July 24th, 2011 by Harriet Hall, M.D. in Opinion, Research
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Antidepressant drugs have been getting a bad rap in the media. I’ll just give 3 examples:
- On the Today show, prominent medical expert
Tom Cruise told us Brooke Shields shouldn’t have taken these drugs for her postpartum depression.
- In Natural News, “Health Ranger” Mike Adams accused pharmaceutical companies and the FDA of covering up negative information about antidepressants, saying it would be considered criminal activity in any other industry.
- And an article in Newsweek said “Studies suggest that the popular drugs are no more effective than a placebo. In fact, they may be worse.”
Yet psychiatrists are convinced that antidepressants work and are still routinely prescribing them for their patients. Is it all a Big Pharma plot? Who ya gonna believe? Inquiring minds want to know:
- Are antidepressants more effective than placebo?
- Has the efficacy of antidepressants been exaggerated?
- Is psychotherapy a better treatment choice?
The science-based answers to the first two questions are Read more »
*This blog post was originally published at Science-Based Medicine*
July 23rd, 2011 by Felasfa Wodajo, M.D. in News
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Since the beginning of this year, there have been clues that the FDA will be heading toward clarification of the complex regulatory issues posed by mobile health devices and software. We have previously reported on testimony and public comments by Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH) alluding to coming guidelines.
Today, the FDA finally released a detailed draft guidance of how it intends to regulate this rapidly exploding sector of mobile medical devices and software.
This is what the Emergo group, regulatory compliance consultants, has gleaned from today’s FDA press release: Read more »
*This blog post was originally published at iMedicalApps*
July 21st, 2011 by DrWes in Opinion, Research
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To ensure rational and responsible dissemination of this new
technology (transcatheter aortic valve replacement [TAVR]), government,
industry and medicine will need to work in harmony.”
– David R. Holmes, Jr., MD, FACC
President, American College of Cardiology
Today, Edwards Lifesciences’ will request pre-market approval of its SAPIEN Transcatheter Heart Valve from the FDA’s Circulatory Systems Devices Panel of the Medical Devices Advisory Committee. And for the first time, the groundwork for our complicated new era of health care rationing will be exposed.
To win an expensive technology on behalf of patients these days, there will have to be “harmony” between doctors and their professional organizations and government regulators. If not, patients lose.
At issue is a transformative technology – another milestone forwarding medical innovation on behalf of some of our oldest and sickest patients: those with critical aortic stenosis who are too sick to undergo open heart surgery. Aortic stenosis tends to be a disease of the elderly that carries at least a 2-year 50% mortality when accompanied by a weakened heart muscle. Yet thanks to the wonders of careful engineering and some daring researchers that paired their expertise and lessons learned from a variety of disciples (cardiothoracic and peripheral vascular surgery, cardiology, and even cardiac electrophysiology), technigues and technology have combined to offer a percutaneous option for aortic valve replacement.
Everyone involved in this research (and even those who have watched from afar) knows this therapy works. Most believe in the long run, it will prove to be a safer option than open heart surgery in these patients.
But that’s about where the harmony ends. Read more »
*This blog post was originally published at Dr. Wes*
July 20th, 2011 by BobDoherty in Health Policy, Opinion
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Joe Scarborough reminds us that the divisions in American government are hardly new, paraphrasing Benjamin Franklin’s observation that “When you assemble a number of men, to have the advantage of their joint wisdom, you inevitably assemble . . . all their prejudices, their passions, their errors of opinion, their local interests, and their selfish views. From such an assembly can a perfect production be expected?” (This comes from a September 17, 1787 speech by Mr. Franklin to urge ratification of the U.S. Constitution, read on his behalf because he was too ill to deliver it in person. The Constitution was ratified the same day.)
I suppose we should be encouraged that Congress’s prejudices, passions, errors of opinion, local interests and selfish views are as American as apple pie, and the Republic has somehow survived nonetheless. Still, I find it deeply troubling that today’s politicians can’t find their way to agree on the debt ceiling.
No one should expect a “perfect production” to come out of this Congress and this administration, given how far apart they are on the need for tax increases and entitlement reforms. But they need to agree to something, and they need to do it soon.
I will leave it to others, who know a lot more about global economics than me, to explain what likely will happen to the economy if the debt ceiling isn’t increased by August 2. Let’s talk about the impact on health care, something I know quite a bit about—and why physicians especially should be concerned: Read more »
*This blog post was originally published at The ACP Advocate Blog by Bob Doherty*
July 13th, 2011 by admin in Opinion
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Both Germany and France have now suspended the marketing of Actos (pioglitazone) due to concerns of a link between Actos and bladder cancer. Though we have known about bladder cancer concerns for some time, these recent concerns about the bladder cancer link stem from a recent report analyzing the FDA’s Adverse Event Reporting System (AERS), which found that 93 cases of cancer were recorded between 2004 and 2009 in patients treated with antidiabetic drugs, of which 31 patients were treated with pioglitazone, representing a statistically significant increased risk of bladder cancer (ROR 4.30, 95% confidence interval, 2.82-6.52; P less than 0.0001).
Interestingly, the FDA announced that it was going to look into the link between Actos and bladder cancer only a few days before it made its final decision on what to do with Avandia (as if they didn’t know about the Actos cancer risk before the July 2010 advisory board).
Despite the many things you have heard about Avandia, back in July 2010, the FDA decided to severely restrict the use of Avandia for three reasons: Read more »
*This blog post was originally published at ACP Internist*
