shortages.
The report includes chilling anecdotes from the respondents about pressure from physicians and administrators to ensure drugs are available, and drastic price gouging from the gray market suppliers. Price mark-ups of 10 times or more than the contract price were reported by about a third of respondents from critical access hospitals and community hospitals, and more than half of university hospitals. Examples include a box of calcium gluconate that cost $750 instead of the contract price of $50 (1,400% mark-up), and a supply of propofol that cost $25,000 instead of $1,500 (1,567% mark-up). Oh, and there’s exorbitant shipping and handling fees, too. Read more »
*This blog post was originally published at ACP Hospitalist*
August 15th, 2011 by Medgadget in News
No Comments »
GE Healthcare has received the FDA OK for its Optima CT660 computed tomography (CT) system. The CT660, which is already available in Europe, Latin America and Asia, distinguishes itself by its compact footprint combined with a modular design and low dose imaging. In addition, it is also one of the most energy efficient CT scanners available and has an “environmental design” that eases refurbishment and end-of-life recycling. The scanner itself is scalable from 32 to 128 slices through purchasable options and features automatic table positioning and a color 12-inch integrated gantry display monitor. Read more »
*This blog post was originally published at Medgadget*
August 13th, 2011 by David Kroll, Ph.D. in Health Policy, Opinion
No Comments »
A rumble of discontent is being heard across the dietary supplement industry since a draft guidance document was published last month by the US Food and Drug Administration. In response to the FDA Food Safety Modernization Act signed into law in January by President Obama, the FDA was required to produce documents requiring dietary supplement and foods companies to submit safety information on any new dietary ingredient (NDI) placed into products after 1994.
The guidance document is open for comments from industry but, when issued, a final rule will require dietary supplement products to file a claim of a New Dietary Ingredient (NDI) for any supplement component that was not part of the diet before 1994. What seems to be riling up the industry is that any change in supplement composition after 1994 will require filing of a NDI disclosure. That is, if you as a manufacturer add more DHA to your fish oil supplement, you have to file a NDI notification.
Stepping back, the goal of the FSMA makes perfect sense: Read more »
*This blog post was originally published at Science-Based Medicine*
