There has been an ongoing debate about placebos on SBM, both in the articles and in the comments. What does it mean that a treatment has been shown to be “no better than placebo?” If our goal is for patients to feel better and they feel better with placebos, why not prescribe them? Do placebos actually do anything useful? What can science tell us about why a patient might report diminished pain after taking an inert sugar pill? The subject is complex and prone to misconceptions. A recent podcast interview offers a breakthrough in understanding.
On her Brain Science Podcast Dr. Ginger Campbell interviewed Dr. Fabrizio Benedetti, a physician and clinical neurophysiologist who is one of the world’s leading researchers on the neurobiology of placebos. A transcript of the interview [PDF] is available on her website for those who prefer reading to listening. The information Dr. Benedetti presents and the expanded remarks by Dr. Campbell after the interview go a long way towards explaining the placebo phenomenon and its consequences for clinical medicine. Dr. Campbell also includes a handy list of references. I’ll try to provide a summary of the main points, but I recommend reading or listening to the original.
A common misconception is that Read more »
*This blog post was originally published at Science-Based Medicine*
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*
Packing hearts on ice destined for transplantation may eventually become a thing of the past. The Organ Care System from TransMedics, which delivers a still-beating heart to a transplant patient, continues to show promise in clinical trials. UCLA recently reported that Rob Evans, a 61-year-old patient suffering from cardiomyopathy, is the most recent recipient of a heart delivered by the device.
We’ve actually covered the Organ Care System (OCS) several times before (we first caught wind of it in 2006). The device, however, is still classified as an investigational device by the FDA; it is undergoing phase II clinical trials in the United States at three sites: the Ronald Reagan UCLA Medical Center, the Cleveland Clinic, and New York-Presbyterian, Columbia University Medical Center.
Check out the UCLA press release explaining the technology and its use in the university’s Heart Transplant Program: Read more »
*This blog post was originally published at Medgadget*
Follow the money.
Earlier this week, I blogged about the growing economic relationships and even mutual dependency between medical device manufactures and physicians, citing a pre-emptive strike against an Institute of Medicine report that recommended closer regulation of medical devices before and after they enter the market. Such ties, though, are only one part of a broader medical-industrial complex that has enormous impact on public policy in the United States.
A 2009 White Paper by the Seton Hall’s Center for Health & Pharmaceutical Law & Policy reported that “ drug and medical device companies fund up to 80% to 90% of all clinical trials; in 2005, and that by 2004, three-quarters of all of the clinical trials paid for by industry were in private physician practices or for-profit research centers.” The paper’s authors argue that such trials “create potential conflicts of interest that possibly jeopardize the rights and well-being of research participants as well as the integrity of research results” and that “the goal for public policy should be to structure physician-investigator payment to achieve financial neutrality between treatment and research.”
A recent web posting by a medical billing company unabashedly crows about the extra income doctors can make from clinical trials. Read more »
*This blog post was originally published at The ACP Advocate Blog by Bob Doherty*
There are big companies like Quintiles that run clinical trials around the world. There are local clinics that specialize in clinical trials and make a lot of money at it. There are, of course, pharmaceutical companies and device manufacturers who depend upon the results to gain marketing approval for new products. People in all those groups know a lot about trials.
But the perspective that counts is the view from you and me – patients. Most of us do not enroll in clinical trials. We don’t want to get too up close and personal with anything “experimental.” And often our doctors never tell us about available trials anyway since it can be a lot of paperwork for them. Given that most people don’t enroll in trials and new science is delayed because of it and also because most people in trials are not journalists, I thought I’d put hunt and peck to the computer keyboard and speak out about trials. I am especially motivated because I have participated twice. The first one, a leukemia trial in 2000, I believe, saved my life. And I enrolled in a second one, studying a new drug for clots in the legs (deep vein thrombosis or DVT) just a week and a half ago.
I enrolled in the DVT trial because 1) the first one worked for me and 2) I crow all the time about how patients should always consider being in a trial as a treatment option. I had to put up or shut up. So I signed on the dotted line.
This particular trial, Read more »
*This blog post was originally published at Andrew's Blog*