March 9th, 2011 by DrWes in Opinion, True Stories
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On September 27, 2010, the peer-reviewed scientific journal Europace published online-before-print a case report entitled “Spontaneous explosion of implantable cardioverter-defibrillator” by Martin Hudec and Gabriela Kaliska. In the pdf of that case report a figure containing a color photo of the affected patient’s chest, chest X-ray, and two pictures of the extracted device (one seen here) were included.
The pictures and case presentation were dramatic and the case very rare. Both were perfect reasons to report such an important case to the medical literature. And so these doctors sent the case to Europace on June 29, 2010, and the article was accepted after revision on August 16, 2010, with the article appearing online September 27, 2010.
The authors must have felt very proud to have an article published relatively quickly, and the editors and reviewers of Europace must have thought the case was unique enough and important enough to have the article revised according to their specifications, then published online — until I reported the case on this blog on October 5, 2010, and included images from a portion of the case report’s figure.
Remarkably, later that same day, Europace removed the case report from its website without comment. The article simply vanished. I attempted to e-mail the editor of Europace to inquire about the reason for the retraction but received no reply, so I contacted the lead author, Martin Hudec, M.D. He kindly responded and I included his email response in the comments to my post two days later. Read more »
*This blog post was originally published at Dr. Wes*
February 24th, 2011 by Harriet Hall, M.D. in Health Tips, Research
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I was surprised to get this e-mail from a reader:
Surely, Dr. Hall, the public mania for nutritional supplements is baseless. All the alleged nutrients in supplements are contained in the food we eat. And what governmental agency has oversight responsibility regarding the production of these so-call nutritional supplements? Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies? I have yet to find a comment on this subject on your otherwise informative website.
My co-bloggers and I have addressed these issues repeatedly.Peter Lipson covered DSHEA (The Diet Supplement Health and Education Act) nicely. It’s all been said before, but perhaps it needs to be said again — and maybe by writing this post I can make it easier for new readers to find the information.
Food, Medicine, or Something In Between?
The FDA regulates foods and has been instrumental in improving the safety of our food supply. It regulates prescription and over-the-counter medications, requiring evidence of effectiveness and safety before marketing. Surveys have shown that most people falsely assume these protections extend to everything on the shelves including diet supplements, but they don’t.
Under the 1994 Diet Supplement Health and Education Act (DSHEA), a variety of products such as vitamins, minerals, herbs and botanicals, amino acids, enzymes, organ tissues, and hormones can evade the usual controls if they are sold as diet supplements. Under the DSHEA, the manufacturer doesn’t have to prove to the FDA that a product is safe and effective; it is up to the FDA to prove that it isn’t safe, and until recently there was no systematic method of reporting adverse effects (required reporting is still limited to serious effects like death).
So far the FDA has only managed to ban one substance, ephedra, and it took the death of a prominent sports figure and considerable skirmishing with the courts to accomplish that. Independent lab tests of diet supplements have found a high rate of contamination (with things like heavy metals and prescription drugs) and dosages wildly varying from the label. A striking example was Gary Null’s recent poisoning with vitamin D from one of his own products which contained 1,000 times the intended amount.
The FDA has issued rules on good manufacturing practices, but standardization is not required and it remains to be seen whether the new rules will effectively improve product quality. Read more »
*This blog post was originally published at Science-Based Medicine*
February 22nd, 2011 by PJSkerrett in Opinion, Research
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Media channels are a-twitter with the news that zinc can beat the common cold. CBS News, the LA Times, the Huffington Post, and hundreds of others are treating a quiet research report as big news that will have a life-changing effect. After reading the report and doing a little digging into the dark side of zinc, I’m not rushing out to stock up on zinc lozenges or syrup.
The latest hubbub about zinc was sparked by a report from the Cochrane Collaboration. This global network of scientists, patients, and others evaluates the evidence on hundreds of different treatments. In the latest review, on zinc for the common cold, researchers Meenu Singh and Rashmi R. Das pooled the results of 13 studies that tested zinc for treating colds. By their analysis, taking zinc within 24 hours of first noticing the signs of a cold could shorten the cold by one day. They also found that taking zinc made colds a bit less severe.
Sounds good so far. But instead of saying, “Hey, take zinc if you have a cold,” the researchers concluded like this:
“People taking zinc lozenges (not syrup or tablet form) are more likely to experience adverse events, including bad taste and nausea. As there are no studies in participants in whom common cold symptoms might be troublesome (for example, those with underlying chronic illness, immunodeficiency, asthma, etc.), the use of zinc currently cannot be recommended for them. Given the variability in the populations studied (no studies from low- or middle-income countries), dose, formulation and duration of zinc used in the included studies, more research is needed to address these variabilities and determine the optimal duration of treatment as well as the dosage and formulations of zinc that will produce clinical benefits without increasing adverse effects [bold is mine], before making a general recommendation for zinc in treatment of the common cold.”
Not exactly a ringing endorsement. Read more »
*This blog post was originally published at Harvard Health Blog*
February 22nd, 2011 by Felasfa Wodajo, M.D. in News, Research
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The word cancer comes from the greek word for crab “karkinos,” so named by Hippocrates who visualized the tumor and its surrounding vessels looking like a crab, dug stubbornly into the sand with its legs. We know far more about cancer today than the ancient Greeks, but the vision of an entrenched opponent, almost impossible to extract whole, appears to be vividly prescient.
What we have realized over the last half century is that removal of the visible tumor is not enough. Even as we learned how to do bigger and more destructive surgeries, the cancer still managed to sneak back in, growing later at different locations. The crab’s legs are still embedded in the patient.
Thus the discovery that certain chemicals could extinguish these rogue cells opened the modern era of cancer therapy and led to the first “cures” from cancer. Many of these compounds were exquisitely toxic. Early experimenters even used nitrogen mustard, quite literally a poison, as Siddhartha Mukherjee tells in his excellent history of cancer, “The Emperor of All Maladies.”
To many, the battle looked grim. For the founder of CollabRx, who himself was living in the shadow of advanced melanoma, this was the signal to take his expertise in internet information technologies and apply it to cancer. Thus a “biomedical software company” was founded, with the mission:
…to save lives by using information technology to personalize cancer treatments and accelerate research.
The rapid proliferation of knowledge about the molecular underpinnings of different cancers, has brought hope for a new age of “targeted” therapies. These drugs are designed to find and destroy cells with aberrant biochemical pathways, while bypassing the normal body tissues. Immense hopes rest on them. Read more »
*This blog post was originally published at iMedicalApps*
February 19th, 2011 by AnnMacDonald in Health Tips, Research
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A paper published in the February issue of Health Affairs — discussed at length in an article in the New York Times — contains the sort of blunt, plain-spoken language you seldom read in academic journals. The authors, who include some of the most prominent neuroscientists and ethicists in the world, warn that manufacturers are misusing the FDA’s humanitarian device exemption to promote deep brain stimulation as a “treatment” for obsessive compulsive disorder (OCD).
In fact, they make clear that deep brain stimulation is very much an experimental procedure. Research is still at an early stage, and the risks to patients are not well defined. When suffering is severe and no other treatment has provided relief, there is value in making available an intervention like deep brain stimulation. But misleading or biased information, no matter where it comes from, certainly undermines patients’ ability to calculate benefits and risks.
To enable deep brain stimulation, a surgeon must first implant electrodes in the brain and connect them to a pair of small electrical generators underneath the collarbone. Deep brain stimulation uses electricity to affect how brain signals are transmitted in particular areas of the brain. The image to the left, from the National Institute of Mental Health, shows how deep brain stimulation depends on the implantation of pulse generators below the collarbone and electrodes in the brain.
Specific concerns are raised by the article in Health Affairs (and in our own article on this topic last year in the Harvard Mental Health Letter). Read more »
*This blog post was originally published at Harvard Health Blog*
