September 21st, 2011 by GarySchwitzer in News, Opinion
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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.
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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 20th, 2011 by Felasfa Wodajo, M.D. in News
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The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.
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Last week (Sep 12-13), the FDA is held an important public workshop near its Washington DC headquarters to help it answer some key questions raised within the Draft Guidance and gather feedback from important stakeholders in mobile health. We are proud that iMedicalApps was invited to participate as one of the panelists.
We want to hear from you iMedicalApps readers – what do you want the FDA to consider in regulating mobile medical apps ?
Please add your voice in the comment section below and we will assemble them for submission to the official FDA docket on the Draft Guidance. Hurry because the deadline is just a few weeks away.
The FDA needs input from clinicians and others interested in mobile medicine and has identified two topics in particular as needing further specification:
- How to assess the risks inherent to clinical decision support software and
- How to classify mobile software that works in concert with a medical device.
*This blog post was originally published at iMedicalApps*
September 15th, 2011 by AndrewSchorr in News, Opinion
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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 12th, 2011 by David Kroll, Ph.D. in News, Research
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As early as 2006, I used to be able to write monthly about US FDA warnings on erectile dysfunction supplements being found adulterated with prescription drugs such as sildenafil, the phosphodiesterase-5 inhibitor found in Viagra. These adulteration episodes raised the question of how many anecdotal reports of herbal products “working” had to do with them containing approved medicines.
So common was this practice that FDA created a site in 2008 that was dedicated to this problem: Hidden Risks of Erectile Dysfunction “Treatments” Sold Online. Indeed, these products were more commonly encountered from online retailers and not in health food stores. Other similar practices include bodybuilding supplement being spiked with anabolic steroids and weight loss supplements being adulterated with sibutramine (formerly Meridia), an anorectant removed from the market last year after showing increased incidence of heart attacks and stroke in patients with preexisting cardiovascular disease.
The herbal industry, led by the American Herbal Products Association (AHPA), aimed to clean up this problem and launched an initiative called, KeepSupplementsClean.org. Spurred by an FDA letter to the industry on 15 December 2010 of increased scrutiny on the adulteration problem, AHPA actually encouraged FDA to Read more »
*This blog post was originally published at Science-Based Medicine*
September 9th, 2011 by GarySchwitzer in Health Policy, Opinion
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In a comment left on my blog, Jamie Bearse, the chief operating officer of Project Zero – The Project to End Prostate Cancer, showed how quickly and deeply discussions about screening tests can devolve into ugly rhetoric. Bearse wrote:
“Your comments along with Otis Brawley’s vendetta against the PSA sentence men to die from prostate cancer testing. Shame on you. It’s important to know your score to make a proper diagnosis and decision of if and how to treat prostate cancer. Groups that create screening guidelines for cancer such as American Urological Association and National Comprehensive Cancer Network say get tested. In fact, Brawley is at odds with his own organization. ACS supports testing as well. Otis Brawley has killed more men by giving them an excuse to not be tested. Don’t follow that path just because of your own bad experience.”
I responded:
“Jamie,
My comments policy states that I will delete comments that make personal attacks. You certainly did that with your statement that the chief medical officer of the American Cancer Society “has killed” and that he has “sentenced men to die.”
Nonetheless I have posted your comment because I think it’s important for other readers to see how some pro-screening rhetoric so quickly and completely devolves into ugliness.
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YOU ARE WRONG Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
